Gastric Space Filler Device, Delivery System, and Related Methods

• US 20080319471A1
• Filed: 06/25/2007
• Published: 12/25/2008
• Est. Priority Date: 06/25/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Sosnowski, Stephen Alexander, Holschlag, Tyler John, Kinlade, Daniel Eugene
• Granted Patent: US 8,142,469 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61F 5/0033 with more than one chamber
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

According to features of the present disclosure, a gastric space filler device and methods effective for reducing stomach volume are disclosed. A gastric space filler comprising at least one inflatable space filler and a sleeve to prevent leakage out of the gastric space filler device is disclosed. The gastric space filler device may be inflated with an insufflation fluid and with mineral oil, which further has the effect of reducing leakage. Delivery systems and methods for inserting a gastric space filler device into a patient are also disclosed. Sheaths and methods for covering a gastric space filler device during delivery into a patient are also disclosed.

Claims

1. A gastric space filler device comprising, in combination:

a space filler, an opening to inflate said space filler, an inflation fluid, and a sleeve, wherein said inflation fluid is displaced from between a mating surface of said sleeve and said opening by a material with physical properties that interact with said mating surface to decrease leakage of inflation fluid out of said opening.

2. The gastric space filler device of claim 1, wherein said sleeve is disposed between said opening and an outer periphery of said space filler.

3. The gastric space filler device of claim 1, wherein said sleeve allows an insufflation fluid to enter said space filler during inflation of said space filler.

4. The gastric space filler device of claim 3, wherein said sleeve does not allow said insufflation fluid to exit said space filler after said mineral oil is received between said sleeve and said opening.

5. The gastric space filler device of claim 1, further comprising an infusing member coupled with said space filler.

6. The gastric space filler device of claim 5, wherein said infusing member comprises an infusing lumen in fluid communication with said opening.

7. The gastric space filler device of claim 6, wherein said infusing lumen comprises a gate to reduce passage of a fluid until a barb is inserted into said infusing lumen.

8. The gastric space filler device of claim 1, further comprising a sheath, wherein said sheath at least partially covers said space filler.

9. The gastric space filler device of claim 8, wherein said sheath is secured around said space filler with a stitch.

10. The gastric space filler device of claim 9, wherein said stitch is released by pulling said stitch.

11. The gastric space filler device of claim 10, further comprising a sheath release clip, wherein said sheath release clip prevents said stitch from being released while said sheath release clip is engaged on said gastric space filler device and said sheath release clip allows said stitch to be released when said sheath release clip is removed from said gastric space filler device.

12. The gastric space filler device of claim 10, further comprising a delivery system comprising a delivery lumen configured to deliver an insufflation fluid to said space filler, a luer connected to said delivery lumen, and a handle removably attached to said delivery lumen, wherein said handle contains an inner compartment and said luer is disposed inside said inner compartment of said handle while handle is attached, said luer is exposed when said handle is removed, and said stitch is attached to said handle such that said stitch is pulled when said handle is removed.

13. The gastric space filler device of claim 8, wherein said sheath automatically uncovers said space filler as said space filler is inflated.

21. The gastric space filler of claim 1, wherein the material with physical properties that interact with said mating surface to decrease leakage of inflation fluid out of said opening is an oil.

22. The gastric space filler of claim 1, wherein the material with physical properties that interact with said mating surface to decrease leakage of inflation fluid out of said opening is petroleum based.

23. The gastric space filler of claim 1, wherein the material with physical properties that interact with said mating surface to decrease leakage of inflation fluid out of said opening has an interaction with said mating surface similar to mineral oil.

24. The gastric space filler of claim 1, wherein the material with physical properties that interact with said mating surface to decrease leakage of inflation fluid out of said opening is mineral oil.

14. A method for treating obesity challenged patients comprising:

providing a gastric space filler device comprising a space filler, an opening to inflate said space filler with a fluid, and a sleeve disposed between said opening and an outer periphery of said space filler;

allowing said fluid to enter said space filler through said opening; and

preventing said fluid from exiting said space filler through said opening.

15. The method of claim 14, wherein the step of allowing said fluid to enter said space filler through said opening comprises moving at least part of said sleeve away from said opening.

16. The method of claim 14, wherein the step of preventing said fluid from exiting said space filler through said opening comprises blocking said opening with said sleeve.

17. The method of claim 14, wherein said fluid comprises mineral oil.

18. A method for emplacing a gastric space filler device in a patient comprising, in combination:

providing a delivery system attached to a gastric space filler device comprising a space filler;

covering at least part of said space filler with a sheath; and

delivering said delivery system and said gastric space filler device through an esophagus into a stomach of a patient; and

implanting said space filler with said sheath within the stomach.

19. The method of claim 18, further comprising the steps of uncovering said space filler and inflating said space filler.

20. The method of claim 18, further comprising the step of inflating said space filler, wherein said sheath automatically uncovers said space filler as said space filler is inflated.