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`USO05492538A
`
`United States Patent
`
`[19]
`
`[11] Patent Number:
`
`5,492,538
`
`Johlin, Jr.
`
`[45] Date of Patent:
`
`Feb. 20, 1996
`
`[54] METHOD FOR TRANSFERRING THE EXIT
`SITE OF A CATHETER FROM THE MOUTH
`TO THE NOSE AND INSTRUMENTATION
`USEFUL THEREFOR
`
`Inventor: Frederick C. Johlin, Jr., 3517 Galway
`CL, Iowa City, Iowa 52246-2765
`
`Appl. No.: 295,595
`
`Aug. 25, 1994
`Filed:
`Int. Cl.6 .................................................. .. A61M 25/00
`U.S. Cl.
`. 604/264; 604/283; 600/12;
`128/657; 128/899 p
`Field of Search ..................................... 604/280, 283,
`604/905, 264; 600/12; 128/899, 657
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,674,014
`5,269,759
`
`7/1972 Tillander ................................. 128/657
`12/1993 Hernandez et al.
`................ 604/280 X
`
`Attamey, Agent, or Firm—Woodward, Emhardt, Naughton,
`Moriarty & McNett
`
`[57]
`
`ABSTRACT
`
`A technique and instrumentation for transferring the exit site
`of a catheter, such as a nasal biliary catheter, from the mouth
`to the nose are described herein. The disclosed instrumen-
`tation includes a nasopharyngeal transfer catheter which has
`a tip of magnetically attractable material and a correspond-
`ing magnetic wand. The transfer catheter also includes a
`lateral hole therein near the its distal end which serves to
`facilitate attachment with the magnetic wand by increasing
`the flexibility of the transfer catheter in the direction towards
`the magnetic wand, while also providing access means for
`passing an nasal biliary catheter therethrough to eifectuate
`the transfer of the nasal biliary catheter from the mouth to
`the nose. Alignment orientation and distance markings are
`also provided on nasalpharyngeal transfer catheter which
`facilitate the locating and attaching the tip of the transfer
`catheter to the magnetic wand.
`
`Primary Examiner—John D. Yasko
`
`3 Claims, 5 Drawing Sheets
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`CORPAK Ex 1011, Page 1
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`U.S. Patent
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`Feb. 20, 1996
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`Sheet 1 of 5
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`CORPAK Ex 1011, Page 2
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`U.S. Péltent
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`Feb. 20, 1996
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`Sheet 2 of 5
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`5,492,538
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`100
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`CORPAK Ex 1011, Page 3
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`U.S. Patent
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`Feb, 20, 1996
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`Sheet 3 of 5
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`5,492,538
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`100
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`CORPAK Ex 1011, Page 4
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`U.S. Patent
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`Feb. 20, 1996
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`Sheet 4 of 5
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`CORPAK Ex 1011, Page 5
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`U.S. Patent
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`Feb. 20, 1996
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`Sheet 5 of 5
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`5,492,538
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`CORPAK Ex 1011, Page 6
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`5,492,538
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`15
`
`1
`METHOD FOR TRANSFERRING THE EXIT
`SITE OF A CATHETER FROM THE MOUTH
`TO THE NOSE AND INSTRUMENTATION
`USEFUL THEREFOR
`
`BACKGROUND OF THE INVENTION
`
`1. Field of the Invention
`
`This invention relates to facilitating the transfer of the exit
`site of a catheter from the mouth to the nose. Devices that
`typically require this assistance include nasobiliary stents
`and endoscopically placed drainage and feeding devices. A
`device of the present invention could be useful in other
`procedures as well, such as, for example, the stabilization of
`nasally placed devices by a maneuver known as “bridling.”
`2. Description of the Prior Art
`It is sometimes desirable to place a catheter into the
`biliary system, pancreas, or upper gastrointestinal
`tract
`through the mouth. After the catheter has been endoscopi-
`cally implanted, the proximal end of the catheter is stationed
`out of the mouth of the patient. It is preferable, however, to
`transfer the exit site of the catheter to the nose, which is
`much more convenient and comfortable for the patient and
`reduces the risk that
`the catheter will be damaged by
`mastication. The transfer procedure is typically accom-
`plished with the use of a well-lubricated nasopharyngeal
`tube which is advanced through the nostril and down the
`pharynx. The endoscopist then grasps the tip of the nasopha-
`ryngeal tube in the posterior oropharynx region with his or
`her index finger (or sometimes with forceps) and pulls it out
`through the mouth. The tip of the catheter is then threaded
`through a hole at or near the oral end of the nasopharyngeal
`tube and advanced until it exits through the nasal end of the
`tube. The nasopharyngeal tube is then slowly pulled out
`through the nostril, bringing the catheter along with it.
`Problems are encountered in this procedure, however, in
`the process of locating, grasping, and pulling the nasopha-
`ryngeal
`tube out
`through the mouth once it has been
`advanced into the posterior oropharynx region. This is at
`least partly because the nasopharyngeal tube ca.n sometimes
`be diflicult to locate and grasp, particularly if the physician
`or assistant performing the maneuver has shorter fingers or
`the patient has an unusually small mouth. On occasion, the
`grasping digit has been bitten by the patient while trying to
`locate and pull the nasopharyngeal tube out through the
`mouth. The alternative of using a grasping instrument such
`as forceps, on the other hand, means that the posterior
`oropharynx region must be probed blindly to locate and
`securely grasp the nasopharyngeal tube for extraction. With-
`out the benefit of a visual or tactile aid, a fair amount of time
`and eflbrt is often required before the nasopharyngeal tube
`can be successfully extracted from the patient with forceps.
`And, as with the experience of having a hand reach into the
`back of your mouth,
`this blind probing with a foreign
`instrument
`into a sensitive region of the body can be
`uncomfortable and unpleasant for the patient and can result
`in trauma to the pharyngeal tissues. Both patient and phy-
`sician would benefit from an improved way of accomplish-
`ing the transfer of a catheter from the mouth to the nose.
`Such an improved procedure would enable the physician to
`easily locate and extract the nasopharyngeal transfer device,
`and would do so in a way that would alleviate the unpleas-
`antness and risks of the experience to the patient.
`SUMMARY OF THE INVENTION
`
`The present invention provides a new and safer way of
`transferring the proximal end of a catheter, such as a nasal
`
`2
`biliary catheter, from the mouth to the nose, and provides
`new instrumentation which is designed for accomplishing
`this transfer. Such instrumentation, as described herein,
`enables the physician to be able to easily locate and extract
`a nasopharyngeal transfer catheter after it has been inserted
`into the nostril and through the nasal passageway and into
`the posterior oropharyngeal region. With the present inven-
`tion, a physician can perform the procedure of transferring
`the exit site of a catheter from the mouth to the nose without
`risking injury from being bitten, and while also removing
`much of the unpleasantness and risk of the experience to the
`patient.
`instrumentation for the present
`As described herein,
`invention includes a specially constructed nasopharyngeal
`transfer catheter with a tip of magnetically attractable mate-
`rial and a corresponding magnetic wand. A lateral hole
`which is fonned near the distal end of the transfer catheter
`which both serves to facilitate attachment and provides
`access for passing a catheter therethrough as part of the
`transfer procedure. Orientation and distance markings are
`also provided which facilitate the locating and attaching of
`the transfer catheter tip to the magnetic wand.
`It is an object of the present invention to provide a safe
`and easy way to transfer the exit site of a catheter from the
`mouth to the nose, and to do so in a way which is less
`traumatic for the patient. A full appreciation of this invention
`and its benefits can be drawn from a review of the following
`detail specification and claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1a is a partially fragmented side elevational view of
`a nasopharyngeal transfer catheter which is specially con-
`structed for use with the present invention. FIG. lb is a side
`elevational view of a magnetic wand which is used with the
`present invention to locate and extract the nasopharyngeal
`transfer catheter of FIG. 1a out through the mouth after the
`transfer catheter has been passed in the nose and through the
`sinus passageways into the posterior oropharynx region.
`FIGS. 2a——c are side cross-sectional views of the head and
`neck portion of a patient 100, and illustrating the nasal-oral-
`pharyngeal passageways therein and showing a nasal biliary
`catheter 30 which has been endoscopically placed into the
`patient. In FIG. 2a, nasopharyngeal transfer catheter 10 has
`been passed through the nasal passageways of the patient
`and in the posterior oralpharyngcal region, and magnetic
`wand 20 has been inserted through the mouth toward this
`region. FIG. 2b shows transfer catheter 10 having been
`magnetically attracted towards wand 20 to form an attach-
`ment therewith. In FIG. 2c, transfer catheter 20 has been
`pulled out through the mouth by magnetic wand 20, and
`nasal biliary catheter 30 has been advanced through lateral
`slot 12 and out through the proximal end 19 of nasopha-
`ryngeal transfer catheter 10.
`FIG. 3 is an illustration of patient 100 with the transfer
`procedure having been completed and with nasal biliary
`catheter 30 in fully in place for use.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`
`For the purposes of promoting an understanding of the
`principles of the invention, reference will now be made to
`the embodiment illustrated in the drawings and specific
`language will be used to describe the same. It will never-
`theless be understood that no limitation of the scope of the
`invention is thereby intended, such alterations and further
`
`CORPAK Ex 1011, Page 7
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`3
`modifications in the illustrated device, and such further
`applications of the principles of the invention as illustrated
`therein being contemplated as would normally occur to one
`skilled in the art to which the invention relates.
`
`4
`biliary catheter 30 can be pulled out together through the
`nasal passageways and out through the nose to effectuate the
`desired transfer of nasal biliary catheter 30 to a nasal exit
`site.
`
`5,492,538
`
`Referring now to the drawings, there is provided nasal
`transfer catheter 10 and magnetic wand 20 which are con-
`structed to accomplish a secure attachment in the posterior
`oropharyngeal region with ease and with minimal resistance.
`For this purpose, wand 20 includes a high gauss magnet (for
`example, an alloy type magnet such as Alnico or reodynium-
`ion-bcron) 21 at its distal tip and tip 11, formed at the end
`of tubular transfer catheter 10, is made of a suitably mag-
`netized material that will attach to magnet 21. Two distance
`markings 14 and 15 have been placed on transfer catheter 10
`in the form of rings at 12 and 14 cm. distances, respectively,
`from distal tip 11 of transfer catheter 10. Distance markings
`have been placed, in distance to distal tip 11, to approximate
`the range of distances normally expected to be encountered
`in an adult patient between the nasolabial fold and his/her
`posterior pharynx.
`Transfer catheter 10 additionally has an alignment orien-
`tation marking in the form of a long line 13 which is to be
`oriented cephalad, and transfer catheter 10 is also formed in
`a curvature along its length to facilitate advancement
`through the nasal passageway. When properly alligned with
`the aid of allignment orientation marking 13, this curved
`structure allows transfer catheter 10 to easily follow the are
`of the palate and pass into the posterior pharynx with less
`effort and trauma. Lateral hole 12, which is disposed oppo-
`sitely of orientation mark 13 on transfer catheter 10, is
`oriented anteriorly to enhance the flexibility of transfer
`catheter 10 near its distal
`tip and to thus facilitate the
`forming of the desired attachment with magnetic wand 20.
`FIGS. 2a—c are side cross—sectional views of the head and
`neck portion of a patient 100, and illustrating the nasal-oral-
`pharyngeal passageways therein and showing a nasal biliary
`catheter 30 which has been endoscopically placed into a
`patient. As shown in FIG. 2a, nasopharyngeal
`transfer
`catheter 10 has been advanced through the nasal passage-
`ways so that the first black ring 14 is no longer showing, and
`magnetic wand 20 has been introduced into the mouth of
`patient 100 and in toward the posterior oralpharyngeal
`region 102. Preferably, magnetic wand 20 should be kept to
`one side and be positioned about 5 m. away from the
`posterior pharynx.
`Ifwand 20 does not engage transfer catheter 10 after wand
`20 and transfer catheter 10 have been advanced as shown in
`FIG. 2a, the physician should then slowly advance transfer
`catheter 10 further until the second distance ring 15 is
`touching nasolabial fold 101. Magnet 21 will then capture
`transfer catheter 10 in most adults. In children, the distance
`is more variable, thus requiring a visual estimation on the
`part of the physician. FIG. 2b shows transfer catheter 10
`having been magnetically attracted towards wand 20 to form
`an attachment therewith. In FIG. 212, it is also seen how
`lateral slot 12 enhances the flexibility of catheter 10 towards
`magnetic wand 20, thereby facilitating the formation of the
`attachment.
`
`transfer catheter 10 has been pulled out
`In FIG. 2c,
`through the mouth by magnetic wand 20, and nasal biliary
`catheter 30 has been advanced through lateral slot 12 and out
`through the proximal end 19 of nasopharyngeal transfer‘
`catheter 10. So configured, transfer catheter 10 and nasal
`
`It is preferred to use a high gauss force magnet 21 in
`magnetic wand 20 to ensure that catheter 10 is gripped with
`enough force to engage and drag catheter 10 out through the
`mouth. It is to be appreciated, though, that the invention may
`be practically performed with magnets of lesser strength.
`Also, a magnet could alternatively be placed on the distal tip
`of transfer catheter 10, with magnetically attractive material
`placed on the distal tip of wand 20, or two magnets, with
`oppositely disposed facing polarities, could be used as well.
`While the invention has been illustrated and described in
`detail in the drawings and foregoing description, the same is
`to be considered as illustrative and not restrictive in char-
`acter, it being understood that only the preferred embodi-
`ment has been shown and described and that all changes and
`modifications that come within the spirit of the invention are
`desired to be protected.
`What is claimed is:
`1. Instrumentation for transferring the proximal end of a
`catheter from the mouth to the nose, said instrumentation
`comprising:
`a nasopharyngeal transfer catheter, said nasopharyngeal
`transfer catheter being generally tubular in structure
`and including a distal
`tip portion formed at
`least
`partially by magnetically attractable material, said
`transfer catheter being sized for insertion into a nostril
`of a patient and advanceable through the nasal passage-
`way to position said distal tip portion of said transfer
`catheter in the posterior oralpharyngeal region; and
`a wand, said wand including a distal tip portion formed at
`least partially by magnetically attractable material, said
`wand being sized for insertion into the mouth of a
`patient and advanceable therein to position said distal
`tip portion of said wand in the posterior oralpharyngeal
`region;
`the magnetically attractable material in one of said distal
`tip portion of said transfer catheter and said distal tip
`portion of said wand being a magnet of suflicient
`strength to attract and attach to the magnetically
`attractable material in the other of said two distal tip
`portions when said two distal
`tip portions are both
`positioned in the posterior oralpharyngeal region, with
`the formed magnetic attachment being strong enough to
`enable said transfer catheter to be pulled out through
`the mouth by said wand.
`2. The instrumentation of claim 1 in which said transfer
`catheter further has formed therein a lateral hole in prox-
`imity to said distal tip portion thereof providing access for
`passing a catheter through said transfer catheter while also
`enhancing the flexibility thereof at the distal tip portion of
`said transfer catheter in the direction of said lateral hole.
`3. The instrumentation of claim 2 wherein said transfer
`catheter further includes an orientation marking along at
`least a portion of the length thereof to thereby provide a
`visual aid to facilitate the anterior allignment of said lateral
`hole when said transfer catheter has been advanced through
`the nasal passageway and into the posterior oralpharyngeal
`region.
`
`CORPAK Ex 1011, Page 8