DEVICE FOR TREATING A BLOOD CIRCULATION CONDUIT

• US 20100280589A1
• Filed: 09/11/2008
• Published: 11/04/2010
• Est. Priority Date: 09/11/2007
• Status: Active Grant

• Current Assignee: Cormove
• Original Assignee: Laboratories Perouse
• Inventors: Styrc, Witold
• Granted Patent: US 8,512,396 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

This device (10) includes an implant (20) which has a tubular endoprosthesis (30) with a radially deployable framework (36). The implant (20) includes a flexible interposition member (24) mounted movably on the endoprosthesis (30) so as to be interposed between the outer surface (40) and a blood circulation conduit (14). The device (10) includes a deployment tool (26) which can adopt a configuration for insertion of the implant (20) and a configuration for release of the implant (20). In the configuration for insertion of the implant (20), the flexible member (24) includes at least one free part (68) held axially away from the outer surface (40) in order to minimise the radial dimension of the implant (20). The free part (68) is at least partly displaceable against the outer surface (40) when the tool (26) moves from its configuration for insertion to its configuration for release.

Claims

1. Device (10;

120;

140;

150;

160;

180;

190;

210) for treating a blood circulation conduit (14), of the type comprising;

an implant (20) for placing in the conduit (14), the implant (20) comprising;

a tubular endoprosthesis (30) with an axis (X-X′

) having a framework (36) which is radially deployable between a contracted state and a dilated state, the framework (36) having an outer surface (40) delimited axially by an axial edge (44);

at least one interposition member (24) which is more flexible than the framework (36), the flexible interposition member (24) being mounted movably on the endoprosthesis (30) for interposition between the outer surface (40) and the conduit (14); and

a tool (26) for deploying the implant (20), which tool can adopt a configuration for insertion of the implant (20) in the conduit (14), in which the tool (26) holds the framework (36) in its contracted state, and a configuration for release of the implant (20), in which the framework (36) adopts its dilated state,

characterised in that in the configuration for insertion, the flexible interposition member (24) comprises at least one free part (68) held axially away from the outer surface (40) beyond the axial edge (44) to minimise the radial dimension of the implant (20), the free part (68) being at least partly displaceable against the outer surface (40) when the tool (26) moves from its configuration for insertion to its configuration for release.

2. Device (10;

120;

140;

150;

160;

180;

210) according to claim 1, characterised in that the interposition member (24) comprises at least a flexible peripheral skirt (60) having an edge (64) fixed to the endoprosthesis (30) and a free edge (66), the skirt (60) being displaceable between a configuration of reduced radial dimension in which the free edge (66) is placed axially away from the axial edge of the outer surface, which the skirt (60) adopts in the configuration for insertion, and a configuration turned down against the outer surface which the skirt (60) adopts in the configuration for release.

3. Device (10;

120;

140;

150;

160;

180;

210) according to claim 2, characterised in that the interposition member comprises at least one radial sealing cushion (62), which projects radially relative to the skirt (60).

4. Device (10;

120;

140;

150;

160) according to claim 1, characterised in that it comprises at least one tie (104) for actuating the interposition member (24), the or each tie (104) releasably connecting the free part (68) and the deployment tool (28), the or each actuation tie (104) being axially displaceable relative to the endoprosthesis (30) to pull the free part (68) towards the outer surface (40) when the deployment tool (26) moves from its configuration for insertion to its configuration for release.

5. Device (10) according to claim 4, characterised in that the or each actuation tie (104) can be broken by axial traction.

6. Device (120;

140) according to claim 4, characterised in that the or each actuation tie (104) comprises a locking loop (124), the deployment tool (26) comprising a pin (130), the pin (130) being movable between an engaged position in the locking loop (124), in which the axial displacement of the actuation tie (104) relative to the endoprosthesis (30) causes the axial displacement of the free part (68) relative to the endoprosthesis (30), and a released position outside the locking loop (124), in which the axial displacement of the tie (104) causes its release relative to the free part (68).

7. Device (10;

120;

140) according to claim 4, characterised in that the deployment tool (26) comprises a sheath (84) for housing the implant (20), which is axially displaceable relative to the implant (20), the actuation tie (104) being engaged releasably in the sheath (84), the displacement of the sheath (84) away from the endoprosthesis (30) causing the displacement of the free part (68) towards the outer surface (40) by traction on the tie (104).

8. Device (160) according to claim 4, characterised in that the deployment tool (26) comprises a stent (80) for holding the endoprosthesis (30) axially before the radial deployment of the framework (36), the actuation tie (104) being engaged in the stent (80) and being movable relative to the endoprosthesis (30) through the stent (80) in order to be actuated from a proximal end of the stent (80).

9. Device (180;

190) according to claim 1, characterised in that the flexible interposition member (24) is spontaneously deformable when the deployment tool (26) moves from its configuration for insertion to its configuration for release, in order to spontaneously cause the free part (68) to be at least partly displaced against the outer surface (40).

10. Device (180) according to claim 9, characterised in that the flexible interposition member comprises at least one resilient component (182) connecting the free part (68) to the outer surface (40), the resilient component (182) being held in an unstable position under tension by the deployment tool (26) in the configuration for insertion.

11. Device (10;

120;

140;

150;

160;

180;

190;

210) according to claim 1, characterised in that the framework (36) has an inner surface (38) delimiting a central blood circulation passage (32), the implant (20) comprising a valve (34) fixed to the inner surface (38) to selectively close the central passage (32).

12. Device (210) according to claim 1, characterised in that it comprises at least one tie (212) for actuating the interposition member, the actuation tie (212) having at least a first point (216) of connection to the interposition member (24), and at least second and third points (218, 220) of connection to the framework (36), the second and third connection points (218, 220) being spaced angularly on the framework (36) about the axis (X-X′

);

the movement of the framework (36) of the endoprosthesis (30) between its contracted state and its dilated state causing the distance separating the second connection point (218) and the third connection point (220) to increase, and the axial displacement of the first connection point (216) between a position axially remote from the second and third connection points (218, 220) and a position axially closer to the second and third connection points (218, 220), in which the first connection point (218) is situated facing the outer surface (40).

13. Device according to claim 2, characterised in that the skirt (60) has a free edge (66) partly turned down towards the connection edge (64) fixed to the endoprosthesis (30) in the configuration of minimum radial dimension.

14. Device according to claim 2, characterised in that the deployment tool (26) comprises a stent (80) to support and axially maintain the endovalve (22) in the conduit (14) and threadlike ties (82) for holding the framework (36) in its contracted state against the stent (80), it being possible for the ties (82) to be actuated between a configuration for holding the framework (36) in its contracted state against the stent (80), and a configuration for release of the framework (36) in which the framework (36) adopts its dilated state, the ties (82) being capable of being loosened to radially expand the framework (36) after the skirt (60) moves from its configuration of reduced radial dimension to its turned-down configuration.

15. Device according to claim 1, characterised in that the implant (20) also comprises a valve reducer (300) which is more flexible than the framework (36) arranged in the central blood circulation passage (32), the valve reducer (300) comprising a tubular inner wall (304) carrying the valve (34), of smaller diameter than the central passage (32), a distal skirt (302) for connection to the framework (36) and a proximal skirt (306) for connection to the framework (36).

16. Device (10;

120;

140;

150;

160) according to claim 2, characterised in that it comprises at least one tie (104) for actuating the interposition member (24), the or each tie (104) releasably connecting the free part (68) and the deployment tool (28), the or each actuation tie (104) being axially displaceable relative to the endoprosthesis (30) to pull the free part (68) towards the outer surface (40) when the deployment tool (26) moves from its configuration for insertion to its configuration for release.

17. Device (10;

120;

140;

150;

160) according to claim 3, characterised in that it comprises at least one tie (104) for actuating the interposition member (24), the or each tie (104) releasably connecting the free part (68) and the deployment tool (28), the or each actuation tie (104) being axially displaceable relative to the endoprosthesis (30) to pull the free part (68) towards the outer surface (40) when the deployment tool (26) moves from its configuration for insertion to its configuration for release.

18. Device (10;

120;

140) according to claim 5, characterised in that the deployment tool (26) comprises a sheath (84) for housing the implant (20), which is axially displaceable relative to the implant (20), the actuation tie (104) being engaged releasably in the sheath (84), the displacement of the sheath (84) away from the endoprosthesis (30) causing the displacement of the free part (68) towards the outer surface (40) by traction on the tie (104).

19. Device (10;

120;

140) according to claim 6, characterised in that the deployment tool (26) comprises a sheath (84) for housing the implant (20), which is axially displaceable relative to the implant (20), the actuation tie (104) being engaged releasably in the sheath (84), the displacement of the sheath (84) away from the endoprosthesis (30) causing the displacement of the free part (68) towards the outer surface (40) by traction on the tie (104).