Centering buttoned device for the occlusion of large defects for occluding

• US 5,433,727 A
• Filed: 08/16/1994
• Issued: 07/18/1995
• Est. Priority Date: 08/16/1994
• Status: Expired due to Term

• Current Assignee: Eleftherios B. Sideris
• Original Assignee: Eleftherios B. Sideris
• Inventors: Sideris, Eleftherios B.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/291,154
• Time in Patent Office: 336 Days
• Field of Search: 606/213, 606/215, 606/216, 606/139, 606/151, 606/157, 128/887, 128/889, 128/899, 623/1, 623/11
• 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: A61B 2017/00623 Introducing or retrieving devices therefor

Abstract

This is an intravascular prosthesis deliverable transvenously for the occlusion of large heart defects. The defects are predominantly large atrial septal defects and ventricular septal defects. The device has an occluder connected with a centering counter-occluder. The device is delivered to the heart by known methods. The occluder is released on the distal side of the defect and the proximal centering counter-occluder is stretched, pulling the device over the center of the defect. Subsequently, the centering counter-occluder is buttoned against the occluder and is opposing the right atrial side of the septum. The radiopaque button is placed upon a string to verify buttoning.

Claims

1. A method of occluding a heart defect having a perimeter by a buttoned device comprising the steps of:

a) introducing the device into a long sheath,

b) positioning the device in the long sheath in a heart chamber where there is a defect,

c) releasing the device from the long sheath on a proximal side of the defect by

d) pushing a pusher catheter against an occluder,

e) pulling a counter-occluder along the pusher catheter with a centering wire to form a pyramid shaped cage of the counter-occluder'"'"'s wires,

f) pulling a loading wire to guide the counter-occluder to the distal side of the defect while

g) forcing the counter-occluder cage to follow the defect'"'"'s perimeter, thereby

h) centering the occluder across the defect,

i) pushing a polyurethane covered latex piece of the counter-occluder with a tip of the long sheath along the pusher catheter until the latex piece touches the occluder and a double figure 8 is formed of the counter-occluder,

j) pulling the pusher catheter back until a radiopaque button is released from the pusher catheter, while

k) holding the tip of the long sheath against the latex piece of the counter-occluder,

l) detaching the device by extracting the centering wire, and the loading wire while

m) holding the device in place with the tip of the long sheath, and

n) removing the long sheath.

2. The method as defined in claim 1 further comprising:

o) covering a button loop with the pusher catheter so that said button, which is a radiopaque spring button on the button loop, is almost parallel to the axial direction of the pusher catheter,

p) positioning the button device in its desired position, and

q) withdrawing the catheter so that the button is released from the pusher catheter

r) causing the button to become perpendicular to the button loop, thus

s) buttoning the button device and

t) preventing the device from unbuttoning.

3. A method of buttoning a button device comprising the steps of:

a) covering a button loop with a catheter so that a radiopaque spring button on the button loop is almost parallel to the axial direction of the catheter,

b) positioning the button device in its desired position, and

c) withdrawing the catheter so that the button is released from the catheter

d) causing the button to become perpendicular to the button loop, thus

e) buttoning the button device and

f) preventing the device from unbuttoning.

4. An intra-cardiac percutaneously deliverable device for the repair of heart defects having:

a) an occluder including;

i) a foldable foam resin disc,

ii) a coated wire skeleton in the form of an "X" sutured to the foam disc, and

iii) an adjustable loop sutured to the center of the wire skeleton;

b) said adjustable loop is formed by

i) a first loop, connected to said wire skeleton,

ii) a middle loop, connected to said first loop,

iii) a terminal small loop connected to said middle loop, and

iv) a radiopaque button connected between said terminal small loop and middle loop;

c) a loading wire having a proximal end and a distal end, wherein said loading wire is a fluorocarbon resin coated hollow wire,

d) a loading, long double thread going through the terminal small loop, through the loading wire, and tied at the distal end of the loading wire;

wherein the improvement comprises;

e) a centering counter-occluder sutured in part to the skeleton wires of the foam disc and covering a central 40% of said skeleton wires;

f) said centering counter-occluder including;

i) two hollow wires threaded with NYLON thread and sutured to the skeleton wires, said thread also sutured and tied at each end of the two hollow wires to

ii) a polyurethane covered latex piece;

g) a centering guidewire having a proximal end and a distal end, wherein said guidewire is a fluorocarbon resin hollow wire;

h) a centering, long double thread going through a small loop that is tied to the covered latex piece of the centering counter-occluder, through the hollow centering wire, and tied at the distal end of the centering wire;

wherein

j) the centering counter-occluder may be pulled along an axial pusher catheter by the centering guidewire, or

k) pushed over the pusher catheter, which contains the loading wire and the button loop, stopping at the occluder by a long sheath.

5. The intra-cardiac percutaneously deliverable device for the repair of heart defects as defined in claim 4 further comprising:

l) said radiopaque button is approximately parallel to the button loop when the spring button is inside a pusher catheter, and

m) said radiopaque button is approximately perpendicular to the button loop when the radiopaque button is released from the pusher catheter.

6. The intra-cardiac percutaneously deliverable device for the repair of heart defects as defined in claim 4 wherein each counter-occluder wire has a length that is 21/2 times a length of the occluder.

7. An intra-cardiac percutaneously deliverable device for the repair of heart defects having:

a) an occluder including;

i) a foldable foam resin disc,

ii) a coated wire skeleton in the form of an "X" sutured to the foam disc, and

iii) an adjustable loop sutured to the center of the wire skeleton;

b) said adjustable loop is formed by

i) a first loop, connected to said wire skeleton,

ii) a middle loop, connected to said first loop,

iii) a terminal small loop connected to said middle loop, and

iv) a radiopaque button connected between said terminal small loop and middle loop;

c) a loading wire having a proximal end and a distal end, wherein said loading wire is a fluorocarbon resin coated hollow wire,

d) a loading, long double thread going through the terminal small loop, through the loading wire, and tied at the distal end of the loading wire;

wherein the improvement comprises;

e) said radiopaque button is approximately parallel to the button loop when the spring button is inside a pusher catheter, and

f) said radiopaque button is approximately perpendicular to the button loop when the radiopaque button is released from the pusher catheter.