Heart valve sealing devices and delivery devices therefor

• US 10,667,912 B2
• Filed: 04/05/2018
• Issued: 06/02/2020
• Est. Priority Date: 04/18/2017
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Dixon, Eric Robert, Chen, Jensen, Moratorio, Guillermo W., Cao, Hengchu, Dominick, Douglas Thomas, Delgado, Sergio, Freschauf, Lauren R.
• Primary Examiner(s): Dukert, Brian A
• Application Number:
  US15/946,604
• Publication Number:
  US 20180296331A1
• Time in Patent Office: 789 Days
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0045 : Omega-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical

Abstract

An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are extendable from a folded closed position to an open position. A clasp is attached to each of the paddles. Each clasp has a fixed arm attached to the paddle and a moveable arm having a barbed portion. A hinge portion connects the fixed arm to the moveable arm. The device does not include catch points when the paddles are in the open position and the clasps are in a closed condition.

Claims

1. An implantable prosthetic device comprising:

a coaption portion;

an anchor portion comprising a plurality of paddles, the paddles having an outer and inner portion and being extendable from a closed position to an open position; and

a clasp attached to each of the plurality of paddles, the clasp comprising;

a fixed arm fixedly attached to the inner portion of the paddle;

a moveable arm having a barbed portion; and

a hinge portion hingeably connecting the fixed arm to the moveable arm;

wherein the clasp has a closed end when the clasp is in a closed position;

wherein when the clasp is in the closed position, a recess between the closed end and the coaption portion has a depth that is less than one-third of a width of the implantable prosthetic device.

2. The implantable prosthetic device according to claim 1, wherein the closed end of the clasp in the closed position is formed by the hinge portion that is rounded when the clasp is in the closed condition.

3. The implantable prosthetic device according to claim 1, wherein the hinge portion comprises a plurality of spring segments, wherein each spring segment is connected to a plurality of spring segments.

4. The implantable prosthetic device according to claim 3, wherein the spring segments are torsional spring segments.

5. The implantable prosthetic device according to claim 3, wherein:

the spring segments comprise a first end and a second end; and

the first end of one spring segment is connected to at least one of the first and second end of another spring segment.

6. The implantable prosthetic device according to claim 3, wherein:

the spring segments comprise a first end, a second end, a first side, and a second side;

a first side joining location is adjacent the first end;

a first end joining location is adjacent the first side;

a second side joining location is adjacent the second end; and

a second end joining location is adjacent the second side.

7. The implantable prosthetic device according to claim 5, wherein:

the spring segments are arranged into a plurality of rows and columns;

the first or second ends of spring segments proximate a side edge of the clasp are joined to one other spring segment; and

the first or second ends of spring segments proximate an adjacent column are joined to at least one other spring segment.

8. The implantable prosthetic device according to claim 3, wherein:

the spring segments are arranged in a pattern having three columns and seven rows of spring segments.

9. The implantable prosthetic device according to claim 1, wherein the clasp is formed from a top layer and a bottom layer, the top and bottom layers formed of shape memory material.

10. The implantable prosthetic device according to claim 9, wherein the top and bottom layers are only joined in one location to allow the top and bottom layers to slide relative to one another during opening of the clasp.

11. The implantable prosthetic device according to claim 1, wherein the clasp is formed from shape memory material and the fixed and moveable arms are shape set in a preloading position so that a pinch force exists between the fixed and moveable arms when the fixed arm is approximately parallel with the moveable arm.

12. The implantable prosthetic device according to claim 11, wherein the fixed arm is bent in the closing direction beyond the closed position to the preloading position.

13. The implantable prosthetic device according to claim 12, wherein the fixed arm is bent in the closing direction to about 45 degrees beyond the closed position to the preloading position.

14. The implantable prosthetic device according to claim 12, wherein the fixed arm is bent in the closing direction to about 90 degrees beyond the closed position to the preloading position.

15. The implantable prosthetic device according to claim 12, wherein after shape setting, the fixed arm is prohibited from returning to the preloading position by a cross-member.

16. The implantable prosthetic device according to claim 15, wherein the cross-member is an integral cross-member.

17. The implantable prosthetic device according to claim 1, wherein a plastic limit of the material of the clasp is not exceeded when the moveable arm is opened to a fully open position about 140 degrees from the fixed arm.

18. The implantable prosthetic device according to claim 1, wherein the clasp is formed from a shape memory material having a thick portion and a thin portion.

19. The implantable prosthetic device according to claim 9, wherein barbs are formed in both of the top layer and the bottom layer.

20. The implantable prosthetic device according to claim 1, wherein barbs of the barbed portion are tapered in the direction of the length of the clasp.

21. The implantable prosthetic device according to claim 1, wherein the movable arm comprises a plurality of independent arms transitionable between a wide, spread-out configuration and a narrow configuration in which the arms are closer together, and wherein barbs of the barbed portion end in a point.

22. The implantable prosthetic device according to claim 1, wherein the clasp is cut from a tubular piece of material.

23. An implantable prosthetic device comprising:

a coaption portion;

an anchor portion comprising a plurality of paddles, the paddles having an outer and inner portion and being extendable from a closed position to an open position; and

a clasp attached to each of the plurality of paddles, the clasp comprising;

a fixed arm attached to the inner portion of the paddle;

a moveable arm having a barbed portion; and

a hinge portion hingeably connecting the fixed arm to the moveable arm, wherein the hinge portion comprises a plurality of spring segments, wherein each spring segment is connected to a plurality of spring segments.

24. An implantable prosthetic device comprising:

a coaption portion;

an anchor portion comprising a plurality of paddles, the paddles having an outer and inner portion and being extendable from a closed position to an open position; and

a clasp attached to each of the plurality of paddles, the clasp comprising;

a fixed arm attached to the inner portion of the paddle;

a moveable arm having a barbed portion; and

a hinge portion hingeably connecting the fixed arm to the moveable arm;

wherein the clasp is formed from shape memory material and the fixed and moveable arms are shape set in a preloading position so that a pinch force exists between the fixed and moveable arms when the fixed arm is approximately parallel with the moveable arm.

25. An implantable prosthetic device comprising:

a coaption portion;

an anchor portion comprising a plurality of paddles, the paddles having an outer and inner portion and being extendable from a closed position to an open position; and

a clasp attached to each of the plurality of paddles, the clasp comprising;

a fixed arm attached to the inner portion of the paddle;

a moveable arm having a barbed portion; and

a hinge portion hingeably connecting the fixed arm to the moveable arm;

wherein a plastic limit of the material of the clasp is not exceeded when the moveable arm is opened to a fully open position about 140 degrees from the fixed arm.