Non-inflatable gastric implants and systems
View Patent ↗A variety of passive intragastric implant devices for obesity treatment are disclosed. Such passive devices do not autonomously change shape, but instead react within the stomach to induce satiety. The devices may take up volume within the stomach, thus reducing the intake capacity. Additionally, the devices may contact areas within the stomach, such as the cardia surrounding the esophageal sphincter, or the greater and lesser curvatures in the middle of the stomach, to stimulate satiety-inducing nerves. Some devices may combine two or more of these satiety-inducing features. Methods of implant are disclosed including compressing the devices within a delivery tube and transorally advancing the devices through the esophagus to be deployed within the stomach. Removal of the devices occurs in the reverse.
1. A passive intragastric obesity treatment implant, comprising:
a series of non-inflatable members each having a through bore, each of the members having a male and a female mating connector which permits each member to connect with another member, each of the members being sized such that it can be easily implanted and removed through the esophagus, the members together capable of taking up volume within the stomach of at least 400 ml and being made of a material that will resist degradation over a period of at least six months within the stomach; and a tether sized to pass through the through bores of the non-inflatable members, a distal end of the tether attaching to a distal one of the non-inflatable members such that the members can be pulled together by pulling the tether taut to cause the male and female mating connectors to couple, thus forming a relatively solid structure, wherein the male and female mating connectors of the members are configured such that the relatively solid structure formed after pulling the tether taut is a non-straight shape, and wherein adjacent non-inflatable members in the series include features that cause the adjacent non-inflatable members to couple with each other in a predefined orientation relative to each other and without being able to move freely relative to one another.
2. The implant of claim 1 , wherein the non-straight shape is a helix.
3. The implant of claim 1 , wherein the members are no wider than 20 mm.
4. The implant of claim 1 , wherein the rotational orientation of any one member relative to another is unrestricted when any one member is not coupled in the predefined orientation relative to the other.
5. The implant of claim 1 , wherein each member is configured to only join together in a particular rotational orientation with another member.
6. The implant of claim 1 , wherein each of the non-inflatable members comprises a body having an opening on one side centered about a radial axis and leading to an internal cavity that narrows into the internal through bore that angles within the spherical body and continues outward through a nipple projecting from another side along a different radial axis, wherein each nipple fits within a cavity of another of the members, and wherein each cavity has a helical ledge that terminates in a small notch, while the nipple has a single protrusion along its length, such that when a nipple is introduced into a cavity and forced together, the members will rotate until the protrusion on the nipple seats in the notch.
7. A passive intragastric obesity treatment implant, consisting of:
a plurality of identically-shaped, non-inflatable members linked in series, each of the members being sized such that it can be easily implanted and removed through the esophagus, and being made of a material that will resist degradation over a period of at least six months within the stomach, wherein the series of members are configured to assume a particular non-straight shape when the series is placed under serial compression; and
a tether configured to apply serial compression to the series of members,
wherein the non-inflatable members each include a male mating connector and a female mating connector which permits each member to connect with another member.
8. The implant of claim 7 , wherein the members together are capable of taking up a volume of at least 400 ml within the stomach.
9. The implant of claim 7 , wherein adjacent non-inflatable members in the series include features that cause the adjacent non-inflatable members to mate with each other in a specific orientation relative to each other.
10. The implant of claim 7 , wherein the tether has proximal and distal ends, wherein each of the non-inflatable members has a through bore, wherein the tether is sized to pass through the through bores of the non-inflatable members, and wherein a distal end of the tether attaches to a distal one of the series of non-inflatable members such that the members can be pulled together into serial compression by pulling the tether taut to cause the male and female mating connectors to couple.
11. The implant of claim 10 , wherein when the tether is taut, the non-straight shape is a relatively solid structure.
12. The implant of claim 10 , wherein the non-straight shape comprises a helix.
13. The implant of claim 10 , wherein the throughbore angles within the non-inflatable member.
14. The implant of claim 13 , wherein the non-inflatable member comprises a spherical body.
15. A passive intragastric obesity treatment implant, comprising:
a series of non-inflatable members each having a through bore, the members each having a male and a female mating connector which permits each member to connect with another member, each of the members being sized such that it can be easily implanted and removed through the esophagus, the members together capable of taking up volume within the stomach of at least 400 ml and being made of a material that will resist degradation over a period of at least six months within the stomach; and
a tether sized to pass through the through bores of the non-inflatable members, a distal end of the tether attaching to a distal one of the non-inflatable members such that the members can be pulled together by pulling the tether taut to cause the male and female mating connectors to couple, thus forming a relatively solid structure,
wherein each of the non-inflatable members comprises a spherical body having an opening on one side centered about a radial axis and leading to an internal cavity, and a nipple projecting from another side.
16. The implant of claim 15 , wherein the radial axis is angled relative to a different radial axis along which the nipple projects.
17. The implant of claim 15 , wherein the cavity is stepped and narrows into the internal through bore that angles within the spherical body and continues outward through the nipple along a different radial axis, the nipple being stepped to fit within a stepped cavity of another of the members.
18. The implant of claim 17 , wherein the axes aligned with the cavity and nipple define an obtuse included angle of between about 120-150°.