U.S. patent application number 17/247154 was filed with the patent office on 2021-03-18 for fluid connection system and production method.
The applicant listed for this patent is SARTORIUS STEDIM FMT SAS. Invention is credited to Florian BLAKE, Isabelle GAY.
Application Number | 20210080043 17/247154 |
Document ID | / |
Family ID | 1000005252102 |
Filed Date | 2021-03-18 |
![](/patent/app/20210080043/US20210080043A1-20210318-D00000.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00001.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00002.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00003.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00004.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00005.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00006.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00007.png)
![](/patent/app/20210080043/US20210080043A1-20210318-D00008.png)
United States Patent
Application |
20210080043 |
Kind Code |
A1 |
BLAKE; Florian ; et
al. |
March 18, 2021 |
FLUID CONNECTION SYSTEM AND PRODUCTION METHOD
Abstract
Disclosed is a fluid connection system including a sleeve, a
pipe and a fluid connector, the fluid connector including at least
one rigid body made from a sterilizable biocompatible material, and
the pipe including a flexible connection portion made from a
sterilizable biocompatible material that is at least partially
elastomeric. The fluid connector and the flexible connection
portion of the pipe are assembled to one another, with the flexible
connection portion of the pipe surrounding the rigid body, and the
sleeve being shrunk tightly, but with free movement, on the
pipe.
Inventors: |
BLAKE; Florian; (La Ciotat,
FR) ; GAY; Isabelle; (Peypin, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SARTORIUS STEDIM FMT SAS |
Aubagne |
|
FR |
|
|
Family ID: |
1000005252102 |
Appl. No.: |
17/247154 |
Filed: |
December 2, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15528298 |
May 19, 2017 |
10883643 |
|
|
PCT/FR2015/053156 |
Nov 20, 2015 |
|
|
|
17247154 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
F16L 33/2071 20130101;
A61M 2207/00 20130101; A61M 2205/0216 20130101; F16L 2201/44
20130101; F16L 47/22 20130101; A61M 39/00 20130101; A61M 39/10
20130101; A61M 39/16 20130101; A61M 39/12 20130101; A61M 39/1011
20130101; F16L 33/30 20130101; F16L 33/22 20130101; A61M 2039/1066
20130101 |
International
Class: |
F16L 47/22 20060101
F16L047/22; A61M 39/00 20060101 A61M039/00; A61M 39/16 20060101
A61M039/16; A61M 39/10 20060101 A61M039/10; F16L 33/22 20060101
F16L033/22; A61M 39/12 20060101 A61M039/12; F16L 33/207 20060101
F16L033/207; F16L 33/30 20060101 F16L033/30 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 21, 2014 |
FR |
14 61311 |
Claims
1. Fluid connection system comprising a sleeve, a hose, a fluid
connector, and a hose clamp, said fluid connector comprising at
least one rigid body made of a sterilizable biocompatible material,
defining a first bore, the rigid body comprising a first endpiece
portion for mechanical assembly, said hose comprising a flexible
connection portion made of at least partially elastomeric
sterilizable biocompatible material, defining a second bore and an
end, the flexible connection portion comprising a second portion
for mechanical assembly, the fluid connector and the flexible
connection portion of the hose being assembled to one another by
mechanical engagement in an assembly region of the first endpiece
portion and second endpiece portion for mechanical assembly, in an
assembly configuration in which the flexible connection portion of
the hose surrounds the rigid body, and the first and second bores
are in fluid communication with each other, said hose clamp being
tightened onto the hose in the assembly region, said sleeve being
shrunk to be tight but with free movement on the hose and on the
hose clamp and extending over a provided stiffening region
extending over at least a portion of the assembly region, the
stiffening region extending from the end of the hose, the sleeve
extending from the end of the hose and along a portion of the hose
beyond the assembly region.
2. Fluid connection system according to claim 1, wherein the hose
clamp is tightened directly onto the hose in the assembly region
before placement of the sleeve.
3. Fluid connection system according to claim 1, wherein the sleeve
fits the shape of the hose clamp at the assembly.
4. Fluid connection system according to claim 1, wherein the hose
clamp is a plastic hose clamp.
5. Fluid connection system according to claim 4, wherein the hose
clamp comprises a system of catches on a strip, engaging with a
locking hook arranger in a head of said hose clamp, such that
clamping of the hose clamp is not reversible.
6. Fluid connection system according to claim 1, wherein the hose
clamp Is a metal hose clamp.
7. Fluid connection system according to claim 6, wherein the hose
clamp comprises a form of a preformed ring having at least one ear
projecting outward relative to the preformed ring, and wherein the
ears are configured to be crimped by a tool to narrow a diameter of
the preformed ring, causing permanent deformation and allowing the
hose clamp to be tightened onto the hose.
8. Fluid connection system according to claim 1, wherein, after
being placed and shrunk, the sleeve totally recovers the hose
clamp; such that the sleeve is able to smoothen any protruding part
of said hose clamp.
9. Fluid connection system according to claim 1, wherein the
sleeve, after being placed and shrunk, extends from either sides of
the hose clamp,
10. Fluid connection system according to claim 1, wherein the
sleeve is of thermoshrinkable material.
11. Fluid connection system according to claim 1, wherein the
sleeve and the hose clamps are the sole means of stiffening the
hose on the fluid connector.
12. Method for manufacturing a fluid connection system between a
hose and a fluid connector, said fluid connector comprising at
least one rigid body made of a sterilizable biocompatible material,
defining a first bore, the rigid body comprising a first endpiece
portion for mechanical assembly, said hose comprising a flexible
connection portion of an at least partially elastomeric
sterilizable biocompatible material, defining a second bore and an
end, the flexible connection portion comprising a second portion
for mechanical assembly, the method comprising the following two
steps carried out in any order: the fluid connector and the
flexible connection portion of the hose are assembled to one
another by mechanical engagement in an assembly region of the first
and second portions for mechanical assembly, in an assembly
configuration in which the flexible portion of the hose surrounds
the rigid body, over an assembly region, the first and second bores
being in fluid communication with each other, a hose clamp is
mounted on the house in the assembly region, and its diameter is
reduced such that the hose clamp is mounted tight on the hose, a
sleeve is positioned loosely around the hose, in such way that said
sleeve recovers the hose clamp, said sleeve being of
thermo-shrinkable material, said sleeve extending over a
predetermined stiffening region extending over at least a portion
of the assembly region, the method then comprising the following
step: said sleeve is shrunk to be tight but with free movement on
the hose, extending over a predetermined stiffening region
extending over at least a portion of the assembly region, the
stiffening region extending from the end of the hose, the sleeve
extending from the end of the hose and along a portion of the hose
beyond the assembly region.
13. Manufacturing method according to claim 12, wherein the sleeve
is shrunk by applying a temperature of more than 80.degree. C. for
longer than 3 seconds at the sleeve.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to fluid connection systems
for the fluidtight transfer of medical and biopharmaceutical
fluids, and to their manufacturing methods.
BACKGROUND OF THE INVENTION
[0002] There are already commonly known fluid connection systems
for the fluidtight transfer of medical and biopharmaceutical fluids
using a hose clamp to retain a tube on a plastic endpiece, in
patent application FR1356350. However, placement of the clamp
requires mechanically clamping it on the hose and cutting off its
end, which runs the risk of particulate contamination. In addition,
there is the problem of tightening all clamps with uniform clamping
forces from clamp to clamp, due to the difficulty of automating
this process. The use of such clamps also poses problems in keeping
a constant tightening torque throughout the life of the product
(difficult because of creep over time in the plastic material of
the elements of the fluid connection system). Finally, the design
of these clamps does not allow uniform clamping all along the
periphery of the fluid connection. This assembly method also
adversely impacts clean room productivity since the hose clamp
placement, tightening, and cutting are done manually and the total
technical time required is particularly long. In addition, certain
constituent materials of the clamp may be sources of contamination
for the very clean environments (clean room, etc.) in which they
are used. And finally, despite precautions, a hose clamp could
damage nearby flexible pouches or tubes with a potentially damaging
part of said clamp.
[0003] Also commonly known is a fluid connection system for the
fluidtight transfer of medical and biopharmaceutical fluids, using
gripping rings. Document EP1998096 for example discloses such
connections. However, these connection systems have limited
resistance to fluid pressure at the connection, and there is the
issue of adapting the dimensions to the use.
[0004] Also known is a fluid connection system between a connector
and a hose using a thermoshrinkable sleeve, for example disclosed
in document DE102005024621. This system calls for adhering the
sleeve to the underlying tube or connector to attach it and to
prevent the entry of foreign particles at the hose/connector
connection. The use of an adhesive may be unsuitable for the
underlying material, and is temperature sensitive. In addition, the
use of an adhesive runs the risk of contaminating the
biopharmaceutical fluid. There is also the risk of deterioration of
the components in contact with the adhesive, and migration into the
biopharmaceutical fluid of contaminants originating from this
deterioration.
[0005] An alternative solution for the hose/connector assembly
specially adapted for the biopharmaceutical field is therefore
sought.
OBJECTS AND SUMMARY OF THE INVENTION
[0006] To this end, according to the invention, a fluid connection
system comprises a sleeve, a hose, and a fluid connector, said
fluid connector comprising at least one rigid body made of a
sterilizable biocompatible material, defining a first bore, the
rigid body comprising a first endpiece portion for mechanical
assembly, said hose comprising a flexible connection portion made
of an at least partially elastomeric sterilizable biocompatible
material, defining a second bore and an end, the flexible
connection portion comprising a second portion for mechanical
assembly, the fluid connector and the flexible connection portion
of the hose being assembled to one another by mechanical engagement
in an assembly region of the first endpiece portion and second
endpiece portion for mechanical assembly, in an assembly
configuration in which the flexible connection portion of the hose
surrounds the rigid body, and the first and second bores are in
fluid communication with each other, said sleeve being shrunk to be
tight but with free movement on the hose and extending over a
predetermined stiffening region extending over at least a portion
of the assembly region.
[0007] In the case of such a connection system, no adhesive is
required between the elements to be assembled, which reduces the
risk of contamination. With such a connection system, the
tightening of the hose and the connector onto one another
compensates for manufacturing tolerances in the connector and hose,
which improves the seal and the mechanical strength. In addition,
the sleeve eliminates the risk of separation between the connector
and hose, related to the increase in pressure inside the hose which
can lead to leaks in the assembly region between the hose and
connector.
[0008] In various embodiments of the connection system according to
the invention, one or more of the following arrangements may
possibly be used: [0009] the stiffening region extends from the
hose end, [0010] the first endpiece portion for mechanical assembly
of the fluid connector comprises at least one catch projecting
radially outward, the second portion for mechanical assembly of the
hose being positioned above said at least one catch during assembly
of the fluid connector and the flexible connection portion of the
hose, said catch being adapted to retain the hose around the rigid
body, [0011] said catch is adapted to ensure proper retention of
the hose when tensile force is applied, [0012] the at least one
catch is molded in the radially outer surface of the fluid
connector, [0013] the first endpiece portion for mechanical
assembly of the fluid connector comprises a stop, said stop forming
an axial stop surface for the second portion for mechanical
assembly in the assembly configuration and a front surface opposite
to the stop surface, [0014] the sleeve covers the stop, bearing
against the front surface of said stop. This allows for better
retention of the sleeve. [0015] the sleeve extends from the hose
end and along a portion of the hose beyond the assembly region, For
a long sleeve which encloses the entire assembly region, it
prevents the flexible hose from swelling near the assembly region,
as such swelling can result in leaks. [0016] the sleeve extends
from the hose end and along a portion of the hose strictly within
the assembly region, [0017] the sleeve extends between the hose end
and the catch, [0018] the components are rotationally symmetrical,
[0019] the sleeve is created as one piece with no predetermined
breaking point, [0020] the sleeve is the sole means of stiffening
the hose on the fluid connector, [0021] a hose clamp is tightened
onto the hose in the assembly region before placement of the
sleeve. In addition, in the possible case where a hose clamp is
used at the assembly between the hose and connector to ensure
better retention of the assembly and a better seal, a sleeve
provided around the assembly and hose clamp will protect the
environment against possible contamination of the environment by
material from the clamp and will prevent the geometry of the clamp
from damaging other components in the environment.
[0022] The invention further relates to a method for manufacturing
a fluid connection system between a hose and a fluid connector,
[0023] said fluid connector comprising at least one rigid body made
of a sterilizable biocompatible material, defining a first bore,
the rigid body comprising a first endpiece portion for mechanical
assembly, [0024] said hose comprising a flexible connection portion
made of an at least partially elastomeric sterilizable
biocompatible material, defining a second bore and an end, the
flexible connection portion comprising a second portion for
mechanical assembly, [0025] the method comprising the following two
steps carried out in any order: [0026] the fluid connector and the
flexible connection portion of the hose are assembled to one
another by mechanical engagement in an assembly region of the first
and second portions for mechanical assembly, in an assembly
configuration in which the flexible portion of the hose surrounds
the rigid body, over an assembly region, the first and second bores
being in fluid communication with each other, [0027] a sleeve is
positioned loosely around the hose, said sleeve being of
thermoshrinkable material, said sleeve extending over a
predetermined stiffening region extending over at least a portion
of the assembly region; [0028] the method then comprising the
following step: [0029] said sleeve is shrunk to be tight but with
free movement on the hose, extending over a predetermined
stiffening region extending over at least a portion of the assembly
region.
[0030] In one embodiment of the method of the invention, the
following provision may possibly also be used: [0031] the sleeve is
shrunk by applying a temperature of more than 80.degree. C. for
longer than 3 seconds at the sleeve.
[0032] With no need for cutting a hose clamp and with no sharp
edges, particulate contamination is reduced and the risk of
protruding areas causing perforation damage to pouches is
reduced.
[0033] In addition, as shrinkage of the sleeve 1 onto the hose 2
can be carried out with an automated machine, possibly in parallel
with other steps, productivity is improved.
[0034] Other features and advantages of the invention will be
apparent from the following description of one of its embodiments,
given by way of non-limiting example, with reference to the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] In the drawings:
[0036] FIG. 1 is a representation of the fluid connection
system,
[0037] FIG. 2 is a representation of a connector mounted between a
hose and a pouch,
[0038] FIGS. 3a-d are a representation of the fluid connection
system when the sleeve covers the entire assembly portion, before
and after shrinking,
[0039] FIG. 4 shows an example of a production facility,
[0040] FIGS. 5a-d are a representation of the fluid connection
system when the sleeve partially covers the assembly portion,
before and after shrinking,
[0041] FIGS. 6a-b are a representation of the fluid connection
system with a sleeve retaining rib,
[0042] FIG. 7 is a representation of the fluid connection system
when a hose clamp is used prior to assembly,
[0043] FIG. 8 illustrates a plastic hose clamp,
[0044] FIG. 9 illustrates a metal hose clamp,
[0045] FIGS. 10a-b are a representation of alternative geometries
of the sleeve.
[0046] In the various figures, the same references designate
identical or similar elements.
MORE DETAILED DESCRIPTION
[0047] FIG. 1 shows a fluid connection system comprising a sleeve 1
that encloses the assembly between a hose 2 and a connector 3
(partially represented). The fluid connection system is intended
for the transfer of biopharmaceutical fluid.
[0048] In the context of the invention, the term "biopharmaceutical
fluid" is understood to mean a fluid derived from
biotechnology--culture media, cell cultures, buffer solutions,
artificial nutrition liquids, blood components and blood products
derived therefrom, or a pharmaceutical fluid, or more generally a
fluid for use in the medical field. Such fluids preferably have
high purity requirements and must not be contaminated with foreign
particles, whether these are particles from devices in contact with
the fluids for their containment, transportation, or processing, or
particles from the atmosphere surrounding these devices.
[0049] In the current example, in the final configuration of the
system the sleeve 1 extends in the longitudinal direction X of
assembly, around the hose 2 and the connector 3.
[0050] The sleeve 1 is positioned in an initial configuration
around the assembly between the hose 2 and the connector 3, and
then shrunk to enclose the assembly. The sleeve extends over a
stiffening region 7. The shrinking consists of reducing the inside
diameter of the sleeve 1, which is concurrent for example with a
decrease in the outside diameter thereof. Thermoshrinking is
performed for example, in which the application of heat or cold to
the sleeve 1 results in this decrease. In particular, such
application leads to a decrease in the inside diameter of the
sleeve to be greater than that of the outside diameter of the
underlying components. This decrease in the inside diameter of the
sleeve 1 thus takes place while the hose 2 and connector 3 remain
assembled together.
[0051] The sleeve 1 is shrunk to be tight but with free movement on
the hose 2. This assembly with free movement is such that the
thermoshrunk sleeve 1 remains movable on the underlying hose 2 if
the friction force between the sleeve 1 and the hose 2 is overcome.
In practice, it is not otherwise attached to the assembly aside
from the friction, but is not movable. The friction force between
the sleeve and hose 2 is greater than another force that would
disassemble the system, for example the force to detach the hose 2
and connector 3.
[0052] The permitted pressure when using this type of connection
assembly after tightening the sleeve can reach 3 bars inside the
hose 2.
[0053] As illustrated in FIG. 1, the sleeve 1 has for example a
generally cylindrical shape along the axis X. The sleeve 1
comprises a hollow elongated body.
[0054] As illustrated in FIG. 1, the fluid connector 3 comprises at
least one rigid body 4, said body defining a first bore 4'. The
body of the connector 3 comprises a first endpiece portion for
mechanical assembly 10.
[0055] As illustrated in FIG. 1, the hose 2 comprises a flexible
connection portion 12 defining a second bore 12' and an end 6. The
flexible connection portion comprises a second mechanical assembly
portion 20.
[0056] The rigid body 4 of the fluid connector 3 is made of a
sterilizable biocompatible material. The rigid body is for example
of plastic, polyethylene (PET), polypropylene (PP), polycarbonate,
polyethersulfone (PES), or other suitable material.
[0057] The flexible connection portion of the hose 2 is deformable.
The flexible portion is made of a sterilizable biocompatible
material, at least partially elastomeric, for example TPE or
silicone. The hose 2 may be created to be flexible, which
facilitates for example the connection of two containers using the
hose. In addition, the flexible connection portion can be deformed
for assembly to the rigid body 4. The outside diameter of the hose
2 is for example not more than 4 cm.
[0058] As also illustrated in FIG. 1, the fluid connector 3 and the
flexible connection portion of the hose 2 are assembled together by
mechanical engagement (friction) in an assembly region 5 of the
first 10 and second 20 portions for mechanical assembly. In this
assembly configuration, the flexible portion 12 of the hose 2
surrounds the rigid body 4 and is in close contact therewith. The
first and second bores 4', 12', are in fluid communication with
each other.
[0059] The assembly may be achieved for example by forced insertion
of the flexible portion 12 of the hose 2 around the rigid body 4,
the bore of the hose 2 and the bore of the connector 3 then being
in fluid communication. This single forced insertion may be
sufficient to hold the hose 2 and connector 3 together, at least
when there is no flow through the connector 3 and/or no significant
mechanical stress on the connector/hose assembly.
[0060] The connector 3 may for example be a hollow rigid body
having two ends: one end comprised within the first endpiece
portion for mechanical assembly 10, and a second opposite end. The
two opposite ends are in fluid communication with each other. The
connector 3 is for example molded as one piece.
[0061] The connector 3 is for example assembled to a container 30
of biopharmaceutical product so as to allow fluid communication
with the interior thereof, as illustrated in FIG. 2. The container
30 is for example a flexible pouch. The connector 3 is for example
welded to a pouch by its second end, for example by a portion 25 of
the rigid body 4 other than the first endpiece portion for
mechanical assembly 10, so that the inside of the pouch is in fluid
communication with the bore 4'.
[0062] The second end may also be integrated with a multi-connector
in the shape of a Y, T, etc., to provide a connection between
hoses, or may be integrated with a clip-on connector, male or
female, to provide a connection of pouch to hose or hose to
hose.
[0063] The connector 3 may also include a flange 23 (FIG. 3a). Said
flange 23 is for example provided at the outer surface of the
connector 3. It extends radially along the circumference of the
connector 3. It comprises a side facing the hose 2 and an opposite
side in the longitudinal direction X. Its side opposite to the side
facing the hose may serve as a support for insertion, abutting
against another element on the connector 3 on the side opposite to
the connector 3/hose 2 assembly in the longitudinal direction
X.
[0064] The thermoshrinkable sleeve 1 may be for example of
polyethylene terephthalate (PET), polypropylene (PP), ethylene
tetrafluoroethylene (ETFE).
[0065] The entire assembly described above is preferably
rotationally symmetrical.
[0066] In a first embodiment, illustrated in FIGS. 3a-d, the first
10 and second 20 portions for mechanical assembly overlap in the
assembly region 5.
[0067] The first endpiece portion for mechanical assembly 10 of the
fluid connector 3 comprises at least one catch 21. The catch 21 is
for example provided on the surface of the first endpiece portion
for mechanical assembly 10 of the fluid connector 3, over the
entire circumference of the connector for example, thus not
defining areas of concentrated stress. The catch 21 could also be
provided on only a portion of the circumference.
[0068] Several catches, for example (regularly) spaced along the
axial direction, may be provided for example on the surface of the
first endpiece portion for mechanical assembly 10.
[0069] During assembly of the fluid connector 3 and the flexible
connection portion 12 of the hose 2, the hose 2 surrounds the rigid
body 4 and the second portion for mechanical assembly 20 of the
hose 2 is placed above said at least one catch 21: the hose 2 then
has a retaining inside diameter that is greater than the inside
diameter of the unmounted hose 2. This deformation guarantees a
certain tightening of the hose 2 on the connector 3. This
configuration is called the "assembly configuration" of the hose 2
and connector 3.
[0070] The catch 21 retains the hose 2 when tensile force is
applied to the hose 2 along its longitudinal axis X.
[0071] Biocompatible coatings on the radially outer surface of the
first endpiece portion for mechanical assembly 10 may be used to
increase adhesion of the surface of the connector 3 to the hose 2
when tensile force is applied.
[0072] The connector 3 may, for example, also include a stop ring
22 which serves as a stop for insertion of the hose 2 onto the
rigid body 4, during assembly of the fluid connector 3 and the
flexible portion 12 of the hose 2.
[0073] The stop 22 may for example be provided on the surface of
the rigid body 4.
[0074] The sleeve 1 is then positioned loosely around the assembly
region 5 as shown in FIGS. 3a and 3b. In this embodiment, said
sleeve 1 extends over a stiffening region 7 provided from the end 6
of the hose 2 and beyond the assembly region 5 on the hose 2.
[0075] Alternatively, the stiffening region 7 may extend
continuously over a portion of the connector 3 upstream of the
assembly region 5 then into the assembly region 5 and beyond the
assembly region 5 on the hose 2 in the longitudinal direction X
(not shown).
[0076] The thermoshrinkable sleeve 1 has an inside diameter that is
greater than the outside diameter of the hose 2 in the assembled
configuration, to enable such assembly. The sleeve 1 has the
ability to shrink onto the hose when heated in order to retain the
hose on the connector as shown in FIGS. 3c and 3d.
[0077] The sleeve may be heated by hot air. Such heating may then
be done for example using one or more nozzle(s) which blow a stream
of hot gas (for example air) around the sleeve 1. FIG. 4 shows an
illustrative example of one embodiment. A gripping system 26 is
used to position the assembly region 5 at the relevant location in
the production facility. This system is for example a clamp holding
the connector 3 and a clamp holding the hose 2, arranged so that
the assembly region 5 is centered about an assembly station axis
X.sub.0. A support 27 surrounds axis X.sub.0 and carries a
plurality of blowing nozzles 28 arranged circumferentially about
axis X.sub.0. The nozzles 28 are connected to a source 29 of hot
gas by means of appropriate piping 31. Such a method can be carried
out in a short period relative to the time required for the
assembly of such fluid connection systems, for example a period of
less than 1 minute, to reach a shrinking temperature above
80.degree. C. at the sleeve.
[0078] The sleeve could also be heated by bringing a heating
element close to the sleeve. The heating time can range from 3
seconds to 30 seconds at temperatures from 80.degree. C. to
350.degree. C. depending on the distance between the heating
element and the sleeve 1. For example, a hot annular element
surrounding axis X.sub.0 is used.
[0079] The method enables shrinking the sleeve onto the hose 2
within a few seconds for example. The diameter of the sleeve 1
would for example shrink by 50% with the present method when there
are no underlying components.
[0080] In another variant, the heat may be provided by thermal
welding (non-contact infrared). In such a method, the radiation
source may be arranged around the sleeve 1 at a distance therefrom,
or extend axially for a limited distance and be moved axially back
and forth along the sleeve (along axis X.sub.0). This also applies
to the other methods described above.
[0081] Alternatively, the heat may be provided by dipping in a hot
liquid (for example water).
[0082] The sleeve 1 could also be elastically stretched to increase
its diameter, prior to its mounting on the assembly, in order to
increase the retention force. The sleeve 1 is stretched for example
and placed on the hose 2 over the assembly region 5. The hose 2 and
connector 3 are then assembled, and the sleeve 1 released so that
it elastically clamps the hose 2. The sleeve 1 accepts the increase
in diameter of the hose 2 resulting from its assembly on the
connector.
[0083] In the case of a rotationally symmetrical system, the
360.degree. clamping of the hose 2 compensates for manufacturing
tolerances of the connector 3 and hose 2, which improves the seal
and mechanical strength.
[0084] The catch 21 also retains the sleeve 1 in position in the
longitudinal direction X.
[0085] Once tightened, the sleeve 1 applies 360.degree. of radial
pressure on the hose 2, to seal the interface between the fluid
connector 3 and the hose 2 under pressure. During the passage of a
biopharmaceutical fluid, possibly under pressure, between the
flexible hose and the connector, the sleeve rigidly maintains the
connection between the flexible hose and the connector, thereby
reducing the risk of hose deformation at the interface with the
connector and consequently the chance of a leak.
[0086] By applying thermal activation of the sleeve 1 in a
controlled manner, the hose 2 is thus uniformly stiffened in the
stiffening region 7 over the periphery of the hose.
[0087] The sleeve 1 follows the shape of the assembly that it
covers, in the area it covers.
[0088] In one embodiment, illustrated in FIGS. 5a-5d, the sleeve 1
is shorter than the assembly region 5. The sleeve 1 extends over a
stiffening region 7 provided from the end of hose 2 and over a
portion of the assembly region 5 in the longitudinal direction
X.
[0089] Alternatively, in the case where the surface of the first
endpiece portion for mechanical assembly 10 comprises both a catch
21 and a stop 22, the sleeve 1 may be placed axially between the
stop 22 and the catch 21.
[0090] Alternatively, the stiffening region 7 may extend
continuously over a portion of the connector 3 upstream of the
assembly region 5 then over a portion of the assembly region 5 in
the longitudinal direction X (not shown).
[0091] In another embodiment, shown in FIGS. 6a-6b, the sleeve 1
shrinks and grips the stop 22 of the first endpiece portion for
mechanical assembly 10, the sleeve enclosing the stop 22 in order
to better encapsulate the assembly of the fluid connector 3 with
the flexible connection portion 12 of the hose 2. In the example
presented, the sleeve 1 shrinks to fit tightly onto the face of the
stop 22 opposite the face receiving the hose 2.
[0092] In another embodiment, shown in FIG. 7, a hose clamp 8 is
mounted beforehand on the previously described assembly of the
connector 3 and hose 2. The thermoshrinkable sleeve 1 is then
positioned on the previously described assembly, to surround the
assembly and the hose clamp 8, and is shrunk. The sleeve 1 then
snugly fits to the shape of the clamping collar 8 at the
assembly.
[0093] A plastic hose clamp may be used for example, of Rilsan.RTM.
polyamide for example. This type of plastic clamp, shown in FIG. 8,
comprises a system of catches 32 on a strip 33 which engage with a
locking hook arranged in the head 34, such that the clamping is not
reversible. In other words, once the strip 33 is engaged with the
head 34 to form a loop, one pulls on the strip 33 to reduce the
diameter of the loop and tighten the hose clamp 8, the locking hook
engaging with one of the catches 32 of the strip 33 to prevent
loosening. Once tightened, to prevent the strip from extending too
far beyond the diameter of the hose clamp loop, the free portion of
the strip is cut near the head of the clamp. The remaining
undetached portion 35 of the strip often has a sharp edge which can
cut.
[0094] Alternatively, one may also use a metal clamp such as a
crimpable ring, illustrated in FIG. 9, which is in the form of a
preformed ring 36 provided having one or two ears 37a, 37b
projecting outward relative to the general shape of the ring, this
type of clamp being sold by the company Oetiker.RTM.. After
insertion of the clamp onto the tube to be retained, a tool is used
to crimp the ear (or ears) of the clamp which causes permanent
deformation and thus narrows the main diameter of the ring and
therefore tightens the clamp on the tube. This type of clamping
with a metal ring is particularly robust and reliable. However, at
the point where the ear is crimped by the tool, there may be
roughness or a burr forming a sharp edge that could cause
damage.
[0095] The addition of the sleeve 1 to the assembly prevents any
protruding portion of the clamp from piercing adjacent pouches for
example during transportation or even from injuring the user. The
clamp is wrapped in the sleeve 1 which smoothes the protruding
ends. In addition, a metal clamp can advantageously be covered to
prevent contamination of the clean environment in which it would be
used, such as a clean room.
[0096] The sleeve 1 is preferably rotationally symmetrical, as
shown in FIG. 10a. Alternatively, the sleeve 1 may be in the form
of two half rings 101 and 102 joined by their respective ends as
illustrated in FIG. 10b. In the case of such a sleeve, the two half
rings 101 and 102 are for example fixed together by their
respective free ends, and each joining of assembled free ends is
flattened so that said joining of assembled free ends protrudes
radially outward from the sleeve 1.
[0097] Alternatively, the sleeve 1 is mounted on the hose 2 before
the hose 2 is mounted on the first endpiece portion for mechanical
assembly 10 of the connector 3.
[0098] In another variant, the hose 2 is mounted on the first
endpiece portion for mechanical assembly 10 of the connector 3,
then the sleeve is mounted on the hose 2 for example by sliding the
sleeve 1 onto the preceding assembly.
[0099] Alternatively, the sleeve 1 has at least one incision along
its entire length, along X, for placing the sleeve around the
assembly after the hose 2 and connector 3 are assembled
together.
* * * * *