United States Patent
`Meer
`
`[19]
`
`[541
`
`[76]
`
`[*1
`
`NASO-ENTERAL TUBE HARNESS
`APPARATUS AND METHOD
`Inventor:
`
`Jeffrey A. Meer, 7380 St. Auburn,
`Birmingham, Mich. 48010
`
`Notice:
`
`The portion of the term of this patent
`subsequent to Jan. 6, 2004 has been
`disclaimed.
`
`Appl. No.:
`Filed:
`
`334,031
`
`Jul. 10, 1986
`
`Related U.S. Application Data
`
`Continuation-in-part of Ser. No. 774,485, Sep. 10, 1985,
`Pat. No. 4,634,425.
`
`Int. Cl.‘ ........................................... .. A61M 25/00
`............. .. 604/54; 604/174;
`604/280; 128/207.18; 128/DIG. 26
`Field of Search ................... .. 604/54, 77, 94, 174,
`604/270, 271, 280; 128/207.18, DIG. 26
`References Cited
`
`U.S. PATENT DOCUMENTS
`3,161,199 12/1964 Sands ................................. 128/D26
`4,050,667
`9/1977 Kossett ................................ 604/281
`
`Patent Number:
`
`[11]
`[451 Date of Patent:
`
`4,778,448
`* Oct. 18,1988
`
`4,133,315
`4,634,425
`
`1/1979 Berman et al. ........................ 604/96
`1/1987 Meer ................................... .. 604/54
`
`OTHER PUBLICATIONS
`
`Barrocas et al., “The Bridle: Increasing the Use of Nas-
`oenteric Feedings”, Nutritional Support Services vol. 2,
`No. 8, Aug. 1982.
`McGuirt, Strout, “Securing of Intermediate Duration
`Feeding Tubes,” The Laryngoscope,
`vol.
`90, pp.
`2046-2048 (1980).
`
`Primary Examiner—Stephen C. Pellegrino
`Assistant Examiner—Ralph Lewis
`Attorney, Agent, or Firm—Robert M. Isackson
`[57]
`ABSTRACT
`
`A harness for a tube for use in patient health care, par-
`ticularly for naso-enteral feeding. The harness is a thin
`elongated length of material, preferably cylindrical or
`tubular, secured to a nasal tube for a distance along the
`length of the tube and inserted into the patient with the
`tube. The harness then may be secured about the pa-
`tient’s nasal septum so that the connection between the
`harness and the tube along the distance is within the
`patient’s nostril.
`
`13 Claims, 4 Drawing Sheets
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`CORPAK Ex 1007, Page 1
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`U.S. Patent
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`Sheet 1 of 4
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`US. Patent
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`CORPAK Ex 1007, Page 3
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`US. Patent
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`Oct. 18,1988
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`CORPAK Ex 1007, Page 4
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`1
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`4,778,448
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`NASO-ENTERAL TUBE HARNESS APPARATUS
`AND METHOD
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`
`This is a continuation-in-part application of applica-
`tion Ser. No. 774,485 entitled Naso-Enteral Tube Appa-
`ratus And Method, filed Sept. 10, 1985 in name of Jef-
`frey A. Meer, now issued as U.S. Pat. No. 4,634,425.
`This invention relates to improvements in nasal tubes,
`and more particularly to a method and apparatus for
`securing nasal tubes to patients.
`BACKGROUND OF THE INVENTION
`
`Nasal tubes, also known as naso-enteral, naso-gastric,
`naso-duodenal, stomach tubes, or feeding tubes, collec-
`tively referred to as naso-enteral tubes, are used com-
`monly in the course of patient health care, most fre-
`quently in preparation for, during, and after surgery.
`These tubes typically comprise a resilient plastic mate-
`rial 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 down-
`wardly 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 re-
`moved 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 en-
`doscopic visualization, or pharmacological assistance.
`At the proximal end, a suction pump may be con-
`nected for using the tube for drainage of gastric secre-
`tions. Altemately, in connection with the preferred use,
`the tube may be connected to a supply of nutrient solu-
`tion 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 be-
`come prevalent with improved techniques for develop-
`ing and administering the nutrient solutions which are
`important for wound healing and tissue rebuilding, par-
`ticularly in post operative head and neck cancer pa-
`tients, patients having severe facial injury or recon-
`structive mouth surgery, and patients that are comatose
`or unwilling to eat, such patients otherwise having in-
`tact gastrointestinal tracts. Naso-enteral feeding is safer
`and less expensive than either intravenous or parenteral
`nutrition techniques, and typically occurs for intermedi-
`ate 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
`displaced or removed by inattentive hospital staff,
`movement of the patient or tube-associated equipment,
`or by the patient coughing, sneezing, gagging or swal-
`lowing. Tube displacement, or extubation, is inconve-
`nient for the physician and hospital staff and requires
`tube replacement for continued treatment, a time con-
`
`2
`suming and costly process, especially where extraordi-
`nary 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 securethe tube to the
`patient as shown in U.S. Pat. Nos. 4,114,626 and
`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. Nos. 2,831,487, 2,931,358,
`3,161,199, 3,648,703, 3,972,321, 4,282,871, 4,284,076,
`and 4,480,639; a spectacle type frame secured to the
`patient by an elastic srrap 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 corre-
`sponding patch secured to the tube. Among the prob-
`lems 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 un-
`cooperative patient, and can be easily dislodged acci-
`dentally, for example, during restless sleep. The har-
`nesses that hold the tube frictionally generally use a
`means surrounding the tube which may be prone to
`sliding alongthe 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 orien-
`tation 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 aggrava-
`tion to the patient. The harness also must be applied
`against the patient with enough pressure to keep the
`harness from moving and that pressure may cause local-
`ized pressure points on the tissue, minimizing the blood
`flow, and requiring frequent readjustment of the har-
`ness.
`
`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 signifi-
`cant damage to the nasal columella, including, for exam-
`ple, sawing the columella in two.
`Yet another technique involves passing one end of a
`web or tube through one nostril, down past the hypo-
`pharynx, 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
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`4,778,448
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`4
`and not easily removed, intentionally or inadvertently,
`except by the application of proper cutting instruments.
`SUMMARY OF THE INVENTION
`
`3
`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 Ser-
`vices, 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 Feed-
`ing Tubes,” The Larvngoscape, 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
`also may be able to remove the tube, for example, by
`reaching into their nostril behind the point of attaching
`the tube to the harness, grabbing the tube, and with-
`drawing it entirely or partially out of the nostril leaving
`the harness intact, and leaving the tube securely at-
`tached to the harness, leaving the harness securely fas-
`tened 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 tubes to the patient’s nasal
`septum that is comfortable, easy to secure, and substan-
`tially free of detrimental side effects such as tissue irrita-
`tion and infection.
`It is another object of this invention to provide a
`harness that will securely retain naso-enteral tubes with-
`out significantly occluding the tube lumen.
`It is another object of this invention to provide an
`apparatus for securing a naso-gastic, naso-enteral, or
`other nasal 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 pa-
`tient, used for long periods of time, and is unobtrusive
`
`5
`
`30
`
`The present invention comprises an apparatus and
`method for anchoring or securing tubes in a nostril of a
`patient, particularly naso-enteral tubes for use in nutri-
`ent solution feeding or gastic fluid drainage. The appa-
`ratus comprises a harness for securing a tube to a pa-
`tient, a naso-enteral tube, and means for securing the
`harness to the naso-enteral tube along a length of the
`tube.
`The naso-enteral tube comprises an elongated tubular
`member having a means for connecting the tube to a
`nutrient fluid supply or means for draining fluids from
`the patient at the proximal end, optionally a weight at
`the distal end for assisting in inserting and maintaining
`the distal end in the stomach or digestive tract, prefera-
`bly in the duodenum or proximal jejunem of the small
`intestine, and typically has a plurality of perforations at
`the distal end for allowing the inflow or outflow of
`liquids depending upon the use of the tube.
`The harness comprises an elongated body having a
`first end disposed toward the distal end of the tube and
`a second end disposed toward the proximal end of the
`tube. The first end is adapted to be passed through the
`nostril (nasal choana), preferably simultaneously with
`insertion of the naso-enternal tube in a first nostril. The
`second end of the harness is adapted to be inserted into
`the second nostril and connected to-the first end so that
`the first and second ends may be secured together to
`form a loop passing through both nostrils that can be
`adjusted to fit closely about the nasal columella and the
`posterior aspect of the nasal septum. In the preferred
`embodiment, the harness comprises a material similar to
`or compatable with the naso-enteral tube, for example,
`polyurethane, polyethylene, or silicone.
`The means for securing the harness to the naso-
`enteral
`tube may comprise any conventional means
`including but not limited to (1) an adhesive, (2) a web of
`material resulting from coextrusion of the tube and
`harness, (3) thermal, dielectric, or ultrasonic welding,
`or (4) application of a material web or tape, resistant to
`body fluids, joining the naso-enteral tube and harness
`together for a distance along the length of the tube. The
`means must be compatible to secure the tube to the
`harness. The distance is preferably less than the distance
`between the posterior aspect of the nasal septum and the
`base of the nasal columella of the patient for a pre-
`selected range of sizes. More preferably, the length of
`the distance is less than half the distance between the
`posterior aspect of the nasal septum and the base of, the
`nasal columella so as to provide a device adaptable to a
`wider range of patients of different sizes. In one embodi-
`ment, the harness may be wrapped or coiled about the
`tube so as to increase the holding power of the harness.
`The preferred method of this invention comprises
`inserting the first end of the harness and the distal end of
`the naso-enteral tube into one of the nostrils (“first nos-
`tril”) of the patient so that the distal end of the tube is
`located at the desired location in the patient, a portion
`of the harness is visible in the hypopharynx and the_
`distance along the length of tubing to which the harness
`is secured is substantially within the nostril between the
`base of the nasal columella and the posterior aspect of
`the nasal septum. The portion of the harness visible in
`the hypopharynx is then extracted and pulled out the
`mouth. The second end of the harness is then passed
`
`CORPAK Ex 1007, Page 7
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`5
`through the other nostril (“second nostril”) until it is
`visible in the hypopharynx and it is then pulled out of
`the mouth. Preferably, Magill forceps or an equivalent
`are used to extract the harness. The first and second
`ends of the harness are then secured together. In accor-
`dance with prior practices, the ends may be secured
`together, side by side, by sutures, tape, or both, or tied
`into a small knot such as a square knot, with or without
`sutures. These steps are time-consuming, difficult in an
`uncooperative patient and can result in a connection
`that may be difficult to pull through the nasal cavity. In
`the preferred embodiment, the ends of the harness may
`be interlocking or interfitting. For example,
`the end
`passing into the first nostril may have a male protrusion
`and the end passing into the second nostril may have a
`female receptacle for receiving the male protrusion for
`frictionally interconnecting the ends together. Alter-
`nately, a separate piece, insertable into or about both
`ends of the harness, may be used to secure the harness
`ends together into a loop. The advantages of the inter-
`fitting ends are that it significantly reduces the time
`needed to connect the ends of the harness together
`outside the mouth as no suturing is required, and the
`end to end connection facilitates smooth passage of the
`harness through the nasal cavity without catching on
`the patient’s sinus or nasal cavities. Reducing the time
`factor is important because the more stress there is on
`the patient’s soft palate during interconnection of the
`harness, the more likely the patient will vomit or at-
`tempt to pull out the tube and harness during the inser-
`tion process.
`'
`In an alternative embodiment, the harness may com-
`prise a webbing of material secured to the tube, the ends
`of which may be tied together and optionally stitched.
`The portion of the harness extending out the second
`nostril is then pulled so that the first and second ends,
`secured together, pass back into the mouth, up the hy-
`popharynx and out the second nostril and the portion of
`the harness inside the nasal cavity is resting against the
`posterior aspect of the nasal septum. The portion of the
`harness extending out of the first and second nostrils is
`then cut and the harness is secured together, for exam-
`ple, by tying a square knot and suturing the knot to-
`gether, or by suturing the ends together so that the
`harness closely surrounds the nasal septum and nasal
`columella, thereby securely fastening the naso-enteral
`tube within the patient’s nasal cavity. However, the fit
`must not be so tight as to cause tissue erosion or pres-
`sure necrosis, nor so loose as to permit a patient to place
`a finger inside the loop without considerable effort.
`Further, the close fit would minimize the likelihood that
`a patient could reach into their nostril, grab the tube
`behind the point at which the tube is secured to the
`harness, and withdraw the tube. For example, a tube
`secured to a harness for a distance extending at least a
`half inch into the nostril from the nostril opening,
`would minimize the likelihood of such an extraction by
`most patients. The patient pulling on the tube or on the
`loop is thereby discouraged from continuing to with-
`draw the tube by the pressure exerted by the harness on
`the posterior aspect of the nasal septum. The naso-
`enteral tube may be removed when the harness is inten-
`tionally severed, for example, at
`the termination of
`scheduled treatment, and can be drawn easily out
`through the first nostril.
`In an alternate embodiment, the ends of the harness
`may be inserted and secured together before the naso-
`enteral tube is inserted. Then the naso-enteral tube is
`
`6
`inserted so that the distance along the length where the
`harness is joined to the tube is located in the nasal cav-
`ity. Finally, the harness is secured closely about the
`nasal septum.
`It may be advantageous to make the harness a differ-
`ent color than the feeding tube, particularly for distin-
`quishing the tube and harness when extracting the ends
`of the harness. It also may be advantageous to tack the
`end of the harness inserted in the nostril with the feed-
`ing tube to promote easy simultaneous insertion of the
`tube and harness as long as the tacking means, e.g., an
`adhesive,
`is either an edible, digestable, or non-toxic
`material which permits separation of the harness from
`the tube without disturbing the location of the distal end
`of the tube. It also may be advantageous with soft har-
`ness tubes to provide the ends of the harness with flexi-
`ble, gently curved end sections or to use an insertion
`wire having a gently curved end section to insert the
`harness so that during insertion the curved harness ends
`will follow the typical anatomical curve along the bot-
`tom of the nostril, and, upon passage through the nasal
`pharynx, pass directly into the mouth. This would sub-
`stantially minimize having to use the time consuming
`step of withdrawing the harness end out of the hypo-
`pharynx with Magill forceps and further, reduce annoy-
`ance and discomfort to the patient, and the time re-
`quired to insert a harness.
`During insertion, it may be advantageous to lubricate,
`anesthetize, or do both to the patient, at least topically,
`to decrease gagging. The length of the naso-enteral tube
`and the location and length of the distance along the
`tube that the harness and tube are secured together may
`be selected in a size appropriate for the size of the pa-
`tient. For feeding patients, one size tube may be adapted
`for use in a large range of differently sized patients
`because the area in the small intestine that is optimal for
`the infusion of nutrient solutions extends at least from
`the duodenum to the proximal jejunem, which is a sub-
`stantial distance of about a foot. This permits an added
`economy in permitting use of one tube length for many
`patients of a given size range, thereby reducing the need
`to customize tubes and harnesses for each patient. The
`length of tubing having the harness secured thereto at a
`preselected location also may be adjusted by cutting the
`distal end to an appropriate length and, optionally, affix-
`ing a weight to the end.
`In an alternate embodiment, the harness is formed as
`a separate item comprising the first and second ends and
`a securing means and is adapted to be secured to a tube
`just prior to insertion. Preferably, the securing means is
`an adhesive coated material or web attached to the
`harness at the location along the harness corresponding
`to the distance along the length of tube that will be
`inside the patient’s nostril. The web may be provided
`with, for example, a tacky adhesive and a conventional
`coated paper release strip so that the release strip may
`be removed from the adhesive coating and the web then
`applied to secure the harness to the tube to be inserted.
`A variety of adhesives or securing means could be used
`including, but not limited to, a polyurethane strip or flap
`coated on one side with a vinyl acrylate or vinyl acetate
`type adhesive, for example,
`the commercial product
`known as Ensure-it TM , Catalog No. 38-1200-l, manu-
`factured by Deseret Medical, Inc., Sandy, Utah. In yet
`another embodiment, the harness and the web having an
`adhesive material also may be separate items so that the
`web may be wrapped around both the harness and the
`tube to secure them together for a distance along their
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`length, e.g., from about an inch to about an inch and a
`half, prior to insertion.
`In an alternate embodiment, the strength of the con-
`nection between the hamess and the naso-enteral tube
`may be controlled so that a patient, intentionally at-
`tempting to pull the tube out, will cause the tube to
`separate from the harness rather than break within the
`nasal septum, which may cause fluids present to be
`aspirated into the lungs. The strength of the joint also
`can be controlled so that the tube and harness will sepa- 10
`rate before the posterior aspect of the nasal septum is
`damaged. In yet another embodiment, the harness could
`have a tensile strength less than the feeding tube or be
`designed to break at a preselected location, for example,
`near the posterior aspect of the nasal septum, so that the
`harness will break rather than have the tube separate
`from the harness when the tube is pulled persistently, to
`reduce the risk of injury to the patient, especially the
`nasal septum.
`BRIEF DESCRIPTION OF THE DRAWING
`
`FIG. 1 is a perspective view of a naso-enteral tube in
`accordance with the present invention.
`FIGS. 2a—2o are a series of schematic views of the
`naso-enteral
`tube of FIG. 1 being inserted into and
`secured within a patient in accordance with the present
`invention. FIGS. 2a, 2c, 2e, 2g, 21‘, 2k, and 2m are side
`sectional views of a patient taken along a line through
`nostril A. FIGS. 2b, 2d, Zfi 2/2, 2}’, 2], 2n. and 20 are front
`sectional perspective views.
`FIG. 3 is a perspective view of a harness in accor-
`dance with the present invention.
`FIG. 3a is a cross sectional representation of a har-
`ness and tube before and after application of an adhesive
`web in accordance with the present invention.
`FIG. 4 is an elevated perspective view of a harness in
`accordance with the present invention.
`FIG. 4a is a cross sectional view of the harness of
`FIG. 4 in a patient in accordance with the present in-
`vention.
`
`40
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`45
`
`An improved naso-enteral tube is shown in FIG. 1. A
`feeding solution supply (not shown) may be connected
`to connector 1 of naso-enteral tube 2 for passing the
`feeding solution directly to the patient’s stomach or
`small intestine. Alternately, a suction pump can be at-
`tached to connector 1 for draining gastric fluids. Tube 2
`may be any sized conventional naso-enteral tube and is
`preferably a polyurethane Dobhoff-type feeding tube,
`about 36 to 43 inches long, such as an ExtriflexTM
`feeding tube Model No. 8 French, 43 inches long, made
`of a Erythrothane ® polyurethane, commercially avail-
`able from Biosearch Medical Products Inc., Raritan,
`N.J. Weight 8 is affixed to the distal end of tube 2 in-
`serted into the patient, for promoting intubation of the
`small intestine and tube passage through the pylorus,
`and for aid in anchoring the tube against movement.
`Secured to tube 2 for a distance along the length of tube 60
`2 at location 5 is harness 4, comprising a length of flexi-
`ble resilient material, preferably an elongated cylindri-
`cal structure having a different color than tube 2. Har-
`ness 4 may be made of polyethylene or polyurethane,
`for example, and may be about eighteen inches long.
`Any means of permanent securement may be used at
`location 5 including but not limited to (1) coextrusion of
`tube 2 and harness 4, (2) joining tube 2 and harness 4
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`with adhesives, (3) wrapping with a tape, (4) thermal
`welding, (5) ultrasonic welding, (6) dielectric welding,
`or the like. In the preferred embodiment, harness 4 is
`adhered to tube 2 by an adhesive such as methyl ethyl
`ketone,
`tetra hydro furan (THF), or an equivalent,
`which can provide a stronger or weaker bond as appro-
`priate for the patient.
`Referring to FIGS. 3 and 3a, an alternate embodi-
`ment is shown. Securing means 20 may be first secured
`to the harness by any of the aforementioned techniques
`or may be formed as an integral part of the harness. In
`the most preferred embodiment, securing means 20 is a
`flexible web or sheet of material, solid or fabric, coated
`with an adhesive capable of adhering securely to tube
`30, but not significantly degraded in effectiveness by
`nasal secretions and moisture commonly present in a
`nostril. A release paper (not shown) covering the adhe-
`sive may be provided to prevent degradation of adhe-
`sive quality during storage and prior to application to a
`tube. For example, the release paper may be removed
`just prior to use and securing means 20 applied about
`tube 30 for the distance along the length, e.g.,
`l-1.5
`inches for average adult patients, so that when tube 30
`and harness 15 are inserted in place and harness 15
`secured about the nasal septum, securing means 20 is
`within the patient’s nostril. FIG. 3a shows the adhesive
`sheet, tube and harness before secured together in phan-
`tom, and after secured together in solid lines.
`Preferably, the adhesive coated web may include a
`polyurethane sheet or web coated on one side with a
`vinyl acrylate adhesive. Such a coated material, known
`as Op-site TM manufactured by Smith and Nephew, has
`been applied to a typical naso-enteral tube and sub-
`merged under water for a period of about three days.
`No weakening of the adhesive connection was discov-
`ered,
`indicating that such adhesive coated webs are
`sufficient for securing the tube to a harness within the
`moist environment of a patient’s nostril.
`Other types of securing means may be used other
`than tacky adhesives. In the most preferred embodi-
`ment, the web of material preferably extends all this
`way around tube 30 and may overlap itself. The
`strength of the retention force of the web may be ad-
`justed for example, by adjusting the size of the web, the
`tear strength of the web (e.g., providing a series of
`perforations designed to separate under a given force),
`the quantity and peel off strength of the adhesive, the
`surface area of adhesive in contact with tube 30, and the
`amount of overlap of web 20 on itself when applied to
`tube 30, harness 15, or both.
`Desirably, harness 4 (or harness 15 or 15') has a
`weaker tensile strength than tube 2 (or tube 30) so that
`if the patient is insistent upon pulling out tube 2, harness
`4 will break before the feeding tube breaks or separates
`from the harness and before there is damage to the nasal
`septum. This would permit removal of tube 2 intact
`along with harness 4. Alternately, the tensile strength
`could be weaker at preselected location 34 about the
`posterior aspect of the nasal septum, shown in FIG. 2m,
`or the harness could be provided with a tearable score
`permitting the harness to separate under a preselected
`force. In some circumstances it may be desireable to
`have tube 2 separate from harness 4 at location 5 before
`the harness breaks, leaving the harness secured about
`the nasal septum. In other circumstances, for example,
`where the danger of aspirating fluid into the lungs is
`particularly high, it may be desirable to have tube 2
`break leaving a portion of tube 2 properly seated and
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`still secured to harness 4 and harness 4 intact about the
`nasal septum, to substantially reduce the likelihood of
`fluid entering the lungs. These situations can be
`achieved by selecting materials with appropriate tensile
`strengths and adjusting the strength of the means secur-
`ing tube 2 to harness 4 accordingly.
`In operation, the patient, particularly the patient’s
`nostrils and pharynx, may be first anesthetized with a
`topical anesthetic which will ease insertion of the tube
`by reducing gagging of the pharynx and rejection of the
`tube by the patient, and also may act to lubricate the
`nasal passages, facilitating insertion.
`Referring to FIGS. 2a—2d the improved naso-enteral
`tube 2 and harness 4 are simultaneously inserted in one
`of the patient’s nostrils (nostril A) until location 5 is
`within the nasal cavity between the base of the nasal
`columella 28 and posterior aspect of the nasal septum
`27, the distal end of tube 2 is properly located in the
`patient, harness portion 6 passes hypopharynx 24 or
`pharynx 25, and the harness can be extracted and pulled
`out of the mouth by a tool such as Magill forceps or the
`like. Referring to FIGS. 2e—2h, portion 7 of harness 4 is
`then passed inwardly through the other nostril (nostril
`B) and similarly pulled out the mouth. The ends of
`portions 6 and 7 are then connected together outside the
`mouth (FIGS. 2g, 2h), for example, by inserting a protu-
`sion on end portion 6 into a complementary receptacle
`on end portion 7 to form a substantially continuous
`harness tube at location 30. In alternate embodiment,
`the connection may be by suturing or tying together in
`a small knot (not shown) that may be passed through
`nostril B, without damaging the patient.
`Referring to FIGS. 2i—2o, harness 4 is then pulled at
`location 26 so that the interconnected ends of harness 4
`re-enter the mouth and then pass out through nostril B
`(FIG. 21). Harness 4 is pulled close against the back of
`nasal septum 2