TECHNICAL FIELD

This invention relates generally to a disposable medical device and, in particular, to a tube holder for 5 holding a naso-gastric tube and the like in position relative to a patient's naris. BACKGROUND ART

It has long been the practice in the medical field to intubate a patient with a naso-gastric tube,

10 enteral feeding tube, sump tube, or the like, which is routed from the patient's nasal passage, through the pharynx and esophagus and into the stomach. While the present invention is hereinafter described in connection with a naso-gastric tube, it will be seen as applicable

-LS to other tubes as well.

The method typically employed for affixing a tube to the patient after intubation is to employ a conventional adhesive tape wrapped at one end around the tube just below the nose and adhering the opposite end of the tape holder to

²⁰ the nose, cheek, or forehead. Recently, formed tube holders or clamps have been used which are either taped or adhered with surgical glue to the patient. The conventional devices have many shortcomings. First of all, water-based adhesive tape tube holders lose their adhesiveness when subject to

25 body fluid secretions and thus require time-consuming re- application or replacement. More importantly, when the naso-gastric tube is pulled to one side and taped down, pressure is applied by the tube to the tissue surfaces surrounding the nasal opening. This pressure causes dermal

30 irritation and necessitates reintubation in the patient's other nostril. Without intervention by medical personnel, such irritation may become severe.

Attempts have been made to overcome the foregoing problems through the provision of devices which, however,

35 are overly complicated or burdensome to apply and which

exhibit other drawbacks.

For example, U.S. Patent No. 4,932,943 to Nowak describes a naso-gastric tube holder which includes pad which is adhesively applied to a patient's nose and a tube holding clamp in the form of interlocking jaws, pivotally supported along one edge of the pad. However, this device is constructed of too many parts is costly and creates additional problems.

U.S. Patent No. 4,804,374 to Laskody discloses a naso-gastric tube holder which includes preformed adhesive body member shaped to conform to a patient's nose, a securement structure for holding the naso-gastric tube, and an elastic connector for attaching the securement member at a predetermined distance from the body member. This device permits longitudinal displacement of the tube by a predetermined amount and prevents excess displacement of the tube.

U.S. Patent No. 4,120,304 to Moor discloses a naso-gastric tube holding device including a tube holding clamp, an adhesive body member for bonding to a patient's nose, and a connecting member. However, while this device effectively anchors a naso-gastric tube, it lacks stability and provides no means for maintaining a tube in substantially fixed alignment with a patient's naris. In U.S. Patent Application No. 743,173, commonly owned herewith, the inventor, Michael M. Dillon, provides an improved construction having an adhesive body to which is integrally formed a relatively rigid cylindrical clamp into which the naso-gastric tube is inserted. Even in view of the improvements made in the prior art devices of the type set forth above, the aforementioned problems have not been sufficiently resolved. For example, by securing a naso-gastric tube in a longitudinally immobile manner as do the devices described above, the adhesive bond created between the patient's nose and the adhesive pad is subject to breakage due to pressure applied by longitudinal

displacement of the tube. The problem of adhesive bond breakage has generally gone unaddressed in the prior art devices. In addition, such a tube holder does not readily facilitate simple reintubation of the patient without removal of the device or extreme discomfort to the patient. Also, such a structure has been found to become tangled or dislodged in bed sheets or clothing during a patient's sleep or even when a patient turns about in bed. There is still a need in the medical profession for a simple, inexpensive, and easily positional naso-gastric tube holder. In addition, further problems have been created by these attempts. The mounting structure have become unduly complicated or burdensome to apply since they generally comprise a plurality of components.

It is accordingly an object of this invention to provide an improved means for mounting a naso-gastric tube on a patient.

Another object of this invention is to provide an improved means for mounting a naso-gastric tube on a patient which is simple and inexpensive, yet highly effective. Another object of this invention is to provide an improved means for mounting a naso-gastric tube on a patient which employs an adhesive member to affix the device to a patient's nose. Another object of this invention is to provide an improved means for mounting a naso-gastric tube on a patient which permits longitudinal displacement of the subject tube to prevent skin irritation while maintaining integrity of the adhesive seal with the patient's nose. Yet another object of this invention is to provide an improved means for mounting a naso-gastric tube on a patient which achieves stable alignment of the naso-gastric tube in the center of the patient's naris, thereby eliminating skin irritation commonly resulting from prolonged contact of the nasal passag with the tube.

Still yet another object of this invention is to provide an improved means for mounting a naso-gastric tube on a patient which meets the above objectives and is of a one-piece construction. DISCLOSURE OF THE INVENTION

With the foregoing objects and others, which will be readily apparent to one skilled in the art, one aspect of this invention lies in providing a device for holding a naso- gastric tube in position relative to a patient's naris, while at the same time permitting a reasonable degree of freedom for the patient to move without significant discomfort. The naso- gastric tube holder of the present invention includes a planar flexible body with an adhesive lower surface for making an adhesive contact with a patient's nose and generally assuming the shape thereof. The present invention also includes a tube holding clamp in the form of a sleeve with a central bore therethrough and a lengthwise slit with interior ridges for spreading the tube holding clamp apart to permit lengthwise insertion, retention and removal of a naso-gastric tube from the bore and for closing upon the naso-gastric tube inserted therein for compressible and frictional retention of the tube.

These two elements are attached via a flexible connecting member with shape retaining resiliency which is integrally formed with the body member and tube holding clamp. The connecting member is attached at one end in an overlapping manner to the body member along its central line and is attached at its opposite end to the tube holding clamp. In addition, the connecting member is angled with respect to the body member so as to flexibly hold the tube holding clamp in proper alignment with the patient's intubated nostril.

As a result of the above combination of elements, the naso-gastric tube may be inserted into either of the patient's nostrils. In addition, in order to prevent the occurrence of dermal irritation, the connecting member permits adequate lateral and longitudinal movement of the

tube in accordance with a patient's movements. Furthermore, due to the location of the connecting means at the central line of the body member, the stress incident on the edges of the body member is relieved, thus preventing breakage of the adhesive bond.

Most advantageously, the body member is formed from soft, pliable plastic resin or rubber-like material so as to be capable of assuming the shape of the nose and to be soft and neither annoying nor harmful to the patient. The body may be provided with a fan or wing-like shape to facilitate matching to the contour of the nose and face. The body is preferably provided with perforations to permit air and moisture to pass therethrough, thus allowing the patient's skin to breath and reducing or eliminating irritation of the skin. Therefore, the following advantages exist due to the cooperative nature of the structural components of the subject assembly and their positioning and cooperative placement on the patient in order to removably retain the naso-gastric tube in its intended and operative position. Occurrence of epidermal irritation is eli¬ minated by utilizing materials which are either porous or which have openings therethrough and thus allow the skin to effectively "breath". Inside the patient's nasal passages, the present invention prevents nasal septal ulcers by permitting adequate longitudinal movement of the naso-gastric tube but preventing excessive movement which would require tube re¬ positioning by medical personnel. The element of the present invention permit rapid mounting and, when required, simple tube repositioning or reintubation without the need for removal of the tube holder.

The invention accordingly comprises the features of the construction, combination of elements and arrangement of components which will be exemplified

in the preferred embodiment hereinafter set forth and in the accompanying drawings, and the scope of the invention will be indicated in the claims. BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention more fully, reference is directed to the accompanying drawings, which are to be taken in conjunction with the detailed description of the invention and in which drawings:

Fig. 1 is an enlarged perspective view of the patient, to which the naso-gastric tube holder embodying the present invention is attached;

Fig. 2 is an enlarged bottom perspective view of the holder shown in Fig. 1, partially fragmented;

Fig. 3 is a bottom plan view of the holder; and

Fig. 4 is a perspective view looking into the sleeve/clamp. BEST MODE FOR CARRYING OUT THE INVENTION

In accordance with the present invention, the preformed naso-gastric tube holder, referred to in the drawings by the reference numeral 10, generally includes three primary elements, i.e. a thin, planar flexible body member 12 for adhesive contact with a patient's nose, a tube holding clamp 14 for frictionally and compressibly holding a naso-gastric tube 18 and a connecting member 16 for flexibly connecting the body member 12 and tube holding clamp 14.

The body member 12 may be formed, for example, by injection molding of silicone material, medical grade rubber, or other plastic resin material, which may be of a porous nature to permit the skin to breathe. Medical grade silicone and rubber materials are well known in the art and are readily available through commercial medical supply channels. The bottom or confrontational surface 20 of the body member 12 may, most advantageously, include an adhesive coating material 22 over at least a portion thereof so as to permit adherence of the naso-gastric

tube holder 10 to the nose in the position shown in Fig. 1. As noted, the material from which the body member is formed may be porous, although it is preferably provided with perforations 24 to allow the skin to which the body member 12 is adhered to effectively "breathe". The perforation further makes the body member more supple, causing it to conform more readily to the contour of the nose. By virtue of this construction, skin irritation due to prolonged contact with adhesive material will be substantially reduced or elimnated, thereby ensuring greater comfort to the patient. In this manner, a one piece integral construction of all components using less costly nonporous material may be achieved having the same advantages as a more expensive porous surgical material.

The adhesive layer 22 may be any one of a number of biologically compatible, nonallergenic adhesives, examples of which include polymethacrylate, polyvinyl ethyl ether, poly- acrylate and acrylic ester copolymer. These adhesives have been used in the past and exhibit good adhesive properties, are substantially nonirritating to epidermal tissue and do not deteriorate when exposed to water and/or body fluids. For storage and handling the adhesive layer may be covered with a nonadhering plastic sheet 26.

The tube holding clamp 14, comprises a tubular sleeve 28 having open ends and defining a hollow interior bor or bore 30, which, if desired, may be tapered from its outer end toward its inner end to more readily hold the tube 18. The sleeve is provided with a longitudinal slit 32, preferabl at its bottom (as applied to the nose) along its entire lengt The side walls of the slit are bevelled, as seen in Fig. 4, to provide ample means on the surface of the sleeve to allow the the user to insert his fingers and easily distend and spread apart the sleeve for reception, retention, or removal of the tube 18. The slit 32 has internally extending ridges 34 along the edges of the sidewalls of the slit. As seen in Fig. 2, the tube holding clamp 14 has a thick wall 36 so as

to be less flexible than the body member 12 and the connecting member 16. This lowered flexibility acts to stabilize the tube 18 where proximal to the patient's nose so as not to unduly flex and irritate the nasal passage. Since the clamp wall 36 is relatively thick, it has a resilient memory and is easily closeable about the tube 18, allowing the ridges 34 to securely hold the tube in place. The position of the ridges about the inner circular surface of the clamp wall 26 is not critical and may be placed where convenient. It is important that the transverse dimension of both the slit 32 and the bore 30 is somewhat less than the transverse dimension of the tube 18 so that the clamp 14 may compressibly grip the outer surface of the tube 18, without compression of the tube 18 and yet permit manual longitudinal repositioning of the tube 18 if necessary, while preventing inadvertent slippage or relative move¬ ment therebetween. Slippage is also reduced by the fric- tional interaction caused by the similarity of the plastic material with the material used for the tube itself. As will be seen from the following description of the connecting member 16, the tube holder can be easily lifted upon from the nose of a patient, although once it is in place, it will retain the tube in a substantially fixed and aligned position. This alleviates excess rubbing of the tube 18 on the inside tissue of the patient's naris and avoids irritation of the edges of the nose as well. Furthermore, as a result of the frictional adherence of the tube 18 to the inside surface of the tube holding- clamp 14, the possibility of inadvertent movement of the tube 18 is decreased.

The connecting member, generally identified by the number 16, is molded into a shape retaining form, having a pair of perpendicular flat legs 38 and 40 respectively connected to the top surface of the body member 12 and the tube holding clamp 14 in such a manner as to position

the clamp 14 below the plane of the body member 12 and in line with the naris chosen for intubation. The connecting member 16 is most advantageously formed integrally with the body member 12 and tube holding clamp 14, for example by injection molding, thus facilitating the construction of a superior device at a reduced cost which is simpler to utilize than prior art devices of the type having a multiplicity of components.

As seen in the figures, the body member 12 is somewhat bell-shaped, although such shape is not critical.

Preferably, the body member has an overall transverse dimension slighly less than either the right or left surfaces of the nose

Therefore, it may be placed in position over either the right or left side of the nose. In this manner, the same device can be interchangeably used for the right or left nostril.

As clearly illustrated, the connecting member is disposed along the central line C-C of the body member 12.

Although not readily apparent, such location of the connecting member serves to alleviate the stress applied to the edges of the body member 12, no matter which side it is placed on.

The connecting member 16 has a larger relative thickness than the body member 12. Thus, while the body member 12 is pliable and easily conformable to a patient's nose, the connecting member 16 exhibits a shape retaining charac- teristic. In order to accomplish this objective, an important aspect of the tube holder of the present invention is that the connecting member 16 is atached to the upper surface 20 of body member 12 in an overlapping fashion rather than merely extend from the edge of the body member 12. In this manner, the increased flexibility of the body member 12 does not serve to reduce the resiliency of the connecting member 16. Conversely, the increased wall 42 resulting in extra thick¬ ness in the overlapping portion of the body 12 acts to reduce any hinge effect and relieves stress incident upon the body member.

In use, the holder of this invention allows the physician to insert the naso-gastric tube 18 through the patient's nose without first attaching the tube 18 to the holder, although the tube 18 may be secured to the patient initially if desired. Once the tube 18 has been inserted through a patient's nasal passage, it is simply attached to the holder 10 by spreading the clamp 14 along its slit 32, inserting the tube 18, and allowing the clamp to grip the tube, after which the body member 12 is attached to the patient's nose if it is not already there.

A holder in accordance with the invention may have a body member 12 approximately 1/16" thick and a clamp 14 having an approximately 1/2" outside diameter and an internal diameter of 1/8". The internal diameter may taper down to 3/16" at the inner portion of the bore. Overall, the holder of this inven¬ tion, has an overall length of about 3" from front to rear, ^' along the center line.

While a specific and detailed description of a pre¬ ferred embodiment of the present invention has been set forth, it will be understood that various changes in the details, materials, and arrangement of components, which have been described and illustrated in order to explain the nature of the invention, will be apparent to those skilled in the art upon a reading of the disclosure, and that such changes as well as others can be made within the scope and principles of the present invention. INDUSTRIAL APPLICABILITY.

The present invention is useful in the treatment of hospital patients requiring naso-gastric intubation.