United States Patent [19]
`Simmons et al.
`
`[54] UNIVERSAL MEDICAL TUBE RETAINER
`AND NASAL WALL TISSUE DILATOR
`
`[76] Inventors: Carl J. Simmons, P.O. Box 668,
`Nolensville, Tenn. 37135; Robert N.
`Sadler, 3713 Sycamore Ln., Nashville,
`Tenn. 37215
`
`(cid:9) (cid:9)
`
`[21] Appl. No.: 755,404
`
`[22] Filed: (cid:9)
`
`Nov. 22, 1996
`
`[51] Int. CI.6 (cid:9)
`[52] U.S. CI.
`
` A61M 15/08
` 128/207.18; 128/206.11;
`128/206.14; 128/DIG. 26
` 128/206.11, 206.14,
`[58] Field of Search (cid:9)
`128/206.18, 207.18, DIG. 26; 604/177,
`180
`
`[56] (cid:9)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`7/1962 Hill (cid:9)
`
`3,046,989
`4,120,304 10/1978 Moor (cid:9)
`
`4,122,857 10/1978 Haerr (cid:9)
`
`4,736,741
`4/1988 Payton et al. (cid:9)
`
`4,804,374
`2/1989 Laskody (cid:9)
`
`4,823,789
`4/1989 Beisang, III (cid:9)
`
`4,932,943
`6/1990 Nowak (cid:9)
`
`
`604/180
`604/180
`604/180
`128/207.18
`604/180
`128/207.18
`604/180
`
`III u 111111111101111111111111111111111
`
`US0057525 11A
`[11] (cid:9) Patent Number:
`[45] (cid:9) Date of Patent:
`
`5,752,511
`May 19, 1998
`
`4,986,815
`1/1991 (cid:9) Schneider (cid:9)
`5,097,827
`3/1992 Izumi (cid:9)
`6/1992 Palfy (cid:9)
`5,117,818
`5,156,641 10/1992 White (cid:9)
`5,172,688 12/1992 Dillon (cid:9)
`5,185,005
`2/1993 Ballantyne (cid:9)
`5,476,091 12/1995 Johnson (cid:9)
`5,513,635 5/1996 Bedi (cid:9)
`5,535,739
`7/1996 Rapoport et al.
`
`
`
`
`
`
`
`
`
`
`604/180
`128/207.18
`128/DIG. 26
`128/207.18
`128/207.18
`604/174
`128/200.24
`128/DIG. 26
`128/207.18
`
`Primary Examiner—Aaron J. Lewis
`Attorney, Agent, or Firm—Elman & Associates
`
`[57] (cid:9)
`
`ABSTRACT
`
`A method for expanding the volume of interior nasal air
`passages (65 and 67) by introducing separating forces in
`anatomical outer nasal wall tissues (62 and 64) to enhance
`oxygen flow and minimize obstruction caused by the pres-
`ence of nasally inserted medical tubing, which further sup-
`ports and retains various combinations of oxygen cannula
`(68), a nasogastric suction tube (35), or an enteral feeding
`tube (40). This method includes a device containing a clip
`assembly (14), adjustable arm (18) and dilator patch assem-
`bly (12). The primary purposes of this method are to reduce
`incidence of secondary infection, increase efficacy of oxy-
`gen therapy and improve patient comfort.
`
`16 Claims, 6 Drawing Sheets
`
`CORPAK Ex 1007, Page 1
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`

`

`U.S. Patent (cid:9)
`
`May 19, 1998
`
`Sheet 1 of 6 (cid:9)
`
`5,752,511
`
`58
`
`64
`
`9
`
`FIG. 1
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`U.S. Patent (cid:9)
`
`May 19, 1998
`
`Sheet 2 of 6
`
`5,752,511
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`64
`
`30
`
`FIG. 3
`
`68
`
`CORPAK Ex 1007, Page 3
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`(cid:9)
`(cid:9)
`

`

`U.S. Patent (cid:9)
`
`May 19, 1998 (cid:9)
`
`Sheet 3 of 6 (cid:9)
`
`5,752,511
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`,.,....••••••••••,....,.,......
`
`FIG. 5
`
`14
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`CORPAK Ex 1007, Page 4
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`U.S. Patent (cid:9)
`
`May 19, 1998
`
`Sheet 4 of 6
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`5,752,511
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`14 (cid:9)
`
`28a 20a
`46a
`
`24
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`28b
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`22
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`26
`
`18
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`20b
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`46b
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`36
`
`FIG. 7 B
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`CORPAK Ex 1007, Page 5
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`U.S. Patent (cid:9)
`
`May 19, 1998 (cid:9)
`
`Sheet 5 of 6
`
`5,752,511
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`64
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`40
`
`67
`
`FIG. 8 A
`
`62
`Ai, -
`1/ IrA
`
`el eV",
`
`6
`5
`
`FIG. 8 B
`16
`
`18 (cid:9)
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`12
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`U.S. Patent (cid:9)
`
`May 19, 1998
`
`Sheet 6 of 6
`
`5,752,511
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`FIG. 9 A
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`FIG. 9 B
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`16
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`62
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`64
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`67
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`65
`60
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`CORPAK Ex 1007, Page 7
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`

`

`5,752,511
`
`1
`UNIVERSAL MEDICAL TUBE RETAINER
`AND NASAL WALL TISSUE DILATOR
`
`CROSS REFERENCES TO RELATED PATENTS
`The invention contains an element of like structural
`composition to that of U.S. Pat. No. 5,476,091, a Dilator For
`Anatomical Outer Wall Tissues Which Is Adhesively
`Mounted, issued to B. Johnson, 12/19/95, and adhesively
`mounted nasal dilator strips of similar construction.
`
`FIELD OF INVENTION
`This invention relates to the field of medical devices,
`specifically to an improved method of retaining medical
`tubing combined with expansion of internal nasal passage
`volume by dilation of outer wall tissues.
`
`5
`
`10
`
`15
`
`2
`are required. U.S. Pat. No. 5,156,641 to White, 10/20/92,
`requires the use of a non-standard nasogastric tube to
`accommodate a delicate connector system intended to secure
`a nose patch to the tube. Standard medical tubing would not
`be compatible with this system. Also, the adjustment link
`described in this system would have little capability for
`bearing subtle pull and twist stresses. These stresses are
`commonly present and result in friction between tubing and
`internal nasal tissues which often produces tissue trauma and
`secondary infection.
`U.S. Pat. No. 5,185,005 to Ballantyne, 2/9/93, is a sub-
`stantially invasive system requiring a high level of attendant
`skill for proper insertion. In addition this invention does
`little to reduce friction with nasal tissues and may signifi-
`cantly increase risk of secondary infection if not properly
`inserted. Further, the device appears to effectively prevent
`other treatments requiring nasally inserted tubing or oxygen
`by occupying the nasal passages with hardware for the
`apparatus and placing an anchoring clip across the breadth
`of the nasal passages when in use.
`Specific limitations are also present with U.S. Pat. No.
`5,172,688 to Dillon, 12/22/92. in that the system allows for
`insertion of nasogastric tubing into only one specific nostril.
`Injury or disease to nasal passages preventing the tubing
`holder from being aligned with the open nostril would
`render this device of little practical use. As depicted in the
`art this device would also appear to present significant
`potential for increased friction between the nasogastric tube
`and outer wall tissues of the corresponding nasal passage.
`U.S. Pat. No. 4,823,789 to Beisang, 4/25/89, fully consists
`of flexible adhesively mounted elements which offer little
`supportive structure and effectively replicate the current
`methods of taping nasally mounted tubing to the face with
`35 strips of medical tape. As with application of tape strips, this
`device would do little to reduce friction with adjoining
`tissues and, although restricting tubing from being pulled
`out, lacks the physical support necessary for limiting the
`tubing's tendency to twist and push against nasal passages.
`U.S. Pat. Nos. 4,932.943 to Nowak, 6/12/90. and 4,986,
`815 to Schneider, 1/22/91, are very much alike. in practice.
`Besides limitations already mentioned common to all the
`prior art, these two devices have the further disadvantage of
`orienting a nasogastric tube directly in line with and above
`the center point of the nostril area. Since the center point of
`each nostril is off this center point the tubing is pushed into
`an orientation where pressure on interior nasal tissues and
`misalignment of the tubing with the nasal passage used will
`likely result. Also, an actual production sample of these
`inventions shows that the clamping jaws for holding tubing
`is both difficult to manipulate and cannot be easily released
`by medical personnel when desirous to do so. It is further
`noted that the location of the clamping jaws can interfere
`with the presence of standard oxygen cannula.
`
`55 (cid:9)
`
`OBJECTS AND ADVANTAGES
`Accordingly several objects and advantages of our
`method are inclusive of a device for combining already
`existing adhesively mounted nasal dilator technology with a
`60 multiple purpose medical tubing retainer. These include the
`ability to retain any clinically valid combination of oxygen,
`feeding or nasogastric medical tubing, reduce incidence of
`secondary infection by preventing friction with adjoining
`tissues, expand internal nasal passage volume to facilitate
`the insertion and presence of medical tubing, and improve
`the efficiency of oxygen delivery therapy through increased
`nasal cavity volume.
`
`BACKGROUND OF THE INVENTION
`Oxygen and other therapies requiring the insertion of
`medical tubing through the nasal cavity have experienced 20
`several problems. First, it is difficult and uncomfortable to
`combine therapies requiring nasal tubing. Oxygen treatment
`in the presence of a nasogastric tube is one example. In such
`a case critical oxygen delivery can easily be interfered with
`by the presence of the nasogastric tube. Both nasal opening 25
`interference caused by competing tubing or injury, and
`limited internal nasal passage volume can limit therapy
`effectiveness.
`In addition, without any means to hold the tubing stable
`it is easy for normal patient movement to disturb or dislodge
`such tubing. Nasogastric and feeding tubes are commonly
`held in place by the subjective placement of adhesive
`medical tape strips to one side of the patient's face. As such,
`effectiveness of application is left to the skill of the medical
`attendant, and can interfere with patient comfort and con-
`tradict the presence of oxygen cannula.
`Prolonged friction of nasally inserted tubing with interior
`nasal tissues is another common problem which can lead to
`secondary infections caused by unsupported or inadequately
`supported tubing. As such, the presence of more than one
`type of tubing within a nasal passage substantially increases
`the chance of tissue infection without remedial and inte-
`grated physical support.
`Several prior patents meant to secure nasogastric medical
`tubing to patients (U.S. Pat. Nos. 5,185,005, to Ballantyne,
`2/9/93 : 4,932,943 to Nowak, 6/12/90 : 4,986,815 to
`Schneider, 1/22/91 : 5,172,688 to Dillon, 12/22/92: 5,156,
`641 to White, 10/20/92: 4,823,789 to Beisang, 4/25/89), do
`not address these problems satisfactorily. One limitation is
`that none are intended to reduce incidence of secondary
`infection when therapies requiring nasal tubing in combi-
`nation are present.
`Also, all prior art discovered, including the previous
`patents and U.S. Pat. No. 5.476,091 to B. Johnson, 12/19/95,
`fails to combine nasal passage dilator technology with a
`medical tubing retainer so as to increase air passage volume
`in the presence of medical tubing, facilitate insertion of such
`tubing, or increase the efficiency of oxygen therapy when in
`use.
`It is also notable that none of the prior art provides an
`effective means for retaining commonly used oxygen can-
`nula in a stable and integrated fashion in conjunction with
`the presence of either a nasogastric or feeding tube.
`On a specific basis, there are several other ways in which 65
`the prior art fails to address prevention of secondary infec-
`tion and patient comfort in cases where combined therapies
`
`30
`
`40
`
`45
`
`50
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`CORPAK Ex 1007, Page 8
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`

`

`5,752,511
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`3
`Other objects and advantages of the invention are that
`more aggressive adhesives may be employed than those
`used on adhesively mounted nasal dilators found at retail
`outlets, and that the device permits adjustment of the retainer
`to accommodate different nose sizes, shapes and physiologi- 5
`cal condition.
`Further objects and advantages of our invention will
`become apparent from a consideration of the drawings and
`ensuing description.
`
`10
`
`4
`-continued
`
`nasogastridoxygen tube retainer clip
`resilient bands
`right adhesive release backing
`left adhesive release backing
`interface adhesive material
`medical grade adhesive
`tip of nose
`nose structure
`right nasal tissue
`left nasal tissue
`right nasal passage
`left nasal passage
`oxygen cannula assembly
`
`46a&b
`48a&b
`50
`51
`54a&b
`56
`58
`60
`62
`64
`65
`67
`68
`
`DESCRIPTION OF DRAWINGS
`FIG. 1 is a view drawing of the human nose for reference
`to FIG. 2 and FIG. 8A through FIG. 9B.
`FIG. 2 is a elevation drawing of the preferred embodiment
`mounted to a human nose with a feeding tube and oxygen
`cannula in use.
`FIG. 3 is a perspective drawing of the preferred embodi-
`ment without the presence of medical tubing.
`FIG. 4 is a perspective drawing of an alternate embodi-
`ment with oxygen cannula and a feeding tube attached.
`FIG. 5 is a perspective drawing of an alternate embodi-
`ment with a nasogastric tube and custom oxygen cannula
`attached.
`FIG. 6 is a perspective drawing of an alternate embodi-
`ment with a nasogastric tube attached, and secured to the
`nose bridge with a standard adhesively mounted nasal
`dilator strip.
`FIG. 7A is an exploded drawing of the preferred embodi-
`ment using typical nasal dilator strip technology.
`FIG. 7B is a detail drawing of the tubing retainer of the
`preferred embodiment.
`FIG. 8A is a sectional view taken from FIG. 4 of a nasal
`cavity with a standard enteral feeding tube present with little
`air flow through the nasal passage.
`FIG. 8B is a sectional view taken from FIG. 2 of a nasal
`cavity assisted by nasal dilator technology with an appre-
`ciable air flow in the nasal passage, and with a standard
`enteral feeding tube present.
`FIG. 9A is a sectional view taken from FIG. 1 of a nasal
`cavity through which little flow of air is passing.
`FIG. 9B is a sectional view of a nasal cavity with an
`appreciable air flow through the nasal passage.
`
`REFERENCE NUMERALS IN DRAWINGS
`
`12 (cid:9)
`14 (cid:9)
`15 (cid:9)
`16 (cid:9)
`18 (cid:9)
`19 (cid:9)
`20a&b (cid:9)
`22 (cid:9)
`24 (cid:9)
`26 (cid:9)
`28a&b (cid:9)
`30 (cid:9)
`32 (cid:9)
`34 (cid:9)
`35 (cid:9)
`36 (cid:9)
`38 (cid:9)
`39 (cid:9)
`40 (cid:9)
`42 (cid:9)
`44 (cid:9)
`
`dilator patch assembly
`retainer clip assembly
`retainer clip
`nose bridge
`adjustable arm
`adjustable arm
`feeding tube fixture
`oxygen cannula detent
`upper cannula retainer
`facial contour detent
`lower cannula retainers
`top material strip
`molded nosepiece
`typical nasal dilator strip
`nasogastric tube
`n.y,Jox. clip corners
`oxygen tube
`adjustable arm serrations
`feeding tube
`standard oxygen supply tube
`custom oxygen supply fixture
`
`15 (cid:9)
`
`SUMMARY
`The invention provides a method for expanding interior
`nasal cavity volume by introducing separating forces in
`anatomical outer wall tissues to enhance oxygen flow and
`20 minimize obstruction caused by the presence of medical
`tubing. The method further retains any typical combination
`of medical tubing, including oxygen cannula, commonly
`administered through the nasal cavity. This method of appli-
`cation also enlarges volume of interior nasal passages to
`25 facilitate tubing insertion, and limits contact and friction of
`the interior anatomical tissues with tubing to reduce inci-
`dence of secondary tissue infection.
`
`30 (cid:9)
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS (FIGS. 1-7B)
`HG. 2 depicts a pictorial view of the preferred embodi-
`ment with oxygen tubing 38, standard oxygen supply tube
`42, and feeding tube 40 attached to retainer clip assembly
`35 14. Oxygen tubing 38 and oxygen supply tube 42 comprise
`what is commonly referred to as oxygen cannula 68 to those
`skilled in the art of medical fixtures. FIG. 3 shows the
`identical embodiment to that in FIG. 2, but without tubing
`attached, while FIG. 4 is an alternative embodiment with
`40 regard to the type of adjustable arm 19 used.
`In basic construction retainer clip 15 is to be formed of a
`semi-rigid, injection molded thermoplastic such as high
`density polyethylene or acetal. Such a material or an equiva-
`lent is desirable since structural integrity to provide support
`45 for tubing, flexibility to provide gripping tension upon the
`nasogastric tubing 35 shown in FIG. 5 and FIG. 6, and a
`clinically inert material are all requirements for effective
`performance. Retainer clip 15 must not consist of a brittle
`material, as it would be highly undesirable to have small
`50 pieces break off during use.
`The various features of retainer clip 15 are illustrated in
`detail in FIG. TB. Oxygen supply tube 42 or custom oxygen
`supply fixture 44 are effectively retained by a combination
`of upper cannula retainer 24 and lower cannula retainers 28a
`55 and 28b. These elements provide a resultant interior diam-
`eter of 5 mm and extend slightly over center as shown in
`upper cannula retainer 24 and lower cannula retainers 28a
`and 28b to capture oxygen supply tube 42 or custom oxygen
`supply fixture 44. In order to fit to a standard oxygen supply
`60 tube 42 commonly used in an oxygen cannula assembly 68,
`the distance from center to center of interior openings to
`hold tubing in each nasogastric/oxygen supply clip 46a and
`46b should be 15 mm. Depending on the flexibility of
`material used to form retainer clip 15 the interior openings
`65 for nasogastric/oxygen clips 46a and 46b should each be
`approximately 5 mm in diameter and be expandable to 6 mm
`diameter without compressing standard 16 or 18 french size
`
`CORPAK Ex 1007, Page 9
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`5,752,511
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`10
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`25
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`30
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`35
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`5
`nasogastric tubing so as to adversely affect specified suction
`rates. The attendant openings to allow tube entry to
`nasogastric/oxygen tube clips 46a and 46b will likewise
`vary slightly according to exact material used in clip assem-
`bly 14, but worked well at 4 mm in inventor prototypes. By 5
`incorporating a symmetrical shape to retainer clip 15 it
`performs the dual functions of accommodating a standard
`oxygen supply tube 42 from an oxygen cannula assembly
`68, and also makes insertion of a nasogastric tube 35 feasible
`in either nostril opening. (cid:9)
`Nasogastric/oxygen clip corners 36 as shown at the tube
`entry flanges which assist clipping of oversize tubing should
`contain generously rounded edges on all surfaces to elimi-
`nate irritation to surrounding skin. In addition, it is recom-
`mended to incorporate a facial contour detent 26 into 15
`retainer clip 15 to reduce incidence of contact with the fleshy
`formation found between the base of the nose and the upper
`lip, also known as the Filtrum. On the plane of facial contour
`detent 26 an added oxygen cannula detent 22 eliminates
`interference with many standard oxygen supply tubes 42 20
`which incorporate a semi-circular tab opposite and between
`the two oxygen outlets. This tab is shown in profile in FIG.
`2.
`In order to fit a standard 8 french enteral feeding tube for
`insertion in either nostril, retainer clip 15 also incorporates
`feeding tube fixtures 20a and 20b symmetrically and in the
`orientation indicated in FIG. 7B. Inventor prototypes indi-
`cate that feeding tube fixtures 20a and 20b be 3 mm in
`diameter, with attendant openings to allow tube entry of
`approximately 1.5 mm. It is important that feeding tube
`fixtures 20a and 20b be oriented in a fashion that when an
`18 french nasogastric tube 35 or standard oxygen supply
`fixture 42 is in use in either nasogastric/oxygen tube clip 46a
`or 46b, a feeding tube 40 in either feeding tube fixture 20a
`or 20b would not interfere with its operation.
`In the preferred and alternate embodiments adjustable arm
`18 would be insert molded with retainer clip 15 to assure a
`durable one-piece retainer clip assembly 14 with no oppor-
`tunity for separation as shown FIG. 6. As shown in FIG. 3
`and FIG. 4, adjustable arm 18 or 19 could be of different
`materials providing a material is used that can be bent by
`finger pressure and will remain in place after such adjust-
`ment. Adjustable arm 18 or 19 has been reduced to practice
`in acceptable prototypes by using either 14 gage, solid core
`copper, coated wire, as indicated in FIG. 4, or flat metal
`stock as shown in FIG. 3 and FIG. 5 consisting of 0.5 mm
`thick, corrosion resistant copper beryllium or an equivalent.
`For adjustment to most adult noses preliminary prototypes
`indicate an exposed length of 17 mm is advisable for
`adjustable arm 18 between retainer clip 15 and dilator patch
`assembly 12.
`FIGS. 4, 5, and 6 show retainer clip assembly 14 holding
`a variety of tubing combinations including standard oxygen
`supply tubing 42 and a feeding tube 40, nasogastric tube 35
`and a custom oxygen supply fixture 44, and a nasogastric
`tube 35 alone. There is no clinical need for accommodating
`a feeding tube 40 and nasogastric tube 35 at the same time.
`FIG. 4 and FIG. 5 indicate two alternate embodiments of
`shapes which dilator patch assembly 12 could take. The
`essential factor is that the patch extend externally over the
`nasal wall tissue areas which would benefit from dilation.
`These areas are depicted as nasal tissue right 62 and nasal
`tissue left 64 in FIG. 8B.
`The construction of dilator patch assembly 12 is generally 65
`indicated in FIG. 7A and is similar to existing nasal dilator
`strip technology. Amore detailed example of this technology
`
`40
`
`45
`
`50
`
`55
`
`60
`
`6
`can be found in U.S. Pat. No. 5,476,091 to B. Johnson,
`12/19/95, titled Dilator For Anatomical Outer Wall Tissues
`Which Is Adhesively Mounted. Adjustable arm 18 is there-
`fore contained within dilator patch assembly 12 by means of
`lamination technology utilizing heat seal, pressure adhesive
`or a similar manufacturing process, and extends throughout
`the length of dilator patch assembly 12. To provide maxi-
`mum ability for the dilator patch assembly 12 to retain
`adjustable arm 18, a series of adjustable arm serrations 39
`may be provided to secure it within the lamination.
`Indicated are resilient bands 48a and 48b which provide
`an effective spring constant to provide the desired pull on the
`outer wall tissues of the user's nose, the exact performance
`of which are adjustable by material, thickness, length, width
`and geometry of notches. Resilient bands 48a and 48b are
`secured by flexible strips of interface adhesive material 54a
`and 54b to the top side of base material consisting of medical
`grade adhesive 56. An example of a suitable compound for
`interface adhesive material 54a and 54b would be an acrylic,
`pressure sensitive, bio-compatible transfer tape such as 3M
`1509 available from Minnesota Mining & Manufacturing
`Company, Inc. Right adhesive release backing 50 and left
`adhesive release backing 51 cover medical grade adhesive
`56 before use, and are readily removeable from medical
`grade adhesive 56 prior to application on a patient's nose.
`The outer contour of dilator patch assembly 12 is variable to
`the extent that it conforms to performance requirements
`stated herein, and is manufacturable by die cutting processes
`common to similar adhesive medical patches and strips.
`FIG. 6 depicts another alternate embodiment of the Uni-
`versal Retainer/Nasal Dilator consisting of a molded nose-
`piece 32 attached to nose bridge 16 by means of a typical
`nasal dilator strip 34 which is adhesively mounted. Research
`conducted by the inventors indicates that an FDA approved
`thermoplastic rubber like Dynaflex G6713 would be a
`suitable material for molded nosepiece 32 as it conforms to
`nose bridge 16 contours, "grips" the skin by becoming
`slightly tacky when warm, and is FDA approved for medical
`applications. This material would permit the entire device to
`be insert injection molded in a one step process. The
`inventors also considered using the same material and
`assembly in this embodiment as skin barrier used for ostomy
`patients, an example of which is Hollister Inc. Premium Skin
`Barrier #7800, to perform the function of molded nosepiece
`32. A primary feature of this material is that it forms a strong
`adhesive quality to skin when warm and conforms easily.
`Both materials and methods of construction for molded
`nosepiece 32 would retain the advantages of accommodating
`nasally inserted medical tubing in combination with oxygen
`therapy, and would utilize the dilation forces of nasal dilator
`strip 34 to expand interior nasal passage volume to assist
`such therapies and increase patient comfort.
`OPERATION (FIGS. 8A-9B)
`FIG. 8A through FIG. 9B depict anatomical factors per-
`taining to the performance of the claimed invention. These
`figures show a nose structure 60 including tissue generally
`referred to as nose bridge 16. right nasal passage 65, left
`nasal passage 67, right nasal tissue 62, and left nasal tissue
`64.
`In FIG. 9B, nose structure 60 is again shown in a sectional
`view. The state of nasal passages 65 and 67 is that occurring
`in the portion of the breathing cycle when little air is flowing
`through them, and are thus the air passages of a person that
`is healthy and without injury to nasal tissues.
`The process of inhaling air causes nasal tissues 62 and 64
`to draw inward slightly as suction forces are caused within
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`air passages 65 and 67. Conversely, in the presence of
`inflammation or obstruction to air passages 65 and 67 caused
`by illness, allergy or injury, inhalation can often result in
`dramatically higher suction forces as the person attempts to
`inhale sufficient air. Nasal tissues 62 and 64 can then pull 5
`inward significantly, in severe cases to the point of near
`closure of air passages 65 and 67. This condition is indicated
`in FIG. 9A, and is most severe at the juncture of the nasal
`passage bone and skull where indicated along the dotted line
`in FIG. 1. This area is known as the nasal valve, and the 10
`severity of closure is determined by the size of this valve in
`each person.
`Hospital patients requiring oxygen, nasogastric suction or
`enteral feeding commonly suffer from the type of nasal
`inflammation described, a condition further exacerbated by
`the presence of medical tubing. Such a condition is illus-
`trated in FIG. 8A, a sectional view of nose structure 60 with
`no separation of nasal tissues 62 and 64 as would be caused
`by nasal dilator patch assembly 12.
`Even patients with normally clear and open air passages
`can experience problems with nasal inflammation when
`medical tubing is in friction with surrounding tissues, and in
`any case efficacy of oxygen therapy is improved the more
`nasal tissues 62 and 64 are held open. Therefore, FIG. 8B
`depicts the benefits of adding nasal dilator technology to the
`practice of nasally applied medical therapies, as described in
`the previous scenarios. This condition is a clear improve-
`ment over previous medical tubing retainers which fail to
`address retention of oxygen cannula or enteral feeding tubes,
`and do not utilize nasal dilator technology.
`Existing nasal dilator technology of the type inclusive of
`the Universal Retainer/Nasal Dilator is a remedy to these
`nasal blockage problems. Therefore, when used in conjunc-
`tion with an adjustable, articulated universal tubing retainer
`the claimed invention is a new and medically effective
`method for retaining a combination of tubing fixtures for
`nasally delivered therapies, reducing incidence of secondary
`infection, enhancing efficacy of oxygen therapy by expand-
`ing nasal air passages, and increasing patient comfort.
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`embodiments, workers skilled in the art will recognize that
`changes may be made in form and detail without departing
`from the spirit and scope of the invention.
`Accordingly, the scope of the invention should be deter-
`mined not by the specific embodiments illustrated, but by the
`appended claims and their legal equivalents.
`What is claimed is:
`1. A medical device for facilitating nasal insertion of
`medical tubing and for improving the flow of oxygen
`through a patient's nasal passages comprising:
`(a) a nasal dilator including a resilient band and a patch
`having adhesive thereon for application to a patient's
`nose, said nasal dilator having means for introducing
`separating forces in outer nasal wall tissues, thereby
`expanding the volume of interior nasal passages; and
`(b) a retainer clip assembly, said retainer clip assembly
`extending distally of a patient's nose from said nasal
`dilator and having means for supporting and retaining
`medical tubing near the entrance to a patient's nose.
`2. The medical device of claim 1 wherein said retainer clip
`assembly is adapted for supporting and retaining a plurality
`of medical tubes.
`3. The medical device of claim 2 wherein said retainer clip
`assembly is adapted for supporting and retaining a plurality
`of medical tubes of a plurality of sizes.
`4. The medical device of claim 3, wherein said retainer
`clip assembly is adapted for supporting medical tubes of the
`sizes of oxygen cannula, nasogastric tubing and enteral
`tubing.
`5. The medical device of claim 1 wherein said nasal
`dilator further comprises:
`an interface strip.
`6. The medical device of claim 1 wherein said retainer clip
`assembly comprises:
`a retainer clip adapted for removably retaining a plurality
`of nasally inserted medical tubes and an arm extending
`from said nasal dilator to said retainer clip.
`7. The medical device of claim 6 wherein said retainer clip
`is of a resilient material and partially encloses a plurality of
`generally cylindrical channels, each channel being adapted
`to support and retain medical tubing of a predetermined
`standard diameter.
`8. The medical device of claim 6 wherein said arm is of
`45 a material which remains in place after bending by finger
`pressure, whereby said arm is adjustable to position said clip
`at a nasal opening.
`9. A method of using the medical device of claim 8 for
`inserting and supporting medical tubing in a patient's nose,
`comprising:
`(a) providing a medical device in accordance with claim
`8;
`(b) fitting it to a patient's nasal anatomy by bending the
`adjustable arm to position the retainer clip so that it will
`be under and adjacent to the patient's nose when the
`device is adhered to the patient's outer nasal tissue;
`(c) adhering the nasal dilator to the patient's outer nasal
`tissue, thereby providing an outward separating force to
`the nasal anatomy, enlarging the interior nasal passage;
`and
`(d) placing medical tubing in said retainer clip, so as to be
`supported and retained thereby.
`10. The medical device of claim 8 wherein said arm
`comprises a coated bendable metal wire or strip.
`11. The medical device of claim 10 wherein said retainer
`clip is formed with a pair of cylindrical channels of differing
`diameters, together having an &-shaped cross section.
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`CONCLUSIONS, RAMIFICATIONS AND SCOPE
`OF INVENTION
`Thus the reader will see that the Universal Medical Tube
`Retainer & Nasal Wall Tissue Dilator provides a highly
`effective and economical method for increasing efficacy and
`patient comfort for therapies requiring oxygen, gastric suc-
`tion or enteral feeding which can be used by properly trained
`medical attendants of average skill.
`While the above description contains many specifics of
`the claimed invention these should not be construed as
`limitations on the scope of the method, but rather as mani-
`festations of both a preferred and small number of alternate
`embodiments thereof. For example clip assembly 14 could
`exclude upper cannula retainer 24 and lower cannula retain- 55
`ers 28a and 28b and still contain provision to retain either a
`nasogastric or feeding tube to reduce incidence of secondary
`infection while providing the therapeutic advantages of
`nasal dilation with such tubing. As another example, several
`alterations could be made in the exact construction of dilator
`patch assembly 12 without altering the intention of the patch
`to be an adhesively applied nasal dilator to assist in the
`function of supporting and directing a combination of thera-
`pies with relation to increased nasal passage volume.
`Therefore, although the Universal Medical Tube Retainer 65
`and Nasal Wall Tissue Dilator has been described with
`reference to the preferred and several alternate
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`12. The medical device of claim 11 wherein said retainer
`(vi) a top material strip.
`clip is symmetrically formed with two pairs of cylindrical
`15. The medical device of claim 14, wherein said retainer
`channels of differing diameters, the axes of each pair of
`clip assembly (v) comprises:
`channels being spaced apart from each other approximately
`an adjustable arm laminated between said resilient bands
`the distance between the axes of a typical patient's nostrils. 5
`and said top material strip, and
`13. The medical device of claim 12 wherein said retainer
`a retainer clip for said medical tubing at the end of said
`clip further includes a pair of cannula retainers and an
`adjustable arm.
`oxygen cannula detent, and in which the inner diameter of
`16. A method for facilitating nasal insertion of medical
`the smaller channels is sized for supporting an enteral
`0 tubing and for improving the flow of oxygen through a
`feeding tube and the inner diameter of the larger channels is 1
`patient's nasal passages, comprising the steps of:
`sized for supporting a nasogastric tube or oxygen cannula,
`whereby oxygen cannula supplying both nostrils and an
`(a) providing a nasal dilator including a resilient band and
`enteral feeding tube may simultaneously be supported by
`a patch having a