Devices and methods for gastrointestinal stimulation
Devices and methods for applying gastrointestinal stimulation include implanting a stimulation device including a body with at least one expandable portion and a bridging portion and at least one stimulation member in the gastrointestinal tract. The at least one stimulation member includes one or more energy delivery members, one or more sensors, or a combination of both. The body maintains the device within the gastrointestinal space, and preferentially within the pyloric portion of the patient's stomach, and prevents passage of the device from the gastrointestinal space, but is not rigidly anchored or affixed to the gastrointestinal wall tissue.
1. A device for delivery of energy to the gastrointestinal tract, comprising:
a body comprising:
a proximal occlusion member which is reconfigurable between a low-profile configuration and an expanded deployment configuration,
wherein the proximal occlusion member comprises a core and a flexible shell;
a bridging member,
wherein the flexible shell extends from the bridging member, and
wherein the flexible shell envelops at least part of the bridging member when the proximal occlusion member is in the low-profile configuration,
wherein the flexible shell is inverted and envelops and surrounds the core when the proximal occlusion member is in the expanded deployment configuration,
wherein the flexible shell maintains an opening at a proximal end of the flexible shell when the proximal occlusion member is in the expanded deployment configuration, and
a distal member attached at a distal end of the bridging member and having a diameter which is larger than a diameter of the bridging member and sized for passage through a pyloric valve;
an energy transmitter configured to generate energy; and
a stimulation member disposed on the body and coupled to the energy transmitter, wherein the stimulation member is configured to be placed in apposition with a target tissue to direct energy from the energy transmitter to the target tissue.
2. The device of claim 1 , wherein the proximal occlusion member has an outer diameter that is larger than the diameter of the bridging member and is sized to prevent passage of the proximal occlusion member through the pyloric valve.
3. The device of claim 2 , wherein the outer diameter is greater than 8 mm.
4. The device of claim 1 , wherein the stimulation member is disposed on the bridging member.
5. The device of claim 1 , wherein the flexible shell has a tissue engagement portion and the stimulation member is disposed adjacent to the tissue engagement portion.
6. The device of claim 5 , wherein the tissue engagement portion of the flexible shell is defined by a conical shape when the flexible shell is inverted and the proximal occlusion member is in the expanded deployment configuration.
7. The device of claim 1 , wherein the length of the bridging member is sized to span a length of the pyloric valve.
8. The device of claim 7 , wherein an outer diameter of the bridging member is at least 5 mm.
9. The device of claim 1 , wherein the distal member is expandable.
10. The device of claim 9 , wherein at least one of the proximal occlusion member, the bridging member and the distal member are adapted to change configurations while residing in the gastrointestinal tract.
11. The device of claim 1 , wherein the distal member is configured to pass through the pyloric valve through natural peristalsis.
12. The device of claim 1 , further comprising at least one sensor, wherein a dimension of at least a portion of the body is configured to change upon the sensor sensing a triggering condition.
13. The device of claim 12 , wherein the at least one sensor is configured to sense at least one signal selected from the group consisting of radiofrequency, electromagnetic, microwave and ultrasound signals.
14. The device of claim 12 , wherein the at least one sensor is configured to sense at least one of pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and hemoglobin in the gastrointestinal tract.
15. The device of claim 1 , further comprising an attachment mechanism for attaching to a catheter device.
16. The device of claim 1 , wherein the flexible shell comprises a compliant material.
17. The device of claim 16 , wherein the compliant material is silicone.
18. The device of claim 1 , further comprising a therapeutic substance that is released from the body or the stimulation member.
19. The device of claim 18 , wherein the therapeutic substance is a drug.