U.S. patent application number 14/802099 was filed with the patent office on 2015-11-12 for secure fluids transfer system for medical use.
The applicant listed for this patent is TECHNOFLEX. Invention is credited to Frederic BONNET, Francois CAPITAINE.
Application Number | 20150320992 14/802099 |
Document ID | / |
Family ID | 47891729 |
Filed Date | 2015-11-12 |
United States Patent
Application |
20150320992 |
Kind Code |
A1 |
BONNET; Frederic ; et
al. |
November 12, 2015 |
SECURE FLUIDS TRANSFER SYSTEM FOR MEDICAL USE
Abstract
A fluid transfer system includes Luer male and female
connectors. The male connector has a main body with a longitudinal
internal opening and an internal threading; the female connector
has a main body containing an internal channel for the passage of
fluids, a collar that surrounds at least a portion of an end of the
main body, and external threading on the portion that is surrounded
by the collar. The corresponding threadings are configured to
engage and ensure a secure fit between the male and female
connectors. An external surface of the male connector at the end
where the threading is located forms a conical male portion, the
internal surface of the collar of the female connector forms a
conical female connecting surface, and the conical male portion is
configured to fit against the conical female connecting surface and
onto the collar when the male and female connectors are fitted
together.
Inventors: |
BONNET; Frederic; (Bayonne,
FR) ; CAPITAINE; Francois; (Anglet, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TECHNOFLEX |
Bidart |
|
FR |
|
|
Family ID: |
47891729 |
Appl. No.: |
14/802099 |
Filed: |
July 17, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13424717 |
Mar 20, 2012 |
|
|
|
14802099 |
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Current U.S.
Class: |
604/535 |
Current CPC
Class: |
A61M 2039/1033 20130101;
A61M 2039/1038 20130101; A61M 2039/1094 20130101; A61M 2039/1027
20130101; A61M 39/10 20130101 |
International
Class: |
A61M 39/10 20060101
A61M039/10 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 16, 2012 |
FR |
12 52412 |
Claims
1. A Luer male connector (10) for use in a fluid transfer system,
comprising a main body containing a longitudinal internal opening
(19, 21), one of the ends of the main body comprising a threading
on at least a part of its internal surface delineating the
longitudinal internal opening (19, 21), the threading configured to
engage with and fit in a corresponding threading of a Luer female
connector (11) to provide a secure fit between the male and female
connectors, and an external surface of the Luer male connector (10)
at the end where the threading is located forms a conical male
portion (24) having a conical axis of revolution, said conical male
portion (24) configured to fit against a conical female connecting
surface (13) and onto a collar (12) of the Luer female connector
(11) when the male and female connectors are fitted together.
2. The Luer male connector according to claim 1, wherein an end of
the male connector opposite to the end forming the conical male
portion (24) comprises gripping elements on its external
surface.
3. The Luer male connector according to claim 1, wherein the Luer
male connector comprises a flange ring that forms a stopping point
for the collar (12) of the Luer female connector (11).
4. The Luer male connector according to claim 1, wherein the
connector is a single piece made of plastic.
5. The Luer male connector according to claim 1, further comprising
an internal wall located in the longitudinal internal opening (19,
21), the internal wall comprising an orifice for the flow of
fluids.
6. The Luer male connector according to claim 5, wherein the
orifice comprises a portion having a second threading (20) located
at an end of the longitudinal internal opening (19, 21).
7. The Luer male connector according to claim 6, wherein the
orifice comprises a second portion that protrudes from the internal
wall located at the end of the longitudinal internal opening (19,
21).
8. A Luer female connector (11) for use in a fluid transfer system,
comprising a main body (14) containing an internal channel (15) for
the passage of fluids, and comprising a collar (12) that surrounds
at least a portion of an end of the main body, the main body (14)
of the female connector containing a threading (16) on the external
surface of the portion that is surrounded by the collar (12), the
threading located at least in part facing an internal surface of
the collar (12), and said internal surface of the collar (12) forms
a conical female connecting surface (13) having a conical axis of
revolution and configured to fit against an external surface of a
conical male portion (24) of a Luer male connector (10) when the
male and female connectors are fitted together.
9. The Luer female connector according to claim 8, wherein the
portion that is surrounded by the collar (12) comprises at least
one orifice opening laterally that allows communication of fluids
between the internal channel (15) and an area located between the
interior surface of the collar (12) and the external surface of the
portion surrounded by the collar.
10. The Luer female connector according to claim 8, wherein the
connector is a single piece made of plastic.
11. The Luer female connector according to claim 8, further
comprising an internal wall located in the internal channel (15),
the internal wall comprising an orifice for the flow of fluids.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Domain of the Invention
[0002] This invention is in the field of Luer connections,
specifically a secure mechanism for the transfer of medical use
solutions.
[0003] 2. Technological Background
[0004] It is a well-known practice to use Luer connections to
connect for example medical devices to each other for introducing
medical solutions from a primary recipient to ducts within human
bodies.
[0005] FIGS. 1 and 2 show state of the art Luer male and female
connectors. A Luer male connector 1 comprises a collar 2 encircling
at least a part of the conical male part 3 whose external surface
joins to the female conical connecting surface of the Luer female
connector 4 when these Luer male 1 and female 4 connectors are
joined together.
[0006] The collar 2 of the Luer male connector 3 features an
internal threading 5 whereas the Luer female connecter 4 contains
the largest of the rims 6 that fit to the internal threading 5 of
the collar 2 of the Luer male connector so that the two parts can
join.
[0007] Connecting the two Luer connections 1, 4 is accomplished
simply by means of a tightening torque. The application of this
tightening torque, or twisting movement, gives rise to a rotating
movement of the Luer female connection 4 around the internal
threading 5 of the male connector collar 2.
[0008] When the two Luer connectors 1, 4 are thus engaged and
directly attached to each other, abrupt separation and
contamination from without of these Luer connectors are prevented
as described in ISO standard 594-2 of the International
Organization of Standardization.
[0009] This standard also prescribes specific dimensions for each
of the Luer connections.
[0010] While these Luer connectors 1, 4 are easy to use, handling
errors by users have been observed during the coupling action in a
large number of Luer connectors.
[0011] In particular, where handling is required in aphaeresis,
there is a risk of inverting the two lines, for example
anticoagulants and saline solution, when the lines both have
identical Luer connectors.
[0012] As such, there is an urgent need to come up with other
connectors that are different from state of the art connectors so
as to avoid handling errors that could result in a risk to the
health of patients.
[0013] Moreover, fluids transfer systems recognized as state of the
art that prevent improper connections are generally complex
structures comprised of a large number of initially distinct parts.
It takes a lot of time to assemble these fluid transfer systems and
they are costly.
[0014] The objective of this invention is to overcome this drawback
by providing a fluids transfer system for medical use that is
particularly simple in terms of design and operational use, that is
aseptic and low cost and that affords a fully secure connection of
Luer male and female connectors.
BRIEF DESCRIPTION OF THE INVENTION
[0015] The invention involves a fluids transfer system for medical
use comprising a Luer male connector and a Luer female connector,
of which the said Luer female connector comprises a main body
containing an internal channel for the passage of said fluids and a
collar surrounding at least a part of the end of the main body,
while the said Luer male connector comprises a main body with a
longitudinal internal opening.
[0016] According to the invention,
[0017] The main body of the female connector contains a first
threading on at least a part of the external surface of that
portion that is surrounded by the collar, located at least in part
facing an internal surface of the collar,
[0018] One of the ends of the main body of the said Luer male
connector contains a second threading on at least a part of its
internal surface delineating the longitudinal internal opening,
which engages into and fits in the initial threading to ensure
joining between the Luer male and female connectors,
[0019] At least the external surface of the Luer male connector end
where the second threading is located forms a conical male portion
having a conical axis of revolution, while the said interior
surface of the collar of the said female connector forms a conical
female connecting surface having a conical axis of revolution, so
that the external surface of the said male conical part fits
against the conical connecting surface of the collar of the Luer
female connector to provide a sealed joint when the Luer male and
female connectors are fitted together.
[0020] Luer male and female connectors are disengaged by means of a
disconnecting torque motion.
[0021] The locking system made up by the first and second helix
threads of the Luer male and female connectors is located between
the fluids passage area and the sealing space of the fluids
transfer system, formed by the contact between the conical male
portion and the conical female connecting surface. This locking
system works to dispel constraints by reducing pressure exerted on
the sealing space during fluids transfer in such a way as to
preserve the space, thus preventing any occurrence of contamination
or leakage.
[0022] In order to reinforce the sealed fit of the Luer male and
female connectors, the collar of the Luer female connector may be
elongated so as to present a larger conical female connection
surface, while the external surface of the conical male portion is
also increased through an elongation of the male conical piece.
[0023] In the various particular embodiments of this system, each
with its particular advantages and possibilities for implementing
numerous technical combinations:
[0024] At least one of the Luer male and female connectors is made
as a single piece of plastic material,
[0025] The Luer male connector features a collar, or skirt, that
surrounds the male conical portion having a conical axis of
revolution, at least partially so as to protect this conical male
portion.
This advantageously protects against the risk of scratches forming
on the conical male portion and against external contamination
during storage of the Luer connector. Naturally, the internal
diameter of the collar is such that the collar of the Luer female
connector fits within this collar surrounding the conical male
portion when the Luer male and female connectors are joined.
[0026] The diameter of the internal longitudinal opening of the
said Luer male connector at the base of the said second threading
is equal, within 0.2 mm, to the diameter of the main body of the
Luer female connector with respect to its exterior threading,
Some play will apply advantageously in the initial joining
assembling part of the Luer male and female connector so that
engaging the screw is facilitated for users, but this play will be
reduced at the end of the screw phase to prevent any transfer of
fluid. Consequently, there may be a forced connection acting on
these two connectors on a part of the threaded connection
corresponding to the end joining phase of the Luer male and female
connectors.
[0027] said Luer male connector, and/or the Luer female connector,
contains an internal wall located in its internal longitudinal
opening, respectively and/or in its internal channel, with the said
internal wall comprising an orifice for the flow of fluids.
It is preferable, concerning the Luer male connector with an
internal wall onto which an orifice is located at its internal
longitudinal opening, that the orifice contain a truncated part
located on the side of the end of the internal longitudinal opening
that contains a second threading, so as to ensure that fluids are
directed into the internal channel at the end of the main body of
the female Luer connector when this end is placed close to the
orifice in the internal wall.
[0028] The Luer female connector collar rotates or does or does not
rotate around the female conical connector
[0029] At least one of the Luer male and female connectors has a
sealed end that ensures a link to the main body that is either
whole or can be split. This end is, from a purely illustrative
perspective, a split blocking element to guarantee its asepsis.
[0030] The invention also concerns a Luer male connector intended
for use in the fluids transfer system for medical use as described
previously.
[0031] According to the invention, this connector comprises
[0032] A main body containing a longitudinal internal opening,
[0033] One of the ends of the main body of the Luer connector
contains a thread on at least a part of its internal surface
delineating the longitudinal internal opening, which engages into
and fits in the threading of a Luer female connector to ensure a
secure fit between the Luer male and female connectors,
[0034] At least the external surface of the Luer male connector end
where the said threading is located forms a conical male portion
having a conical axis of revolution, said conical male portion
fitting against the conical female connecting surface onto the
collar of the Luer female connector when the said Luer male and
female connectors are fitted together.
[0035] The end of the male connector opposite that forming a
conical male portion having a conical axis of revolution may
contain gripping elements on its external surface to facilitate
handling.
[0036] The invention also concerns a Luer female connector intended
for use in the fluids transfer system for medical use as described
previously.
[0037] According to the invention, this Luer female connector
comprises:
[0038] A main body containing an internal channel for the passage
of fluids and a collar surrounding at least a part of the end of
the said main body,
[0039] The main body of the female connector contains a first
threading on at least a part of the external surface of that
portion that is surrounded by the collar, located at least in part
facing an internal surface of the collar,
[0040] the internal surface of the collar of the said female
connector forms a conical female connecting surface having a
conical axis of revolution so that the external surface of the
conical male part of a Luer male connector fits against said
conical female connecting surface when the Luer male and female
connectors are fitted together, said conical male part having a
conical axis of revolution.
[0041] The main body of the Luer female connector surrounded by the
collar includes at least a single orifice opening laterally that
can advantageously allow communication of fluids between the
internal channel and the area comprising the internal surface of
the collar and the external surface of the piece in order to limit
any loss of fluids during their transfer.
[0042] The invention also pertains to a medical device comprising
at least one recipient containing a medical use fluid equipped with
a fluid transfer system for medical uses as described
previously.
[0043] This recipient may be, for purely illustration purposes, a
flexible pouch or a bottle.
[0044] The invention also concerns a medical device consisting of a
syringe with a Luer male connector or Luer female connector
attached as described previously.
BRIEF DESCRIPTION OF DRAWINGS
[0045] Other particular benefits, objectives and features of this
invention will appear from the following description, which is done
with regard to the appended drawings for the purposes of
description and which are in no way limiting, in which:
[0046] FIG. 1 is an overall view of the Luer male/female connector
using prior art embodiment;
[0047] FIG. 2 is a partial section of the Luer male connecter of
FIG. 1,
[0048] FIG. 3 is a side view of the fluids transfer system for
medical use consisting of a Luer male connector and a Luer female
connector, from an initial embodiment of the invention,
[0049] FIG. 4 is a partial view in longitudinal section of the
fluids transfer system shown in FIG. 3,
[0050] FIG. 5 is a side view of the Luer female connector of the
fluids transfer system shown in FIG. 3,
[0051] FIG. 6 is a side view of the Luer male connector of the
fluids transfer system shown in FIG. 3,
[0052] FIG. 7 is a partial sectional view of the fluids transfer
system for medical use consisting of a Luer male connector and Luer
female connector, from a second embodiment of the invention,
[0053] FIG. 8 is a side view of the Luer female connector of the
fluids transfer system shown in FIG. 7,
[0054] FIG. 9 is a side view of the Luer male connector of the
fluids transfer system shown in FIG. 7,
[0055] FIG. 10 is a partial side view of the fluids transfer system
for medical use consisting of a Luer male connector and a Luer
female connector, from a third embodiment of the invention,
[0056] FIG. 11 is a partial side view of the fluids transfer system
for medical use consisting of a Luer male connector and a Luer
female connector, from a fourth embodiment of the invention,
[0057] FIG. 12 represents partial sectional views showing
unsuccessful attempts at joining a Luer male or female connector of
FIGS. 3 to 6 and a prior art connector, specifically:
[0058] FIG. 12a) represents a Luer male connector shown in FIG. 6
and a state of the art female connector
[0059] FIG. 12b) represents a Luer male connector shown in FIG. 6
and a state of the art male connector
[0060] FIG. 12c) represents a Luer female connector shown in FIG. 5
and a state of the art male connector
[0061] FIG. 12d) represents a Luer female connector shown in FIG. 5
and a state of the art female connector
[0062] FIG. 12e) represents a Luer male connector shown in FIG. 6
and a state of the art Slip fit Luer connector
[0063] FIG. 12f) represents a Luer female connector shown in FIG. 5
and a state of the art Slip fit Luer connector
DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION
[0064] It should first be noted that the drawings are not to
scale.
[0065] FIGS. 3 to 6 are schematic representations of a fluids
transfer system for medical use indicating the preferred embodiment
of the invention. This transfer system consists of a Luer male
connector 10 and a Luer female connector 11 to be joined by means
of tightening torque to enable the transfer of fluids.
[0066] The Luer female connector 11 features a fixed collar, or a
skirt 12 with an internal surface 13 and an external surface. While
the external surface of this collar 12 is cylindrical, its internal
surface 13 presents a conical surface having a conical axis of
revolution, said conical surface being smooth. This internal
surface 13 thus forms a cone trunk with a taper angle of 6%, this
surface being known as the female conical connection surface.
[0067] This collar 12 surrounds one end of a main body 14 of the
Luer female connector 11. This main body 14 consists of an internal
channel 15 for the passage of fluids.
[0068] This internal channel 15 has a diameter superior or equal to
the diameter of the internal channel of the male conical portion of
the Luer male connector set out in ISO standard 594-2. Thus the
Luer female connector 11 presents a flow of medical solution at
least equal to that of prior art Luer connectors.
[0069] However, the diameter of the internal channel 15 is such
that it is not possible to insert a male conical portion of a Luer
male connector described in ISO standard 594-2.
[0070] This main body 14 also features an initial thread 16 on the
external surface of its end surrounded by a collar 12, located
opposite of the internal surface 13 of the collar 12.
[0071] Alternatively, the main body 14 end could be placed
protruding from the collar 12, with a portion of the first thread
16 being located facing the internal surface 13 of the collar 12,
while another portion of this threading would be located protruding
from the collar.
[0072] This initial threading 16 is a constant pitch propeller as
defined by ISO standard 594-2 and presents a trapezoidal profile
that offers good resistance to wrenching.
[0073] The diameter of the main body 14 of the said Luer female
connector 11 with respect to its exterior threading is beneficially
too large to be able to be accidentally inserted into the internal
channel of a Luer female connector described by ISO standard
594-2.
[0074] The main body 14 of the Luer female connector 11 features a
conical profile on its end 17 opposite that surrounded by the
collar 12, so that it can be inserted in a conduit such as tubing
(not shown). This conical end 17 of the main body 14 of the Luer
female connector 11 can alternatively be attached divisibly to the
collar 12.
[0075] The end of the internal channel 15 located at the truncated
end of the main body 14 of the Luer female connector 11 is
advantageously blocked here by a removable stopping element.
[0076] The Luer male connector 10 includes a main body 18
containing an internal longitudinal opening. This internal
longitudinal opening delineating an initial connecting area 19 that
contains a second thread 20 which engages and fits into the initial
threading to ensure a secure fit between the Luer male and female
connectors, and a second connecting area 21 for receiving a
tube.
[0077] This could be assembled at the wall of the main body 18 of
the Luer male connector 10 delineating the second connection area
21 through joining by means of an adhesive solvent.
[0078] These two connection areas 19, 21 are separated by a wall
bearing an orifice 22 that provides communication between these
entities. This wall also constitutes a stopping point for the
insertion of a tube in the second connection area 21.
[0079] The orifice 22 on this wall advantageously presents a flared
portion 23 on the side of the connection area 19 so that with the
Luer male and female connectors being joined, and an end of the
internal channel of the main body 14 of the Luer female connector
being located near this orifice 22, fluids leaving the internal
channel 15 are directed toward the second connection area 21 of the
Luer male connector 10 without contact with the second thread
20.
[0080] It should be noted that the internal diameter of the
connection area 19 between the tops of two screw threads located
facing each other is such that it cannot ensure that the conical
male portion of a Luer male connector as described by ISO standard
594-2 will be maintained in place if inadvertently inserted in the
connection area 19 when Luer male and female connectors are
joined.
[0081] The end of the main body 18 of the Luer connector 10 that
contains a connection area 19 presents an exterior surface 24 with
a conical profile of a 6% taper.
[0082] This male conical portion 24 rests against the female
conical connecting surface 13 of the collar 12 of the Luer female
connector 11 when the Luer male and female connectors 10, 11 are
joined so as to ensure a sealed fit.
[0083] Moreover, the main body of the Luer male connector 10
contains gripping elements 25 on its external surface so as to
facilitate handling, as well as a flange 36 located at the non-free
end of the male conical portion 24. This flange 36 delineates the
end of the male conical portion 24 and prevents contamination of
this conical portion with the stopper.
[0084] These Luer male 10 and female 11 connectors are one piece
units obtained through a mold by means of injecting a medically
inert thermoplastic material. They may, for purely illustrative
purposes, be of polycarbonate, polystyrene, acrylonitrile butadiene
styrene (ABS) or PC-ABS copolymers, polyolefin (such as
polyethylene, polypropylene, a homopolymer or a copolymer of
polypropylene) or of a polyolefin comprising a thermoplastic
elastomer (TPE) such as SEB (styrene, ethylene or butylene block
copolymers), SEBS (styrene, ethylene, butylene, styrene block
copolymers) or of cyclopolyolefin, etc.
[0085] The fluids transfer system of this invention is therefore
particularly low cost to produce and does not require the assembly
of several elements that would render the structure complex.
[0086] Advantageously, a user who must connect several pairs of
connectors cannot erroneously connect a state of the art Luer
female or male connector with a Luer male or female connector
produced as a result of this invention.
[0087] FIGS. 7 to 9 are schematic representations of a fluids
transfer system for medical use according to another embodiment of
the invention.
The elements of FIGS. 7 to 9 bear the same references as the
elements of FIGS. 3 to 6 that represent the same objects, which
will not be described again here.
[0088] The fluids transfer system in FIG. 7 differs from that
described above in that the end of the main body of the Luer female
connector 11 surrounded by the collar 12 is made up of two half
cylindrical parts 27, 28 that are spaced apart from each other and
parallel.
[0089] Each of the parts 27, 28 contain a portion of the helical
thread 29 on its rounded exterior surface, with the threads on the
exterior surface of one of the parts continuing on the exterior
surface of the other half-cylindrical part such that a
semi-continuous threading is formed that will match the threading
20 located on the internal surface of the main body 18 of the Luer
male connector 10 to ensure that the Luer male and female
connectors join up.
[0090] Moreover, following joining of the Luer male and female
connectors, the internal cylindrical surface of the connecting area
19 of the Luer male connector, containing the second threading 20,
surrounds the two half-cylindrical parts 27, 28 on at least a part
of their longitudinal extension.
[0091] The component formed by the internal surface parts of the
connection area 19 between the two half-cylindrical parts 27, 28
that are spaced apart from each other and the flat surfaces 30, 31
facing the two half-cylindrical parts make up a channel for the
circulation of fluids. These fluids are then directed toward the
second connection area 21 in the internal longitudinal opening of
the Luer male connector 10.
[0092] The channel thus formed by the assembly of the Luer male and
female connectors is in fluid communication with a chamber 32
formed at the base of the two half-cylindrical parts 27, 28, this
chamber 32 being itself in fluid communication with both an
internal channel 15 of the Luer female connector 11 for the passage
of fluids with said channel 15 located at the other end of the
[0093] Luer female connector 11, and with the base 33 of the collar
12 connected to the Luer female connector 11.
[0094] In this way any discharge that may occur along the threads
between the internal cylindrical surfaces of the connection area of
the Luer male connector and rounded exteriors of the two
half-cylindrical parts will be recovered. Consequently, this
ensures the minimizing of any loss of transferred fluid and the
possible stagnation of fluids.
[0095] FIG. 10 shows a partial view of the fluids transfer system
for medical use in a third embodiment of the invention. The fluids
transfer system in FIG. 10 differs from that described in FIGS. 3
to 6 in that the Luer male connector 10 with an internal wall
containing an orifice 22 in its internal longitudinal opening has a
truncated portion 23 located at the end of the internal
longitudinal opening that has the said second threading 20, and the
end of the main body of the Luer female connector 11 is conical 34
so that with this end being located near the orifice 22, 23 of the
said internal wall, fluids are directed through the orifice.
Advantageously, no fluid retention is observed with this fluids
directional system.
[0096] These conical parts 23, 34 are kept away from contact with
each other in order to avoid dual alignment.
[0097] FIG. 11 shows a partial view of the fluids transfer system
for medical use in a fourth embodiment of the invention. The fluids
transfer system in FIG. 11 differs from that described in FIGS. 3
to 6 in that the Luer male connector 10 with an internal wall
containing an orifice 22 in its internal longitudinal opening and
this orifice has a portion 35 protruding from the said wall being
located at the end of the internal longitudinal opening that has
the before-mentioned second threading 20. This protruding portion
35, here for illustrative purposes a portion of a tube, has an
external diameter inferior to the diameter of the internal channel
15 of the main body of the Luer female connector 11 so formed that
it can be received in the internal channel 15 when the said Luer
male 10 and female 11 connectors are joined so as to direct fluids
through the said orifice 22.
[0098] This protruding part 35 and the wall of the main body of the
Luer female connector delineating the internal channel 15 are kept
away from contact with each other so as to avoid dual
alignment.
* * * * *