专利摘要:
This device (24) for placing a seal around an implant in a blood circulation passage, comprises a sheath having a longitudinal axis, at least one release member, deployable relative to the sheath. The device (24) comprises, for the or each release member, a sealing body (64) releasably attached to this release member, the sealing body (64) having an angular extent of less than 360 ° around of the longitudinal axis, and a filiform link (67) connecting at least one release member to another release member and / or to a control member (68) disposed in the sheath, the filiform link (67) being deformable between a relaxed configuration and a tight configuration for limiting the radial displacement of the sealing bodies (64).
公开号:FR3020265A1
申请号:FR1453699
申请日:2014-04-24
公开日:2015-10-30
发明作者:Witold Styrc
申请人:Cormove SAS;
IPC主号:
专利说明:

[0001] The present invention relates to a device for placing a seal around an implant in a passageway of a patient. blood circulation, of the type comprising a hollow sheath having a longitudinal axis and at least one release member, deployable relative to the sheath between a retracted position in the sheath and a position extracted from the sheath. This device is particularly applicable to the treatment of heart valves.
[0002] The heart has valves that are present at the outlet of the right ventricle (pulmonary valve and tricuspid) and the left ventricle (aortic and mitral valve). These valves provide unambiguous flow of blood, avoiding blood reflux after ventricular contraction. However, diseases or malformations affect the proper functioning of the valves. In particular, these may suffer from calcification thus allowing reflux or regurgitation to the ventricle or atrium that has expelled blood flow. The problem of regurgitation leads to an abnormal dilation of the ventricle which eventually produces heart failure. In some cases, the valve includes a number of sheets lower than that generally observed for this type of valve, which can affect its operation in the long term. To treat this type of disease surgically, it is known to implant an endovalve between the leaflets of the sick native valve. This endovalve comprises a tubular stent formed by an autoextensible lattice and a flexible closure or valve made most often in a tissue of animal origin. The flexible obturator is fixed permanently in the stent. Such endovalves are implantable endoluminally, which considerably limits the risks associated with the implantation of the valve, especially in terms of mortality.
[0003] In some cases, endovalves are not completely satisfactory after implantation. Indeed, although the outer surface of the stent applies spontaneously against the seat of the native valve, by plating the leaflets between the seat and the outer surface of the stent, leakage may remain around the outer surface of the stent. the endoprosthesis, especially at the commissures defined between the leaves of the native valve. These leaks occur in more than 50% of patients who have had such an operation.
[0004] To overcome this problem, it is known in the state of the art a treatment device comprising an implant that can be implanted in a sealed manner in a blood circulation conduit. Such sealing is provided by a sealing body suitable for closing off the commissures between the sheets of the native valve.
[0005] However, the exact position of the commissures defined by a native valve varies from one patient to another and the existing device does not make it possible to perform the positioning of the sealing bodies in these commissures in a completely satisfactory manner. The object of the present invention is to obtain a device for positioning a seal for positioning sealing bodies in the commissures between the sheets of the native valve of a patient in a very precise manner and adapted to the structure. of the native valve of this patient. To this end, the subject of the invention is a treatment device of the aforementioned type, comprising: for the or each release member, a sealing body releasably fixed on this release member to be released from the release member, the sealing body having an angular extent strictly less than 360 ° about the longitudinal axis; and - a filiform link connecting at least one release member to another release member and / or to a control member disposed in the hollow sheath, the filiform link being deformable between a relaxed rest configuration and a tensile configuration limiting the radial displacement away from the longitudinal axis of the sealing bodies. According to other advantageous aspects of the invention, the device comprises one or more of the following characteristics, taken individually or in any technically possible combination: it comprises a plurality of drop members angularly spaced from one another around the longitudinal axis, each release member carrying a sealing body releasably fixed on the release member to be released from the release member, at least one filamentary connection connecting a release member to an adjacent release member; it comprises at least three release members, the device comprising a filiform link connecting each release member to each of the adjacent release members, the filiform links forming a peripheral chain delimiting a central space; it comprises at least one filiform link connecting a release member to a control member, the or each control member being inserted into the sheath independently of the or each release member, and having a proximal end adapted to be manipulated by a practitioner and a distal end on which the filiform link is engaged; the or each control member comprises a maneuvering tutor adapted to be rotated from its proximal end, the filiform link being able to be wound on the distal end of the stent during the rotation to move the body transversely sealing corresponding to the longitudinal axis; it comprises a plurality of release members spaced angularly from each other about the longitudinal axis, each release member carrying a sealing body releasably fixed on the release member to be released from the release member, the control member comprising at least two operating stakes, each maneuvering tutor being adapted to wind a filamentary link connecting it to a release member; the stakes are mounted telescopically one inside the other; the or each control member has a loop engaged on at least one filiform link; it comprises a plurality of release members spaced angularly from each other about the longitudinal axis, each release member carrying a sealing body releasably fixed on the release member to be released from the release member, the filiform link on which the passer is engaged connecting two release members; at least one filiform link is releasably connected to the control member; the or each filiform link is formed from a silicone thread; the or each sealing body contains an opaque radio marker; and - it comprises a filter deployable transversely around the sheath. The invention also relates to a treatment kit for a blood flow passage, comprising an implant intended to be implanted in a blood circulation passage and comprising a deployable stent between a contracted state and an expanded state, the stent advantageously carrying a valve, and a device as described above, the or each sealing body being intended to be arranged around the implant in the blood circulation passage. According to other advantageous aspects of the invention, the treatment kit comprises an implant release tool capable of being introduced into the blood circulation passage independently of the delivery device.
[0006] The invention will be better understood on reading the description which will follow, given solely by way of example, and with reference to the appended drawings, in which: FIG. 1 is a schematic partial sectional view of a treatment kit comprising a device for placing a seal according to a first embodiment of the invention; FIG. 2 is a view of a detail of the device of FIG. 1, illustrating a first variant of the sealing body intended to be placed around an implant; - Figure 3 is a view similar to Figure 2, illustrating a second variant of the sealing body; - Figure 4 is a view similar to Figure 2, illustrating a third variant of the sealing body; - Figure 5 is a schematic perspective view of the device of Figure 1, in a first step of providing sealing around an implant; - Figure 6 is a view, taken in section along a transverse plane, of a portion of Figure 5; - Figure 7 is a view similar to Figure 6, in a second step of providing sealing around an implant; FIG. 8 is a view, taken in section along a transverse plane, of a blood circulation passage in which an implant is implanted and a plurality of sealing bodies having been released by the device of FIG. 1; - Figure 9 is a view similar to Figure 5 of a sealing implementation device according to a second embodiment of the invention. A first treatment 10 for a blood flow passage according to a first embodiment of the invention is illustrated in Figures 1 to 7. This kit 10 is intended in particular for the implantation of an endovalve comprising a stent tubular and a valve, replacing a native heart valve 12, partially visible in Figures 7 and 8. As shown in Figures 7 and 8, the native valve 12 is located in a passage of blood circulation 14 delimited to The native valve 12 comprises a plurality of native leaflets 18 movable in the passage 14 from the wall 16. The native valve 12 illustrated as an example in FIG. 8, comprises three native leaflets 18.
[0007] The native valve 12 delimits, between each pair of native sheets 18, a commissure 20 located at the junction between the native sheets 18 at the wall 16.
[0008] The kit 10 further comprises an implant 22, visible in FIGS. 7 and 8, intended to be placed in the blood circulation passage 14, and a tool (not shown) for delivering the implant 22 into the passage 14. The kit 10 further comprises a device 24 for placing a seal in the intermediate space located between the implant 22 and the peripheral wall 16, around the implant 22. With reference to FIG. implant 22 comprises a stent 30, which advantageously forms an endovalve. The stent 30 has a tubular shape of axis X-X '. It delimits a central passage 32 of blood flow opening axially on either side of the stent 30. The stent 30 carries a valve 34 or shutter attached to the stent 30 inside the passage 32. The Endoprosthesis 30 is formed by a perforated tubular frame 36 comprising a wire mesh which has spring properties. The armature 36 is obtained by braiding at least one stainless steel wire, a shape memory alloy, or a polymer. Alternatively, the armature 36 is obtained by cutting a tube, for example using a laser. With reference to FIG. 8, the armature 36 defines an inner peripheral surface 38 and an outer peripheral surface 40. The surfaces 38 and 40 are substantially cylindrical and extend about the axis XX 'between a proximal peripheral edge 42, located on the right in FIG. 7 and a distal peripheral edge 44, located on the left in FIG. 7. The inner surface 38 internally defines the central passage 32. The outer surface 40 is intended to be applied at least partially against the wall 16 and / or against the leaflets 18, as will be seen below. The armature 36 of the stent 30 is deployable between a contracted state, in which it has a small diameter, for introduction into the conduit 14, and an expanded state, constituting its state of rest, in which it has a large diameter. In the example shown in Figures 1 to 4, the armature 36 is deployable spontaneously between its contracted state and its expanded state. She is thus self-expanding. The valve 34 is for example made based on a native valve of an animal such as a pig. Alternatively, it is made from natural tissues such as bovine pericardium, ovine or porcine, or based on synthetic fabrics. In a conventional manner, the valve 34 comprises a tubular base 46 fixed on the inner surface 38 of the armature 36, and a plurality of flexible closure sheets 48 of the central passage 32 which extend downwards the base 46.
[0009] The sheets 48 are movable radially towards the axis XX 'of the passage 38 between a closed position, in which they substantially completely prevent the passage of blood through the passage 32, and a position of release of the passage 32 in which they are substantially pressed against the inner surface 38 and let the blood pass through the passage 32. In the closed position, the leaflets 48 have a section converging towards the proximal edge 42 of the valve. The delivery tool (not shown) is for example of the type described in FR-A-2 863 160. It is adapted to maintain the armature 36 in its contracted state when it is inserted into the passage 14 of blood circulation, then to deploy the armature 36 in its expanded state at its point of introduction, advantageously facing the native valve 12. With reference to FIGS. 1 to 7, the positioning device 24 comprises a sheath 60 for confinement and transport, and at least one release member 62, movably mounted in the sheath 60 between a retracted position in the sheath 60, visible in Figure 1, and a position extracted from the sheath 60, visible in Figures 5 to 7. The delivery device 24 further comprises, for each release member 62, a sealing body 64 intended to be interposed between the implant 22 and the wall 16, and a releasable attachment assembly 66 of the body sealing 64 on the release member 62. The disposit The positioning device 24 comprises at least one filiform link 67 intended to connect a release member 62 with another release member 62. The positioning device 24 further comprises at least one central control member 68 inserted in the sheath 60 independently of the release members 62.
[0010] Each filamentary link 67 is further connected to a central control member 68 in a releasable manner. It comprises a substantially cylindrical internal guide 68A defining a guide passage 68B of each release member and a circulation passage 68C of each control member 68.
[0011] The delivery device 24 advantageously comprises an assembly 69 for closing the sheath 60 and a surgical guide 70 for introducing and guiding the device 24 into the passage 14. The confinement sheath 60 extends along a longitudinal axis YY 'between a proximal end 71 visible in Figure 5 and intended to be located outside the body of the patient, and a distal end 72, intended to be introduced into the passage 14 of the blood circulation to the point of implantation of the implant 22.
[0012] The sheath 60 is for example formed by a hollow tube 74 of flexible material. It delimits a central lumen 76 opening at the proximal end (not visible), intended to be placed outside the patient's body and at the distal end 72, intended to be inserted in the passageway 14.
[0013] In the example shown in FIG. 1, the sheath 60 comprises a tubular proximal portion 78, advantageously a filter 79 mounted on this proximal portion 79, and a distal capsule 80, having a transverse extension greater than the transverse extent of the portion. 78. The filter 79 is deployable transversely around the sheath 60 between a contracted state (Figure 1) and an expanded state of rest (Figure 5). In the expanded state, the filter 79 has a conical shape of axis YY 'and whose base is oriented towards the distal end 72 of the sheath 60. The filter 79 makes it possible to recover any calcification debris released from native leaflets 18 during the establishment of the sealing body 64. The deployment and contraction of the filter 79 are performed by deployment and contraction means (not shown) operable by a practitioner outside the body of the patient. The capsule 80 receives each sealing body 64 in the retracted position of the release member 62. In this example, the positioning device 24 comprises a plurality of independent release members 62 each carrying a sealing body. 64. The number of release members 62 is for example between 1 and 4. The release members 62 are arranged at least in part in the inner slot 76 of the sheath 60 being spaced angularly from each other. Each delivery member 62 has a shaft 82 extending between a proximal end 81 visible in Figure 5 and adapted to be pulled out of the sheath 60 to be operated by a user of the device out of the patient's body, and a distal end. 83 on which is fixed the sealing body 64. The rod 82 is self-supporting to allow a user of the device to push the sealing body 64 out of the sheath 60 in the passage 14, during the displacement of the release 62 from its retracted position to its extracted position. The rod 82 is inserted into a guide passage 68B of the guide 68A. The release member 62 has a distal portion 84 which is deformable spontaneously from a configuration contracted radially towards the axis YY 'which it occupies in the retracted position (see FIG. 1) and a configuration deployed radially away from the axis. Y-Y ', which it occupies in the extracted position (see Figure 6).
[0014] In the deployed configuration, the distal portion 84 flares transversely. It has a proximal section 86 deviating from the Y-Y 'axis and a distal section 88 parallel to the Y-Y' axis or approaching the Y-Y 'axis. The distal portions 84 of the different release members 62 thus delimit between them a central insertion insertion space 90 of the implant 22, facilitating the placement of the implant 22. As illustrated by FIGS. 1, 5 and 6, each release member 62 is slidably movable along the axis YY 'between the retracted position, visible in Figure 1, and the extracted position, visible in Figures 5 and 6.
[0015] In the retracted position, the distal portion 84 of the release member 62 and the sealing body 64 fixed on the release member 62 are totally received in the sheath 60, advantageously at the level of the capsule 80. The sheath 60 thus maintains the distal portion 84 in its contracted configuration. In the extracted position, the distal portion 84 and the sealing body 64 have been pushed distally out of the sheath 60, beyond the distal end 72. The distal portion 84 occupies its radially expanded configuration. In the example shown in Figures 1 and 2, the rod 82 forming the release member 62 is hollow. It defines an internal channel 92 for the circulation of the releasable fastening assembly 66.
[0016] With reference to FIGS. 2 and 8, each sealing body 64 has an angular extent around the Y-Y 'axis of less than 360 °, advantageously less than 180 °, advantageously still less than 45 °. Each sealing body 64 thus forms a point cushion and preferably contains an opaque radio marker.
[0017] With reference to FIG. 2, each sealing body 64 is elongated along an axis of elongation Z-Z '. It advantageously has an olive shape. In the example of FIG. 2, the sealing body 64 comprises a block 92 of deformable material and a rigid central reinforcement 94 placed in the block 92. The block 92 is for example formed on the basis of foam, in particular foam of silicone or polymethane. Alternatively, it is formed of discrete elements of tissue housed in an outer shell. In the example of Figure 2, the armature 94 comprises a hollow central tubular member of axis ZZ 'around which the block and 92 is disposed. The armature 94 is formed from a material that is more rigid than the material forming the block 92.
[0018] Thus, the sealing body 64 is able to deform when it is inserted between the implant 22 and the peripheral wall 16 to match the shape of the space between the implant 22 and the peripheral wall 16. The body sealing member 64 is releasably attached to the distal portion 84 of the release member 62, preferably end-to-end with the distal end 83. Its extension axis ZZ 'thus forms a small or no angle, advantageously less than 300, relative to the local axis of the distal patient 84 at the point of contact with the sealing body 64. The releasable fastening assembly 66 comprises in this example a retaining member 96 movable in the internal channel 91 and through the sealing body 64, between a configuration engaged with the sealing body 64, and a release configuration of the sealing body 64. In this example, the retaining member 96 is formed by a pin, which extends forward the retaining member 96 is thus adapted to be manipulated by an operator of the device 24 out of the patient's body to move from its engaged configuration to its release configuration. In the engaged configuration, visible in FIG. 2, the retaining member 96 is engaged through the sealing body 64. In the particular example shown in FIG. 2, the retaining member 96 comprises, in the vicinity its distal end, a proximal free section 98 disposed in the channel 92 and in the armature 94, and a radially deformed convex section 100 which enters the block 92 of deformable material. It advantageously comprises a distal free section 102. In the release configuration, the radially deformed section 100 and the distal free section 102 have been extracted out of the sealing body 64. In the example illustrated in FIG. emplacement 24 comprises three release members 62 and three filiform links 67 respectively connecting a pair of adjacent release members 62. In this example, the release members 62 are angularly spaced apart from each other about the longitudinal axis YY 'and each filiform link 67 connects two adjacent release members 62 at their distal ends 83. Thus, as seen in FIG. 5, the filiform links 67 form a peripheral chain delimiting a central space 103. This central space 103 is able to receive the stent 30 when all the release members 62 are extracted from the sheath 60 and the stent 30 is in its shape. dilated state. Thus, the total length of all filiform links 67 is substantially greater than the circumference of the stent 30 in its expanded state. When the release members 62 are in their retracted positions, the filiform links 67 are received in the capsule 80.
[0019] Each filamentary link 67 is reversibly deformable between a relaxed rest configuration and a tensioned configuration. With reference to FIG. 5, each central control member 68 has a loop having a proximal end 105 and a distal end 106 on which the corresponding threadlike link 67 is engaged.
[0020] Each central control member 68 is partially engaged in a flow passage 68C of the guide 68A. Each control member is for example formed of a folded looped wire at the proximal end 106. Each proximal end 105 is adapted to be pulled by the practitioner out of the body of the patient to deform the filiform link 67 corresponding to the relaxed relaxed configuration of rest in Figures 1 and 5, the tensioned configuration visible in Figures 6 and 7. Thus, in the tensioned configuration, the filiform link 67 is able to limit the radial displacement away from the axis longitudinal YY 'of the release members 62 to which this link is connected. This in particular makes it possible to limit the radial displacement of the corresponding sealing bodies 64 away from the Y-Y 'axis in order to position them accurately in the corresponding commissures. Thus, each filiform link 67 is intended to be interposed between the implant 22 and the peripheral wall 16. Each filiform link 67 is for example formed of a silicone wire or any other wire made from a biocompatible material. This wire is able to remain in the body of the patient after implantation of the implant 22. As illustrated by FIGS. 1, 6 and 7, the closure assembly 69 includes a guard 110 inserted into the sheath 60, and a distal nose 112 for closing the sheath 60. The guard 110 is disposed in the sheath 60 substantially in the center thereof. It delimits, in the internal volume 76, an annular space 114 receiving each release member 62. The nose 112 has a maximum transverse extent greater than or equal to the maximum transverse extent of the sheath 60, at the distal end 72 It has a distal profiled portion to facilitate its insertion into the blood circulation passage 14. The tutor 110 and the nose 112 internally define a through axial passage 114, partially shown in Figure 7, to receive the surgical guide 70.
[0021] The closure assembly 69 is movable between a proximal position of closure of the sheath 60, visible in FIG. 1, and a distal opening position of the sheath 60, visible in FIG. 5. In the proximal position, the nose 112 is placed in contact with the distal end 72 of the sheath 60 to close the internal lumen 76. Advantageously, a proximal portion of the nose 112 is inserted into the internal lumen 74, and the distal portion of the nose 112 protrudes out of 76. The nose 112 thus prevents the passage of each release member 62 from the retracted position to the extracted position. In the distal position, the nose 112 is disposed axially apart from the distal end 72. The stent 110 is partially pulled out of the inner lumen 76 through the distal end 72. The inner lumen 76 opens out at the distal end 72. the distal end 72 and the passage of each delivery member 62 from the retracted position to the extracted position is possible.
[0022] In addition, when the closure assembly 69 is in its distal position, and each release member 62 is in its extracted position, the closure assembly 69 is movable to an intermediate transverse spacing position of each seal body 64. 6, in this position, the nose 112 has approached the distal end 72 of the sheath 60. It cooperates with each release member 62 to move it transversely away from the longitudinal axis YY '. This radially departs each sealing body 64. The operation of the treatment kit 10 according to the first embodiment of the invention will now be described. Initially, a kit 10 according to the invention is provided to the practitioner. The delivery device 24 is then configured so that each release member 62 occupies its retracted position in the containment sheath 60 as illustrated in FIG. 1. Each seal body 64 is then attached to the end of a release member 62 by the releasable fastening assembly 66. Each sealing body 64 is received in the interior volume 76 of the sheath 60, advantageously at the level of the capsule 80.
[0023] The filiform links 67 are in the relaxed position of rest and are in the inner volume 76 of the sheath 60, advantageously at the level of the capsule 80.
[0024] Each filiform link 67 is engaged on the distal end 106 of a corresponding central control member 68. The distal end 106 of each central member 68 is received in the sheath 60 at the capsule 80. The filter 79 is in its contracted state.
[0025] The closure assembly 69 then occupies its proximal position of closing the sheath 60. The guard 110 is disposed between the release members 62 and received in the central space 103 delimited by the filiform links 67, in the center of the sheath 60. The nose 112 closes the distal end 72 of the sheath 60. The practitioner then grasps the guide 70 and introduces it endoluminally into the blood system to the point of implantation provided in a passage 14 of blood circulation . When the implant 22 is an endovalve, the implantation point is for example located opposite a native valve 12. Then, the practitioner puts the delivery device 24 on the surgical guide 70 and brings the device 24 up to At the sliding implantation point on the guide 70. Thereafter, the practitioner passes the closure assembly 69 from its proximal position to its distal position, to open the sheath 60 at the distal end 72. Practitioner extracts each release member 62 carrying a sealing body 64 out of the sheath 60. In the extracted position, the distal portion 84 of each release member 62 moves from its radially contracted configuration to its radially expanded configuration. The filiform links 67 follow the release members 62 in their radial expansion. The central organs 68 follow in turn the filiform links 67 associated. During this passage, each sealing body 64 approaches the wall 16 delimiting the passage 14 to advantageously come into contact with this wall 16. In the case where the implantation point is located in a native valve 12, the practitioner For example, each sealing body 64 is introduced into a commissure 20 of the valve 12 situated between two adjacent native sheets 18. Then, the practitioner moves the closure assembly 69 towards the distal end 72 to reach the intermediate position of spacing. . The nose 112 then cooperates with each release member 62 to cause additional radial spacing of the sealing body 64 fixed on the release member 62. Then, the practitioner specifies the position of each sealing body 64 in the commissure 20 corresponding by pulling the proximal end 81 of the central control member 68 corresponding to the sealing body 64.
[0026] This action causes the deformation of the filiform link 67 corresponding to its relaxed configuration of rest towards its taut configuration. This thus limits the radial spacing of the pair of sealing bodies 64 connected to the filiform link 67. It is thus possible to retract partially towards the axis YY 'each sealing body 64 to adjust its positioning with respect to the commissures, actuating a central control member 68 associated, causing a proximal pull on the filamentary link 67 and an associated radial displacement of the release member 62. This then allows to pivot the release members 62 about the Y-axis Y ' , depending on the morphology of the patient to ensure that the seal body 64 is well placed in the desired commissure. Then, the practitioner actuates the deployment of the filter 79 to recover any calcification debris released from the native sheets 18. The central space 90 located between the release members 62 and the central space 103 delimited by the filiform links are released. The practitioner then introduces an additional surgical guide (not shown) to the central space 90, advantageously by a way opposite to the insertion path of the guide 70. The practitioner then guides the implant release tool 22 on the additional guide and deploys the implant 22 in the central space 90, facing each sealing body 64, as shown in FIG. 6. With reference to FIG. 7, the outer peripheral surface 40 of the armature 36 then pushes each sealing body 64 radially away from the axis YY 'against the wall 16. Each sealing body 64 and each filiform link 67 thus interpose between the implant 22 and the peripheral wall 16 in the blood flow passage 14, to substantially close the intermediate space between the implant 22 and the wall 16, in particular at the commissures 20 of the native valve 12. Then, the practitioner releases each seal body 64 of the body of 62 release on which it is attached. For this purpose, it moves the retaining member 96 from its configuration engaged with the sealing body 64 towards the release configuration, by maintaining the sealing body 64 substantially in position by pressing on the release member 62 The practitioner also releases each filiform link 67 from the corresponding central organ 68. Then, the practitioner actuates the contraction means to contract the filter 79 in its initial position.
[0027] The practitioner then retracts each release member 62 in the sheath 60, then proceeds to remove the sheath 60. The device 24 allows a positioning of each sealing body 64 very precisely and adapted to a variable structure of a valve native.
[0028] In addition, the opaque radio markers contained in the sealing bodies 64 allow the practitioner to see the position of each sealing body 64 and to correct it if necessary. In a variant illustrated in FIG. 3, the sealing body 64 is formed of a block 92 devoid of central reinforcement 94. The retaining member 96 comprises two parallel strands 120, 122 folded into a loop 124 at the level of the distal end of the retaining member 96 introduced into the block 92. The loop 124 comprises two opposite deformed sections 100 projecting transversely to the axis ZZ '. The release of the sealing body 64 shown in Figure 3 is carried out in a similar manner to that described for the body 64 of Figure 2, by pulling on the strands 120, 122 of the retaining member 96 disposed in the channel 91. In another variant illustrated in FIG. 4, the central armature 94 is formed by a substantially flat member, such as an elongate disc 125. The disc 125 is provided with eyelets 126 allowing the passage of the Retention 96. The release of the sealing body 64 shown in Figure 4 is performed in a similar manner to that described for the body 64 of Figure 2. The device 24 for placing a kit 130 in a second mode embodiment of the invention is illustrated in Figure 9. Unlike the device 24 shown in Figures 1 to 7, the central members of the device 24 of Figure 9 comprise operating rods 168 inserted into the sheath 60 and mounted in a loud way scopic one in the other. In addition, the filiform links 67 of the device 24 of Figure 9 connect one of the release members 62 to one of the central control members 168, preferably releasably. Each central control member 168 comprises a proximal end 170 adapted to be pivoted by the practitioner and a distal end 172 capable of winding the filiform link 67 corresponding. Thus, the rotation of the proximal end 170 involves the winding of the filiform link 67 on the distal end 172 to deform this filiform link 67 of the relaxed rest configuration to the taut configuration to move transversely the corresponding sealing body 64 to the longitudinal axis Y-Y '.
[0029] The operation of the kit 130 according to the second embodiment of the invention differs from the operation of the kit 10 according to the first embodiment in that to clarify the position of each sealing body 64, the practitioner pivots the proximal end 170 the corresponding central control member 168 for winding the filiform link on its distal end. This then allows to bring the sealing body corresponding to the longitudinal axis YY '.
权利要求:
Claims (15)
[0001]
1. Apparatus (24) for placing a seal around an implant (22) in a passage (14) for circulating blood, comprising: - a hollow sheath (60) having a longitudinal axis (Y- Y '); - At least one release member (62), expandable relative to the sheath (60) between a retracted position in the sheath (60) and a position extracted from the sheath (60); and characterized in that it comprises: - for the or each release member (62), a sealing body (64) releasably fixed on this release member (62) to be released from the organ (62), the sealing body (64) having an angular extent strictly less than 360 ° about the longitudinal axis (YY); and a filamentary link (67) connecting at least one release member (62) to another release member (62) and / or a control member (68; 168) disposed in the hollow sheath (60); filamentary link (67) being deformable between a relaxed rest configuration and a tensile configuration for limiting the radial displacement away from the longitudinal axis (Y-Y ') of the sealing bodies (64).
[0002]
2.- Device (24) according to claim 1, characterized in that it comprises a plurality of release members (62) spaced angularly from each other about the longitudinal axis (Y-Y '), each member with a seal body (64) releasably secured to the release member (62) to be released from the release member (62), at least one filamentary link (67) connecting a member release device (62) to an adjacent delivery member (62).
[0003]
3. - Device (24) according to claim 2, characterized in that it comprises at least three release members (62), the device (24) having a filiform link (67) connecting each release member (62) to each of the adjacent release members (62), the filiform links (67) forming a peripheral chain defining a central space (103).
[0004]
4.- Device (24) according to any one of the preceding claims, characterized in that it comprises at least one filiform link (67) connecting a release member (62) to a control member (68; 168), the or each control member (68; 168) being inserted into the sheath (60) independently of the or each release member (62), and having a proximal end (105; 170) adapted to be manipulated by a practitioner and an end distal (106; 172) on which the filiform link is engaged.
[0005]
5.- Device (24) according to claim 4, characterized in that the or each control member (168) comprises a maneuvering tutor adapted to be rotated from its proximal end (170), the filiform link (67) being able to be wound on the distal end (172) of the guard during rotation to bring transversely the sealing body (64) corresponding to the longitudinal axis (Y-Y ').
[0006]
6.- Device (24) according to claim 5, characterized in that it comprises a plurality of release members (62) spaced angularly from each other about the longitudinal axis (Y-Y '), each member method (62) carrying a sealing body (64) releasably secured to the release member (62) to be released from the release member (62), the control member (168) comprising at least two operating stakes, each maneuvering tutor being adapted to wind a filiform link (67) connecting it to a release member (62).
[0007]
7.- Device (24) according to claim 6, characterized in that the stakes are mounted telescopically one in the other.
[0008]
8.- Device (24) according to any one of claims 4 to 7, characterized in that the or each control member (68; 168) has a loop engaged on at least one filiform link (67).
[0009]
9.- Device (24) according to claim 8, characterized in that it comprises a plurality of release members (62) spaced angularly from each other about the longitudinal axis (Y-Y '), each member method (62) carrying a sealing body (64) releasably secured to the release member (62) to be released from the release member (62), the filiform link (67) on which the passer is engaged connecting two release members (62).
[0010]
10.- Device (24) according to any one of claims 4 to 9, characterized in that at least one filamentary link (67) is releasably connected to the control member (68; 168) .35
[0011]
11.- Device (24) according to any one of the preceding claims, characterized in that the or each filiform link (67) is formed from a silicone wire.
[0012]
12.- Device (24) according to any one of the preceding claims, characterized in that the or each sealing body (64) contains an opaque radio marker.
[0013]
13.- Device (24) according to any one of the preceding claims, characterized in that it comprises a filter (79) deployable transversely around the sheath.
[0014]
14.- Necessary (10; 130) for treating a blood circulation passage (14), comprising: - an implant (22) intended to be implanted in a blood circulation passage (14) and comprising a stent ( 30) deployable between a contracted state and an expanded state, the stent (30) advantageously having a valve (34); - A device (24) according to any one of the preceding claims, the or each sealing body (64) being intended to be arranged around the implant (22) in the passage (14) of blood circulation.
[0015]
15.- kit (10; 130) according to claim 14, characterized in that it comprises a tool for releasing the implant (22) adapted to be introduced into the passage (14) of blood circulation independently of the device ( 24) of setting up.25
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同族专利:
公开号 | 公开日
DE102015106142A1|2015-10-29|
US20150305869A1|2015-10-29|
US9763785B2|2017-09-19|
FR3020265B1|2019-09-06|
引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题
WO2006027499A2|2004-09-07|2006-03-16|Laboratoires Perouse|Valve prosthesis|
WO2006089236A1|2005-02-18|2006-08-24|The Cleveland Clinic Foundation|Apparatus and methods for replacing a cardiac valve|
WO2009044082A2|2007-09-11|2009-04-09|Laboratoires Perouse|Device for treating a blood circulation conduit|
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WO2014056754A1|2012-10-12|2014-04-17|Cormove|Device for treating a blood vessel|
US7267685B2|2000-11-16|2007-09-11|Cordis Corporation|Bilateral extension prosthesis and method of delivery|
US8579966B2|1999-11-17|2013-11-12|Medtronic Corevalve Llc|Prosthetic valve for transluminal delivery|
FR2863160B1|2003-12-09|2006-03-03|Perouse Laboratoires|DEVICE FOR TREATING A BLOOD VESSEL AND METHOD FOR PREPARING THE SAME|
US7780725B2|2004-06-16|2010-08-24|Sadra Medical, Inc.|Everting heart valve|
FR2885794B1|2005-05-19|2007-08-17|Perouse Soc Par Actions Simpli|NECESSARY FOR LANDING A CAVITY TREATMENT BODY AND METHOD FOR PREPARING A TREATMENT BODY THEREFOR|
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CN103997990A|2011-06-21|2014-08-20|托尔福公司|Prosthetic heart valve devices and associated systems and methods|US9345573B2|2012-05-30|2016-05-24|Neovasc Tiara Inc.|Methods and apparatus for loading a prosthesis onto a delivery system|
US10493248B2|2016-11-09|2019-12-03|Medtronic Vascular, Inc.|Chordae tendineae management devices for use with a valve prosthesis delivery system and methods of use thereof|
US10368988B2|2016-11-09|2019-08-06|Medtronic Vascular, Inc.|Valve delivery system having an integral displacement component for managing chordae tendineae in situ and methods of use thereof|
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CN111263622A|2017-08-25|2020-06-09|内奥瓦斯克迪亚拉公司|Sequentially deployed transcatheter mitral valve prosthesis|
法律状态:
2015-04-23| PLFP| Fee payment|Year of fee payment: 2 |
2015-10-30| PLSC| Search report ready|Effective date: 20151030 |
2016-03-30| PLFP| Fee payment|Year of fee payment: 3 |
2017-04-20| PLFP| Fee payment|Year of fee payment: 4 |
2018-03-22| PLFP| Fee payment|Year of fee payment: 5 |
2019-03-21| PLFP| Fee payment|Year of fee payment: 6 |
2020-03-13| PLFP| Fee payment|Year of fee payment: 7 |
2021-03-11| PLFP| Fee payment|Year of fee payment: 8 |
优先权:
申请号 | 申请日 | 专利标题
FR1453699|2014-04-24|
FR1453699A|FR3020265B1|2014-04-24|2014-04-24|DEVICE FOR PLACING A SEAL AROUND AN IMPLANT IN A BLOOD CIRCULATION PASSAGE, AND TREATMENT NECESSARY THEREFOR|FR1453699A| FR3020265B1|2014-04-24|2014-04-24|DEVICE FOR PLACING A SEAL AROUND AN IMPLANT IN A BLOOD CIRCULATION PASSAGE, AND TREATMENT NECESSARY THEREFOR|
DE102015106142.2A| DE102015106142A1|2014-04-24|2015-04-22|Device for placing a seal around an implant in a blood circulation passage and corresponding treatment set|
US14/693,122| US9763785B2|2014-04-24|2015-04-22|Device for placing a seal around an implant in a blood circulation passage, and associated treatment kit|
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