Gastro-esophageal reflux control system and pump

• US 20080154191A1
• Filed: 12/21/2006
• Published: 06/26/2008
• Est. Priority Date: 12/21/2006
• Status: Active Grant

• Current Assignee: Avent Incorporated (Avanos Medical, Inc.)
• Original Assignee: Fred Gobel
• Inventors: Gobel, Fred
• Granted Patent: US 7,794,425 B2
• Time in Patent Office: Days
• US Class Current: 604/101.05
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61J 15/0003 Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
• CPC Class Codes: A61J 15/0049 Inflatable Balloons balloon catheters A61M25/10
• CPC Class Codes: A61J 15/0073 Multi-lumen tubes
• CPC Class Codes: A61J 15/0076 Feeding pumps A61M1/00, A61M5/142, A61M25/1018 take precedence
• CPC Class Codes: A61J 15/0088 for sensing parameters related to the device

Abstract

An enteral feeding unit or system that minimizes the occurrence of gastro-esophogeal-pharynegal reflux during feeding is described. The enteral feeding unit or device includes an automatable feeding pump with a feedback sensor for sensing a relative pressure in a patient'"'"'s stomach and esophagus, and a regulator system for controlling or monitoring feeding rate to said patient as a function of said relative gastro-esophageal pressure. The system includes a stomach probe that has a fluid-tight closure of the esophagus. The stomach probe, according to the invention, is characterized by a tampon-bladder for watertight closure of the esophagus, in which the tampon-bladder forms from flexible and/or elastic material at least a closed inner cavity for the reception of a fluid medium, through a means (11) of establishing a prescribed pressure for the medium in the tampon-bladder (16) by an inner lumen forming the actual stomach probe, from which an outer hose-like lumen (18) extending to the tampon-bladder (16) is so arranged that between the outer lumen (18) and the inner lumen (17) a channel is formed connected to the inner cavity of the tampon-bladder (16) arranged on the outer lumen (18) by a number of openings (20), whereby the inner cavity of the tampon-bladder (16) is connected via the canal formed between the inner and outer lumina (17, 18) with the means of production of pressure in the tampon-bladder, that is, with a suitably graded reservoir or equalizing vessel (11) for the liquid medium situated above the tampon-bladder and outside the patient.

Claims

1. A process for effectuating reducing gastric reflux into a patient'"'"'s esophagus, the process comprises:

providing an enteral feeding tube having a double lumen, a gastric balloon, and an esophageal balloon;

inserting said enteral feeding tube into said patient'"'"'s upper alimentary canal, to position said gastric balloon in said patient'"'"'s stomach and said esophageal balloon in said patient'"'"'s esophagus;

providing an sensor for monitoring gastric pressure when enteral feeding is in process;

receiving a signal that is averaged using a filter algorithm;

setting a gradient value that is added to actual gastric pressure, thereby defining a relative level of esophageal pressure applied to seal from gastro-pharyngeal reflux.

2. An anti-gastro-esophageal reflux device for use during enteral feeding, the device comprising:

a tube having a double lumen, a gastric bladder, and esophageal bladder connected by a conduit to a pressure-regulating unit, said esophageal bladder having a compressible volume and an outer surface with an plurality of pleats that can intermesh with a patient'"'"'s esophagus wall structures, and said pressure-regulating unit maintains a pressure within said esophageal bladder at a level greater than gastric pressure exerted on said gastric bladder.

3. An apparatus for controlling gastro-pharyngeal reflux in a patient, the apparatus comprises:

an enteral feeding tube having a double lumen, a gastric balloon, an esophageal balloon, a sensor for monitoring gastric pressure when enteral feeding is in process, and a external pump that regulates air or fluid pressure within said esophageal balloon, said sensor receives a signal that is averaged using a filter algorithm that sets a gradient value that is added to actual gastric pressure, thereby defining a relative level of esophageal pressure applied to seal from gastro-pharyngeal reflux.

4. The apparatus according to claim 3, wherein said esophageal balloon is inflatable with either a liquid or a gaseous fluid.

5. The apparatus according to claim 3, further comprising a feeding pump that senses and adjusts relative amount of pressure in a patient'"'"'s stomach as well as esophagus.

6. An enteral-feeding device comprising:

an automatable feeding pump with a feedback sensor for sensing a relative pressure in a patient'"'"'s stomach and esophagus, and a regulator system for controlling or monitoring feeding rate to said patient as a function of said relative gastro-esophageal pressure.

7. The enteral-feeding device according to claim 6, wherein said feedback sensor includes a gastric bladder and an esophageal bladder.

8. The enteral-feeding device according to claim 6, wherein said regulator system includes a timer device that can be adjusted, as a function of amount of content to be fed and said relative pressure within said patient'"'"'s stomach and esophagus, either manually or electronically, for controlling said feeding rate.

9. The enteral-feeding device according to claim 6, wherein said regulator system pumps a defined volume into said gastric balloon to fill said balloon to a volume smaller than the gastric balloon itself in its freely inflated preshaped state.

10. The enteral-feeding device according to claim 9, wherein said gastric balloon is inflated up to about 75-80% of a volume in free inflation without hull distension.

11. The enteral-feeding device according to claim 6, wherein said esophageal seal pressure is regulated at a predetermined value that is preset with computer software or that can be defined by a user, once a pressure in said gastric balloon reaches a stable reading of the intra-gastric filling pressure.

12. The enteral-feeding device according to claim 6, wherein a desired value for a range or limit for change in pressure (Δ

P), affecting esophageal pressure parameters, is calculated thus;

gastric pressure+Δ

P value.

13. The enteral-feeding device according to claim 6, wherein as the pressure in said gastric balloon is adjusted to compensate for change in pressure and conditions in abdominal and thoraxic cavities contiguously over a course of enteral feeding.

14. The enteral-feeding device according to claim 6, wherein said regulator system permits a user to enter a desired feeding volume to be administered over a predetermined period, such that volume and time values can be separately defined and programmed to achieve the desired feeding regime.

15. The enteral feeding device according to claim 6, wherein said regulator system includes an associated computer software that determines an actual rate of feed volume delivered over a primary feeding interval.

16. The enteral-feeding device according to claim 6, wherein said device has a visual display for volume/time calculations, and a programming means for a user to enter a desired feeding duration and calculate a volume delivered within a preset unit of time, or over an entire feeding period selected.

17. The enteral feeding device according to claim 6, wherein said regulator system has a memory system that enables said device to apply software preset or user defined feeding rate to determine relative compliance of a patient'"'"'s stomach against said feed volume.

18. The enteral feeding device according to claim 6, wherein said regulator system automatically increases a slope of a determined graph (V/P), based on relative pressure increase over an applied volume, to reach a desired volume (V/t_total).

19. The enteral-feeding device according to claim 6, wherein once a maximum gastric pressure is reached under a certain parameter setting, said regulator system will stop pumping and wait until intra-gastric pressure has sufficiently decrease to within predetermined feeding levels before starting feeding again.

20. The enteral-feeding device according to claim 6, wherein said regulator system calculates and determines continuously, hourly and expected feeding volumes over a selected time period.