Method and Apparatus for Clearing Occluded Lumens of Enteral Feeding Tubes

The invention is further illustrated by the accompanying drawings wherein:

FIG. 1 is a side view of the apparatus of the invention;

FIG. 2 is a sectional view of syringe adaptor 14 showing the means for controlling movement of tube 16 in the open or slidable position; and

FIG. 3 is a sectional view of syringe adaptor 14 showing the means for controlling movement of tube 16 in the closed or locked position.

Referring to FIG. 1, the Introreducer.RTM. 10, of this invention comprises a pressure distributor adaptor 12 and a syringe adaptor 14, within each of which a polycarbonate tube 16 is positioned. In syringe adaptor 14, tube 16 is normally fixedly positioned while in pressure distributor adaptor 12, tube 16 is alternately fixedly or slidably positioned. Handle 30, of pressure distributor adaptor 12, serves as a force distributor or means to prevent kinking of tube 16 as pressure is applied to dislodge the occlusion. Handle 30 is generally about 2 to 4 inches in length. Polycarbonate tube 16 advantageously has an outside diameter of from 0.025 to 0.060 inches and is preferably about 0.040 inches outside diameter with an inner lumen of from 0.010 to 0.030 inches and preferably about 0.020 inches, and is advantageously from 9 to 60 inches long. Adaptors 12 and 14 each comprise means for controlling the movement of tube 16 as shown in FIGS. 2 and 3.

Referring to FIG. 2, deformable O-ring 18 is shown slidably positioned within adaptor 14 such that a space 20 exists between tube 16 and O-ring 18, the latter being in contact with screw cap 22, threaded cylinder 24 and front portion 26 of adaptor 14. In this position adaptor 14 can be slidably moved along tube 16 at will.

In FIG. 3 it is seen that when screw cap 22 is moved forward or tightened onto cylinder 24, O-ring 18 is compressed such that space 20 is eliminated and tube 16 is tightly grasped by O-ring 18, thus holding adaptor 14 in place on tube 16. In normal operation of Introreducer.RTM. 10, adaptor 14 is positioned on tube 16 such that an end thereof protrudes only part way into chamber 28 as shown in the drawings.

In the operation of Introreducer.RTM. 10, tube 16 is inserted into an occluded enteral feeding tube and pressure distributor adaptor 12 is positioned a short distance from the entrance of the enteral feeding tube with a first end of tube 16 in contact with the occlusion to be removed. At this position, screw cap 22 is tightened so tube 16 is held in place as illustrated in FIG. 3.

In a preferred embodiment, screw cap 22 is tightened only sufficiently to provide movement to tube 16 in the absence of any obstruction, thereby permitting pressure distributor adaptor 12 to slide or slip if an obstruction is met. This prevents perforating the feeding tube wall necessitating the removal and replacement of said feeding tube.

The polycarbonate tube chosen is such that the outside diameter of the tube of said Introreducer is at least about 0.002 inch less than the diameter of the occluded lumen and is preferably about 0.01 to 0.02 inch less, the Introreducer being of sufficient length to reach the occlusion that is to be removed and preferably, the end of the tube to be cleaned and cleared. Furthermore, depending on the nature of that occlusion, the Introreducer tube is chosen to have appropriate fluid injection properties. The Introreducer is then filled with the appropriate solution, for example, warm water, preferably about 100.degree. to about 130.degree. F. or an enzyme solution and is inserted into the occluded tube, with small amounts of the fluid being injected to assist in lubrication. When the inserted Introreducer meets an obstruction, as indicated by retrograde flow of the water or solution, the injection rate of the water or enzyme solution is increased and the Introreducer is mechanically rotated and/or oscillated, usually by hand movement employing pressure distributor adaptor 12, to facilitate the erosive force of the injected fluid. This procedure is continued until the retrograde flow of the injected fluid stops, indicating that the occlusion has been removed and the feeding tube is now clear.

In the removal of food occlusions, warm water is preferably used if the occlusion is of short duration, i.e., several hours or less. If the occlusion is of longer duration an enzyme solution such as, for example, a solution of

at a pH of 7.0 to 8.5 is preferred. The pH may be adjusted with baking soda, e.g. 1/4 teaspoon of baking soda in a total volume of 45 cc of warm water, 100.degree.-130.degree. F. When using enzymes, it is at times beneficial to allow the enzyme to remain in contact with the occluded material for a short time, e.g. 1/2 hour, before continuing to inject more solution.

To illustrate the advantageous effects of employing the apparatus and method of the present invention, a dried sample of Ensure.RTM. plus HN was placed in water at room temperature. There were no observable effects after six hours. In 12 hours the edge of the sample was dissolving. A similar experiment except for employing Adolph's tenderizer, produced some edge dissolution in six hours. The sample was still shaped and hard after 12 hours. A third experiment employing the enzyme solution described above dissolved the edge of the sample in about one hour. In three hours the sample was soft with major liquefaction. In six hours the sample was totally dissolved. In contrast to the above, employing the Introreducer of this invention and 80 cc of warm water, 100.degree.-150.degree. F., a hole through the sample was produced in two minutes. Employing an Introreducer having a pointed cutting end resulted in the hole being produced in less than one minute.

The invention is further illustrated by the following examples:

Patient Mrs. X is in need of enteral feeding for a mental and emotional disorder. She has a Dobbhoff post-pyloric feeding tube, (8 FR) placed with x-ray confirmation of position. Her tube becomes occluded after about 24 hours of feeding with Osmolite.RTM. at 30 cc/hour. The tube can not be cleared by the nurse educator working with the nutritional support service.

Procedure:

1. A 6 FR high pressure 42 inch Introreducer having high flow properties is selected.

2. The 6 FR Introreducer is filled with warm water with a 60 cc syringe.

3. The Introreducer is inserted into the 8 FR Dobbhoff occluded tube and with irrigation it is advanced to the occlusion.

4. The warm water flows retrograde with movement of the Introreducer in and out against the occlusion with turning action.

5. The occlusion resistance becomes less. When the injected solution stops its retrograde flow, the Introreducer advanced.

6. The Introreducer is pulled.

7. The 60 cc syringe is used to inject directly in the 8 FR Dobbhoff feeding tube.

8. The Dobbhoff tube is clear, no resistance in injecting the warm water, and the tube is put back to 30 cc/hour of enteral feeding as ordered for the patient.

A six-year old boy with a long-term feeding problem and a permanent J-tube is having a problem with his feeding injections. This tube is placed by surgical operation and would have to be removed and replaced the same way. The parents are most concerned as they had worked with the tube for along time and had no luck in clearing the occlusion. Their doctor had also tried without success.

This tube has a tapered lumen with the small end being around 6 FR in about 9 inches from the entrance of the tube. The tube has been blocked for 72 hours with the last feeding being Pulmocare.RTM..

Precedure:

1. Enzyme solution is set up by pharmacy (Lipase, Amylase, Protease as above described).

2. A 17 gauge high pressure walled 9 inch long with a high fluid force orifice Introreducer is selected.

3. The enzyme solution is instilled into the Introreducer.

4. The Introreducer is inserted into the J-tube until it meets resistance.

5. The enzyme solution is then injected with a collection basin for the retrograde flow and enzyme solution at the entrance port of the feeding tube.

6. The occlusion is hard and initially can not be removed by the direct flow and moving the tube back and forth against the occlusion with turning and cutting.

7. The enzyme is left in the J-tube for 30 minutes.

8. The Introreducer is again moved back and forth after the 30 minutes with injection of additional enzyme.

9. Resistance is still high.

10. The Introreducer was removed and 60 cc of fresh warm water is instilled into the Introreducer.

11. The J-tube is irrigated with warm water for 5 minutes while applying high fluid cutting force while collecting the spent solution in the basin from the retrograde flow. This solution shows some food is being removed.

12. The enzyme solution is reinstilled in the Introreducer and injected into the J-tube and let set for 30 minutes.

13. The J-tube is tested again by trying to advance the Introreducer, this time only minimal resistance is encountered and the Introreducer can be readily advanced.

14. The Introreducer is pulled and the J-tube irrigated with 120 cc of warm water to assure a clear lumen.