SYSTEMS AND METHODS FOR REMOVING INGESTED MATERIAL FROM A STOMACH

• US 20080033364A1
• Filed: 02/15/2007
• Published: 02/07/2008
• Est. Priority Date: 08/03/2006
• Status: Active Grant

• Current Assignee: Aspire Bariatrics, Inc.
• Original Assignee: Aspire Bariatrics, Inc.
• Inventors: Kamen, Dean, Grant, Kevin L., Altobelli, David E., Klein, Samuel, Solovay, Kenneth S., Soederberg, Eric M., Flynn, David M.
• Granted Patent: US 8,414,561 B2
• Time in Patent Office: Days
• US Class Current: 604/173
• 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 method of removing ingested food from a patient'"'"'s stomach via a gastrostomy tube that passes through the patient'"'"'s abdominal wall into the patient'"'"'s stomach, the method comprising the steps of:

(a) siphoning a first portion of the ingested food out of the patient'"'"'s stomach via the gastrostomy tube;

(b) infusing liquid into the patient'"'"'s stomach via the gastrostomy tube; and

(c) siphoning at least some of the infused liquid out of the patient'"'"'s stomach via the gastrostomy tube, together with a second portion of the ingested food.

2. The method of claim 1, further comprising the steps of:

(d) infusing liquid into the patient'"'"'s stomach via the gastrostomy tube; and

(e) siphoning at least some of the infused liquid out of the patient'"'"'s stomach via the gastrostomy tube, together with a third portion of the ingested food, wherein step (d) is performed after step (c), and wherein step (e) is performed after step (d).

3. An apparatus for removing food from a patient'"'"'s stomach via a gastrostomy tube that passes through the patient'"'"'s abdominal wall into the patient'"'"'s stomach, the apparatus comprising:

a connector configured to connect to a proximal end of the gastrostomy tube with a fluid-tight connection;

a first fluid path provided between the connector and a drain port, configured to permit siphoning or pumping food from the patient'"'"'s stomach out to the drain port;

a second fluid path provided between the connector and an input port, configured to permit infusion of liquid from the input port into the patient'"'"'s stomach; and

a fluid circuit configured to alternately (a) open the first fluid path during a first interval of time to permit siphoning or pumping food out of the patient'"'"'s stomach and (b) open the second fluid path during a second interval of time to permit infusion of the liquid in the reservoir into the patient'"'"'s stomach.

4. The apparatus of claim 3, wherein the fluid circuit comprises an actuator and at least one valve.

5. The apparatus of claim 4, wherein the actuator has a first position that causes the at least one valve to open the first fluid path and close the second fluid path, and wherein the actuator has a second position that causes the at least one valve to close the first fluid path and open the second fluid path.

6. The apparatus of claim 3, further comprising a reservoir for holding liquid to be infused into the patient'"'"'s stomach, wherein a fluid outlet of the reservoir is connected to the input port.

7. The apparatus of claim 3, wherein the first fluid path and the second fluid path share a common portion that is located adjacent to the connector

8. A method of removing ingested material from a stomach of a patient fitted with an external gastrostomy connection to the stomach, the method comprising:

coupling a siphon tube to the connection so as to create a siphon system having an aggregate length in excess of 25 cm; and

draining content of the stomach through the siphon tube.

9. The method of claim 8, wherein the siphon system has a length sufficient to run from the stomach of a standing patient to a position proximate to a floor-based disposal arrangement.

10. The method of claim 8, wherein the siphon tube used in the coupling step comprises flat tubing.

11. A method of removing ingested material from a stomach of a patient fitted with an external gastrostomy connection to the stomach, the method comprising:

pumping a fluid through the connection into the stomach to increase fluid in the stomach without ingestion of fluid; and

draining content of the stomach through the connection.

12. The method of claim 11, wherein the fluid includes water.

13. The method of claim 11, wherein the fluid includes at least one of (a) a nutrient and (b) a medication.

14. The method of claim 11, wherein the fluid includes returned gastric juices.

15. The method of claim 11, wherein the pumping step is implemented by a hand-operated pump.

16. The method of claim 11, wherein the draining step is implemented by siphoning.

17. An apparatus for removing ingested material from a stomach of a patient fitted with an external gastrostomy connection to the stomach, the apparatus comprising:

a fluid source for infusing fluid into the stomach through the connection; and

a drain line for draining content of the stomach received from the connection.

18. The apparatus of claim 17, wherein the drain line forms part of a siphon system for passively draining content of the stomach.

19. The apparatus of claim 18, wherein the siphon system has an aggregate length in excess of 25 cm.

20. The apparatus of claim 19, wherein the siphon system has a length sufficient to run from the stomach of a standing patient to a position proximate to a floor-based disposal arrangement.

21. The apparatus of claim 17, wherein the drain line includes a siphon tube made from flat tubing.

22. The apparatus of claim 17, wherein, in a first mode, the fluid source infuses fluid through the connection into the stomach;

and in a second mode, the drain line receives content drained from the stomach through the connection.

23. The apparatus of claim 22, further comprising a valve arrangement providing in the first mode an open first path between the fluid source and the connection;

and in the second mode an open second path between the connection and the drain line.

24. The apparatus of claim 23, wherein the second path is closed when the first path is open and the first path is closed when the second path is open.

25. The apparatus of claim 23, wherein the valve arrangement includes a diverter valve.

26. The apparatus of claim 23, wherein the valve arrangement includes a blade occluder.

27. The apparatus of claim 17, further comprising a pump coupled to the drain line for pumping content from the stomach through the drain line.

28. The apparatus of claim 17, further comprising a pump coupled to the fluid source for pumping fluid through the connection into the stomach.

29. The apparatus of claim 28, further comprising an actuation handle in communication with the fluid source for allowing the fluid to flow through the connection into the stomach.

30. The apparatus of claim 17, wherein the fluid source comprises a squeeze bottle.