U.S. patent application number 13/376455 was filed with the patent office on 2012-06-07 for kit comprising a supporting device for a transparent article and a polarimeter.
This patent application is currently assigned to BECTON DICKINSON FRANCE. Invention is credited to Ronan Garrec.
Application Number | 20120140204 13/376455 |
Document ID | / |
Family ID | 41210521 |
Filed Date | 2012-06-07 |
United States Patent
Application |
20120140204 |
Kind Code |
A1 |
Garrec; Ronan |
June 7, 2012 |
KIT COMPRISING A SUPPORTING DEVICE FOR A TRANSPARENT ARTICLE AND A
POLARIMETER
Abstract
The present invention relates to a kit comprising a supporting
device for maintaining a transparent article having a longitudinal
axis A, a proximal end and a distal end, said supporting device
including a proximal holder including a port intended to receive
the proximal end of said article, and a distal holder including a
receiving part intended to receive the distal end of said article,
said port and said receiving part being aligned on the same
longitudinal axis B, said supporting device further comprising
compression means for putting said article under longitudinal
compression directed towards a center of said article, when said
article is mounted on said supporting device with its longitudinal
axis A aligned on said longitudinal axis B, and a polarimeter. The
invention also pertains to a method for measuring the stress inside
an article made of transparent material.
Inventors: |
Garrec; Ronan; (Claix,
FR) |
Assignee: |
BECTON DICKINSON FRANCE
Le Pont De Claix
FR
|
Family ID: |
41210521 |
Appl. No.: |
13/376455 |
Filed: |
June 9, 2010 |
PCT Filed: |
June 9, 2010 |
PCT NO: |
PCT/EP2010/058074 |
371 Date: |
February 27, 2012 |
Current U.S.
Class: |
356/34 |
Current CPC
Class: |
G01N 3/08 20130101; G01N
2203/0019 20130101; G01N 2203/0274 20130101; G01N 21/23 20130101;
G01N 2203/027 20130101; G01N 21/90 20130101 |
Class at
Publication: |
356/34 |
International
Class: |
G01J 4/00 20060101
G01J004/00; G01B 11/16 20060101 G01B011/16 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 10, 2009 |
EP |
09356040.7 |
Claims
1. A kit, comprising a supporting device for maintaining under
longitudinal compression an article made of a transparent material
having a longitudinal axis A, a proximal end and a distal end, said
supporting device comprising: a proximal holder including a port
intended to receive the proximal end of said article, and a distal
holder including a receiving part intended to receive the distal
end of said article, wherein said port and said receiving part are
being aligned on the same longitudinal axis B, and compression
means for putting said article under longitudinal compression
directed towards a center of said article, when said article is
mounted on said supporting device with its longitudinal axis A
aligned on said longitudinal axis B, said kit further comprising a
polarimeter for measuring the stress in the article, when said
article is mounted on said supporting device.
2. The kit according to claim 1, wherein at least one of said port
and receiving part is rotatable around said longitudinal axis
B.
3. The kit according to claim 1, wherein said port is fixed in
translation with respect to said proximal holder along the
direction of said longitudinal axis B.
4. The kit according to claim 1, wherein said receiving part is
movable in translation with respect to said distal holder along the
direction of said longitudinal axis B.
5. The kit according to claim 1, wherein said compression means
comprises biasing means for directing one of said port and said
receiving part toward the other one of said port and receiving
part.
6. The kit according to claim 1, wherein said port is provided with
a distal conic part distally tapered.
7. The kit according to claim 1, wherein said receiving part
comprises a ring traversed by a central channel aligned on said
longitudinal axis B.
8. The kit according to claim 1, comprising said article.
9. The kit according to claim 8, wherein said article has a
substantially tubular shape.
10. The kit according to claim 8, wherein said transparent material
is selected from glass, polyolefin, polycarbonate and combinations
thereof.
11. The kit according to claim 8, wherein said transparent material
is glass.
12. The kit according to claim 8, wherein said article is a syringe
body having a tubular barrel provided with a substantially conic
distal tip, said supporting device comprises a port provided with a
distal conic part distally tapered and a receiving part comprising
a ring traversed by a central channel aligned on said longitudinal
axis B, said distal conic part being engaged by friction in a
proximal end of said tubular barrel and said conic distal tip being
engaged in said central channel when said syringe body is mounted
on said supporting device.
13. The kit according to claim 8, wherein said article is mounted
on said supporting device, and said transparent material has a
refraction index R1, said supporting device and article are
immersed within a liquid having a refraction index substantially
identical to R1.
14. A method for measuring the stress inside an article having a
longitudinal axis A, a proximal end and a distal end and made of a
transparent material, comprising: providing a supporting device for
maintaining under longitudinal compression an article made of a
transparent material having a longitudinal axis A, a proximal end
and a distal end, comprising: a proximal holder including a port
intended to receive the proximal end of said article, and a distal
holder including a receiving part intended to receive the distal
end of said article, wherein said port and said receiving part are
aligned on the same longitudinal axis B, and compression means for
putting said article under longitudinal compression directed
towards a center of said article, when said article is mounted on
said supporting device with its longitudinal axis A aligned on said
longitudinal axis B, and providing a polarimeter for measuring the
stress in the article, when said article is mounted on said
supporting device; mounting said article on the supporting device
by engaging said proximal end of said article into said port and
said distal end of said article into said receiving part, and
applying on said article a longitudinal compressive force of more
than 0 Newton, and measuring the stress inside the article with the
polarimeter by directing the light of said polarimeter towards said
article.
15. The method according to claim 14, wherein said longitudinal
compressive force ranges from above 0 to 1000 N.
16. The method according to claim 14, wherein said longitudinal
compressive force ranges from above 0 to 20 N.
17. The method according to claim 14, wherein said article having a
substantially tubular shape, such as a barrel, said article is
rotated around the longitudinal axis B of an angle selected in the
range of 0-360.degree..
18. The kit according to the claim 8, wherein the article is
selected from the group of a syringe body, a cartridge, a vial and
an ampoule.
19. The method according to claim 14, wherein said longitudinal
compressive force ranges from above 20 to 1000 N.
20. The method according to claim 14, wherein said longitudinal
compressive force ranges from above 300 N to 1000 N.
Description
[0001] The present invention relates to a kit comprising a
supporting device for maintaining under compression in a
substantially determined position an article made of a transparent
material, and a polarimeter for measuring the stress in the
material of the article once said article is mounted on said
supporting device. The article may be a medical device like syringe
bodies or ampoules. The invention further relates to a method for
putting under compression an article made of a transparent
material, such as syringe bodies and/or cartridges and/or ampoules
and/or vials, using such a supporting device and a polarimeter, in
order for example to perform further analysis of said article.
[0002] A lot of medical devices are made of transparent material
such as glass, polycarbonate, polyolefin like polyethylene,
polypropylene, CCP (Cristal Clear polymer) or polystyrene. For such
uses as those of the medical field, these medical devices must be
totally safe and must not break when handled. Moreover, the medical
devices made in brittle material such as glass or polycarbonate
usually show complex shapes such as tubular shapes: this is the
case in particular of syringe bodies, cartridges, ampoules or vials
used for storing and/or administering medicine to a patient.
[0003] Nevertheless, although it is known to measure the stress in
a classical planar piece of transparent material such as flat glass
for example, there still lacks a reproducible method for putting
under compression an article and measuring the amount of stress
inside such an article made of such a transparent material, in
particular when the article has a complex shape.
[0004] Indeed, such a method and means for completing such a method
in a reproducible way would be of great interest. Actually, it
happens that a percentage of the just manufactured syringe bodies
and/or ampoules which are provided to the pharmaceutical companies
in order to be filled in with the adequate medicine may break at
the time they are handled.
[0005] There is therefore a need for a reproducible method for
maintaining in compression, and optionally further measuring the
resistance of, medical articles made of brittle transparent
material such as glass, polyolefin or polycarbonate, and showing
relatively complex shapes, such as tubular shapes.
[0006] The present invention aims at providing means, and in
particular a kit comprising a specific supporting device, able to
maintain, preferably under compression, and rotate the article to
be measured, for completing such a reproducible method.
[0007] A first aspect of the present invention is a kit comprising
a supporting device for maintaining under longitudinal compression
an article made of transparent material and having a longitudinal
axis A, a proximal end and a distal end, said supporting device
including a proximal holder including a port intended to receive
the proximal end of said article, and a distal holder including a
receiving part intended to receive the distal end of said article,
said port and said receiving part being aligned on the same
longitudinal axis B, wherein said supporting device further
comprises compression means for putting said article under
longitudinal compression directed towards a center of said article,
when said article is mounted on said supporting device with its
longitudinal axis A aligned on said longitudinal axis B, said kit
further including a polarimeter for measuring the stress in the
material of the article when said article is mounted on said
supporting device.
[0008] As will appear from the description below, "under
longitudinal compression" means in the present application that,
once the article is mounted on the supporting device of the kit of
the invention, it is submitted to a minimum compressive force,
exerted along the longitudinal axis A of said article and in the
direction of the center of said article, so that said article does
not detach or fall off from said supporting device under the effect
of gravity, regardless of the direction of said longitudinal axis A
and B, which are aligned on each other, with respect to the
environing space: in other words, once the article is mounted on
said supporting device, the article is submitted to said
longitudinal compression regardless of the fact that the
longitudinal axis B is vertical (supporting device in a vertical
position), horizontal (supporting device in a horizontal position)
or inclined (supporting device in any inclined position). In other
words, the longitudinal compressive force applied to said article
corresponds to a force above 0 Newton. As it will also appear from
the description, this longitudinal compressive force may vary in a
range from above 0 to less than 1000 Newton depending on which
measurements need to be performed on said article. For example, the
longitudinal compressive force is the force applied at least one
end, for example at both ends, of the article, in the direction of
the center of the article along its longitudinal axis, once the
article is mounted on the supporting device.
[0009] In the present application, the distal end of an article is
to be understood as meaning the end furthest from the user's hand
and the proximal end is to be understood as meaning the end closest
to the user's hand when the article is in use. Likewise, in this
application, the "distal direction" is to be understood as meaning
the direction of injection, and the "proximal direction" is to be
understood as meaning the opposite direction to the direction of
injection. By similarity, although the supporting device of the kit
of the invention is not intended to be used for an injection
operation, the term "proximal" applied to the supporting device of
the kit of the invention, is used in reference to the part of the
supporting device receiving the proximal end of said article, and
the term "distal" applied to the supporting device of the kit of
the invention, is used in reference to the part of the supporting
device receiving the distal end of said article.
[0010] Thanks to the supporting device of the kit of the invention,
and as will appear from the description below, the medical article,
and in particular the tubular barrel of a syringe body or of a
cartridge or of an ampoule or of a vial, is maintained under
longitudinal compression in a determined position, for example
horizontal, vertical or inclined, by means of its proximal and
distal ends only contacting said supporting device. As a result,
the space surrounding the article to be measured, and in particular
the space surrounding the part of the article to be measured, is
totally free of any disturbing element in the three directions. For
example, the part of the article to be measured need not be in
contact with or bear on an additional support, which would be
likely to distort potential measures to be made on said article. In
addition, in such determined position, the article or the tubular
barrel may be rotated, again by means of its proximal and distal
ends only contacting said supporting device. For example, if
measurements are to be performed on the article with a polarimeter,
there is no need of any additional supporting element that would
interfere with the light sent by the polarimeter in the direction
of the central part of the article or the tubular barrel. In
particular, thanks to the structure and arrangement of the
supporting device of the kit of the invention, the space between
the proximal holder and the distal holder is free from any
additional element. As a consequence, it is possible to use a
polarimeter, and to focus the light of said polarimeter on the
article or on the part of the article to be measured without any
intermediate element located between the polarimeter and the
article or such part of the article to be measured. The light of
the polarimeter encounters therefore no obstacle before reaching
the part of the article to be measured, for example the tubular
barrel of a syringe body.
[0011] In an embodiment of the invention, at least one of said port
and receiving part is rotatable around said longitudinal axis
B.
[0012] In such an embodiment, because at least the port or the
receiving part of the supporting device of the kit of the invention
is rotatable, the article to be measured, once mounted on the
supporting device of the kit of the invention, may be rotated. In
case a polarimeter is used, this allows measuring the value of
stress inside the article, for example inside the tubular barrel,
or inside the distal tip, of a syringe body, after several
rotations of the article or of the tubular barrel or of the distal
tip to be measured. In case the article to be measured has a
complex shape such as a tubular shape, for example a tubular
barrel, this allows obtaining measures at different points of the
circumference of the article or of the barrel, all along said
circumference, and therefore to eventually obtain reproducible
average values of the stress inside the article or barrel.
[0013] In an embodiment of the invention, said port and said
receiving part are both rotatable around said longitudinal axis B.
Such an embodiment allows a safer and smoother rotation of the
article to be measured. The rotation may be completed manually by
the user, or automatically by means of a motor.
[0014] In an embodiment of the invention, said port is fixed in
translation with respect to said proximal holder along the
direction of said longitudinal axis B. For example, when said port
is also rotatable, such an embodiment allows to provide said
proximal holder with a motor so as to render the rotation of said
port automatic: an automatic rotation allows a quicker, safer, more
repeatable and more reproducible rotation. In an embodiment of the
invention, said port being rotatable, said proximal holder is
further provided with a motor so as to render said rotation of said
port automatic.
[0015] In an embodiment of the invention, said receiving part is
movable in translation with respect to said distal holder along the
direction of said longitudinal axis B. Such an embodiment allows
adjusting the length of the space located between the port and the
receiving part, so that articles of various lengths may be mounted
on the supporting device. Such an embodiment also allows adjusting
the longitudinal compressive force to be applied on the article
once said article is mounted on said supporting device, by
increasing or decreasing the distance between the port and the
receiving part.
[0016] In an embodiment of the invention, the compression means
comprises biasing means tending to urge one of said port and said
receiving part toward the other one of said port and receiving
part: for example, said distal holder is provided with biasing
means tending to urge said receiving part in the proximal
direction. Said biasing means may for example be under the form of
a helical spring located around a longitudinal shaft bearing either
the port or the receiving part. The presence of such a biasing
means tending for example to urge the receiving part in the
proximal direction allows the receiving part to abut on the distal
end of the article to be measured, and contributes to set up the
longitudinal compressive force enabling the safe maintaining of the
article in the determined position. Such a longitudinal compressive
force should nevertheless preferably not be greater than 1000 N so
as to avoid that the article breaks once mounted on the supporting
device. For example, in order to warrant that said longitudinal
compressive force does not interfere with the optical vision at the
time of measuring the stress inside the article with a polarimeter,
said longitudinal compressive force is preferably less than 20
N.
[0017] In an embodiment of the invention, said port is provided
with a distal conic part distally tapered. As it will appear later
in the description, such an embodiment allows the port to be
engaged, in particular with friction due to the presence of the
longitudinal compressive force, inside the proximal end of the
tubular barrel of a syringe body, for example at the level of the
flange in the case the syringe body is provided with a proximal
flange. Because the port is engaged with friction inside the
proximal end of the article to be measured, the rotation of the
port will cause the rotation of the article to be measured, such as
the syringe body for example.
[0018] In another embodiment of the invention, said port is
provided with a ring, the distal face of which is provided with a
central recess. Such an embodiment may be used in particular with
an ampoule, a cartridge or a vial having a proximal end provided
with a flat bottom. In such a case, when the ampoule, cartridge or
vial is mounted on the supporting device of the kit of the
invention, the flat bottom of the ampoule, cartridge or vial is
engaged in the central recess provided in the distal face of the
ring, preferably by friction, in particular due to the presence of
the longitudinal compressive force. As seen above for the previous
embodiment, because the flat bottom of the proximal end of the
ampoule, cartridge or vial is engaged with friction inside the
central recess of the distal face of the ring of the port, the
rotation of the port will cause the rotation of the article, ie the
ampoule, the cartridge or the vial for example, to be measured.
[0019] In an embodiment of the invention, said receiving part is
provided with a ring traversed by a central channel aligned on said
longitudinal axis B. Such an embodiment allows the distal tip of a
syringe body or an ampoule for example to be received safely within
the receiving part. In particular, it is possible to mount a
syringe body provided with a needle on the distal tip, the needle
being received within said central channel.
[0020] For example, the proximal portion of said central channel
has the shape of a cone distally tapered. Such a shape is
particularly useful when the article to be measured, such as a
syringe body or an ampoule, has a distal conic tip.
[0021] In alternative embodiments, the receiving part is adapted
for receiving the distal end of a vial, such as a collar for
example. In such a case, the receiving part may be provided with a
ring, the proximal face of which is provided with a central recess
intended to receive said collar.
[0022] In alternative embodiments, the receiving part is fixed in
translation with respect to the distal holder and said distal
holder is provided with a motor so as to render the rotation of
said receiving part automatic. In other embodiments also, the port
may be movable in translation with respect to the proximal holder,
so as to adjust the length of the space defined between the port
and the receiving part to the length of the article to be measured,
and/or so as to adjust the value of the compressive force to be
applied on said article.
[0023] Also, the port may be urged towards the distal direction by
means of a biasing means, in the same manner as described above for
the receiving part.
[0024] In embodiments of the present invention, the kit further
comprises said article made of a transparent material and having a
longitudinal axis A, a proximal end and a distal end.
[0025] By "transparent material" is meant according to the present
application, a material allowing at least 5% of light transmission
in the visible, preferably allowing at least 50% of light
transmission in the visible, and more preferably allowing at least
90% of light transmission in the visible. As an example, glass
usually allows at least 90% of light transmission in the visible.
For example, opalescent materials, which allow at least 5% of light
transmission in the visible, for example at least 50% of light
transmission in the visible, may be used in the present invention.
Translucent materials, which allow the diffusion of a certain
percentage of the light they receive, and which also allow at least
5% of light transmission in the visible, for example at least 50%
of light transmission in the visible, may also be used in the
present invention. Opalescent materials and translucent materials
are therefore comprised in the term "transparent" according to the
present application.
[0026] In an embodiment of the kit of the invention, said article
has a substantially tubular shape, such as a syringe body, a
cartridge, a vial or an ampoule.
[0027] For example, said transparent material is selected from
glass, polyolefin, polycarbonate and combinations thereof. In
embodiments, the transparent material is glass.
[0028] In an embodiment of the kit of the invention, said article
is a syringe body having a tubular barrel provided with a
substantially conic distal tip, said supporting device comprising a
port provided with a distal conic part distally tapered and a
receiving part provided with a ring traversed by a central channel
aligned on said longitudinal axis B, said distal conic part being
engaged by friction in a proximal end of said tubular barrel and
said conic distal tip being engaged in said central channel when
said syringe body is mounted on said supporting device. In
particular, in such an embodiment, when said syringe body is
mounted on said supporting device, said syringe body is maintained
under longitudinal compression.
[0029] In an embodiment of the invention, said syringe body is made
of glass.
[0030] In an embodiment of the invention, said article being
mounted on said supporting device, and said transparent material
having a refractive index RI, said supporting device and article
are immersed within a liquid having a refractive index
substantially identical to RI. Such an embodiment allows measuring
the stress within the thickness of the transparent material forming
the article with a polarimeter: for instance, in the case of a
syringe body having a barrel out of glass, such an embodiment
allows to measure the stress within the thickness of the barrel
wall, using a polarimeter.
[0031] The kit of the invention further includes a polarimeter for
measuring the stress inside the article, once said article is
mounted on said supporting device.
[0032] Alternatively or in combination, the kit of the invention
may further include other analysis instruments, like for example
microscopes or cameras used in combination with a light source such
as UV, visible or LASER light, for measuring other parameters
and/or properties of the article. As examples of such instruments,
one can cite instruments for analyzing the quality of the
homogeneity of the material forming the article along a
circumference of said article for example or along the length of
the article, or the quality of printings performed on the outer or
inner surface of the article, etc. . . . . In embodiments, the
articles to be measured may be provided with an inner coating
and/or an outer coating. In such cases, the kit of the invention
may also include analysis instruments for measuring properties,
like thickness, homogeneity, etc., of said coating(s).
[0033] Another aspect of the invention is a method for measuring
the stress inside an article having a longitudinal axis A, a
proximal end and a distal end and made of a transparent material,
comprising the steps of i) mounting said article on a supporting
device as described above, by engaging said proximal end of said
article into said port and said distal end of said article into
said receiving part, ii) applying on said article a longitudinal
compressive force of more than 0 Newton and iii) measuring the
stress inside the article with a polarimeter by directing the light
of said polarimeter towards said article.
[0034] In embodiments, the longitudinal compressive force ranges
from above 0 to less than 1000 N. In embodiments, the compressive
force ranges from 20 to 1000 N. The longitudinal compressive force
may range from 300 to 1000N.
[0035] For example, the method of the invention may be used for
first stressing the material forming the article and then measuring
the stress inside the article in order to test such material in
such a stressing condition. In such embodiments, the longitudinal
compressive force may range from 20 to 1000 N, preferably from 300
to 1000 N.
[0036] In other embodiments, for example when one wishes to measure
the stress inside the article when said article is not submitted to
specific stressing conditions, the longitudinal compressive force
may range from above 0 to 20 N.
[0037] For example, the longitudinal compressive force may be
adjusted by increasing or decreasing the distance between the port
and the receiving part of the supporting device of the invention.
Alternatively or in combination, the longitudinal compressive force
may be adjusted by selecting a specific constant K for the helical
spring of the supporting device of the kit of the invention as
described above.
[0038] Preferably, said article has a substantially tubular shape,
such as a barrel. Preferably, said article is as described above.
Said article may be chosen among cartridges, syringe bodies,
ampoules and vials as described on FIGS. 2a to 2d and may be made
of transparent material such as glass, polyolefin or
polycarbonate.
[0039] In an embodiment of the method of the invention, said
article having a substantially tubular shape, such as a barrel,
said article is rotated around the longitudinal axis B of an angle
selected in the range of 0-360.degree. and the stress inside the
article is measured.
[0040] Generally, the window of analysis is adapted to the rotation
angle. The smaller the window is, the smaller the angle of analysis
is, the higher the number of measurements is, and then, the more
precise the resulting measurement is.
[0041] For example, the article is rotated 6 times of an angle of
30.degree. and the stress inside the article is measured after each
rotation. A repeatable, reproducible average value of the stress
present inside the article, the barrel in the case of a syringe
body, can therefore be obtained.
[0042] Such a method, thanks to the kit of the invention, allows
obtaining reproducible measures of the stress inside the article
made of the transparent material, the barrel in the case of a
syringe body. In embodiments, the article being a syringe body
comprising a barrel and a distal tip, the stress may be measured
inside the barrel and/or inside the distal tip.
[0043] It is therefore possible to set up a limit value above which
the measured article should not be kept for future operations and
should be disposed of, because too likely to break when
handled.
[0044] The kit and method of the invention will now be further
described in reference to the following description and attached
drawings in which:
[0045] FIG. 1 is a perspective view of the supporting device of the
kit of the invention,
[0046] FIG. 2a is a cross section view of a syringe body that can
be assessed with the measuring method of the invention,
[0047] FIG. 2b is a cross section view of first embodiment of an
ampoule that can be assessed according to the method of the
invention,
[0048] FIG. 2c is a cross section view of a second embodiment of an
ampoule that can be assessed according to the method of the
invention,
[0049] FIG. 2d is a cross section view of a vial that can be
assessed according to the method of the invention,
[0050] FIG. 3 is a cross section view of the supporting device of
FIG. 1 along a plane containing the longitudinal axis B,
[0051] FIG. 4 is a cross section view of the supporting device of
FIG. 3 once the syringe body of FIG. 2a is mounted on said
supporting device.
[0052] With reference to FIGS. 1 and 3 is shown a supporting device
1 of a kit according to the invention, capable of maintaining under
longitudinal compression and rotating an article having a
longitudinal axis A, such as those shown on FIGS. 2a to 2d.
[0053] On FIG. 2a, is shown an article having a substantially
tubular shape under the form of a syringe body 2 comprising a
tubular barrel 3 having a longitudinal axis A, a proximal end 3a
and a distal end 3b. The proximal end 3a of the barrel 3 is
provided with an outer flange 4 providing bearing surfaces for the
user at the time of injection. The distal end 3b of the barrel 3 is
provided with a conic distal tip 5 providing a passage for the
transfer of a medicine contained in the barrel 3 from the syringe 2
to the site of injection. The conic distal tip 5 is intended to
receive a needle (not shown).
[0054] The syringe body 2, as well as the barrel 3, of FIG. 2a are
preferably made out of a transparent material, such as glass,
polyolefin or polycarbonate. Glass and polycarbonate are brittle
material which may break.
[0055] By "transparent material" is meant according to the present
application, a material allowing at least 5% of light transmission
in the visible, preferably allowing at least 50% of light
transmission in the visible, and more preferably allowing at least
90% of light transmission in the visible. Opalescent and
translucent materials are comprised in the term "transparent" as
used in the present application.
[0056] On FIG. 2b is shown another embodiment of an article
suitable for the supporting device 1 of the kit of the invention.
The article of FIG. 2b has a longitudinal axis A and has a
substantially tubular shape under the form of an ampoule 6 intended
to contain a product (not shown) to be administered. Although the
two opposite ends of such an ampoule 6 are identical, for purposes
of the present application, it is hereinafter referred to a
proximal end of the ampoule 6, under the form of a proximal tapered
tip 6a, and to a distal end of said ampoule 6, under the form of a
distal tapered tip 6b, as shown on FIG. 2b.
[0057] The ampoule 6 of FIG. 2b may be made out of transparent
brittle material such as glass, polyolefin or polycarbonate.
[0058] On FIG. 2c is shown another embodiment of an article
suitable for the supporting device 1 of the kit of the invention.
The article of FIG. 2c has a longitudinal axis A and has a
substantially tubular shape under the form of an ampoule 7. The
ampoule 7 has a proximal end under the form of flat bottom 7a, and
a distal end under the form of a distal tapered tip 7b.
[0059] The ampoule 7 of FIG. 2c may be made out of transparent
brittle material such as glass, polyolefin or polycarbonate.
[0060] On FIG. 2d is shown another embodiment of an article
suitable for the supporting device 1 of the kit of the invention.
The article of FIG. 2d has a longitudinal axis A and has a
substantially tubular shape under the form of a vial 8. The vial 8
has a proximal end under the form of flat bottom 8a, and a distal
end under the form of a collar 8b.
[0061] The vial 8 of FIG. 2d may be made out of transparent brittle
material such as glass, polyolefin or polycarbonate.
[0062] Alternatively, the article suitable for the present
invention may be a cartridge.
[0063] With reference to FIGS. 1 and 3, the embodiment of the
supporting device 1 of the kit of the invention shown is
particularly suitable for receiving a syringe body 2 such as
described at FIG. 2a. The supporting device 1 includes a proximal
holder 100, intended to receive the proximal end 3a of the barrel 3
of the syringe body 2 of FIG. 2a, and a distal holder 200, intended
to receive the distal end 3b of the barrel 3 of the syringe body 2
of FIG. 2a.
[0064] On the example shown the proximal holder 100 comprises a
solid body 10 traversed by a shaft 11 extending along the
longitudinal axis B of said solid body 10. At its proximal end 11a,
the shaft 11 is provided with a handle 12 allowing the shaft 11 to
be rotated manually around the longitudinal axis B. In an
alternative embodiment not shown, the solid body 10 is provided
with a motor allowing the automatic rotation of the shaft 11. In
order to facilitate and to better control the rotation of the shaft
11, the solid body 10 may include ball bearings 13 located between
the solid body 10 and the shaft 11, as shown on FIG. 3.
[0065] The shaft 11 is further provided at its distal end 11b with
a port 14 extending beyond said solid body 10 in the distal
direction. The port 14 is provided with a distal conic part 15
distally tapered, the function of which will be explained
later.
[0066] On the example shown, the shaft 11 and therefore the port 14
are fixed in translation with respect to the solid body 10 along
the direction of said longitudinal axis B.
[0067] On the example shown on FIGS. 1 and 3, the distal holder 200
also comprises a solid body 20 traversed by a shaft 21 extending
along the longitudinal axis B of said solid body 20 of said distal
holder 200. The shaft 21 of the distal holder 200 is movable in
translation with respect to said solid body 20 along the direction
of said longitudinal axis B, in the distal or in the proximal
direction. In order to block the shaft 21 in translation with
respect to said solid body 20 in a determined position
corresponding for example to the size of the article to be mounted
on the supporting device, said shaft 21 is provided with a
traversing hole 21a perpendicular to its longitudinal axis: the
traversing hole 21a receives a screw 22 able to slide within a
longitudinal recess 33 arranged in said solid body 20 as said shaft
21 is moved in the distal or proximal direction: when the shaft 21
has reached the adequate determined position, the screw 22 is
tightened so as to come in abutment on the solid body 20, thereby
blocking said shaft 21 in said determined position. The shaft 21
may be advanced in the distal direction or withdrawn in the
proximal direction in order to adjust to the length of the article
to be mounted on the supporting device of the kit of the invention,
and then blocked in translation as just described.
[0068] In an embodiment not shown, the shaft is not provided with a
traversing hole, and the screw is directly tightened on said shaft
21 so as to block it in translation.
[0069] On the embodiment shown on FIGS. 1 and 3, the shaft 21 of
the distal holder 200 is provided at its proximal end with a head
23 lodging a receiving part 24 intended to receive the conic distal
tip 5 of the syringe body 2 of FIG. 2a. The receiving part 24 is
provided with a ring 25 traversed by a central channel 26 aligned
on said longitudinal axis B. The proximal portion 26a of the
central channel 26 has the shape of a cone distally tapered, the
function of which will be explained later.
[0070] As shown on FIG. 3, the central channel 26 of the head 23
may be prolonged by a central hole 27 extending within the shaft 21
on a certain length.
[0071] Moreover, ball bearings 28 are provided between the head 23
and the receiving part 24 allowing the receiving part 24 to rotate
with respect to the head 23.
[0072] An annular seal 32 is mounted around the ring 25 for
securing said ring 25 to the head 23. Biasing means, under the form
of a helical spring 29 located around the shaft 21, are provided,
between the solid body 20 and the head 23. Whatever the relative
position of the shaft 21 with respect to the solid body 20, the
helical 29 spring is in a stressed state, so as to urge the head
23, and therefore the receiving part 24, in a proximal direction.
The inner force of the helical spring 29 contributes to setting up
the desired longitudinal compressive force to be applied to the
article to be mounted on the supporting device 1. For instance, a
specific constant K of the helical spring 29 may be selected in
order to obtain the desired longitudinal compressive force in
function of the size of the article to be mounted on the supporting
device 1. As a result, the helical spring 29 forms part of
compression means for putting the article under longitudinal
compression directed towards the center of the article, when the
article is mounted on the supporting device with its longitudinal
axis A aligned on the longitudinal axis B.
[0073] On the embodiment shown on FIGS. 1 and 3, the supporting
device 1 of the kit of the invention is further provided with a
sole 30 having an even bottom face 31 intended to be put on a
horizontal plane. Both proximal and distal holders (100, 200) of
the supporting device 1 of the kit of the invention are permanently
fixed to said sole 30 so that their position with respect to each
other may not vary.
[0074] As will appear from description of FIG. 4 below, the article
to be measured by the supporting device 1 of FIGS. 1 and 3 is
maintained under longitudinal compression in a substantially
horizontal position once installed on said supporting device 1. As
seen above, the longitudinal compressive force applied to the
article, once said article is mounted on the supporting device is
above 0 Newton, so that said article does not fall off or detach
from the supporting device. Depending on the purposes for which the
article is mounted on the supporting device 1, the longitudinal
compressive force may vary from above 0 to 1000 N.
[0075] For instance, as will appear below, the user may wish to
measure with a polarimeter the properties of the material forming
the article when said material is submitted to a specific stress:
in such a case, the longitudinal compressive force may vary from 20
N to 1000 N, or even from 300 N to 1000 N. In other embodiments,
the user may wish to measure the stress inside the article, with a
polarimeter, under conditions as close to the regular use of said
article as possible. In such a case, the longitudinal compressive
force may vary from above 0 to 20 N in order not to interfere with
the measures of the stress inside the article with the
polarimeter.
[0076] In an embodiment not shown, the proximal and distal holders
(100, 200) may be in a fixed position with respect to each other,
so that the article to be measured is maintained in a vertical
position or in an inclined position, in other words, so that the
longitudinal axis B is vertical or inclined.
[0077] With reference to FIG. 4, the supporting device 1 of FIGS. 1
and 3 is shown with the syringe body 2 of FIG. 2a mounted thereon.
The references designating the same elements as in FIGS. 1, 2a and
3 have been maintained. The syringe body 2 of FIG. 2a is further
provided with a needle 8 fixed at the conic distal tip 5 of the
barrel 3.
[0078] As appears on FIG. 4, the proximal end 3a of the barrel 3 of
the syringe body 2 is engaged on the distal conic part 15 of the
port 14, and the distal end 3b of the barrel 3 of the syringe body
2, in other words the conic distal tip 5, is engaged in the
proximal portion 26a of the central channel 26 of the head 23. As
appears from the figure, the shape of the distal conic part 15 of
the port 14 is adapted to receive syringes having open proximal
ends with a wide range of diameters. The needle 8 is received
within the central hole 27 of the shaft 21, aligned on the central
channel 26. Moreover, the helical spring 29 being in a stressed
state, it contributes to the longitudinal compressive force applied
on the syringe body 2 along its longitudinal axis A and in the
direction of the center of said syringe body, thereby allowing the
proximal end 3a and the distal end 3b to be engaged respectively
with said port 14 and said receiving part 24 with friction. This
longitudinal compressive force, while being above 0 Newton, is
nevertheless preferably less than 1000 N, and more preferably less
than 20 N in order not to interfere with the measures of the stress
inside the article with a polarimeter as described below.
[0079] As a consequence, when the shaft 11 of the proximal holder
10 is rotated around the longitudinal axis B, for example manually
by a user operating the handle 12, the syringe body 2 and the
barrel 3 are caused to also rotate around the longitudinal axis
B.
[0080] Moreover, as appears clearly on FIG. 4, the structure and
arrangement of the supporting device 1 of the kit of the invention
allows the syringe body 2, and in particular the barrel 3, to be
maintained in a determined position, and to be rotated in said
position, by means of its proximal and distal ends (3a, 3b) only
being in contact with the supporting device 1. Thanks to the
supporting device 1 of the kit of the invention, there is no need
of any intermediate part or element having to be operated in the
vicinity of the tubular barrel 3. As a consequence, when the
article, for example the syringe body 2, is analyzed with a
polarimeter, the light coming from the polarimeter, for example
along the direction materialized by the arrow R on FIG. 4 or from
any other direction around the article or syringe body 2, does not
encounter undesired obstacle before reaching the barrel 3. This
allows obtaining reliable measures of the stress present inside the
barrel 3. Actually, the light sent by the polarimeter goes through
a first wall of the barrel 3 and through the diametrically opposed
wall of said barrel 3. The polarimeter therefore measures the
addition of the stress present inside the two walls of the barrel 3
traversed by the light: it measures the stress present inside the
barrel 3.
[0081] In an embodiment not shown, the syringe body 2 of FIG. 4 is
replaced by one of the ampoule (6; 7) of FIGS. 2b and 2c. In such
embodiments, the port of the supporting device of the kit of the
invention is provided with a ring, the distal face of which is
provided with a central recess. When the ampoule 6 of FIG. 2b is to
be mounted on the supporting device of the kit of the invention,
the central recess is similar to the central channel of the
receiving part 24 of FIGS. 1 and 3 in order to receive the conic
proximal end 6a of the ampoule 6. Alternatively, when the ampoule 7
of FIG. 2c is to be mounted on the supporting device of the kit of
the invention, the central recess of the ring of the port has inner
dimensions adapted to receive the flat bottom 7a of the proximal
end 7a of the ampoule 7.
[0082] In an embodiment not shown, the vial 8 of FIG. 2d is mounted
on the supporting device of the kit of the invention: in such a
case, each of the port and the receiving part comprises a ring
provided with a central recess intended to receive the flat bottom
8a, respectively the collar 8b.
[0083] Alternatively, a cartridge may be mounted and put under
longitudinal compression on the supporting device of the kit of the
invention, so as to be further assessed.
[0084] The method of the invention for putting under compression,
measuring the stress inside, and optionally further assessing the
quality and/or the strength of, an article having a longitudinal
axis A, a proximal end and a distal end, said article being made of
a transparent material such as glass, polyolefin or polycarbonate
can therefore be implemented as follows: the article to be measured
is mounted on the supporting device 1 as described above for FIG.
4, ie by engaging said proximal end of said article into said port
and said distal end of said article into said receiving part, and
applying on said article a longitudinal compressive force of more
than 0 Newton. The value of the longitudinal compressive force may
be adjusted as described above. In case a measure of the stress
inside the article under no specific stressing conditions is to be
performed, the longitudinal compressive force is generally less
than 20 N and a polarimeter is used. Alternatively, in case a
measure of the stress inside the article under specific stressing
conditions is to be performed, the longitudinal compressive force
ranges generally from 20 N to 1000 N, or even from 300 N to 1000 N
and a polarimeter is used. A first measure may be completed using
the polarimeter, the light of which is directed towards the part of
the article to be assessed, in particular towards the tubular
barrel 3 in case of a syringe body 2 as described in FIG. 2a.
Alternatively or in combination, the stress inside the distal tip
may also be measured.
[0085] Any known polarimeter is suitable for the method of the
invention. As an example, one can cite the polarimeter "STRAMO"
from the company SGCC.
[0086] For example, the following steps may be completed: After a
first measure is completed, the article, the syringe body 2 of FIG.
4, is rotated for example by an angle of 30.degree.. A second
measure is completed. This step is repeated 5 times. The method of
the invention allows performing a series of at least six measures
for example, all around the circumference of the barrel 3 of the
syringe 2, thereby enabling to obtain reliable average values. The
method of the invention is therefore reproducible and can be used
in an industrial process in order to determine whether the syringe
bodies of a batch just manufactured are likely to break in the
future or not.
[0087] For example, it is possible to determine a maximum limit
value of stress above which it is decided that the risk that the
syringe body breaks when subsequently handled for example during a
fill in operation is too high, therefore justifying that said
syringe body be disposed of. It is then possible to implement the
method of the invention at an industrial process level in order to
maintain only the syringe bodies satisfying to a stress value,
measured according to the method of the invention, below said
maximum limit value.
[0088] In an embodiment of the invention not shown, the supporting
device 1 and the syringe body 2 mounted thereon as shown on FIG. 4
are immersed within a liquid having a refractive index
substantially identical to that of the transparent material forming
the barrel 3, for example glass. Such an embodiment allows
measuring the stress within the thickness of the wall of the
barrel, with a polarimeter, and not only inside the barrel 3, as
explained above.
[0089] The kit and the method of the invention therefore allow
improving the manufacturing process of articles made of a brittle
transparent material such as syringe bodies and ampoules in the
medical field.
* * * * *