APPARATUS AND METHODS FOR MINIMALLY INVASIVE OBESITY TREATMENT

• US 20080195092A1
• Filed: 11/02/2007
• Published: 08/14/2008
• Est. Priority Date: 11/03/2006
• Status: Active Grant

• Current Assignee: GEP Technology, Inc.
• Original Assignee: GEP Technology, Inc.
• Inventors: Kim, Daniel H., Robeson, David J.
• Granted Patent: US 8,874,216 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Systems, apparatus, and methods for the treatment of obesity and/or gastro-esophageal reflux disease (GERD). An embodiment includes an implantable device having an adjustable curved portion configured for exerting a suitable mechanical force on one or more tissues or organs targeted for treatment. Embodiments of the device neuromodulate nerve tissue to effect treatment of obesity and/or GERD. Another embodiment includes an intraluminal guide for guiding placement of the implantable device in the patient.

Claims

1. A method for treating a patient, comprising:

a) placing a device extraluminally with respect to the esophagus such that said device at least partially encircles the esophagus of the patient, wherein;

said device includes a curved portion configured for radially outward expansion thereof, and

said radially outward expansion is independent of any radially inward expansion of said curved portion; and

b) expanding said curved portion in at least one dimension, such that a surface of said curved portion exerts a mechanical force on at least one tissue or organ of the patient.

2. The method of claim 1, wherein said placing step comprises advancing a linear conformation of said device sub-fascially around the esophagus and beneath the diaphragmatic fascia of the patient, whereby said linear conformation is transformed to an arcuate conformation.

3. The method of claim 1, wherein said placing step comprises placing said device within esophageal tissue, whereby said device is retained in an arcuate conformation extraluminally around the esophagus at a location in at least close proximity to the gastro-esophageal junction.

4. The method of claim 1, wherein said placing step comprises placing said device within esophageal tissue between an outer muscular layer of the esophagus and a fascial layer of the esophagus.

5. The method of claim 1, wherein said placing step comprises placing said device at the gastro-esophageal junction, the esophageal-diaphragmatic junction, or the gastro-diaphragmatic junction of the patient.

6. The method of claim 1, wherein:

said expanding step comprises expanding said curved portion radially outward or radially inward,

the tissue comprises nerve tissue, and

said mechanical force comprises a first mechanical force sufficient to mechanically neuromodulate the nerve tissue.

7. The method of claim 1, wherein:

said curved portion is configured for radially inward expansion thereof, and

said radially inward expansion is independent of said radially outward expansion of said curved portion.

8. A method for treating a patient, comprising:

a) advancing a linear conformation of a device sub-fascially around the esophagus of the patient, whereby said linear conformation is transformed to an arcuate conformation; and

b) disposing said arcuate conformation beneath the diaphragmatic fascia at the distal esophagus.

9. The method of claim 8, wherein said advancing step comprises advancing said device along a path of least resistance such that said arcuate conformation at least partially encircles the esophagus.

10. The method of claim 8, further comprising:

c) prior to step a), implanting said device beneath the diaphragmatic fascia of the patient, and wherein said advancing comprises pushing said linear conformation sub-fascially around the esophagus.

11. A method for treating a patient, comprising:

a) advancing a first segment of a device from a first side of the patient'"'"'s body towards a first side of the patient'"'"'s esophagus;

b) advancing a second segment of said device from a second side of the patient'"'"'s body towards a second side of the patient'"'"'s esophagus;

c) at least partially encircling the esophagus with at least one of said first segment and said second segment; and

d) coupling said first and second segments.

12. The method of claim 11, further comprising:

e) prior to step d), implanting at least one of said first segment and said second segment beneath the diaphragmatic fascia of the patient.

13. The method of claim 11, wherein:

said device includes an expandable curved portion, and the method further comprises;

f) expanding said curved portion to an expanded configuration;

g) via step f), exerting a mechanical force on at least one nerve tissue; and

h) via said mechanical force, mechanically neuromodulating the nerve tissue.

14. A method for treating a patient, comprising:

a) placing a device around the esophagus of the patient such that said device at least partially encircles the esophagus, wherein said device includes;

a curved portion configured for transformation between an expanded configuration and an unexpanded configuration, and

at least one electrode disposed on said curved portion; and

b) via said electrode, applying an electrical signal to at least one nerve tissue, wherein said electrical signal is sufficient to electrically neuromodulate the nerve tissue.

15. A method for treating gastro-esophageal reflux disease in a patient, comprising:

a) implanting a device beneath the diaphragmatic fascia of the patient;

b) disposing said device sub-fascially at the distal end of the esophagus; and

c) disposing said device extraluminally around the esophagus, wherein said device inhibits reflux from the stomach into the esophagus.

16. A method for treating a patient, comprising:

a) placing a device extraluminally with respect to the esophagus such that said device at least partially encircles the esophagus of the patient, wherein;

said device includes a curved portion configured for exerting a mechanical force, on at least one tissue or organ, via adjustment of a diameter of said curved portion,

said curved portion is cannulated to allow passage of a filament therethrough, said device further includes a collar configured for slidably accommodating a first strand and a second strand of said filament, and

said device is configured for adjusting said diameter of said curved portion by passage of at least one of said first strand and said second strand of said filament within said collar; and

b) via said passage of said filament, adjusting said diameter of said curved portion.

17. The method of claim 16, wherein step a) comprises embedding said device within esophageal tissue at the distal esophagus.

18. The method of claim 16, further comprising:

c) after step b), locking said collar with respect to movement of said filament relative to said collar.

19. A device comprising:

at least one curved portion, wherein;

said device is configured for radially outward expansion of said curved portion independently of radially inward expansion of said curved portion, and

said curved portion is configured for at least partially encircling the esophagus of a patient.

20. An apparatus for treating a patient, said apparatus comprising:

a device including at least one curved portion, wherein said curved portion includes at least one expandable element for expanding said curved portion in at least one dimension; and

at least one electrode disposed on said curved portion, wherein said device is configured for making electrical contact with a targeted nerve tissue of the patient.

21. The apparatus of claim 20, wherein expansion of said curved portion urges said electrode into said electrical contact with the nerve tissue.

22. The apparatus of claim 20, wherein said device is configured for at least partially encircling the esophagus of the patient.

23. A system for treating a patient, comprising:

an introducer element including a shaft, said shaft having a proximal end and a distal end, wherein said introducer element is adapted for insertion of said distal end into the thorax or abdomen of the patient; and

a device for implantation within the patient, said device adapted for passage within said shaft, said device configured for adopting a substantially linear conformation when said device is disposed within said shaft, and said device further configured for adopting a substantially arcuate conformation when said device is implanted in the patient, said device including an expandable curved portion formed from said arcuate conformation, said curved portion is configured for at least partially encircling the esophagus of the patient, said curved portion having an internal diameter and an external diameter, and said device is configured for adjusting said external diameter independently of adjustment of said internal diameter.