FIELD OF THE INVENTION
The subject matter of this invention has been divided out of the specification of the
parent Indian Patent Application No. 1293/DEL/2008 dated May 28, 2008 and this
application constitutes a divisional 5 of the parent case.
The present invention relates to a catheter introducer, in particular an over-theneedle
peel-away catheter introducer, comprising a tube-like introducer sheath; an
introducer hub having a distal section and a proximal section, wherein the distal
10 section is joined to a proximal end of the introducer sheath and the proximal section
defines a chamber; a needle extending through the introducer hub and the
introducer sheath and having opposite proximal and distal ends, wherein the distal
end forms a needle tip; and a needle hub attached to the proximal end of the needle.
15
As used herein, the term “proximal” refers to a location on the device closest to, for
example, a clinician using the device. Conversely, the term “distal” refers to a
location on the device farthest from the clinician, such as the distal needle tip to be
inserted into a patient's vein.
20
A catheter introducer of the above kind is generally known and typically used to
facilitate insertion and placement of a catheter or another medical device into a
patient's vasculature. A conventional peel-away catheter introducer, which is also
referred to as a peelable or splittable or a tear-away catheter introducer, compris25
es a pair of wings extending transversely from the introducer hub.
When using the peel-away catheter introducer a clinician grabs the needle hub
along with the introducer hub and inserts the distal portions of the needle and of
the introducer sheath at a selected site into a patient's skin. The clinician advances
30 the device until venipuncture has been confirmed, for example, when blood enters
a flashback chamber formed in the needle hub. After venipuncture has been con3
firmed, the clinician advances the distal end portion of the introducer sheath into
the patient's vein and withdraws the needle. With the catheter introducer properly
placed, the clinician can then insert a medical device, such as a catheter, into the
proximal opening of the introducer sheath and advance the medical device
through the introducer sheath until it is properly placed in the 5 patient's vasculature.
After placement of the medical device the clinician withdraws the introducer sheath
out of the venipuncture site. The clinician then splits the introducer hub and introducer
sheath into two respective separate halves by a combination of twisting
and/or pulling apart of the wings along tear lines provided in the introducer hub
10 and introducer sheath until the two halves of the introducer hub and introducer
sheath split apart. The clinician can thus remove the introducer hub and introducer
sheath while the catheter inserted into the patient's vein remains in place.
Due to the increasing incidence of blood-borne pathogens such as human immu15
nodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) there
is a need to protect clinicians or other medical professionals or personnel handling
catheter introducers from accidental contact with the sharp needle tip after withdrawal
of the needle from the introducer sheath and introducer hub.
20 SUMMARY OF THE INVENTION
It is an object of the present invention to provide a catheter introducer which provides
reliable protection against accidental pricking by the needle once the needle
has been withdrawn from the introducer sheath and introducer hub.
25
This object is satisfied by a catheter introducer having the features of claim 1.
The catheter introducer of the invention comprises a tube-like introducer sheath;
an introducer hub having a distal section and a proximal section, wherein the distal
30 section is joined to a proximal end of the introducer sheath and the proximal section
defines a chamber; a needle extending through the introducer hub and the
4
introducer sheath and having opposite proximal and distal ends, wherein the distal
end forms a needle tip; a needle hub attached to the proximal end of the needle;
and a needle safety device slidably arranged on the needle, wherein the needle
safety device is retained in the chamber of the introducer hub when the needle
extends through the introducer hub and the introducer sheath 5 and is removable
from the introducer hub once the needle tip is received in the needle safety device
upon withdrawal of the needle from the introducer sheath.
The needle safety device is operative as a guard for the needle tip by automatical10
ly covering the needle tip during withdrawal of the needle from a patient and subsequently
from the introducer sheath. The needle safety device thereby serves to
prevent accidental pricking of, for example, a clinician by the needle tip after removal
of the needle from the introducer sheath. Hence, the needle can be safely
disposed of after use.
15
According to one embodiment, a part of the needle safety device is, seen in a
radial direction, arranged between the introducer hub and the needle hub. In this
way, not only a safe seat of the needle safety device in the chamber of the introducer
hub but also a secure connection between the introducer hub and the nee20
dle hub are achieved prior to withdrawal of the needle from the introducer sheath.
Furthermore, the arrangement of a part of the needle safety device between the
introducer hub and the needle hub facilitates a correct positioning of the needle
safety device in the introducer hub and thus makes the assembly and ultimately
the manufacture of the catheter introducer easier and less expensive.
25
According to a further embodiment, the needle safety device comprises two generally
L-shaped extensions formed on opposite sides of the needle safety device,
preferably in the region of a proximal end thereof. Each L-shaped extension may
have an axial section extending generally in an axial direction at a distance from a
30 base portion or a reinforced jaw portion of the needle safety device. As used here5
in, the axial direction is defined by the longitudinal axis of the introducer sheath
and of the needle extending therethrough.
Preferably, the proximal section of the introducer hub is configured to be received
between the axial sections and the base portion or the reinforced 5 jaw portions of
the needle safety device.
According to a further embodiment, the proximal section of the introducer hub is
formed from two opposite proximal tube sections extending in the axial direction.
10 Similarly, the needle hub may comprise a main body and two opposite tube sections
extending in the axial direction from a distal end of the main body.
Preferably, the tube sections of the needle hub are configured to engage between
the proximal tube sections of the introducer hub such that the tube sections of the
15 needle hub and the proximal tube sections of the introducer hub together form a
substantially closed tube. Because of this substantially closed tube the chamber
defined by the proximal section of the introducer hub is also substantially closed,
such that the needle safety device received in the chamber is protected from outside
influences. This helps to permanently maintain a reliable functioning of the
20 needle safety device.
According to a further embodiment, the main body of the needle hub comprises a
tube-like portion configured to receive both a base portion of the needle safety
device and a portion of the proximal section of the introducer hub. In the assem25
bled state, i.e. prior to withdrawal of the needle, the tube-like portion of the main
body of the needle hub hence surrounds a part of the needle safety device as well
as a part of the proximal section of the introducer hub, thereby not only protecting
the needle safety device but also preventing the introducer hub and consequently
the introducer sheath from accidentally splitting into halves.
30
6
According to a further embodiment, locking means are provided to hold the portion
of the proximal section of the introducer hub in place between the axial sections
and the base portion or the reinforced jaw portions of the needle safety device.
The locking means help to secure the needle safety device at the introducer hub
as long as the needle has not been fully withdrawn from the 5 introducer sheath and
the needle tip has not been received in the needle safety device. Hence, the needle
can move relative to the needle safety device until the needle tip is safely received
in the needle safety device. The locking means thus ensure a correct functioning
of the needle safety device.
10
According to a further embodiment, locking means are provided to hold the proximal
section of the introducer hub in place in the tube-like portion of the needle
hub. The locking means ensure a safe connection between the introducer hub and
needle hub and thereby prevent the needle from being accidentally withdrawn
15 from the introducer sheath.
Preferably, both the locking means operating between the introducer hub and the
needle safety device and the locking means operating between the introducer hub
and the needle hub comprise a locking protrusion on the respective one part and a
20 corresponding locking depression in the respective other part. For instance, respective
locking protrusions may be provided in the region of the proximal ends of
the proximal tube sections of the introducer hub, whereas corresponding grooves
may be provided at the inner side of the tube-like portion of the needle hub and of
the generally L-shaped extensions of the needle safety device.
25
The needle safety device may comprise first and second jaws extending from the
base portion in a generally axial direction.
According to one embodiment, the first jaw is integrally formed with the base por30
tion and, preferably, substantially rigid. Due to the first jaw being formed integrally
with the base portion, the number of parts in the needle safety device is reduced
7
and the simplicity thereof increased. Forming the base portion, and thus preferably
also the first jaw, from a plastic material helps to reduce the costs of manufacturing
the needle safety device. The first jaw being substantially rigid increases the
integrity of the needle safety device. At the same time, a reliable functioning of the
needle safety device can be ensured by a suitable deflectability 5 of both the first
and second jaw.
The second jaw may include a strip of material having spring-like properties, for
example a strip of sheet metal or a strip of a suitable plastic material. Because of
10 the first and second jaws being made from two separate parts, the needle safety
device can easily be adapted to needles of different thicknesses. Furthermore, due
to its simple design the needle safety device and, thus, the entire catheter introducer
can be manufactured at low cost. Due to its spring-like properties the second
jaw may be deflected against a restoring force by the needle extending all
15 the way through the needle safety device, such that the second jaw snaps in front
of the needle tip as soon as the needle tip is moved in between the two jaws,
thereby safely guarding the needle tip.
According to an alternative embodiment that can also be manufactured at low
20 cost, the first and second jaws may be formed integrally with the base portion,
wherein preferably both jaws have spring-like properties.
The second jaw may have a distal end section which extends towards the first jaw
such that it sits on the needle when the needle extends through the needle safety
25 device, thereby deflecting the second jaw outwardly against a restoring force, and
blocks the needle tip from protruding from the needle safety device when the needle
tip is received between the jaws, thereby safely guarding the needle tip in the
needle safety device.
30 According to a further embodiment, an elastic element, in particular a tension ring,
surrounds the first and second jaws in order to positively collapse the jaws when
8
the needle tip is received between the jaws. Preferably, the elastic element and
the jaws are configured such that the second jaw can be spread away from the
first jaw against a restoring force of the elastic element in order to allow the needle
to extend all the way through the needle safety device.
5
Due to the elastic element exerting its restoring force on the second jaw in the
deflected state of the second jaw, which is the state in which the catheter introducer
is typically shelved prior to use, the elastic element ensures that the spreadapart
jaws will snap together and guard the needle tip upon withdrawal of the needle
from the introducer sheath even after a longer shelf time, 10 thereby continuously
ensuring a correct functioning of the needle safety device. In addition, the elastic
element prevents the jaws from becoming loose when the needle safety device
slides along the needle, thereby further adding to a correct functioning of the needle
safety device. Furthermore, the elastic element helps prevent the needle tip
15 from protruding sideways out of the needle safety device, thereby further increasing
the protective function of the needle safety device.
According to a further embodiment, the needle extends through an axial bore in
the base portion of the needle safety device, wherein the cross section of the bore
20 is adapted to the main profile of the needle, and the needle has an enlargement
near the needle tip rendering the outer diameter of the needle, seen in at least one
direction, greater than the diameter of the bore. The enlargement prevents the
needle safety device from sliding off the needle when the needle tip is received
between the jaws, thereby even further improving the protective function of the
25 needle safety device.
Further subject matter of the invention is a needle safety device for guarding the
tip of a needle of a medical apparatus, for example a catheter introducer of the
above-described type or an intravenous catheter apparatus, which comprises a
30 base portion and two jaws extending therefrom and defining an axial direction and
two generally L-shaped extensions formed on opposite sides of the needle safety
9
device, wherein each L-shaped extension has an axial section extending generally
in the axial direction at a distance from the base portion or from reinforced portions
of the jaws. Apart from that, the needle safety device may be configured similar to
the needle safety device of the above-described catheter introducer.
5
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the invention are described in the following description
and in the accompanying drawings.
10
FIGS. 1a to 1c show (a) a first longitudinal sectional view of a catheter introducer
according to the invention, (b) a second longitudinal sectional view of the catheter
introducer, and (c) an enlargement of a portion of FIG. 1a;
FIGS. 2a and 2b show perspective views of an introducer hub 15 of the catheter introducer
of FIG. 1 and of the introducer hub attached to an introducer sheath;
FIGS. 3a and 3b show (a) a perspective view of a needle hub of the catheter introducer
of FIG. 1 and (b) a side view of the needle hub attached to a needle;
20
FIGS. 4a to 4f show (a) a perspective view of a needle safety device of the catheter
introducer of FIG. 1, (b) a longitudinal sectional view of the needle safety device,
(c) a side view of the needle safety device, (d) a plan view of the needle
safety device, (e) a side view of the needle safety device guarding the tip of a
25 needle, and (f) a longitudinal sectional view of the needle safety device guarding
the needle tip; and
FIGS. 5 a to 5f show (a) a perspective view, (b) a side view, (c) a longitudinal
sectional view, and (d) a plan view of an alternative needle safety device for the
30 catheter introducer of FIG. 1, and (e) a side view and (f) a longitudinal sectional
view of the needle safety device guarding the tip of a needle.
10
DETAILED DESCRIPTION OF THE INVENTION
FIGS. 1a and 1b show longitudinal sectional views of an over-the-needle peelaway
catheter introducer of the invention. The catheter 5 introducer comprises a
tube-like introducer sheath 10 having a proximal end region 12 that is joined to an
introducer hub 14.
Furthermore, the catheter introducer comprises a needle 16 having a distal end
10 that forms a needle tip 18 and a proximal end that is attached to a needle hub 20.
Prior to use of the catheter introducer, the needle hub 20 is connected to the introducer
hub 14 such that the needle 16 extends all the way through the introducer
hub 14 and the introducer sheath 10 and the needle tip 18 protrudes beyond a
15 distal end of the introducer sheath 10.
In order to prevent accidental pricking by the needle tip 18 prior to use of the catheter
introducer, an elongate cap 22 or protective tube is mounted to the introducer
hub 14, which covers the length of the introducer sheath 10 and also the needle
20 tip 18 protruding therefrom.
As can be seen in more detail from FIG. 2, the introducer hub 14 includes a distal
section 24 and a proximal section 26. The distal section 24 has smaller inner and
outer diameters than the proximal section 26 and is joined to the proximal end
25 region12 of the introducer sheath 10.
In the transition region between the distal section 24 and the proximal section 26 a
funnel-like structure 28 is formed in the introducer hub 14, which helps to facilitate
the introducing of a medical device, for example a catheter, into the introducer
30 sheath 10 after the introducer sheath 10 has been inserted into the vein of a pa11
tient. Furthermore, two wings 30 extend transversely from the introducer hub 14 in
the transition region between the distal section 24 and the proximal section 26.
Both the distal section 24 and the proximal section 26 of the introducer hub 14 are
formed from pairs of opposite axially extending tube sections 5 32, 34 which define
first and second halves of the introducer hub 14. Prior to use, the first and second
halves of the introducer hub 14 are connected to each other by the funnel-like
structure 28.
10 Once a medical device, such as a catheter, has been introduced through the introducer
sheath 10 into a patient's vein, the person handling the catheter introducer,
for example a clinician, withdraws the introducer sheath 10 from the venipuncture
site. By a combination of twisting and/or pulling apart of the wings 30 the clinician
then splits the introducer hub 14 into its two separate halves, thereby also tearing
15 the introducer sheath 10, such that the introducer hub 14 and the introducer
sheath10 can be removed from the catheter. In order to facilitate the breaking of
the introducer hub 14 into its two halves, tear lines36 may be provided in the funnel-
like structure 28 and also in the introducer sheath 10.
20 As can be seen in FIG. 3, the needle hub 16 comprises a main body 38 and two
opposite tube sections 40 which extend in an axial direction from a distal end of
the main body 38. The tube sections 40 of the needle hub 20 are configured to
engage between the proximal tube sections 34 of the introducer hub 14 such that
the proximal tube sections 34 of the introducer hub14 and the tube sections 40 of
25 the needle hub 20 form a substantially closed tube.
To this end, the tube sections 40 of the needle hub 20 and the proximal tube sections
34 of the introducer hub 14 have substantially the same length and curvature,
and the tube sections 40 of the needle hub 20 have a width corresponding to
30 the gap between the proximal tube sections 34 of the introducer hub 14.
12
Referring again to FIGS. 1 a and 1 b, the proximal tube sections 34 of the introducer
hub 14 and the tube sections 40 of the needle hub 20 together form a
chamber 42 for a needle safety device 44 which is slidably arranged on the needle
16.
5
As shown in FIG. 4, the needle safety device 44 comprises a main part 46, a
clip 48 and a tension ring 50.
The main part 46 is made from a plastic material and comprises a base portion
52 and an elongate portion 54 forming a first jaw 55. The 10 base portion 52 is of
substantially cylindrical shape and has a bore 56 extending therethrough in the
axial direction for receiving the needle 16. Other non-cylindrical shapes of the
needle safety device, in particularly of the base portion 52, as for example, oval or
polygonal, elliptic or the like can also be used.
15
The elongate portion 54 is of semi-cylindrical shape and extends from the base
portion 52 in the axial direction. The elongate portion 52 has a groove 58 formed in
its flat side 60, which extends in the axial direction along the entire length of the
elongate portion 54 and forms an extension of the bore 56 in the base portion 52.
20 While the bore 56 has a generally circular cross section that is adapted to the main
outer profile of the needle 16, the groove 58 has a generally semi-circular cross
section.
The clip 48 is formed from a strip of sheet metal having spring-like properties, such
25 as steel or the like. Alternatively, the clip48 could be formed from a plastic material
which has suitable spring-like properties.
The clip 48 forms a second jaw 62 and comprises a base section 64 and a deflectable
section 66. The base section 64 includes an axial section part 68 and a
30 radial section part 70. It is adapted to engage with the base portion 52 of the main
part 46 such that the axial section part 68 lies against the outer surface of the base
13
portion 52 while the radial section part 70lies against a rear or proximal end face of
the base portion 52, when the clip 48 is attached to the main part 46. In order to
ensure a correct positioning of the main part 46 and the clip 48, the base portion
52 is provided with a guide 74 for the clip 48.
5
The clip 48 is secured to the main part 46 by means of a heat sealing connection.
To this end, the main part 46 initially has a pillar or pin 76 formed at its proximal
end face and extending generally in the axial direction. The clip 48 has a corresponding
opening 78 formed in its radial section part 70 for receiving the pillar or
pin 76 when the clip 48 is mounted on the main part46. Once 10 the clip 48 has been
brought into its correct position relative to the main part 46, the pillar or
pin 76 extending through the opening 78 of the clip 48 is deformed by heat and/or
pressure in order to increase the diameter of the pillar or pin76. By making the
diameter of the pillar or pin 76 larger than the diameter of the opening 78, the
15 clip 48 is safely fixed at the main part 46. Alternatively, the clip 48 could be secured
to the main part 46 by means of gluing or welding or any other suitable type
of connection.
The base section 64 of the clip 48 passes into the deflectable section 66 via a
20 step-like bending of the sheet metal strip. The deflectable section 66 includes a
straight section part 80 which is reinforced by two elongate wings 82 that extend
on either side of the straight section part 80 and are bent inwards, i.e. towards the
elongate portion 54, by an angle of substantially 90°. In a relaxed state of the
clip 48 mounted on the main part 46 (FIGS. 4 b and 4 c), the straight section
25 part 80 does not exactly extend in the axial direction, but is bent slightly towards
the elongate portion 54 of the main part 46.
In the region of its distal end, the straight section part 80 passes into a head section
part 84 which extends beyond the free end of the elongate portion 54 of the
30 main part 46. The head section part 84 has a generally V-like shape with the peak
14
of the V pointing in the axial direction and the free leg 86 of the V extending towards
the elongate portion 54.
The tension ring 50 surrounds the elongate portion 54 of the main part 46 and the
straight section part 80 of the clip 48 in the region of the elongate 5 wings 82. The
tension ring 50 is made from a material having elastic properties, for example
rubber. The tension ring 50 is configured so that the deflectable section 66 of the
clip 48 is deflected against a restoring force of the tension ring 50, when the needle
16 extends all the way through the needle safety device 44. This situation is
10 called the deflected state of the needle safety device 44 and is shown in FIG. 1b.
When the needle 16 does not extend all the way through the needle safety device
44 (FIGS. 4e and 4f) or when there is no needle 16 at all (FIGS. 4b and 4c),
the deflectable section 66 of the clip 48 is drawn towards the elongate por15
tion 54 of the main part 46 by the tension ring 50. In this situation, which is referred
to as the collapsed state of the needle safety device44, the head section part 84 of
the clip 48 overlaps with or extends over at least a portion of the distal end
face 90 of the elongate portion 54, thereby preventing the needle tip 18 from protruding
out of the needle safety device 44 at the distal end thereof.
20
As has been mentioned above, the bore 56 provided in the base portion 52 of the
main part 46 of the needle safety device 44is adapted to the main outer profile of
the needle 16. As is indicated in FIG. 3b, the needle 16 is provided with an enlargement
92 near the needle tip 18, which renders the outer diameter of the nee25
dle 16, seen in at least one direction, greater than the diameter of the bore 56. The
enlargement 92 prevents the needle safety device 44 from sliding off the needle16
when the needle tip 18 is received between the first and second
jaws 55, 62 as is shown in FIGS. 4e and 4f.
30 As illustrated in FIGS. 4a and 4d, two generally L-shaped extensions 94 are
formed on opposite sides of the needle safety device 44 in the proximal region of
15
the base portion 52 of the main part 46. Each L-shaped extension 94 has an axial
section96 which extends in the axial direction at a distance from the base portion
52 of the needle safety device 44.
The L-shaped extensions 94 are dimensioned such that 5 proximal end portions
98 of the proximal tube sections 34 of the introducer hub 14 are tightly received
between the axial section 96 of the L-shaped extensions and the base
portion 52 of the needle safety device 44 when the needle safety device 44 is
received in the chamber 42 defined by the tube sections 34, 44of the introducer
10 hub 14 and the needle hub 20, as shown in FIGS. 1a and 1c.
In order to retain the proximal tube sections 34 of the introducer hub 14 in engagement
with the L-shaped extensions 94 of the needle safety device 44, locking
grooves 100 are provided in the inner surfaces of the axial sections 96 of the L15
shaped extensions 94 and corresponding locking protrusions 102 are provided at
the outer surfaces of the proximal tube sections 34of the introducer hub 14 (FIGS.
1c and 2).
As is best seen in FIG. 3, the tube sections 40 of the needle hub 20 pass into a
20 tube-like portion 104 of the main body 38 of the needle hub 20. The tube-like portion
104 is configured to receive not only the base portion 52 of the needle safety
device44 but also a part of the proximal tube sections 34 of the introducer
hub 14 (FIGS. 1a and 1c).
25 In order to secure the proximal tube sections 34 of the introducer hub 14 in the
tube-like portion 104 of the needle hub 20, locking grooves 106 are provided in the
inner surface of the tube-like portion 104 of the needle hub 20 (FIG. 3) and corresponding
locking protrusions 108 are formed at the outer surface of the proximal
tube sections 34 of the introducer hub14 in a distance distal from the locking pro30
trusions 102 provided for engagement with the needle safety device 44 (FIGS. 1c
and 2).
16
The engagement of the locking protrusions 108 with the locking
grooves 106 prevents the needle hub 20 from being accidentally released from the
introducer hub 14.
5
At the same time, the locking engagement of the locking protrusions 102 with the
locking grooves 100 secures the needle safety device 44 at the introducer hub 14,
thereby preventing the needle safety device 44 from being accidentally withdrawn
from the introducer hub 14 before the needle tip 18 has been received between
the first and second jaws 55, 62 of the needle 10 safety device 44.
FIG. 5 shows an alternative embodiment of a needle safety device 44.
Similar to the embodiment of FIG. 4 the needle safety device 44 shown in FIG.
15 5 comprises a main part 46 and a tension ring50. However, in contrast to the embodiment
of FIG. 4, the needle safety device 44 shown in FIG. 5 does not have
any separate clip 48. Instead, the main part 46 comprises a base portion 52 and
two elongate portions 110, 112 that extend from the base portion 52 generally in
the axial direction to form the first and second jaws 55, 62.
20
The base portion 52 and the two elongate portions 110, 112 are integrally formed
and made, for example, from a plastic material. The base portion 52 is of substantially
cylindrical shape and has a bore 56 extending therethrough in the axial direction
for receiving the needle 16. The bore 56 has a generally circular cross section
25 that is adapted to the main outer profile of the needle 16.
The elongate portions 110, 112 each have a proximal section 114 and a distal
section 116. While the proximal sections 114 extend generally parallel to each
other, the distal sections 116 are inclined towards each other in the collapsed state
30 of the needle safety device 44 (FIGS. 5e and 5f) or when no needle 16 extends
through the needle safety device 44 (FIGS. 5a to 5d).
17
The distal section 116 of the second jaw 62 passes into a head section
part 84 which extends beyond the free end of the first jaw 55. The head section
part 84 includes an end section 118 which extends in a radial direction towards the
first jaw 55. The length of the end section 118 is such that it 5 covers at least a portion
of the free end of the first jaw 55 when the needle safety device 44 is in its
collapsed state in order to prevent the needle tip 18 from protruding out of the
needle safety device 44 (FIGS. 5e and 5f).
10 The tension ring 50 surrounds the first and second jaws 55, 62 in the region of
their distal sections 116. The tension ring 50 is made from a material having elastic
properties, for example rubber. The tension ring 50 is configured so that the first
and second jaws 55, 62 are deflected against a restoring force of the tension
ring 50, when the needle 16 extends all the way through the needle safety de15
vice 44.
Two generally L-shaped extensions 94 are formed on opposite sides of the needle
safety device 44. The L-shaped extensions94 emerge from reinforced portions
120 of the first and second jaws 55, 62 in the proximal end region of the first
20 and second jaws 55, 62. Each L-shaped extension 94 has an axial section
96 which extends in the axial direction at a distance from the respective reinforced
portion 120.
The L-shaped extensions 94 are dimensioned such that proximal end por25
tions 98 of the proximal tube sections 34 of the introducer hub 14 are tightly received
between the axial sections 96 of the L-shaped extensions and the reinforced
portions120 of the needle safety device 44 when the needle safety device
44 is received in the chamber 42 defined by the tube sections 34, 44 of the
introducer hub 14 and the needle hub 20, as shown in FIGS. 1a and 1c.
30
18
Contrary to the embodiment of FIG. 4, the L-shaped extensions 94 of the needle
safety device 44 shown in FIG. 5 do not have any locking grooves 100 in the inner
surfaces of the axial sections 96 of the L-shaped extensions 94. Instead, the reinforced
portions 120 are provided with locking shoulders 122 for retaining the proximal
tube sections 34 of the introducer hub 14 between the axial 5 sections 96 of the
L-shaped extensions and the reinforced portions 120 of the needle safety device
44. Accordingly, the proximal tube sections 34 of the introducer hub 14 should
be provided with corresponding locking means at their inner surfaces, for example
suitable depressions.
10
It can be understood, that other non-cylindrical shapes of the needle safety device
44 and non-circular inner cross-section of the introducer hub 14 can be used to
ensure a correct engagement of the needle safety device 44 with the introducer
hub 14, as for example, oval or polygonal shapes or the like.
15
LIST OF REFERENCE NUMERALS
 10 introducer sheath
 12 proximal end region
20  14 introducer hub
 16 needle
 18 needle tip
 20 needle hub
 22 elongate cap
25  24 distal section
 26 proximal section
 28 funnel-like structure
 30 wing
 32 distal tube section
30  34 proximal tube section
 36 tear line
19
 38 main body
 40 tube section
 42 chamber
 44 needle safety device
5  46 main part
 48 clip
 50 tension ring
 52 base portion
 54 elongate portion
10  55 first jaw
 56 bore
 58 groove
 60 flat side
 62 second jaw
15  64 base section
 66 deflectable section
 68 axial section part
 70 radial section part
 74 guide
20  76 pin
 78 opening
 80 straight section part
 82 wing
 84 head section part
25  86 free leg
 90 end face
 92 enlargement
 94 L-shaped extension
 96 axial section
30  98 proximal end portion
 100 locking groove
20
 102 locking protrusion
 104 tube-like portion
 106 locking groove
 108 locking protrusion
5  110 elongate portion
 112 elongate portion
 114 proximal section
 116 distal section
 118 end section
10  120 reinforced portion
 122 locking shoulder

WE CLAIM:
1. A catheter introducer comprising:
a tube-like introducer sheath (10);
an introducer hub (14) having a distal section (24) and 5 a proximal section
(26), wherein the distal section (24) is joined to the introducer sheath (10) and the
proximal section (26) defines a chamber (42);
a needle (16) extending through the introducer hub (14) and the introducer
sheath (10) and having opposite proximal and distal ends, wherein the distal end
10 forms a needle tip (18);
a needle hub (20) attached to the proximal end of the needle (16); and
a needle safety device (44) slidably arranged on the needle (16), wherein
the needle safety device (44) is retained in the chamber (42) of the introducer hub
(14 when the needle (16) extends through the introducer hub (14) and the
15 introducer sheath (10), and removable from the introducer hub (14) once the
needle tip (18) is received in the needle safety device (44) upon withdrawal of the
needle (16) from the introducer sheath (10), and wherein the needle safety device
(44) comprises a base portion (52) and first and second jaws (55, 62) extending
from the base portion (52) in a generally axial direction; and an elastic element
20 surrounds the first and second jaws (55, 62) in order to positively collapse the jaws
(55, 62) when the needle tip (18) is received between the jaws (55, 62).
2. The catheter introducer as claimed in claim 1, wherein a part of the needle
safety device (44) is arranged between the introducer hub (14) and the needle hub
25 (20) as seen in a radial direction.
3. The catheter introducer as claimed in any of the preceding claims, wherein
the needle safety device (44) comprises two generally L-shaped extensions
formed on opposite sides of the needle safety device (44) arranged in the region of
30 a proximal end of the needle safety device (44), and/or each L-shaped extension
(94) has an axial section (96) extending generally in an axial direction at a
distance from a base portion (52) or a reinforced jaw portion (120) of the needle
safety device (44), and/or the proximal section (26) of the introducer hub (14) is
22
configured to be received between the axial sections (96) and the base portion
(52) or the reinforced jaw portions (120) of the needle safety device (44).
4. The catheter introducer as claimed in claim 3, wherein locking means (100,
102; 122) are provided to hold the proximal section (26) of the 5 introducer hub (14)
in place between the axial sections (96) and the base portion (52) or the reinforced
jaw portions (120) of the needle safety device (44).
5. The catheter introducer as claimed in any one of the preceding claims,
10 wherein the proximal section (26) of the introducer hub (14) is formed from two
opposite tube sections (34) extending in an axial direction, and/or the needle hub
(20) comprises a main body (38) and two opposite tube sections (40) extending in
an axial direction from a distal end of the main body (38), and/or the tube sections
(40) of the needle hub (20) are configured to engage between the tube sections
15 (34) of the introducer hub (14) such that the tube sections (34) of the introducer
hub (14) and the tube sections (40) of the needle hub (20) form a substantially
closed tube.
6. The catheter introducer as claimed in any one of the preceding claims,
20 wherein a main body (38) of the needle hub (20) comprises a tube-like portion
(104) configured to receive both a base portion (52) of the needle safety device
(44) and a portion of the proximal section (26) of the introducer hub (14).
7. The catheter introducer as claimed in claim 6, wherein the needle hub (20)
25 is provided with locking means (106, 108) to hold the portion of the proximal
section (26) of the introducer hub (14) in place in the tube-like portion (104) of the
needle hub (20).
8. The catheter introducer as claimed in claim 4 or 7, wherein the locking
30 means (100, 102, 106, 108; 122) comprise a locking protrusion on the respective
one part and a corresponding locking depression in the respective other part.
23
9. The catheter introducer as claimed in any one of the preceding claims,
wherein the first jaw (55) is integrally formed with the base portion (52), and/or
the second jaw (62) includes a strip of material having spring-like properties, e.g. a
strip of sheet metal or plastic.
5
10. The catheter introducer as claimed in any one of the preceding claims,
wherein the first jaw (55) and the second jaw (62) are integrally formed with the
base portion (52), wherein both jaws (55, 62) have spring-like properties.
11. The catheter introducer as claimed in any one of 10 the preceding claims,
wherein the second jaw (62) has a distal end section (86; 118) which extends
towards the first jaw (55) such that it sits on the needle (16) when the needle (16)
extends through the needle safety device (44), thereby deflecting the second jaw
(62) outwardly against a restoring force, and blocks the needle tip (18) from
15 protruding from the needle safety device (44) when the needle tip (18) is received
between the jaws (55, 62).
12. The catheter introducer as claimed in any one of the preceding claims,
wherein the elastic element is a tension ring (50).
20
13. The catheter introducer as claimed in any one of the preceding claims,
wherein the needle (16) extends through an axial bore (56) in the base portion (52)
of the needle safety device (44), wherein the cross section of the bore (56) is
adapted to the main profile of the needle (16), and the needle (16) has an
25 enlargement (92) near the needle tip rendering the outer diameter of the needle
(16), seen in at least one direction, greater than the diameter of the bore (56).
14. A needle safety device (44) for guarding the tip (18) of a needle (16) of a
medical apparatus, in particular a catheter introducer or an intravenous catheter
30 apparatus as claimed in any one of the preceding claims, comprising: a base
portion (52) and first and second jaws (55, 62) extending therefrom in a generally
axial direction; and an elastic element surrounding the first and second jaws (55,
62) when the needle tip (18) is received between the jaws (55, 62).
24
15. The needle safety device as claimed in claim 14 comprising the features of
any one of claims 1 to 13.