U.S. patent application number 17/060707 was filed with the patent office on 2021-01-21 for conduit and method of forming.
The applicant listed for this patent is Fisher & Paykel Healthcare Limited. Invention is credited to Nathan Lee Gray, Blair Victor Skelton, Daniel John Smith.
Application Number | 20210016043 17/060707 |
Document ID | / |
Family ID | 1000005121279 |
Filed Date | 2021-01-21 |
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United States Patent
Application |
20210016043 |
Kind Code |
A1 |
Smith; Daniel John ; et
al. |
January 21, 2021 |
CONDUIT AND METHOD OF FORMING
Abstract
A thin ribbon spirally wound polymer conduit and method of
forming, wherein a helical reinforcing bead is interposed adjacent
overlapping layers of ribbon. Further, a method of continuously
forming spirally wound conduit wherein a sacrificial layer,
preferably having a different base polymer to that of the conduit,
is first applied to the former before the conduit is formed
overtop.
Inventors: |
Smith; Daniel John;
(Auckland, NZ) ; Gray; Nathan Lee; (Auckland,
NZ) ; Skelton; Blair Victor; (Pukekohe, NZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fisher & Paykel Healthcare Limited |
Auckland |
|
NZ |
|
|
Family ID: |
1000005121279 |
Appl. No.: |
17/060707 |
Filed: |
October 1, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15634934 |
Jun 27, 2017 |
10828456 |
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17060707 |
|
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|
14614209 |
Feb 4, 2015 |
9717874 |
|
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15634934 |
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|
11862875 |
Sep 27, 2007 |
8980036 |
|
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14614209 |
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10656574 |
Sep 5, 2003 |
7291240 |
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11862875 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0875 20130101;
B29C 66/83413 20130101; B29C 48/151 20190201; B29C 53/582 20130101;
B32B 37/1284 20130101; Y10T 156/19 20150115; B32B 2037/268
20130101; Y10T 156/1944 20150115; B29C 48/09 20190201; B29C 66/431
20130101; B29C 66/71 20130101; B29C 48/001 20190201; B29C 63/065
20130101; B29C 66/49 20130101; B29C 66/135 20130101; B29L 2023/007
20130101; B29L 2023/18 20130101; A61M 2207/00 20130101; B29C
66/4329 20130101; B29C 48/10 20190201; B29C 48/19 20190201; B29C
66/83415 20130101; B32B 37/142 20130101; B29C 48/0021 20190201;
B29C 66/723 20130101; F16L 9/16 20130101; Y10T 156/1132 20150115;
A61M 11/08 20130101; F16L 11/24 20130101; B29C 63/0013 20130101;
B29C 65/18 20130101; B29C 63/0073 20130101; B29C 66/4322 20130101;
B29C 66/81457 20130101; B32B 38/10 20130101; F16L 11/115 20130101;
B29C 66/112 20130101; B29C 65/40 20130101; B29C 53/36 20130101;
Y10T 428/139 20150115; A61M 16/08 20130101; B29C 59/007 20130101;
B29C 53/60 20130101; B29C 2053/365 20130101; B32B 2535/00 20130101;
Y10T 156/11 20150115; B29C 48/13 20190201; B29C 66/496 20130101;
B32B 37/26 20130101; B29C 53/607 20130101; B29C 66/1122
20130101 |
International
Class: |
A61M 16/08 20060101
A61M016/08; B29C 48/10 20060101 B29C048/10; B29C 48/13 20060101
B29C048/13; B29C 48/00 20060101 B29C048/00; B29C 48/151 20060101
B29C048/151; A61M 11/08 20060101 A61M011/08; B29C 53/36 20060101
B29C053/36; B29C 53/58 20060101 B29C053/58; B29C 53/60 20060101
B29C053/60; B29C 63/00 20060101 B29C063/00; B29C 65/40 20060101
B29C065/40; B29C 65/00 20060101 B29C065/00; F16L 9/16 20060101
F16L009/16; F16L 11/24 20060101 F16L011/24; F16L 11/115 20060101
F16L011/115; B32B 37/12 20060101 B32B037/12; B32B 37/14 20060101
B32B037/14; B32B 38/10 20060101 B32B038/10; B29C 63/06 20060101
B29C063/06; B32B 37/26 20060101 B32B037/26 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 9, 2002 |
NZ |
521274 |
Sep 11, 2002 |
NZ |
521364 |
Claims
1. A method of continuously forming conduit comprising:
continuously applying at least one thin film ribbon, each having
"leading" and "trailing" lateral edges, spirally around a former
rotating and advancing said conduit, with the leading edge of each
turn of ribbon overlapping the trailing edge of a previous turn of
ribbon on the former and the trailing edge of each turn under
lapping the leading edge of a succeeding turn, while, in advance of
said overlapping of said turns, applying a bead of molten plastic,
having "leading" and "trailing" edges, adjacent the exposed
trailing edge of the most recently applied turn on said former,
such that said bead is interposed between the overlapping and under
lapping portions, said bead when cooled forming a helical
reinforcing bead, and wherein said overlapping portion is supple,
at least laterally, and conforms around the contour of said molten
bead as it is applied thereto, such that said overlapping portion
continuously contacts said bead and bonds along said conforming
portion; and said overlapping portion of said ribbon meets or
substantially meets said trailing edge of said under lapping
portion of said ribbon, at the trailing edge of said bead.
2. A method of continuously forming conduit as claimed in claim 1,
wherein said conduit is reinforced against crushing, and said
reinforcement consists of said polymer bead.
3. A method of continuously forming conduit as claimed in claim 2,
wherein said leading edge of said over lapping ribbon meets or
substantially meets said under lapping ribbon at the leading edge
of said bead.
4. A method of continuously forming conduit as claimed in claim 2,
wherein said method further comprises the steps of, applying one or
more heating wires to the exposed trailing edge of the ribbon prior
to applying the bead, such that the bead encapsulates the said one
or more heating wires onto the said trailing edge.
5. A method of continuously forming conduit as claimed in claim 1,
wherein said leading edge of said over lapping ribbon meets or
substantially meets said under lapping ribbon at the leading edge
of said bead.
6. A method of continuously forming conduit as claimed in claim 1,
wherein said thin film ribbon has a thickness of less than 50
microns.
7. A method of continuously forming conduit as claimed in claim 1,
wherein said ribbon is a breathable plastic material.
8. A method of continuously forming conduit as claimed in claim 7,
wherein said ribbon is a laminate where a layer of breathable
plastic material is laminated to a reinforcing layer which also
allows the passage of water vapour.
9. A method of continuously forming conduit as claimed in claim 1,
wherein said method further comprises the steps of, applying one or
more heating wires to the exposed trailing edge of the ribbon prior
to applying the bead, such that the bead encapsulates the said one
or more heating wires onto the said trailing edge.
10. A method of continuously forming conduit as claimed in claim 1,
where the former includes a plurality of rotating rods spaced about
an axis and acting to support and advance the conduit during
forming, further comprising: first applying a sacrificial layer of
thin plastic directly around said former, before said conduit is
formed on said former over top of said sacrificial layer, and
subsequent to forming said conduit, removing said sacrificial layer
from inside said thin walled conduit after cooling.
11. A method of continuously forming conduit as claimed in claim
10, wherein said sacrificial layer is a thin ribbon having
"leading" and "trailing" lateral edges, and said sacrificial layer
is spirally wound around said former in a continuous fashion, with
the leading edge of each turn of said sacrificial layer overlapping
the trailing edge of a previous turn of said sacrificial layer on
the former and the trailing edge of each turn under lapping the
leading edge of a succeeding turn.
12. A method of continuously forming conduit as claimed in claim
10, wherein said sacrificial layer is of a material having a
different base polymer than that of said conduit, such that no
substantial adhesion occurs when adjacent layers of said
sacrificial layer and said conduit are heated.
Description
[0001] This patent application is a continuation of U.S. patent
application Ser. No. 10/656,574, filed Sep. 5, 2003 and entitled
"Conduit and Method of Forming", which claims priority from New
Zealand Patent Application No. 521274, filed Sep. 9, 2002 and New
Zealand Patent Application No. 521364, filed Sep. 11, 2002 which
disclosures are hereby incorporated by reference.
BACKGROUND TO THE INVENTION
1. Field of the Invention
[0002] The present invention relates to components for breathing
circuits and in particular to conduits for use in the limbs of
breathing circuits. The invention also relates to methods of
manufacturing such conduits.
2. Summary of the Prior Art
[0003] In assisted breathing, particularly in medical applications,
gases are supplied and returned through conduits. Such conduits are
ideally light and flexible to achieve the highest possible level of
comfort for the patient. In the prior art, thin walled conduits are
known which include helical or annular reinforcing ribs which act
to give the conduit better resistance to crushing and pinching,
while still allowing the conduit to be light and flexible. A cross
section of the wall of an example of such a conduit is shown in
FIG. 1.
[0004] It is advantageous to manufacture this type of conduit as a
continuous process. In the prior art this is achieved by the spiral
winding of a thin polymer tape (ribbon or film) onto a former such
that the edges of adjacent layers overlap a small amount. A bead of
molten polymer is then applied over top the overlapping edges
welding them together and simultaneously forming the helical
reinforcing ribs. A disadvantage with this forming technique is the
difficulty welding several adjacent layers. This problem is
especially severe when multiple layer conduit walls are to be
formed. While combining the application of a molten bead with
another secondary thermal welding process or applying the polymer
to the former as a still molten plastic does go some way to
alleviating this difficulty, these solutions add complexity to the
tube former and may be difficult to achieve with very thin
walls.
SUMMARY OF THE INVENTION
[0005] The present invention provides a conduit, with particular
application to the limbs of a breathing circuit, which will at
least go some way towards improving on the above or which will at
least provide the public and the medical profession with a useful
choice, and/or to provide a method of manufacturing conduit which
will at least go some way towards providing the public and
manufacturers with a useful choice.
[0006] In a first aspect the invention may broadly be said to
consist in a method of continuously forming conduit comprising:
[0007] continuously applying at least one thin film ribbon, each
having "leading" and "trailing" lateral edges, spirally around a
former rotating and advancing said conduit, with the leading edge
of each turn of ribbon overlapping the trailing edge of a previous
turn of ribbon on the former and the trailing edge of each turn
under lapping the leading edge of a succeeding turn, while,
[0008] in advance of said overlapping of said turns, applying a
bead of molten plastic, having "leading" and "trailing" edges,
adjacent the exposed trailing edge of the most recently applied
turn on said former, such that said bead is interposed between the
overlapping and under lapping portions, said bead when cooled
forming a helical reinforcing bead, and wherein
[0009] said overlapping portion is supple, at least laterally, and
conforms around the contour of said molten bead as it is applied
thereto, such that said overlapping portion continuously contacts
said bead and bonds along said conforming portion; and said
overlapping portion of said ribbon meets or substantially meets
said trailing edge of said under lapping portion of said ribbon, at
the trailing edge of said bead.
[0010] Preferably said leading edge of said over lapping ribbon
meets or substantially meets said under lapping ribbon at the
leading edge of said bead.
[0011] Preferably said conduit is reinforced against crushing, and
said reinforcement consists of said polymer bead.
[0012] Preferably said ribbon is a breathable plastic material.
[0013] Preferably said ribbon is a laminate where a layer of
breathable plastic material is laminated to a reinforcing layer
which also allows the passage of water vapour.
[0014] Preferably said thin film ribbon has a thickness of less
than 50 microns.
[0015] Preferably said method further comprises the steps of,
[0016] applying one or more heating wires to the exposed trailing
edge of the ribbon prior to applying the bead, such that the bead
encapsulates the said one or more heating wires onto the said
trailing edge.
[0017] Preferably the former includes a plurality of rotating rods
spaced about an axis and acting to support and advance the conduit
during forming, further comprising:
[0018] first applying a sacrificial layer of thin plastic directly
around said former, before said conduit is formed on said former
over top of said sacrificial layer, and
[0019] subsequent to forming said conduit, removing said
sacrificial layer from inside said thin walled conduit after
cooling.
[0020] Preferably said sacrificial layer is a thin ribbon having
"leading" and "trailing" lateral edges, and said sacrificial layer
is spirally wound around said former in a continuous fashion, with
the leading edge of each turn of said sacrificial layer overlapping
the trailing edge of a previous turn of said sacrificial layer on
the former and the trailing edge of each turn under lapping the
leading edge of a succeeding turn.
[0021] Preferably said sacrificial layer is of a material having a
different base polymer than that of said conduit, such that no
substantial adhesion occurs when adjacent layers of said
sacrificial layer and said conduit are heated.
[0022] To those skilled in the art to which the invention relates,
many changes in construction and widely differing embodiments and
applications of the invention will suggest themselves without
departing from the scope of the invention as defined in the
appended claims. The disclosures and the descriptions herein are
purely illustrative and are not intended to be in any sense
limiting.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 is a cross sectional side elevation of a wall of a
conduit according to an embodiment of the prior art.
[0024] FIG. 2 is a cross sectional elevation of a wall of a conduit
according to one embodiment of the present invention.
[0025] FIG. 3 is a plan view of a conduit forming device for
forming a reinforced conduit according to a further embodiment of
the present invention, such as the conduit pictured in FIG. 2.
[0026] FIG. 4 is a cross sectional elevation of a conduit wall
showing a rough inner surface resulting from the tape not
completely following the contour of the molten bead.
[0027] FIG. 5 is a side elevation of a conduit according to a
further embodiment of the present invention including outer axial
reinforcing threads.
[0028] FIG. 6 is a plan view of a conduit forming device for
forming a reinforced conduit according to an embodiment of the
present invention, such as the conduit pictured in FIG. 5.
[0029] FIG. 7 is a cross sectional side elevation of a conduit wall
according to a further embodiment of the present invention
including a pair of heater wires within the conduit wall.
[0030] FIG. 8 is a plan view of a conduit forming device for
forming the conduit pictured in FIG. 7.
[0031] FIG. 9a is a cross section of a tape or ribbon illustrating
the assembly of a pre-formed tape including a pair of heater wires
according to a further embodiment of the present invention.
[0032] FIG. 9b is a cross section view of the pre-formed ribbon of
FIG. 9a, shown assembled.
[0033] FIG. 10 is a cross section view of a conduit wall including
a pair of heater wires formed from the pre-formed ribbon shown in
FIG. 9b.
[0034] FIG. 11 is a cross sectional elevation of a conduit wall
showing a defect caused by the bead flowing between overlapping
adjacent layers.
[0035] FIG. 12 is a plan view of an apparatus for removing the
sacrificial layer.
[0036] FIG. 13 is a plan view of the apparatus of FIG. 12, shown
with a conduit overtop.
DETAILED DESCRIPTION
[0037] The present invention relates to breathing conduits in
general and in particular to improved methods of forming thin film
(tape or ribbon) spiral wound conduits. Consequently the present
invention finds application in breathing conduits fabricated from a
variety of materials which may include breathable and/or
non-breathable materials (breathable materials being capable of
transmitting water vapour but not liquid water).
[0038] In assisted breathing, particularly in medical applications,
gases having high levels of relative humidity are supplied and
returned through conduits of a relatively restricted size. Build up
of condensation on the inside wall of the conduit is a potential
result of this high humidity. The purpose of including a breathable
region or regions in the conduit wall is to allow diffusion of
water vapour from the expiratory limb of the breathing circuit
along the path thereof. This can reduce the build up of
condensation within the expiratory limb by drying the humidified
gases during their flow through the expiratory limb. This
furthermore reduces the humidity of the gases arriving at ancillary
equipment, such as filters, ventilators and the like, reducing the
risk of condensation accumulation, thereby improving their
operation, or alleviating potential detrimental effects.
[0039] The preferred breathable material is a hydrophilic polyester
formed into a homogeneous flat film or ribbon. This material has
been found particularly suited to thin film productions having a
wall thickness of less than approximately 50 microns, and therefore
find particular suitability in the manufacturing methods of the
present invention. It will be appreciated that other breathable
materials may also be suitable for forming breathable conduits.
Such breathable materials may be breathable due to their
composition, physical structure or a combination thereof.
[0040] The following embodiments will be described with particular
reference to breathable thin film wall construction from materials
such as those referred to above. It will be appreciated however,
that in the following described embodiments the material used to
form the conduit walls may be either breathable or non-breathable
and may also include combinations of both breathable and
non-breathable materials. It will be also appreciated for the
following described embodiments that the film(s) supplied to the
former may be supplied either as a preformed flat ribbon wound onto
a reel or may alternatively be supplied directly to the former from
an extruder. Each of these options may have associated advantages
and disadvantages which will be discussed later. It will also be
appreciated by those skilled in the art that the materials supplied
to the former may require a number of guides tensioners and/or
rollers in order to position the materials accurately and provide
the necessary tension.
[0041] As a corollary of material cost it is preferred that the
conduit wall be manufactured to have a relatively low wall
thickness, so much so that the conduit wall membrane may be
insufficiently sturdy to be self supporting. Spiral or helical
reinforcing members are therefore provided as part of the tubular
membrane to provide support. The helical or spiral supporting
members (beads) are formed from polymer materials and may be of the
same material used in the wall of the conduit or any other
compatible plastics material.
[0042] Referring to FIG. 1, the lay-up arrangement of a flexible
breathing conduit known in the art is shown. Referring to FIG. 2, a
breathing circuit limb wall cross section is shown with a thin film
flexible wall. The thin film or ribbon is arranged in a spiral or
helix such that the edge portions 45, 46 of adjacent layers overlap
and form the wall of a tube. Interposed the overlapping edges 45,
46 of adjacent winds of ribbon, is a bead of polymer material
bonded with the overlapping portions of ribbon sealing the joint
between windings and forming a continuous tube. The seam is formed
between the edge of a first layer of film and the edge of a second,
adjacent layer of film which is laid over top of the polymer bead
while the bead is molten. The overlapping layer of film because it
is so thin, closely follows the contour of the bead and results in
a smooth inner conduit wall. It is desirable for the ribbon to be
sufficiently supple at least laterally, to conform along its
overlapping portion to the contour of the bead, so that the
overlapping ribbon may meet or substantially meet the under lapping
ribbon at the edge of the bead.
[0043] The accompanying figures show small gaps or spaces between
the reinforcing bead and the overlapping portion of ribbon. It is
to be understood that these spaces are present for illustration
purposes only, in order to differentiate the bead from the
overlapping layer in the diagrams. In practice the overlapping
layer conforms to the bead and bonds, without forming large gaps or
bubbles.
[0044] An example of continuous forming apparatus suitable for
manufacturing the breathing tube according to a first embodiment of
the present invention described in FIG. 2 is shown in FIG. 3. The
apparatus includes a former 1 preferably of a known type including
a plurality of rotating rods arranged around a central support rod.
The rods extend from and are rotated by a gearbox within a machine
stock 2. At least in the tube forming region the rotating rods
follow a helical path. The pitch angle of the rods relative to the
support rod controls the pitch angle of the tube being formed. An
example of such a machine is a spiral pipeline mandrel available
from OLMAS SRL of Italy.
[0045] Tube being formed on the former is rotated and advanced in
the direction of arrow 3 by the movement of the rotating rods. The
advance speed of the former is selected relative to the rotational
speed so that the pitch of the helical laying of the strip or tape
on to the former 1 is a little less than the width of the strip so
that adjacent turns narrowly overlap. A first extruder 4 supplies a
tape or ribbon 5 of thin film polymer materials with a preferred
width of approximately 10 millimetres. It will be readily
understood that variation from this preferred ribbon width and size
of overlap is possible in order to achieve reinforcing beads or
conduits having varying pitches and/or dimensions. The ribbon 5
deposits on the former 1 in a helical fashion by action of the
former. The pitch of the helical disposition of ribbon 5 is
slightly less than the width of ribbon 5 and results in preferred
overlap of approximately 2.5 millimetres. The helical deposition of
ribbon 5 forms the wall 6 of the conduit.
[0046] An extruder 7 extrudes a bead 8 of molten or semi-molten
polymer material. The molten bead 8 deposits between the
overlapping portions of adjacent winds of ribbon 5 and is
sufficiently heated to weld the strips of ribbon 5. In the
preferred embodiment of the present invention the dimensions of the
molten bead 8 are approximately 2.5 millimetres wide and 1.5
millimetres high. The conduit formed according to a preferred
embodiment has an approximate internal diameter of 19 millimetres,
although it will be appreciated that the methods of the present
invention may be suitable for forming conduits having thin walls,
irrespective of diameter of the conduit or the dimensions of the
reinforcing bead.
[0047] For breathable wall conduits the thickness of the breathable
film or ribbon 5 must be thick enough so that the conduit does not
become too flimsy in use, but must also be thin enough so that the
conduit wall is sufficiently breathable. It has been found that
with polyester block copolymers, such as those described above, a
wall thickness between 15 and 35 microns fulfil these requirements.
The preferred wall thickness for breathable conduits according to
the present invention is approximately 25 microns. A wall thickness
of 25 microns has been found to provide a useful balance between
breathability, flexibility and strength. The wall thickness for
providing an optimal compromise of properties will ultimately
depend on the specific material employed. In this regard the
materials and preferred dimensions referred to in the description
are illustrative and are not intended to be in any way
limiting.
[0048] During the continuous manufacture of breathing conduits
according to the method described above it has been found that
overheating problems may occur when thin film (whether breathable
or not) is used in the conduit walls. Further, the action of the
helical rods rotating and advancing the conduit, may wrinkle or
even damage the thin ribbon deposited on the former and may reduce
the finish quality of the conduit. The mandrel temperature is
raised by the continuing application of the molten bead which may
also result in the thin film overheating and sticking to the
mandrel or rotating rods, causing the quality of the conduit wall
to suffer and/or disrupting the forming process. In order to
overcome these potential problems it has been found that a
sacrificial layer, wound onto the mandrel in an overlapping helix
pattern before the application of the film reduces these problems
and increases the quality of the conduit produced.
[0049] In order to accomplish this task the sacrificial layer of
tape is significantly more rigid compared to the conduit wall and
must not permanently stick to the mandrel or to the inside of the
conduit wall. It has been found that a material such as bi-axially
orientated polypropylene is ideally suited for the sacrificial
layer. It will be appreciated that many alternative materials
having a different base polymer to that of the conduit wall may
also be suitable. The preferred thickness of the polypropylene
sacrificial layer is between approximately 20 and 60 microns.
[0050] Referring to FIG. 3, a sacrificial layer 17 is wound from
reel 16 onto the former before the breathable extruded tape 5. The
heat from the applied molten bead may weld the overlapping layers
of sacrificial layer to each other, but does not result in any
significant bonding between the sacrificial layer and the conduit
wall. Alternatively, a secondary thermal welding process may be
employed to weld the overlapping layers of sacrificial tape before
the conduit is formed overtop. The sacrificial layer may perform
many additional advantageous functions such as those described
below: [0051] 1. The dummy layer protects the helically arranged
rotating rods on the mandrel from being fouled by molten plastic.
[0052] 2. The sacrificial layer increases the stability of the
process and may help prevent the overlapping layers that form the
conduit wall from slipping and moving relative to each other.
[0053] 3. The sacrificial layer provides a protective barrier
between sharp edges or small protrusions on the mandrel or rotating
rods, and the film or ribbon. [0054] 4. The sacrificial layer
shields the thin film from the higher operating temperatures of the
mandrel and reduces overheating of the film.
[0055] It will be readily appreciated by those skilled in the art
that the benefits derived from the application of a sacrificial
layer onto the mandrel before forming a conduit, are not limited
only to material lay-up and construction wherein the helical
reinforcing bead is interposed the overlapping layers.
[0056] The polypropylene layer can be easily removed from the inner
wall of the finished conduit product after cooling as it does not
bond significantly to the conduit. Additional means such as water
cooling of the mandrel may also be provided to reduce
overheating.
[0057] A method of removing a releasable inner layer (for example
the sacrificial layer 17) from within a length of conduit 37,
subsequent to forming the conduit, will be described with reference
to FIGS. 12 and 13. A shaft 39 is provided having a substantially
hollow cylindrical shape of a length longer than that of the
desired conduit product length. The shaft 39 has a longitudinal
slot 40 and is cantilevered from stock 42. The slot of shaft 39 is
in fluid connection with a suction or vacuum source 38 via stock
42.
[0058] The outer diameter of the shaft is preferably smaller than
that of the conduit 37. A tapered shoulder region 41 is provided at
the built-in end of the shaft 39 in order to enable an effective
seal to be formed between the inner layer and the shoulder portion
when suction is applied. Alternatively, the seal may be formed
between the shaft and the outside of the conduit. The effect is to
seal (so far as necessary) at least the inside of the releasable
inner layer from the surroundings.
[0059] In use, and in order to remove the sacrificial layer 17 from
the inner wall of the conduit 37, without damaging the conduit
wall, the conduit (including sacrificial layer) is placed overtop
the shaft as shown in FIG. 13. An end of the conduit is slid over
the shoulder portion 41 of the shaft 39 forming an adequate seal.
The other end of the conduit is pulled back in an axial direction
so that the conduit is contracted as shown in region 42, exposing
and separating the end portion of sacrificial layer 17 from the
conduit. Vacuum source 38 applied to the inner space of the shaft,
leads to a pressure differential between the inside and the outside
of the inner layer where it has separated from the conduit. This
urges the inner layer onto the shaft, and into the slot, and the
separation propagates along the length of the section of conduit,
sucking the sacrificial layer from the inner wall of the conduit
37. The portion of sacrificial layer 17 immediately opposite slot
40 is sucked so that it protrudes into the shaft interior. It may
be necessary to initiate this release process at the exposed end
(free end of the shaft) of the sacrificial layer 17 by hand (by
bringing the separated end portion of the inner layer adjacent the
slot. Helical reinforcing bead 43 prevents the conduit itself from
being drawn into slot 40). After release of the sacrificial layer
from the inner wall of the conduit 37, the conduit can be easily
removed by sliding it off the shaft. Removal of the vacuum from the
shaft allows removal of the remaining sacrificial layer more
easily.
[0060] Applying the molten bead between the overlapping layers of
tape instead of over the top of the overlapping layers may improve
the weld quality, as both layers of tape that are to be welded are
in physical contact with the molten bead. This lay-up may also
reduce overheating problems by lowering the temperature necessary
to properly bond the molten bead. When the prior art forming method
shown in FIG. 1 is employed to manufacture conduits from very thin
film or ribbon, (for example, having a wall thickness less than
approximately 50 microns), consistently producing a high quality
surface within the conduit has been found to be problematic.
[0061] FIG. 4 and FIG. 11 illustrates some potential problems which
may occur during the production of conduit resulting in inferior
wall smoothness. The quality of the surface finish for the inner
surface of a breathing conduit is important, because rough inner
surfaces may hinder gases flow and may cause more condensation to
build up in the conduit. A protruding or flapping portion 33 may
result if the underlapping layer of film is not completely bonded
to the molten bead. This problem may occur if the underlapping
portion of film is too wide or positioned on the former
incorrectly. Similarly, overflow of molten bead 35, may result in a
protrusion or defect 34, if the underlapping portion 36 of the
under lapping layer does not extend far enough under the bead.
Small voids 9 or undulations, may result between adjacent strips of
ribbon if the film does not closely conform to the contour of the
molten bead. This may occur if the thin ribbon is not sufficiently
supple. For this reason the construction technique of the present
invention is especially suited to conduits fabricated from thin
supple film. The thin film is highly flexible and able to conform
closely to the shape of the raised rib of the applied molten bead 8
during fabrication. By lapping very closely on to the bead and
wrapping around the bead, the thin film maintains a smooth inner
surface on the finished conduit product. A further defect 44, is
shown where the overlapping portion of the layer overlaps the bead
too much. The molten bead will also flow to fill voids or
undulations between the lay-up, resulting in a smooth conduit wall.
It will be appreciated that the conduit wall cross section shown in
FIG. 2 and FIG. 11 is illustrative and not meant to be interpreted
strictly in regard to the space shown between the bead and the
conduit wall layers. The application of a sacrificial layer onto
the fonner before the conduit wall is formed, is especially suited
to the conduit forming method wherein the molten bead is applied
between overlapping layers. The presence of the sacrificial layer
ensures that the helically arranged rotating rods on the former do
not become fouled with molten polymer.
[0062] Throughout the diagrams, the helical reinforcing bead is
shown as having a substantially semi-circular cross section. It is
however envisaged that the actual cross sectional shape of the
reinforcing bead may vary. For example the presence and thickness
of the film which overlaps the reinforcing bead, may affect the
shape of the reinforcing bead by flattening the bead, resulting in
a less rounded and more square or rectangular cross section.
Further, rollers may be employed to shape the bead. The
semi-circular reinforcing bead shown in the accompanying drawings
is purely illustrative and not intended to be in any way
limiting.
[0063] It has been found that breathing conduits formed according
to the first preferred embodiment described above are extremely
light, flexible and provide good crush resistance. However conduits
having very thin walls may have a reduced resistance to axial
deformation and/or stretching. Due to the thin tape used to form
the walls of the conduit, the resulting product may be prone to
expansion and/or contraction along the axis of the conduit. In use
axial forces arising from patient breathing are capable of
producing axial extension/contraction along the length of the
conduit. In order to improve the axial stiffness of such breathing
conduits, a further embodiment will now be described.
[0064] In a further embodiment shown in FIG. 5 a plurality of
reinforcing threads 10, running the length of the wall and spaced
around the perimeter of the tube are aligned parallel to one
another and substantially parallel to the major axis of the
conduit. The threads 10 are supported by the helical bead 11, with
the threads spanning the spaces between turns of the helical bead.
In this embodiment it is may be desirable to choose the reinforcing
threads (material, gauge, type and number) such that the threads
are sufficiently stiff to improve the conduits ability to resist
buckling under the transiently reduced internal pressures that
could be expected during patient breathing. Unrestrained or
excessive buckling of the threads may result in unacceptable levels
of conduit axial contraction and/or extension. The axial threads 10
may be spun or braided fibres or drawn or extruded mono filaments
or other equivalent forms. Tensile reinforcement may be provided by
braided or spun fibres while compressive and/or flexural
reinforcement may be provided by drawn or extruded mono
filaments.
[0065] A method of forming the tube according to the embodiment of
FIG. 5 is described with reference to the apparatus shown in FIG.
6. In particular in the machine of FIG. 6 the tube 12 is formed by
helically wrapping a preformed tape or strip of polymer 13 on to a
rotating former 14. The strip 13 unrolls from reel 15. In an
analogous manner to that described previously for the first
preferred embodiment, a sacrificial layer of polypropylene 17, is
wound in an overlapping helix onto former 14 from spool 16. The
sacrificial layer 17, between the mandrel and the conduit being
formed, allows the extremely thin film to be shielded from the
mandrel and higher operating temperatures.
[0066] Tube being formed on the former is rotated and advanced in
the direction of arrow 3. The advance speed of the former is
selected relative to the rotational speed so that the pitch of the
helical laying of the strip or tape on to the former 14, is a
little less than the width of the strip so that adjacent turns
narrowly overlap. An extruder 18 extrudes a bead 19 of molten
polymer material. The molten bead 19 deposits between the
overlapping portions of adjacent winds of tape 13 and is
sufficiently molten to weld to the strips of tape 13. The molten
bead becomes the helical reinforcement for the finished
conduit.
[0067] A freely rotatable thread laying head 20 is located over the
former after the bead extruder 18. The rotating head 20 carries a
plurality of spools 21 holding reinforcing thread. The head 20 is
rotatable by an electric motor and drive belt 22 and 23
respectively. The head 20 is preferably rotated at a speed
synchronized with the speed of effective rotation of the product
12. Advancement of tube along the former 14 draws thread 24 from
the spools 21 to be laid as parallel threads 10 on the outside of
the reinforcing bead 19. Another thread 25 is drawn from spool 26
and wound onto the former overtop of the longitudinal threads 10,
laid by thread laying head 20. The thread 25 is laid on the former
in a helical pattern such that the thread lies between the helical
bead of molten polymer extruded from extruder 18. The purpose of
thread 25 is to provide a temporary means of securing the plurality
of longitudinal threads in position in preparation for permanent
fixing. A second extruder 27 extrudes a second bead of molten
polymer material 28 and deposits it over top the plurality of
reinforcing threads 10 and directly on top of the first reinforcing
bead 19 and bonds. The second bead of molten polymer sandwiches the
plurality of longitudinal threads between itself and the first
reinforcing rib formed by polymer bead 19. Thread 25 however, lies
between these overlapping reinforcing beads and does not become
permanently bonded to the conduit wall, allowing it to be removed.
Thread 25, may be discarded or drawn from the former in a position
subsequent to the application of the second reinforcing bead 28 and
wound onto a spool for re-use.
[0068] This embodiment of the invention provides a breathing
circuit limb reinforced against crushing by the helical bead and
against longitudinal extension by the axial threads 10 as well as
providing a breathing conduit having all the advantages of the
first preferred embodiment. The spanning threads 10 also provide an
additional advantage by reducing direct contact between the
user/environment and the surface of the tube, therefore reducing
the risk of punctures and damage. The threads effectively provide
an additional barrier against potential damage around the conduit
wall. It will be appreciated that the foregoing method of
reinforcing a conduit is not limited to conduits wherein the
helical reinforcing bead is interposed between the overlapping
layers.
[0069] A further breathing circuit component to which the present
invention may be applied is catheter mounts. A catheter mount
connects between a patient interfacing component such as a mouth
piece, nasal mask or endotracheal tube and the dual limbs of the
breathing circuit. Connection with the dual limbs of the breathing
circuit is generally via a wye connector. The extreme flexibility
of very thin walled tubes manufactured according to the methods
herein, makes them particularly useful in a catheter mount
component.
[0070] It should be appreciated that with all of the forming
methods described involving winding of a narrow ribbon or strip to
create a tube, it would be possible to wind two or more ribbons or
films simultaneously onto the former so that the turns created by
each ribbon are interposed by turns of other ribbons, edges
overlapping and being bonded together by an interposed extruded
helical rib. For example a pair of ribbons may be laid as a double
helix. This would require a multiplication in the number of forming
stations associated with the wound on components of the tube or
conduit. Further it is envisaged that for methods where a preformed
tape is supplied to a former, the tape may be provided as a
laminate having a thin film layer and a reinforcing layer bonded to
it. Where the thin film layer is a breathable layer, the
reinforcing layer is also permeable and allows the passage of water
vapour.
[0071] A further embodiment of the present invention is envisaged
where thin walled breathing conduits are manufactured in a similar
manner as described above but, where the conduit wall also
preferably contains at least one thin conductive wire. A pair of
wires may be included in order to provide a means for heating the
conduit and or to carry electrical signals to sensors or
transducers. Heated conduits may reduce the build up of
condensation in the conduit and may also offer a means to
maintaining the temperature of humidified gases flowing through the
conduit. Heated conduits are most often used in only the
inspiratory arm of a breathing circuit but can also be used in the
expiratory arm. Heated wall conduits may also be components of
coaxial (unilimb) circuits, or be used in single limb applications
such as for CPAP therapy. In such breathing conduits where the
inspiratory arm includes heater wires, the corresponding connectors
at at least one end of the conduit will include an electrical
connection suitable for connection with the humidified gases source
in order to supply electrical energy to the conduit heater wires.
Referring to FIG. 7, a breathing conduit is shown including a pair
of heater wires 31, embedded in the helical reinforcing bead.
[0072] A method of forming a conduit according to this embodiment
of the present invention including a pair of heater wires will now
be described with reference to FIG. 8. The method is similar to the
method previously described and illustrated in FIG. 3, but an
additional stage is required to lay a pair of parallel wires in
between the overlapping adjacent winds of film in the edge area of
the film that will become the seam. A pair of wires 31 are supplied
from two reels 29 and 30. The wires are laid on top of the first
wind of film, towards the edge, after it is laid on the former but
before the molten bead is applied. FIG. 8 shows a pair of heater
wires 31 in hidden detail under the molten bead 8. The molten bead
8 is then laid over the wires on top of the first layer of film
before the following overlapping wind of film wraps around the
former and completes the tube. It will be appreciated that each of
the film, heating wire(s), and reinforcing bead may be applied in a
different plane in order to achieve the desired spatial lay-up.
[0073] The resulting conduit is shown in FIG. 7 and is similar to
the previous embodiment shown in FIG. 2, but includes an additional
pair of heater wires embedded in the helical reinforcing bead of
the conduit wall. In this embodiment, a sacrificial layer 17 may
also be wound in an overlapping helix onto the former from spool
16. The sacrificial layer 17 may be a polypropylene layer or some
other material that will not weld to the conduit wall. The
sacrificial layer 17 between the mandrel and the conduit being
formed, allows the extremely thin film to be shielded from the
higher operating temperature of the mandrel and alleviates
overheating of the film.
[0074] A further method of forming a conduit according to the
present invention including a pair of heater wires will now be
described.
[0075] The above method of forming a conduit discloses an online
process for winding a pair of heater wires into the conduit wall.
It is envisaged that a pair of heater wires may be included in a
preformed tape which would then be used to form the walls of the
conduit in a similar method to that described above and illustrated
in FIG. 3. FIGS. 9a and 9b show cross sections of such a tape being
formed by laying a pair of parallel wires a distance x from one
edge of the tape. The length x of tape between the wires and the
edge is then folded over and back onto the rest of the tape so as
to enclose the pair of parallel wires, as shown by arrow 32. A
secondary thermal welding process may then be employed to bond the
folded portion of tape so as to permanently embed the parallel
wires. It will be appreciated however that a secondary thermal
welding process may not be necessary if the extruded tape is molten
or semi-molten when the folding occurs. In this case the two
regions of molten layer, when folded and pressed together will
bond.
[0076] Such a pre-formed folded tape including embedded wires may
then be wound on to reels and supplied to a conduit forming process
such as that described previously and illustrated in FIG. 3 to
produce a breathing conduit with a pair of integral heating wires.
FIG. 10 shows the lay-up of a breathing conduit formed by this
embodiment of the present invention. The portion of thin film that
wraps over the reinforcing bead and the adjacent wind on the former
is only one layer thick and therefore is able to conform to the
contour of the reinforcing bead. A tube formed according to this
embodiment of the present invention therefore is able to retain all
of the advantages of the previously described preferred
embodiments, while having the additional advantage that a forming
apparatus as described in FIG. 3 may be employed to manufacture a
conduit including embedded heater wires without substantial
modification to the forming apparatus. In such a case the extruder
4 is replaced with a reel of pre-formed folded tape such as that
shown in FIG. 9b and supplied to the forming apparatus.
* * * * *