Balloon assisted occlusion device

• US 8,292,907 B2
• Filed: 08/31/2007
• Issued: 10/23/2012
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Kurrus, Michael R.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): EASTWOOD, DAVID C
• Application Number:
  US11/848,777
• Publication Number:
  US 20090062836A1
• Time in Patent Office: 1,880 Days
• Field of Search: 623/2.11, 623/1.21, 604/101.01, 604/101.03, 604/101.05, 128/831, 128/843, 128/887
• US Class Current: 606/157
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22065 Functions of balloons dilating A61M29/02
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A vascular occlusion device for occluding a body cavity. The device includes an elongate member having an inflation lumen, an occlusion lumen, and a first portion extending distally from a proximal end and a second portion extending distally from the first portion to the distal end. An inflatable proximal balloon is disposed about the first portion and an inflatable distal balloon is disposed about the second portion. The inflation lumen is configured to inflate at least one of the balloons. The occlusion lumen is configured to introduce an occlusive material into the body cavity by way of an occlusion port located between the two balloons to occlude the body cavity. In some examples, the body cavity includes a patent foramen ovale.

Claims

1. A vascular occlusion device for occluding a body cavity defined by cavity walls, the device comprising:

an elongate member extending from a proximal end to a distal end and including a first portion extending distally from the proximal end and a second portion extending distally from the first portion to the distal end, a first inflation lumen and an occlusion lumen being formed longitudinally in the first portion, and a second inflation lumen being formed longitudinally in the second portion;

an occlusive material configured to permanently occlude the body cavity disposed within the occlusion lumen, the occlusive material including extracellular matrix (ECM);

an inflatable proximal balloon including a proximal balloon wall being disposed about the first portion and defining a proximal balloon interior;

an inflatable distal balloon including a distal balloon wall being disposed about the second portion and defining a distal balloon interior;

the first and second portions respectively having first and second inflation orifices, the first inflation lumen being configured to introduce an inflation fluid into at least one of the balloon interiors by way of the respective inflation orifices; and

the elongate member having an occlusion port defined between the proximal and distal balloons, the occlusion lumen being configured to introduce the occlusive material into the body cavity by way of the occlusion port to occlude the body cavity;

wherein a first removable film is attached to a distal part of the proximal balloon and a second removable film is attached to a proximal part of the distal balloon, the removable films being configured to inflate with the balloons, attach to the occlusive material following introduction of the occlusive material into the body cavity, and detach from the balloons upon deflation of the balloons.

2. The device of claim 1 wherein the second inflation lumen is in fluid communication with the first inflation lumen, the first inflation lumen being configured to introduce the inflation fluid into each of the balloon interiors by way of the respective inflation orifices and the second inflation lumen.

3. The device of claim 1 wherein the elongate member further comprises an inner wall defining an inner lumen extending through the distal end of the elongate member.

4. The device of claim 1 wherein the occlusive material further includes at least one of a polyvinyl alcohol and a cyanoacrylate, and the extracellular matrix (ECM) includes small intestine submucosa.

5. The device of claim 1 wherein an occlusion device is disposed about the occlusion port to provide a support structure for the occlusive material.

6. The device of claim 5 wherein the occlusion device includes an embolization coil.

7. The device of claim 1 wherein the balloons are removably attached to the elongate member.

11. The device of claim 1 wherein the extracellular matrix (ECM) includes small intestine submucosa provided in a gel form.

8. A vascular occlusion assembly for occluding a body cavity defined by cavity walls, the assembly comprising:

an outer sheath having a proximal section extending to a distal section and defining a sheath lumen therein, an elongate vascular occlusion device being disposed within the sheath lumen and the outer sheath being configured to translate axially relative to the elongate occlusion device;

the occlusion device comprising an elongate member extending from a proximal end to a distal end and including a first portion extending distally from the proximal end, a second portion extending distally from the first portion to the distal end, a first inflation lumen and an occlusion lumen being formed longitudinally in the first portion, a second inflation lumen being formed longitudinally in the second portion, and an inner wall defining an inner lumen extending longitudinally through the elongate member, the inner lumen extending through the distal end of the elongate member;

an occlusive material configured to permanently occlude the body cavity disposed within the occlusion lumen, the occlusive material including extracellular matrix (ECM);

an inflatable proximal balloon including a proximal balloon wall being disposed about the first portion and defining a proximal balloon interior;

an inflatable distal balloon including a distal balloon wall being disposed about the second portion and defining a distal balloon interior;

the first and second portions respectively having first and second inflation orifices, the first inflation lumen being configured to introduce an inflation fluid into at least one of the balloon interiors by way of the respective inflation orifices; and

the elongate member having an occlusion port defined between the proximal and distal balloons, the occlusion lumen being configured to introduce the occlusive material into the body cavity by way of the occlusion port; and

a longitudinally extending wire guide being disposed within the inner lumen and configured such that the elongate occlusion device may translate axially along the wire guide;

wherein a first removable film is attached to a distal part of the proximal balloon and a second removable film is attached to a proximal part of the distal balloon, the removable films being configured to inflate with the balloons, attach to the occlusive material following introduction of the occlusive material into the body cavity, and detach from the balloons upon deflation of the balloons.

9. The device of claim 8 wherein the second inflation lumen is in fluid communication with the first inflation lumen, the first inflation lumen being configured to introduce the inflation fluid into each of the balloon interiors by way of the respective inflation orifices and the second inflation lumen.

10. The device of claim 8 wherein the occlusive material further includes at least one of a polyvinyl alcohol and a cyanoacrylate, and the extracellular matrix includes small intestine submucosa.

12. A vascular occlusion device for occluding a body cavity defined by cavity walls, the device comprising:

an elongate member extending from a proximal end to a distal end and including a first portion extending distally from the proximal end and a second portion extending distally from the first portion to the distal end, a first inflation lumen and an occlusion lumen being formed longitudinally in the first portion, and a second inflation lumen being formed longitudinally in the second portion;

an occlusive material configured to permanently occlude the body cavity disposed within the occlusion lumen, the occlusive material including extracellular matrix (ECM);

an inflatable proximal balloon including a proximal balloon wall being disposed about the first portion and defining a proximal balloon interior;

an inflatable distal balloon including a distal balloon wall being disposed about the second portion and defining a distal balloon interior;

the first and second portions respectively having first and second inflation orifices, the first inflation lumen being configured to introduce an inflation fluid into at least one of the balloon interiors by way of the respective inflation orifices; and

the elongate member having an occlusion port defined between the proximal and distal balloons, the occlusion lumen being configured to introduce the occlusive material into the body cavity by way of the occlusion port to occlude the body cavity,

wherein the second inflation lumen is in fluid communication with the first inflation lumen, the first inflation lumen being configured to introduce the inflation fluid into each of the balloon interiors by way of the respective inflation orifices and the second inflation lumen, and

wherein the inflatable proximal balloon and the inflatable distal balloon are disposed adjacent to each other about the elongate member with no intervening inflatable balloons disposed therebetween;

wherein a first removable film is attached to a distal part of the proximal balloon and a second removable film is attached to a proximal part of the distal balloon, the removable films being configured to inflate with the balloons, attach to the occlusive material following introduction of the occlusive material into the body cavity, and detach from the balloons upon deflation of the balloons.

13. The device of claim 12, the inflatable proximal and distal balloons being integrally formed with the elongate member.

14. The device of claim 13 wherein the extracellular matrix (ECM) includes small intestine submucosa provided in a gel form.

15. A vascular occlusion device for occluding a body cavity defined by cavity walls, the device comprising:

an elongate member extending from a proximal end to a distal end and including a first portion extending distally from the proximal end and a second portion extending distally from the first portion to the distal end, a first inflation lumen and an occlusion lumen being formed longitudinally in the first portion, and a second inflation lumen being formed longitudinally in the second portion;

an inflatable proximal balloon including a proximal balloon wall being disposed about the first portion and defining a proximal balloon interior;

an inflatable distal balloon including a distal balloon wall being disposed about the second portion and defining a distal balloon interior;

the first and second portions respectively having first and second inflation orifices, the first inflation lumen being configured to introduce an inflation fluid into at least one of the balloon interiors by way of the respective inflation orifices; and

the elongate member having an occlusion port defined between the proximal and distal balloons, the occlusion lumen being configured to introduce an occlusive material into the body cavity by way of the occlusion port to occlude the body cavity;

wherein a first removable film is attached to a distal part of the proximal balloon and a second removable film is attached to a proximal part of the distal balloon, the removable films being configured to inflate with the balloons, attach to the occlusive material following introduction of the occlusive material into the body cavity, and detach from the balloons upon deflation of the balloons.