Naso-enteral tubes, also known as naso-gastric, naso-duodenal, stomach tubes, or feeding tubes, are commonly used in the course of patient health care, most frequently in preparation for, during, and after surgery. These tubes typically comprise a resilient plastic material such as polyurethane, polyethylene, or silicone, having a proximal end, a central lumen or passageway, a distal end, and optionally, a weight affixed to the distal end. The distal end may have one or more apertures providing for fluid flow in or out of the tube. In use, the tube is inserted upwardly into a patient's nostril, pushed along a path past the nasal pharynx, and then downwardly past the oral pharynx, through the esophagus and into the stomach, more preferably into the small intestine for feeding. A laterally flexible longitudinally rigid wire disposed within the central passageway may be used to aid insertion, the wire preferably being removed following proper placement of the distal end into the patient. Often, expensive and time-consuming extraordinary means may be required to aid proper tube placement in the patient. Such means may include, for example, X-ray fluoroscopy, direct placement with endoscopic visualization, or pharmacological assistance.
At the proximal end, a suction pump may be connected for using the tube for drainage of gastric secretions. In connection with the preferred use, the tube may be connected to a supply of nutrient solution for naso-enteral feeding of the patient by passing liquid nutrient solutions through the tube directly into the stomach or small intestine. The latter use has become prevalent with improved techniques for developing and administering the nutrient solutions which are important for wound healing and tissue rebuilding, particularly in post operative head and neck cancer patients, patients having severe facial injury or reconstructive mouth surgery, and patients that are comatose or unwilling to eat, such patients otherwise having intact gastrointestinal tracts. Naso-enteral feeding is safer and less expensive than either intravenous or parenteral nutrition techniques, and typically occurs for intermediate periods lasting from a few days to several weeks or more.
A major problem with using in-dwelling naso-enteral tubes is that patients tend to pull them out prematurely, either deliberately, accidentally, or while disoriented. An unsecured or inadequately secured tube can also be removed by inattentive hospital staff, movement of the patient or tube associated equipment, or by the patient coughing, sneezing, gagging or swallowing. Tube displacement, or extubation, is inconvenient for the physician and hospital staff and requires tube replacement for continued treatment, a time consuming and costly process, especially where extraordinary means are involved. Tube replacement also can be traumatic and discomforting to the patient, hazardous to a patient having fresh facial sutures, and it also may adversely affect the patient's emotional and physical well being. Further, extubation can be dangerous to the patient particularly if a tube is only partially removed which can result in the patient aspirating fluid into the lungs. In addition, time and resources must be spent in frequent monitoring of the patient, to make sure that the tube is properly in place and that either the nutrients are properly being administered to the stomach or suction is properly occurring.
Various techniques have been developed for securing a naso-enteral tube to the patient to prevent accidental or premature removal of the tube. Such techniques include using adhesive tape to secure the tube to the patient as shown in U.S. Pat. No. 4,114,626 and U.S. Pat. No. 3,046,989 and as illustrated in U.S. Pat. No. 4,282,871; using an adjustable or flexible tube holder for retaining the tube placed adjacent the nostril opening and secured to the patient by a harness going around the patient's head as shown in U.S. Pat. No. 2,831,487, U.S. Pat. No. 2,931,358, U.S. Pat. No. 3,161,199, U.S. Pat. No. 3,648,703, U.S. Pat. No. 3,972,321, U.S. Pat. No. 4,282,871, U.S. Pat. No. 4,284,076, and U.S. Pat. No. 4,480,639; a spectacle type frame secured to the patient by an elastic strap about the head and having a means for securing the tube to the frame as shown in U.S. Pat. No. 3,209,775, a tube holder that has a self-attaching hook means that holds a nosepiece onto the nose as shown in U.S. Pat. No. 3,568,678; or an adhesive patch of Velcro.TM. on the patient's cheek and a corresponding patch secured to the tube. Among the problems associated with adhesive tape are that it stretches the skin, takes considerable time and effort to secure and release the tube, and loses effectiveness and must be replaced when the tape becomes wet. The problem with the aforementioned external harnesses is that they are clumsy, can be removed easily, for example, by an uncooperative patient, and can be easily dislodged accidentally, for example, during restless sleep. The harnesses that hold the tube frictionally generally use a means surrounding the tube which may be prone to sliding along the tube, or which compresses the tube, reducing the overall efficiency of fluid flow in the feed or drain system. Other problems with such harnesses include holding the tube in an unnaturally curved orientation relative to the nostril so that the tube bends or twists against the nostril or upper lip which may cause tissue erosion or increase the discomfort and aggravation to the patient. The harness must also be applied against the patient with enough pressure to keep the harness from moving and that pressure may cause localized pressure points on the tissue, minimizing the blood flow, and requiring frequent readjustment of the harness.
A further attempt to secure the tube to the patient has involved suturing the tube to the patient's tissue, for example the nasal columella. The problems with such stitching is that chronic pulling on the tube and constant nasal secretions may result in local infection and significant damage to the nasal columella, including, for example, sawing the columella in two.
Yet another technique involves passing one end of a web or tube through one nostril, down past the hypopharynx, retrieving both ends from the hypopharynx and securing the two ends together by suturing. The loop of web or tube at the base of the nasal columella is then pulled so that the tied ends of the tube pass back into the mouth, by the posterior aspect of the nasal septum, and out the nostril where the web or the tube is cut and tied together at the base of the columella. The knot may be sutured to prevent slippage. A naso-enteral tube is then inserted into the nostril and secured to the loop by sutures and adhesive tape. See Barrocas, A., Jastram, C., St. Romain, C., "The Bridle: Increasing the Use of Nasoenteric Feedings", Nutritional Support Services, Vol. 2, No. 8, August 1982. In an alternate form, the free ends of the loop are tied into a second knot about the naso-enteral tube where the naso-enteral tube may have a boss designed to prevent the tube from slipping relative to the loop. See McGuirt, W. F., Strout, J. J., "Securing of Intermediate Duration Feeding Tubes," The Laryngoscope, Vol. 90, pp. 2046-48 (1980).
The problem with these techniques is that they suffer the problems of all external harnesses in that the tube is secured to the harness at a location that the patient can reach and unsecure and remains subject to dislodgement or loosening by movement of the patient. The patient may be able to remove the tube, for example, by reaching into his nostril behind the point of attaching the tube to the harness, grabbing the tube, and withdrawing the tube entirely or partially out of the nostril, leaving the tube secured to the harness and the harness intact, secured about the nasal septum. In addition, the presence of sutures in or about the naso-enteral tube may weaken the structural integrity of the tube and may result in leakage of fluids outside the tube. If the sutures are too tight, they may restrict or cause a particle in the fluid to obstruct the lumen of the tube. This would interfere with the ability to pass fluids through the lumen and increase the the likelihood that the tube may be improperly used. Constant tugging on the tube may result in a sawing action, causing the tube to break. The knots or sutures may be broken by being pulled on or may become loosened by the constant nasal secretions or moisture, or may be untied or weakened by stress so that the naso-enteral tube can be slid or pulled out of the harness notwithstanding that the loop remains securely fastened to the patient. Further, these jury-rigged loops or bridles must be customized for each patient which is cumbersome and time-consuming for the doctor and may result in inconsistent results which could discourage use of an extremely beneficial feeding technique.
It is therefore an object of this invention to provide a simple and inexpensive apparatus and method for safe, consistent, anchoring of naso-enteral tubes to patients that is comfortable, easy to secure, and substantially free of detrimental side effects such as tissue irritation and infection.
It is another object of this invention to provide a harness that will securely retain naso-enteral tubes without significantly occluding the tube lumen.
It is another object of this invention to provide an apparatus for securing a naso-enteral tube to a patient that substantially will not slide relative to the harness while the harness is fixed in place.
It is yet another object of this invention to provide a harness for naso-enteral tubes that can be inserted and secured quickly with minimum discomfort to the patient, used for long periods of time, and is unobtrusive and not easily removed, intentionally or inadvertently, except by the application of proper cutting instruments.