Systems and methods for treating obesity and other gastrointestinal conditions
View Patent ↗Systems and methods affect tightening of the pyloric sphincter and/or serve to mediate or moderate receptive relaxation of muscles in the stomach, to treat or mitigate various physiologic conditions, such as obesity, biliary reflex, GERD, and/or Barrett's esophagus. The systems and methods may be used as either a primary treatment modality, or applied as a supplementary treatment before, during or after a primary intervention.
1. A method to treat obesity comprising
(i) providing an expandable member expandable between a collapsed condition and an expanded condition, the expandable member including at least one energy-delivery electrode movable between a retracted position within the expandable member and an extended position piercing tissue,
(ii) introducing the expandable member into a pyloric sphincter in the collapsed condition and with the energy-delivery electrode in the retracted position,
(iii) expanding the expandable member to dilate the pyloric sphincter,
(iv) moving the energy-delivery electrode into the extended position piercing tissue in, at or near the pyloric sphincter,
(v) delivering energy through the energy-delivery electrode to ablate tissue in, at, or near the pyloric sphincter to create a first lesion pattern,
(vi) moving the energy-delivery electrode into the retracted position,
(vii) axially advancing or retracting the expandable member to reposition the energy-delivery electrode with respect to the pyloric sphincter, and
(viii) moving the energy-delivery electrode into the extended position piercing tissue in, at or near the pyloric sphincter,
(ix) delivering energy through the energy-delivery electrode to ablate tissue in, at, or near the pyloric sphincter to create another lesion pattern, and
(x) repeating (vi) to (ix) until a desired pattern of multiple lesions spaced apart axially along the pyloric sphincter is formed to affect tightening of the pyloric sphincter.
2. A method as in claim 1 , further comprising applying a treatment agent in, at, or near the pyloric sphincter.
3. A method as in claim 2 wherein the treatment agent leads to a physical tightening of the sphincter.
4. A method as in claim 3 wherein the treatment agent is a cytokine subtype.
5. A method as in claim 3 wherein the treatment agent is a tissue bulking agent.
6. A method as in claim 2 wherein the treatment agent is selected from a class of agents that interrupt afferent nerve impulses that trigger transient sphincter relaxation.
7. A method as in claim 6 wherein the treatment agent is a vanilloid.
8. A method as in claim 1 wherein the expandable member is introduced using an endoscope.
9. A method as in claim 1 wherein the expandable structure includes an array of tubular spines that form a basket.
10. A method as in claim 9 wherein the expandable structure further comprises an inflatable body within the basket.
11. A method as in claim 10 wherein the inflatable body is a balloon.
12. A method as in claim 9 wherein one of the spines includes a lumen sized and configured for passage of a guidewire.
13. A method as in claim 9 wherein at least one spine includes a lumen sized and configured to convey a cooling liquid.
14. A method as in claim 1 , further comprising delivering a cooling fluid in, at, or near the pyloric sphincter.
15. A method to treat biliary reflux comprising
(i) providing an expandable member expandable between a collapsed condition and an expanded condition, the expandable member including at least one energy-delivery electrode movable between a retracted position within the expandable member and an extended position piercing tissue,
(ii) introducing the expandable member into a pyloric sphincter in the collapsed condition and with the energy-delivery electrode in the retracted position,
(iii) expanding the expandable member to dilate the pyloric sphincter,
(iv) moving the energy-delivery electrode into the extended position piercing tissue in, at or near the pyloric sphincter,
(v) delivering energy through the energy-delivery electrode to ablate tissue in, at, or near the pyloric sphincter to create a first lesion pattern,
(vi) moving the energy-delivery electrode into the retracted position,
(vii) axially advancing or retracting the expandable member to reposition the energy-delivery electrode with respect to the pyloric sphincter, and
(viii) moving the energy-delivery electrode into the extended position piercing tissue in, at or near the pyloric sphincter,
(ix) delivering energy through the energy-delivery electrode to ablate tissue in, at, or near the pyloric sphincter to create another lesion pattern, and
(x) repeating (vi) to (ix) until a desired pattern of multiple lesions spaced apart axially along the pyloric sphincter is formed to affect tightening of the pyloric sphincter.
16. A method as in claim 15 , further comprising applying a treatment agent in, at, or near the pyloric sphincter.
17. A method as in claim 16 wherein the treatment agent leads to a physical tightening of the sphincter.
18. A method as in claim 17 wherein the treatment agent is a cytokine subtype.
19. A method as in claim 17 wherein the treatment agent is a tissue bulking agent.
20. A method as in claim 16 wherein the treatment agent is selected from a class of agents that interrupt afferent nerve impulses that trigger transient sphincter relaxation.
21. A method as in claim 20 wherein the treatment agent is a vanilloid.
22. A method as in claim 15 wherein the expandable member is introduced using an endoscope.
23. A method as in claim 15 wherein the expandable structure includes an array of tubular spines that form a basket.
24. A method as in claim 23 wherein the expandable structure further comprises an inflatable body within the basket.
25. A method as in claim 24 wherein the inflatable body is a balloon.
26. A method as in claim 24 wherein one of the spines includes a lumen sized and configured for passage of a guidewire.
27. A method as in claim 23 wherein at least one spine includes a lumen sized and configured to convey a cooling liquid.
28. A method as in claim 15 , further comprising delivering a cooling fluid in, at, or near the pyloric sphincter.