U.S. patent application number 09/780864 was filed with the patent office on 2001-07-26 for intravenous catheter assembly and a method of making a combination hub and catheter.
Invention is credited to Kafrawy, Adel, Onwumere, Fidelis C..
Application Number | 20010009988 09/780864 |
Document ID | / |
Family ID | 23017862 |
Filed Date | 2001-07-26 |
United States Patent
Application |
20010009988 |
Kind Code |
A1 |
Kafrawy, Adel ; et
al. |
July 26, 2001 |
Intravenous catheter assembly and a method of making a combination
hub and catheter
Abstract
According to one aspect of the invention a method is provided
for making a combination hub and catheter. A material is molded
into a body having at least a first hub, and at least a first nose
extending from the first hub. The first nose is then elongated into
a catheter.
Inventors: |
Kafrawy, Adel; (Kingston,
MA) ; Onwumere, Fidelis C.; (Mansfield, TX) |
Correspondence
Address: |
James C. Scheller, Jr.
BLAKELY, SOKOLOFF, TAYLOR & ZAFMAN LLP
Seventh Floor
12400 Wilshire Boulevard
Los Angeles
CA
90025-1026
US
|
Family ID: |
23017862 |
Appl. No.: |
09/780864 |
Filed: |
February 8, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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09780864 |
Feb 8, 2001 |
|
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09267225 |
Mar 11, 1999 |
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6192568 |
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Current U.S.
Class: |
604/168.01 ;
264/291; 264/296; 29/412; 29/430; 425/588 |
Current CPC
Class: |
B29C 45/0055 20130101;
A61M 25/0009 20130101; B29L 2031/7542 20130101; Y10T 29/49826
20150115; Y10T 29/49829 20150115; Y10T 29/49789 20150115 |
Class at
Publication: |
604/168.01 ;
29/412; 29/430; 264/291; 264/296; 425/588 |
International
Class: |
A61M 005/32; B29C
045/06; B29C 055/22; B29C 069/02; A61M 025/06; A61M 025/16 |
Claims
What is claimed:
1. A method of making a combination hub and catheter, which
includes: molding a material into a body having at least a first
hub, and at least a first nose extending from the first hub; and
elongating the first nose into a catheter.
2. A method as in claim 1 wherein the hub has a luer lock formation
thereon.
3. A method as in claim 1 wherein catheter has a length of at least
12 mm.
4. A method as in claim 1 wherein the catheter has a length of at
least 30 mm.
5. A method as in claim 1 wherein the catheter has an outer
diameter of between 0.37 mm and 3.7 mm.
6. A method as in claim 1 wherein the catheter is sufficiently
flexible so as to substantially conform to a curved body lumen when
inserted into the body lumen.
7. A method as in claim 1 wherein the material is selected from the
group comprising a polyamide, a blend of
acrylonitrile/butadiene/styrene and polyurethane, polyetheramide, a
fluorinated ethylene propylene copolymer, polypropylene, an
ethylene propylene copolymer, polyurethane, and a blend of a
polyamide and a polyetheramide.
8. A method as in claim 1 wherein the nose is elongated at a
temperature wherein the material is malleable.
9. A method as in claim 1 wherein the catheter is rigid at room
temperature and flexible when exposed to moisture and body
temperature.
10. The method as in claim 1 wherein (i) the body has a second hub,
and a second nose extending from the second hub, an end of the
first nose which is distant from the first hub is joined with an
end of the second nose which is distant from the second hub, and
(ii) the first and second hubs are moved away from one another so
that both the first nose and the second nose are elongated,
respectively into a first catheter and a second catheter, the
method further including: severing the first and second catheters
from one another.
11. The method as in claim 10 which includes: simultaneously
molding a plurality of said bodies; and simultaneously elongating
the first nose and the second nose of each of the plurality of
bodies.
12. The method as in claim 11 wherein the bodies are molded in a
mold which is mounted to a turntable when the turntable is rotated
so that the mold is at a first station, the method including:
rotating the turntable so that the mold is moved to a second
station where the first nose and the second nose of each of the
plurality of bodies are elongated.
13. The method as in claim 12 which includes: rotating the
turntable so that the mold is moved to a third station, the first
and second catheters being severed while the mold is at the third
station.
14. The method as in claim 12 which includes: rotating the
turntable so that the mold is moved to a third station; and
ejecting the bodies from the mold while the mold is at the third
station.
15. A mold for making a combination hub and catheter, the mold
including: a first component; and a second component, the first and
second components defining a volume into which a material can be
injected so that the material takes the shape of a hub and a nose,
the hub connecting to the first component and the nose connecting
to the second component so that the nose is elongated into a
catheter when the first and second components are moved away from
one another.
16. The mold as in claim 15 wherein the volume includes a first hub
volume in the first component, a second hub volume in the second
component, and a nose passage from the first hub volume to the
second hub volume so that the material in the nose passage is
elongated when the first and second components are moved away from
one another.
17. The mold as in claim 16 wherein the first and second components
define a plurality of said volumes.
18. An intravenous catheter assembly which includes: a hollow hub;
a catheter having a length of at least 12 mm, a first end which is
secured to the hub in a unitary construction, a second end distant
from the hub, and a passage extending from the hub out of the
second end; and a needle, which is removably located within the
passage, having a sharp tip in proximity to the second end of the
catheter.
19. An intravenous catheter assembly as in claim 18 wherein the hub
and the catheter are made of the same material.
20. An intravenous catheter assembly as in claim 18 wherein the hub
has a luer lock formation thereon.
21. An intravenous catheter assembly as in claim 18 wherein the
catheter has a length of at least 30 mm.
22. An intravenous catheter assembly as in claim 18 wherein the
catheter has an outer diameter of between 0.37 mm and 3.7 mm.
23. An intravenous catheter assembly as in claim 18 wherein the
catheter is sufficiently flexible so as to substantially conform to
a curved body lumen when inserted into the body lumen.
24. An intravenous catheter assembly as in claim 18 wherein the
material is selected from the group comprising a polyamide, a blend
of acrylonitrile/butadiene/styrene and polyurethane,
polyetheramide, a fluorinated ethylene propylene copolymer,
polypropylene, an ethylene propylene copolymer, polyurethane, and a
blend of a polyamide and a polyetheramide.
25. An intravenous catheter assembly as in claim 18 wherein the
catheter is rigid at room temperature and flexible when exposed to
moisture and body temperature.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates to a method of making a combination
hub and catheter, and to an intravenous catheter assembly.
[0003] 2. Discussion of Related Art
[0004] Catheter assemblies are frequently used for passing fluids
between a device such as a syringe or a drip to or from body lumens
such as veins or arteries, or other internal target sites. Such an
assembly usually includes a hub, a catheter, and a needle. An
eyelet ring is usually inserted into the catheter. The catheter,
together with the eyelet ring, is then inserted into an opening in
a nose of the hub and is secured to the hub by press fitting the
eyelet ring within the nose of the hub. A needle is then inserted
into the catheter. A sharp tip of the needle is used for piercing a
body lumen so that access can be gained into the body lumen by the
catheter and the needle. Once the catheter and the needle are
located within the body lumen, the needle is removed. A syringe or
a pipe of a drip is then attached to the hub so that fluids can be
passed through the hub and the catheter between the drip or the
syringe and the body lumen.
[0005] The hub is usually made of a material providing sufficient
rigidity thereto and the catheter is usually made of a material
which is flexible, at least when inserted into a body lumen and
when exposed to moisture within the body lumen.
[0006] The above described method by which the catheter is attached
to the hub is cumbersome and expensive and requires complex
assembly machines.
SUMMARY OF THE INVENTION
[0007] According to one aspect of the invention a method is
provided for making a combination hub and catheter. A material is
molded into a body having at least a first hub, and at least a
first nose extending from the first hub. The first nose is then
elongated into a catheter.
[0008] The hub may have a luer lock formation thereon.
[0009] The catheter may have a length of at least 12 mm, more
preferably at least 18 mm, and more preferably at least 30 mm.
[0010] The catheter may have an outer diameter of between 0.37 mm
and 3.7 mm.
[0011] The catheter is preferably sufficiently flexible so as to
substantially conform to a curved body lumen when inserted into the
body lumen.
[0012] The material may be a polyamide such as a nylon, a blend of
acrylonitrile/butadiene/styrene and polyurethane, polyetheramide,
polypropylene, ethylene propylene copolymers, polyurethane or a
blend of a polyamide and a polyetheramide.
[0013] The nose is preferably elongated at a temperature wherein
the material is malleable.
[0014] The catheter is preferably rigid at room temperature and
flexible when exposed to moisture and body temperature.
[0015] The body preferably has a second hub, and a second nose
extending from the second hub, wherein an end of the first nose
distant from the first hub is joined with an end of the second nose
distant from the second hub, and both the first nose and the second
nose are elongated, respectively, into a first catheter and a
second catheter. The method may further include the step of
severing the first and second catheters from one another.
[0016] A plurality of the bodies may be molded simultaneously and
the first nose and the second nose of each of the plurality of
bodies may simultaneously be elongated.
[0017] The bodies may be molded in a mold which is mounted to a
turntable and the turntable is rotated so that the mold is at a
first station. The method may include the step of rotating the
turntable so that the mold is moved to a second station where the
first nose and the second nose of each of the plurality of bodies
are elongated.
[0018] The method may include the steps of rotating the turntable
so that the mold is moved to a third station, and ejected the
bodies from the mold while the mold is at the third station.
[0019] The invention also provides a mold for making a combination
hub and catheter, the mold including a first component, and a
second component. The first and second components define a volume
into which a material can be injected so that the material takes
the shape of a hub and nose. The hub may be connected to the first
component and the nose connected to the second component so that
the nose is elongated into a catheter when the first and second
components are moved away from one another.
[0020] The volume may include a first hub volume in the first
component, a second hub volume in the second component, and a nose
passage from the first hub volume to the second hub volume. The
material in the nose passage may be elongated when the first and
second components are moved away from one another.
[0021] The first and second components may define a plurality of
these volumes.
[0022] The invention further provides an intravenous catheter
assembly which includes a hollow hub, a catheter, and a needle. The
catheter has a length of at least 12 mm, a first end which is
secured to the hub in a unitary construction, a second end distant
from the hub, and a passage extending from the hub out of the
second end. The needle is removably located within the passage and
has a sharp tip in proximity to the second end of the catheter.
[0023] The hub and the catheter are preferably made of the same
material.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The invention is further described by way of examples with
reference to the accompanying drawings wherein:
[0025] FIG. 1 is a sectioned side view of a mold which is used for
making a combination hub and catheter according to an embodiment of
the invention;
[0026] FIG. 2 is a view similar to FIG. 1 after a second component
of the mold is moved relative to a first component thereof to
stretch a nose of a body, formed by the mold in FIG. 1, into a
catheter;
[0027] FIG. 3 is a sectioned side view of a combination hub and
catheter which is made according to the method illustrated in FIG.
1 and FIG. 2;
[0028] FIG. 4 illustrates an intravenous catheter assembly, which
includes the combination hub and catheter, after being inserted
into a body lumen;
[0029] FIG. 5 illustrates the combination hub and catheter after a
needle product of the assembly of FIG. 4 is removed therefrom and
the catheter of the combination hub and catheter substantially
conforms to a natural shape of the body lumen;
[0030] FIG. 6 is a sectioned side view of a mold which is used for
making two combinations hub and catheter according to another
embodiment of the invention;
[0031] FIG. 7 is a view similar to FIG. 6 after the second
component of the mold is moved relative to a first component
thereof to stretch noses of a body, formed in the mold of FIG. 6
into respective catheters;
[0032] FIG. 8 is a sectioned side view of two combinations hub and
catheter which are made according to the method illustrated in
FIGS. 6 and 7;
[0033] FIG. 9 illustrates a mold in which a plurality of
combinations hub and catheter can be made; and
[0034] FIG. 10 is a plan view of an apparatus which is used in
manufacturing combinations hub and catheter according to the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0035] FIG. 1 of the accompanying drawings illustrates a mold 10
which is used for making a combination hub and catheter. The mold
10 includes a first component 12, a second component 14, and a core
pin 16.
[0036] The first component 12 has an opening formed therein with a
lower portion, or first nose volume, 18 having a relatively small
diameter, and an upper portion, or hub volume, 20 having a
relatively large diameter. The upper portion 20 is slightly
enlarged at a mouth 22 at a top thereof.
[0037] An opening is formed in the second component having an upper
portion, or second nose volume, 24 which has a diameter which is
the same size as the lower portion 18 in the first component 12,
and a lower portion 26 which is smaller than the upper portion 24.
The second component 14 is located below the first component 12 and
is positioned so that surfaces of the first and second components
12 and 14 contact one another and the lower portion 18 in the first
component 12 is aligned with the upper portion 24 in the second
component 14.
[0038] The core pin 16 has a base portion 28, a stem portion 30
extending from the base portion, the stem portion 30 having a
relatively large diameter, and a pin portion 32 extending from the
stem portion 30, the pin portion 32 having a relatively small
diameter when compared to the stem portion 30. The pin portion 32
is inserted into the upper portion 20 in the first component 12 and
from there into the lower portion 18 of the first component 12, the
upper portion 24 of the second component 14 and through the lower
portion 26 of the second component 14 so that the pin portion 32
protrudes out of the second component 14. The stem portion 30 is so
located within the upper portion 20 in the first component 12. The
first and second components 12 and 14 together with the core pin
define a volume 34 around the core pin and within the openings in
the first and second components 12 and 14, but excluding between
the pin portion 32 and lower portion 26 in the second component
14.
[0039] A material 36 is injected into the volume 34 so that the
material 36 fills the volume 34. The material 36 is above its
melting point and above room temperature, and is preferably also
color coded.
[0040] The material within the volume 34 is then allowed to cool to
a temperature below the melting point of the material, but still
above a temperature when the material becomes malleable and above
room temperature. A malleable body 40 is so molded within the mold
10, the body 40 having a hub 42 and a nose 44 extending from the
hub 42. The hub 42 is formed within the upper portion 20 in the
first component 12 and the nose 44 is formed in the lower portion
18 in the first component 12 and in the upper portion 24 in the
second component 14. An enlargement or a notch 46 is formed low
down within the upper portion 24 in the second component 14 and the
material fills the notch 46 so that the nose 44 has a rib 48
located within the notch 46. As illustrated in FIG. 2, the second
component 14 is then moved away from the first component 12 along
the pin portion 32 while the material is still in a malleable
condition. The rib 48 engages within the notch 46 so that the nose
44 of FIG. 1 is elongated or stretched into a catheter 50. An outer
diameter of the nose 44 reduces in size while it is being elongated
into the catheter 50 to form an outer diameter 52 of the catheter
50. An inner diameter 54 of the catheter 50 is generally determined
by the outer diameter of the pin portion 32.
[0041] The outer diameter 54 can also be more accurately controlled
by controlling the rate at which the catheter 50 is stretched and
by heating or cooling the catheter 50 while being formed. The
catheter 50 can also be selectively heated or cooled at different
locations along the length thereof while being formed in order to
influence the diameters 52 and 54 selectively over the length of
the catheter. For example, by maintaining a lower portion of the
catheter 50 at a lower temperature than the remainder of the
catheter 50, the lower portion can have an outer diameter which is
smaller than an upper portion of the catheter 50, so that an outer
surface of the catheter tapers inward towards a lower end thereof,
or which is beveled.
[0042] The second component 14 is then released from the catheter
50. The core pin 16 is pulled out of the catheter 50 and the hub
42. The pin portion 32 extends only a short distance into the
catheter 50, thus facilitating its release from the catheter 50.
The hub 42 and catheter 50 are then removed from the first
component 12. A combination hub and catheter 56 as illustrated in
FIG. 3 is so provided which includes a hub 42 and a catheter 50.
The combination hub and catheter 56 is then allowed to cool to room
temperature which is below the temperature when the material
becomes malleable. A primary advantage is that the combination hub
and catheter 56 is made according to an easy, inexpensive method
which does not require assembly of a catheter and a hub utilizing
complex equipment or assembly procedures.
[0043] The hub 42 has a luer lock formation 58 on a side thereof
opposing the catheter 50, and a first passage 60 therethrough.
[0044] The catheter 50 has a first end 62 which is secured to the
hub 42 in a unitary construction in the sense that the hub 42 and
the catheter 50 are made of a single component, i.e. without an
interface between one component of which the hub 42 is made and
another component of which the catheter 50 is made. The catheter 50
is cut off just above the rib 48 to rid the catheter 50 of the rib
48. A second end 64 of the catheter 50 is located distant from the
hub 42. A second passage 66 is formed through the catheter 50 and
extends from the first passage 60 in the hub 42, through the
catheter 50 out of the second end 64. The catheter 50 has an outer
diameter 52, an inner diameter 54, and a length 68. The material of
the combination hub and catheter 56 is color coded, the color of
the combination hub and catheter 56 depending on the gauge of the
catheter 50. Specifications of different combinations hub and
catheters are recited in the table which follows wherein dimensions
are given in millimeters.
1TABLE Outer diameter 52 Inner diameter 54 Length 68 Color 2.13
1.75 31 Orange 2.13 1.75 56 Orange 1.70 1.38 31 Gray 1.70 1.38 56
Gray 1.28 0.98 44 Green 1.28 0.98 31 Green 1.10 0.80 31 Pink 1.10
0.80 25 Pink 1.10 0.80 44 Pink 0.83 0.63 25 Blue 0.70 0.50 19
Yellow
[0045] FIG. 4 illustrates an intravenous catheter assembly 76
according to an embodiment of the invention which includes the
combination hub and catheter 56, and a needle product 78. The
needle product 78 includes a body, a fluid detecting transparent
chamber 80 and a needle 82. The needle has a first end 84 which is
secured to the chamber 80, and a second end 86, having a sharp tip
located distant from the chamber 80. A passage is formed through
the needle 82 and is in communication with the confines of the
chamber 80. A porous plug 88 closes an open end of the chamber 80
opposing the needle 82. The second end 86 is inserted first into
the hub 42, and from the hub 42 through the catheter 50 until the
second end 86 protrudes from the second end 64 of the catheter 50,
while still being in proximity to the second end 64 of the catheter
50.
[0046] In use, the second end 86 of the needle 82 is used to pierce
a body lumen 90 such as a vein or an artery so that an opening 92
is formed into the body lumen 90. The catheter 50 is then inserted
together with the needle 82 into the body lumen 90 through the
opening 92. As mentioned, the catheter may be tapered or beveled at
its second end 86. Because of the tapered or beveled second end 86,
the catheter may more easily enter the lumen 90 than may otherwise
be possible. The plug 88, due to its porosity, allows for venting
of air from within the chamber 80 to allow for fluid within the
lumen 90 to flow through the needle 82 into the chamber 80 where
the fluid is visible through a wall of the chamber 80.
[0047] As illustrated in FIG. 5, the needle product 78 of FIG. 4 is
then removed from the combination hub and catheter 56. Another
device 94 such as a syringe or a pipe of a drip is then connected
to the luer lock formation 58. Fluids can then be passed through
the hub and the catheter 50 between the body lumen 90 and the
device 94.
[0048] The lumen 90 may be naturally curved, as illustrated in FIG.
5. The catheter 50 is preferably made of a material which is
relatively strong when inserted into the lumen, but should
preferably be sufficiently flexible so as to substantially conform
to the natural shape of the body lumen 90 when inserted into the
body lumen 90 and the needle 82 is removed. As will be discussed
herein below, certain materials are rigid at room temperature and
in dry conditions, but are hydrophilic so that the catheter 50
becomes sufficiently flexible when exposed to warmer temperatures
and moisture generally found within a lumen. The material of the
catheter 50 should also preferably allow for at least 24 hours,
more preferably up to 72 hours of indwelling. Since the hub 42 and
the catheter 50 are made of the same material, the materials should
still be strong enough to provide the necessary rigidity to the hub
42.
[0049] One material which can be used for making the combination
hub and catheter 56 is a polyamide such as nylon 6, nylon 66, nylon
11 or nylon 12. A polyamide is also easily molded and can be easily
stretched. A polyamide is also a material which can be easily
colored. A combination hub and catheter as hereinbefore described
which is made of a polyamide has a hub which is sufficiently rigid
when ribs or other strengthening formations are formed on the hub,
and a catheter which is sufficiently flexible to conform to the
shape of a curved body lumen. A polyamide, in particular, is
hydrophilic so that it becomes more flexible when exposed to heat
and moisture.
[0050] Another material which can be used for the combination hub
and catheter 56 hereinbefore described is a blend of
acrylonitrile/butadiene/- styrene resin (ABS) and polyurethane,
such as a material which is sold under the name PREVAIL 3050,
PREVAIL 3100, or PREVAIL 3150 by Dow Chemicals of Midland, Mich.
PREVAIL can be easily colored, molded and stretched. A hub made of
PREVAIL is sufficiently rigid when ribs or other strengthening
formations are formed on the hub, and a catheter formed of PREVAIL
is sufficiently flexible to conform to the shape of a curved body
lumen. PREVAIL, in particular, is hydrophilic so that it becomes
more flexible when exposed to moisture and heat.
[0051] Another material which can easily be molded and stretched is
fluorinated ethylene propylene copolymers (FEP). FEP is also
sufficiently flexible to conform to the shape of a curved body
lumen. FEP provides a hub which is sufficiently rigid, and a
catheter which is hydrophilic so as to become flexible when exposed
to moisture and heat. Other materials mentioned herein are,
however, more easily color coded than FEP.
[0052] Another material which may be used for a combination hub and
catheter 56 as hereinbefore described is polyurethane. Polyurethane
provides a hub which is sufficiently rigid when ribs and other
strengthening formations are provided on the hub, and a catheter
which is generally sufficiently flexible for purposes of forming a
sufficiently flexible catheter. Polyurethane is also hydrophilic so
as to become more flexible when exposed to heat and moisture.
Polyurethane can also be easily color coded, molded and
stretched.
[0053] Another material which may be used for making a combination
hub and catheter 56 of the kind herein before described is a
polyetheramide such as sold under the name PEBAX by Elf Atochem of
Philadelphia, Pa. PEBAX has similar characteristics to nylon.
[0054] Polypropylene may also be used for making a combination hub
and catheter of the afore described kind. Polypropylene generally
has sufficient stiffness for purposes of providing rigidity to a
hub of such a combination hub and catheter. A catheter which is
formed of polypropylene will generally be relatively stiff, but may
suffice for particular purposes.
[0055] Other materials which may be used are ethylene propylene
co-polymers. Such co-polymers have similar characteristics as
ethylene and propylene hereinbefore described and, depending on
ratios of ethylene to propylene used, provide hubs which are
sufficiently rigid and catheters which are sufficiently
flexible.
[0056] Another material which may be used is a blend of PEBAX and a
polyamide which, depending on the blend which is used, may provide
some characteristics of PEBAX which are superior to a polyamide and
other characteristics of polyamide that are superior to PEBAX.
[0057] FIG. 6 illustrates another mold 100 which may be used for
making two combinations hub and catheter. The mold 100 includes a
first component 102, a second component 104, a first core pin 106,
and a second core pin 108.
[0058] The first component 102 has an opening formed therein with a
lower portion 110 having a relatively small diameter, and an upper
portion 112 having a relatively large diameter. The upper portion
112 is slightly enlarged at an upper end 114 thereof.
[0059] The first core pin has a stem portion 118 having a
relatively large diameter, and a pin portion 120 extending from the
stem portion, the pin portion 120 having a relatively small
diameter when compared to the stem portion 118.
[0060] The first component 102 includes first and second parts 122
and 124 which jointly define an enclosure which is open only at the
lower portion 110. In order to locate the first core pin 106 within
the first component 102, the first and second parts 122 and 124
thereof are moved apart. The first core pin 106 is then inserted
and the first and second parts 122 and 124 are again moved against
one another so that the first core pin 106 is located within the
first component 102.
[0061] A first hub volume 128 and a first nose volume 130 are
defined by the first component 102 and the first core pin 106.
[0062] The second component 104 and the second core pin 108 have
exactly the same constructions as the first component 102 and the
first core pin 106 respectively. A second hub volume 132 and a
second nose volume 134 are defined by the second component 104 and
a second core pin 108.
[0063] The first and second components 102 and 104 are initially
located next to one another so that the first and second nose
volumes 120 and 124 are located over one another and the pin
portions 120 of first and second core pins 106 and 108 contact one
another. A volume 136 is thereby defined which includes the first
and second hub volumes 128 and 132, and a nose passage defined by
the first and second nose volumes 130 and 134 jointly. A material
138 is injected into the volume 136 so that the material 138 flows
into the hub volumes 128 and 132 and the nose volumes 130 and
134.
[0064] The material within the volume 136 is allowed to solidify,
thereby forming a body having a first hub 140 in the first hub
volume 128, a second hub 142 in the second hub volume 132, a first
nose 144 in the first nose volume 130, and a second nose 146 in the
second nose volume 134.
[0065] While the material is still malleable, as illustrated in
FIG. 7, the first and second components 102 and 104 are moved away
from one another. The first nose 144 is elongated into a first
catheter 148, and the second nose 146 is elongated into a second
catheter 150. Ends of the first and second catheters 148 and 150
are joined to one another. The first and second parts 122 and 124
are then moved away from one another, and the core pins 106 and 108
are removed. The first and second catheters 148 and 150 are then
severed from one another to leave two combinations hub and
catheter, 152 and 154 respectively, as illustrated in FIG. 8.
[0066] Each combination hub and catheter 152 or 154 is the same as
the combination hub and catheter 56 as illustrated in FIG. 3. The
material used for making the combinations hub and catheter 152 and
154 may be the same as for the combination hub and catheter 56 of
FIG. 3, the manner in which the combinations hub and catheter 152
and 154 are made, including the mold used for making them are the
same as for the combination hub and catheter 56 of FIG. 3 in all
other respects.
[0067] FIG. 9 illustrates another mold 160 which includes first and
second components 162 and 164 respectively. The mold 160 defines a
plurality of volumes 166. Each volume 166 is the same as the volume
136 in FIG. 6. Bodies are simultaneously molded within each of the
volumes 166 and the nose portions of all the bodies are then
simultaneously elongated. An advantage of using the mold 100 of
FIG. 6, and more particularly the mold 160 of FIG. 9, is that more
combinations hub and catheter can be manufactured in the same
cycle.
[0068] FIG. 10 illustrates manufacturing apparatus 170 which
includes a turntable 172, a mold 160 such as the mold 160 in FIG.
9, an injection molding machine 174, pulling apparatus 176, cutting
and ejection apparatus 178, and closing apparatus 180.
[0069] The mold 160 is mounted to the turntable 172. The injection
molding apparatus 174, the pulling apparatus 176, the cutting and
ejection apparatus 178, and the closing apparatus 180, are
respectively located at a first, a second, a third, and a fourth
station around the turntable 172. The turntable 172 is first
rotated so that the mold 160 is at the first station where material
is injected into the mold 160. The turntable 172 is then rotated
through about 90.degree. so the mold 160 is moved to the second
station where the pulling apparatus 176 stretches the nose portions
into catheters. The turntable 172 is then again rotated though
about 90.degree. to the third station so the cutting and ejection
apparatus 178 removes the bodies from the mold 160 and subsequently
sever or cut the catheters from one another. The turntable 172 is
then again rotated through about 90.degree. until the mold 160 is
moved to the fourth station where the closing apparatus 180 again
moves the first and second components 162 and 164 of the mold 160
towards one another. The mold 160 is then ready for another
injection step at the first station.
[0070] In another embodiment the bodies may be removed from the
injection molding machine and located in a stretching machine such
as an Instron universal testing instrument, to be stretched by the
stretching apparatus under conditions that can be optimally
controlled.
[0071] While certain exemplary embodiments have been described and
shown in the accompanying drawings, it is to be understood that
such embodiments are merely illustrative and not restrictive of the
current invention, and that this invention is not restricted to the
specific constructions and arrangements shown and described, since
modifications may occur to those ordinarily skilled in the art.
* * * * *