Device for treating a blood circulation conduit

• US 8,512,396 B2
• Filed: 09/11/2008
• Issued: 08/20/2013
• Est. Priority Date: 09/11/2007
• Status: Active Grant

• Current Assignee: Cormove
• Original Assignee: Laboratories Perouse
• Inventors: Styrc, Witold
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): WOLF, MEGAN YARNALL
• Application Number:
  US12/677,314
• Publication Number:
  US 20100280589A1
• Time in Patent Office: 1,804 Days
• Field of Search: None
• US Class Current: 623/1.24
• 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 minimize 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. A device for treating a blood circulation conduit (14), comprising:

an implant (20) for placing in the conduit (14), the implant (20) that 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), and

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

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

wherein, in the configuration for insertion, the interposition member (24) comprises at least one free part (68) that is 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 deployment tool (26) moves from the configuration for insertion to the configuration for release,

wherein the interposition member (24) comprises a flexible peripheral skirt (60) having a connection 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 turned-down configuration that is turned down against the outer surface, which the skirt (60) adopts in the configuration for release, and

wherein the interposition member further comprises at least one radial sealing cushion (62) which projects radially relative to the skirt (60) and is attached to an outside of the skirt (60) along the free edge (66) of the skirt (60).

2. The device according to claim 1, further comprising:

at least one actuation tie (104) for actuating the interposition member (24), the at least one actuation tie (104) releasably connecting the free part (68) and the deployment tool (26),

the at least one 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 the configuration for insertion to the configuration for release.

3. The device according to claim 2, wherein the at least one actuation tie (104) is breakable by axial traction.

4. The device according to claim 3, wherein the deployment tool (26) comprises a sheath (84) for housing the implant (20), which is axially displaceable relative to the implant (20), the at least one actuation tie (104) being engaged releasably in the sheath (84), a displacement of the sheath (84) away from the endoprosthesis (30) causing a displacement of the free part (68) towards the outer surface (40) by traction on the tie (104).

5. The device according to claim 2,

wherein the at least one actuation tie (104) comprises a locking loop (124), and

wherein the deployment tool (26) comprises a pin (130), the pin (130) being movable between an engaged position in the locking loop (124), in which an axial displacement of the at least one actuation tie (104) relative to the endoprosthesis (30) causes an 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 at least one actuation tie (104) causes the at least one actuation tie to be released relative to the free part (68).

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

7. The device according to claim 2, wherein the deployment tool (26) comprises a sheath (84) for housing the implant (20), which is axially displaceable relative to the implant (20), the at least one actuation tie (104) being engaged releasably in the sheath (84), a displacement of the sheath (84) away from the endoprosthesis (30) causing a displacement of the free part (68) towards the outer surface (40) by traction on the tie (104).

8. The device according to claim 2, wherein 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. The device according to claim 1, wherein 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).

10. The device according to claim 1, further comprising:

at least one actuation tie (212) for actuating the interposition member, the actuation tie (212) having at least a first connection point (216) to the interposition member (24), and at least second and third connection points (218, 220) to the framework (36), the second and third connection points (218, 220) being spaced angularly on the framework (36) about the axis (X-X′

),

wherein the movement of the framework (36) of the endoprosthesis (30) between the contracted state and the dilated state causes a distance separating the second connection point (218) and the third connection point (220) to increase, and causes an 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).

11. The device according to claim 1, wherein the deployment tool (26) comprises a stent (80) to support and axially maintain an endovalve (22) in the conduit (14), and threadlike ties (82) for holding the framework (36) in the contracted state against the stent (80), the threadlike ties (82) being configured to be actuated between a configuration for holding the framework (36) in the contracted state against the stent (80), and a configuration for release of the framework (36) in which the framework (36) adopts the dilated state, the threadlike ties (82) being configured to be loosened thereby to radially expand the framework (36) after the skirt (60) moves from the configuration of reduced radial dimension to the turned-down configuration.

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

13. The device according to claim 1, wherein the radial sealing cushion (62) is annular.