DEVICE AND METHOD FOR REVERSE RELEASE OF AN EXPANSABLE IMPLANT OF THE STENCIL OR ENDOPROSTHESIS TYPE

The reverse release device facilitates precise and safe deployment of implants in unidirectional access sites by using a flexible central tubular element and a secondary outer sheath for proximal-distal movement, addressing the limitations of existing devices that require bidirectional access.

FR3163832A1Pending Publication Date: 2026-01-02ID NEST MEDICAL +1
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Patent Information

Application Number
FR2024006946
Authority / Receiving Office
FR · FR
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-06-27
Publication Date
2026-01-02

AI Technical Summary

Technical Problem

Existing implant release devices are unsuitable for unidirectional access sites, requiring bidirectional access for precise deployment and connection of implants, especially in anatomical locations like the renal vein or artery, which can only be accessed from one direction.

Method used

A reverse release device with a flexible central tubular element, a secondary outer sheath, and a control mechanism allowing for proximal-distal movement of the secondary outer sheath to progressively release the implant, enabling precise and safe deployment in unidirectional access sites.

Benefits of technology

Enables precise and safe deployment of implants in unidirectional access anatomical locations, optimizing the release process and ensuring optimal connection of branch implants to mother implants.

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Abstract

The invention relates to a launcher (1) for releasing an expandable implant (9) into an anatomical canal, comprising a flexible part characterized in that the flexible part comprises a central flexible tubular element (2) supporting the implant (9), a secondary outer sheath (7) radially compressing the compressible implant (9), a main outer sheath (6) slidably mounted on the central flexible tubular element (2) and surrounding the secondary outer sheath (7), a movable ring (13) slidably mounted on the implant (9) in line with the secondary outer sheath (7), and operating elements (14) whose actuation allows movement of the movable ring (13). Figure for the abstract: [Fig 15]
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Description

Title of the invention: DEVICE AND METHOD FOR REVERSE RELEASE OF AN EXPANSABLE IMPLANT OF THE STENT OR ENDOPROSTHESIS TYPE technical field

[0001] The present invention relates to the general technical field of expandable or self-expanding implants, also called stents or endoprostheses. These implants are intended to be placed in any duct of bodily fluid circulation or cavity of a living organism. 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 launchers in the present, allowing the release, deployment and where appropriate the connection of implants in conduits or in anatomical cavities.

[0003] In the present, the term implant should be understood in a broad sense, that is to say including all types of implants, prostheses or endoprostheses that are expandable or self-expandable or that require 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 artery.

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

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

[0010] The placement of an implant according to the invention 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 prosthesis or T-shaped implant system is not limiting for the present invention. It also concerns any type of prosthesis whose structures require, by design, a proximal to distal release, or more generally a construction whose elements are subject to any singularity, for example, a variation in profile, radial force, type of cover, window, structure, etc. State of the art

[0013] Various implant release devices are known, allowing the implant to be progressively released. These known devices are not without drawbacks and prove unsuitable or unusable for certain applications or pathologies.

[0014] Indeed, in the case of certain pathologies, the implantation site can only be reached from one direction. An example may be the renal vein or artery, which, due to anatomical construction, only allows access via the vena cava in the case of the renal vein, or via the abdominal aorta in the case of the renal artery.

[0015] This anatomical specificity, in the case of an application of T-shaped prostheses with a compliant connection, requires releasing the prosthesis in two distinct steps with antagonistic directions.

[0016] In a conventional application, the surgeon maintains the central part of the launcher supporting the prosthesis (fixed point) and slides the outer sheath (outer sheath retraction movement). 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-to-proximal direction causes the progressive release of the prosthesis from its distal end. The connection of two implants is achieved only through access bidirectional to the drop zone. Such a drop procedure is therefore not applicable in a number of cases. Description of the invention

[0017] 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 deposition and / or connection in an anatomical area of ​​unidirectional access, a so-called reverse release procedure is required.

[0018] Another object of the invention aims to provide a launcher whose manufacture and use are particularly simple.

[0019] Another object of the invention aims to provide a launcher enabling precise and safe implementation of the different phases of release of the implant / prosthesis.

[0020] Another object of the invention aims to provide an optimized release method for an anatomical implant according to specific constraints such as unidirectional access to the implant release zone.

[0021] Unidirectional access is understood to mean access in the plane relative to the prosthesis instead of the window (of a mother prosthesis) by the same direction of crossing said prosthesis, for example through the inside of the mother prosthesis.

[0022] Reverse release is understood to mean a release technique antagonistic to the movement usually used to release prostheses in a dual-access anatomical location, for example, but not limited to, an ilio-cave bifurcation or in the aortic arch.

[0023] In the case of unidirectional implantation, and within the framework of a set of T-shaped prostheses / implants, since the release of the branch prosthesis must be from the connection area to the distal area of ​​the prosthesis and given that the implantation cavity is not open (absence of another access route to the cavity), this prosthesis must be released following the direction of withdrawal of the sheath in the proximal-distal direction.

[0024] The objects assigned to the invention are reached using a launcher for releasing an expandable implant into a conduit or anatomical cavity, comprising a flexible part containing at least one implant in a non-deployed state and a control mechanism for releasing said implant, characterized in that the flexible part comprises: - a flexible central tubular element supporting the undeployed implant and featuring a central longitudinal lumen to allow it to slide along a surgical guide, - a secondary outer sheath radially compressing the implant and capable of sliding and / or compressing longitudinally on said implant, the length of the secondary outer sheath being greater than or equal to the length of the implant, - a main outer sheath slidably mounted on the flexible central tubular element and surrounding the secondary outer sheath, - an end tip comprising an atraumatic tip, mounted on the flexible central tubular element, the implant comprising a distal end located on the end tip side and a proximal end located on the control mechanism side, and - operating elements mechanically connected to the secondary outer sheath at or near its proximal end, the actuation of which allows action on said secondary outer sheath in a proximal-distal direction to move the distal end of the secondary outer sheath onto the end piece and to compress said secondary outer sheath against a stop on said end piece and thus release the implant progressively from an area located towards or at the proximal end of said implant.

[0025] According to one embodiment, the operating elements are connected to the secondary external sheath directly via welds, seams, knots or other attachment devices.

[0026] According to another embodiment, the operating elements are connected to the secondary external sheath via a rigid ring attached to said secondary external sheath.

[0027] According to another embodiment, the operating elements are mechanically connected to the secondary outer sheath by means of a movable ring, mounted to slide on the implant and in the extension of the secondary outer sheath in the vicinity of its proximal end and bearing on said proximal end.

[0028] According to one embodiment, the flexible central tubular element has at least two additional longitudinal lights arranged in the vicinity of the central longitudinal light, in which the operating elements passing over the secondary outer sheath or between the secondary outer sheath and the implant are guided.

[0029] According to one embodiment, the end tip has at least two radial openings opposite each other with a corresponding radial opening of the flexible central tubular element, each of the radial openings communicating with an additional longitudinal light to allow the operating elements to extend between the proximal end of the secondary outer sheath and the control mechanism, a pull on the operating elements causing a displacement of the secondary outer sheath towards the end tip.

[0030] According to one embodiment, the control mechanism includes a control handle having mechanical control elements for independently moving the main outer sheath and the secondary outer sheath.

[0031] According to one embodiment, the control elements comprise two separate mobile carriages, one of which is mechanically connected to the main external duct and the other is mechanically connected to the secondary external duct, the movement of a mobile carriage causing the corresponding external duct to move.

[0032] According to one embodiment, the control handle includes, for each of the mobile carriages, identifiable and retractable stable stops, materializing the successive phases of the release and deployment of the implant.

[0033] According to one embodiment, the mobile carriages are each associated respectively with a separate assembly of screws or cams, integrated into the control handle, to control the successive movement strokes of said mobile carriages.

[0034] According to one embodiment, the operating elements are wires.

[0035] According to one embodiment, the secondary outer sheath comprises a spring spiral, a wavy spring or an association of elastic washers.

[0036] According to another embodiment, the secondary outer sheath includes a compressible bellows.

[0037] According to another embodiment, the secondary outer sheath comprises a succession of independent movable rings, mounted to slide on the implant, the operating elements being mechanically connected to the first movable ring disposed on the proximal side of the implant.

[0038] 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 the connection zone of a branch implant at the level of a diaphragm of a mother implant and to make the connection only if the position of said branch implant is optimal.

[0039] 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 monitor, at all times, visually and sensorially using a control handle, the phases of the implant release. Brief description of the figures

[0040] 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:

[0041] [Fig.1] [Fig.1] is a schematic illustration of an example of the reverse release of a vascular implant using an example of a release device or launcher according to the invention,

[0042] [Fig.2] [Fig.2] is a partial exploded view of an example embodiment of a launcher according to the invention,

[0043] [Fig.3] [Fig.4] [Fig.5] Figures 3, 4 and 5 are illustrations of details of an example embodiment of a launcher according to the invention,

[0044] [Fig.6] [Fig.7] [Fig.8] [Fig.9] Figures 6 to 9 are illustrations of an atraumatic end tip of a launcher according to the invention,

[0045] [Fig. 10] [Fig. 10] is an enlarged view of a part of a launcher according to the invention,

[0046] [Fig. 11] [Fig. 12] Figures 11 and 12 are cross-sectional views along plane A- A of the launcher in [Fig. 10], in two usage configurations corresponding respectively to confinement and partial release of the implant,

[0047] [Fig. 13] [Fig. 14] Figures 13 and 14 are illustrations of another detail of a launcher according to the invention,

[0048] [Fig. 15] [Fig. 15] a partial view of an example embodiment of a launcher according to the invention, showing a release and partial deployment of an implant,

[0049] [Fig. 16] [Fig. 16] is an enlarged view of part of another example embodiment of the launcher according to the invention,

[0050] [Fig. 17] [Fig. 18] Figures 17 and 18 are cross-sectional views along plane A- A of the launcher in [Fig. 17], in two usage configurations corresponding respectively to confinement and partial release of the implant,

[0051] [Fig. 19] [Fig. 19] is a partial view of another embodiment of a launcher according to the invention, showing a release and partial deployment of an implant,

[0052] [Fig.20] [Fig.20] is an exploded view of an example embodiment of a control mechanism for the release device according to the invention, and

[0053] [Fig.21] [Fig.21] is a profile view of the control mechanism of [Fig.20], once assembled. Detailed description of the invention

[0054] Elements that are structurally and functionally identical and present on several distinct figures are assigned the same numeric or alphanumeric reference.

[0055] Figure 1 is a schematic illustration of an exemplary embodiment of a release device or launcher 1 according to the invention. The launcher 1 allows for the reverse release of a branch implant 2 into an anatomical bifurcation 3. The branch implant 2 is for example connected to a mother implant 4 previously dropped into a main anatomical conduit 5.

[0056] The launcher 1 includes in particular a main outer sheath 6 and a secondary outer sheath 7.

[0057] Figure 2 is a partial exploded view of an example embodiment of the launcher 1. The latter also includes a flexible central tubular element 8 supporting a non-deployed implant 9. The flexible central tubular element 8 has a central longitudinal slot 10 to allow it to slide along a surgical guide.

[0058] The secondary outer sheath 7 radially compresses the implant 9 and is capable of sliding and / or compressing longitudinally on said implant 9. The outer sheath 7 therefore covers the implant over at least part of its length.

[0059] In one embodiment, the length of the secondary outer sheath 7 is greater than or equal to that of the implant 9. In another embodiment, the length of the secondary outer sheath 7 is less than that of the implant 9 and covers the latter only partially or in segments. Partial coverage of the implant 9 by the secondary outer sheath allows, for example, the implant 9 to be partially deployed along part of its length.

[0060] The main outer sheath 6 is slidably mounted on the flexible central tubular element 8 and surrounds the secondary outer sheath 7.

[0061] The launcher 1 also includes an end tip 11 having an atraumatic tip 12. The end tip 11 is mounted on the flexible central tubular element 8.

[0062] The implant 9 has a distal end 9a located on the side of the end piece 11 and a proximal end 9b located on the side of a control mechanism, not shown in this figure.

[0063] The launcher 1 also includes a movable ring 13, of diameter 13b allowing a sliding mounting on the implant 9. The movable ring 13 is located in the extension of the secondary outer sheath 7 in the vicinity of its proximal end 7b.

[0064] Maneuvering elements 14 are mechanically connected to the secondary outer sheath 7 via the movable ring 13, which is slidably mounted on the implant 9 in the extension of said secondary outer sheath 7. The movable ring 13 is therefore located, before the release of the implant 9, in the vicinity of the proximal end 7b and bearing against said proximal end 7b.

[0065] The launcher 1 therefore comprises the operating elements 14, for example wires, the actuation of which allows the movable ring 13 to be moved in a proximal-distal direction. Advantageously, the distal end 7a of the secondary outer sheath 7 engages with a portion of the end piece 11 before said outer sheath secondary 7 is not compressed against a stop 18 of said end piece 11 by the movable ring 13.

[0066] According to another embodiment, the operating elements 14 are connected to the secondary external sheath 7 directly via welds, heat welds, seams, knots or other attachment devices.

[0067] According to another embodiment, the operating elements 14 are connected to the secondary external sheath 7 via a rigid ring integral with said secondary external sheath 7.

[0068] Figures 3, 4 and 5 are detailed illustrations of an example embodiment of the launcher 1. Figure 3 is a perspective view of a portion of the flexible central tubular element 8, which has at least two additional longitudinal slots 15 in which the maneuvering elements 14 are guided as they pass over the secondary outer sheath 7 or between the secondary outer sheath 7 and the implant 9. The additional longitudinal slots 15 are, for example, arranged in the vicinity of the central longitudinal slot 10. According to another example embodiment, the additional longitudinal slots 15 are distributed around the central longitudinal slot 10.

[0069] According to another embodiment, the central flexible tubular element 8 has three or four additional longitudinal lights 15.

[0070] Fig. 4 is a profile view of the flexible central tubular element 8, which is provided near its distal end 8a with a radial opening 16 communicating with each additional longitudinal light 15.

[0071] Fig. 5 is a longitudinal sectional view of the flexible central tubular element 8 of Fig. 4.

[0072] Figures 6 to 9 are illustrations of the end piece 11 comprising the atraumatic tip 12. [Fig.6] illustrates an example of an embodiment, according to a perspective view, respectively from the side, of the end piece 11.

[0073] The end tip 11 has a hollow cylindrical part 1 la into which the end of the flexible central tubular element 8 is fitted. The atraumatic tip 12 has a guide orifice 12a centered in the extension of the cylindrical part 1 la and thus allowing the passage of a surgical guide.

[0074] The atraumatic tip 12 advantageously has a base 12b, in the form of an annular collar constituting a stop for the distal end of the main external sheath 6. The cylindrical part 1 presents towards the base 12b an annular collar 18 used as a stop for the distal end of the secondary external sheath 7, when the latter is displaced and compressed in the proxhnal-distal direction.

[0075] Figures 7 and 8 show the end piece 11 in profile views. The end piece 11 has at least two radial passages 17 located between the base 12b and the flange 18 and communicating with the hollow cylindrical portion 1a. The annular flange 18 advantageously has, in the longitudinal extension of each radial passage 17, a longitudinal groove 18a facilitating the guidance of the operating elements 14 extending longitudinally from the movable ring 13 on or under the secondary outer sheath 7 and then passing through their engagement in the radial passages 17.

[0076] The operating elements 14, connected to the movable ring 13, pass over the secondary outer sheath 7 or between the secondary outer sheath 7 and the implant 9 then through the longitudinal groove 18a and the radial passage 17 to extend via the hollow cylindrical part 1 and the central longitudinal light 10, for example towards the control mechanism.

[0077] Figure 10 is an enlarged view of an example embodiment of a part of the launcher 1. The secondary outer sheath 7 consists of a spiral spring. According to another example embodiment, the secondary outer sheath 7 is a wave spring or a combination of elastic washers. The main outer sheath 6 is not shown to avoid cluttering the figure.

[0078] Figures 11 and 12 are cross-sectional views along plane AA of the launcher 1 of [Fig. 10], in two usage configurations corresponding respectively to a confinement and a partial release of the implant 9.

[0079] In [Fig. 12], the secondary outer sheath 7 has slid with its distal end along the cylindrical portion 1a and begins to be compressed towards its proximal end when the movable ring 13 is displaced by traction on the operating elements 14 in the distal-proximal direction. The released proximal portion of the implant 9 is shown undeployed for the sake of simplicity in the drawing. Such a configuration can also occur when the implant 9 is not self-expanding and requires additional mechanical action (inflation of a balloon, for example) to achieve its deployment.

[0080] Figures 13 and 14 are enlarged illustrations of the movable ring 13, in perspective and in section. The movable ring 13 has an annular cylindrical shape with longitudinal holes 13a. These holes are provided for the passage and / or attachment of the operating elements 14, such as wires. The inner diameter of the movable ring 13 is chosen to allow sliding on the implant 9 and bearing against the proximal end of the secondary outer sheath 7.

[0081] Fig. 15 shows a partial view of an example embodiment of the launcher 1, showing a release and partial deployment of the implant 9. The latter has a distal end portion still trapped in the secondary outer sheath 7 and a portion The proximal end comprises a deployed retaining bead 9a and a deployed attachment flower 9b. Implant 9 is, for example, a branch implant intended to connect to a mother implant, not shown. The mother implant then includes a diaphragm that encloses the branch implant between the bead 9a and the flower 9b.

[0082] Fig. 16 is an enlarged view of part of another example embodiment of the launcher 1 in which the secondary outer sheath 7 is a compressible bellows.

[0083] Figures 17 and 18 are cross-sectional views along plane AA of the release device of [Fig. 16], in two usage configurations corresponding respectively to a confinement and a partial release of the implant 9.

[0084] The operation of the launcher 1 comprising a secondary external sheath 7 in the form of a spring or bellows is rigorously identical.

[0085] The operation of the launcher 1 is illustrated and explained for example by means of a reverse release method of an implant 9, of the type expandable or self-expandable prosthesis, in a cavity or in an anatomical conduit.

[0086] The implementation of the implant 9 release process comprises several successive steps, namely:

[0087] - the guidance and movement of the launcher 1 along the surgical guide,

[0088] - the identification of the release position of implant 9 and the positioning of the launcher in a corresponding manner,

[0089] - the retraction of the main outer sheath 6 over at least one stroke of sliding in the distal-proximal direction to expose the secondary outer sheath 7, and

[0090] - the progressive retraction of the secondary outer sheath 7 over a stroke of The implant 9 slides in a proximal-distal direction to release and deploy progressively from its proximal end. This method is advantageous, for example, when overlapping implants are required, such as for reoperation or in the case of a specific pathology.

[0091] According to another embodiment, the method for releasing a 9-branch implant comprises various successive steps, namely:

[0092] - the guidance and movement of the launcher 1 along the surgical guide,

[0093] - the identification of the release position of implant 9 and the positioning of the launcher 1 in a corresponding manner,

[0094] - the retraction of the main outer sheath 6 on at least a first stroke of sliding in the distal-proximal direction to uncover a proximal portion of the secondary outer sheath 7 located at the connection zone of the implant 9 branch with a previously deployed complementary mother implant,

[0095] - the progressive retraction of the secondary outer sheath 7 over a stroke of sliding in the proximal-distal direction to release and deploy part of the connection area of ​​the 9-branch implant,

[0096] - retraction of the main outer sheath 6 on sliding stroke additional distal-proximal movement to fully expose the connection zone of the 9-branch implant, which is already freed by the secondary outer sheath 7, and thus achieve the complete deployment of the 9-branch implant and its connection to the mother implant, and

[0097] - the progressive retraction of the secondary outer sheath 7 over a stroke of additional sliding in the proximal-distal direction to fully release and deploy the remainder of the 9-branch implant.

[0098] According to one embodiment, the release process consists of sliding the outer main sheath in the proximal-distal direction until it stops against the end tip to cover the area corresponding to the housing of the branch implant of the secondary sheath and removing the launcher along the surgical guide.

[0099] Figure 19 is a partial view of another embodiment of the launcher 1, showing a release and partial deployment of an implant 9. In this embodiment, the secondary outer sheath 7 consists of a series of movable rings 13. The operating elements 14 are mechanically connected to the first movable ring 13 located on the proximal side of the implant 9. Before the partial deployment of the implant 9, the movable rings 13 can be distributed over all or part of the length of said implant 9.

[0100] Fig. 20 is an exploded view of an example embodiment of a control mechanism for the release device according to the invention and Fig. 21 is a profile view of the control mechanism of Fig. 20, once assembled.

[0101] According to one embodiment, the control mechanism includes a control handle 20 having mechanical control elements for independently moving the main outer duct 6 and the secondary outer duct 7. The control elements include two separate movable carriages 21 and 21bis, one of which is mechanically connected to the main outer duct 6 and the other is mechanically connected to the secondary outer duct 6, the movement of a carriage 21 or 21bis causing the movement of the outer ducts, main 6 and secondary 7.

[0102] Advantageously, the control handle 20 includes, for each of the mobile carriages 21 and 2Ibis, retractable stable stops, materializing the successive phases of the release and deployment of the implant 9.

[0103] The mobile trolleys 21 and 21bis are for example connected to the secondary external ducts 7 and primary ducts 6, respectively via a wired sub-assembly 22 and a watertight connection element 23.

[0104] The wire subassembly 22 passes inside a cannula 24 and exits through two openings. The wire subassembly 22 and the airtight connection element 23 are able to slide around the cannula 24.

[0105] The wire subassembly 22 cooperates via a cylindrical surface with the cannula 24.

[0106] Component 19 cooperates with the cylindrical surface of the cannula 24 via the seal sealing.

[0107] In order to guide the trolleys in translation, in a non-limiting configuration, the trolley 21 is equipped with four guide pads suitable for coinciding with the handle shells 25 and 26.

[0108] The drive of the carriages 21 and 21bis is achieved for example via sliding hemispheres.

[0109] The carriage 21bis, controlling the secondary external sheath 7, is actuated via the rotation of a wheel 27. The rotation of the wheel 27 is ensured by a rotational guide around an axis 28, cooperating with the handle shells 25 and 26.

[0110] The carriage 21, driving the main external sheath 6, is actuated via the rotation of the second knob 29.

[0111] An intermediate spacer 30 is mounted around the axis 28 and stopped in rotation and translation via pins 31 passed through slots provided in the intermediate spacer 30, and slots provided in the axis 28.

[0112] The mobile carriages 21, 21bis are each associated respectively with a separate assembly of screw segments or cams 32, 32bis, integrated into the control handle 20, to control the successive displacement strokes of said mobile carriages 21, 21bis.

[0113] Each component of the screw assembly 32 and 32bis, mounted around the surface of the intermediate spacer 30, includes a portion of a helical thread, which, once assembled, forms a drive element for the corresponding carriage 21, 21bis.

[0114] The drive shaft 28 is guided in rotation by its surface vis-à-vis the handle shells 25 and 26.

[0115] The stop is translation of the axis 28 is ensured by the pins 31, cooperating with the surfaces of the handle shells 25 and 26.

[0116] The rotational action on the second wheel 29 drives the intermediate spacer 30, which drives the series of screws 32, which by tangential contact with the hemispheres causes the translation of the carriage 21, driving the main external sheath 6.

[0117] The rotational action on the wheel 27 drives a series of screws 32bis, which by tangential contact with the hemispheres causes the translation of the carriage 21bis, driving the secondary external sheath 7.

[0118] To ensure proper adherence to the flowchart specific to the appropriate release procedure, the launcher is equipped with safety systems including a cam lock 33 and a secondary external sheath safety lock 34 7.

[0119] The present invention also finds its application in the field of endoprostheses covered by a textile or a membrane.

[0120] Clearly, 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 could make numerous modifications and imagine other variations without departing from the scope of the invention as defined by the claims. Thus, a technical feature can be replaced by an equivalent technical feature without departing from the scope of the present invention and the protection conferred by the claims, and an implementation step can be replaced by an equivalent step without departing from the scope of the present invention and the protection conferred by the claims.

Claims

Demands

1. Launcher (1) for releasing an expandable implant (9) into a conduit or anatomical cavity, comprising a flexible portion containing at least one implant (9) in a non-deployed state and a control mechanism for releasing said implant (9), characterized in that the flexible portion comprises: - a flexible central tubular element (8) supporting the non-deployed implant (9) and having a central longitudinal lumen (10) to allow its sliding on a surgical guide, - a secondary outer sheath (7) radially compressing the implant (9) and capable of sliding and / or compressing longitudinally on said implant (9), the length of the secondary outer sheath (7) being greater than or equal to the length of the implant (9), - a main outer sheath (6) slidably mounted on the flexible central tubular element (2) and surrounding the secondary outer sheath (7), - an end tip (11) having an atraumatic point (12),mounted on the flexible central tubular element (8), the implant (9) having a distal end (9a) located on the side of the end piece (11) and a proximal end (9b) located on the side of the control mechanism, and - operating elements (14) mechanically connected to the secondary outer sheath (7) at or near its proximal end (7b), the actuation of which allows action on said secondary outer sheath (7) in a proximal-distal direction to move the distal end (7a) of the secondary outer sheath (7) onto the end piece (11) and to compress said secondary outer sheath (7) against a stop (18) of said end piece (11) and thus progressively release the implant (9) from an area located towards or at the proximal end (9b) of said implant (9).

2. Launcher (1) according to claim 1, characterized in that the operating elements (14) are connected to the secondary outer sheath (7) directly via welds, seams, knots or other attachment features.

3. Launcher (1) according to claim 1, characterized in that the operating elements (14) are connected to the secondary outer sheath (7) via a rigid ring attached to said secondary outer sheath (7).

4. Launcher (1) according to claim 1, characterized in that the operating elements (14) are mechanically connected to the secondary outer sheath (7) by means of a movable ring (13), mounted to slide on the implant (9) and in the extension of the secondary outer sheath (7) in the vicinity of its proximal end (7b) and bearing on said proximal end (7b).

5. Launcher (1) according to any one of claims 1 to 4, characterized in that the central flexible tubular element (8) has at least two additional longitudinal lights (15) arranged in the vicinity of the central longitudinal light (10), in which the maneuvering elements (14) passing over the secondary outer sheath (7) or between the secondary outer sheath (7) and the implant (9) are guided.

6. Launcher (1) according to claim 5, characterized in that the end tip (11) has at least two radial openings (17) opposite each with a corresponding radial opening (16) of the flexible central tubular element (8), each of the radial openings (17) communicating with an additional longitudinal light (15) to allow the operating elements (14) to extend between the proximal end (7b) of the secondary outer sheath (7) and the control mechanism, a pull on the operating elements (14) causing a displacement of the secondary outer sheath towards the end tip (11).

7. Launcher (1) according to any one of claims 1 to 6, characterized in that the control mechanism comprises a control handle (20) having mechanical control elements for independently moving the main outer sheath (6) and the secondary outer sheath (7).

8. Launcher (1) according to claim 7, characterized in that the control members comprise two separate movable carriages (21, 21bis), one of which is mechanically connected to the main outer sheath (6) and the other is mechanically connected to the secondary outer sheath (7), the movement of a movable carriage (21, 21bis) causing the movement of the corresponding outer sheath (6, 7).

9. Launcher (1) according to claim 8, characterized in that the control handle (20) comprises for each of the movable carriages (21, 21bis), identifiable and retractable stable stops, materializing the successive phases of the release and deployment of the implant (9).

10. Launcher (1) according to claim 9, characterized in that the mobile carriages (21, 21bis) are each associated respectively with a separate assembly of screws or cams (32, 32bis), integrated into the control handle (20), to control the successive displacement strokes of said mobile carriages (21, 21bis).

11. Launcher (1) according to any one of claims 1 to 10, characterized in that the operating elements (14) are wires.

12. Launcher (1) according to any one of claims 1 to 11, characterized in that the secondary outer sheath (7) comprises a spiral spring, a wave spring or a combination of elastic washers.

13. Launcher (1) according to any one of claims 1 to 11, characterized in that the secondary outer sheath (7) comprises a compressible bellows.

14. Launcher (1) according to any one of claims 1 to 11, characterized in that the secondary outer sheath (7) comprises a succession of independent movable rings (13), mounted to slide on the implant (9), the operating elements (14) being mechanically connected to the first movable ring (13) disposed on the proximal side of the implant (9).

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