Implant intended for positioning in a blood flow passage and associated treatment device

• US 10,098,736 B2
• Filed: 05/15/2014
• Issued: 10/16/2018
• Est. Priority Date: 11/17/2011
• Status: Active Grant

• Current Assignee: Laboratoires Invalv
• Original Assignee: Laboratoires Invalv
• Inventors: Carmi, Doron, Peltier, Marcel
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/278,665
• Publication Number:
  US 20140249622A1
• Time in Patent Office: 1,615 Days
• 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 designed to be placed in a blood flow passage and to be fixed on a tissue, the implant being deployable between a contracted configuration and a deployed configuration, the implant comprising:

a tubular frame along a central axis, defining an inner blood flow conduit, the tubular frame extending between a proximal end and a distal end, 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 extending perpendicular to the central axis in the deployed configuration to press on a first face of the tissue;

a plurality of proximal arms having one end 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 of the frame and the proximal arms, and a second integral assembly including the second part of the frame and the distal arms, the first assembly and the second assembly being attached one on top of the other;

the first part of the frame is in the form of a proximal sleeve, with the central axis, extending longitudinally between a proximal end and a distal end of the sleeve;

each proximal arm is elastically deformable towards a rest position; and

the connected end of each proximal arm is connected to the distal end of the proximal sleeve, and the free end of each proximal arm extends in the direction of the central axis beyond that distal end of the proximal sleeve when this proximal arm is in the rest position.

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

3. The implant according to claim 1, wherein the first and second parts of the frame are each formed by a mesh of interlaced threads.

4. The implant according to claim 1, wherein:

the proximal arms delimit a space between them for receiving the tissue,

the second part of the frame is in the form of a distal sleeve, with the central axis, said distal sleeve extending longitudinally;

partially inside the proximal sleeve, coaxially to the proximal sleeve;

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

partially beyond the tissue receiving space.

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

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

7. The implant according to claim 6, wherein the intermediate region of each proximal arm has a curved shape, with the convex side oriented radially away from the central axis, the intermediate region comprising at least one proximal segment diverging radially away from the connected end and at least one distal segment converging radially toward the free end.

8. The implant according to claim 6, wherein at least one proximal arm defines, at its free end, a distal region protruding radially away from the central axis relative to the intermediate region, the distal region being pressed below a distal arm, the stiffness in flexure of the intermediate region being greater than the stiffness in flexure of the distal region.

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

10. The implant according to claim 1, wherein each distal arm forms a loop protruding transversely relative to the central axis.

11. The implant according to claim 10, wherein the distal arms are adjacent to one another to form a transverse collar perpendicular to the axis in the deployed configuration, the collar advantageously being covered with a skirt made from tissue capable of guiding the blood through the frame.

12. The implant according to claim 1, wherein the radial expanse of a first distal arm in a first annular sector around the central axis is greater than the radial expanse of a second distal arm situated in a second annular sector, advantageously greater than 50% of the radial expanse of a second distal arm.

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