Implant Intended for Positioning in a Blood Flow Passage and Associated Treatment Device

• US 20140249622A1
• Filed: 05/15/2014
• Published: 09/04/2014
• Est. Priority Date: 11/17/2011
• Status: Active Grant

• Current Assignee: Laboratoires Invalv
• Original Assignee: Laboratoires Invalv
• Inventors: CARMI, Doron, PELTIER, Marcel
• Granted Patent: US 10,098,736 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

The implant (12) according to the invention comprises a tubular frame (16), a plurality of distal arms (18) capable of pressing on a first face of a tissue, and a plurality of proximal arms (20) having an end (62) connected to the frame and a free end (64) intended to press on a second face of the tissue to clamp the tissue. The implant comprises a first integral assembly including a first part (38) of the frame and the proximal arms (20), and a second integral assembly including a second part of the frame (40) and the distal arms (18), the first assembly and the second assembly being attached one on top of the other. The first part (38) of the frame is in the form of a proximal sleeve, extending longitudinally between a proximal end (41) and a distal end (43) of the sleeve. The connected end (62) of each proximal arm (20) is connected to the distal end (43) of the proximal sleeve (38), and the free end (64) of each proximal arm (20) extends beyond that distal end (43) of the proximal sleeve (38).

Claims

1. An implant (12) designed to be placed in a blood flow passage and to be fixed on a tissue, the implant (12) being deployable between a contracted configuration and a deployed configuration, the implant (12) comprising:

a tubular frame (16) along a central axis (A-A′

), defining an inner blood flow conduit (32), the tubular frame (16) extending between a proximal end (44) and a distal end (46), the tubular frame comprising a first part and a second part, said first and second parts being separated and said first and second parts being assemblable so as to form the tubular frame when assembled;

a plurality of distal arms (18) extending perpendicular to the central axis (A-A′

) in the deployed configuration to press on a first face of the tissue;

a plurality of proximal arms (20) having one end (62) connected to the frame and one free end (64) designed to press on a second face of the tissue to clamp the tissue;

wherein;

the implant comprises a first integral assembly including the first part (38) of the frame and the proximal arms (20), and a second integral assembly including the second part of the frame (40) and the distal arms (18), the first assembly and the second assembly being attached one on top of the other;

the first part (38) of the frame is in the form of a proximal sleeve, with a central axis (A-A′

), extending longitudinally between a proximal end (41) and a distal end (43) of the sleeve;

the connected end (62) of each proximal arm (20) is connected to the distal end (43) of the proximal sleeve (38), and the free end (64) of each proximal arm (20) extends in the direction of the central axis (A-A′

) beyond that distal end (43) of the proximal sleeve (38).

2. The implant (12) according to claim 1, wherein, the proximal arms (20) delimiting a space (39) between them for receiving the tissue, the proximal sleeve (38) extends completely outside that receiving space (39).

3. The implant (12) according to claim 1, wherein the first (38) and second (40) parts of the frame are each formed by a mesh of interlaced threads, for example delimiting polygonal meshes.

4. The implant (12) according to claim 1, wherein:

the proximal arms (20) delimit a space (39) between them for receiving the tissue,

the second part (40) of the frame is in the form of a distal sleeve, with a central axis (A-A′

), said distal sleeve (40) extending longitudinally;

partially inside the proximal sleeve (38), coaxially to the proximal sleeve (38);

partially inside the space (39) for receiving the tissue, such that the tissue is capable of being received between the proximal arms (20) and the distal sleeve (40); and

partially beyond the tissue receiving space (39).

5. The implant (12) according to claim 1, wherein, in the deployed configuration, when no outside bias is present, the free end (64) of at least one proximal arm (20) is positioned in contact with the distal arm (18) and/or the frame (16), the proximal arm (20) including at least one intermediate region (66) extending along and radially separated from the frame (16) to define a longitudinal cavity (68) for receiving the tissue.

6. The implant (12) according to claim 5, wherein the intermediate region (66) of each proximal arm (20) has a curved shape, with the convex side oriented radially away from the axis (A-A′

), the immediate region (66) comprising at least one proximal segment (72) diverging radially away from the connected end (62) and at least one distal segment (74) converging radially toward the free end (64).

7. The implant (12) according to claim 5, wherein at least one proximal arm (20) defines, at its free end (64), a distal region (70) protruding radially away from the central axis (A-A′

) relative to the intermediate region (66), the distal region (70) being pressed below a distal arm (18), the stiffness in flexure of the intermediate region (66) preferably being greater than the stiffness in flexure of the distal region (70).

8. The implant (12) according to claim 1, wherein each proximal arm (20) has two branches (78) distally converging toward one another to substantially assume the shape of an upside down V in the deployed configuration.

9. The implant (12) according to claim 1, wherein each distal arm (18) forms a loop (50A, 50B) protruding transversely relative to the central axis (A-A′

).

10. The implant (12) according to claim 9, wherein the distal arms (18) are adjacent to one another to form a transverse collar (60) perpendicular to the axis (A-A′

) in the deployed configuration, the collar (60) advantageously being covered with a skirt made from tissue capable of guiding the blood through the frame.

11. The implant (12) according to claim 1, wherein the radial expanse of a first distal arm (18) in a first annular sector (S1) around the axis (A-A′

) is greater than the radial expanse of a second distal arm (18) situated in a second annular sector (S2), advantageously greater than 50% of the radial expanse of a second distal arm (18).

12. The implant (12) according to claim 1, wherein at least one first proximal arm (20) has a first distal region (70) pressed across from a first distal arm (18), a second proximal arm (20) having a second distal region (70) pressed across from a second distal arm (18), the radial expanse of the first distal region (70) being greater than the radial expanse of the second distal region (70).

13. The implant (12) according to claim 4, wherein the proximal sleeve (38) has, when it is separated from the distal sleeve (40), and when no outside bias is present, a diameter smaller than that of the distal sleeve (40) when no outside bias is present.

14. A treatment device (10;

210) for a blood flow passage, including;

an implant designed to be placed in a blood flow passage and to be fixed on a tissue, the implant (12) being deployable between a contracted configuration and a deployed configuration, the implant (12) comprising;

a tubular frame (16) along a central axis (A-A′

), defining an inner blood flow conduit (32), the tubular frame (16) extending between a proximal end (44) and a distal end (46), the tubular frame comprising a first part and a second part, said first and second parts being separated and said first and second parts being assemblable so as to form the tubular frame when assembled;

a plurality of distal arms (18) extending perpendicular to the central axis (A-A′

) in the deployed configuration to press on a first face of the tissue;

a plurality of proximal arms (20) having one end (62) connected to the frame and one free end (64) designed to press on a second face of the tissue to clamp the tissue;

wherein;

the implant comprises a first integral assembly including the first part (38) of the frame and the proximal arms (20), and a second integral assembly including the second part of the frame (40) and the distal arms (18), the first assembly and the second assembly being attached one on top of the other;

the first part (38) of the frame is in the form of a proximal sleeve, with a central axis (A-A′

), extending longitudinally between a proximal end (41) and a distal end (43) of the sleeve;

the connected end (62) of each proximal arm (20) is connected to the distal end (43) of the proximal sleeve (38), and the free end (64) of each proximal arm (20) extends in the direction of the central axis (A-A′

) beyond that distal end (43) of the proximal sleeve (38).

a tool (14) for deploying the implant (12), the implant (12) being mounted in its contracted configuration in the deployment tool (14).

15. The device (10) according to claim 14, including a locking head (92) delimiting at least one housing (100) for receiving the frame (16), a stent (93) engaged in the frame (16), an inner sheath (94) for retaining each distal arm (18) in an axial configuration positioned around the frame (16), and an outer sheath (96) for pressing each proximal arm (20) against the outer sheath (96), the inner sheath (92) being positioned around the frame (16) and each distal arm (18) to keep the distal arm in an axial configuration.

16. The device (210) according to claim 14, including a locking head (92) delimiting at least one housing (100) for receiving the frame (16) and retaining each distal arm (18) in an axial configuration, a stent (93) engaged through the frame (16), an outer sheath (96) for pressing the proximal arm (20) against the frame (16), the frame (16) and the distal arms (18) being substantially immobile relative to the stent (93) during the movement of the outer sheath (96), the device (210) further including an intermediate wall (220) protruding from the head (92) in the outer sheath (96) to keep the proximal arms (20) in position and separate them from the distal arms (18).

17. The device according to claim 14, including:

a locking head (92) delimiting at least one housing (100) for receiving the frame (16),

a stent (93) engaged in the frame (16), comprising a distal end fixed to the locking head (92),

an inner sheath (94) for retaining the second part of the frame (40) in the contracted configuration, the inner sheath (92) being positioned around the second part of the frame (40),

an outer sheath (96) for pressing each proximal arm (20) against the outer sheath (96), the outer sheath (96) being positioned around the proximal arms (20),

an intermediate sheath (95) for keeping the first part of the frame (38) in the contracted configuration, the intermediate sheath being positioned around the first part of the frame (38), said first part (38) being positioned between the inner sheath (94) and the intermediate sheath (95).

18. A method for placing an implant in a blood flow passage and to fix it on leaflets of a native valve, between an atrial cavity and a ventricular cavity of a hearth, said leaflets having an atrial face and a ventricular face, and said implant (12) being deployable between a contracted configuration and a deployed configuration, the implant (12) comprising:

a tubular frame (16) along a central axis (A-A′

), defining an inner blood flow conduit (32), the tubular frame (16) extending between a proximal end (44) and a distal end (46), the tubular frame comprising a first part and a second part, said first and second parts being separated and said first and second parts being assemblable so as to form the tubular frame when assembled;

a plurality of distal arms (18) extending perpendicular to the central axis (A-A′

) in the deployed configuration to press on the atrial face of the leaflets;

a plurality of proximal arms (20) having one end (62) connected to the frame and one free end (64) designed to press on the ventricular face of the leafleats to clamp the leaflets;

a first integral assembly including the first part (38) of the frame and the proximal arms (20), and a second integral assembly including the second part of the frame (40) and the distal arms (18);

wherein;

the first part (38) of the frame is in the form of a proximal sleeve, with a central axis (A-A′

), extending longitudinally between a proximal end (41) and a distal end (43) of the sleeve;

the second part (40) of the frame is in the form of a distal sleeve, the proximal sleeve being slidably movable relative to the distal sleeve while not assembled,

the connected end (62) of each proximal arm (20) is connected to the distal end (43) of the proximal sleeve (38), and the free end (64) of each proximal arm (20) extends in the direction of the central axis (A-A′

) beyond that distal end (43) of the proximal sleeve (38);

the method comprising;

a step of positioning the distal arms in the atrial cavity,

a step of deploying the distal arms in the atrial cavity,

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

a step of moving the proximal sleeve towards the leaflets, with proximal arms deployed so that the proximal arms define a receiving space for the leaflets, so as to insert the leaflets in the receiving space, and pressing the proximal arms against the ventricular face of the leaflets by applying an axial force towards said leaflets,

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

19. The method of claim 18, using a tool (14) for deploying the implant (12), the implant (12) being mounted in its contracted configuration in the tool (14), the tool including:

an inner sheath (94) for retaining the distal sleeve in a contracted configuration, and for retaining each distal arm (18) in an axial configuration, and

another sheath (95) for retaining the proximal sleeve in a contracted configuration, and for pressing each proximal arm (20) against the other sheath (95), the method comprising;

a step of deploying the proximal arms, by retracting the other sheath so as to release the proximal arms,

the step of positioning the distal arms in the atrial cavity, with the inner sheath still positioned around the distal arms,

the step of deploying the distal arms in the atrial cavity, by retracting the inner sheath so as to release these distal arms,

the step of 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 towards the ventricular cavity,

the step of moving the proximal sleeve towards the leaflets, with the other sheath still covering the proximal sleeve, and pressing the proximal arms against the ventricular face of the leaflets so as to apply an axial force towards the atrial cavity,

the step of deploying the distal sleeve and the proximal sleeve, by retracting the inner sheath and the other sheath.

20. The method of claim 19, wherein:

the step of positioning the distal arms in the atrial cavity follows the step of deploying the proximal arms,

the step of deploying the distal arms in the atrial cavity follows the step of positioning the distal arms in the atrial cavity,

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

the step of moving the proximal sleeve towards the leaflets follows the step of pressing the distal arms against the atrial face of the leaflets, and

the step of deploying the distal sleeve and the proximal sleeve follows the step of moving the proximal sleeve towards the leaflets.

21. The method of claim 18, wherein:

said other sheath, and the proximal sleeve in the contracted configuration within the other sheath, are introduced in the ventricular cavity from a first way,

the inner sheath, and the distal sleeve in the contracted configuration within the inner sheath, are introduced in the atrial cavity, from a second way different from said first way.

22. The method of claim 18, wherein the native valve is chosen between a mitral valve or a tricuspid valve.