IMPLANT, INTENDED TO BE PLACED IN A BLOOD CIRCULATION PASSAGE, COMPRISING A SYSTEM FOR SEPARATING THE PROXIMAL ARMS

• US 20160095700A1
• Filed: 04/17/2014
• Published: 04/07/2016
• Est. Priority Date: 04/19/2013
• Status: Active Grant

• Current Assignee: Laboratoires Invalv
• Original Assignee: Laboratoires Invalv
• Inventors: Righini, Giovanni
• Granted Patent: US 10,058,418 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

The implant comprises a tubular proximal sleeve, extending between a proximal end and a distal end, and deployable between a contracted configuration and a deployed configuration. Proximal arms each extend between an end connected to the distal end, and a free end positioned past the distal end. At least one proximal arm is elastically deformable between a separating position and an anchoring position, the radial distance between its free end and its connected end being larger in the separating position rather than in the anchoring position. This proximal arm is elastically recalled toward its anchoring position. The implant includes: a first stop, supported by this proximal arm, and a second stop, cooperating with the first stop in the contracted configuration to keep this proximal arm in its separating position, and releasing this first stop in the deployed configuration.

Claims

1. An implant designed to be placed in a blood circulation passage, and to be fastened on a tissue, and comprising:

a proximal sleeve, generally tubular around a central axis, extending longitudinally between a proximal end and a distal end, the proximal sleeve being deployable between a contracted configuration and a deployed configuration,

a plurality of proximal arms, each extending between a connected end connected to the distal end of the proximal sleeve (14), and a free end designed to bear on a first face of the tissue, each proximal arm extending in the direction of the central axis such that its free end is positioned beyond the distal end of the proximal sleeve,

a distal sleeve, with a generally tubular shape around the central axis, deployable between a contracted configuration and a deployed configuration, designed to be assembled with the proximal sleeve to form a tubular armature together, that armature defining an internal blood circulation conduit when the proximal sleeve and the distal sleeve are assembled and each in the deployed configuration,

a plurality of distal arms, supported by the distal sleeve, and extending substantially perpendicular to the central axis in the deployed configuration, designed to bear on a second face of the tissue, such that the tissue is then pinched between the proximal arms and the distal arms, wherein;

at least one of the proximal arms is a deformable proximal arm, elastically deformable between a separating position and an anchoring position, such that, when there is no outside bias, the radial distance between its free end and its connected end is larger in the separated position rather than in the anchoring position, this deformable proximal arm being elastically returned toward its anchoring position,

the implant includes a first stop and a second stop for maintaining said at least one deformable proximal arm in its separating position, wherein;

the first stop is supported by said deformable proximal arm, and

the second stop is designed to cooperate with the first stop when the proximal sleeve is in the contracted configuration to keep that deformable proximal arm in its separating position, and to release that first stop when the proximal sleeve is in the deployed configuration to allow the deformable proximal arm to move toward its anchoring position.

2. The implant according to claim 1, wherein the first stop of the deformable proximal arm extends laterally relative to that deformable proximal arm, the first stop preferably being arranged near the connected end of that deformable proximal arm (18).

3. The implant according to claim 1, wherein the second stop is supported by the proximal sleeve.

4. The implant according to claim 3, wherein the proximal sleeve is formed by different filiform elements arranged in a grid, forming cells (M), each deformable proximal arm provided with a first stop being arranged circumferentially on the proximal sleeve between two consecutive cells, the corresponding second stop being supported by at least one of the filiform elements forming those two consecutive cells, these filiform elements being brought closer to one another in the contracted configuration, such that the second stop cooperates with the first stop, and separated from one another in the deployed configuration, so as to leave a radial passage for the first stop, thus releasing that first stop.

5. The implant according to claim 1, wherein the proximal sleeve supports at least two deformable proximal arms each provided with a first stop, such that the distance between the first stop and the connected end of one of those two deformable proximal arms (18) is greater than the distance between the first stop and the connected end of the other of those two deformable proximal arms.

6. The implant according to claim 1, wherein the first stop of at least one of the deformable proximal arms is formed by a protruding part of that deformable proximal arm, extending laterally relative to that deformable proximal arm.

7. The implant according to claim 1, wherein the first stop of at least one of the deformable proximal arms is formed by an element attached on that deformable proximal arm, that element extending laterally relative to that deformable proximal arm.

8. A treatment device for a blood circulation passage, including an implant and a tool for releasing the implant, wherein the implant is designed to be placed in a blood circulation passage, and to be fastened on a tissue, and comprises:

a proximal sleeve, generally tubular around a central axis, extending longitudinally between a proximal end and a distal end, the proximal sleeve being deployable between a contracted configuration and a deployed configuration,

a plurality of proximal arms, each extending between a connected end connected to the distal end of the proximal sleeve, and a free end designed to bear on a first face of the tissue, each proximal arm extending in the direction of the central axis such that its free end is positioned beyond the distal end of the proximal sleeve,

a distal sleeve, with a generally tubular shape around the central axis, deployable between a contracted configuration and a deployed configuration, designed to be assembled with the proximal sleeve to form a tubular armature together, that tubular armature defining an internal blood circulation conduit when the proximal sleeve and the distal sleeve are assembled and each in the deployed configuration,

a plurality of distal arms, supported by the distal sleeve, and extending perpendicular to the central axis in the deployed configuration, designed to bear on a second face of the tissue, such that the tissue is then pinched between the proximal arms and the distal arms, wherein;

at least one of the proximal arms is a deformable proximal arm, elastically deformable between a separating position and an anchoring position, such that, when there is no outside bias, the radial distance between its free end and its connected end is larger in the separated position rather than in the anchoring position, this proximal arm being elastically returned toward its anchoring position,

the implant includes a first stop and a second stop for maintaining said at least one deformable proximal arm in its separating position, wherein;

the first stop is supported by said deformable proximal arm, and

the second stop is designed to cooperate with the first stop when the proximal sleeve is in the contracted configuration to keep that at least one deformable proximal arm in its separating position, and to release that first stop when the proximal sleeve is in the deployed configuration to allow the at least one deformable proximal arm to move toward its anchoring position,

and wherein the proximal and distal sleeves are mounted in their respective contracted configurations in the release tool.

9. The treatment device according to claim 8, wherein:

the release tool includes a sheath for maintaining each deformable proximal arm provided with a first stop in its separating position,

said maintaining sheath has a general shape of revolution around the longitudinal axis, and is designed to be positioned around the proximal sleeve in the contracted configuration,

said maintaining sheath includes longitudinal strips separated by longitudinal openings, each longitudinal strip being designed to pass through an opening provided in a respective proximal arm,

each longitudinal strip includes a second stop designed to cooperate with the first stop of the proximal arm through which that longitudinal strip passes.

10. The treatment device according to claim 9, wherein said longitudinal strip is provided with a boss, protruding radially toward the outside of the maintaining sheath, bearing said second stop.

11. A method for installing an implant on the leaflets of a native valve, between an atrial cavity and a ventricular cavity of the heart, the leaflets having an atrial face and a ventricular face, the implant comprising:

a proximal sleeve, generally tubular around a central axis, extending longitudinally between a proximal end and a distal end, the proximal sleeve being deployable between a contracted configuration and a deployed configuration,

a plurality of proximal arms, each extending between a connected end connected to the distal end of the proximal sleeve, and a free end designed to bear on a first face of the tissue, each proximal arm extending in the direction of the central axis such that its free end is positioned beyond the distal end of the proximal sleeve,

a distal sleeve, with a generally tubular shape around the central axis, deployable between a contracted configuration and a deployed configuration, designed to be assembled with the proximal sleeve to form a tubular armature together, that tubular armature defining an internal blood circulation conduit when the proximal sleeve and the distal sleeve are assembled and each in the deployed configuration,

a plurality of distal arms, supported by the distal sleeve, and extending perpendicular to the central axis in the deployed configuration, designed to bear on a second face of the tissue, such that the tissue is then pinched between the proximal arms and the distal arms, wherein;

at least one of the proximal arms is a deformable proximal arm, elastically deformable between a separating position and an anchoring position, such that, when there is no outside bias, the radial distance between its free end and its connected end is larger in the separated position rather than in the anchoring position, this proximal arm being elastically returned toward its anchoring position,

the implant includes a first stop and a second stop for maintaining said at least one deformable proximal arm in its separating position, wherein;

the first stop is supported by said deformable proximal arm, and

the second stop is designed to cooperate with the first stop when the proximal sleeve is in the contracted configuration to keep that at least one deformable proximal arm in its separating position, and to release that first stop when the proximal sleeve is in the deployed configuration to allow the at least one deformable proximal arm to move toward its anchoring position,

and the method including;

positioning the distal arms in the atrial cavity,

deploying said distal arms in the atrial cavity,

pressing the distal arms against the atrial face of the leaflets,

moving the proximal sleeve toward the leaflets, with the proximal arms deployed so as to define a receiving space for the leaflets, in order to insert the leaflets into the receiving space, and pressing the proximal arms against the ventricular face of the leaflets by applying an axial force toward those leaflets,

deploying the distal sleeve and the proximal sleeve, and assembling the distal sleeve with the proximal sleeve so as to form a tubular armature of the implant.

12. The method of claim 11, using a release tool in which the implant is housed in the contracted position, the tool including:

an inner sheath for keeping the distal sleeve in the contracted configuration, and keeping the distal arms in the axial configuration,

an outer sheath for keeping the proximal sleeve in the contracted configuration, the method including;

deploying the proximal arms, in particular by retracting the outer sheath so as to release the proximal arms,

positioning the distal arms in the atrial cavity, while the inner sheath is still positioned around the distal arms,

deploying the distal arms in the atrial cavity, while retracting the inner sheath so as to free those distal arms,

pressing the distal arms against the atrial face of the leaflets, by moving the tool toward the ventricular cavity so as to apply an axial force toward that ventricular cavity,

moving the proximal sleeve toward the leaflets, while the outer sheath covers the proximal sleeve, and pressing the proximal arms against the ventricular face of the leaflets to apply an axial force oriented toward the atrial cavity, and

applying the proximal and distal sleeves, while retracting the inner and outer sheaths.

13. The method of claim 11, wherein:

positioning the distal arms in the atrial cavity takes place after deploying the proximal arms,

deploying the distal arms in the atrial cavity takes place after positioning the distal arms in the atrial cavity,

pressing the distal arms against the atrial face of the leaflets follows deploying the distal arms in the atrial cavity,

moving the proximal sleeve toward the leaflets is done following the pressing of the distal arms against the atrial face of the leaflets,

deploying the proximal and distal sleeves takes place after moving the proximal sleeve toward the leaflets.

14. The method of claim 11, wherein:

the outer sheath and the proximal sleeve in the contracted configuration in the outer sheath are introduced into the ventricular cavity by a first route, and

the inner sheath and the distal sleeve in the contracted configuration in the inner sheath are introduced into the atrial cavity by a second route different from the first.

15. The method of claim 11, wherein the native valve is chosen between a mitral valve or a tricuspid valve.