GEOMETRIC CONFIGURATIONS FOR GASTRIC RESIDENCE SYSTEMS
The invention provides gastric residence systems with configurations and geometrical dimensions that allow for improved shelf life during prolonged storage, and optimal residence properties when the systems are deployed in the stomach of a patient.
1 - 42 . (canceled)
43 . A method of making a gastric residence system assembly comprising:
a) overmolding an elastomer component over a first portion of a plurality of at least three intercomponent anchors; and
b) overmolding a plurality of interfacing polymer components over a second portion of each intercomponent anchor, wherein each interfacing polymer component is overmolded over a corresponding one of the at least three intercomponent anchors.
44 . The method of claim 43 , wherein the overmolding of the elastomer component and the overmolding of the interfacing polymer components is performed by injection molding.
45 . The method of claim 43 , wherein the intercomponent anchors comprise a material selected from the group consisting of polycarbonate, polyphenylsulfone, a polyphenylene ether-polystyrene blend, polyphenylene ether, polystyrene, and polyether ether ketone, and the elastomer component comprises a material selected from the group comprising silicone rubber, a polysiloxane, polydimethylsiloxane, silicone rubber mixed with silica, a polysiloxane mixed with silica, and polydimethylsiloxane mixed with silica.
46 . (canceled)
47 . The method of claim 43 , wherein the plurality of intercomponent anchors are connected by a first scaffold, where the first scaffold maintains the anchors in a desired position prior to overmolding the elastomer component.
48 . The method of claim 47 , further comprising removing the first scaffold after overmolding the elastomer component.
49 . The method of claim 43 , wherein the overmolded plurality of interfacing polymer components are connected by a second scaffold formed during the overmolding of the interfacing polymer components, where the second scaffold maintains the interfacing polymer components in a desired position.
50 . The method of claim 49 , further comprising removing the second scaffold after overmolding the interfacing polymer components.
51 . The method of claim 43 , further comprising trimming the interfacing polymer components to a radial length of about 1 mm to 5 mm.
52 . The method of claim 51 , further comprising attaching a plurality of linkers to the plurality of interfacing polymer components, wherein each one of the linkers is attached to a corresponding one of the interfacing polymer components.
53 . The method of claim 52 , wherein the linkers are enteric linkers or time-dependent linkers.
54 . The method of claim 52 , further comprising attaching a plurality of carrier polymer-agent components to the plurality of linkers, wherein each one of the carrier polymer-agent components is attached to a corresponding one of the linkers, to form a gastric residence system.
55 . The method of claim 54 , wherein the attaching is performed by heat welding and comprising the steps of:
a) contacting each linker with a heated platen at a first temperature to form a heated surface on the linker,
b) contacting each carrier polymer-agent component with a heated platen at a second temperature to form a heated surface on the carrier polymer-agent component, and
c) contacting the heated surface of the linker with the heated surface of the carrier polymer-agent component to form a heat weld between each linker and each corresponding carrier polymer-agent component.
56 . (canceled)
57 . The method of claim 55 , further comprising annealing the heat weld, wherein the annealing is performed by one of heating the gastric residence system in an oven at a third temperature or irradiating the heat weld with infrared radiation.
58 - 59 . (canceled)
60 . The method of claim 54 , wherein the attaching is performed by infrared welding.
61 . The method of claim 60 , further comprising annealing the infrared weld.
62 . The method of claim 52 , further comprising attaching a plurality of interfacing polymer-(carrier polymer-agent) components to the plurality of linkers, wherein each one of the interfacing polymer-(carrier polymer-agent) components is attached to a corresponding one of the linkers, to form a gastric residence system.
63 . The method of claim 62 , wherein the attaching is performed by heat welding and comprising the steps of:
a) contacting each linker with a heated platen at a first temperature to form a heated surface on the linker,
b) contacting the interfacing polymer portion of each interfacing polymer-(carrier polymer-agent) component with a heated platen at a second temperature to form a heated surface on the interfacing polymer portion of the interfacing polymer-(carrier polymer-agent) component, and
c) contacting the heated surface of the linker with the heated surface on the interfacing polymer portion of the interfacing polymer-(carrier polymer-agent) component to form a heat weld between each linker and each corresponding interfacing polymer-(carrier polymer-agent) component.
64 . (canceled)
65 . The method of claim 63 , further comprising annealing the heat weld, wherein the annealing is performed by one of heating the gastric residence system in an oven at a third temperature or irradiating the heat weld with infrared radiation.
66 - 67 . (canceled)
68 . The method of claim 62 , wherein the attaching is performed by infrared welding.
69 . The method of claim 68 , further comprising annealing the infrared weld.
70 - 72 . (canceled)