(12) United States Patent
`Kirn
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 6,631,715 B2
`Oct. 14, 2003
`
`US006631715B2
`
`MAGNETIC NASAL TUBE BRIDLE SYSTEM
`AND RELATED METHOD
`
`Inventor: David S. Kirn, Lexington, KY (US)
`
`Assignee: Kirn Medical Design, L.L.C.,
`Lexington, KY (US)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`Appl. N0.: 09/939,399
`
`Filed:
`
`Aug. 24, 2001
`Prior Publication Data
`
`US 2002/0026936 A1 Mar. 7, 2002
`
`Related U.S. Application Data
`Provisional application No. 60/230,525, filed 011 Sep. 1,
`2000.
`
`Int. Cl.7 ....................... .. A61M 15/00; A61F 11/00
`U.s. Cl.
`................................. .. 128/200.24; 606/108
`Field of Search ..................... .. 128/200.24, 200.26,
`128/206.11, 207.14—207.16, 207.18, 912,
`DIG. 26; 606/108
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,323,208
`3,705,586
`3,744,104
`3,896,527
`3,993,081
`4,176,756
`4,193,174
`4,244,362
`4,249,529
`4,275,485
`4,284,076
`4,392,857
`4,431,005
`4,458,385
`
`>3>>3>>>>>>3>>>3>>
`
`6/1967 Hurley, J1’.
`12/1972 Sarracino
`7/ 1973 Ford
`7/1975 Miller et al.
`11/1976 Cussell
`12/1979 Gellman
`3/1980 Stephens
`1/1981 Anderson ............ .. 128/200.26
`2/1981 Nestor et al.
`6/1981 l-lutchison
`8/1981 Hall
`7/1983 Beran
`2/1984 McCormick ......... .. 128/207.14
`7/1984 Espinoza
`
`128/207. 18
`
`-19
`
`4,480,639
`4,498,903
`4,514,882
`4,634,425
`4,775,121
`4,778,448
`4,913,139
`4,943,770
`
`5,024,220
`5,026,352
`5,069,206
`5,113,717
`
`
`
`5,115,542>>>>3>3>>>>>3>3>>
`
`128/207.18
`604/174
`
`11/1984 Pctcrson ct al.
`2/1985 Mathew
`5/1985 Lavielle
`1/1987 Meer
`10/1988 Carty
`10/1988 Meer
`4/1990 Ballew
`7/1990 Ashley—Rollman
`et al.
`................... .. 128/200.26
`6/1991 Holmgreen et al.
`128/200.26
`6/1991 Anderson
`...... .. 604/178
`12/1991 Crosbic ............... .. 128/207.17
`5/1992 Plamper
`5/1992 Gelnes
`
`(List continued on next page.)
`OTHER PUBLICATIONS
`
`Thomas N. Zweng, MD, FACS; Bradley B. Hill, MD; and
`William E. Strodel, MD, FACS, An Improved Technique for
`Securing Nasoenteral Feeding Tubes, Journal of the Ameri-
`can College of Surgeons, Sep. 1996, Vol. 183.
`
`(List continued on next page.)
`
`Primary Examir1er—Weilun Lo
`Assistant Examiner—Teena Mitchell
`(74) Attorney, Agent, or Fz'rm—King & Schickli, PLLC
`
`(57)
`
`ABSTRACT
`
`A bridle system for placing and securing a nasal tube in a
`patient includes a flexible member having a magnet attached
`to a first end thereof for insertion into a nare of a patient’s
`nose, a magnetic probe for insertion into a second nare of the
`nose. The magnetic probe attracts the flexible member
`magnet to assist in retrieving the first end of the flexible
`member through the second nare of the nose. The system
`further includes a receiver for securing the nasal tube and the
`flexible member externally, adjacent the nose to prevent
`dislodgement by the patient or otherwise. The receiver
`includes first and second pivotally connected portions form-
`ing a main body. Channels are provided for receiving the
`nasal tube and flexible member in a snap—fit manner.
`
`32 Claims, 5 Drawing Sheets
`
`CORPAK Ex 1001, Page 1
`
`

`
`US 6,631,715 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`OTHER PUBLICATIONS
`
`5,185,005
`5,226,892
`5,389,082
`5,398,679
`5,492,538
`5,535,969
`5,555,881
`5,560,351
`5,613,655
`5,624,430
`5,782,236
`5,806,516
`5,815,894
`5,817,103
`6,029,668
`6,067,985
`6,394,092
`
`F_U>>>>3>>>3>3>>>>>3>>>
`
`128/207.17
`
`2/1993 Ballamyue
`7/1993 Boswell
`2/1995 Baugues et al.
`3/1995 Breed
`2/1996 Johlin, Jr.
`7/1996 Duffy, -II.
`~~~~~~~ ~~ 123/29717
`9/1996 loge“ 91 91-
`19/1996 Gnwenslein 6‘ a1~
`~~ 128/29926
`3/1997 1:/I*“i°n
`4/1997 '30“ et ‘*1’
`7/1998 355
`9/1998 Beattie
`10/1998 Soriano
`10/1998 Be"
`128/207.17
`2/2000 jreed
`. 128/207.17
`5/2000
`slava
`5/2002 Barrett et al. ........ ..
`I28/207.17
`
`128/20717
`128/207.17
`
`Marc J. Popovich, MD; John D. Lockrem, MD; and Joel B.
`Zivot, MD, Nasal Bridle Revisted: An Improvement in the
`Technique to Prevent Unitntentional Removal of SmallBore
`Nasoenteric Feeding Tubes, Crit Care Med 1996 vol. 24, No.
`3,
`Brandt, C.P., Millendorf, E.A. Endoscopic placement of
`nasojejrlnal feeding tubes in ICU patients. Surgical Endos-
`copy (1999) 13:1211—1214. Springer—Verlag, New York.
`Meer, J .A., A New Nasal Bridle for Securing Nasoenteral
`Feeding Tubes. J. Parenteral and Enteral Nutrition, vol. 13,
`No. 3 (1989). American Society for Parenteral and Enteral
`Nutrition.
`.
`.
`.
`Barrocas, A., Jastram, C. et al., The Bridle. Increasing the
`Use of Nasoenteric Feedings. Nutritional Support Services,
`V01‘ 2= N0" 8>A“g' 1982'
`* cited by examiner
`
`CORPAK Ex 1001, Page 2
`
`

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`U.S. Patent
`
`Oct. 14, 2003
`
`Sheet 1 0f5
`
`US 6,631,715 B2
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`

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`U.S. Patent
`
`30024:1tncO
`
`Sheet 2 of 5
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`US 6,631,715 B2
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`

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`Oct. 14, 2003
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`US 6,631,715 B2
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`CORPAK Ex 1001, Page 6
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`

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`U.S. Patent
`
`Oct. 14, 2003
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`Sheet 5 of5
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`US 6,631,715 B2
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`

`
`US 6,631,715 B2
`
`1
`MAGNETIC NASAL TUBE BRIDLE SYSTEM
`AND RELATED METHOD
`
`This application claims the benefit of U.S. Provisional
`Application No. 60/230,525, filed Sep. 1, 2000.
`TECHNICAL FIELD
`
`The present invention relates generally to systems for
`placing and securing a nasal tube; and more particularly to
`such a system which utilizes magnets in the placement of a
`bridle used in combination with a receiver to secure the nasal
`tube.
`
`BACKGROUND OF THE INVENTION
`
`Many different methods have been used to place nasal
`tubes, such as feeding tubes, nasogastric tubes, and nasotra-
`cheal tubes into patients and to secure the tubes once placed.
`One such method disclosed in U.S. Pat. No. 5,185,005 to
`Ballantyne requires a bridle which is pulled into a nare of a
`patient’s nose, around the posterior nasal septum, and out
`the other nare by a cord attached to the bridle and an
`insertion tool. Specifically, first and second installation tools
`are inserted into the nares of the patient’s nose. Magnets
`associated with each tool couple together behind the poste-
`rior nasal septum. In the preferred embodiment, the pulling
`cord is attached to a magnetic assembly which is pulled free
`of its insertion tool by the removal of the remaining insertion
`tool. In this manner, removal of the second insertion tool
`pulls the bridle via the pulling cord through the first insertion
`tool and into a nare of the patient’s nose, behind the nasal
`septum, and out of the other nare.
`In an alternate embodiment described in tlie ’005 patent,
`the bridle itself is associated with the magnet utilizing a
`fastening plate which is drilled and countersunk. The bridle
`is inserted through the drilled hole and knotted. The knot
`rests in the countersunk cavity of the fastening plate which
`is magnetically coupled to the magnet. Although the utili-
`zation of magnets to loop a bridle behind the nasal septum
`of a patient represents an advancement
`in the art,
`the
`apparatus described in the ’005 patent includes numerous
`parts which are difficult to manufacture and time consuming
`to assemble. These difficulties increase the per unit cost of
`the apparatus and the opportunities for defects.
`Prior to the ’005 patent, U.S. Pat. No. 4,778,448 to Meer
`represented the state of the art. The ’448 patent requires ends
`of a bridle to be inserted into first and second nares of a
`patient’s nose until the ends are visible in the posterior
`pharynx of the patient. The visible ends of the bridle are then
`pulled out of the mouth of the patient using forceps or the
`like. The ends are then secured together forming a loop. The
`end of the loop adjacent the posterior nasal septum is then
`pulled such that the end of the loop protruding through the
`mouth is pulled back into the mouth, up the posterior
`pharynx and out of one of the nostrils. The harness is
`subsequently cut to a desired size such that the exterior end
`of the loop is adjacent
`the posterior nasal septum and
`rejoined. Although effective, the placement of the harness in
`this manner is both time consuming and diflicult to under-
`take. Further, the process of placing the harness is uncom-
`fortable for the patient and carries the risk of dislocation of
`the mandible since the patient’s jaw must be opened widely
`to identify the ends of the harness in the posterior pharynx.
`Additional methods for securing nasal
`tubes include
`attaching the tubes directly to the skin of the recipient
`utilizing an adhesive such as tape or the like, as described for
`example in U.S. Pat. Nos. 4,114,626 and 4,282,871, or
`
`2
`sutures. All of these methods which rely on an adhesive to
`secure the feeding tubes have in common the disadvantages
`of being uncomfortable for the patient, gradually losing
`adhesion over time, risking injury to the underlying skin, or
`causing pressure necrosis of the nose itself from holding the
`tube tightly opposed to the nose.
`Thus, as demonstrated by the limitations and disadvan-
`tages of the prior art methods for placing and securing nasal
`tubes in patients, there is a need identified for an improved
`bridle system and related method for placing and securing
`nasal tubes which allows rapid, easy looping of a bridle
`around the posterior nasal septum with minimal patient
`discomfort and no risk of mandibular dislocation. A need
`also exists for tools utilized to place the bridle which are few
`in number and simple to manufacture thus lowering the per
`unit cost of the bridle system such that the system may be
`pre-packaged and disposable. An additional need exists for
`a universal system capable of use with any type and/or size
`of nasal tube in order to limit the amount of storage space
`required in the medical facility.
`SUMMARY OF THE INVENTION
`
`The present invention meets these needs by providing an
`improved system for placing and securing at least one nasal
`tube in a patient comprising a flexible member having a first
`end portion for insertion into a first nare of a patient’s nose
`and a second end portion, a first magnet secured substan-
`tially within the first end portion, a magnetic probe for
`insertion into a second nare of the nose for attracting the first
`magnet and retrieving the flexible member through the
`second nare, and a receiver for securing the tube and the
`flexible member once placed.
`In accordance with a first aspect of the present invention,
`the receiver includes first and second pivotally connected
`portions forming a main body. A first channel having an
`opening along an axial direction thereof is formed in a first
`portion of the main body. At least portions of the channel
`opening, and preferably all of the opening, are smaller than
`an outer diameter of the tube for receiving and securing, or
`snapping, the tube into place. Additional channels may be
`formed in one or both portions of the main body for
`receiving the end portions of the flexible member.
`In accordance with a second aspect of the present
`invention, an axis of the first channel may be oflset from a
`hne drawn through axes of the additional channels in order
`to minimize the size of the receiver. In addition, the receiver
`may be selected from a group of integrally molded receivers
`having first channels of different radii which allows the
`system to be utilized with any type and/or size nasal tube.
`Additional channels or recesses may be formed along exte-
`rior surfaces of one or both main body portions of the
`receiver for partially receiving the first, or additional nasal
`tubes,
`if desired. A fastener may also be provided for
`securing the tubes against
`the exterior surfaces of the
`receiver which are preferably smooth or contoured to pre-
`vent irritation of the patient’s skin.
`In accordance with another aspect of the present
`invention, the flexible member may be tubular and capable
`of receiving a rod or stylus inserted into a lumen thereof to
`provide additional rigidity during its insertion. Depending
`upon the initial rigidity of the flexible member, the rigidity
`of the stylus may vary and the stylus may even be unnec-
`essary. In addition, the flexible member and/or the magnetic
`probe may include at least one indicia thereon indicating at
`least one insertion distance. The distance indicated by the
`indicia is preferably equal to an average distance from the
`nares to just beyond the choanal aperture.
`
`CORPAK Ex 1001, Page 8
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`US 6,631,715 B2
`
`3
`According to yet another aspect of the present invention,
`a disposable kit for placing and securing a tube in a patient
`comprises a flexible member having first and second ends
`for insertion into a first nare of the patient’s nose, a magnet
`attached to the first end of the flexible member, a magnetic
`probe for insertion into a second nare of the nose to attract
`the magnet and retrieve the magnet and the flexible member,
`and a group of integrally molded receivers for securing
`different types and/or sizes of tubes and the flexible member.
`Advantageously, the kit is self-contained with each of its
`component parts sterilized before placement therein.
`In accordance with still ar1otl1er aspect of the present
`invention, a method for placing and securing a tube through
`a nose into a patient is provided. The method includes the
`steps of inserting at least one tube into a first or a second nare
`of the nose, inserting an end portion of a flexible member
`having a magnet substantially secured therein into the first
`nare of the nose, inserting a magnetic probe into the second
`nare of the nose for attracting the magnet/flexible member,
`removing the magnetic probe from the second nare of the
`nose thereby retrieving the end portion of the flexible
`member through the second nare of the nose, and securing
`the at least one tube and the flexible member. The step of
`securing the at
`least one tube may include the step of
`snapping the tube into a channel of a receiver. The method
`may further comprise the step of selectively removing the
`receiver from a group of integrally molded receivers for use
`in the securing step. The unselected receivers which may
`include spare receivers and/or receivers for use with differ-
`ent size tubes may be discarded.
`Additional advantages, and other novel features of the
`invention will be set forth in part in the description that
`follows and in part will become apparent to those skilled in
`the art upon examination of the following or may be learned
`with the practice of the invention. The objects and advan-
`tages of the invention may be realized and attained by means
`of the instrumentalities and combinations particularly
`pointed out in the appended claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`'Ihe accompanying drawings incorporated in and forming
`a part of the specification, illustrate several aspects of the
`present invention, and together with the description serve to
`explain the principles of the invention. In the drawings:
`FIG. 1 is a perspective view of a flexible member for
`securing a nasal tube and having a magnet substantially
`secured within an end portion thereof;
`FIG. 2 is a perspective view of an alternate flexible
`member for securing a nasal tube having a rod inserted into
`a lumen of the flexible member to provide additional rigidity
`during insertion of the flexible member;
`FIG. 3 is a perspective view of a magnetic probe for
`attracting and coupling with a magnet attached to a flexible
`member and retrieving the flexible member;
`FIG. 4 is a perspective view of a receiver shown in an
`open position for receiving and securing a nasal tube and
`ends of a flexible member;
`FIG. 5 is a perspective View of a receiver for securing a
`nasal tube and ends of a flexible member;
`FIG. 6 is a top view of a group of four integrally molded
`receivers from which a receiver for securing a nasal tube and
`ends of a flexible member is selected;
`the
`FIGS. 7a—7d are cross—sectional views showing:
`initial
`insertion of the first end portion of the flexible
`member into a first nare; (b) the first end portion of the
`
`4
`flexible member inserted an average distance to a point just
`beyond the choanal aperture and the initial insertion of a
`magnetic probe into a second nare; (C) the removal of the
`probe magnetically coupled to the flexible member from the
`second nare of the nose; and
`the flexible member after
`placement in the nose, trimming of the ends of the flexible
`member, placement of the nasal tube, and application of the
`receiver.
`
`Reference will now be made in detail to the present
`preferred embodiment of the invention, an example of which
`is illustrated in the accompanying drawings.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`
`With reference to the perspective view of FIG. 1, there is
`shown a preferred embodiment of a flexible member 10 for
`use in placing and securing a nasal tube T1 in a patient. The
`overall length of the flexible member 10 should be suflicient
`to allow a complete loop around the patient’s nasal septum
`N such that end portions 11 and 12 of the flexible member
`10 extend beyond first and second nares of the patient for
`securing the nasal tube T1 as shown in FIG. 711'.
`In the present preferred embodiment, the flexible member
`10 or catheter consists of a soft flexible tube having a
`powerful rare-earth magnet 13 or a ferromagnetic cylinder
`attached to the end portion 12. Preferably, the end portion 12
`of the flexible tube 10 is slid over the magnet 13 such that
`the magnet
`is substantially within the end portion 12.
`Alternatively, the flexible tube 10 may be molded around the
`magnet 13 thereby securing the magnet 13 in an integrated
`manner within the tube as shown in FIG. 2. Advantageously,
`either embodiment provides for smooth passage of the
`magnet 13 during its insertion and retrieval from the patient.
`Of course, other methods of securing the magnet 13 to the
`end portion 12 of the flexible tube 10, such as adhesives,
`tapes, etc. may be utilized in accordance with the broadest
`teachings of the present invention.
`The flexible tube 10 may further include at least one
`indicia or mark 14, or a plurality of marks, indicating an
`average insertion distance. The distance indicated by the
`indicia 14 is preferably equal to an average distance from the
`nares to just beyond the choanal aperture within the nasal
`cavity. Advantageously, utilization of these marks substan-
`tially eliminates unnecessary contact with the posterior wall
`of the pharynx.
`For relatively small diameter tubes 16 or catheters as
`shown in FIG. 2, a rod 17 or stylet may be inserted through
`a lumen 18 of an end portion 19 of the tube to provide
`additional rigidity during the insertion process. Depending
`upon the size and rigidity of the flexible tube 16, the rigidity
`of the rod 17 may vary.
`With reference to the perspective view of FIG. 3, there is
`shown a magnetic probe 20 for insertion into a second nare
`of the patient’s nose to attract the magnet 13 and retrieve the
`end portion 12 of the flexible tube 10. In the present
`preferred embodiment of the invention, the magnetic probe
`20 consists of a rigid or semirigid plastic or rubber cylinder
`of relatively small diameter having a powerful rare-earth
`magnet 21 or ferromagnetic cylinder attached to a first end
`portion 22. Preferably, the probe 20 is sized for receiving the
`magnet 21 in a force flt manner or integrally molded around
`the magnet 21 such that
`the magnet
`is secured in an
`integrated manner within the probe. Of course, other meth-
`ods of attaching the magnet 21 to the end portion of the
`magnetic probe 20, such as adhesives, tapes, etc. may be
`utilized in accordance with the broadest teachings of the
`
`CORPAK Ex 1001, Page 9
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`US 6,631,715 B2
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`5
`present invention. In order to attract the magnet 13 attached
`to the end portion 12 of the flexible tube 10, the polarity of
`the probe magnet 21 is selected to be opposite that of the
`magnet 13. The length of the magnetic probe 20 must be
`sufficient to reach from the nare beyond the choanal aperture
`while still being grasped by the operator’s hand or a suitable
`instrument.
`With reference to FIGS. 4 and 5, there is shown a receiver
`24 for securing the nasal tube T1 and the end portions 11 and
`12 of the flexible tube 10. In the present preferred embodi-
`ment of the invention, the receiver 24 consists of a molded
`plastic main body having first and second pivotally con-
`nected members or portions 25 and 26. The members 25 and
`26 are connected by a living hinge 27 formed during
`molding of the receiver 24. Integrally formed snap-type
`locking hooks 28 extend from member 25 and mating holes
`29 are formed in member 26 for firmly securing the mem-
`bers together following placement of the nasal tube T1 and
`end portions 1 and 12 therein during use. Of course, other
`known means for securing the members 25 and 26 together
`during use may be used in accordance with the broadest
`teaching of the invention.
`The preferred receiver 24 further includes a first channel
`30 formed in member 25 for receiving the nasal tube T1.
`Preferably, the channel 30 includes an opening along an
`axial direction thereof which is smaller along at least por-
`tions of its length than an outer diameter of the nasal tube T1
`for securing the tube in the channel. In other words, the size
`of the axial opening allows the nasal tube T1 to be snapped
`into place. Advantageously, this significantly simplifies the
`placement of the nasal tube T1 within the receiver 24 during
`installation. Amating channel 31 may be formed in member
`26. Preferably, the channels 30 and 31 form a hole through
`the receiver 24 which firmly grasps the exterior of the nasal
`tube T1 to prevent dislodgement by the patient or otherwise
`and without occluding the lumen of the tube.
`The preferred receiver 24 further includes first and second
`channels 32 formed in member 26 for receiving the flexible
`tube 10. Preferably, the channels 32 include openings along
`an axial direction thereof which are smaller along at least
`portions of their length than an outer diameter of the flexible
`tube 10 for securing the end portions 11 and 12 of the tube
`in the channels. In other words, the size of the axial opening
`allows the end portions 11 and 12 of the flexible tube 10 to
`be snapped into place. Again, this significantly simplifies the
`placement of the flexible tube 10 within the receiver 24
`during installation. Mating channels 33 may be formed in
`member 25. Preferably, the channel pairs 32 and 33 form
`holes through the receiver 24 which firmly grasp the exterior
`of the flexible tube 10 to prevent dislodgement by the patient
`or otherwise. Additional means, such as barbs 35 in the
`preferred embodiment, may be used to impinge the exterior
`of the nasal tube T1 or end portions 11 and 12 of the flexible
`tube 10 to further assist in the prevention of their dislodge-
`ment during use.
`As best shown in FIG. 5, the three channels 30 and 32 in
`the preferred embodiment are non-linear. In other words, an
`axis A of the channel 30 is offset a distance D from a line L
`drawn through axes of channels 32. In accordance with an
`important aspect of the present invention, this allows the
`receiver 24 to be smaller and therefore less intrusive to a
`patient than a receiver utilizing a linear arrangement. Addi-
`tional advantages of the preferred receiver include rounded
`or contoured exterior surfaces which provide a smooth
`contact surface for the patient to prevent irritation and an
`additional recess or channel 37 formed in the exterior
`surface 5, for example, for receiving an additional and
`
`6
`In this manner, a
`possibly oversized tube (not shown).
`secondary nasal tube (not shown) perhaps having a large
`diameter can be easily secured against the exterior surface of
`the receiver 24 using a plastic binding strap (not shown), for
`example, wl1icl1 may be integrated with the receiver 24 to
`facilitate its securement. Of course, other methods for secur-
`ing tubes against the receiver 24, such as snap-fit recesses or
`channels, adhesives, tapes, etc. may be utilized in accor-
`dance with the broad teachings of the present invention.
`As further shown in FIG. 6, the receiver 24 may include
`a group of integrally molded receivers 38. Although four
`such receivers 24 are shown in FIG. 6, any number of
`receivers maybe attached one to another in accordance with
`the present invention. The integrally molded receivers 38
`may include receivers 24 designed to accommodate different
`size nasal tubes or even spare receivers of the same size and
`may be attached one to another at any location on their
`respective exterior surfaces.
`The present preferred method of placing and securing a
`tube in a patient includes the steps of inserting the tube into
`a nare of the patient’s nose, inserting an end portion 12 of
`a flexible member 10 into a first nare of the patient’s nose,
`inserting a magnetic probe 20 into a second nare of the nose
`for attracting the end portion of the flexible member, remov-
`ing the magnetic probe 20 from the second nare of the nose
`thereby retrieving the end portion of the flexible member
`through the nare, and securing the tube and end portions of
`the flexible member.
`
`Prior to insertion into the patient, the tube T1, the end
`portion 12 of the flexible member 10, and the magnetic
`probe 20 are preferably lubricated with a biologically com-
`patible lubricant. For the comfort of an awake patient, a
`nasal anesthetic may also be applied. As shown by action
`arrow B in FIG. 7a,
`the end portion 12 of the flexible
`member 10 attached to the magnet 13 is inserted into a first
`nare of the nose. The flexible member 10 is threaded along
`a floor of the nose until the end portion 12 of the flexible
`member and magnet 13 have passed just beyond the poste-
`rior border of the nasal septum N through the choanal
`aperture as shown in FIG. 7b. Preferably, the approximate
`depth of insertion of the flexible member 10 is indicated by
`one or more indicia 14 on the flexible member 10. Iess
`preferably, the practitioner may rely on resistance encoun-
`tered when the end portion 12 of the flexible member and
`magnet 13 reach the posterior wall of the pharynx as an
`indicator.
`
`At this point, the magnetic probe 20 is similarly inserted
`into a second nare of the nose as shown by action arrow C
`in FIG. 7b. The magnetic probe 20 attracts and connects with
`the magnet 13 attached to the end portion 12 of the flexible
`member 10 thus allowing the end portion of the flexible
`member to be retrieved through the second nare of the nose.
`The magnetic probe 20 is preferably inserted in a substan-
`tially parallel course to that of the flexible member 10 along
`the nasal
`floor. When the magnetic probe 20 has been
`inserted to an appropriate depth which may be indicated by
`indicia 18 on the probe, the magnet 13 attached to the end
`portion 12 of the flexible member 10 is attracted to the
`magnetic probe 20.
`As shown by action arrow D in FIG. 7c, the magnetic
`probe 20 is then withdrawn from the second nare of the
`patient’s nose, pulling the magnetically coupled flexible
`member 10 into the first nare and out through the second
`nare (shown by action arrows E and D in FIG. 7c). Hence,
`the flexible member 10 is now looped around the nasal
`septum N posteriorly as shown in FIGS. 7c and 7d.
`
`CORPAK Ex 1001, Page 10
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`US 6,631,715 B2
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`7
`The magnet 13 and the magnetic probe 20 are then
`separated and the first end portion 12 of the flexible member
`10 and magnet 13 are trimmed to a suitable length. The
`receiver 24 is then secured to the end portions 11, 12 of the
`flexible member extending from tl1e nares, as well as the
`nasal tube(s) T1 .
`.
`. T" such that a sufficient distance is
`provided between the nose and the receiver 24 to avoid
`contact with the patient’s nose. In the present preferred
`method, the step of securing the tube T1 includes the step of
`snapping the tube into a channel 30 formed in the receiver
`24. Of course, in accordance with the broad teachings of the
`present invention, the nasal tube T1 is similarly inserted in
`either nare before or after the above steps are performed.
`In an alternate embodiment of the present invention, the
`method may include the additional step of selectively
`removing a receiver 24 from a group of integrally molded
`receivers 38 for use in the securing step. The unselected
`receivers 24 which may include spare receivers and/or
`receivers for use with different size tubes are preferably
`discarded.
`
`The foregoing description of the preferred embodiment of
`the invention has been presented for purposes of illustration
`and description. It is not intended to be exhaustive or to limit
`the invention to the precise form disclosed. Obvious modi-
`fications or variations are possible in light of the above
`teachings. The embodiment was chosen and described to
`provide the best illustration of the principles of the invention
`and its practical application to thereby enable one of ordi-
`nary skill
`in the art
`to utilize the invention in various
`embodiments and with various modifications as are suited to
`the particular use contemplated. All such modifications and
`variations are within the scope of the invention as deter-
`mined by the appended claims when interpreted in accor-
`dance with the breadth to which they are fairly, legally and
`equitably entitled.
`What is claimed is:
`1. A bridle system for placing and securing at least one
`tube in a patient comprising:
`a flcxiblc member having first and second ends, said first
`end for insertion into a first nare of a nose;
`a magnet secured substantially within said first end;
`a magnetic probe for insertion into a second nare of the
`nose to attract said magnet and retrieve said magnet and
`said first end of said flexible member; and
`a receiver for securing the at least one tube and said first
`and second ends of said flexible member.
`2. The bridle system for placing and securing at least one
`tube in claim 1, wherein said flexible member is tubular; and
`further comprising a rod for insertion into said flexible
`member to provide additional rigidity for said flexible
`member during insertion of said flexible member into
`the first nare.
`3. The bridle system for placing and securing at least one
`tube in claim 1, wherein said flexible member and said
`magnetic probe include at least one indicia thereon.
`4. The bridle system for placing and securing at least one
`tube in claim 1, wherein said receiver is selected from a
`group of integrally molded receivers.
`5. The bridle system for placing and securing at least one
`tube in claim 1, wherein said receiver includes first and
`second pivotally connected portions; and
`wherein said first pivotally connected portion includes a
`channel formed therein for receiving the at least one
`tube and securing the at least one tube in said channel.
`6. The bridle system for placing and securing at least one
`tube in claim 5, further comprising second and third chan-
`
`8
`nels formed in said first and second pivotally connected
`portions of said receiver for receiving the flexible member.
`7. The bridle system for placing and securing at least one
`tube in claim 6, wherein at least one of said second and third
`channels secures said flexible member.
`8. The bridle system for placing and securing at least one
`tube in claim 6, wherein said first and second pivotally
`connected portions each have exterior surfaces; and
`wherein said exterior surfaces contacting the patient are
`smooth to prevent irritation.
`9. A bridle system for placing and securing at least one
`tube in a patient comprising:
`a flexible member having first and second ends, said first
`end for insertion into a first nare of a nose;
`a magnet attached to said first end of said flexible mem-
`ber;
`a magnetic probe for insertion into a second nare of the
`nose to attract said magnet and retrieve said magnet and
`said first end of said flexible member; and
`a group of integrally molded receivers for securing dif-
`fcrcnt sizes of the at least one tube and said flcxiblc
`member.
`10. The bridle system for placing and securing at least one
`tube in claim 9, wherein said integrally molded receivers
`include first and second pivotally connected members, said
`first pivotally connected member including a channel for
`securing the at least one tube in said channel.
`11. The bridle system for placing and securing at least one
`tube in claim 10, further comprising second and third
`channels formed in said first or second pivotally connected
`portions of said receiver for receiving the flexible member.
`12. The bridle system for placing and securing at least one
`tube in claim 11, wherein said first and second pivotally
`connected mcmbcrs cach havc smooth cxtcrior surfaces to
`prevent irritation of the patient.
`13. A method of placing and securing at least one tube in
`a patient comprising:
`inserting the at least one tube into a first or second nare of
`the nose;
`inserting an end portion of a flexible member having a
`magnet substantially secured therein into a first nare of
`the nose;
`inserting a probe into a second nare of the nose for
`attracting said magnet;
`removing said probe from the second nare of the nose
`thereby r