Jan 19, 2006 - Primar Examiner * Justine Yu. A61M 15/08. (200601). Assislaiil Examiner * Kristen C Matter. A623 18/02. (
USO0RE42843E
(19) United States (12) Reissued Patent
(10) Patent Number:
Strickland et al. (54)
(45) Date of Reissued Patent:
NASAL CANNULA
(56)
U-S- PATENT DOCUMENTS
(US); Jonathan Lee, St.Augustine, FL
1,362,766 A * 12/1920 McGargill ............. .. 128/20527
.
2,663,297 A *
FL (Us)
Assignee:
J.
4,367,735
.... ‘ ‘ ‘ ‘ .. n
*
1/1983
Dali
12/1983
Tiep
4/1990 Kopala et al. ..
.... .. 128/207.l8
4,996,983
A
*
3/1991
AmRhein
. . . . ..
128/206.ll
5,046,491
A
*
9/1991
Derrick
. . . . ..
128/20024
_
_
_
_
*
4/1990
Lee
128/20718
.... .. 128/207.l8
4,919,128 A *
_
A
‘‘‘‘‘‘‘
4,915,105
~~~~~~~~~~~~~
Th1s patent 1s subject to a tennlnal dls-
5,137,017 A *
Claimer_
5,165,133 A *
11/1992
5,269,296 A
12/1993 Landis
(21)
Appl-NO-I 11/334322
(22)
Filed:
A
*
5,400,776 A * 5,477,852 A *
... ...
. . . . . . .
8/1992 Salter ........ ..
8/1994
128/20527
.. 128/207.18
Armbruster .................. .. 15/971 Pologe
.. ... ... ...
3/1995 Bartholomew 12/1995
~ ~ ~ ~ ~~
. . . . . ..
600/473
.. 128/20024
Landis etal. .......... .. 128/207.l8
Jan. 19, 2006
5,513,634 A *
(Under37CFR1'47)
5,682,881 A *
11/1997 Winthrop etal. ...... .. 128/20718
5,687,715 A
ll/l997 Landis etal.
5,533,506 A Related US. Patent Documents
5,724,965 A
Relssue 0ft
(64)
.... .. 128/207.l3
4,422,456 A *
5,335,659
.
Turnberg
Creek FL (Us) _
Notlce:
A
12/1953
Innomed Technologies, Inc., Coconut
’
(*)
Oct. 18, 2011
References Cited
(75) Inventors: Roger Strickland, Blackshear, GA
(73)
US RE42,843 E
patent NO;
6,679,265
Issued:
Jan. 20, 2004
Appl. NO.Z
10/042,042
PCT Filed:
Oct. 25, 2001
5/1996 Jackson ................. .. 128/207.l8
7/1996 Wood 3/1998 Handkeetal'
5,794,619 A *
8/l998
5,928,189 A *
7/1999 Phillips et al. ................ .. 604/65
Edelman et al. ....... .. 128/207.l8
(Continued) OTHER PUBLICATIONS U.S. Appl. No. 12/842,271, ?led Jul. 23, 2010, for Nasal Cannula.
(51)
Int' Cl'
Primar Examiner * Justine Yu
A61M 15/08
(52) (58)
(200601)
Assislaiil Examiner * Kristen C Matter
A623 18/02
(2006-01)
(74) Attorney, A gent, or Firm 4 Bacon & Thomas, PLLC
A62B 7/00 A62B 18/08
(2006.01) (2006.01)
(57)
U-s- Cl- ~~~~~~~~ ~~ 128/207-18; 128/207-11; 128/207-13 Field of Classi?cation Search ........... .. 128/200.24,
128/202 18 203 22 203 29 204 12 205 25
inserts each ofWhich conform to the shape ofthe nare. Prop
128/206'11’ 206'12’ 206'18’ 206'27’ 206'28’ '
’
'
’
'
’
'
’
'
’
128/207.11, 207.13, 207.14, 20723622365398, See application ?le for complete search history.
ABSTRACT
A nasal cannula for delivering air to a patient’s nares. Two delivery tubes are provided to supply air to a Pair of nasal
erly placed bleed ports reduce noise and reduce carbon diox ide retained in the system. The cannula is positioned on the
face with the aid Ofa strap System_ 15 Claims, 5 Drawing Sheets
US RE42,843 E Page2 US. PATENT DOCUMENTS 6,165,133 A 6,213,955 B1* 6,298,850 B1*
6,354,293 B1* 6,422,240 B1* 6,439,234 B1*
7,000,613 B2
12/2000 Rapoportetal 4/2001 Karakasoglu et a1. ...... .. 600/529 10/2001 Argraves .......... .. 128/207.17 . 3/2002 Mad1son 128/204.13 .
7/2002 LeV1tsky et a1. .
128/207.18
8/2002 (3111116161. ..
128/207.18
6,478,026 B1*
11/2002
Wood ..... ..
128/207.18
6,478,029 B1*
11/2002 Boydetal.
...... .. 128/898
6,595,215 B2*
7/2003
6,679,265 B2 6,776,162 B2
1/2004 Stncklandetal. 8/2004 Wood
6,807,967 B2* 6,863,069 B2*
6,994,089 B2 6,997,177 B2 6,997,187 B2
10/2004 3/2005
Wood ..... ..
.
. 128/207.18
Wood ..................... .. 128/207.18 Wood ..................... .. 128/207.18
200% Wood 2/2006 Wood 2/2006 Wood et a1.
2/2006 Wood et :11.
7,047,974 B2*
5/2006
7,059,328 B2* * 7,188,624 B2
6/2006 Wood ......... ..
7,191,781 B2 7,234,465 B2
3/2007 Wood 6/2007 Wood
2002/0059935 A1
2002/0162558 A1
* ,,
3/2007
Stricklandetal. ..... .. 128/207.18
5/2002
Wood ..................... .. 128/207.18
11/2002
Noble .................... .. 128/207.18
2004/0182397 A1 2005/0028821 A1
9/2004 Wood 2/2005 Woodetal.
2005/0039757 A1
2/2005
2005/0121037 2005/0133040 2005/0235999 2005/0252515 2007/0137653
A1 A1 A1 A1 A1
* cited by examiner
.. 128/207.18
Wood ..................... .. 128/207.18
6/2005 6/2005 10/2005 11/2005 6/2007
Wood
Wood Wood Wood et a1. Wood Wood
US. Patent
0a. 18, 2011
Sheet 1 015
F1ng
US RE42,843 E
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0a. 18, 2011
Sheet 2 0f5
US RE42,843 E
US. Patent
Oct. 18, 2011
Sheet 3 0f 5
US RE42,843 E
US. Patent
Oct. 18, 2011
Sheet 4 0f 5
US RE42,843 E
US. Patent
Oct. 18, 2011
Sheet 5 0f 5
US RE42,843 E
US RE42,843 E 1
2
NASAL CANNULA
section of the insert are essentially equal. The compliance of the material used to manufacturer the device is suf?cient to provide an extremely comfortable ?t in the nares.
Matter enclosed in heavy brackets [ ] appears in the original patent but forms no part of this reissue speci?ca
BRIEF DESCRIPTION OF THE DRAWING
tion; matter printed in italics indicates the additions made by reissue.
Throughout the ?gures of the drawing like reference numerals indicate identical structure wherein: FIG. 1 is a schematic representation of the nasal cannula on
FIELD OF THE INVENTION
the head of a user;
The present invention relates generally to a nasal mask or cannula and more particularly to a nasal cannula for treating a patient with a positive ventilation pressure machine for assisted ventilation.
FIG. 2 is a projection of the nasal cannula in isolation; FIG. 3 is cross section of a portion of the nasal cannula
showing the bleed ports; FIG. 4 is cross section of a portion of the nasal cannula
showing the bleed ports; BACKGROUND OF THE INVENTION
FIG. 5 is cross section of a portion of the nasal cannula
showing the bleed ports; Positive air pressure (PAP) assisted ventilation systems have been adopted for the treatment of various disorders. PAP systems are commonly used to treatment sleep apnea. Varia tions of PAP systems have been used to administer drugs and the like. In operation the patient’ s respiration is assisted by an exter nal pump which supplies air to the patient under a slight positive pressure. In the conventional system, air is delivered in response to preset conditions selected for each individual
FIG. 6 is cross section of a portion of the nasal cannula
showing the bleed ports; and, 20
DETAILED DESCRIPTION 25
patient. In normal operation the patient’s inspiratory phase is assisted by a pump which delivers an adequate supply of air at a slight positive pressure to a mask or cannula that is placed on
the face of the patient. Full face mask systems which cover
30
In use, when the patient exhales, the higher pressure in the mask or cannula system is used to open an exhaust valve. 35
by positive pressure while the expiration phase takes place at
approximately atmospheric pressure.
the patient’s face with a strap system 18 which may be of any convenient and conventional construction. The left and right
supplies air under pressure to the nasal cannula 10 and releases exhaled air to the atmosphere. Conventional machines have a valve that is overpressure during exhalation to exhaust air. In some instances the system may also warm
In instances where the patient compliance is affected by the comfort of the mask it is now widely accepted that “nose only” cannula devices are preferred. Examples of current
Turning to FIG. 1 there is shown a nasal cannula 10 which shows a nasal insert 12 placed into a patient’s nare 14. Directly beneath each nasal insert is a bleed port as seen at reference numeral 16. The complete nasal cannula is held on
delivery tubes typi?ed by delivery tube 20 terminate in a coupler 22. This Y-shaped coupler 22 is connected to a con ventional positive pressure ventilation machine 24. In operation, the positive pressure ventilation machine 24
both the mouth and the nose are used. Systems which cover the mouth or nose alone are also common.
Thus the patient respiration is assisted on the inhalation phase
FIG. 7 is diagram of volumes and dimensions related to the calculation of the size and location of the bleed ports.
and humidify the delivered air. In some instances the 40
machines are used to deliver medications.
The left delivery tube and the right delivery tube 20 should lie close to the face of the patient and the coupler 22 should be positioned in the vicinity of the neck as seen in the ?gure. FIG. 2 shows the nasal cannula 10 in perspective view. The
devices can be seen in US. Pat. No. 5,477,852 to Landis; US.
Pat. No. 5,533,506 to Wood; US. Pat. No. 5,269,296 to Lan dis; U.S. Pat. No. 5,687,715 to Landis; US. Pat. No. 5,724, 965 to Handke. 45
SUMMARY OF THE INVENTION
entire cannula 10 may be molded out of a polymeric material such as silicone rubber or urethane. Portions of the nasal
cannula may be locally reinforced to increase rigidity. For
In contrast to prior air nasal masks, the present system includes a pair of nasal inserts which are fed bilaterally from a pair of delivery tubes which includes both a left and a right leg. If the patient occludes one leg on one side of the mask, the
example it may be useful to reinforce the structure at the location where the strap 18 system meets the cannula device
complimentary side is su?icient to provide all of the air
10 In the ?gure a portion of the strap system 18 is shown coupled to delivery tube 20. The various changes in section depicted in the ?gure add stiffness or rigidity to the device.
required by the patient.
The optimal shape and cross section is not known and some
50
experimentation may be required to optimize the device.
Air is introduced into the system through a Y-shaped
adapter or coupler. The shape of the coupler cooperates with
55
However the softness and compliance of the elastomer is an
other elements to minimize noise.
important factor in patient comfort. The Y-shaped connector
A pair of bleed ports are placed in the cannula body near the patient’s nose. These bleed ports reduce the amount of carbon dioxide retained by the system. The two complex ports are placed in the cannula body to reduce noise and to reduce carbon dioxide build up in the system. Example calculations show how the size, shape and location of each of these ports cooperate to reduce the inhaled carbon dioxide concentration. An additional feature relates directly to the shape of the nasal inserts. The nasal inserts are su?iciently long and com pliant that they may be inserted into the nose until they adopt
22 is adapted for connection to the PAP system 24.
a location where the cross-section of the nare and the cross
Nasal insert 12 and nasal insert 13 are tubes connected to 60
and extending from the delivery tube 20 and delivery tube 21 respectively. The most distal portion of the insert 12 termi nates in a ?ange 26. It is expected that each ?ange 26 will be
quite soft. The ?ange 26 is designed to readily conform to the patient’s nare. In use the patient will direct the inserts into the 65
nose and the inserts 12 and 13 will move in the nare until the inner cross section of the nare matches the outer cross section
of the ?ange. The anatomy of the nose will deform the shape of the insert and its ?ange to achieve a comfortable seal. It is
US RE42,843 E 3
4
expected that only one or two sizes will be required to ?t a
about 10 times the wall thickness at the location of the bleed
large population as most patients have similarly sized nares. The bleed port typi?ed by port 16 is a tube extending from the delivery tube 20 into the insert 12. Each tube has a char acteristic height or length. These bleed ports serve several functions. If the bleed ports 16 and 17 are appropriately placed and sized they can reduce the accumulation of carbon dioxide. If they are properly con?gured, sized and located
port. The diameter of the bleed ports (BPD) is established to reduce the accumulation of carbon dioxide. The height of the bleed ports “hl or h2” is established to reduce the incidence of
parasitic acoustic effects. The relationship between the bleed
port diameter (BPD) and the height (hl) is optimized between a value of0.l and 0.5. that is when 0. l:0.l
where ‘A’ is a constant of proportionality an ‘X’ is the cross
sectional area of the delivery tubes. 4. A nasal cannulafor use with a constantpositive pressure 50
cient to provide all the air required by apatient;
2. A nasal cannula for use with a constant positive pressure
?rst and second nasal inserts for insertion into a patient’s
air supply, supplying air (F) at between about 10 to 50 liters/
nares, said inserts connected to and extending at an
minutes, said cannula comprising:
angle relative to respective portions of said tubes;
?rst and second nasal inserts for insertion into a patient’s nares;
said inserts adapted for a sealing relationship with the patients nares; a left and right delivery tube coupled to both of said nasal inserts, each of said delivery tubes is suf?cient to pro vide all of the air (F) required by the user; each nasal insert communicates with both the left delivery
55
said nasal inserts each being elongated and comprising a
soft, compliant material con?gured to conform to the cross-section of a nare of a patient when inserted into a nare up to a location where the inner cross-section ofthe
nare equals the outer cross-section ofthe insert to @fect
said sealing relationship with the patient ’s nares; and 60
tube and right delivery tube; a coupler located remote from said nasal inserts for cou
pling said cannula to a source of respiration air; at least two bleed ports having an internal lumen directly
air supply, comprising: left and right delivery tubes, each tube having a size su?i
65
two tubular bleed ports, each bleed port having an open
internal lumen directly opening into a respective deliv ery tube and connecting an interior of the delivery tube with an exterior of the delivery tube; and wherein each bleed port is located directly opposite and aligned with a respective nasal insert, said bleed ports
opening into said delivery tubes connecting the interior
comprising together one ofthree air exit paths leading
of the cannula with the exterior of the cannula;
away from the nasal inserts.
US RE42,843 E 7
8
5. The nasal cannula as claimed in claim 4, including a soft ?ange located at a distal terminal end of each nasal insert,
extending into the interior of a respective delivery tube from
each ?ange readily conformable with a patient’s nare and enabling a sealing with the interior ofa nare in which the
direction ofmotion ofthe air supply?owing in the respective delivery tube, each bleed tube further extending toward and
insert is placed when the insert is inserted up to a location
parallel with a respective nasal insert. 1]. The nasal cannula as claimed in claim 10, each bleed tube terminating at a location spaced inwardlyfrom an inner wall of a respective delivery tube and directly opposite an inner end of a respective nasal insert at its juncture with a
an inner wall thereofin a direction generally normal to the
where the cross-section of the?ange equals the cross-section of the nare. 6. The nasal cannula as claimed in claim 5, wherein said
left and right delivery tubes include portions adjacent to the nasal inserts, wherein said delivery tube portions adjacent to
delivery tube. 12. The nasal cannula as claimed in claim 1], wherein each delivery tube has a wall thickness, and each bleed tube has a characteristic height that is at least twice and less than 10 times the wall thickness of a respective delivery tube at the
the nasal inserts, the nasal inserts and the?anges are made in one integralpiece. 7. The nasal cannula as claimed in claim 6, wherein said
delivery tube portions adjacent the nasal inserts, the nasal
location of the bleed tube.
inserts and the ?anges are made of silicone rubber.
13. The nasal cannula as claimed in claim 10, wherein the
8. The nasal cannula as claimed in claim 4, further com
bleed tube has a tapered outer shape, tapering inwardlyfrom the respective delivery tube inner wall towards each nasal
prising a coupler located remote from said nasal inserts for enabling coupling said delivery tubes to a source of respira tion gas. 9. The nasal cannula as claimed in claim 4, wherein each
20
cannula, including nasal inserts, bleed tubes, and at least part of the delivery tubes adjacent to the nasal inserts, are made in a single unitary and integralpiece.
bleed port extends inwardly of an inner wall of a respective delivery tube, and comprises a bleed tube that extends toward a respective nasal insert. 10. The nasal cannula as claimed in claim 4, wherein said
delivery tubes include portions generally aligned adjacent to the nasal inserts so as to feed pressurized air towards a
central area between the delivery tubes beneath the nasal inserts, and wherein each bleed port comprises a bleed tube
insert. 14. The nasal cannula as claimed in claim 10, wherein the
15. The nasal cannula as claimed in claim 14, wherein the 25
cannula, including said nasal inserts, bleed tubes and said at least part of the delivery tubes adjacent to the nasal inserts, are made ofsilicone rubber. *
*
*
*
*
UNITED STATES PATENT AND TRADEMARK OFFICE
CERTIFICATE OF CORRECTION PATENT No.
; RE42,843 E
APPLICATION NO.
: 11/334822 : October 18, 2011 : Strickland et a1.
DATED INVENTOR(S)
Page 1 of 1
It is certified that error appears in the above-identi?ed patent and that said Letters Patent is hereby corrected as shown below:
On the Title Page:
Item [64], Replace sub-heading, PCT Filed: With sub-heading, Filed.
Signed and Sealed this First Day of November, 2011
David J. Kappos Director 0fthe United States Patent and Trademark O?ice
