Self-centering umbrella-type septal closure device

• US 5,709,707 A
• Filed: 11/19/1996
• Issued: 01/20/1998
• Est. Priority Date: 10/30/1995
• Status: Expired due to Term

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Lock, James E., Ryan, Carol A., Dwyer, Clifford J.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Snow, Bruce E.
• Application Number:
  US08/751,371
• Time in Patent Office: 427 Days
• Field of Search: 606/151, 606/213, 606/215, 606/232, 606/220, 128/887, 128/889, 128/899
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol

Abstract

A self-centering umbrella-type septal closure device which includes a proximal and distal occluder each having a plurality of arms supporting the occlusion shells. Each of the proximal and distal support arms have at least three coils any one or more of which is secured by a centering mechanism so as to control the positioning of the closure device so that it is centered about a defect.

Claims

1. A septal defect closure device, comprising:

a proximal occluder including a plurality of outwardly extending proximal arms supporting a proximal occlusion shell;

a distal occluder including a plurality of outwardly extending distal arms supporting a distal occlusion shell; and

a centering mechanism secured between said proximal occluder and said distal occluder to center said proximal and said distal occluders about a defect, said centering mechanism comprising at least two centering members, each of said centering members secured between a separate one of said proximal arms and a corresponding one of said distal arms, at least one of said centering members comprising an elastomeric material.

2. The closure device according to claim 1, wherein each of said at least two centering members is secured between a separate one of said proximal arms and an adjacent one of said distal arms.

3. The closure device according to claim 1, wherein each of said at least two centering members is secured between a separate one of said proximal arms and a diametrically opposed one of said distal arms.

4. The closure device according to claim 1, wherein said at least one elastomeric centering member is secured between one of said proximal arms and an adjacent one of said distal arms.

5. The closure device according to claim 1, wherein said at least one elastomeric centering member is secured between one of said proximal arms and a diametrically opposed one of said distal arms.

6. The closure device according to claim 1, wherein each of said proximal arms includes a resilient shoulder coil adjacent the center point of said proximal occluder, a resilient elbow coil radially spaced from said shoulder coil and a resilient wrist coil radially spaced from said elbow coil and each of said distal arms includes a resilient shoulder coil adjacent the center point of said distal occluder, a resilient elbow coil radially spaced from shoulder coil and resilient wrist coil radially spaced from said elbow coil.

7. The closure device according to claim 6, where said elastomeric centering member is passed through said proximal and distal shoulder coils and said proximal and distal elbow coils to center said proximal occluder and said distal occluder about a defect.

8. The closure device according to claim 6, wherein said proximal occluder and said distal occluder each include at least three outwardly extending arms, said elastomeric centering member being first passed through said shoulder coil of a first proximal arm and subsequently threaded through said elbow coil of said first proximal arm, said elastomeric centering member then being passed through said elbow coil of an adjacent distal arm and threaded alternately through said elbow coils of said remaining proximal and distal arms until said elastomeric centering member is looped through said elbow coil of said first proximal arm for a second time, then passing said suture centering member through said shoulder coil of said first proximal arm for a second time leaving both ends of said elastomeric centering member accessible.

9. The closure device according to claim 6, wherein said elastomeric centering member is passed through said shoulder coils and said wrist coils to center said proximal occluder and said distal occluder about a defect.

10. The closure device according to claim 6, wherein said proximal occluder and said distal occluder each include at least three outwardly extending arms, said elastomeric centering member being first passed through said shoulder coil of a first proximal arm and subsequently threaded through said wrist coil of said first proximal arm, said elastomeric centering member then being passed through said wrist coil of an adjacent distal arm and threaded alternately through said wrist coils of said remaining proximal and distal arms until said elastomeric centering member is looped through said wrist coil of said first proximal arm for a second time, then passing said suture centering member through said shoulder coil of said first proximal arm for a second time leaving both ends of said elastomeric centering member accessible.

20. A method of repairing a septal defect comprising the steps of:

(a) providing the septal defect closure device of claim 1;

(b) positioning said distal occluder and said proximal occluder on different sides of said septal defect; and

(c) opening said distal occluder and said proximal occluder such that each of said proximal and distal occluders occlude said septal defect.

11. A septal defect closure device, comprising:

a proximal occluder including a plurality of outwardly extending proximal arms supporting a proximal occlusion shell;

a distal occluder including a plurality of outwardly extending distal arms supporting a distal occlusion shell; and

a centering mechanism secured between said proximal occluder and said distal occluder to center said proximal and said distal occluders about a defect, said centering mechanism comprising at least two centering members, each of said centering members secured between a separate one of said proximal arms and a corresponding one of said distal arms, at least one of said centering members comprising a spring.

12. The closure device according to claim 11, wherein said at least one spring centering member is secured between one of said proximal arms and an adjacent one of said distal arms.

13. The closure device according to claim 11, wherein said at least one spring centering member is secured between one of said proximal arms and a diametrically opposed one of said distal arms.

14. The closure device according to claim 11, wherein each of said at least two centering members is secured between a separate one of said proximal arms and a diametrically opposed one of said distal arms.

15. The closure device according to claim 11, wherein each of said at least two centering members is secured between a separate one of said proximal arms and an adjacent one of said distal arms.

21. A method of repairing a septal defect comprising the steps of:

(a) providing the septal defect closure device of claim 11;

(b) positioning said distal occluder and said proximal occluder on different sides of said septal defect; and

(c) opening said distal occluder and said proximal occluder such that each of said proximal and distal occluders occlude said septal defect.

16. A septal defect closure device, comprising:

a proximal occluder including a plurality of outwardly extending proximal arms supporting a proximal occlusion shell;

a distal occluder including a plurality of outwardly extending distal arms supporting a distal occlusion shell; and

a centering mechanism secured between said proximal occluder and said distal occluder to center said proximal and said distal occluders about a defect, said centering mechanism comprising at least two centering members, each of said centering members secured between a separate one of said proximal arms and a corresponding one of said distal arms, at least one of said centering members comprising a shape memory material.

17. The closure device according to claim 16, wherein said proximal arms extend outwardly from said proximal occluder center point to support said proximal occlusion shell and said distal arms extend outwardly from said distal occluder center point to support said distal occlusion shell and wherein

said at least one memory material centering member is secured between one of said proximal arms and one of said distal arms at a position radially spaced from said proximal and distal occluder center points.

18. The closure device according to claim 17 where said one of said proximal arms is adjacent said one of said distal arms.

19. The closure device according to claim 17 wherein said one of said proximal arms is diametrically opposed to said one of said distal arms.

22. A method of repairing a septal defect comprising the steps of:

(a) providing the septal defect closure device of claim 16;

(b) positioning said distal occluder and said proximal occluder on different sides of said septal defect; and

(c) opening said distal occluder and said proximal occluder such that each of said proximal and distal occluders occlude said septal defect.