Systems and methods for removing ingested material from a stomach

• US 8,632,513 B2
• Filed: 04/01/2011
• Issued: 01/21/2014
• Est. Priority Date: 08/03/2006
• Status: Expired due to Fees

• Current Assignee: Aspire Bariatrics, Inc.
• Original Assignee: Aspire Bariatrics, Inc.
• Inventors: Kamen, Dean, Grant, Kevin L., Soederberg, Eric M., Altobelli, David E., Flynn, David, Solovay, Kenneth S., Klein, Samuel
• Primary Examiner(s): MARCETICH, ADAM M
• Application Number:
  US13/078,838
• Publication Number:
  US 20110190719A1
• Time in Patent Office: 1,026 Days
• Field of Search: 604/320, 604/9, 604/10, 604/19, 604/27, 604/30, 604/32, 604/35, 604/36, 604/48, 604/513, 604/93.01, 604/263, 604/264, 604/276, 604/278, 604/3, 604/17, 604/327, 604/332, 604/335, 222/548
• US Class Current: 604/320
• CPC Class Codes: A61F 5/44 Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aidsabsorbent pads, e.g. sanitary towels, A61F13/15; drainage appliances for wounds A61M27/00; emptying devices for urine bags B65B69/0016; Colostomy devices adhesives for colostomy devices A61L24/00; materials for colostomy devices A61L28/00
• CPC Class Codes: A61F 5/4405 Valves or valve arrangements specially adapted therefor A61F5/441 takes precedence; Fluid inlets or outlets A61F5/4407 takes precedence
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0065 Fixing means and tube being one part
• CPC Class Codes: A61J 15/0092 Valves on feeding tubes tube valves A61M39/22

Abstract

When a patient is fitted with an external gastrostomy connection to the stomach, ingested food can be removed through the gastrostomy connection using a pump-based or siphon-based system to achieve weight loss. The process of removing ingested food can be improved by alternating the infusion of liquid into the stomach with the removal of material from the stomach. Optionally, stomach acid may be captured and returned to the stomach. Optionally, nutritional supplements or medicines may be added to the infused liquid. Optionally, a flush mount connectorized system with a built in valve may be used to simplify the interface with the gastrostomy hardware that remains installed in the patient. Optionally, the system may be configured to disable itself from further use after a triggering event (e.g., the passage of time or a predetermined number of uses) has occurred.

Claims

1. A valve assembly for alternately providing and preventing the passage of fluid and food through a fluid pathway comprising:

a bottom platform having a first thru-hole biased to one quadrant;

a top platform having a second thru-hole biased to one quadrant;

a middle layer having a third thru-hole biased to one quadrant, the middle layer comprising an elastomeric material and being sandwiched between the bottom platform and the top platform; and

a retainer configured to retain the bottom platform in proximity to the middle layer and top platform such that the middle layer and top platform can be moved together with respect to the bottom platform between a first position and a second position, wherein in the first position the first, second, and third thru-holes align to provide access to the fluid pathway and in the second position the first, second and third thru-holes are not aligned to provide a fluid tight seal and to prevent passage of fluid and food through the fluid pathway;

wherein

the first thru-hole of the valve assembly is configured to mate with and remain stationary with respect to a gastrostomy tube.

2. The valve assembly according to claim 1, the bottom platform being configured to sit against a patient'"'"'s skin.

3. The valve assembly according to claim 1, the first, second and third thru-holes each having a diameter from about 6 to about 8 mm.

4. The valve assembly according to claim 1, each platform having a diameter from about 3.5 to about 7 times larger than diameter of the thru-hole that passes therethrough.

5. The valve assembly according to claim 1, the middle layer being sandwiched between the top platform and bottom platform with a force that is high enough to prevent leaks and yet low enough to permit movement of the middle layer with respect to the bottom platform.

6. The valve assembly according to claim 1, the middle layer being attached to the top platform.

7. The valve assembly according to claim 1, one platform being capable of moving with respect to the other platform by a rotational force.

8. The valve assembly according to claim 1, one platform being capable of moving in a generally linear direction with respect to the other platform.

9. The valve assembly according to claim 1, the valve assembly being configured to provide access to the fluid pathway without changing the internal diameter of the fluid pathway.

10. An apparatus comprising:

a valve assembly for alternately providing and preventing the passage of fluid and food through a fluid pathway comprising;

a bottom platform having a first thru-hole biased to one quadrant;

a top platform having a second thru-hole biased to one quadrant,

a middle layer having a third thru-hole biased to one quadrant, the middle layer comprising an elastomeric material and being sandwiched between the bottom platform and the top platform; and

a retainer configured to retain the bottom platform in proximity to the middle layer and top platform such that the middle layer and top platform can be moved together with respect to the bottom platform between a first position and a second position, wherein in the first position the first, second, and third thru-holes align to provide access to a fluid pathway and in the second position the first, second and third thru-holes are not aligned to provide a fluid tight seal and to prevent passage of fluid and food through the fluid pathway; and

a gastrostomy tube having a distal end and a proximal end;

the first thru-hole of the valve assembly being mated with and remaining stationary with respect to the proximal end of the gastrostomy tube.

11. The apparatus according to claim 10, the fluid pathway comprising a uniformly sized lumen extending from a gastrostomy tube through the valve assembly.

12. The apparatus according to claim 11, the lumen having a sufficiently large diameter to accommodate food particles.

13. The apparatus of claim 10, wherein the middle layer is attached to the top platform by an adhesive.

14. The apparatus of claim 10, wherein the middle layer and top platform can be rotated together with respect to the bottom platform.

15. An apparatus for providing and preventing access to a fluid pathway of a gastrostomy tube that passes through a patient'"'"'s abdominal wall into the patient'"'"'s stomach, the apparatus comprising:

a first connector comprising a valve assembly, the valve assembly comprising;

a first platform having a first thru-hole biased to one quadrant, the first platform being mounted to a gastrostomy tube so as to remain stationary with respect to the gastrostomy tube and to provide a fluid pathway directly between the gastrostomy tube and the first thru-hole,

a second platform having a second thru-hole biased to one quadrant,

a third platform having a third thru-hole biased to one quadrant, the third platform being sandwiched between the first and second platforms and being fixed with respect to the second platform such that the third thru-hole is aligned with the second thru-hole, and

a retainer that retains the first platform in proximity to the second platform such that the second platform can be rotated with respect to the first platform between a first position wherein the first and second thru-holes align to provide access to the fluid pathway of the gastrostomy tube and a second position wherein the first and second thru-holes offset to prevent access to the fluid pathway of the gastrostomy tube,

the connector being configured for flush mounting on a patient'"'"'s skin and having a low profile with respect to the patient'"'"'s skin.

16. The apparatus of claim 15, the first connector further comprising a skin flange, the skin flange being capable of interfacing with the first platform, sitting flush against a patient'"'"'s skin and being connected to a gastrostomy tube positioned in a patient.

17. The apparatus of claim 16 further comprising one or more protrusions disposed on the first platform that fasten to one or more complementary recesses in the skin flange.

18. The apparatus of claim 15 further comprising:

a second connector having a disk defining a disk thru-hole sized and positioned to complement the first and second thru-hole and one or more protrusions that removably couple to one or more structures disposed on the first connector.

19. The apparatus of claim 18 where the second connector further comprises a ridge configured to mate with a valley on the first connector.

20. The apparatus of claim 18 wherein the second connector further comprises a tube having a second fluid pathway that couples to the disk thru-hole.

21. The apparatus of claim 20 wherein the fluid pathway and the second fluid pathway are joined when the first and second thru-holes align in the first position.

22. The apparatus of claim 18 wherein the first and second thru-holes align in the first position to provide access to the fluid pathway when the second connector is coupled to the first connector.

23. The apparatus of claim 18 wherein the first and second thru-holes are offset in the second position to prevent access to the fluid pathway when the second connector is separate from the first connector.

24. The apparatus of claim 15 wherein aligning the first and second thru-holes in the first position avoids restriction of the gastrostomy tube.

25. The apparatus of claim 15 wherein the first platform further comprises a spout surrounding at least a portion of the first thru-hole, the spout being sized to enter the lumen at the proximal end of the gastrostomy tube.

26. The apparatus according to claim 15, the first, second and third thru-holes each having a diameter from about 6 to about 8 mm.

27. The apparatus according to claim 15, the first, second and third platforms each having a diameter from about 3.5 to about 7 times larger than the diameter of the thru-hole.

28. The apparatus according to claim 15, the third platform being sandwiched between the first platform and second platform with a force that is high enough to prevent leaks and yet low enough to permit movement of the third platform with respect to the first platform.

29. The apparatus according to claim 15, the third platform comprising an elastomeric material.

30. The apparatus according to claim 15, the valve assembly being configured to provide access to the fluid pathway without changing the internal diameter of the fluid pathway.

31. The apparatus of claim 15, wherein the low profile measures between about 5 and about 20 mm.

32. The apparatus of claim 15, wherein the low profile measures between about 7 and about 9 mm.

33. The apparatus of claim 15, wherein the first platform directly contacts the patient'"'"'s skin.

34. The apparatus of claim 15, further comprising an outer skirt that surrounds the first connector and tapers down towards the patient'"'"'s skin at the periphery of the outer skirt.

35. The apparatus of claim 34, wherein the outer skirt comprises a soft, compliant material.

36. The apparatus of claim 34, wherein the outer skirt comprises an elastomer.

37. The apparatus of claim 34, wherein the outer skirt comprises a foam material.

38. The apparatus of claim 15, wherein the third platform is attached to the second platform by an adhesive.