WO1992012756A1

WO1992012756A1 - Feeding and drainage tube declogger

Info

Publication number: WO1992012756A1
Application number: PCT/US1992/000610
Authority: WO
Inventors: Carlton J. Young; Andrew J. Milligan
Original assignee: Nova Design Technologies, Ltd.
Priority date: 1991-01-24
Filing date: 1992-01-24
Publication date: 1992-08-06

Abstract

A device and method for unclogging clogged jejunostomy tubes is disclosed. The device is a flexible, elongated, cylindrical member (1) with a blunt end (4) and threaded portion (6). Upon rotation of the device at a handle (2), blockages in clogged jejunostomy tubes are removed by the threaded portion (6) of the device and carried out towards the open end of the jejunostomy tube. Removal of blockage site material is accomplished without a plunging motion and with reduced risk of perforation of the intestine. A use of the device to minimize or eliminate the formation of blockages in jejunostomy tubes is also disclosed.

Description

FEEDING AND DRAINAGE TUBE DECLOGGER Techniral Ffclfl

The present invention relates generally to to a device designed to unclog feeding and drainage tubes and a method of use of the device to unclog such tubes. In particular, the invention relates to jejunostomy tubes.

Jejunostomy tubes (J-Tubes) are used to deliver nutrients or nutritional supplements to the small intestine in patients who are unable to orally ingest required amounts of nutritional materials. Commonly, jejunostomy tubes are surgically placed into the small intestine of patients who are paraplegics, trauma victims, cancer victims or persons suffering from any illness which prevents them from eating.

Frequently, the tubes become blocked because of the drying of the liquid nutritional supplement within the tube. It is estimated that 50% -60% of all jejunostomy tubes become clogged at some point after surgical placement. When that occurs, a physician must try to dislodge the trapped food. Presently, this entails using a syringe full of saline to forcibly expel the food or by using a guide wire to break up the particles and then flushing the tube.

The guide wires are routinely obtained from central venous catheter trays or, if available, are individually wrapped. These wires are designed for placement of catheters into veins. They are not designed for declogging. These wires are longer than the jejunostomy tubes and, therefore, have a great potential to pass through one of the side-holes at the end of the jejunostomy tube and into the intestine. If perforation of the intestine occurs, surgical intervention is required.

If the tube cannot be declogged, a new jejunostomy tube can be replaced at bedside if no more than three or four weeks have elapsed from the initial procedure of placing the tube in the intestine. Otherwise, the patient must return to the operating room for the placement of another jejunostomy tube. This is a costly procedure with significant patient morbidity. If a new jejunostomy tube can be placed at bedside, the patient must have a contrast study through the new tube to insure its proper positioning. The patient must be taken to radiology for a study where the radiologist injects the contrast material into the jejunostomy tube. If the jejunostomy tube is in the intestine, the patient returns to the floor to continue feeding. If the tube is not in the lumen, i.e., in the free intraperitoneal space, operative correction is needed. Some institutions report the insertion of coat hangers or Coca-Cola into jejunostomy tubes to break or dislodge the clog. Thus, it can be seen that there is a long-felt but unsatisfied need for safe and controlled removal of blockages in jejunostomy tubes. There is also a long-felt need to avoid surgical procedures with its increased morbidity for the purpose of unclogging jejunostomy tubes. Therefore, a procedure or device that can unclog blocked jejunostomy tubes safely, effectively, inexpensively and with less risk than presently used procedures would satisfy this long-felt need.

Disclosure of Invention In accordance with the present invention, a declogger and a method of use of the declogger is disclosed for unclogging debris in feeding and drainage tubes, particularly trapped food particles within jejunostomy tubes. For the purpose of the present disclosure, reference to jejunostomy tube(s) shall, in addition to its generally accepted meaning include any tube which enters the human body for the purpose of feeding or drainage.

The device consists of a flexible auger with a diameter suitable for insertion into a jejunostomy tube. Generally, the declogger will have a diameter of approximately 2, 4, 6, 8 or 10 millimeters, depending on the particular jejunostomy tube to be unclogged. Jejunostomy tubes of different sizes are used in practice, depending upon clinical conditions necessitating different sized decloggers.

The decloggers have a length dependent on presently used jejunostomy tubes. A disk may be located at the handle of the device which prevents the operator of the device from pushing the declogger beyond the jejunostomy tube into the intestine. The end of the device which is inserted into the jejunostomy tube is blunt to avoid puncturing the intestine.

A portion of the declogger is threaded at its non-handle end. This threaded portion extends from the blunt end along a portion of a cylindrical section of the declogger toward the handle. The threads extend along a portion of the cylindrical member until they are discontinued, at which point the declogger consists of a smooth, unthreaded cylindrical portion with a smooth cylindrical surface which extends to the handle. The threads are pitched at an angle designed to carry away the debris causing the blockage once the declogger is rotated. The smooth cylindrical surface forms the mid-section of the declogger. The declogger at the handle end expands in diameter to facilitate the handling and operation of the declogger.

The declogger is typically made from polypropylene, although the declogger can be made from any number of materials which possess the properties suitable for forming it into the elongated threaded auger and suitable for use in jejunostomy tubes. Such materials include synthetic, natural, organic and inorganic materials.

The declogger is used to clear blocked jejunostomy tubes by insertion of the auger into the tube to a length sufficient for the blunt end to reach the site of the blockage. The declogger is then rotated at the handle. The pitched threads gradually remove the material causing the blockage away from the site of the blockage. The material causing the blockage is removed toward the handle end of the declogger. This removal of the clogged material is accomplished without a plunging movement or back-and-forth movement of the declogger in the jejunostomy tube.

In clinical use, the declogger will be inserted into the jejunostomy tube at regular intervals to prevent the formation of clogs, as well as to remove clogs which have already formed.

The use of this device reduces a significant number of surgeries with their resultant morbidity which would otherwise have been necessary as a result of clogged jejunostomy tubes. Thus, it is an object of the present invention to provide a device and method of use of the device to remove trapped food particles within jejunostomy tubes which eliminates the need for costly and risk-attendant surgery.

It is an object of the present invention to provide a device and method of use of the device which provides a safe and effective means for the removal of blockages in jejunostomy tubes. It is a further object of the invention to provide a device and a method of use of the device that will enable blockages to be removed less expensively and more quickly from jejunostomy tubes.

It is a further object of the present invention to provide a device and method of use for removing blockages from jejunostomy tubes without risking puncture of the bowel.

It is a further object of the invention to provide a device and method of use of removing blockages from jejunostomy tubes without replacing the existing jejunostomy tubes with new tubes. Further, it is also an object of the present invention to provide a device and method of use which prevents blockages from forming in jejunostomy tubes, as well as being capable of removing blockages from jejunostomy tubes.

Brief Description of the Drawings

Figure 1 shows a side plan view of the jejunostomy tube declogger. Detailed Description of the Invention

And Best Mode for Carrying Out the invention

As shown in Figure 1, the jejunostomy tube declogger has an elongated cylindrical-like member 1.

The declogger has a handle 2 and a handle end 3. The opposite end is a blunt end 4.

The declogger has a smooth non-threaded cylindrical mid-section 5.

Extending from the blunt end 4 is a threaded portion 6 wherein the cylindrical member 1 is threaded.

The smooth non-threaded cylindrical mid-section 5 and threaded portion 6 constitute the cylindrical-like member 1.

The threads 7 are placed at a pitch which simulates the threads of a screw and are pitched at an angle suitable for removal of debris from the clogged portion of the tube. The threads can be pitched at an angle in the range of about 10° to about 40°.

Typically, the threads 7 are pitched at an angle in the range of about 15° to about 25°. It will be understood that the number of threads 7 per length of the declogger are the function of the pitch of the threads.

The threaded portion 6 extends along the elongated cylindrical member 1 toward the handle end 3 of the declogger. In a preferred embodiment, the threaded portion 6 need extend only a fraction of the distance towards the handle end 3, such as one-quarter or one-fifth of the length of the cylindrical member 1 toward the handle end 3. Typically, the declogger will effectively remove blockages from jejunostomy tubes with a threaded portion of about one to four inches in length. However, in heavily clogged jejunostomy tubes or tubes with multiple sites of blockages, it may be desireable to have a longer threaded portion 6 along the cylindrical member 1 of the declogger. In such situations, a declogger whose threaded portion 6 extends most of the cylindrical member's length towards the handle end 3 or along the entire cylindrical member 1 up to the handle 2 may be desired and is included within the scope of the invention.

The smooth non-threaded mid-section 5 and threaded portion 6 constitute a flexible unit which conform to the bends and twists of jejunostomy tubes. It is important that the mid-section 5 and threaded portion 6 have flexibility in order to be able to be inserted the length of the jejunostomy tube to reach the site of the blockage. Since many blockages occur at the far end of jejunostomy tubes where the tube enters the intestine, the declogger must have the ability to reach this site. The flexibility of the declogger enhances the ability of the declogger to be inserted into the tube and moved along the twists and turns of the jejunostomy tube with little resistance. The declogger can be then be inserted slowly and gradually without fear of puncture of a patient's intestine, which would result as pressure is applied to the declogger to push past a frictionally resistant or blocked site. Nevertheless, the declogger must possess sufficient rigidity to not collapse in response to minimal pressure when the declogger meets with some resistance as it is inserted into the jejunostomy tube.

Thus, a material which possesses the required properties of flexibility and rigidity is needed to form the declogger. An effective material for use as a declogger in accordance with this invention will yield threads when cut of a hardness and sharpness sufficient to cut through, dislodge and remove the material causing blockages in jejunostomy tubes.

Furthermore, the declogger must be inert with respect to the liquid material present in jejunostomy tubes.

It should also be understood that the declogger may be delivered to the user in a sterile condition and optimumly would be capable of being re-sterilized after use.

It has been found in a preferred embodiment of the present invention that when polypropylene is used to form the declogger, the declogger exhibits the required flexibility and rigidity. Polypropylene also provides low frictional resistance along the inner walls of jejunostomy tubes as it is moved through the tube. This further enhances the ease of insertion and application of the declogger.

It has also been found that the hardness and sharpness of polypropylene' s threads are sufficient to break up and remove the blockages in the tubes. Furthermore, the polypropylene declogger is inert with respect to the liquid material present in jejunostomy tubes and can be re-sterilized for further subsequent use.

It should be understood that other materials can be employed to form the declogger in accordance with the invention disclosed herein, such materials having the required properties as described above. Such materials include various synthetic, organic and inorganic materials. Specifically, materials which can be used include, but are not limited to polypropylene, polyethylene and nylon.

The declogger has a handle 2 at the handle end 3. This handle is cylinder-like with a larger diameter than the diameter of the cylindrical-like member 1. The larger diameter facilitates the handling and rotation of the declogger. The handle 2 may have flattened sides along its periphery to assist in ease of handling.

A disk 8 may be located at the handle end 3 of cylindrical member 1 for the purpose of preventing the declogger from being inserted too far into the tube, in which case the declogger could enter the intestine. In operation, a sterile declogger in accordance with the present invention is inserted with its blunt end 4 first into an open end of a clogged jejunostomy tube. In some embodiments of the invention a pointed end may be used. The declogger is gradually moved along the length of the tube to the site of a blockage. When the blockage site is reached, the blunt end 4 of the declogger is positioned to abut up against the blockage site. The declogger at this point is no longer subject to forward or backward movement within the tube. Rather, the declogger is rotated by the rotation of the handle 2. The rotation of the declogger allows the threads 7 to cut into and break up the food materials at the blockage site. The continued rotation of the declogger moves the broken debris of the blockage site back along the threads 7 of the threaded portion 6 away from the blockage site towards the handle end 3 and end of the jejunostomy tube. After sufficient rotation, the material causing the blockage has been sufficiently removed from the blockage site. At this point, rotation of the declogger can be stopped. The declogger is then removed from the jejunostomy tube by pulling the declogger by the handle 2 out of the tube. Once removed from the jejunostomy tube, the declogger can be cleaned, and if needed, reinserted for further removal of blockage sites.

.Alternatively, in another embodiment of the present invention, decloggers with extensive threaded portions 6, continued rotation may be sufficient to entirely remove broken debris from the jejunostomy tube. In such cases, the declogger need not be pulled out to entirely remove the blockage material. In such applications, a container or receptacle would be provided to capture the blockage material and liquid material present in jejunostomy tubes as it issues from the end of the jejunostomy tube where the declogger has been inserted.

In accordance with the ease of operation of the declogger, it is contemplated that the rotational movement will be supplied by an operator's fingers. However, it should be understood that it is within the scope of the invention that any other means to rotate the declogger may be employed, including automatic means.

In accordance with the present invention, the declogger can be used as a preventative measure to minimize or eliminate the formation of clogs in jejunostomy tubes. In such usage, the declogger would be used periodically by insertion into the length of the jejunostomy tube, rotated and then removed. When used for preventive purposes, the threaded portion 6 can be placed at selected locations along the jejunostomy tube known to be sites of blockages and rotated at such selected sites. Alternatively, the threaded portions 6 can be successively positioned along the entire length of the tube so that the entire length of the jejunostomy tube is subjected to preventative cleaning.

While a preferred embodiment of the present invention has been illustrated and described, it will be understood by those skilled in the art that changes and modifications may be practiced without departing from the spirit and scope of the invention.

Claims

We Claim:

1. A jejunostomy tube declogger comprising:

(a) a flexible, elongated, cylindrical member having a handle end and an opposite end; (b) a handle extending from the handle end; and

(c) solid spiral threads extending along the cylindrical member from the opposite end for removing blockages in jejunostomy tubes upon rotation of the declogger.

2. The declogger of Claim 1 wherein the threads are pitched at an angle in the range from about 10° to about 40°.

3. The declogger of Claim 2 wherein the threads are pitched at an angle of about 15° to about 25°.

4. The declogger of Claim 2 wherein a smooth unthreaded cylindrical mid- section extends between the handle end and the threaded portion.

5. The declogger of Claim 2 wherein a disk is positioned at the handle end of the cylindrical member for preventing the declogger from being pushed beyond the jejunostomy tube.

6. The declogger of Claim 2 wherein the threads extend along the entire length of the cylindrical member.

7. The declogger of Claim 2 wherein the threads extend in length along the length of the cylindrical member in the range of about one to four inches.

8. The declogger of Claim 2 wherein the cylindrical member has a diameter in the range of approximately two to ten millimeters.

9. The declogger of Claim 2 wherein the declogger is formed from a material from the group consisting of polypropylene, polyethylene and nylon.

10. The declogger of Claim 2 wherein the handle has a larger diameter than the cylindrical member.

11. The declogger of Claim 2 wherein the handle has flattened surfaces along its sides.

12. The method of using the declogger of Claim 1 to remove blockages from jejunostomy tubes comprising:

(a) inserting the declogger into an open end of jejunostomy tube;

(b) moving the declogger along the jejunostomy tube until the blunt end contacts a blockage site; (c) rotating the declogger to break up the blockage; and

(d) removing the declogger and blockage from the jejunostomy tube by pulling the declogger out of the open end of the jejunostomy tube into which the declogger was inserted.

13. The method of Claim 12 wherein the declogger is rotated by automatic means.

14. The method of Claim 12 wherein the declogger is rotated by rotation of the handle.

15. The method of Claim 12 wherein the declogger is moved along the length of the jejunostomy tube until a disk located at the handle end of the declogger contacts the open end of the jejunostomy tube into which the declogger has been inserted.

16. The method of using the declogger of Claim 1 to prevent blockages from forming in jejunostomy tubes comprising:

(a) inserting the declogger into an open end of a jejunostomy tube; (b) moving the declogger along the length of the jejunostomy tube up to the end of the tube which is adjacent to the intestine; and

(c) rotating the declogger and removing the declogger from the jejunostomy tube by pulling the declogger out of the end of the jejunostomy tube into which the declogger was inserted.

17. The method of Claim 16 wherein the declogger is repositioned at other locations along the length of the jejunostomy tube and rotated.