INTRA-ESOPHAGEAL BALLOON SYSTEM

• US 20110082488A1
• Filed: 07/30/2010
• Published: 04/07/2011
• Est. Priority Date: 10/06/2009
• Status: Active Grant

• Current Assignee: Niazi Patent Holdings LLC
• Original Assignee: Niazi Licensing Corporation
• Inventors: Niazi, Imran K.
• Granted Patent: US 9,937,329 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device and system are disclosed for selective inflation of an inflatable body, such as a balloon, received through an oral cavity and into the esophagus of a patient. The inflatable body is operably coupled to a pressurized fluid source. The inflatable body has a relatively flexible portion and a relatively inflexible portion. When pressurized fluid is delivered to the body to inflate the body, the flexible portion expands more than the inflexible portion, resulting in asymmetrical expansion and movement of the esophagus away from the ablation site to avoid accidental injury while performing a procedure on the patient'"'"'s left atrium. This movement may be opposite from or directly away from the heart or, alternatively, may be sideways relative to the heart to a location in which the esophagus is interposed between the ablation site and the phrenic nerve. The supplied fluid may be radio-opaque liquid to allow for imaging thereof to assist in positioning the balloon. The liquid may additionally be relatively cool as compared to the patient'"'"'s body temperature so serve as a heat sink against heat applied to surrounding areas.

Claims

1. An intra-esophageal inflation device comprising:

a balloon configured for selective insertion into an esophagus, the balloon having a proximal end and a distal end with respect to an oral cavity of a patient, wherein, when viewed in transverse cross section, the balloon has a relatively flexible portion and a relatively inflexible portion; and

a source of pressurized fluid configured to selectively deliver the fluid to the balloon, wherein,

upon inflation of the balloon while inserted into the esophagus, the balloon expands asymmetrically and causes the esophagus to move in a transverse direction.

2. The intra-esophageal inflation device of claim 1, wherein the inflexible portion of the balloon comprises an elongate strip extending along one side of the balloon.

3. The intra-esophageal inflation device of claim 1, wherein the source of pressurized fluid comprises a pump and a reservoir operably coupled to a pump, and wherein the pump is configured to deliver the fluid to the balloon.

4. The intra-esophageal inflation device of claim 3, wherein the inflexible portion of the balloon is integrally formed with the flexible portion thereof.

5. The intra-esophageal inflation device of claim 3, wherein the inflexible portion of the balloon comprises a strip of stiffening material mounted to an exterior of the balloon, wherein an entire inner circumference of the balloon is constructed from flexible material.

6. The intra-esophageal inflation device of claim 1, wherein the balloon is at least substantially circular in cross section when uninflated.

7. The intra-esophageal inflation device of claim 1, wherein the fluid is a liquid at a temperature substantially below that of a body temperature.

8. The intra-esophageal inflation device of claim 7, wherein the liquid is iced saline.

9. The intra-esophageal inflation device of claim 1, wherein the fluid is radiopaque.

10. The intra-esophageal inflation device of claim 1, further comprising a relief valve that relieves pressure from the balloon when the pressure exceeds a predetermined pressure.

11. The intra-esophageal inflation device of claim 1, further comprising a plurality of electrodes coupled to the balloon and an electrical power source by way of a conductor, and wherein the plurality of electrodes are configured to operably communicate with a three-dimensional mapping system to allow a three-dimensional model of the balloon to be rendered.

12. The intra-esophageal inflation device of claim 1, further comprising at least one temperature sensor configured to detect a temperature of the balloon within the esophagus.

13. The intra-esophageal inflation device of claim 1, wherein, when inflated in the absence of an obstruction to a pressure of 60 mm the balloon expands at least 10% more, on one side of a longitudinal bisector of the balloon than the other side.

14. A method of preventing injury to an esophagus during ablation site on a heart, the method comprising the steps of:

inserting a selectively inflatable balloon into a patient'"'"'s esophagus, wherein, when viewed in transverse cross section, the balloon has a relatively flexible portion and a relatively inflexible portion, the inflexible portion being located relatively close to the patient'"'"'s heart;

inflating the balloon asymmetrically to move at least a portion of the esophagus away from the ablation site;

ablating the tissue of the heart; and

removing the balloon from the esophagus.

15. The method of claim 14, wherein the step of inflating the balloon is accomplished by introducing a pressurized liquid to the balloon.

16. The method of claim 15, further comprising the step cooling the liquid, wherein the cooled liquid serves to provide the esophagus with a heat sink such that the esophagus is further protected against injury during the ablating step.

17. The method of claim 15, wherein the liquid is radio-opaque.

18. The method of claim 14, further comprising the step of releasing excess pressure from the balloon by way of a relief valve.

19. The method of claim 14, wherein, at its maximum point of distortion, the esophagus preferably moves at least 5 mm, and more preferably at least 20 mm, laterally away from its initial position.

20. An inflation device for insertion into a patient'"'"'s esophagus, the inflation device being adapted for selective movement of a portion of the esophagus, the inflation device comprising:

a body which, when viewed in transverse cross section, is has a relatively flexible portion and a relatively inflexible portion,

a fluid delivery device that selectively delivers a pressurized liquid to the body, wherein flow of pressurized liquid into the body from the fluid delivery device causes the body to inflate such that the flexible portion of the body expands more than the inflexible portion, thereby expanding the body asymmetrically to move the esophagus in a direction substantially away from the patient'"'"'s heart to avoid accidental injury to the esophagus while a procedure is performed on the heart; and

a relief valve operably coupled to an end of the body for the selective release of excess pressure from the body once a predetermined pressure is reached.