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United States Patent us
`5,492,538
`[11] Patent Number:
`[45] Date of Patent:
`Feb. 20, 1996
`Johlin, Jr.
`
`00a
`
`[54] METHOD FOR TRANSFERRING THE EXIT
`SITE OF A CATHETER FROM THE MOUTH
`TO THE NOSE AND INSTRUMENTATION
`USEFUL THEREFOR
`
`[76]
`
`Inventor: Frederick C. Johlin, Jr., 3517 Galway
`Ct., lowa City, lowa 52246-2765
`
`[21] Appl. No.: 295,595
`
`[22] Filed:
`
`Aug. 25, 1994
`
`Tint, C9 nececeeceseccetttseeettetttttceeee A61M 25/00
`(51)
`
`[52] U.S. Cl....
`. 604/264; 604/283; 600/12;
`128/657; 128/899 _
`(58] Field of Search occas 604/280, 283,
`604/905, 264; 600/12; 128/899, 657
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`3,674,014
`5,269,759
`
`7/1972 Tillander ......csesssesessseresseserseees 128/657
`12/1993 Hernandez et al.
`........... 604/280 K
`
`Attorney, Agent, or Firm—Woodward, Emhardt, Naughton,
`Moriarty & McNett
`
`[57]
`
`ABSTRACT
`
`A technique and instrumentation for transferring the exit site
`of acatheter, 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 effectuate
`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—Jobn D. Yasko
`
`3 Claims, 5 Drawing Sheets
`
`it
`
`
`
`CORPAK Ex 1011, Page 1
`
`

`

`Sheet 1 of 5
`
`5,492,538
`
`U.S. Patent
`
`Feb. 20, 1996
`
`—_ 19
`
`CORPAKEx 1011, Page 2
`
`CORPAK Ex 1011, Page 2
`
`

`

`Feb. 20, 1996
`
`Sheet 2 of 5
`
`5,492,538
`
`U.S. Patent
`
`100
`
`Fig. 2a
`
`CORPAKEx 1011, Page 3
`
`CORPAK Ex 1011, Page 3
`
`

`

`Feb. 20, 1996
`
`Sheet 3 of 5
`
`5,492,538
`
`U.S. Patent
`
`100
`
`Fig. 2b
`
`CORPAKEx 1011, Page 4
`
`CORPAK Ex 1011, Page 4
`
`

`

`Feb. 20, 1996
`
`Sheet 4 of 5
`
`US. Patent
`
`5,492,538
`
`Fig. 2c
`
`CORPAKEx 1011, Page 5
`
`CORPAK Ex 1011, Page 5
`
`

`

`U.S. Patent
`
`Sheet 5 of 5
`
`Feb. 20, 1996
`
`5,492,538
`
`CORPAKEx 1011, Page 6
`
`CORPAK Ex 1011, Page 6
`
`

`

`5,492,538
`
`1
`METHOD FOR TRANSFERRING THE EXIT
`SITE OF A CATHETER FROM THE MOUTH
`TO THE NOSE AND INSTRUMENTATION
`USEFUL THEREFOR
`
`BACKGROUNDOF THE INVENTION
`
`1. Field of the Invention
`
`This inventionrelates 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
`proceduresas well, such as, for example,the stabilization of
`nasally placed devices by a maneuver knownas “bridling.”
`2. Description of the Prior Art
`Tt
`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 catheteris 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 endoscopistthen grasps the tip of the nasopha-
`ryngeal tube in the posterior oropharynx region with his or
`her index finger (or sometimes with forceps) andpulls 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 advanceduntil it exits through the nasal end of the
`tube. The nasopharyngeal tube is then slowly pulled out
`through the nostril, bringing the catheter along withit.
`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 can sometimes
`be difficult 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 amountof time
`and effort is often required before the nasopharyngeal tube
`can be successfully extracted from the patient with forceps.
`And, as with the expericnce 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.
`SUMMARYOF THE INVENTION
`
`The present invention provides a new and safer way of
`transferring the proximal end of a catheter, such as a nasal
`
`20
`
`25
`
`40
`
`45
`
`55
`
`60
`
`65
`
`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
`muchofthe 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 formed 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
`andits 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. 1b 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, andillustrating 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 cathcter 10 has
`been passed through the nasal passageways of the patient
`and in the posterior oralpharyngeal region, and magnetic
`wand 20 has been inserted through the mouth toward this
`region. FIG. 2b showstransfer 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 throughlateral
`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 embodimentillustrated 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
`
`CORPAKEx 1011, Page 7
`
`CORPAK Ex 1011, Page 7
`
`

`

`5,492,538
`
`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 inventionrelates.
`
`4
`biliary catheter 30 can be pulled out together through the
`nasal passageways andoutthroughthe noseto effectuate the
`desired transfer of nasal biliary catheter 30 to a nasal exit
`site.
`
`10
`
`15
`
`20
`
`Referring now to the drawings, there is provided nasal
`It is preferred to use a high gauss force magnet 21 in
`transfer catheter 10 and magnetic wand 20 which are con-
`magnetic wand 20 to ensure that catheter 10 is gripped with
`enoughforce to engage and drag catheter 10 out through the
`structed to accomplish a secure attachmentin the posterior
`oropharyngeal region with ease and with minimal resistance.
`mouth.It is to be appreciated, though,that the invention may
`Forthis purpose, wand 20 includes a high gauss magnet(for
`be practically performed with magnets of lesser strength.
`Also, a magnet could alternatively be placed on thedistal tip
`example, an alloy type magnet such as Alnico or reodynium-
`of transfer catheter 10, with magnetically attractive material
`ion-boron) 21 atits distal tip and tip 11, formed at the end
`placed on the distal tip of wand 20, or two magnets, with
`of tubular transfer catheter 10, is made of a suitably mag-
`netized material that will attach to magnet 21. Two distance
`oppositely disposed facing polarities, could be used as well.
`While the invention has been illustrated and described in
`markings 14 and 15 have been placedon transfer catheter 10
`in the form of rings at 12 and 14 cm.distances, respectively,
`detail in the drawings and foregoing description, the sameis
`to be considered as illustrative and notrestrictive in char-
`from distal tip 11 of transfer catheter 10. Distance markings
`have been placed, in distance to distal tip 11, to approximate
`acter, it being understood that only the preferred embodi-
`the range of distances normally expected to be encountered
`ment has been shown and described and that all changes and
`in an adult patient between the nasolabial fold and his/her
`modifications that come within the spirit of the invention are
`posterior pharynx.
`desired to be protected.
`Whatis claimedis:
`Transfer catheter 10 additionally has an alignmentorien-
`1. Instrumentation for transferring the proximal end of a
`tation marking in the form of a long line 13 which is to be
`catheter from the mouth to the nose, said instrumentation
`oriented cephalad, and transfer catheter 10 is also formed in
`a curvature along its length to facilitate advancement
`comprising:
`through the nasal passageway. When properly alligned with 35
`a nasopharyngeal transfer catheter, said nasopharyngeal
`the aid of allignment orientation marking 13, this curved
`transfer catheter being generally tubular in structure
`structure allowstransfer catheter 10 to easily follow the arc
`and including a distal
`tip portion formed at
`least
`of the palate and pass into the posterior pharynx with less
`partially by magnetically atiractable material, said
`effort and trauma. Lateral hole 12, which is disposed oppo-
`transfer catheter being sized for insertion into a nostril
`sitely of orientation mark 13 on transfer catheter 10, is
`of a patient and advanceable through the nasal passage-
`oriented anteriorly to enhance the flexibility of transfer
`way to position said distal tip portion of said transfer
`catheter 10 near its distal
`tip and to thus facilitate the
`catheter in the posterior oralpharyngeal region; and
`forming of the desired attachment with magnetic wand 20.
`a wand,said wandincludingadistal tip portion formedat
`FIGS. 2a—c are side cross-sectional viewsof the head and
`35
`least partially by magnetically attractable material, said
`neck portion of a patient 100,and illustrating the nasal-oral-
`wand being sized for insertion into the mouth of a
`pharyngeal passageways therein and showinga nasal biliary
`patient and advanceable therein to position said distal
`catheter 30 which has been endoscopically placed into a
`tip portion of said wandin the posterior oralpharyngeal
`patient. As shown in FIG. 2a, nasopharyngeal
`transfer
`Tegion;
`catheter 10 has been advanced through the nasal passage-
`the magnetically aitractable material in one ofsaid distal
`ways so that thefirst black ring 14 is no longer showing, and
`tip portion of said transfer catheter and said distal tip
`magnetic wand 20 has been introduced into the mouth of
`portion of said wand being a magnet of sufficient
`paticnt 100 and in toward the posterior oralpharyngeal
`strength to attract and attach to the magnetically
`region 102. Preferably, magnetic wand 20 should be keptto
`attractable material in the other of said two distal tip
`one side and be positioned about 5 mm. away from the
`portions when said two distal
`tip portions are both
`posterior pharynx.
`positioned in the posterior oralpharyngeal region, with
`If wand 20 does not engagetransfer catheter 10 after wand
`the formed magnetic attachmentbeing strong enough to
`20 and transfer catheter 10 have been advanced as shownin
`enable said transfer catheter to be pulled out through
`FIG. 2a, the physician should then slowly advance transfer
`the mouth by said wand.
`2. The instrumentation of claim 1 in which said transfer
`catheter 10 further until the second distance ring 15 is
`touching nasolabial fold 101. Magnet 21 will then capture
`catheter further has formed therein a lateral hole in prox-
`transfer catheter 10 in most adults. In children, the distance
`imity to said distal ttp portion thereof providing access for
`is more variable, thus requiring a visual estimation on the
`passing a catheter through said transfer catheter while also
`part of the physician. FIG. 2b showstransfer catheter 10
`enhancing the flexibility thereof at the distal tip portion of
`said transfer catheter in the direction of said lateral hole.
`having been magnetically attracted towards wand 20 to form
`an attachment therewith. In FIG. 2b, it is also seen how
`3. The instrumentation of claim 2 wherein said transfer
`lateral slot 12 enhancesthe flexibility of catheter 10 towards
`catheter further includes an orientation marking along at
`magnetic wand 20, thereby facilitating the formation of the
`least a portion of the length thereof to thereby provide a
`attachment.
`visual aid to facilitate the anterior allignmentof said lateral
`hole when said transfer catheter has been advanced through
`the nasal passageway and into the posterior oralpharyngeal
`region.
`
`40
`
`45
`
`50
`
`55
`
`60
`
`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 throughlateral slot 12 and out
`through the proximal end 19 of nasopharyngeal transfer
`catheter 10. So configured, transfer catheter 10 and nasal
`
`CORPAKEx 1011, Page 8
`
`CORPAK Ex 1011, Page 8
`
`

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