(12) United States Patent
`Lau et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 7,178,528 B2
`Feb. 20, 2007
`
`US007l78528B2
`
`(54) HEADGEAR FOR NONINVASIVE
`VENTILATION INTERFACE
`
`3,156,923 A *
`3,441,020 A *
`3,683,907 A *
`
`11/1964 Walter ......................... .. 2/419
`4/1969
`128/205.25
`8/1972 Cotabish .............. .. 128/200.28
`
`
`
`(75)
`
`1nVemO1S, Greg Y_ Lau, 155 Boyce D11,
`MOCkSV111e,NC(US)27028;
`Chrimpher B‘ Reed’ 155 Boyce Dr"
`M°°kSVi11e=NC(US)27028
`.
`.
`.
`.
`Subjectto any disclaimer, the term ofthis
`Patent 15 extended er adfllsted under 35
`U.S.C. 154(b) by 0 days.
`
`*
`
`(
`
`.
`) Notice:
`
`........... .. 128/201.23
`5/1976 Hutter, 111
`3,955,570 A :
`2,032,123 A * 12/13;: knab ................ .. 1282//884;
`4,593,688 A *
`6/1986 P:IySt(<))Ir11
`.... "128/200 28
`4,774,946 A * 10/1988 Ackermaiiiietnal............. 128/207.18
`5,704,916 A *
`1/1998 Byrd ........................ .. 604/179
`6,119,694 A =1
`9/2000 Correa e1 31.
`128/207.13
`6,889,689 B1*
`5/2005 Neuman .............. .. 128/201.22
`
`(21) Appl. N0.: 11/069,170
`
`(22)
`
`Filed:
`
`Mar. 1, 2005
`
`(65)
`
`Prior Publication Data
`
`US 2006/0196511 A1
`
`Sep. 7, 2006
`
`(51)
`
`Int. Cl.
`(2006.01)
`A61M 15/08
`(2006.01)
`A62B 7/00
`(52) U.S. Cl.
`......................... ..
`128/207.18; 128/206.21;
`128/206.24; 128/207.11; 128/206.28; 128/201.22;
`128/206.26;128/206.18; 128/206.11;128/202.27;
`128/206.27; 128/201.23; 128/201.29
`(58) Field of Classification Search ......... .. 128/207.18,
`128/200.24, DIG. 26, 206.21, 206.24, 207.11,
`128/206.28, 201.22, 206.26, 206.18, 206.11,
`128/202.27, 206.27, 201.23, 201.29
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`8/1942 Kanter et al.
`2,292,568 A *
`........ .. 128/203.28
`
`2,525,236 A * 10/1950 Palmer ...... ..
`128/205.25
`2,617,415 A "‘ 11/1952 Rosen et al.
`......... .. 128/206.28
`
`* cited by examiner
`
`Primary Examiner—Henry Bennett
`Assistant Examiner—Nihir Patel
`
`(74) Attorney, Agent, or Firm—Gilbert J. Andia, Jr.
`
`(57)
`
`ABSTRACT
`
`The present invention is a headgear for noninvasive venti-
`lation interface made up of a nasal carmula including can-
`nula tubing having a given outside diameter, and a headgear
`yoke with ends including tubing retainers. The yoke is
`adapted to extend transversely over a wearer’s head. The
`tubing retainers are C-shaped projections having a given
`length and an inside diameter substantially equal
`to the
`tubing outside diameter. The present
`invention further
`includes a retainer mating element for each of the C-shaped
`tubing retainers to prevent the tubing from kinking near the
`C-shaped tubing retainers. The retainer mating element has
`an elbow section with an open side and a clip section
`connected to the elbow section by a rigid beam having a
`length substantially equal to the C-shaped tubing retainer
`given length, wherein both of the sections have an inside
`diameter substantially equal
`to the tubing given outside
`diameter.
`
`6 Claims, 4 Drawing Sheets
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`
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`RIVID 1037
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`RMD 1037
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`U.S. Patent
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`Feb. 20, 2007
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`Sheet 1 of 4
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`U.S. Patent
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`Feb. 20, 2007
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`U.S. Patent
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`Feb. 20, 2007
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`Sheet 3 of 4
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`Feb. 20, 2007
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`US 7,178,528 B2
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`1
`HEADGEAR FOR NONINVASIVE
`VENTILATION INTERFACE
`
`BACKGROUND OF lHa INVWNTION
`
`(1) Field of the Invention
`The present invention relates to an adjustable, semi-rigid
`headgear for maintaining the proper positioning of a head-
`gear for a noninvasive ventilation interface about a wearer’s
`head and on the wearer’s face. in particular, the present
`invention prevents the kinking of medical gas tubing and
`holds a nasal cannula in proper position as the wearer sleeps
`an(l’or changes their head’s position.
`(2) Description of the Prior Art
`There are certain medical situations in which it is neces-
`sary or desirable to deliver a flow of breathing gas to the
`airway of a patient without intubating the patient or surgi-
`cally inserting a tube in the patient’s trachea. For example,
`a patient might be ventilated using a technique known as
`non—invasive ventilation. Non—invasive ventilation inter-
`faces are also used with patients having a medical disorder
`such as sleep apnea who might require continuous positive
`airway pressure (CPAP) or Bilevel Positive Airway Pressure
`in which positive pressure is maintained during inspiration
`but reduced during expiration, and Intermittent Mechanical
`Positive Pressure Ventilation ir1 which pressure is applied
`when an episode of apnea is sensed.
`Such non-invasive ventilation and pressure support meth-
`odologies involve the placement of a patient non—invasive
`interface device, which is typically a nasal cannula or face
`mask or nasal pillows, on the face of a patient. The patient
`interface device communicates the flow of breathing gas
`from the ventilator or pressure support device with the
`airway of the patient. so that the therapeutic flow of breath-
`ing gas ca11 be delivered from the p1‘€SSl.11‘€/fl0W generating
`device to the airway of the patient. lt is known to maintain
`such interface devices on the face of a wearer by a headgear
`having upper and lower straps, each having opposite ends
`threaded through connecting elements provided on the oppo-
`site sides and, on some, the top of the interface device.
`Because such devices are typically worn for an extended
`period of time. it is important that the headgear maintain the
`device ir1 a tight enough seal against a patient’s face or nose
`without discomfort.
`Persons with medical conditions such as lung disease or
`those recovering from surgery often require supplemental
`oxygen. Usually,
`the supplemental oxygen is delivered
`through medical gas tubing attached to a nasal cannula or
`medical gas mask. Generally, some fastening means is
`needed to properly hold the nasal cannula or medical gas
`mask properly against a wearer‘s face.
`There are problems with typical headgear used with these
`interface devices. Many patients find the harness, headband,
`or other headgear used to keep the mask in position uncom-
`fortable, particularly when sleeping. The headband or har-
`ness must typically maintain the interface device against the
`face or nose of the wearer with some pressure, resulting in
`significant patient discomfort and irritation.
`Examples of prior art fastening means include fabric
`headbands and fabric harnesses that fasten about a wearer’s
`head. US. Pat. No. 6,684,833 to Burns discloses an example
`of the fabric headband type. Burns teaches a nasal carmula
`headband apparatus in which medical gas tubing is attached
`to the outer side of the headband by fasteners that keep the
`ca1n1ula tubing ir1 place relative to the headband and direct
`the cannula tubing behind the wearer’s ears. While this type
`of headband apparatus may be adequate for some patients,
`
`2
`others will no doubt find the headband too uncomfortable for
`long term use because of restriction to blood vessels in their
`forehead region. Moreover, Burns does not teach a means to
`prevent the cannula tubing from kinking caused by the
`wearer's movements. U.S. Pat. No. 6,119,694 to Correa et
`al. discloses a harness type mask as shown in FIG. 2 of the
`disclosure’s drawings. As with Burns, some patients will
`find this type of tubing fastening apparatus to be too restric-
`tive to be comfortable. Moreover, Correa et al does not
`disclose a means to direct medical gas tubing such that it
`does not kink as the wearer changes positions while sleep-
`ing, etc. What
`is needed is a medical
`tubing fastening
`apparatus that does 11ot restrict blood llow in the wearer’s
`forehead, while also providing a means to prevent
`the
`medical gas tubing from kinking as the wearer changes head
`positions.
`fabric or elastic headbands or headgear
`Additionally,
`often become tangled and twisted, and are therefore difficult
`for the user to easily place on the user’s head. Additionally,
`the prior art headgear are often tightened significantly about
`the wearer’s head in order to maintain the interface device
`in proper position. Lastly,
`the prior art headgear causes
`significant difficulty in properly locating the interface device
`on the wearer and requires significant adjustment. Thus,
`what is needed is a headgear that is simpler to place on the
`wearer's head, that does not become twisted or entangled,
`and that requires minimal adjustment for proper placement
`of the interface device.
`
`SUMMARY OF THE TNVFNTION
`
`The present invention is directed to a headgear for non-
`invasive ventilation interface made up of a nasal carmula and
`tubing having a given outside diameter, and a headgear yoke
`with curved ends including tubing retainers. The yoke is
`adapted to extend transversely over a wearer’s head and
`includes side sections with top and bottom ends and a top
`section cormectable to the side section top ends. Preferably,
`the yoke is adjustable in length. For example,
`in one
`embodiment
`the headgear yoke includes spaced index
`notches near the top end of at least one of its side sections
`along with at least one side section receiving slot witl1ir1 the
`yoke top section. The yoke top section also includes at least
`one index notch lock having locking and unlocking positions
`usable to secure or release the at least one indexed side
`section. The sections of the headgear yoke are semi-rigid
`and lightweight. Suitable construction materials for the
`headgear yoke include, but are not limited to metal such as
`aluminum alloy and plastics such as polyvinyl chloride and
`nylon. Preferably, the headgear yoke sections are molded
`from a single type of material, but the yoke section could
`also be made of composite materials. For example, the yoke
`top section can be made from metal and the side sections
`rigid plastic or vice versa. The headgear yoke is semi-rigid
`in that the yoke is flexible and therefore is bendable and
`twistable, but is neither longitudinally elastic nor compress-
`ible.
`The apparatus of the present invention also includes a
`length adjustable strap adapted to extend transversely behind
`the wearer’s head. The strap has ends that are attachable to
`the headgear yoke at locations adjacent opposite sides of the
`wearer’s head when the headgear yoke is extending trans-
`versely over the wearer’s head. The strap has spaced index
`holes near both of the strap ends. The headgear yoke side
`sections include outwardly projecting studs that engage the
`strap’s index holes in order to secure the strap to the
`headgear yoke. In one embodiment, the strap is made from
`
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`US 7,178,528 B2
`
`3
`a tl1in elongated plastic strip. However, the strap ca11 be
`made from any durable flexible material. The studs can be
`mushroom shaped, or any other conventional shape to retain
`the strap to the yoke.
`The tubing retainers are C-shaped outwardly projecting
`clips having a given length and an inside diameter substan-
`tially equal to the tubing outside diameter. It is preferred that
`the C-shaped tubing retainers be integrally formed with the
`yoke side section bottom ends. Therefore, if the yoke side
`sections are molded from a semi-rigid plastic, the C-shaped
`tubing retainers would also be made of the same seini-rigid
`plastic. The yoke side section bottom ends are preferably
`curved so that the C-shaped tubing retainers place the clips
`in a position forward of the wearer’s ears.
`A mating element for each ofthe C-shaped tubing retain-
`ers is included to prevent the tubing from kinking near the
`C-shaped tubing retainers. Each retainer mating element has
`an elbow section witl1 a11 open side and a clip section
`connected to the elbow section by a rigid beam having a
`length substantially equal to the C-shaped retainer given
`length, wherein both of the sections have an inside diameter
`substantially equal to the tubing given outside diameter for
`receiving the tubing’s outside diameter. These retainer inat-
`ing elements are mateable with the C-shaped tubing retain-
`ers to capture and direct the tubing from in back of the
`wearer’s head to along the sides of the wearer’s face
`whenever the headgear yoke is worn extending transversely
`over the wearer’s head. The tubing may be directed behind
`the wearer’s head and downwardly, or behind the wearer’s
`head and upwardly. Alternatively. the tubing may be directed
`downwardly but in front of the wearer’ neck and chest.
`In operation, the length of the headgear yoke is adjusted
`to comfortably fit transversely over a wearer’s head. To
`adjust the length, the notch lock is placed i11 the tuilocking
`position and the notched yoke side section is either moved
`a number of index notches inwardly or outwardly of the at
`least one side section receiving slot until a desired effective
`yoke length is achieved. Once the length of the yoke is
`appropriately adjusted,
`the notch lock is placed in the
`locking position to maintain the desired yoke length. Next
`the tubing of the nasal caimula is placed into the C-shaped
`tubing retainers such that the nasal caimula fits properly on
`the wearer’s face. Then, the retainer mating elements are
`mated with the C-shaped tubing retainers to prevent the
`tubing from kinking near the C-shaped tubing retainers. In
`a first mating configuration, the elbow section ofthe retainer
`elements direct sections of the tubing in a direction that is
`adjacent the wearer’s head and substantially parallel with
`each respective yoke side section. In second mating con-
`figuration. the elbow section of the retainer elements direct
`sections of the tubing in a direction that is adjacent the
`wearer’s neck. The retainer element rigid beam section
`encloses the tubing within the C-shaped tubing retainer, and
`the retainer element clip section fastens over the tubing at
`the end ofthe rigid beam at a location just beyond the lei1gtl1
`of the C-shaped tubing retainer. Once the tubing is captured
`by the C-shaped tubing retainers and retainer element mated
`combination, the headgear yoke is placed transversely over
`the wearer’s head. Next, the length adjustable strap adapted
`to extend transversely behind a wearer’s head is positioned
`such that the index holes near the ends of the strap are
`engaged by the studs projecting from the yoke side sections
`to result in the strap having a desired elfective length. The
`headgear yoke and strap will then hold the nasal caimula in
`place even as the wearer moves, such as movements during
`sleep.
`
`4
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a perspective View of the medical gas delivery
`device with the C -shaped tubing retainers combined with the
`retainer mating elements in the first mating position.
`FIG. 2 is a perspective view of the medical gas delivery
`device with the C-shaped tubing retainers combined the
`retainer mating elements in the second mating position.
`FIG. 3 is a close-up perspective view of the notch lock
`mechanism for adjusting the yoke length of the headgear.
`FIG. 4 is a close-up perspective view of a C-shaped tubing
`retainer.
`FIG. 5 is a perspective view of the retainer mating
`elements.
`
`DETAII I) D ‘SCRIPTION OF THE
`INVENTION
`
`’
`
`In the following description. terms such as horizontal,
`upright, vertical, above, below, beneath and the like are used
`solely for the purpose of clarity in illustrating the invention
`and should not be taken as words of limitation. The drawings
`are for the purpose of illustrating the invention and are not
`intended to be to scale.
`Referring to the drawings and first to FIGS. 1 and 2, a
`headgear for noninvasive ventilation interface 10, comprises
`a nasal caruiula 12 including caruiula tubing 14 having a
`given outside diameter 16; and a headgear yoke 18 with ends
`including carmula tubing retainers 20. In particular, head-
`gear yoke 18 includes a top section 21 and side sections 22
`with lower ends 24. Moreover, headgear yoke 18 includes
`spaced index notches 26 near the top end of at least one of
`its side sections 22 along with at least one side section
`receiving slot 28 within yoke top section 21. The yoke top
`section 21 also includes at least one index notch lock 30
`having an unlocking position 32 shown in FIG. 1. and a
`locking position 34 shown in FIGS. 2 and 3. These positions
`are usable to secure or release the at least one indexed side
`section 22.
`Ileadgear for noninvasive ventilation interface 10, further
`includes a length adjustable strap 36 adapted to extend
`transversely behind the wearer’s head. Strap 36 has ends 38
`attachable to yoke side sections 22 at locations adjacent
`opposite sides of the wearer’s head when headgear yoke 18
`is extending transversely over the wearer’s head. Strap 36
`has spaced index holes 40 near both of ends 38 of strap 36.
`The headgear yoke side sections 22 include outwardly
`projecting studs 44 that engage index holes 40 in order to
`secure strap 36 to headgear yoke 18.
`Cannula tubing retainers 20 are C-shaped outwardly pro-
`jecting clips having a given length 46 and an inside diameter
`48 substantially equal to the tubing outside diameter 16. A
`retainer mating element 50 for each of the C-shaped tubing
`retainers 20 is included to prevent the tubing from kinking
`near C-shaped tubing retainers 20. As best seen in FIG. 4, the
`retainer mating elements 50 have an elbow section 52 with
`an open side 54 and a clip section 56 connected to the elbow
`section 52 by a rigid beam 58 having a length 60 substan-
`tially equal
`to the C-shaped retainer given length 46,
`wherein both elbow section 52 and clip section 56 have an
`inside diameter 62 and 64, respectively that are substantially
`equal to tubing given outside diameter 16.
`In operation, the length of headgear yoke 18 is adjusted to
`comfortably lit transversely over a wearer’s head. To adjust
`the length, notch lock 30 is placed into unlocking position 32
`and notched yoke side section 22 is either moved a number
`of index notches inwardly or outwardly of the at least one
`side section receiving slot 28 until a desired elfective yoke
`length is achieved. Once the length of yoke 18 is appropri-
`ately adjusted, notch lock 30 is placed into locking position
`
`7
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`US 7,178,528 B2
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`5
`34 to maintain the desired yoke ler1gth. Next, the tubing 14
`is placed into the C-shaped clips such that the nasal cannula
`12 [its properly on the wearer’s face. Then,
`the retainer
`mating elements 50 are mated with (7-shaped clips 20 to
`prevent the tubing from kinking near the C-shaped clips.
`Retainer elements 50 and C-shaped clips 20 are shown in
`FIG. 1 in the first mating position. In this position, elbow
`section 52 of retainer elements 50 direct sections of tubing
`14 in a direction that is substantially parallel with yokc side
`sections 22. A retainer element rigid beam section 58
`encloses tubing 14 within C-shaped clip 20, and retainer
`element clip 56 fastens over tubing 14 at the end of rigid
`beam 58 at a location just beyond the length ofC-shaped clip
`20. Once the tubing is captured by C-shaped clips 20 and
`retainer mating element 50, headgear yoke 18 is placed
`transversely over the wearer’s head. Next, length adjustable
`strap 36 is positioned such that index holes 40 near strap
`ends 38 are engaged by studs 44 projecting from yoke side
`sections 22 to result in strap 36 having a desired e ective
`length Headgear yoke 18 and strap 36 will then maintain
`nasal cannula 12 in its proper position even as the wearer
`tosses and turns in their sleep.
`Certain modifications and improvements will occur to
`those skilled in the art upon a reading of the description. lt
`should be understood that all
`such modifications and
`improvements have been deleted herein for the sake of
`conciseness and readability but are witl1ir1 the scope of the
`following claims.
`What is claimed is:
`1. A headgear for maintaining the position of a noninva-
`sive ventilation interface proximate to the nares of a patient
`comprising:
`a) a nasal cannula providing a seal with said nares
`including cannula tubing having a given outside diam-
`eter;
`b) a semi-rigid headgear yoke with a first and second side
`sections, said side sections having lower ends exter1d-
`ing below the ears of said patient, said yoke being
`adapted to extend transversely over a wearer’s head;
`c) cannula tubing retainers on said lower ends adapted for
`connection to said cannula tubing wherein said cannula
`tubing retainers are C-shaped projections having a
`given length and an inside diameter substantially equal
`to said carmula tubing outside diameter, and said pro-
`jections are positioned in front of and below said
`patient’s ears when worn, and
`d) further including a retainer mating element for each of
`said C-shaped rctaincrs to prevent said carmula tubing
`from kinking near said C-shaped retainers, said retainer
`mating element having an elbow section with an open
`side and a clip section connected to said elbow section
`by a rigid beam having a length substantially equal to
`said C-shaped retainer given length, both of said sec-
`tions having an inside diameter substantially equal to
`said tubing given outside diameter.
`2. The headgear for maintaining the position of a nonin-
`vasivc vcntilation interface proximate to the nares of a
`patient of claim 1, wherein said C-shaped retainers and said
`retainer mating elements are mateable to capture and direct
`said cannula tubing to along the sides of the wearer’s face
`whenever said headgear yoke is worn extending transversely
`over the wearer’s head.
`3. A headgear for supporting cannula tubing, and posi-
`tioning a carmula in position to maintain a seal with the nares
`of a patient, said headgear comprising:
`a) a headgear yoke adapted to extend transversely over a
`wearer’s head, said yokc having a top section and first
`and second side sections each having lower ends that
`
`40
`
`6
`when said headgear yoke is wom extend adjacent to
`opposite sides of the wearer’s head;
`b) tubing retainers in the form of C-shaped clips integral
`with said lower ends for retaining and directing said
`cannula tubing to along the sides of the wearer’s face
`and said C-shaped clips are positioned in front of and
`below a patient’s ears when wom; and
`c) further including a retainer mating element for each of
`said C-shaped retainers to prevent said cannula tubing
`from kinking near said C-shaped retainers, said retainer
`mating element having an elbow section with an open
`side and a clip section connected to said elbow section
`by a rigid beam having a le11gth substantially equal to
`said C-shaped retainer given length, both of said sec-
`tions having an inside diameter substantially equal to
`said camiula tubing given outside diameter.
`4. Aheadgear for noninvasive ventilation interface, corn-
`prising:
`a) a nasal carmula including camiula tubing having a
`given outside diameter;
`b) a semi-rigid headgear yoke with a first and second side
`sections, said side sections having lower ends, said
`yoke being adapted to extend fransversely over a
`wearer s head;
`c) C-shaped cannula tubing retainers on said lower ends
`having a given length and an inside diameter substan-
`tially equal to said cannula tubing outside diameter; a11d
`d) a retainer mating element for each of said C-shaped
`retainers to prevent said cannula tubing from kinking
`near said C-shaped retainers, said retainer mating ele-
`ment having an elbow section with an open side and a
`clip section connected to said elbow section by a rigid
`beam having a length substantially equal
`to said
`C-shaped retainer given length, both of said sections
`having an inside diameter substantially equal to said
`tubing given outside diameter.
`5. The headgear for noninvasive ventilation interface of
`claim 4, wherein said C-shaped retainers and said retainer
`mating elements are matcablc to capture and direct said
`carmula tubing to along the sides of the wearer’s face
`whenever said headgear yoke is worr1 extending transversely
`over the wearer’s head.
`
`6. A headgear for supporting carmula tubing, said head-
`gear comprising:
`a) a headgear yoke adapted to extend transversely over a
`wearer’s head, said yoke having a top section and first
`and second side sections each having lower ends that
`when said headgear yoke is wom extend adjacent to
`opposite sides of the wearer’s head;
`b) tubing retainers in the form of C-shaped clips integral
`with said lower ends for retaining and directing said
`cannula tubing to along the sides of the wearer’s face,
`and
`
`c) a retainer mating eler11er1t for each of said C-shaped
`retainers to prevent said cannula tubing from kinking
`near said C-shaped retainers, said retainer mating ele-
`ment having an elbow section with an open side and a
`clip section connected to said elbow section by a rigid
`beam having a length substantially equal
`to said
`C-shaped retainer given length, both of said sections
`having an inside diameter substantially equal to said
`cannula tubing given outside diameter.
`
`8