U.S. patent application number 11/035779 was filed with the patent office on 2005-07-28 for needle type safety connector.
This patent application is currently assigned to P2A Medical. Invention is credited to Commaret, Pierre-Andre, Orlu, Alain.
Application Number | 20050165330 11/035779 |
Document ID | / |
Family ID | 34630670 |
Filed Date | 2005-07-28 |
United States Patent
Application |
20050165330 |
Kind Code |
A1 |
Orlu, Alain ; et
al. |
July 28, 2005 |
Needle type safety connector
Abstract
A safety needle connector according to the invention comprises a
hollow needle through which fluid may pass fastened to a needle
support sleeve itself connected to a fluid tube. The needle support
sleeve may be connected by clipping it axially into a receiving
structure of a protective cylinder that surrounds a projecting
needle portion. The receiving structure comprises receiving
cylinders in which the needle support sleeve is engaged and
comprising locking tongues that cooperate with a bearing flange to
allow penetration of the needle support sleeve and prevent its
withdrawal. A closure sleeve is engaged around the projecting
needle portion to form a sealed connection in the needle
passage.
Inventors: |
Orlu, Alain; (Viuz La
Chiesaz, FR) ; Commaret, Pierre-Andre; (Bogis-Bossey,
SZ) |
Correspondence
Address: |
WILLIAM H. EILBERG
THREE BALA PLAZA
SUITE 501 WEST
BALA CYNWYD
PA
19004
US
|
Assignee: |
P2A Medical
|
Family ID: |
34630670 |
Appl. No.: |
11/035779 |
Filed: |
January 14, 2005 |
Current U.S.
Class: |
600/576 |
Current CPC
Class: |
A61B 5/150389 20130101;
A61B 5/150992 20130101; A61M 5/348 20130101; A61B 5/150572
20130101; A61B 5/154 20130101; A61B 5/150595 20130101; A61B
5/150221 20130101; A61B 5/150519 20130101; A61B 5/150732 20130101;
A61B 5/15003 20130101 |
Class at
Publication: |
600/576 |
International
Class: |
B65D 081/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 22, 2004 |
FR |
04 00681 |
Claims
There is claimed:
1. A safety needle connector comprising a hollow needle through
which fluid can pass, a needle support sleeve, and a protective
cylinder, the needle support sleeve carrying the needle and
connecting it and sealing it to a fluid tube to which it is fixed,
a projecting needle portion axially extending the needle support
sleeve at the end opposite the fluid tube, the protective cylinder
having an interior space containing the projecting needle portion,
with an open distal end for inserting a sampling container to be
connected by the needle and with a closed proximal end with
connection means for connecting it to the needle support sleeve,
the connection means comprising a proximal cylinder with a large
diameter and a proximal opening followed by a distal cylinder with
a smaller diameter whose bottom communicates with the interior
space of the protective cylinder via a needle passage and
comprising retaining means for axially retaining the needle support
sleeve engaged in the proximal cylinder and in the distal cylinder,
wherein the lateral walls of the proximal cylinder and the distal
cylinder are fluid-tight, the needle support sleeve comprises a
bearing flange conformed to penetrate with appropriate peripheral
clearance into the proximal cylinder and to abut against an
intermediate shoulder connecting the proximal cylinder and the
distal cylinder, the proximal cylinder comprises elastically
flexible locking tongue means which when at rest, and starting from
an intermediate region of the protective cylinder, are oriented in
an oblique direction toward the proximal end to bear against the
distal face of the bearing flange, and then, following flexing in
the downstream direction of the locking tongue means upon
penetration of the needle support sleeve, to bear against the
proximal face of the bearing flange, thereby opposing withdrawal of
the needle support sleeve from the protective cylinder.
2. A safety connector according to claim 1, wherein the locking
tongue means comprise two diametrically opposite tongues.
3. A safety connector according to claim 1, wherein a closure
sleeve is engaged around the projecting needle portion and passes
through the needle passage in the bottom of the distal cylinder to
provide a seal between the needle and the bottom of the distal
cylinder.
4. A safety connector according to claim 1, wherein the needle
support sleeve comprises a sealing flange, offset in the upstream
direction from the bearing flange, and bearing against the locking
tongue means when the needle support sleeve is engaged in the
protective cylinder.
5. A safety connector according to claim 1, wherein the protective
cylinder is molded from a first plastic material such as
polypropylene.
6. A safety connector according to claim 1, wherein the needle
support sleeve is molded from a second plastic material such as
polycarbonate.
7. A safety connector according to claim 1, wherein the closure
sleeve is made from a closed cell resilient foam or an elastically
flexible elastomer such as latex.
Description
TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates to safety connectors for
connecting a sampling container to a fluid tube. The invention
relates in particular to connectors of the above kind for taking
blood samples in applications in the health field.
[0002] When taking blood samples, in particular for blood
donations, the blood must be systematically analyzed by taking a
small sample of blood in a sampling container. To this end, a fluid
tube must be removably connected and sealed to a sampling container
under conditions of absolute hygiene, necessitating minimum
movement of the operator to connect the sampling container to the
tube and to disconnect it therefrom.
[0003] At the same time, the operator must be protected against all
risks of injury and contamination by the blood sample.
[0004] To this end, there has already been designed a safety needle
connector as described in the document U.S. Pat. No. 4,784,650,
comprising a hollow needle through which fluid can pass, a needle
support sleeve and a protective cylinder. The needle support sleeve
carries the needle and connects it and seals it to the fluid tube
to which it is fixed. A protruding needle portion axially extends
the needle support sleeve at the end opposite the fluid tube. The
protective cylinder defines an interior space containing the
projecting needle portion, with an open distal end for inserting
the sampling container to be connected by the needle and a closed
proximal end for connection to the needle support sleeve.
[0005] In practice, it is necessary to produce the needle support
sleeve and the protective cylinder as separate components, in order
to be able to use different components having satisfactory
properties in respect of clipping, on the one hand, and firm
retention of the needle in the needle support sleeve, on the other
hand.
[0006] To this end, the prior art devices comprise a safety
connector in two main parts designed to be assembled together,
namely a needle support sleeve and a protective cylinder, with
connecting means for clipping the protective cylinder to the needle
support sleeve.
[0007] The connecting means comprise a large-diameter proximal
cylinder with a proximal opening followed by a smaller diameter
distal cylinder whose bottom communicates with the interior of the
protective cylinder via a needle passage. Retaining means are
provided for axially retaining the needle support sleeve engaged in
the proximal cylinder and in the distal cylinder.
[0008] In the prior art devices, the retaining means comprise
clipping holes in the lateral wall of the distal cylinder in which
engage protuberances on the needle support sleeve.
[0009] The prior art needle type safety connectors have drawbacks
that affect their safety in use. In particular, the resistance to
tearing out of the needle is poor; sometimes drops of blood may
flow out of the sampling phial during the movement of withdrawing
the phial, and these drops of blood may flow through the clipping
holes in the proximal cylinder; there is also a non-negligible risk
of permanent deformation of the distal cylinder when the needle
support sleeve is pushed into the distal cylinder and the proximal
cylinder; this kind of permanent deformation further increases the
risks of a defective seal and of blood flowing out of the
protective cylinder; because of the small axial clipping travel, it
is also difficult to control the clipping of the protective
cylinder onto the needle support sleeve.
SUMMARY OF THE INVENTION
[0010] The problem addressed by the present invention is that of
designing a new safety needle connector structure that is easy to
assemble to the needle support tube by simple clipping, that is
sealed, that may be closed for safety after use, and that retains
the needle sufficiently to prevent any movement caused by the axial
force of pushing in the sampling phial.
[0011] To achieve the above and other objects, the invention
proposes a safety needle connector comprising a hollow needle
through which fluid can pass, a needle support sleeve, and a
protective cylinder, the needle support sleeve carrying the needle
and connecting it and sealing it to a fluid tube to which it is
fixed, a projecting needle portion axially extending the needle
support sleeve at the end opposite the fluid tube, the protective
cylinder having an interior space containing the projecting needle
portion, with an open distal end for inserting a sampling container
to be connected by the needle, and with a closed proximal end with
connection means for connecting it to the needle support sleeve;
the connection means comprising a proximal cylinder with a large
diameter and a proximal opening followed by a distal cylinder with
a smaller diameter whose bottom communicates with the interior
space of the protective cylinder via a needle passage and
comprising retaining means for axially retaining the needle support
sleeve engaged in the proximal cylinder and in the distal cylinder;
according to the invention:
[0012] the lateral walls of the proximal cylinder and the distal
cylinder are fluid-tight,
[0013] the needle support sleeve comprises a bearing flange
conformed to penetrate with appropriate peripheral clearance into
the proximal cylinder and to abut against an intermediate shoulder
connecting the proximal cylinder and the distal cylinder,
[0014] the proximal cylinder comprises elastically flexible locking
tongue means which when at rest, and starting from an intermediate
region of the protective cylinder, are oriented in an oblique
direction toward the proximal end to bear against the distal face
of the bearing flange, and then, following flexing in the
downstream direction of the locking tongue means upon penetration
of the needle support sleeve, to bear against the proximal face of
the bearing flange, thereby opposing withdrawal of the needle
support sleeve from the protective cylinder.
[0015] In one advantageous embodiment of the invention the locking
tongue means comprise two diametrically opposite tongues.
[0016] To provide an effective seal for the needle after removing
the sampling phial, a closure sleeve is engaged around the
projecting needle portion and passes through the needle passage in
the bottom of the distal cylinder to provide a seal between the
needle and the bottom of the distal cylinder. Simultaneously, the
sleeve retracted by virtue of elastic deformation in the axial
direction when the phial is engaged around the needle, and is
axially deployed again around the needle to close off its distal
orifice upon withdrawal of the sampling phial.
[0017] In practice, the needle support sleeve comprises a sealing
flange, offset in the upstream direction from the bearing flange,
and bearing against the locking tongue means when the needle
support sleeve is engaged in the protective cylinder.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Other objects, features and advantages of the present
invention will emerge from the following description of particular
embodiments of the invention, which is given with reference to the
appended drawings, in which
[0019] FIG. 1 is a diagrammatic general view of a blood sampling
system using a safety needle connector of the present
invention;
[0020] FIG. 2 is a partial detail view to a larger scale and in
longitudinal section of one embodiment of a safety needle connector
of the invention, prior to assembly;
[0021] FIG. 3 is a view to a larger scale of the safety connector
from FIG. 1 in longitudinal section taken along the line A-A in
FIG. 4 and in the assembled state; and
[0022] FIG. 4 is an end view of the FIG. 3 safety connector.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] FIG. 1 shows the general structure of a blood sampling
device using a safety connector of the present invention.
[0024] From a blood source 1 shown diagrammatically, for example a
catheter inserted into the venous system of a patient, tubes convey
blood either to a series of sachets 2, 3 and 4 or to a test
sampling assembly 5, according to the settings of valves 6 and 7
controlled by the operator.
[0025] The test sampling assembly 5 comprises a buffer sachet 19 in
series in a fluid tube 8, for example. The end of the fluid tube 8
carries the safety needle connector 9 of the invention.
[0026] The safety needle connector 9 comprises a hollow needle 10
through which fluid can pass, a needle sleeve 11, and a protective
cylinder 12. The needle support sleeve 11 is fixed to the end of
the fluid tube 8 and carries the needle 10, which it connects and
seals to the fluid tube 8. The needle 10 has a projecting needle
portion 10a at the end opposite the fluid tube 8 that extends the
needle support sleeve 11 axially.
[0027] The protective cylinder 12 defines an interior space 12a
whose shape is adapted to contain the whole of the projecting
needle portion 10a to prevent any contact of an operator's hand
with the sharp end portion 10c of the needle 10. The protective
cylinder 12 further comprises an open distal end 12b for inserting
a sampling container 13 to be connected to the fluid tube 8. The
distal end 12b may be closed off by a seal 14 adapted to be folded
over. In a manner that is known in the art, the sampling container
13 comprises a stopper 13a made from a material that may be pierced
by the projecting needle portion 10a, and the shape of the sampling
container 13 is adapted to fit into the interior space 12a of the
protective cylinder 12. On applying pressure 13b to push the
sampling container 13 axially in the direction of the needle 10,
the stopper 13a is pierced by the needle 10, which establishes
communication between the interior of the sampling container 13 and
the fluid tube 8 to introduce an appropriate quantity of blood into
the sampling container 13, which may then simply be extracted
axially from the protective cylinder 12: the stopper 13a closing
elastically on itself to seal the sampling container 13.
[0028] Consider now the details of the structure of the safety
connector 9, as shown in FIGS. 2 to 4.
[0029] These figures show again the needle support sleeve 11, the
needle 10 and the protective cylinder 12.
[0030] The protective cylinder 12 has a closed proximal end 12c
with means for connecting it to the needle support sleeve 11. The
connecting means are adapted to enable the protective cylinder 12
and the needle support sleeve 11 to be assembled together by
clipping them together by virtue of a simple movement in axial
translation 11e toward each other. At the same time, the same
movement in axial translation 11e toward each other makes a seal
that makes it impossible for blood to flow from the interior space
12a of the protective cylinder 12 onto its exterior surface and
onto the needle support sleeve 11.
[0031] The connecting means for the protective cylinder 12 comprise
a proximal cylinder 12d having an inside diameter D.sub.d larger
than the diameter of the needle support sleeve 11. The proximal
cylinder 12d is followed by a distal cylinder 12e with a smaller
inside diameter D.sub.e, with an intermediate shoulder 12f which
connects the proximal cylinder 12d and the distal cylinder 12e.
[0032] The distal cylinder 12e terminates at a bottom 12g that
communicates with the interior space 12a of the protective cylinder
12 via a small diameter needle passage 12h.
[0033] The lateral walls of the proximal cylinder 12d and the
distal cylinder 12e are fluid-tight, i.e. comprise no openings that
would allow a fluid such as blood to pass through them.
[0034] The needle support sleeve 11 comprises a bearing flange 11a
shaped to penetrate into the proximal cylinder 12d and to abut
against the intermediate shoulder 12f when the needle support
sleeve 11 is engaged on the protective cylinder 12 in the assembly
position, as shown in FIG. 3.
[0035] The proximal cylinder 12d comprises elastically flexible
locking tongue means, for example two diametrically opposite
tongues 12i and 12j, that cooperate with the bearing flange 11a to
provide the clipping means opposing separation of the needle
support sleeve 11 and the protective cylinder 12 when they are
assembled together.
[0036] To this end, when at rest, the elastically flexible locking
tongues 12i and 12j are, starting from an intermediate region of
the proximal cylinder 12d, oriented obliquely toward the proximal
end 12k of the proximal cylinder 12d, as may be seen in FIG. 2, and
their free ends are at a distance from each other less than the
diameter of the bearing flange 11a. As a result, when the needle
support sleeve 11 is moved toward the protective cylinder 12, the
bearing flange 11a bears on the free ends of the locking tongues
12i and 12j, pushing them back toward the shoulder 12f. The locking
tongues 12i and 12j then flex until they assume an opposite oblique
orientation toward the shoulder 12f, as may be seen in FIG. 3.
[0037] Because an appropriate peripheral clearance is provided
between the bearing flange 11a and the peripheral wall of the
proximal cylinder 12d, or because of the elasticity of the material
constituting the proximal cylinder 12d, which is able to spread
slightly when the bearing flange 11a passes between the locking
tongues 12i and 12j, the bearing flange 11a may continue its travel
until it abuts against the intermediate shoulder 12f, the locking
tongues 12i and 12j then bearing against the proximal face of the
bearing flange 11a, as may be seen in FIG. 3. In this position, the
locking tongues 12i and 12j also bear on the adjacent cylindrical
portion 11b of the needle support sleeve 11, this cylindrical
portion 11b having a diameter that is sufficient to maintain the
locking tongues 12i and 12j oriented obliquely toward the shoulder
12f. The locking tongues 12i and 12j then oppose withdrawal of the
needle support sleeve 11 from the protective cylinder 12.
[0038] In the embodiment shown in FIGS. 1, 3 and 4, a closure seal
15 is fitted around the protecting needle portion 10a and passes
through the needle passage 12h in the bottom 12g of the distal
cylinder 12e, providing the seal between the needle 10 and the
bottom 12g of the distal cylinder 12e. The closure sleeve 15 is
simultaneously made from an elastically retractable material and
closes the free end 10c of the needle 10 when there is no sampling
phial 13 engaged over the needle 10.
[0039] In the assembled position shown in FIG. 3, a proximal end
portion 15a of the closure sleeve 15 is compressed axially between
the distal end 11c of the needle support sleeve 11 and the bottom
12g of the distal cylinder 12e. This improves the seal.
[0040] In the embodiment shown in FIGS. 1 and 3, the needle support
sleeve 11 further comprises a sealing flange 11d offset in the
upstream direction from the bearing flange 11a and adapted to bear
against the locking tongues 12i and 12j when the needle support
sleeve 11 is engaged in the protective cylinder 12.
[0041] The protective cylinder 12 may advantageously be molded from
a first plastic material such as polypropylene.
[0042] Simultaneously, the needle support sleeve 11 may be molded
from a second plastic material such as polycarbonate.
[0043] The closure sleeve 15 is advantageously made from a closed
cell resilient foam or an elastically flexible elastomer such as
latex.
[0044] The present invention is not limited to the embodiments that
have been explicitly described and includes variants and
generalizations thereof within the scope of the following
claims.
* * * * *