throbber
_
`United States Patent
`
`[19]
`
`||||ll|l||1|1|l|1l||l|||l|1|l|||||1|1Illllllllllllll||1l1||||||l|1l||1||||1
`USOOSISSOOSA
`[11] Patent Number:
`
`5,185,005
`
`Ballantyne
`
`[45] Date of Patent:
`
`Feb. 9, 1993
`
`[54] METHOD AND APPARATUS FOR
`5};cUR1x(; A NA5o(;A5TR1c TUBE
`
`Inventor: Alando J. Ballantyne, Houston, Tex.
`[75]
`[73] Assigneez Board of Regemflhe Univmityof
`.
`'1-°’“‘5 System’ Austlm Te”
`[2]] App]. No_; 710,050
`[22] Filed:
`Jun. 4, 1991
`[51]
`Int. Cl.-‘ ............................................... AGIM 5/32
`[52] U.S. Cl. ............................. .. 604/174; 123/207.18;
`123/DIG 26: 604/179
`[58] Field of Search ............. .. 604/174, 175, 177, 179,
`604/54" 93- 2643 128/DIG 26: 207-139 606/108
`References Cited
`,
`,
`US’ PATEKT DOCUMENTS
`3151-199 13/1964 5113“ --------------------------------- ~- 604/179
`3.568.678
`3/1971 Pouquier el al.
`604-/174
`3.977.407
`8/1976 Coleman et al.
`604/179
`4.28-1.07b
`8/1981 Hall
`128/207.18
`4.480.639 11/198-1 Peterson
`604/179
`
`.
`
`4.658.814 4/1987 Anderson .......................... .. 604/179
`4.778.448 10/1988 Meer . . . .. . .
`. . . .. 604/174
`4.795.442
`l/1989 Traflet
`604/174
`4,so4_374
`2/1939 1_,a5L;ody ,
`(304/130
`4.932.943
`6/1990 Nowak .............................. .. 604/180
`Primary Examz'ner—Gene Mancene
`Assistant Examiner——.1effrey A. Smith .
`Attorney, Agent, or FIrm—Arnold, White & Durkee
`[571
`ABSTRACT
`A nasogastric tube anchor, and a method of its use
`employing a bridle which passes through the patient's
`nostrils and nasopharynx, the ends of me bridle being
`fastened to a nasogastric tube exterior to the patients
`nose to anchor said tube against undesired movement
`relative to the patient‘s nostril. Installation tools and
`methods are provided for positioning said bridle within
`the patient‘s nose such that one end ofthe bridle extends
`from each nostril‘
`
`17 Claims, 2 Drawing Sheets
`
`CORPAK Ex 1002, Page 1
`
`

`
`U.S. Patent
`
`Feb. 9, 1993
`
`Sheet 1 of 2
`
`5,185,005
`
`CORPAK Ex 1002, Page 2
`
`

`
`U.S. Patent
`
`Feb. 9, 1993
`
`Sheet 2 of 2
`
`5,185,005
`
`5
`
`2%’-4
`
`66
`
`54
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`64
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`..—55
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`CORPAK Ex 1002, Page 3
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`

`
`1
`
`5,185,005
`
`METHOD AND APPARATUS FOR SECURING A
`NASOGASTRIC TUBE
`
`BACKGROUND OF THE INVENTION
`11. Field of the Invention
`This invention relates to an apparatus which is used
`to anchor a nasogastric tube external to the nose. In
`particular, the apparatus employs an elongated flexible
`member which passes through one nostril, around the
`posterior nasal septum. and out the other nostril. The
`two ends of the flexible member. one passing out each
`nostril, are attached to a nasogastric tube or are affixed
`to an anchoring clip, to which also may be anchored a
`nasogastric tube. The invention also includes an appara-
`tus and method for installing the elongated flexible
`member through the patient’s nose to pass around the
`nasal septum.
`11. Description of Related Art
`is common
`In the medical treatment of patients it
`practice to use a nasogastric tube for entering the gas-
`trointestinal tract of the patient by initially passing the
`tube into a nostril. While placement and operation of
`such tubes is quite common and effective. certain prob-
`lems are recognized in the medical profession regarding
`efficient. safe and comfortable mounting or placement
`of such tubes. especially since such tubes are frequently
`maintained in their operative position for extended peri-
`ods.
`It is well recognized that conventional gastrointesti-
`nal tubes utilize securing means such as tape. sutures or
`complex headgear. The irritation and discomfort associ-
`ated with such securement methods and devices may
`render many conventional devices unsuitable. A typical
`means for securing such a tube is to wrap adhesive
`around the outer surface ofthe tube and secure the same
`adhesive strip or material to the outer surface of the
`nose. This method is troublesome in that normal move-
`ment of the patient sometimes causes nasal septa] ulcers
`and/or necrosis by causing excessive tube movement
`while the tube is in direct contact with an inner portion
`ofthe nose. such as when the tube is continuously repo-
`sitioned or due to the normal movement of the patient.
`Many conventional securing devices such as head-
`gear or headband assemblies attempt to overcome prob-
`lems of the type set forth above through the provision
`of specific anchoring or mounting structures. While
`operable for their intended function, numerous forms of
`these conventional devices have been found to be
`overly complicated or somewhat difficult or time con-
`suming in their installation. maintenance or removal
`from the patient, thereby necessitating extensive nurs-
`ing care for repositioning or readjusting the tube prop-
`erly into its operative position.
`The prior art consists primarily of tube anchoring
`devices which rely on adhesive means for connecting
`the anchoring device to the patient‘s nose, or which rely
`on some sort of strap encircling the head to hold the
`securing device in its proper position. Devices incorpo-
`rating adhesive means include those described in pa-
`tents issued to Liskody, U.S. Pat. No. 4,804,374, and
`Nowak, U.S. Pat. No. 4,932.94-3. Patents disclosing
`devices which utilize a strap around the patient's head
`include Hall. U.S. Pat. No. 4,284.076, and Coleman et
`al., U.S. Pat. No. 3.977.407.
`Both adhesive and head-band type securements can
`be easily removed by a belligerent patient, and pro-
`longed use of adhesive tape can cause skin irritation.
`
`2
`Furthermore. it is possible for these securement devices
`to hold the tube too securely. Some amount of normal
`movement of the tube relative to the nose and nostril
`
`through which it enters is desired. However, excessive
`movement relative thereto is to be prevented so as to
`reduce the possibility of ulcers or irritation to portions
`ofthe nose, skin, etc. disposed in direct contact with the
`adhesive tape or tube.
`the need for a
`The above discussion points out
`method to securely anchor a transnasal tube, such as
`e.g. a nasogastric tube, at the point where it exits the
`patient‘s body through a nostril. There is particular
`need for such a method which will effectively resist the
`efforts of an uncooperative or belligerent patient
`to
`withdraw or excessively move the tube, and which
`avoids the other problems associated with adhesive and
`headband type securements.
`SUMMARY OF THE INVENTION
`
`The claimed invention comprises an apparatus for
`anchoring a tube such as a nasogastric tube which ex-
`tends into a patient‘s nostril, more particularly compris-
`ing an elongated flexible bridle with two ends, one end
`protruding from each nostril, operatively positioned
`from one nostril, through the nasopharynx beyond the
`posterior nasal septum and out the other nostril, and
`means connected to said two ends of the bridle external
`to said nostrils for anchoring the tube relative to the
`nostril. The bridle may be constructed of a suitable
`elongated flexible material in the form of, for example,
`a tube, tape, ribbon. or cable.
`The anchoring means, with which the nasogastric
`tube is anchored, may, for example, comprise an an-
`choring clip removably attachable to the two ends of
`the bridle. said anchoring clip having an outer surface
`upon which the tube can be connected, or having a bore
`or other structure which grips or holds the tube to be
`anchored. Said anchoring means may alternatively
`comprise. for example, a piece of material such as tape
`or string which is used to tape or tie together the pro-
`truding ends of the bridle and the nasogastric tube.
`The anchoring clip may. for example, comprise sim-
`ply a properly bent piece of wire or rod sized such that
`the two ends of a tubular bridle may be securely posi-
`tioned over the two ends of said wire or rod with a fit
`that is tight enough to inhibit removal of the wire or rod
`from the bridle. In another embodiment, the anchoring
`means may comprise a clip removably attachable in
`other ways to the two ends of the bridle. Such a clip
`may also comprise a bore or other structure for receiv-
`ing the nasogastric tube to be anchored. Such clip may
`further comprise two members which are designed to
`be snap fitted together with the two ends of the bridle
`seized between them to rigidly hold the ends of the
`bridle. Any of the above described anchoring means
`may be constructed to be either permanently or remov-
`ably attachable to the ends of the bridle.
`The claimed invention further comprises an appara-
`tus providing means for operatively positioning the
`bridle through a patient’s nose such that
`it passes
`through the nasopharynx and around the posterior nasal
`septum such that one end protrudes from each nostril.
`This apparatus comprises two installation tools.
`In a preferred embodiment, a pulling cord is utilized,
`one end of which is affixed to a first magnet and the
`other end of which is affixed to one end of the bridle.
`The bridle and pulling cord are then slidably inserted
`
`50
`
`CORPAK Ex 1002, Page 4
`
`

`
`5,185,005
`
`3
`is
`the magnet
`installation tool until
`through the first
`pulled flush against the distal end of said tool. The first
`magnet is held in place against the distal end of the first
`installation tool by tension applied to the bridle and
`pulling cord which extend from the proximal end of
`said tool.
`The second installation tool has a second magnet
`securely attached to its distal end. Both installation
`tools and magnets are sufficiently rigid and sized so as
`to be slidable into a patient's nostrils to a point in the
`nasopharynx beyond the posterior nasal septum. This
`positioning apparatus further comprises means for in-
`serting the distal end of the first installation tool. com-
`plete with the first magnet, within one nostril. and for
`inserting the distal end of the second installation tool,
`complete with the second magnet, within the other
`nostril such that the magnets positioned by each instal-
`lation tool magnetically couple behind the posterior
`nasal septum.
`the pulling
`in another embodiment,
`Alternatively,
`cord is omitted and the leading end of the bridle is
`directly attached to the first magnet. The bridle is then
`inserted through the first installation tool until the first
`magnet is held in place against the distal end of said
`installation tool prior to insertion of the tool into the
`nostril.
`~
`In either of the above described embodiments, both
`magnets may comprise one or more permanent mag-
`nets. or one or more permanent magnets combined with
`ferromagnetic material, to provide adequate magnetic
`force to effect the coupling of the magnets within the
`nasopharynx and to enable both magnets. magnetically
`coupled together. to be pulled from the patient‘s nostril.
`Also claimed is a method for anchoring a tube extend- 35
`ing into a patient's nose, comprising passing one end of
`a bridle into one nostril, around the posterior nasal
`septum. and out the other nostril. one end of said bridle
`extending from each nostril exterior to the patient's
`nose. fastening the two ends of the bridle to one another
`with an anchoring clip or otherwise. and securing a
`nasogastric tube extending into one of the patient's
`nostrils to the bridle ends or to the anchoring clip.
`The claimed method of inserting the bridle into the
`patient‘s nose may further comprise the steps of con-
`necting a proximal end of a pulling cord to the bridle,
`placing a distal end of the pulling cord into one of the
`patient‘s nostrils to a point beyond the posterior nasal
`septum, and pulling the pulling cord around the poste-
`rior nasal septum and out the other nostril, such that the
`bridle is installed in the patient's nose passing behind the
`posterior nasal septum with one end extending out each
`nostril. The distal end ofthe pulling cord may be placed
`within the first nostril by positioning it with a first in-
`stallation tool which is removably inserted within the
`nostril. The pulling cord may be pulled around the
`posterior nasal septum and out the second nostril by the
`use of a second installation tool comprising means to
`couple the end of the pulling cord inserted into the first
`nostril to the end of the second installation tool, en-
`abling the leading end of the pulling cord to be pulled
`out of the second nostril by removing the second instal-
`lation tool from the second nostril.
`Said coupling may comprise magnetic coupling of
`one magnet attached to the leading end of the pulling 65
`cord and one magnet fastened to the distal end of the
`second installation tool, which magnets are placed into
`close proximity in the nasopharynx beyond the poste-
`
`they couple by magnetic
`
`4
`rior nasal septum such that
`force.
`Both of the magnets involved may comprise perma-
`nent magnets or combinations of permanent magnets
`and ferromagnetic material. These methods for insert-
`ing the bridle into the patient's nose may be performed
`with the bridle itself directly attached to the first mag-
`net, omitting the pulling cord connecting the leading
`end of the bridle to the first magnet.
`Finally, the claimed invention comprises a method
`for anchoring a tube extending into a patient’s nostril
`comprising inserting a bridle within a patient’s nose by
`the methods discussed above or otherwise, and further
`comprising connecting an anchoring clip to both ends
`of said bridle, inserting the tube to be anchored into the
`patient‘s nostril and then securing that tube to the an-
`choring clip. Alternatively, the ends of the bridle and
`the tube may be securely joined together by, for exam-
`ple, tying with tape or string, or by gluing.
`The present
`invention therefore provides an im-
`proved device and method which allows anchoring of a
`tube, such as a nasogastric tube.
`in a generally fixed
`position relative to the nostril by which it enters the
`patient's body. This invention avoids the problems asso-
`ciated with conventional means for anchoring such a
`tube, including discomfort, the need for replacing and
`repositioning, and efforts by belligerent patients to
`move or remove a transnasal
`tube. These and other
`advantages of the present invention will be further ap-
`preciated from the drawings and the detailed descrip-
`tion provided below.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`So that the manner in which the above-recited advan-
`tages and features of the present invention, as well as
`others which will become apparent, are attained and
`can be understood in detail. a more particular descrip-
`tion of the invention summarized above may be had by
`reference to the embodiment thereof which is illustrated
`in the appended drawings, which drawings form a part
`of this specification.
`It is to be noted, however, that the appended draw-
`ings illustrate only typical embodiments of the inven-
`tion and are therefore not to be Considered limiting ofits
`scope, for the invention may admit to other equally
`effective embodiments.
`FIG. I is a frontal elevation view of an embodiment
`of an assembled nasogastric tube anchor.
`FIG. 2 is a frontal elevation View of an assembled
`nasogastric tube anchor of the present
`invention in-
`stalled on a patient in its operative position.
`FIG. 2A is a frontal elevation’ view of an alternative
`embodiment of an assembled nasogastric tube anchor of
`the present invention installed on a patient in its opera-
`tive position.
`FIG. 3 illustrates a first installation tool used to install
`the bridle of the present invention, complete with bri-
`dle, pulling cord, and magnetic member.
`FIG. 3A is a lateral cross-sectional view of a first
`installation tool used to install the present invention.
`FIG. 4 illustrates a second installation tool used to
`install the bridle of the present invention.
`FIG. 5 is a frontal elevation view of another embodi-
`ment of an assembled nasogastric tube anchor.
`FIG. 6 illus“1tes the method of installation ofa bridle
`in a patient's nose after the magnets have coupled to-
`gether and during withdrawal of the first installation
`tool.
`’
`
`CORPAK Ex 1002, Page 5
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`

`
`5
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`5,185,005
`
`the nasogastric tube
`Referring to FIGS. 1 and 2.
`anchor of this invention in the embodiment illustrated
`comprises bridle 10 and anchoring clip 12. Bridle 10
`comprises an elongated flexible member which passes
`through both nostrils 14 and around the posterior nasal
`septum 16 ofa patient who requires the use of a nasogas-
`tric or other tube 18. The ends 20, 22 ofbridle 10 extend
`from the patient's nostrils 14, where they are secured to
`bridle attaching means 24 of anchoring clip 12.
`Nasogastric tube 18 is also attached to anchoring clip 12
`by, for example, being passed through a bore in anchor-
`ing clip 12 which is adapted to securely grip said tube.
`The assembly comprising bridle 10 and anchoring
`clip 12 operates to secure nasogastric tube 18 in a de-
`sired position relative to a patient’s nose, allowing mini-
`mal normal movement of tube 18, without requiring
`adhesive, suture or other attachment to the skin of the
`face and without requiring a band around the head. This
`invention is particularly well suited to be used on a
`belligerent patient. as it is designed to_be more difficult
`to remove than other tube anchoring devices.
`This nasogastric tube anchor can be easily adapted to
`securely anchor any tube or other apparatus which
`must be maintained in a position extending from a pa-
`tients nose.
`The assembly comprising bridle 10 and anchoring
`clip 12 constitutes a continuous loop encircling the
`patient's nasal septum which cannot be removed inad-
`vertently by movement ofthe patient. nor by the efforts
`of a belligerent patient. It can, however, be easily re-
`moved by medical personnel by severing bridle 10 with
`scissors or by manipulation of anchoring clip 12. Bridle ..
`10 is formed of a flexible elastomer. fabric. or other
`material. chosen for flexibility. softness. tensile strength
`and non-irritating qualities. It can take any convenient
`form. such as. for example. a tube. tape. cable or mono-
`filament.
`
`As shown in FIG. 5, anchoring clip 26 in one pre-
`ferred embodiment may consist of an appropriately bent
`rod. constructed of, for example. stainless steel. whose
`upturned ends 28 are configured to receive the ends of
`bridle 10. In this embodiment, bridle 10 is tubular. and 45
`the diameter of rod 26 is selected such that its ends 28
`can be slidably inserted into the ends 20, 22 of bridle 10.
`By proper material selection and treatment. for example
`by knurling ends 28 or use of adhesives, it can be made
`very difficult in this embodiment to remove a bridle end
`from its attachment. A nasogastric tube is attached to
`anchoring clip 26 by, for example,
`taping. Alterna-
`tively, the anchoring clip can be omitted altogether and
`the ends 20. 22 of bridle 10 can be secured together and
`to tube 18 by alternative anchoring means. For example,
`ends 20, 22 of bridle 10 can be glued to tube 18, as
`illustrated in FIG. 2A. or ends 20, 22 can be tied or
`taped together and to tube 18 with string. tape, or other
`suitable material.
`-
`A method for installing the nasogastric tube anchor
`of this invention is described with reference to FIGS. 3
`and 4.
`FIG. 3 illustrates first installation assembly 32. First
`installation tool 34 comprises an adequately rigid tube
`sized to be slidable over bridle member 10, yet narrow
`enough to be easily insertable into a nostril such that the
`distal end 68 of first
`installation assembly 32 resides
`within the nasopharynx beyond the posterior nasal sep-
`
`_
`
`6
`turn. Installation assembly 32 comprises bridle 10 to
`which is tied. eg. with a needle knot 36. a trailing end
`of pulling cord 38. Pulling cord 38 and bridle 10 can be
`connected by means other than a needle knot 36, which
`includes but is not limited to use of adhesives, tape or
`fabrication of pulling cord 38 and bridle 10 from a single
`piece of material. Pulling cord 38 can be a flexible
`monofilament string. such as, for example, fishing line.
`The leading end of pulling cord 38 is secured to ma-g-
`netic member 40. Magnetic member 40 is disk shaped
`and has a diameter approximately equal to that of the
`outside diameter of first installation tool 34, for exam-
`ple, about 5 mm. In a preferred embodiment, fastening
`plate 42 comprises a steel disk that is drilled and prefera-
`bly countersunk. The leading end of pulling cord 38 is
`shown inserted through the drilled hole from the non-
`countersunk side of fastening plate 42, knotted and
`trimmed such that knot 44 fits into the counter-sunk
`cavity 46 (FIG. 3A) without pulling out of the drilled
`hole. Countersunk cavity 46 is then filled flush with
`epoxy to further secure cord 38 to fastening plate 42.
`Magnets 48, 50. 52 (e.g., three dental magnets) are glued
`to the leading face of fastening plate 42 to make up
`magnetic member 40. When connected together as
`shown in FIG. 3, magnets 48, 50, and 52 have sufficient
`magnetic force to maintain magnetic coupling with
`magnet 54 of assembly 56 described below. Sumarium
`Cobalt .lobMax #18 (5 mm.><l.5 mm.) magnets have
`been successfully used for magnets 48, 50, 52 and 54. Of
`course, the described configuration of assembly 32 is
`exemplary only and can be replaced by other suitable
`configurations as would be apparent to one skilled in the
`art.
`
`The leading end of pulling cord 38 is attached to
`magnetic member 40 and the trailing end of pulling cord
`38 is attached to bridle 10. The trailing end of bridle 10
`is inserted into the distal end of and through first instal-
`lation tool 34. Bridle 10 and pulling cord 38 are pulled
`through first installation tool 34 until fastening plate 42
`is flush against
`the distal end of installation tool 34,
`where it
`is held by tension applied in direction X to
`pulling cord 38 external to the proximal end of installa-
`tion tool 34, as illustrated in FIG. 3A. In a preferred
`embodiment, an epoxy cone 58 is constructed on the
`trailing face of fastening plate 42 around cord 38. When
`fastening plate 42 is pulled against the distal end of first
`installation tool 34, cone 58 enters the distal end of said
`tool and centers fastening plate 42 thereon.
`Alternatively, the first installation assembly can be
`assembled without a pulling cord. In such an embodi-
`ment, the leading end of bridle member 10 itself is di-
`rectly attached to magnetic member 40, for example. by
`providing a fastening plate 42 which is drilled and coun-
`tersunk such that the leading end of bridle 10 can be
`inserted through the drilled hole and knotted, such that
`knot 60 fits within the countersunk cavity but does not
`pull through the drilled hole. This embodiment is con-
`structed and operated in the same manner as is the em-
`bodiment described above, except that no pulling cord
`is present between magnetic member 40 and the leading
`end of bridle 10.
`Referring to FIG. 4, second installation assembly 56
`comprises adequately rigid member 62 with one or
`more permanent magnets 54, 64 preferably permanently
`affixed to the ‘istal end thereof. Magnet 54 is oriented
`such that its outwardly facing surface 66 is magnetically
`attractive to outwardly facing surface 68 of magnetic
`member 40 of first
`installation assembly 32. Second
`
`CORPAK Ex 1002, Page 6
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`

`
`7
`installation assembly 56 is sized to permit it to be easily
`inserted into a patient‘s nostril sufficiently to position
`magnet 54 beyond the posterior nasal septum. Magnet
`64 may be a stirring magnet inserted lengthwise into the
`distal end of rigid member 62 and fastened into position.
`Magnet 54 may be a dental magnet attached to the distal
`end of rigid member 62 and magnet 64, for example by
`gluing. Magnet 64 is oriented to act in series with mag-
`net 54.
`Rigid members 34, 62 of first installation assembly 32
`and second installation assembly 56 may, for example,
`comprise suction catheter tubes of suitable diameter and
`cut to the desired length.
`Referring to FIGS. 3 and 4, in a preferred embodi-
`ment, bridle 10 is installed in a patient’s nose by a
`method comprising inserting the distal end 68 of first
`installation assembly 32 into a first nostril of the patient
`until magnetic member 40 is positioned beyond the
`posterior nasal septum. The distal end 66 of second
`installation assembly 56 is then inserted into a second
`nostril of the patient until magnet 54 is beyond the pos-
`terior nasal septum,
`in close proximity to magnetic
`member 40. When this configuration is achieved, pull-
`ing cord 38 extending from the proximal end of first
`installation tool 34 is released, allowing magnetic mem-
`ber 40 to be pulled by magnetic force toward and to
`couple with magnet 54. At this point the two magnets,
`40 and 54. are coupled together by magnetic force.
`When the magnets magnetically couple within the naso-
`pharynx an audible click can be heard as the magnets
`slap together, which click serves to verify proper place-
`ment of the tools.
`Referring to FIG. 6, first installation tool 34 is with-
`drawn in direction Z from the nostril, while pulling
`cord 38 and bridle 10 are allowed to slide through tool
`34 as it is withdrawn. Tool 34 is slidably removed over
`cord 38 and bridle 10 until it
`is entirely separated from
`cord 38 and bridle 10. Second installation tool 56 is then
`withdrawn from the second nostril in direction Y, pull-
`ing with it magnetic member 40 with the leading end of 40
`pulling cord 38 attached thereto. As second installation
`tool 56 and the leading end of pulling cord 38 are with-
`drawn from the second nostril, the trailing end of pull-
`ing cord 38 and the leading end of bridle 10 enter the
`first nostril. When second installation tool 56 is entirely
`removed from the second nostril, pulling cord 38 can be
`grasped and bridle 10 pulled into its proper position by
`exertion of tension on pulling cord 38, pulling the lead-
`ing end of bridle 10 into the first nostril, around the
`posterior nasal septum, and down through the second
`nostril until it passes out of the nasal opening.
`Alternatively, first installation tool 34 can be left in
`place in the nostril. or partially withdrawn, after the
`magnets have coupled, while second installation tool 56
`and pulling cord 38 are pulled from the second nostril to
`draw bridle 10 into first installation tool 34, around the
`posterior nasal septum, and further into its operative
`position with the leading end of bridle 10 external to the
`second nostril. First installation tool 34 is then removed
`from the nostril, while the portion of bridle 10 remain-
`ing inside said tool slides-relative to said tool and retains
`its position in the nose. In this way first installation tool
`34 may operate to shield nasal tissues from abrasion and
`irritation while bridle 10 is pulled into position.
`Referring to FIGS. 2 and 2A, once bridle 10 is posi-
`tioned in the patient’s nose with ends 20, 22 extending
`from each nostril 14, both ends 20. 22 of bridle 10 are
`cut to the desired length and trimmed to fit bridle at-
`
`. _
`
`5,185,005
`
`8
`tachment means 24, 24 of anchoring clip 12. Both ends
`20, 22 of bridle 10 are then attached to clip 12, which
`comprises anchoring means for attachment to nasogas-
`tric tube 18 which is inserted through one of the pa-
`tient‘s nostrils 14.
`Bridle attachment means 24, 24 may be ofany suitable
`construction which allows attachment of bridle ends 20,
`22 while inhibiting or preventing withdrawal of bridle
`ends 20, 22 once they have been inserted or attached.
`Such means may incorporate, e.g., pinch rollers or le-
`vers, or barbs, which permit “one-way” movement of
`the bridle ends into or onto clip 12. In another embodi-
`ment, anchoring clip 12 comprises two pieces which are
`snap-fitted together upon the ends 20, 22 of bridle 10
`and perhaps also upon tube 18. The ends 20, 22 and tube
`18 are secured within such a clip, e.g., by compression
`and friction means.
`Referring to FIG. 5, in a preferred embodiment the
`tubular ends of bridle 10 are slid over bridle attachment
`means 28 of clip 26. Bridle attachment means 28 are, for
`example, stainless steel rod segments selected to be
`insertable tightly into the ends 20, 22 of bridle 10. In this
`embodiment, a nasogastric tube (e.g. 18) may be an-
`chored by suitable means of attachment to the center
`portion of anchoring clip 26, e.g. by taping.
`In yet other embodiments, for example, the ends 20,
`22 of the bridle extending from the nostrils and the
`nasogastric tube being anchored may be glued together
`(FIG. 2A), or they may be tied or taped together with
`e.g. string, umbilical tape, or adhesive tape.
`Further modifications and alternative embodiments
`of the apparatus and method of this invention will be
`apparent to those skilled in the art in View of this de-
`scription. Accordingly, this description is to be con-
`strued as illustrative only and is for the purpose of
`teaching those skilled in the art the manner of carrying
`out the invention. It is to be understood that the forms
`of the invention herein shown and described are to be
`taken as the presently preferred embodiments. Various
`changes may be made in the shape, size and arrange-
`ment of parts. For example, equivalent elements or
`materials may be substituted for those illustrated and
`described herein, parts may be reversed, and certain
`features of the invention may be utilized independently
`of the use of other features, all as would be apparent to
`one skilled in the art after having the benefit of this
`description of the invention.
`What is claimed is:
`1. An apparatus for anchoring a nasogastric tube,
`comprising:
`an elongated flexible bridle having first and second
`ends, the bridle adapted to by inserted around a
`patient's nasal septum with one of said first and
`second ends extending outwardly from each of the
`patient’s nostrils;
`first means adapted to releasably couple to the first
`end of the bridle for inserting the first end of the
`bridle into a patient’s first nostril to a point beyond
`the nasal septum; and
`second means insertable through a patient’s second
`nostril adapted to engage the first end of the bridle
`and for pulling the first end of the bridle exterior to
`the patient’s second nostril.
`2. An apparatus providing means for operatively
`positioning a bridle through a patient’s nostrils, com-
`prising:
`a pulling cord having a distal end and a proximal end,
`said distal end attached to at least one first mag-
`
`CORPAK Ex 1002, Page 7
`
`

`
`10
`
`9
`netic member and said proximal end attached to
`said bridle:
`first
`installation tool having an inside dimension
`slidable over said bridle and said pulling cord, said
`tool having a distal end configured to releasably
`retain said first magnetic member and said pulling
`cord extending within said tool;
`a second installation tool having a distal end and a
`proximal end, said distal end having a second mag-
`, netic member connected thereto; and
`means for inserting the distal end of said first installa-
`tion tool within one nostril and the distal end of
`said second installation tool within the other nos-
`tril. whereby the magnetic members at the distal
`ends of said tools magnetically couple behind the
`posterior nasal septum.
`3. An apparatus providing means for operatively
`positioning a bridle through a patient‘s nostrils, com-
`prising:
`a bridle having a distal end and a proximal end. said
`distal end attached to at
`least one first magnetic
`member;
`‘
`a first
`installation tool having an inside dimension
`slidable over said bridle. said tool having a distal
`end configured to releasably retain said first mag-
`netic member:
`a second installation tool having a distal end and a
`proximal end. said distal end having a second mag-
`netic member connected thereto; and
`means for inserting the distal end of said first installa- 30
`tion tool within one nostril and the distal end of
`said second installation tool within the other nos-
`tril. wheteby the magnetic members connected to
`the distal ends of said tools magnetically couple
`behind the posterior nasal septum.
`4. The apparatus of claim 2 or 3. wherein said mag-
`netic members comprise permanent magnets.
`5. A nasogastric tube anchoring kit. comprising:
`a bridle having first and second ends.
`the bridle
`adapted to be operatively positioned around a pa-
`tients posterior nasal septum with one of said ends
`protruding from each of a patients first and second
`- nostrils:
`an installation tool adapted to insert the first end of
`the bridle into a first nostril to a point beyond a 45
`posterior nasal septum: and
`a retrieval tool adapted to be inserted into a second
`nostril to a point beyond the posterior nasal septum
`and further adapted to engage the first end of the
`bridle and to pull the first end of the bridle out
`through the second nostril.
`. A nasogastric tube anchoring kit, comprising:
`bridle having first and second ends,
`the bridle
`adapted to be operatively positioned around a pa-
`tient‘s posterior nasal septum with one of said ends 55
`protruding from each ofa patient's first and second
`nostrils:
`a pulling cord having a leading end and a trailing end.
`the trailing end adapted to be connected to the first
`end of the bridle;
`an installation tool ad

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