Apparatus and method for occluding a defect or aperture within body surface

• US 5,861,003 A
• Filed: 10/23/1996
• Issued: 01/19/1999
• Est. Priority Date: 10/23/1996
• Status: Expired due to Fees

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Latson, Larry A., Kapitan, John M.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): PHAM, THUY D
• Application Number:
  US08/734,862
• Time in Patent Office: 818 Days
• Field of Search: 606/213, 606/214, 606/215, 606/216, 606/151, 606/232, 606/220, 606/157, 623/12, 600/32, 128/898, 128/899, 128/887
• 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

An apparatus and a method for occluding an aperture within a body surface, including an occlusion bag having a proximal sac and a distal sac, a delivery catheter, a guide catheter, a super-elastic wire, a release mechanism and a delivery sheath. The method of the invention includes affixing the delivery catheter to the proximal sac and then inserting the guide catheter into the delivery catheter. The super-elastic wire is attached to the release mechanism and the wire, release mechanism, occlusion bag, guide catheter and delivery catheter are inserted into a delivery sheath for transport to the aperture. After delivery, the occlusion bag is placed within the aperture and the wire is deployed within the bag. The bag and wire are repositioned if necessary, and the release mechanism is activated to release the wire. The guide catheter, delivery catheter, release mechanism and delivery sheath are then withdrawn.

Claims

1. A method for occluding an aperture within a body surface comprising the steps of:

a) providing an occlusion bag comprising a proximal sac and a distal sac, said proximal sac connected to said distal sac by a central and said proximal sac having a proximal connector oriented opposite said central connector;

b) affixing a delivery catheter to said proximal connector of said occlusion bag;

c) inserting a guide catheter into said delivery catheter;

d) affixing a proximal end of a super-elastic wire to a release mechanism;

e) inserting said super-elastic wire and said release mechanism into said guide catheter;

f) collapsing proximal and distal sacs of said occlusion bag;

g) inserting a sub-assembly comprising said occlusion bag, said guide catheter, said delivery catheter, said super-elastic wire and said release mechanism, into a delivery sheath;

h) transporting and positioning said delivery sheath containing said sub-assembly into said aperture;

i) withdrawing said delivery sheath from said aperture to expose said sub-assembly;

j) advancing said distal sac of said occlusion bag into a distal portion of said aperture, withdrawing said guide catheter to a mid-portion of said distal sac, advancing a distal portion of said super-elastic wire into said distal sac, and deploying said distal portion of said super-elastic wire within said distal sac of said occlusion bag wherein said super-elastic wire is movably contained within said occlusion bag;

k) withdrawing said delivery sheath to expose said proximal sac of said occlusion bag, withdrawing said guide catheter to a portion of said proximal sac, advancing a proximal portion of said super-elastic wire into said proximal sac, and deploying said proximal portion of said super-elastic wire within said proximal sac of said occlusion bag;

l) activating said release mechanism to release said super-elastic wire within said occlusion bag;

m) withdrawing said guide catheter from said occlusion bag;

n) disengaging and withdrawing said delivery catheter from said occlusion bag; and

o) withdrawing said delivery sheath containing said delivery catheter, said guide catheter and said release mechanism.

2. The method of claim 1 wherein activating said release mechanism to release said super-elastic wire causes said super-elastic wire to form a wire frame movably contained within and seperate from said occlusion bag and said wire frame is comprised of multiple loops.

3. The method of claim 1 wherein prior to the step of activating said release mechanism, said super-elastic wire and said occlusion bag may be repositioned within the aperture.

4. An apparatus for occluding an aperture within a body surface comprising:

a) an occlusion bag comprising a proximal sac, and distal sac, said proximal sac connected to said distal sac by a central connector and said proximal sac having a proximal connector oriented opposite said central connector;

b) a delivery catheter removably attached to said proximal connector of said occlusion bag;

c) a guide catheter inserted into said delivery catheter and movably contained within said occlusion bag;

d) a super-elastic wire having a proximal end and a distal end and insertable into said guide catheter wherein said super-elastic wire is movably contained within said occlusion bag;

e) a release mechanism connected to said proximal end of sid super-elastic wire;

f) said occlusion bag, said delivery catheter, said guide catheter, said super-elastic wire and said release mechanism comprising a sub-assembly; and

g) a delivery sheath for containing delivering and deploying said sub-assembly to the aperture.

5. The apparatus of claim 4 wherein said super-elastic wire may be deployed within said occlusion bag as a super-elastic wire frame and the super-elastic wire frame is movably contained within and seperate from said occlusion bag.

6. An apparatus for occluding an aperture within a body surface comprising:

a) an occlusion bag comprising a proximal sac and a distal sac, said proximal sac connected to said distal sac by a central connector and said proximal sac having a proximal connector oriented opposite said central connector; and

b) a super-elastic wire frame having two sets of multiple loops wherein said super-elastic wire frame is movably contained within and unattached to said occlusion bag.

7. A method for occluding an aperture within a body surface comprising the steps of:

a) providing an occlusion bag comprising a proximal sac and a distal sac, said proximal sac connected to said distal sac by a central connector and said proximal sac having a proximal connector oriented opposite said central connector;

b) affixing a delivery catheter to said proximal connector of said occlusion bag;

c) inserting a guide catheter into said delivery catheter;

d) affixing a proximal end of a super-elastic wire to a release mechanism;

e) inserting said super-elastic wire and release mechanism into said guide catheter

f) collapsing said proximal and distal sacs of said occlusion bag;

g) inserting a sub-assembly comprising said occlusion bag, said guide catheter, said delivery catheter, said super-elastic wire and said release mechanism into a delivery sheath;

h) transporting and positioning said delivery sheath containing said sub-assembly into said aperture;

i) withdrawing said delivery sheath from said aperture to expose said sub-assembly;

j) advancing said distal sac of said occlusion bag into a distal portion of said aperture, withdrawing said guide catheter to a mid-portion of said distal sac, advancing a distal portion of said super-elastic wire into said distal sac, and deploying said distal portion of super-elastic within said distal sac of said occlusion bag;

k) withdrawing said sheath to expose said proximal sac of said occlusion bag, withdrawing said guide catheter to a portion of sid proximal sac, advancing a proximal portion of said super-elastic wire into said proximal sac, and deploying said proximal portion of super-elastic wire within said proximal sac of said occlusion bag and said super-elastic wire is deployed within and unattached to said occlusion bag; and

l) repositioning said super-elastic wire and said occlusion bag within the aperature.