Device and method for reverse release of an expandable implant of the stent or endoprosthesis type

Abstract

The invention relates to a launcher (1) provided for the release of an expandable implant (9) in an anatomical duct and comprising a flexible part, characterized in that the flexible part comprises a flexible central tubular element (2) supporting the implant (9), a secondary outer sheath (7) radially compressing the implant (9) capable of compressing, a main outer sheath (6) mounted slidably on the flexible central tubular element (2) and surrounding the secondary outer sheath (7), a movable ring (13) mounted slidably on the implant (9) in the continuation of the secondary outer sheath (7), and manoeuvring elements (14), the actuation of which makes it possible to move the movable ring (13).

Description

[0001] DEVICE AND METHOD FOR REVERSE RELEASE OF AN EXPANDABLE IMPLANT OF THE TYPE OF STENT OR ENDOPROSTHESIS

[0002] technical field

[0003] 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 designed 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.

[0004] 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.

[0005] In this document, 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.

[0006] Connected implants, for example, are 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.

[0007] 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 junction of the renal veins and the superior vena cava or at the level of the junction of its collateral branches.

[0008] In one application example, 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.

[0009] 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.

[0010] The invention also relates to implants intended for use in urology.

[0011] The implant(s) mentioned above are intended to be implanted in blood circulation channels, particularly to treat areas with defects or diseases such as aneurysms or dissections.

[0012] The placement of an implant according to the invention is also used in cases of vascular disease such as obliterative lesions and compressive syndromes.

[0013] The implantations in question are generally performed using endoluminal techniques. These minimally invasive techniques result in lower mortality and morbidity for the patient, as well as a reduction in operating time.

[0014] It is evident that the application to a T-shaped prosthesis or 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 coverage, window, structure, etc.

[0015] State of the art

[0016] Various implant release devices are known, allowing for the gradual release of the implant. These known devices are not without drawbacks and prove unsuitable or unusable for certain applications or pathologies.

[0017] Indeed, in the case of certain pathologies, the implantation site can only be reached from one direction. An example is the renal vein or artery, which, due to anatomical structure, can only be accessed via the vena cava in the case of the renal vein, or via the abdominal aorta in the case of the renal artery.

[0018] This anatomical specificity, in the case of an application of T-shaped prostheses with a comping connection, requires releasing the prosthesis in two distinct steps with antagonistic directions.

[0019] 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. Connecting two implants requires bidirectional access to the release zone. Therefore, such a release procedure is not applicable in a number of cases.

[0020] A system for the reverse deployment of a prosthesis is known from document US2011 / 0034987. This document does not describe an atraumatic tip attached to an end piece mounted on a central tubular element, nor do it describe operating mechanisms mechanically connected to the secondary outer sheath near its proximal end. The operating mechanisms are made from a portion of said outer sheath, folded and rolled back on itself. This portion of the sheath is pulled directly into the central lumen intended for a surgical guide. This central lumen must therefore have a sufficient diameter, which is not suitable for small-diameter implants. In such a configuration, the surgical guide is in contact with the portion of the sheath contained within the central lumen and slides on said sheath, thus creating a risk of sheath rupture when a tensile force is applied.Furthermore, the described sheath does not slide over the prosthesis and is not configured to be compressed against a tip.

[0021] A reversed release system is also known, through patent US2014 / 0200649. This system uses rings to drive a secondary outer sheath, thereby releasing a prosthesis. These rings are actuated via wire-like control mechanisms. Furthermore, the secondary outer sheath, which constrains the prosthesis, is folded back on itself, and the rings are positioned between two overlapping sheath sections. During prosthesis deployment, the two sheath sections are displaced distally, creating an excess thickness. This directly impacts the safety of the launcher retraction steps at the end of the reversed deployment, as the secondary sheath is no longer in a configuration that prevents interference with the released prosthesis. The sheath does not slide longitudinally along the prosthesis during deployment to compress against a tip.In addition, the described sheath is fixed at both ends to the central tube, which substantially increases the complexity of the launcher assembly operations.

[0022] Description of the invention

[0023] 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 a unidirectional access anatomical area, a so-called reverse release procedure is required.

[0024] Another object of the invention is to provide a launcher whose manufacture and use are particularly simple.

[0025] Another object of the invention is to provide a launcher enabling precise and safe implementation of the different phases of release of the implant / prosthesis.

[0026] Another object of the invention aims to provide an optimized release method for an anatomical implant based on specific constraints such as unidirectional access to the implant release zone.

[0027] 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.

[0028] Reverse release is understood to be a release technique antagonistic to the movement usually used to release prostheses in anatomical locations with dual access, for example, but not limited to, an ilio-cave bifurcation or in the aortic arch.

[0029] In the case of unidirectional implantation, and within the framework of a set of T-shaped prostheses / implants, because 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 sheath removal in the proximal-distal direction.

[0030] 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:

[0031] - a flexible central tubular element supporting the undeployed implant and featuring a central longitudinal lumen to allow it to slide along a surgical guide,

[0032] - a secondary external sheath radially compressing the implant and capable of sliding and / or compressing longitudinally on said implant,

[0033] - a main external sheath mounted to slide on the flexible central tubular element and surrounding the secondary external sheath,

[0034] - 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

[0035] - 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 secondary outer sheath on 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.According to one embodiment, the secondary outer sheath is positioned in the launcher so as to position a distal end of said secondary outer sheath away from the stop, thus allowing, when the operating elements are actuated, the secondary outer sheath to slide longitudinally towards the stop during at least one first phase of implant release and to compress longitudinally against the stop when the distal end is in contact with said stop during at least one subsequent release phase.

[0036] According to one embodiment, the operating elements are connected to the secondary external sheath directly via welds, seams, knots or other attachment devices.

[0037] According to another embodiment, the operating elements are connected to the secondary external sheath via a rigid ring attached to said secondary external sheath.

[0038] 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.

[0039] According to one embodiment, the flexible central tubular element has at least two additional longitudinal slots arranged in the vicinity of the central longitudinal slot, in which the operating elements passing over the secondary outer sheath or between the secondary outer sheath and the implant are guided.

[0040] According to another embodiment, the launcher includes a guide sleeve concentric to the central flexible tubular element and fixed to the latter, the inner diameter of the guide sleeve is greater than the outer diameter of the central flexible tubular element so as to delimit an annular traction space in which the maneuvering elements passing over the secondary outer sleeve or between the secondary outer sleeve and the implant are guided.

[0041] According to one exemplary 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 or with the annular traction space, to allow the operating elements to extend between the proximal end of the secondary outer sheath and the control mechanism, traction on the operating elements causing displacement of the secondary outer sheath towards the end tip.

[0042] 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, said control elements.

[0043] According to one embodiment, the mechanical control elements comprise a knob and a second knob, arranged in projection and offset longitudinally on the control handle, the knob and the second knob acting respectively on the main outer sheath and the secondary outer sheath.

[0044] According to one embodiment, the mechanical 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.

[0045] 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.

[0046] 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.

[0047] According to another embodiment, the launcher includes a pre-closing sleeve disposed in the annular space delimited between, on the one hand, the flexible central tubular element or the guide sleeve and, on the other hand, the main outer sleeve, upstream of the implant and the secondary outer sleeve, said pre-closing sleeve being mechanically connected to a pre-closing slide disposed on the control handle, so as to be moved and compressed on the end tip by an action on said pre-closing slide when the implant is fully released, thus securing the closing operation consisting of moving the main outer sleeve on the end tip.

[0048] According to an example of implementation, the maneuvering elements are fds.

[0049] According to an advantageous embodiment example, the secondary outer sheath comprises a spiral spring or is made of a spiral spring.

[0050] According to another embodiment, the secondary outer sheath comprises an association of elastic washers, a wave spring or a spring of the "SMALLEY" type.

[0051] According to another embodiment, the secondary outer sheath includes a compressible bellows or is made of a compressible bellows.

[0052] 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 located on the proximal side of the implant.

[0053] The launcher according to the invention has the advantage of being able to release an implant precisely and safely. The launcher allows for the precise positioning of the connection zone of a branch implant at the level of a diaphragm of a mother implant, and ensures that the connection is only made if the position of said branch implant is optimal.

[0054] 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 the implant release phases at all times, visually and sensorially using a control handle.

[0055] Furthermore, the launcher according to the invention has the advantage of being able to be configured to recapture the implant, which is not entirely released.

[0056] The launcher according to the invention is very easy to industrialize and use. Furthermore, the launcher exhibits remarkable radial and longitudinal compactness.

[0057] Furthermore, the launcher according to the invention can accommodate implants with very high radial force without risk of tearing a membrane associated with said implant. A secondary metallic outer sheath, or one in the form of a reinforced bellows or a bellows with a metallic band, is therefore particularly suitable.

[0058] The launcher according to the invention can thus be configured to exhibit remarkable longitudinal flexibility, facilitating access to a pathological area.

[0059] Brief description of the figures

[0060] 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:

[0061] - Figure 1 is a schematic illustration of an example of the reverse release of a vascular implant using an example of an embodiment of a release device or launcher according to the invention,

[0062] - Figure 2 is a partial, exploded view of an example of a launcher according to the invention.

[0063] - Figures 3, 4 and 5 are illustrations of details of an example embodiment of a launcher according to the invention,

[0064] - Figures 6 to 9 are illustrations of an atraumatic end tip of an example embodiment of a launcher according to the invention,

[0065] - Figure 10 is an enlarged view of part of an example embodiment of a launcher according to the invention,

[0066] - Figures 11 and 12 are cross-sectional views along plane AA of the launcher in Figure 10, in two usage configurations corresponding respectively to confinement and partial release of the implant,

[0067] - Figures 13 and 14 are illustrations of another detail of a launcher according to the invention; - Figure 15 is a partial view of an example embodiment of a launcher according to the invention, showing a release and partial deployment of an implant.

[0068] - Figure 16 is an enlarged view of part of another example of an embodiment of the launcher according to the invention,

[0069] - Figures 17 and 18 are cross-sectional views along plane AA of the launcher in Figure 16, in two usage configurations corresponding respectively to confinement and partial release of the implant,

[0070] - Figure 19 is a partial view of another example of an embodiment of a launcher according to the invention, showing a release and partial deployment of an implant,

[0071] - Figure 20 is an exploded view of an example of an embodiment of a control mechanism for the release device according to the invention,

[0072] - Figure 21 is a side view of the control mechanism of Figure 20, once assembled.

[0073] - Figure 22 is a side view of another example of an embodiment of a launcher according to the invention,

[0074] - Figure 23 is an enlarged representation of a cross-section AA of the launcher in Figure 22, and

[0075] - Figure 24 is a representation of an enlarged detail D and in longitudinal section of the launcher of Figure 22.

[0076] Detailed description of the invention

[0077] Elements that are structurally and functionally identical and present on several distinct figures are assigned the same numerical or alphanumeric reference.

[0078] Figure 1 is a schematic illustration of an example 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 released into a main anatomical conduit 5.

[0079] The launcher 1 includes, in particular, a main outer sheath 6 and a secondary outer sheath 7. 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 implant 9 can advantageously serve as either a branch implant 2 or a mother implant 4. The implant 9 has a distal end 9a and a proximal end 9b. The flexible central tubular element 8 has a central longitudinal slot 10 to allow it to slide along a surgical guide.

[0080] 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.

[0081] According to a preferred embodiment, the length of the secondary outer sheath 7 is less than or equal to that of the implant 9. According to 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.

[0082] The main outer sheath 6 is slidably mounted on the flexible central tubular element 8 and surrounds the secondary outer sheath 7.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] The launcher 1 therefore includes the operating elements 14, for example wires, the actuation of which allows the movable ring 13 to be moved in a proximal-distal direction. The operating elements 14 are preferably wires exhibiting little or no elongation, for example PTFE or KEVLAR wires.

[0088] Advantageously, the distal end 7a of the secondary outer sheath 7 engages on a part of the end tip 11 before said secondary outer sheath 7 is compressed against a stop 18 of said end tip 11 by the movable ring 13.

[0089] 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.

[0090] According to another embodiment, the operating elements 14 are connected to the secondary external sheath 7 via a rigid ring attached to said secondary external sheath 7.

[0091] 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 includes 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.

[0092] According to another embodiment, the flexible central tubular element 8 has three or four additional longitudinal lights 15.

[0093] Figure 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.

[0094] Figure 5 is a longitudinal cross-sectional view of the flexible central tubular element 8 of Figure 4.

[0095] Figures 6 to 9 are illustrations of the end piece 11 comprising the atraumatic tip 12. Figure 6 illustrates an example of an embodiment, according to a perspective view, respectively from the side, of the end piece 11.

[0096] The end tip 11 has a hollow cylindrical part l ia 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.

[0097] 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 proximal-distal direction.

[0098] 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 11a. 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 over or under the secondary outer sheath 7 and then passing through their engagement in the radial passages 17.

[0099] 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 portion 1ia and the central longitudinal opening 10, for example, towards the control mechanism. 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. This spring is advantageously made of stainless steel or any other chemically inert alloy. Furthermore, a spiral spring chosen with sufficient stiffness allows for the possible recapture of the implant 9, as long as the latter has not been completely released.

[0100] In another embodiment, the secondary outer sheath 7 is a wave spring or a combination of spring washers. The main outer sheath 6 is not shown to avoid cluttering the figure.

[0101] Figures 11 and 12 are cross-sectional views along plane AA of launcher 1 of figure 10, in two usage configurations corresponding respectively to confinement and partial release of implant 9.

[0102] In Figure 12, the secondary outer sheath 7 has slid with its distal end along the cylindrical portion 11a 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 deployment.

[0103] Figures 13 and 14 are enlarged illustrations of the movable ring 13, in perspective and cross-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.

[0104] Figure 15 shows a partial view of an example embodiment of the launcher 1, demonstrating the release and partial deployment of the implant 9. The implant has a distal end portion still enclosed within the secondary outer sheath 7 and a proximal end portion comprising a deployed retaining ridge 9c and a deployed attachment flower 9d. The implant 9 is, for example, a branch implant designed to connect to a mother implant, not shown. The mother implant then includes a diaphragm that encloses the branch implant between the ridge 9c and the flower 9d.

[0105] Figure 16 is an enlarged view of part of another example embodiment of launcher 1 in which the secondary outer sheath 7 is a compressible bellows.

[0106] Figures 17 and 18 are cross-sectional views along plane AA of the release device of Figure 16, in two usage configurations corresponding respectively to confinement and partial release of implant 9.

[0107] Advantageously, the secondary outer sheath 7 is positioned in the launcher 1 so that its distal end 7a is located at a distance from the stop 18. This allows the secondary outer sheath 7 to slide longitudinally towards the stop 18 when the operating elements are actuated, during at least one initial phase of implant 9 release. Subsequently, during at least one later release phase, this allows the secondary outer sheath 7 to be compressed longitudinally against the stop 18 when its distal end 7a is in contact with said stop 18. Such a configuration advantageously allows for a reduced length of the launcher 1 for a given implant length 9. Indeed, the secondary outer sheath 7, and consequently its distal end 7a, are translated by sliding along a stroke C, shown for example in Figure 10, before coming into contact with the stop 18.The implant 9 is fully released or jettisoned when the proximal end 7b of the secondary outer sheath 7 has passed the distal end 9a of the implant 9. This passing must occur when the secondary outer sheath 7 is compressed to its maximum. This corresponds, for example, to a configuration in which the secondary outer sheath 7, in the form of a spiral spring, has tightly wound coils. The length of the launcher 1 can therefore be reduced by a value corresponding to the stroke C.

[0108] The operation of the launcher 1, which includes a secondary external sheath 7 in the form of a spring or bellows, is exactly the same. The operation of the launcher 1 is illustrated and explained, for example, by means of a reverse release method for an implant 9, such as an expandable or self-expanding prosthesis, into a cavity or an anatomical conduit.

[0109] The implementation of the implant 9 deployment process comprises several successive steps, namely:

[0110] - the guidance and movement of the launcher 1 along the surgical guide,

[0111] - identifying the release position of implant 9 and positioning the launcher accordingly,

[0112] - the retraction of the primary outer sheath 6 over at least one sliding stroke in the distal-proximal direction to expose the secondary outer sheath 7, and

[0113] - the progressive retraction of the secondary outer sheath 7 over a sliding stroke in the proximal-distal direction to release and deploy the implant 9, progressively from its proximal end. Such an implementation is advantageous, for example, when it is necessary to perform an overlap of implants, for a reoperation or a specific pathology.

[0114] According to another implementation example, the process of deploying a 9-branch implant comprises several successive steps, namely:

[0115] - the guidance and movement of the launcher 1 along the surgical guide,

[0116] - identifying the release position of implant 9 and positioning launcher 1 accordingly,

[0117] - the retraction of the main outer sheath 6 over at least one initial sliding stroke in the distal-proximal direction to expose a proximal portion of the secondary outer sheath 7 located at the connection zone of the branch implant 9 with a previously deployed complementary mother implant,

[0118] - the progressive retraction of the secondary outer sheath 7 over a sliding stroke in the proximal-distal direction to release and deploy part of the connection area of ​​the implant branch 9,

[0119] - the retraction of the main outer sheath 6 over an additional sliding stroke in the distal-proximal direction to fully expose the connection area 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

[0120] - the progressive retraction of the secondary outer sheath 7 over a complementary sliding stroke in the proximal-distal direction to fully release and deploy the remainder of the implant branch 9.

[0121] According to one example of implementation, 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 implant branch housing of the secondary sheath and removing the launcher along the surgical guide.

[0122] Figure 19 is a partial view of another embodiment of the launcher 1, showing the 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.

[0123] Figure 20 is an exploded view of an example embodiment of a control mechanism for the release device according to the invention, and Figure 21 is a profile view of the control mechanism of Figure 20, once assembled.

[0124] 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 2 Ibis, 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 2 Ibis causing the movement of the outer ducts, main 6 and secondary 7.

[0125] Advantageously, the control handle 20 has, for each of the mobile carriages 21 and 2 Ibis, retractable stable stops, materializing the successive phases of the release and deployment of the implant 9. The mobile carriages 21 and 2 Ibis 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.

[0126] 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.

[0127] The wire subassembly 22 cooperates via a cylindrical surface with the cannula 24.

[0128] Component 19 cooperates with the cylindrical surface of the cannula 24 via the sealing joint.

[0129] 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.

[0130] The drive of the 21 and 2 Ibis trolleys is achieved, for example, via sliding hemispheres.

[0131] The carriage 2 Ibis, 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.

[0132] The carriage 21, which drives the main external sheath 6, is actuated via the rotation of the second knob 29.

[0133] 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.

[0134] The mobile carriages 21, 2 Ibis 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, 2 Ibis.

[0135] 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, 2 Ibis.

[0136] The drive shaft 28 is guided in rotation by its surface vis-à-vis the handle shells 25 and 26.

[0137] 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.

[0138] 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.

[0139] 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 2 Ibis, driving the secondary external sheath 7.

[0140] 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.

[0141] Figure 22 is a side view of another embodiment of a launcher 1 according to the invention. Figure 23 is a cross-sectional representation AA of the launcher 1 of Figure 22, and Figure 24 is an enlarged longitudinal sectional detail D of the launcher 1 of Figure 22.

[0142] In this embodiment, the launcher 1 includes a guide sleeve 8a concentric with the flexible central tubular element 8. The latter is a simple tube. The guide sleeve 8a is bonded to the flexible central tubular element 8 via a beveled end, not shown in the figures. The inner diameter of the guide sleeve 8a is larger than the outer diameter of the flexible central tubular element 8 so as to mutually define an annular traction space 8b in which the operating elements 14 are guided as they pass over the secondary outer sleeve 7 or between the secondary outer sleeve 7 and the implant 9. The beveled end of the guide sleeve 8a allows the guide sleeve 8a to be easily bonded to the flexible central tubular element 8, avoiding any risk of obstructing the annular traction space 8b.

[0143] The launcher 1 further includes a pre-closing slide 35 cooperating mechanically with a pre-closing sleeve 36 disposed in an annular pre-closing space 6a delimited between on the one hand the central flexible tubular element 8 or the guide sleeve 8a (figure 24) and on the other hand the main external sleeve 6.

[0144] The pre-closing sleeve 36 is positioned upstream of the undeployed implant 9 and the secondary outer sleeve 7. The movement of the pre-closing sleeve 36 is controlled by an action on the pre-closing slider 35 located on the control handle 20. To implement a phase called "pre-closing of the launcher nose", the pre-closing sleeve 36 is moved towards the end piece 11 to compress the secondary outer sleeve 7, for example consisting of a spiral spring, on the stop 18, when the implant 9 is fully released and deployed.

[0145] The pre-closure sheath 36 advantageously has a beveled distal end 36a, to engage slightly with the proximal end 7b of the secondary outer sheath 7 and exert on said proximal end 7b an isotropic radial force concurrently with a longitudinal force. The streamlined shape also prevents, thanks to its continuous profile, contact with the mesh or cells of the implant (prosthesis) when the latter is not covered.

[0146] The compression of the secondary outer sheath 7 against the stop 18 is thus achieved by reducing the risk of torsion or radial deformation, which could hinder the closing operation. The closing operation consists of moving the main outer sheath 6 onto the end piece 11 to close the launcher 1 before its extraction from the anatomical release cavity of the implant 9. The end of the main outer sheath 6 has an annular edge in cross-section. This edge, radially offset from the guide sheath 8a, forms a sharp attack face that could strike and force the mesh of the implant 9 towards the pre-closing annular space 6a. This risk is therefore substantially reduced by the pre-closing sheath 36, which longitudinally compresses the secondary outer sheath 7 against the stop 18, the pre-closing sheath 36, on which the main outer sheath 6 slides.The continuous profile achieved via the beveled distal end 36a and the end of the main outer sheath 6 thus allows the launcher 1 to be closed without risk of damaging the deployed implant 9. The present invention also finds application in the field of endoprostheses covered by a textile or membrane.

[0147] Clearly, the invention is not limited to the preferred embodiment or implementation described above and shown in the various figures. 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 part 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 part comprises: - a flexible central tubular element (8) supporting the undeployed implant (9) and comprising a central longitudinal lumen (10) to allow its sliding on a surgical guide, - a secondary external sheath (7) radially compressing the implant (9) and capable of sliding and / or compressing longitudinally on said implant (9), - a main outer sheath (6) mounted to slide on the flexible central tubular element (2) and surrounding the secondary outer sheath (7), - an end tip (11) having an atraumatic tip (12), mounted on the flexible central tubular element (8), the implant (9) having a distal end (9a) located on the side of the end tip (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 secondary outer sheath (7) towards the end tip (11) and to compress said secondary outer sheath (7) against a stop (18) of said end tip (11) and thus release the implant (9) progressively 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 secondary outer sheath (7) is positioned in the launcher (1) so as to position a distal end (7a) of said secondary outer sheath (7) at a distance from the stop (18), allowing, when the operating elements are actuated, the secondary outer sheath (7) to slide longitudinally towards the stop (18) when of at least one first release phase of the implant (9) and to compress longitudinally against the stop (18) when the distal end (7a) is in contact with said stop (18) during at least one subsequent release phase.

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

4. Launcher (1) according to claim 1 or 2, characterized in that the operating elements (14) are connected to the secondary outer sheath (7) via a rigid ring integral with said secondary outer sheath (7).

5. Launcher (1) according to claim 1 or 2, 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).

6. Launcher (1) according to any one of claims 1 to 5, 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.

7. Launcher (1) according to any one of claims 1 to 5, characterized in that it comprises a guide sleeve (8a) concentric with and fixed to the central flexible tubular element (8), the inner diameter of the guide sleeve (8a) being greater than the outer diameter of the central flexible tubular element (8) so as to delimit an annular space of traction (8b), in which the maneuvering elements (14) are guided, passing over the secondary outer sheath (7) or between the secondary outer sheath (7) and the implant (9).

8. Launcher (1) according to claim 6 or 7, 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) or with the annular traction space (8b), 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 (7) towards the end tip (11).

9. Launcher (1) according to any one of claims 1 to 8, 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), said control elements.

10. Launcher (1) according to claim 9, characterized in that the mechanical control elements comprise a wheel (27) and a second wheel (29) arranged in projection and offset longitudinally on the control handle (20), the wheel (27) and the second wheel (29) acting respectively on the main outer sheath (6) and the secondary outer sheath (7).

11. Launcher (1) according to claim 9 or 10, characterized in that the mechanical control elements comprise two separate movable carriages (21, 2 Ibis), one of which is mechanically connected to the outer main sheath (6) and the other is mechanically connected to the secondary outer sheath (7), the displacement of a mobile trolley (21, 2 Ibis) causing the movement of the corresponding external sheath (6, 7).

12. Launcher (1) according to claim 11, characterized in that the control handle (20) comprises for each of the mobile carriages (21, 2 Ibis), identifiable and retractable stable stops, materializing the successive phases of the release and deployment of the implant (9).

13. Launcher (1) according to claim 12, characterized in that the mobile carriages (21, 2 Ibis) 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, 2 Ibis).

14. Launcher (1) according to any one of claims 7 to 13, characterized in that it comprises a pre-closing sleeve (36) disposed in an annular pre-closing space (6a) delimited between the central flexible tubular element (8) and the main outer sleeve (6), upstream of the implant (9) and the secondary outer sleeve (7), said pre-closing sleeve (36) being mechanically connected to a pre-closing slide (35) disposed on the control handle (20), so as to be moved and compressed on the end piece (11) by an action on said pre-closing slide (35) when the implant (9) is fully released, thus securing the closing operation consisting of moving the main outer sleeve (6) on the end piece (11).

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

16. Launcher (1) according to any one of claims 1 to 15, characterized in that the secondary outer sheath (7) comprises a spiral spring or is made up of a spiral spring.

17. Launcher (1) according to any one of claims 1 to 15, characterized in that the secondary outer sheath (7) comprises an association of elastic washers, a wave spring, or a spring of the “SMALLEY” type.

18. Launcher (1) according to any one of claims 1 to 15, characterized in that the secondary outer sheath (7) comprises a compressible bellows or is made of a compressible bellows.

19. Launcher (1) according to any one of claims 1 to 15, 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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