Systems and methods for removing ingested material from a stomach

• US 20080039809A1
• Filed: 08/03/2007
• Published: 02/14/2008
• Est. Priority Date: 08/03/2006
• Status: Active Grant

• Current Assignee: Aspire Bariatrics, Inc.
• Original Assignee: Deka Products Limited Partnership
• Inventors: Grant, Kevin, Altobelli, David, Soederberg, Eric, Kamen, Dean, Flynn, David, Solovay, Kenneth, Klein, Samuel
• Granted Patent: US 8,002,758 B2
• Time in Patent Office: Days
• US Class Current: 604/335
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0089 Instruments for placement or removal
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61M 1/71 Suction drainage systems containers therefor A61M1/60, A61M1/64; negative pressure wound therapy systems A61M1/90
• CPC Class Codes: A61M 1/772 operating alternately
• CPC Class Codes: A61M 2039/0255 for access to the gastric or digestive system
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 3/0229 Devices operating in a closed circuit, i.e. recycling the irrigating fluid
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps

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 access to a fluid pathway, the valve assembly comprising:

a first platform and having a first thru-hole that passes therethrough, wherein the first platform is adapted for placement adjacent to a patient'"'"'s skin;

a second platform having a second thru-hole that passes therethrough; and

a retainer configured to retain 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 and a second position, wherein in the first position the first and second thru-holes align to provide access to the fluid pathway and in the second position the first and second thru-holes offset to provide a fluid tight seal and to prevent access to the fluid pathway.

2. The valve assembly of claim 1 wherein the first thru-hole is adjacent the fluid pathway.

3. The valve assembly of claim 1 further comprising a gastrostomy tube, wherein the lumen of the gastrostomy tube is adjacent the first thru-hole.

4. The valve assembly of claim 1 wherein at least one platform has a plurality of protrusions on one surface.

5. The valve assembly of claim 1 wherein the first platform diameter is at least 3.5 times larger than the first thru-hole diameter.

6. The valve assembly of claim 1 further comprising a layer of elastomer sandwiched between the first platform and the second platform.

7. The valve assembly of claim 6 wherein the layer of elastomer is attached to the second platform.

8. The valve assembly of claim 6 wherein the layer of elastomer has a third thru-hole.

9. The valve assembly of claim 6 wherein the retainer attaches to the first platform to retain the second platform and the layer of elastomer and to allow the second platform and the layer of elastomer to rotate with respect to the first platform

10. The valve assembly of claim 1 wherein a quadrant of the first platform contains the first thru-hole and the second thru-hole of the second platform is biased to align with the first thru-hole in the first position to provide access therethrough and to be offset from the first thru-hole in the second position to prevent access therethrough.

11. The valve assembly of claim 1 further comprising one or more protrusions disposed on the first platform that fasten to one or more complementary recesses in a flange of a first connector.

12. The valve assembly of claim 11 further comprising one or more structure disposed on the second platform that removably couples to a second connector.

13. The valve assembly of claim 11 wherein the one or more protrusions removably fastens to the one or more complementary recesses.

14. A method of alternately providing and preventing access to a fluid pathway of a tube disposed in the body of a patient, the method comprising:

mating a proximal end of the tube with a first thru-hole that passes through a first platform of a connector, the first platform is placed adjacent to the patient'"'"'s skin;

rotating the connector to a first position to cause a second thru-hole that passes through a second platform to substantially align with the first thru-hole to provide access to the fluid pathway during a first period of time; and

rotating the connector to a second position to cause the second thru-hole to be offset from the first thru-hole to provide a fluid tight seal to the proximal end of the tube and to prevent access to the fluid pathway during a second period of time.

15. A method of 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 method comprising:

mating a proximal end of the gastrostomy tube with a first thru-hole that passes through a first platform of a connector, the first platform is placed adjacent to the patient'"'"'s skin;

rotating the connector to a first position to cause a second thru-hole that passes through a second platform to substantially align with the first thru-hole to provide access to the fluid pathway during a first period of time; and

rotating the connector to a second position to cause the second thru-hole to be offset from the first thru-hole to provide a fluid tight seal to the proximal end of the gastrostomy tube and to prevent access to the fluid pathway during a second period of time.

16. The method of claim 15 wherein rotating the connector to the first position avoids restriction of the gastrostomy tube.

17. The method of claim 15 further comprising the step of:

aspirating the patient'"'"'s stomach contents through the gastrostomy tube when the connector is in the first position.

18. 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 having a valve assembly disposed inside a flange, the valve assembly has a first platform having a first thru-hole that passes therethrough and a second platform having a second thru-hole that passes therethrough, wherein the first platform is adapted for placement adjacent to the patient'"'"'s skin and the fluid pathway of the gastrostomy tube is adjacent the first thru-hole, and wherein a retainer 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 and a second position so that in the first position the first and second thru-holes align to provide access to the fluid pathway and so that in the second position the first and second thru-holes offset to provide a fluid tight seal to a proximal end of the gastrostomy tube and to prevent access to the fluid pathway.

19. The apparatus of claim 18 further comprising one or more protrusions disposed on the first platform that fasten to one or more complementary recesses in the flange.

20. The apparatus of claim 18 wherein aligning the first and second thru-holes in the first position avoids restriction of the gastrostomy tube.

21. The apparatus of claim 18 wherein the first platform further comprises a spout surrounding at least a portion of the first thru-hole, the spout is sized to enter the lumen at the proximal end of the gastrostomy tube.

22. The apparatus of claim 21 wherein the flange defines a flange thru-hole having a funnel shape and the spout and the funnel shape interact to compress at least a portion of the gastrostomy tube therebetween.

23. The apparatus of claim 18 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.

24. The apparatus of claim 23 where the second connector further comprises a ridge configured to mate with a valley on the first connector.

25. The apparatus of claim 23 wherein the second connector further comprises a tube having a second fluid pathway that couples to the disk thru-hole.

26. The apparatus of claim 25 wherein the fluid pathway and the second fluid pathway are joined when the first and second thru-holes align in the first position.

27. The apparatus of claim 23 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.

28. The apparatus of claim 23 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.

29. The apparatus of claim 18 wherein the first connector measures from about 7 mm to about 9 mm above the patient'"'"'s skin.

30. A method of adjusting a gastrostomy tube that passes through a patient'"'"'s abdominal wall into the patient'"'"'s stomach, the method comprising:

providing a connector with a flange having one or more recesses and a valve assembly having a first platform and a second platform, a first thru-hole passes through the first platform and a proximal end of the gastrostomy tube mates with the first thru-hole, the first platform has one or more protrusions fastened to the one or more recesses and the first platform is placed adjacent to the patient'"'"'s skin; and

exerting a force to the one or more recesses to unfasten the one or more protrusions thereby releasing the valve from the flange.

31. The method of claim 30 further comprising the steps of:

adjusting the length of the gastrostomy tube; and

coupling a connector to the proximal end of the gastrostomy tube.

32. The method of claim 30 further comprising removing a spout surrounding at least a portion of the first thru-hole from the lumen in the proximal end of the gastrostomy tube.

33. An assembly for providing substantially consistent flow through a fluid pathway, the assembly comprising:

a first tube having a first fluid pathway for disposal in a body of a patient;

a valve comprising a first platform, a second platform and a retainer, the first platform having a first thru-hole that passes therethrough, wherein the first platform is adapted for placement adjacent to a patient'"'"'s skin and a proximal end of the first tube is mated with the first thru-hole, the second platform having a second thru-hole that passes therethrough, and wherein a retainer is configured to retain the first platform in proximity to the second platform such that the second platform can be moved with respect to the first platform between a first position and a second position; and

a second tube having a second fluid pathway, a distal end of the second tube is adjacent the second thru-hole, the first fluid pathway and the second fluid pathway join to form a fluid pathway, wherein in the first position the first and second thru-holes align to provide access through the fluid pathway and in the second position the first and second thru-holes offset to provide a fluid tight seal and to prevent access through the fluid pathway.

34. The assembly of claim 33 wherein each of the first tube, the first and second thru-holes, and the second tube has a substantially similar internal diameter and the flow of fluid through the fluid pathway is substantially consistent.

35. The assembly of claim 33 wherein the second platform can be moved with respect to the first platform in a substantially linear direction.

36. An assembly comprising:

a first tube having a first fluid pathway for disposal in a body of a patient;

a valve comprising a first platform, a second platform and a retainer, the first platform having a first thru-hole that passes therethrough, wherein the first platform is adapted for placement adjacent to a patient'"'"'s skin and a proximal end of the first tube is mated with the first thru-hole, the second platform having a second thru-hole that passes therethrough, and wherein a retainer is configured to retain the first platform in proximity to the second platform such that the second platform can be moved with respect to the first platform between a first position and a second position; and

a second tube having a second fluid pathway, a distal end of the second tube is adjacent the second thru-hole, the first fluid pathway and the second fluid pathway join to form a fluid pathway, wherein in the first position the first and second thru-holes align to provide access through the fluid pathway and in the second position the first and second thru-holes offset to provide a fluid tight seal and to prevent access through the fluid pathway when the second tube is disconnected from the first tube.

37. An assembly comprising:

a first tube having a first fluid pathway for disposal in a body of a patient;

a valve comprising a first platform, a second platform and a retainer, the first platform having a first thru-hole that passes therethrough, wherein the first platform is adapted for placement adjacent to a patient'"'"'s skin and a proximal end of the first tube is mated with the first thru-hole, the second platform having a second thru-hole that passes therethrough, and wherein a retainer is configured to retain the first platform in proximity to the second platform such that the second platform can be moved with respect to the first platform between a first position and a second position; and

a second tube having a second fluid pathway, a distal end of the second tube is adjacent the second thru-hole, the first fluid pathway and the second fluid pathway join to form a fluid pathway, wherein in the first position the first and second thru-holes align to provide access through the fluid pathway and in the second position the first and second thru-holes offset to provide a fluid tight seal and to prevent access through the fluid pathway, wherein to disconnect the second tube from the first tube the valve is in the second position.