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Removable inflatable intragastrointestinal device for delivering beneficial agents
| Details |
Inventors: Garay, Garbiel L.; Garay, Kathleen M. K.;
Assignee: Transpharm Group Inc. (San Francisco, CA)
Primary Examiner: Truluck; Dalton L.
Assistant Examiner:
Attorney, Agent or Firm: Irell & Manella
A removable inflatable beneficial agent delivery device that is adapted to reside in the stomach for a prolonged time period. The device comprises (1) an inflatable member which in its deflated state can be inserted into the stomach via a naso-gastric tube and which in its inflated state resides comfortably in the stomach but cannot pass through the pyloric sphincter, (2) an inflation tube connected to the inflatable member by which the inflatable member can be inflated from outside the body and which is dropped into the stomach after inflation, and (3) one or more agent-containing cartridges that are carried exteriorly on the inflatable member or the inflation tube and are capable of delivering agent to the gastrointestinal tract over a prolonged time period. |
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DETAILED DESCRIPTION OF EMBODIMENTS SHOWN IN DRAWINGS The term "beneficial agents" as used herein is intended to include drugs, vitamins, and other chemicals or compositions that are administered gastrointestinally to humans or animals to achieve a beneficial effect on the recipient.
The term "drug" as used herein broadly includes physiologically and/or pharmacologically active substances for producing a local effect within the gastrointestinal tract or a systemic effect at a remote site within the body.
FIGS.
1-4 depict an embodiment of the invention, generally designated 10.
Device 10 is composed of three principal elements: an inflatable member 11, an inflation tube 12, and a plurality of beneficial agent-containing cartridges 13.
The inflatable member 11 is sized and shaped so that when deflated it can be inserted into the stomach 14 via a naso-gastric tube 15 (FIG.
2) that extends through the mouth 16 and esophagus 17 and opens into the stomach.
Its size and shape in the inflated state (FIG.
1) are such that it resides comfortably within the stomach without being able to pass through the pyloric sphincter 18.
While the inflated shape of member 11 is toroidal it will be appreciated that other shapes such as ovoidal, ellipsoidal, spheroidal, triangular, and the like may be employed.
Shapes that have a central opening (such as a toroidal shape) allow stomach contents to pass through the pyloric sphincter even if the device settles against the pyloric region of the stomach.
For human use the volume of the inflated member will normally be 20 to 1,000 cc, preferably 50 to 500 cc.
Member 11 may be made solely of an elastomeric polymer or be an elastomeric laminated composite of metal foil, polymer or fiber.
Member 11 is inflated using hollow inflation tube 12, one end 18 (FIG.
3) of which operably connects into the lumen 19 of the inflatable member and the other end 20 of which carries a valve 21.
The length of the tube is sufficient to extend through the mouth and esophagus and into the stomach with its end 20 outside the mouth
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