Intra-esophageal balloon system

• US 9,937,329 B2
• Filed: 07/30/2010
• Issued: 04/10/2018
• Est. Priority Date: 10/06/2009
• Status: Active Grant

• Current Assignee: Niazi Patent Holdings LLC
• Original Assignee: Niazi Licensing Corporation
• Inventors: Niazi, Imran K.
• Primary Examiner(s): Houston, Elizabeth
• Assistant Examiner(s): MENDOZA, MICHAEL G
• Application Number:
  US12/847,018
• Publication Number:
  US 20110082488A1
• Time in Patent Office: 2,811 Days
• Field of Search: 606192, 606196
• 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 with different compartments A61M2025/1072
• 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.

Claims

1. An intra-esophageal inflation device for esophageal deformation in a human comprising:

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

a supply tube having a proximal end and having a distal end that opens into the proximal end of the balloon; and

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

in an uninflated state of the balloon, the balloon extends at least generally linearly and has a longitudinal bisector extending from the proximal end thereof to the distal end thereof, wherein

upon inflation of the balloon while inserted into the esophagus, the balloon expands and assumes an inflated state in which the balloon is expanded asymmetrically but circumferentially about an axial centerline of the balloon and asymmetrically about the longitudinal bisector of the balloon and in which the balloon as a whole, including the relatively inflexible portion, is bent or bowed in a common direction relative to the longitudinal bisector, wherein

inflation of the balloon causes the esophagus to move in a transverse direction, and wherein

the inflexible portion of the balloon is formed by a stiffening strip embedded in or attached to a surface of the balloon and being no longer than a length of the balloon.

2. 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.

3. The intra-esophageal inflation device of claim 2, wherein the relatively inflexible portion of the balloon is integrally formed with the relatively flexible portion thereof.

4. The intra-esophageal inflation device of claim 2, wherein the stiffening strip is mounted to an exterior of the balloon, wherein an entire inner circumference of the balloon is constructed from a flexible material.

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

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

7. The intra-esophageal inflation device of claim 6, wherein the liquid is iced saline.

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

9. 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.

10. The intra-esophageal inflation device of claim 1, further comprising a plurality of electrodes positioned in the balloon and coupled to 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.

11. 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.

12. 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.

13. The intra-esophageal inflation device of claim 1, wherein the relatively inflexible portion of the balloon includes a stiffening strip that is integrally formed with a wall of the balloon.

14. The intra-esophageal inflation device of claim 1, wherein no structures extend completely through an interior of the balloon from the proximal end thereof to the distal end thereof.

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

a tube having a first end and a second end;

a body having a proximal end and a distal end with respect to an oral cavity of a human patient, wherein the proximal end is coupled to the second end of the tube and, when viewed in transverse cross section, has a relatively flexible portion and a relatively inflexible portion;

a fluid delivery device that selectively delivers a pressurized liquid to the body through the tube, wherein

in an uninflated state of the balloon, the body extends at least generally linearly and has a longitudinal bisector extending from the proximal end thereof to the distal end thereof,

in an inflated state of the balloon, the body as a whole, including the relatively inflexible portion, is bent or bowed in a common direction relative to the longitudinal bisector, wherein

flow of pressurized liquid into the body from the fluid delivery device and the tube causes the body to inflate and distort from the uninflated state thereof to the inflated state thereof such that the flexible portion of the body expands more than the inflexible portion, thereby expanding the body asymmetrically but circumferentially about an axial centerline of the balloon, and to cause the esophagus to move in a transverse direction substantially away from the patient'"'"'s heart to avoid accidental injury to the esophagus while a procedure is performed on the heart, wherein the relatively inflexible portion of the body is formed by a stiffening strip embedded in or attached to a surface of the balloon and being no longer than a length of the body; and

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

16. The inflation device of claim 15, wherein the relatively inflexible portion of the body is integrally formed within a wall of the body.

17. The intra-esophageal inflation device of claim 15, wherein no structures extend completely through an interior of the body from the proximal end thereof to the distal end thereof.

18. An intra-esophageal inflation device for esophageal deformation in a human comprising:

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

a supply tube having a proximal end and having a distal end that opens into the proximal end of the balloon; and

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

in an uninflated state of the balloon, the balloon extends at least generally linearly and has a longitudinal bisector extending from the proximal end thereof to the distal end thereof, wherein

upon inflation of the balloon while inserted into the esophagus, the balloon expands and assumes an inflated state in which the balloon is expanded asymmetrically about the longitudinal bisector of the balloon and the balloon as a whole, including the relatively inflexible portion, is bent or bowed in a common direction relative to the longitudinal bisector, wherein

inflation of the balloon causes the esophagus to move in a transverse direction, and wherein

the inflexible portion of the balloon is formed by a stiffening strip embedded in or attached to a surface of the balloon and being no longer than a length of the balloon, and wherein

the stiffening strip has a width of 1 mm to 2 cm.

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

a tube having a first end and a second end;

a body having a proximal end and a distal end with respect to an oral cavity of a human patient, wherein the proximal end is coupled to the second end of the tube and, when viewed in transverse cross section, has a relatively flexible portion and a relatively inflexible portion;

a fluid delivery device that selectively delivers a pressurized liquid to the body through the tube, wherein

in an uninflated state of the balloon, the body extends at least generally linearly and has a longitudinal bisector extending from the proximal end thereof to the distal end thereof,

in an inflated state of the balloon, the body is expanded asymmetrically about the longitudinal bisector and the body as a whole, including the relatively inflexible portion, is bent or bowed in a common direction relative to the longitudinal bisector, wherein

flow of pressurized liquid into the body from the fluid delivery device and the tube causes the body to inflate and distort from the uninflated state thereof to the inflated state thereof such that the flexible portion of the body expands more than the inflexible portion, and to cause the esophagus to move in a transverse direction substantially away from the patient'"'"'s heart to avoid accidental injury to the esophagus while a procedure is performed on the heart, wherein the relatively inflexible portion of the body is formed by a stiffening strip embedded in or attached to a surface of the balloon and being no longer than a length of the body; and

a relief valve operably coupled to the distal end of the body for the selective release of excess pressure from the body once a predetermined pressure is reached, and wherein

the stiffening strip has a width of 1 mm to 2 cm.

20. An intra-esophageal inflation device for esophageal deformation in a human comprising:

a balloon configured for selective insertion into an esophagus of a human, the balloon having a proximal end and a distal end with respect to an oral cavity of a patient and having a circumference, wherein, when viewed in transverse cross section, the balloon has a first, relatively flexible portion and a second, relatively inflexibly portion spaced circumferentially from the first portion;

a supply tube having a proximal end and having a distal end that opens into the proximal end of the balloon; and

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

in an uninflated state of the balloon, the balloon extends at least generally linearly and has a longitudinal bisector extending from the proximal end thereof to the distal end thereof, wherein

upon inflation of the balloon while inserted into the esophagus, the balloon expands and assumes an inflated state in which the balloon is expanded asymmetrically about the longitudinal bisector of the balloon and the balloon as a whole, including the relatively inflexible portion, is bent or bowed in a common direction relative to the longitudinal bisector, wherein

inflation of the balloon causes the esophagus to move in a transverse direction, and wherein

the inflexible portion of the balloon is formed by a stiffening strip embedded in or attached to a surface of the balloon and being no longer than a length of the balloon

wherein, in the inflated state thereof, the balloon has a length of 4 cm to 7 cm and a diameter of less than or equal to 2 cm.

21. An intra-esophageal inflation device for esophageal deformation in a human comprising:

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

a supply tube having a proximal end and having a distal end that opens into the proximal end of the balloon; and

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

in an uninflated state of the balloon, the balloon extends at least generally linearly and has a longitudinal bisector extending from the proximal end thereof to the distal end thereof, wherein

upon inflation of the balloon while inserted into the esophagus, the balloon expands and assumes an inflated state in which the balloon is expanded asymmetrically about the longitudinal bisector of the balloon and the balloon as a whole, including the relatively inflexible portion, is bent or bowed in a common direction relative to the longitudinal bisector, wherein

inflation of the balloon causes the esophagus to move in a transverse direction, and wherein

the inflexible portion of the balloon is formed by a stiffening strip embedded in or attached to a surface of the balloon and being no longer than a length of the balloon, and wherein,

in the inflated state thereof, the balloon has a diameter of less than or equal to 2 cm.