U.S. patent number 3,877,436 [Application Number 05/331,185] was granted by the patent office on 1975-04-15 for apparatus and method for molding a nasal cannula.
This patent grant is currently assigned to Hudson Oxygen Therapy Sales Co.. Invention is credited to Harold R. Havstad.
United States Patent |
3,877,436 |
Havstad |
April 15, 1975 |
Apparatus and method for molding a nasal cannula
Abstract
A flexible nasal cannula having improved characteristics is
produced in a mold cavity incorporating a forming means comprising
a transverse core having straight upper portion and a lower portion
extending at an angle from the upper portion and a nipple core
portion comprising a pair of rodlike extensions located toward the
upper end of the upper portion and which extend substantially
perpendicular to its axis. In a molding process, the forming means
is maintained in spacial relation within a mold cavity, a
thermoplastic material is flowed within the cavity around the
forming means, cooled sufficiently to set the material and
thereafter the cannula is removed from the forming means.
Inventors: |
Havstad; Harold R. (Lakewood,
CA) |
Assignee: |
Hudson Oxygen Therapy Sales Co.
(Temecula, CA)
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Family
ID: |
26824669 |
Appl.
No.: |
05/331,185 |
Filed: |
February 9, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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126452 |
Mar 22, 1971 |
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Current U.S.
Class: |
604/94.01 |
Current CPC
Class: |
B29C
37/0014 (20130101); B29C 45/26 (20130101); A61M
16/0666 (20130101); B29C 33/76 (20130101); A61M
2210/0618 (20130101) |
Current International
Class: |
B29C
33/76 (20060101); B29C 37/00 (20060101); B29C
45/26 (20060101); A61M 16/06 (20060101); A61m
025/00 () |
Field of
Search: |
;128/206,198,348
;264/318 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Seiler; Jerry R.
Parent Case Text
This is a division of application Ser. No. 126,452, filed Mar. 22,
1971.
Claims
I claim:
1. A molded device for forming a nasal cannula comprising:
an elongated hollow tubular body
b. a pair of hollow nasal tips extending from said tubular body;
and
c. a lipped slot extending along a portion of said tubular body
adapted to be sealed and removed to form the cannula.
2. A device of claim 1 wherein said lipped slot is located along
said tubular body opposite said nasal tips.
3. A device of claim 2 including a pair of flattened ends each
attached to opposite ends of said tubular body.
4. A device of claim 1 wherein said tubular body comprises an
elongated main tube portion and a hollow angled inlet tube
extending at an angle from said main tube portion.
Description
BACKGROUND OF THE INVENTION
More recently nasal cannula devices have become very important as a
means of administering oxygen to patients. Such devices are known
to incorporate a flexible plastic tube which is placed on the
patient's upper lip and maintained in such a position by an elastic
strap or other retention means extending around the patient's head
and attached to the ends of the plastic tube. Such a device also
incorporates a pair of extensions, usually referred to as nasal
tips which are hollow and join the plastic tube. The nasal tips
extend into the patient's nares or nasal passages while oxygen
containing theraputic gases introduced from a supply tube flows
into the main tube of the cannula, through the nasal tips and
directly into the patient's nasal cavity and pharynx.
Various features have been incorporated into the cannula devices in
an effort to improve their efficiency as well as patient comfort.
Examples of improved design characteristics include nasal tips
curved to conform to the contour of the nares, flattened surface
and/or ends which lie against the patient's upper lip and cheek
respectively. Such features provide greater patient comfort and
maintain the cannula properly on the patient so that the nasal tip
will not slip out of the nares.
In certain of the cannula devices presently in use the oxygen
supply tube is attached directly to the main tube of the cannula in
such a manner that the main tube and the supply tube lie along the
same axis at the point of attachment. Such a feature is similar to
that shown in U.S. Pat. No. 2,735,432. The major disadvantage of
such a construction is that during use, the oxygen supply tube may
become twisted which, in turn, causes the main tube of the cannula
to rotate. Such rotation in one direction causes the nasal tips to
be forced toward the patient's nares. If the rotation is extensive,
discomfort to the patient may result due to pressure caused by the
tips at the patient's nostrils or in the nares. Excessive twist may
even cause collapse or folding of the tips to reduce or cut off
oxygen flow. Rotation in the other direction will pull the nasal
tips out of the patient's nostrils whereby effective oxygen therapy
is eliminated. It will be appreciated by those skilled in the art
that in the latter instance, if the patient is unconscious or
otherwise disabled to the extent of not being able to again insert
the nasal tips into his nostrils, where a constant or necessary
oxygen supply to the patient is absent, further injury could
insue.
In order to eliminate cannula rotation caused by twisting of the
oxygen supply tube, certain cannula devices have been improved by
incorporating hollow angled inlet tube which joins and extends from
the main cannula tube and to which inlet tube an oxygen supply tube
is attached. Such a feature is illustrated in U.S. Pat. No.
2,868,199. The use of an angled inlet tube, greatly reduces any
rotational movement of the cannula device otherwise caused by the
twisting of the oxygen supply tube. This feature will be
appreciated since any rotation or twisting of the oxygen supply
tube will only tend to rotate the angled inlet tube but will not be
passed on to the main tube of the cannula which does not lie along
the axis of either the oxygen supply tube or the angled inlet tube.
Thus, the force of a twisted oxygen supply tube substantially
terminates at the angled inlet tube portion of the cannula.
In molding a nasal cannula of the type described above, it has been
the practice to use a plurality of forming means referred to as
cores at least one of which is retractable. Thus, separate cores
are used in forming the tubular body portion of the cannula and the
tube-like hollow nasal tips. Again, these cores are maintained in
spacial relationship to the mold cavity within the closed mold
while a thermoplastic material is injected into the cavity and
around the cores. Thereafter, as the mold is opened, the cores
around which the tubular body portion or the hollow nasal tips are
formed are retracted leaaving the cannula remaining on the
unretracted core. The mold operator then peels the cannula from the
core.
In producing a cannula having a tubular main body portion and
hollow nasal tips without an angled inlet tube portion only two
forming cores are required. The core about which the tubular main
body is formed is referred to as a transverse core. The cores used
to form the hollow nasal tips are nipple cores. In the mold
apparatus the transverse and nipple cores are brought together in
an attempt to simulate a unitary or integral core at the phase
during the molding process in which the material is injected into
the mold cavity and around the cores. Thus, the nipple cores
comprising two spaced rods will meet and contact the transverse
core so that when the injected material flows around these cores
the hollow nasal extensions and hollow main tube will join.
It will be appreciated that in attempting to produce a cannula in
which the interior passageways for the flow of oxygen or other
gases is to be unobstructed, i.e., flow along the main tube and
through the nasal tips, the respective cores must be carefully
machined so that no spaces are present between the nipple core and
transverse core at the junction area. However, as the mold is used
these cores become worn at the interfaces and common points of
contact. This wear due to friction and abrasion, results in small
spacial areas being formed which in turn, allows for the jected
material to flow in these small spaces. This material which remains
on the finished molded device is referred to as flash. Further,
small diameter cores are sometimes deflected by the flowing
thermoplastic producing a deformed product, uneven interior and
exterior surfaces and flash.
On the exterior of the cannula, flash can be trimmed to improve the
appearance of the product. On the other hand, where flash occurs on
the interior of the cannula and especially in the tubular or hollow
passageways, cannula performance can be significantly altered.
Especially troublesome is flash located at the areas where the
nasal tips join the main tube. It will be appreciated that
significant amounts of flash at those areas will cause restriction
in the interior gas passageway and may greatly reduce the amount of
gas passing into either or both of the nasal tips and possibly shut
them off altogether. Accordingly, the avoidance of flash at the
interior joinder areas of the hollow nasal tips and main cannula
tube will be appreciated as will the disadvantage of using separate
nipple and transverse cores.
In a well known and extensively used cannula device prepared by an
injection molding process, an angled inlet tube is present adjacent
one end of main cannula tube with the hollow interiors of cannula
body portions communicaating as previously described. In producing
such a device four separate cores are used: two nipple cores for
forming the two hollow nasal tips, a transverse core for forming
the hollow main tube and an angle core for forming the angled inlet
tube. Thus, a further problem of flash on the interior of the
cannula device is caused where the angled inlet tube communicates
with the main cannula tube, thereby presenting the same problems of
possible stoppage or interruption of gaseous flow from the angled
inlet tube into the main cannula tube as above noted for the nasal
tips. Further, since the transverse core used is substantially a
straight rod, the main tube of the cannula has an open end when
initially formed which must be plugged so that only the nasal tips
and angled inlet tube are opened to the exterior of the cannula
device. The plugging of this opening is usually accomplished by
hand and obviously requires additional time and effort to complete
the device which concomitantly increases production costs.
SUMMARY OF THE INVENTION
In the cannula molding process of the present invention a unitary
core is utilized having an angle core portion, an axial transverse
core portion and a nipple core portion each of which portions are
integral with and a part of the single unitary forming core. In the
injection molding process the unitary core is maintained in spacial
relationship with the mold cavity, material is injected into the
cavity around the core, the mold is opened and the cannula device
is removed from the core. since the core is unitary in
construction, no separate cores are used thereby eliminating flash
on the interior of the molded cannula device. The device is removed
from the core and a lipped slot formed at the bridge where the core
is attached to a core support is closed by a radio frequency
welding process. The unique forming means or core described herein,
in addition to eliminating interior flash, produces a cannula
having hollow nasal tips, a hollow main tube and a hollow angled
inlet tube. The device has no other tube openings which must be
plugged as previously described except for the lipped slot which is
sealed and the lips removed. A further embodiment of the invention
utilizing multiple cores will be more fully described
hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a cannula forming core of the present
invention;
FIG. 2 shows cannula forming cores of the type previously used;
FIG. 3 illustrates a cannula device prepared according to the
present invention; and
FIG. 4 illustrates a plurality of forming cores as shown in FIG. 1
on a molding rack according to the invention.
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIG. 1, a forming core shown generally as 10 has an
upper portion 12, an angle portion 18 and nipple portions 14 and
15. These portions are integral thus comprising the unitary forming
core 10. The nipple portions 14 and 15 are separated rod-like
extensions, one located at or near the upper end 17 of the upper
portion 12, and the other somewhat lower.
The nipple portions 14 and 15 are spaced apart and etend
substantially perpendicular from the axis of the upper portion 2.
These nipple core portions 14 and 15 in cooperation with the mold
cavity form the nasal tips of the cannula during the molding
process. Accordingly, the distance between nasal tips desired for
the cannula to be produced are dependent on the distance between
the portioons 14 and 15. The nipple core portions 14 and 15 may be
substantially straight or curved where curved nasal tips are
desired. The length of these nipple portions 14 and 15 may also be
varied depending on the intended length of the nasal tips of the
cannula.
The angle portion 18 extends directly from the upper portion 12 at
the joinder area 19 of the upper portion 12 opposite the end 17.
The angle at which the angle portion 18 extends from the upper
portion 12 may be varied depending on the angle desired for the
angled inlet tube of the cannula produced. Generally, angles
between about 20 and about 80.degree. are suitable with those
between about 30 and about 45.degree. preferred. The length of the
angle portion 18 will also depend on the desired length of the
angled inlet tube.
The core 10 is attached to a core support, not shown, by bridge
member 54 which is preferably flat and extends along a side of the
upper portion 12. The location of the bridge member 54 is shown as
extending from the end 17 of the upper partion to somewhat below
lower nipple core portion 14, and opposite the nipple core portions
14 and 15. The length of the bridge 54 is important since if it
does not extend beyond the lower nasal core portion 14 the cannula
can not be easily removed from the core, as will be more fully
explained hereinafter.
The location of the bridge 54 along the upper core portion 12 and
relative to the nipple core portions 14 and 15 may be varied
somewhat depending on the mold cavity and the length of the nipple
core portions 14 and 15. Again, as shown, the bridge 54 is
preferably opposite the nipple core portions 14 and 15. In that
location, as the cannula is removed from the forming core 10, the
nipple core portions 14 and 15 can directly exit through a lipped
slot of the cannula formed by the bridge 54. However, the bridge 54
may join the upper portion 12 closer to the joinder are as of the
npple cores 14 and 15 with the upper portion 12 other than as shown
in FIG. 1.
The shape of the various core portions 12, 14, 15 and 18 are
preferably circular in cross-section thus forming a tubular hollow
cannula interior. However, other cross-sectional shapes may be used
such as rectangular, hexagonal, ellipsoidal and the like.
Referring to FIG. 2 which illustrates a state of the art forming
means and by way of distinguishing the unitary forming core of the
invention shown in FIG. 1 therefrom, separate transverse core 20,
nipple cores 24 and 25 and angle core 22 are shown. The nipple
cores 24 and 25 comprise rodlike extensions around which hollow
nasal tips of a cannula are formed in a previously used mold
apparatus. The transverse core 20 forms the hollow main tube
portions of a cannula while the angle care 22 forms the hollow
angled inlet tube of the cannula.
In a cannula molding process using a state of the art core assembly
as shown in FIG. 2, the individual cores 22 and 26 are maintained
in spacial relationship within a hollow cannula mold as
thermoplastic material is injected into the mold cavity. Just prior
to material injection, the end of the angle core 22 is brought into
contact with the side of the transverse core 20. Similarly, the
rod-like nipple core extensions 24 and 25 contact the side of the
transverse core 20. Each of the cores 20, 22, 24 and 25 are
attached to separate core supports and core slides, not shown. When
the cores are brought into position, the fluid thermoplastic is
injected into the mold cavity and around the separate cores. The
thermoplastic is cured and the mold is opened. During the mold
opening stroke, the transverse core 20 is retracted by an air
cylinder or other retracting means, the angle core 22 is then
retracted, and the nipple cores are brought forward from the
parting plane or part line of the mold halves. The cannula which is
attached to the nipple cores is then peeled off.
The core of the present invention shown in FIG. 1 eliminates the
requirement of separate forming cores shown in FIG. 2 thereby
simplifying the molding apparatus since only a single unitary core
is used. However, even more important is the elimination of
internal flash in a cannula produced by the core of the invention
as previously explained. Thus, by eliminating the assembly of
separate cores 20, 22, 24 and 25 which must contact in order to
form the hollow interior of a cannula, flash occurring around the
areas of contact of the individual cores is avoided, thereby
producing a superior cannula.
A cannula prepared by the use of the forming core of the invention
is illustrated in FIG. 3. The cannula 30 includes a hollow main
tube portion 32, hollow angled inlet tube 36 joining and extending
at an angle from the main tube 32, and hollow nasal tips 34 and 35
extending substantially perpendicular from the axis of the main
tube 32. The hollow interior of the main tube 32 communicates with
the hollow interior of tips 34 and 35 and angled inlet tube 36.
An elongated portion 40, also part of the cannula body, terminates
in a flattened end 39 while a similar flattened end 38 joins the
exterior wall of angled inlet tube 36 where the latter joins the
main tube 32. It will be noted that the elongated portion 40 and
flattened ends 38 and 39 lie generally along the axis of main tube
32. Each of these flattened ends 38 and 39 are for the purpose of
maintaining the cannula in a fixed and comfortable position on a
patient with the aid of an adjustable elastic strap, not shown,
secured through openings 44 and 45 on the respective flattened
ends.
Referring to both FIG. 3 and 4 the unitary forming core 10 (FIG. 4)
is attached to a core support 52 by a bridge 54, which bridge in
cooperation with the mold cavity forms a lipped slot 48 having a
lip 42. This slot 48 is simply an elongated opening which enables
the removal of the cannula from the forming core. When the mold
halves are separated leaving the cannula formed on the unitary
core, the cannula 30 is peeled from the core 10 by pulling the
cannula in the area of the nasal tips 34 and 35 away from nipple
core portions 14 and 15. Accordingly, the nipple core portions 14
and 15 are pulled through the slot 43 and parting lip 42. Once the
nipple core portions 14 and 15 clear the lip 42 the cannula is
pulled downward off of core portions 12 and 18 respectively.
Thereafter, the lip 42 of the cannula is removed by sealing means
which both cuts the lip 42 from the cannula body and seals the slot
along seam 43 shown in FIG. 3. If necessary, any exterior flash may
be trimmed from the cannula body. A strap is threaded through
openings 44 and 45 of the flattened ends 38 and 39 and the cannula
is ready for use.
It will be evident that the length of bridge 54 and in turn the
lipped slot 48 should be sufficient to permit easy removal of the
cannula from the core without exceeding the elastic limits of the
thermoplastic material. In otherwords, the lipped slot 48 should
permit withdrawal of the nipple core portions 14 and 15
therethrough without unduly stretching the cannula.
FIG. 4 illustrates a further embodiment of the invention utilizing
a plurality of forming cores 10 shown in FIG. 1. The individual
unitary forming cores 10 are attached to a removable rack device
50. The rack 50 comprises a primary rod 56 along which extend
substantially evenly spaced core support rods 52. Attached along
one side of each core support rod 52 is a bridge 54 to which is
attached the forming core 10. Such a bridge is preferably flat, and
relatively thin. It is the presence of the bridge 54 which causes
formation of the lipped slot 48 on the cannula as shown in FIG. 3
and previously described. Pins 58 fit into recesses on a mold
apparatus and hold the rack 50 inproper position or alignment until
the mold is closed prior to injection of thermoplastic
material.
The rack 50 is itself of unitary construction. Its advantage is not
only to enable the simultaneous formation of a plurality of molded
cannula devices but generally permits improved efficiency in a mold
operation. For example, such a rack is removable from the cannula
mold by simply disengaging the pins 58 from cooperating mold
recesses. This may be done by hand or automatically during the
phase when mold halves are opened or opening. Thus, an operator may
then peel off the cannulae outside of the mold apparatus which is
advantageous from both a convenience standpoint as well as for
safety. Where two of such racks are used, a single operator can
remove and inspect cannulae while the other rack is engaged in the
molding operation. Thus, speed is also facilitated in such an
operation.
Although the rack of FIG. 4 engages four forming cores any number
may be used depending on the construction of the mold apparatus and
the capacity of the machine used in the molding operation. Thus,
the invention is not limited to the specific device shown but may
incorporate fewer or more forming cores. Similarly, the rack may
incorporate equivalent features other than those specifically shown
to achieve substantially the same results.
A variety of thermoplastic materials may be used in forming a
cannula according to the invention although polyvinyl chloride and
polyvinyl acetate are usually preferred. These as well as
alternative embodiments within the purview of the invention will be
evident to those skilled in the art.
* * * * *