WO1993016750A1 - Naso-gastric tube holder - Google Patents

Naso-gastric tube holder Download PDF

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Publication number
WO1993016750A1
WO1993016750A1 PCT/US1993/001682 US9301682W WO9316750A1 WO 1993016750 A1 WO1993016750 A1 WO 1993016750A1 US 9301682 W US9301682 W US 9301682W WO 9316750 A1 WO9316750 A1 WO 9316750A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
body member
patient
holding clamp
clamp means
Prior art date
Application number
PCT/US1993/001682
Other languages
French (fr)
Inventor
Scott Bebry
Henry J. Alletto
Original Assignee
Innovative Medical Design Corp.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innovative Medical Design Corp. filed Critical Innovative Medical Design Corp.
Priority to EP93907032A priority Critical patent/EP0630273A4/en
Priority to JP5515071A priority patent/JPH07504107A/en
Priority to JP6505316A priority patent/JPH07509689A/en
Publication of WO1993016750A1 publication Critical patent/WO1993016750A1/en
Priority to NO943150A priority patent/NO943150D0/en
Priority to KR1019940703008A priority patent/KR950700094A/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • C—CHEMISTRY; METALLURGY
    • C04—CEMENTS; CONCRETE; ARTIFICIAL STONE; CERAMICS; REFRACTORIES
    • C04B—LIME, MAGNESIA; SLAG; CEMENTS; COMPOSITIONS THEREOF, e.g. MORTARS, CONCRETE OR LIKE BUILDING MATERIALS; ARTIFICIAL STONE; CERAMICS; REFRACTORIES; TREATMENT OF NATURAL STONE
    • C04B35/00—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products
    • C04B35/01—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics
    • C04B35/48—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates
    • C04B35/49—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates containing also titanium oxides or titanates
    • C04B35/491—Shaped ceramic products characterised by their composition; Ceramics compositions; Processing powders of inorganic compounds preparatory to the manufacturing of ceramic products based on oxide ceramics based on zirconium or hafnium oxides, zirconates, zircon or hafnates containing also titanium oxides or titanates based on lead zirconates and lead titanates, e.g. PZT
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01G—CAPACITORS; CAPACITORS, RECTIFIERS, DETECTORS, SWITCHING DEVICES, LIGHT-SENSITIVE OR TEMPERATURE-SENSITIVE DEVICES OF THE ELECTROLYTIC TYPE
    • H01G7/00—Capacitors in which the capacitance is varied by non-mechanical means; Processes of their manufacture
    • H01G7/06—Capacitors in which the capacitance is varied by non-mechanical means; Processes of their manufacture having a dielectric selected for the variation of its permittivity with applied voltage, i.e. ferroelectric capacitors
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L21/00—Processes or apparatus adapted for the manufacture or treatment of semiconductor or solid state devices or of parts thereof
    • H01L21/02—Manufacture or treatment of semiconductor devices or of parts thereof
    • H01L21/02104—Forming layers
    • H01L21/02107—Forming insulating materials on a substrate
    • H01L21/02109—Forming insulating materials on a substrate characterised by the type of layer, e.g. type of material, porous/non-porous, pre-cursors, mixtures or laminates
    • H01L21/02112—Forming insulating materials on a substrate characterised by the type of layer, e.g. type of material, porous/non-porous, pre-cursors, mixtures or laminates characterised by the material of the layer
    • H01L21/02172—Forming insulating materials on a substrate characterised by the type of layer, e.g. type of material, porous/non-porous, pre-cursors, mixtures or laminates characterised by the material of the layer the material containing at least one metal element, e.g. metal oxides, metal nitrides, metal oxynitrides or metal carbides
    • H01L21/02197—Forming insulating materials on a substrate characterised by the type of layer, e.g. type of material, porous/non-porous, pre-cursors, mixtures or laminates characterised by the material of the layer the material containing at least one metal element, e.g. metal oxides, metal nitrides, metal oxynitrides or metal carbides the material having a perovskite structure, e.g. BaTiO3
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L21/00—Processes or apparatus adapted for the manufacture or treatment of semiconductor or solid state devices or of parts thereof
    • H01L21/02—Manufacture or treatment of semiconductor devices or of parts thereof
    • H01L21/02104—Forming layers
    • H01L21/02107—Forming insulating materials on a substrate
    • H01L21/02225—Forming insulating materials on a substrate characterised by the process for the formation of the insulating layer
    • H01L21/0226—Forming insulating materials on a substrate characterised by the process for the formation of the insulating layer formation by a deposition process
    • H01L21/02263—Forming insulating materials on a substrate characterised by the process for the formation of the insulating layer formation by a deposition process deposition from the gas or vapour phase
    • H01L21/02266—Forming insulating materials on a substrate characterised by the process for the formation of the insulating layer formation by a deposition process deposition from the gas or vapour phase deposition by physical ablation of a target, e.g. sputtering, reactive sputtering, physical vapour deposition or pulsed laser deposition
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L21/00—Processes or apparatus adapted for the manufacture or treatment of semiconductor or solid state devices or of parts thereof
    • H01L21/02—Manufacture or treatment of semiconductor devices or of parts thereof
    • H01L21/02104—Forming layers
    • H01L21/02107—Forming insulating materials on a substrate
    • H01L21/02296—Forming insulating materials on a substrate characterised by the treatment performed before or after the formation of the layer
    • H01L21/02299—Forming insulating materials on a substrate characterised by the treatment performed before or after the formation of the layer pre-treatment
    • H01L21/02304—Forming insulating materials on a substrate characterised by the treatment performed before or after the formation of the layer pre-treatment formation of intermediate layers, e.g. buffer layers, layers to improve adhesion, lattice match or diffusion barriers
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L28/00—Passive two-terminal components without a potential-jump or surface barrier for integrated circuits; Details thereof; Multistep manufacturing processes therefor
    • H01L28/40—Capacitors
    • H01L28/55—Capacitors with a dielectric comprising a perovskite structure material
    • H01L28/56—Capacitors with a dielectric comprising a perovskite structure material the dielectric comprising two or more layers, e.g. comprising buffer layers, seed layers, gradient layers
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L28/00—Passive two-terminal components without a potential-jump or surface barrier for integrated circuits; Details thereof; Multistep manufacturing processes therefor
    • H01L28/40—Capacitors
    • H01L28/60—Electrodes
    • H—ELECTRICITY
    • H10—SEMICONDUCTOR DEVICES; ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10B—ELECTRONIC MEMORY DEVICES
    • H10B53/00—Ferroelectric RAM [FeRAM] devices comprising ferroelectric memory capacitors
    • H—ELECTRICITY
    • H10—SEMICONDUCTOR DEVICES; ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10N—ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10N15/00—Thermoelectric devices without a junction of dissimilar materials; Thermomagnetic devices, e.g. using the Nernst-Ettingshausen effect
    • H10N15/10—Thermoelectric devices using thermal change of the dielectric constant, e.g. working above and below the Curie point
    • H—ELECTRICITY
    • H10—SEMICONDUCTOR DEVICES; ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10N—ELECTRIC SOLID-STATE DEVICES NOT OTHERWISE PROVIDED FOR
    • H10N30/00—Piezoelectric or electrostrictive devices
    • H10N30/01—Manufacture or treatment
    • H10N30/07—Forming of piezoelectric or electrostrictive parts or bodies on an electrical element or another base
    • H10N30/074—Forming of piezoelectric or electrostrictive parts or bodies on an electrical element or another base by depositing piezoelectric or electrostrictive layers, e.g. aerosol or screen printing
    • H10N30/079—Forming of piezoelectric or electrostrictive parts or bodies on an electrical element or another base by depositing piezoelectric or electrostrictive layers, e.g. aerosol or screen printing using intermediate layers, e.g. for growth control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0213—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
    • A61M2025/0226—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body specifically adapted for the nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/024—Holding devices, e.g. on the body having a clip or clamp system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0618—Nose
    • H—ELECTRICITY
    • H01—ELECTRIC ELEMENTS
    • H01L—SEMICONDUCTOR DEVICES NOT COVERED BY CLASS H10
    • H01L28/00—Passive two-terminal components without a potential-jump or surface barrier for integrated circuits; Details thereof; Multistep manufacturing processes therefor
    • H01L28/40—Capacitors
    • H01L28/55—Capacitors with a dielectric comprising a perovskite structure material

Definitions

  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the naso-gastric tube may be inserted into either of the patient's nostrils.
  • 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.
  • 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".
  • 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.
  • 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.
  • Fig. 4 is a perspective view looking into the sleeve/clamp. BEST MODE FOR CARRYING OUT THE INVENTION
  • the preformed naso-gastric tube holder 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.
  • 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.
  • skin irritation due to prolonged contact with adhesive material will be substantially reduced or elimnated, thereby ensuring greater comfort to the patient.
  • 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.
  • 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.
  • 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.
  • the connecting member 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.
  • the body member 12 is somewhat bell-shaped, although such shape is not critical.
  • the body member has an overall transverse dimension slighly less than either the right or left surfaces of the nose
  • the same device can be interchangeably used for the right or left nostril.
  • the connecting member is disposed along the central line C-C of the body member 12.
  • the connecting member 16 has a larger relative thickness than the body member 12.
  • the connecting member 16 exhibits a shape retaining charac- teristic.
  • 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.
  • 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.
  • 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.
  • the tube 18 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.
  • the present invention is useful in the treatment of hospital patients requiring naso-gastric intubation.

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Abstract

A tube holding clamp (14) in the form of a cylinder open at both ends is attached at one end to a connection (16) which is attached to an adhesive member for attachment to the nose of a patient. The cylinder is slit (32) along its length to permit the tube (18) free entry and to resiliently hold the tube. The connecting member (16) is angular to hold the clamp forward of and in line with the nostrils.

Description

TITLE: NASO-GASTRIC TUBE HOLDER
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.

Claims

CLAIMS :
1. A holder for attaching a naso-gastric tube in position relative to a patient's naris characterized
- by: 5 a planar flexible body member having upper and lower surfaces, said body member generally assuming the shape of a portion of the patient's nose when said inner surface is adhered thereto; a tube holding clamp means comprising a sleeve
10 having a central bore and a lengthwise slit for spreading said tube holding clamp means apart to permit lengthwise insertion in and retention and removal of said naso-gastric tube from said bore, and for closing upon the tube inserted therein for frictional and compressible retention of said
15 tube; and connecting means of shape retaining resiliency inte¬ grally attached in an overlapping fashion at one end to said body member along a central line of said body member and
20 integrally attached at the opposite end to said tube holding clamp means and angled with respect to said body member so as to maintain the tube holding clamp means in proper alignment with the patient's naris, whereby the connecting means permits adequate lateral
25 and longitudinal movement of said tube in accordance with a patient's movements proximate to the clamp while holding said tube stationary within said nose preventing the occurrence of skin irritation and resists any excess movement, and in. additio breakage of the adhesive bond is prevented by location of the
_0 connecting member along the central line of the body member.
2. The holder according to Claim 1, characterized by the fact that said clamp is formed with inwardly directed longitudinally extending ridges on the inner surface of said bore.
35 3. The holder according to Claim 1, characterized by the fact that a one piece construction wherein said body member, said tube holding clamp means, and said connecting means are formed integrally with each other in a one-piece construction.
4. The holder according to Claim 1, characterized by the fact that the lower surface of said body member includes an
5 adhesive coating thereon, thus permitting said body member to be removably and adhesively secured to the exterior skin surface of the patient's nose.
5. The holder according to Claim 1, characterized by the fact that said body member, said tube holding clamp means, and said connecting means are made of flexible resilient moldabl material.
6. The holder according to Claim 5, characterized by the fact that the body member is provided with a plurality of perforations through the surface thereof. 5
7. The holder according to Claim 1, characterized by the fact that said tube holding clamp means and said connecting means are less flexible than said body member and wherein said connecting means and said tube holding clamp means have a respective inherent resilient memory, and further wherein said 0 tube holding clamp means is dimensioned and structured to removably grip said naso-gastric tube along a portion of its length.
8. The holder according to Claim 1, characterized by the fact that said bore is tapered from the proximal to the 5 distal end.
9. The holder according to Claim 4, including a removable protective sheet covering applied to said adhesive coating.
10. The holder according to Claim 1, characterized by O the fact that said connecting means comprises a pair of perpen¬ dicularly disposed legs, one leg being integrally formed with the body, and the other leg being integrally formed with the clamp means, said one leg being placed on the upper surface of said body, and said other leg depending below the plane of 5 said body.
11. The holder for attaching a naso-gastric tube in position relative to a patient's naris ccharacterized by: a planar flexible body member having upper and lower surfaces, wherein said lower surface includes an adhesive coating thereon, said body member generally assuming the shape of a portion of the patient's nose when said inner surface is adhesively bonded thereto; a tube holding clamp means comprising a sleeve with a central bore therethrough and a lengthwise slit with longitudinally extending interior ridges for spreading said tube holding clamp means apart to permit lengthwise insertion in and retention and removal of said naso-gastric tube from said bore and for closing upon the tube inserted therein for frictional and compressible retention of said tube, wherein said tube holding means is dimensioned and structured to removably grip said naso-gastric tube along a portion of its length; and connecting means of shape retaining resiliency integrally attached in an overlapping fashion at one end to said body member along a central line of said body member and integrally attached at an opposite end to said tube holding clamp means and angled with respect to said body member so as to maintain the tube holding clamp means in proper alignment with the patient's naris, wherein said body member, said tube holding clamp means, and said connecting means are formed integrally in a one-piece construction of a flexible resilient material and wherein said tube holding clamp means having a respective inherent resilient memory.
12. The holder according to Claim 11, charac¬ terized by the fact that the lower surface of said body member includes an adhesive coating thereon to permit said body member to be removably and adhesively secured to the exterior skin surface of the patient's nose.
13. The holder according to Claim 11, charac¬ terized by the fact that said connecting means comprises a pair of perpendicularly disposed legs, one leg being integrally formed with the body, and the other leg being integrally formed with the clamp means, said one leg being placed on the upper surface of said body, and said other leg depending below the plane of said body.
14. The holder according to Claim 11, charac¬ terized by the fact that said bore is tapered from the proximal end to the distal end.
PCT/US1993/001682 1992-02-28 1993-02-25 Naso-gastric tube holder WO1993016750A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP93907032A EP0630273A4 (en) 1992-02-28 1993-02-25 Naso-gastric tube holder.
JP5515071A JPH07504107A (en) 1992-02-28 1993-02-25 Nasogastric insertion tube holder
JP6505316A JPH07509689A (en) 1992-02-28 1993-07-13 Cubic metal oxide thin film grown epitaxially on silicon
NO943150A NO943150D0 (en) 1992-02-28 1994-08-25 Holder for naso-gastric tube
KR1019940703008A KR950700094A (en) 1992-02-28 1994-08-27 Naso-Gastric Tube Holder

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/843,304 1992-02-25
US84330492A 1992-02-28 1992-02-28

Publications (1)

Publication Number Publication Date
WO1993016750A1 true WO1993016750A1 (en) 1993-09-02

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Application Number Title Priority Date Filing Date
PCT/US1993/001682 WO1993016750A1 (en) 1992-02-28 1993-02-25 Naso-gastric tube holder

Country Status (8)

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EP (1) EP0630273A4 (en)
JP (2) JPH07504107A (en)
KR (1) KR950700094A (en)
CN (1) CN1080876A (en)
AU (1) AU3777993A (en)
CA (1) CA2130898A1 (en)
NO (1) NO943150D0 (en)
WO (1) WO1993016750A1 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL1021473C2 (en) * 2002-09-17 2004-03-18 Amc Amsterdam Plaster assembly and a nasal bridge plaster forming part thereof.
WO2012052717A1 (en) 2010-10-21 2012-04-26 Andrew Levy Tube anchor assembly
FR2978669A1 (en) * 2011-08-05 2013-02-08 Patrick Georges Renard Device for holding e.g. drain on e.g. patient body, has split, sliding or fixed ring positioned in external part of invasive probe or drain on human or animal body for maintaining predefined positioning of probe or drain with safety
RU2775139C1 (en) * 2021-06-18 2022-06-28 Чиен-Чунг Су Nasogastric probe fixation device

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JP4362581B2 (en) * 2003-08-20 2009-11-11 独立行政法人産業技術総合研究所 Manufacturing method of parallel plate capacitor
JP2010179029A (en) * 2009-02-09 2010-08-19 Sasaki Seisakusho:Kk Protector for nasal cavity
JP6709033B2 (en) * 2015-10-13 2020-06-10 泉工医科工業株式会社 Tube retainer
TWI747549B (en) * 2020-10-12 2021-11-21 蘇建忠 Nasogastric tube fixing device

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL1021473C2 (en) * 2002-09-17 2004-03-18 Amc Amsterdam Plaster assembly and a nasal bridge plaster forming part thereof.
WO2004026388A1 (en) 2002-09-17 2004-04-01 Academisch Medisch Centrum Combi-plaster and a nose-bridge plaster forming part thereof
WO2012052717A1 (en) 2010-10-21 2012-04-26 Andrew Levy Tube anchor assembly
FR2978669A1 (en) * 2011-08-05 2013-02-08 Patrick Georges Renard Device for holding e.g. drain on e.g. patient body, has split, sliding or fixed ring positioned in external part of invasive probe or drain on human or animal body for maintaining predefined positioning of probe or drain with safety
RU2775139C1 (en) * 2021-06-18 2022-06-28 Чиен-Чунг Су Nasogastric probe fixation device

Also Published As

Publication number Publication date
JPH07504107A (en) 1995-05-11
EP0630273A4 (en) 1995-04-19
EP0630273A1 (en) 1994-12-28
CA2130898A1 (en) 1993-08-26
NO943150D0 (en) 1994-08-25
KR950700094A (en) 1995-01-16
CN1080876A (en) 1994-01-19
AU3777993A (en) 1993-09-13
JPH07509689A (en) 1995-10-26

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