NZ758144B2 - Low-profile extension for a catheter assembly - Google Patents
Low-profile extension for a catheter assembly Download PDFInfo
- Publication number
- NZ758144B2 NZ758144B2 NZ758144A NZ75814418A NZ758144B2 NZ 758144 B2 NZ758144 B2 NZ 758144B2 NZ 758144 A NZ758144 A NZ 758144A NZ 75814418 A NZ75814418 A NZ 75814418A NZ 758144 B2 NZ758144 B2 NZ 758144B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- cantilever arm
- extension
- catheter adapter
- catheter
- distal end
- Prior art date
Links
- 238000003780 insertion Methods 0.000 claims abstract description 49
- 239000012530 fluid Substances 0.000 claims abstract description 17
- 229920005992 thermoplastic resin Polymers 0.000 claims abstract description 4
- 238000011105 stabilization Methods 0.000 claims description 22
- 239000000853 adhesive Substances 0.000 claims description 2
- 230000001070 adhesive Effects 0.000 claims description 2
- 210000004369 Blood Anatomy 0.000 abstract description 10
- 239000008280 blood Substances 0.000 abstract description 10
- 230000003247 decreasing Effects 0.000 abstract description 5
- 210000003491 Skin Anatomy 0.000 description 17
- 230000000875 corresponding Effects 0.000 description 7
- 239000000463 material Substances 0.000 description 6
- 238000001990 intravenous administration Methods 0.000 description 3
- 238000001802 infusion Methods 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 210000001331 Nose Anatomy 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000001808 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 201000009910 diseases by infectious agent Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
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- 238000005755 formation reaction Methods 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 235000016236 parenteral nutrition Nutrition 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920000139 polyethylene terephthalate Polymers 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
- 239000002952 polymeric resin Substances 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 230000037380 skin damage Effects 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
Abstract
extension (20) for a catheter assembly (10) may include a distal end and a proximal end. The distal end may include a connector element comprising one or more cantilever arms (26) and an blunt insertion feature (24) spaced apart from the cantilever arms. The blunt insertion feature may be configured to insert into a lumen of a catheter adapter (12) to provide a fluid connection between the catheter adapter and the extension. The one or more cantilever arms may be configured to engage in a snap-fit with the catheter adapter. The proximal end of the extension may include a female luer fitting (30). The extension may include an elongated tubular element comprising a distal end and a proximal end. The distal end of the elongated tubular element may be integrated with the connector element. The proximal end of the elongated tubular element may be integrated with the female luer fitting. The elongated tubular element may be constructed of a thermoplastic resin. The one or more cantilever arms may be configured to engage in a snap-fit with the catheter adapter. The one or more cantilever arms may be configured to be fixed with respect to the catheter adapter when the one or more cantilever arms are engaged in the snap-fit with the catheter adapter, decreasing a risk of the user to blood exposure. gured to insert into a lumen of a catheter adapter (12) to provide a fluid connection between the catheter adapter and the extension. The one or more cantilever arms may be configured to engage in a snap-fit with the catheter adapter. The proximal end of the extension may include a female luer fitting (30). The extension may include an elongated tubular element comprising a distal end and a proximal end. The distal end of the elongated tubular element may be integrated with the connector element. The proximal end of the elongated tubular element may be integrated with the female luer fitting. The elongated tubular element may be constructed of a thermoplastic resin. The one or more cantilever arms may be configured to engage in a snap-fit with the catheter adapter. The one or more cantilever arms may be configured to be fixed with respect to the catheter adapter when the one or more cantilever arms are engaged in the snap-fit with the catheter adapter, decreasing a risk of the user to blood exposure.
Description
(12) Granted patent specificaon (19) NZ (11) 758144 (13) B2
(47) Publicaon date: 2021.12.24
(54) LOW-PROFILE EXTENSION FOR A CATHETER ASSEMBLY
(51) Internaonal Patent Classificaon(s):
A61M 25/00 A61M 39/10 A61M 25/06
(22) Filing date: (73) Owner(s):
2018.03.05 BECTON, DICKINSON AND COMPANY
(23) Complete specificaon filing date: (74) Contact:
2018.03.05 FB Rice Pty Ltd
(30) Internaonal Priority Data: (72) Inventor(s):
US 15/481,690 2017.04.07 HARDING, Weston F.
STALEY, Shaun
(86) Internaonal Applicaon No.:
(87) Internaonal Publicaon number:
WO/2018/186964
(57) Abstract:
An extension (20) for a catheter assembly (10) may include a distal end and a proximal end.
The distal end may include a connector element comprising one or more canlever arms (26)
and an blunt inseron feature (24) spaced apart from the canlever arms. The blunt inseron
feature may be configured to insert into a lumen of a catheter adapter (12) to provide a fluid
connecon between the catheter adapter and the extension. The one or more canlever arms may
be configured to engage in a snap-fit with the catheter adapter. The proximal end of the extension
may include a female luer fing (30). The extension may include an elongated tubular element
comprising a distal end and a proximal end. The distal end of the elongated tubular element may
be integrated with the connector element. The proximal end of the elongated tubular element
may be integrated with the female luer fing. The elongated tubular element may be constructed
of a thermoplasc resin. The one or more canlever arms may be configured to engage in a snap-
fit with the catheter adapter. The one or more canlever arms may be configured to be fixed with
respect to the catheter adapter when the one or more canlever arms are engaged in the snap-fit
with the catheter adapter, decreasing a risk of the user to blood exposure.
NZ 758144 B2
LOW-PROFILE EXTENSION FOR A CATHETER ASSEMBLY
BACKGROUND OF THE INVENTION
Catheters are commonly used for a variety of infusion therapies. For example,
catheters may be used for infusing fluids, such as normal saline solution, various medicaments,
and total parenteral nutrition into a patient. Catheters may also be used for withdrawing blood
from the patient. Each catheter is typically coupled to a catheter adapter to enable coupling of the
catheter to tubing connected to a fluid source. In further detail, the tubing connected to the fluid
source may terminate in a male luer fitting, which may be coupled to a female luer fitting of the
catheter adapter, and fluid from the fluid source may be infused into the vasculature of the
patient via the catheter.
Often the male luer fitting and/or the female luer fitting are bulky and/or may
have protruding, sharp edges that may irritate or damage skin of the patient, particularly when
the patient is an elderly or neonate patient. In some instances, the sharp edges may result in pain
or even infection. The bulkiness of the male luer fitting and/or the female luer fitting may also
raise the catheter from the patient, which may increase a chance of accidental dislodgement of
the catheter from the vasculature of the patient. Accordingly, there is a need for catheter systems
and methods that stabilize the catheter within the vasculature of the patient and reduce a risk of
skin damage.
Any discussion of documents, acts, materials, devices, articles or the like which
has been included in the present specification is not to be taken as an admission that any or all of
these matters form part of the prior art base or were common general knowledge in the field
relevant to the present disclosure as it existed before the priority date of each of the appended
claims.
BRIEF SUMMARY OF THE INVENTION
Throughout this specification the word "comprise", or variations such as
"comprises" or "comprising", will be understood to imply the inclusion of a stated element,
integer or step, or group of elements, integers or steps, but not the exclusion of any other
element, integer or step, or group of elements, integers or steps.
According to the present disclosure, there is provided an extension for a catheter
assembly, the extension comprising a distal end, comprising a connector element, comprising a
cantilever arm and an insertion feature spaced apart from the cantilever arm, wherein the blunt
insertion feature and the cantilever arm are monolithically formed as a single unit, wherein the
blunt insertion feature is configured to insert into a lumen of a catheter adapter to provide a fluid
connection between the catheter adapter and the extension, wherein the cantilever arm is
configured to engage in a snap-fit with the catheter adapter; a proximal end comprising a female
luer fitting; and an elongated tubular element, comprising a distal end and a proximal end,
wherein the distal end of the elongated tubular element is integrated with the connector element,
wherein the proximal end of the elongated tubular element is integrated with the female luer
fitting, wherein the elongated tubular element is constructed of a thermoplastic resin, wherein the
cantilever arm is configured to engage in a snap-fit with the catheter adapter, wherein the
cantilever arm is configured to be fixed with respect to the catheter adapter when the cantilever
arm is engaged in the snap-fit with the catheter adapter.
According to the present disclosure, there is further provided a catheter system,
comprising: a catheter adapter, comprising a proximal end, a distal end, and a lumen extending
therebetween, wherein the proximal end comprises a plurality of slots and a proximal lumen
opening, wherein the lumen comprises a septum, wherein the distal end comprises a catheter
configured to be inserted into vasculature of a patient, wherein the catheter comprises a
longitudinal axis, wherein the catheter adapter is configured to be selectively coupled with a
distal end of a needle shield; and an extension, comprising a distal end, an elongated tubular
element, a proximal end, and a lumen extending through the distal end, the elongated tubular
element, and the proximal end, wherein a longitudinal axis extending through the distal end, the
elongated tubular element, and the proximal end is aligned with the longitudinal axis of the
catheter, wherein the distal end of the extension comprises a first cantilever arm, a second
cantilever arm, and a blunt insertion feature spaced apart from the first cantilever arm and the
second cantilever arm, wherein the blunt insertion feature, the first cantilever arm, and the
second cantilever arm are monolithically formed as a single unit, wherein the blunt insertion
feature is configured to insert into the lumen of the catheter adapter to open the septum and
provide a fluid connection between the catheter adapter and the extension, wherein the first
cantilever arm and the second cantilever arm are configured to insert into the plurality of slots to
engage in a snap-fit with the catheter adapter, wherein in response to the first cantilever arm and
second cantilever arm being engaged in the snap-fit with the catheter adapter, the extension is
fixed with respect to the catheter adapter.
The present disclosure may relate generally to devices, systems, and associated
methods to stabilize a catheter inserted into vasculature of a patient and/or prevent irritation of
skin of the patient by a catheter adapter coupled to the catheter or by a luer fitting. In some
embodiments, a low-profile extension may be coupled to the catheter adapter, which may allow
the catheter adapter to sit closer to the skin. If the catheter adapter is disposed close to the skin,
an insertion depth of the catheter extending from the catheter adapter may increase, reducing a
risk of dislodgement of the catheter and providing stability to the catheter. The extension may
also allow remote manipulation of a luer connection, which may prevent disruption of an
insertion site of the catheter.
In some embodiments, the catheter adapter may include a proximal end, a distal
end, and a lumen extending therebetween. In some embodiments, the proximal end of the
catheter adapter may include one or more slots and/or a proximal lumen opening. In some
embodiments, the distal end of the catheter adapter may include the catheter, which may be
configured to be inserted into the vasculature of the patient.
In some embodiments, the extension may include a distal end, a proximal end,
and a lumen extending therebetween. In some embodiments, the distal end of the extension may
include one or more cantilever arms and/or an insertion feature spaced apart from the cantilever
arms. In some embodiments, the insertion feature may be configured to insert into the lumen of
the catheter adapter to provide a fluid connection between the catheter adapter and the extension.
In some embodiments, each of the cantilever arms may be configured to engage in a snap-fit
with the catheter adapter.
In further detail, in some embodiments, the cantilever arms may be configured to
insert into the slots to engage in a snap-fit with the catheter adapter. In some embodiments, distal
ends of each of the cantilever arms may include a hook. In some embodiments, each of the
cantilever arms may deflect as the hook of the corresponding cantilever arm is inserted into a
corresponding slot of the catheter adapter. In some embodiments, as the hook reaches a groove
proximate the slot, the cantilever arm may return to an original shape of the cantilever arm prior
to insertion into the slot.
In some embodiments, the insertion feature may be spaced apart from the
cantilever arms by separator elements that may extend outwardly with respect to a longitudinal
axis of the extension. In some embodiments, the cantilever arms may include a first cantilever
arm and a second cantilever arm. In some embodiments, the first cantilever arm may oppose the
second cantilever arm.
In some embodiments, the proximal end of the extension may be configured to be
coupled to a male luer fitting or another connector. For example, the proximal end of the
extension may include a female luer fitting.
In some embodiments, the extension may include an elongated tubular element,
which may be disposed between the distal end and the proximal end. In some embodiments, the
extension may include a grip portion, which may be disposed between the distal and proximal
ends of the extension. In some embodiments, the grip portion may include one or more wings
and/or one or more protrusions. In some embodiments, the grip portion may be disposed
proximal to the tubular element.
In some embodiments, the catheter adapter may include a stabilization platform.
In some embodiments, the slots may be disposed within the stabilization platform. In some
embodiments, a width of each of the separator elements may be approximately equal to a width
of the stabilization platform, which may prevent formation of any protruding edges when the
extension is secured to the catheter adapter. Protruding edges could contact the skin of the patient
and cause irritation.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE FIGURES
In order that the manner in which the above-recited and other features and
advantages of the invention will be readily understood, a more particular description of the
devices, systems, and associated methods to secure and stabilize a catheter briefly described
above will be rendered by reference to specific embodiments thereof, which are illustrated in
Figures 1-8. Understanding that these Figures depict only typical embodiments and are not,
therefore, to be considered to be limiting of its scope, the invention will be described and
explained with additional specificity and detail through the use of the accompanying Figures in
which:
Figure 1 is an upper perspective view of an example needle shield coupled to an
example catheter assembly ready for insertion into vasculature of a patient, according to some
embodiments;
Figure 2 is an upper perspective view of the catheter assembly of Figure 1 and an
example extension ready to be coupled to the catheter assembly, according to some
embodiments;
Figure 3A is a widthwise cross-sectional view of the catheter assembly of Figure
1 and the extension of Figure 2, according to some embodiments;
Figure 3B is a widthwise, enlarged cross-sectional view of the extension of Figure
2 secured to the catheter assembly of Figure 1, according to some embodiments;
Figure 4 is an upper perspective view of the extension of Figure 2 secured to the
catheter assembly of Figure 1, according to some embodiments;
Figure 5A is a longitudinal cross-sectional view of a conventional catheter
assembly inserted into skin of the patient and coupled to an example male luer fitting, according
to some embodiments;
Figure 5B is a longitudinal cross-sectional view of the extension of Figure 2
secured to the catheter assembly of Figure 1 and the male luer fitting of Figure 5A, according to
some embodiments;
Figure 6 is an upper perspective, cutaway view of the catheter assembly of Figure
1 secured to the extension of Figure 2, according to some embodiments;
Figure 7 is an upper perspective view of the catheter assembly of Figure 1 and the
example extension of Figure 2 ready to be coupled to the catheter assembly, according to some
embodiments; and
Figure 8 is a longitudinal cross-sectional view of the extension of Figure 2
secured to the catheter assembly of Figure 1 and the male luer fitting of Figure 5A, according to
some embodiments.
DETAILED DESCRIPTION OF THE INVENTION
It will be readily understood that the components of the present invention, as
generally described and illustrated in the Figures in the present disclosure, could be arranged and
designed in a wide variety of different configurations. Thus, the following more detailed
description of the embodiments, represented in Figures 1-8, is not intended to limit the scope of
the invention, as claimed, but is merely representative of some embodiments of the invention.
Figure 1 illustrates a catheter assembly 10 in accordance with one or more
embodiments. In some embodiments, the catheter assembly 10 may include a catheter adapter 12
coupled to a needle safety feature, which may include a needle shield 14. In some embodiments,
a catheter 16 may extend distally from the catheter adapter 12, and a proximal end of the catheter
16 may be secured within the catheter adapter 12. In some embodiments, the needle shield 14
may include a needle hub (not illustrated), which may secure a proximal end of an introducer
needle 18. In some embodiments, when the needle 18 is ready to be inserted into vasculature of
the patient, the needle 18 may extend through the catheter 16 and beyond a tip of the catheter 16,
as illustrated in Figure 1.
In some embodiments, once the needle 18 has been used to insert the catheter 16
into the vasculature of a patient, the needle hub may be retracted into the needle shield 14 such
that the needle 18 is fully contained within the needle shield 14. In some embodiments, when the
needle 18 is retracted into the needle shield 14, a blood control septum disposed within a lumen
of the catheter adapter may close to prevent blood leakage. In some embodiments, the needle
shield 14 may be uncoupled from the catheter adapter 12 in response to the catheter 16 being
inserted into the vasculature of the patient and/or the needle 18 being retracted into the needle
shield 14. Generally, a male luer fitting may then be coupled to the catheter adapter 12, and fluid
may be infused into the vasculature of the patient via the catheter 16. As an alternative, in some
embodiments, an extension may be coupled with the proximal end of the catheter adapter, and
the male luer fitting may be coupled to a proximal end of the extension, as will be described in
further detail. In these embodiments, the fluid may be infused into the vasculature of the patient
via a fluid pathway that includes the extension.
The catheter assembly 10 may include any suitable type of catheter assembly. In
some embodiments, the catheter assembly 10 may include an intravenous (IV) catheter assembly.
As an example, the catheter assembly 10 may include one or more features of the BD INSYTE™
AUTOGUARD™ Shield IV Catheter, and the needle shield 14 may be spring loaded. As another
example, the catheter assembly 10 may include one or more features of the BD NEXIVA™
DIFFUSICS™ Closed IV Catheter System. Suitable materials for the catheter adapter 12 and/or
the extension 20 may include, but are not limited to, thermoplastic polymeric resins such as
polycarbonate, polystyrene, polypropylene, polyethylene terephthalate glycol (PETG), and the
like.
Referring now to Figure 2, in some embodiments, the extension 20 may include
an elongated body. In some embodiments, a distal end of the extension 20 may include a
connector element 22. In some embodiments, the connector element 22 may include an insertion
feature 24 and one or more cantilever arms 26 spaced apart from the insertion feature 24. In
some embodiments, the cantilever arms 26 may be disposed generally parallel to the insertion
feature 24. In some embodiments, the cantilever arms 26 may extend in a distal direction. In
some embodiments, the cantilever arms 26 may be spaced apart from the insertion feature 24 by
outwardly-extending separator elements 28. In some embodiments, the insertion feature 24 may
be aligned with a longitudinal axis of the extension 20.
The connector element may include any number of cantilever arms 26. In some
embodiments, a first cantilever arm 26 and a second cantilever arm 26 may be aligned on
opposite sides of the extension 20, as illustrated in Figure 2. In some embodiments, the connector
element 22 may include an annular cantilever arm 26, which may surround the insertion feature
In some embodiments, the proximal end of the extension 20 may be configured to
connect to another device. In some embodiments, the proximal end of the extension may include
a female luer fitting 30. In some embodiments, the proximal end of the extension 20 may include
one or more threads for connection to the male luer fitting or another connector.
In some embodiments, the extension 20 may include a grip portion 32, which may
facilitate insertion of the extension 20 into the catheter adapter 12 by a user. In some
embodiments, the grip portion 32 may include one or more wings 34 and/or protrusions 36.
Referring now to Figures 3A-3B, in some embodiments, the cantilever arms 26
may engage in a snap-fit with the catheter adapter 12. In further detail, in some embodiments,
each of the cantilever arms 26 may include a distal end that includes a hook 38. In some
embodiments, each of the cantilever arms 26 may deflect as the hook 38 of the corresponding
cantilever arm 26 is inserted into a corresponding slot 40 of the catheter adapter 12. In some
embodiments, as the hook 38 reaches a groove 42 proximate the slot 40, the cantilever arm 26
may return to an original shape of the cantilever arm 26 prior to insertion into the slot 40. In
some embodiments, the insertion feature 24 may be sized and configured to insert into the lumen
44 of the catheter adapter 12 and open the blood control septum 46 when the cantilever arms 26
engage in the snap-fit with the catheter adapter 12. Thus, in some embodiments, the insertion
feature 24 may include an actuator.
In some embodiments, once the connector element 22 is secured in the catheter
adapter 12 via the snap-fit, a connection between the extension 20 and the catheter adapter 12
may be permanent, decreasing a risk of the user to blood exposure. In further detail, it may be
difficult for the user to remove the extension 20 from the catheter adapter 12 without a tool once
the connector element 22 is secured in the catheter adapter 12 in the snap-fit. In some
embodiments, the grooves 42 may include an adhesive 47, which may increase a strength of the
connection between the extension 20 and the catheter adapter 12.
In some embodiments, the catheter adapter 12 may include a stabilization
platform 48. In some embodiments, the stabilization platform 48 may include one or more wings,
which may extend outwardly from a body of the catheter adapter 12. In some embodiments, the
slots 40 may be disposed within the stabilization platform 48. In some embodiments, a first slot
40 corresponding to a first cantilever arm 26 may be disposed on a first side of the stabilization
platform 48, and a second slot 40 corresponding to a second cantilever arm 26 may be disposed
on a second side of the stabilization platform 48. In some embodiments, the slots 40 may be
generally parallel to a longitudinal axis 50 of the catheter adapter 12 and the extension 20. In
some embodiments, the slots 40 may be spaced apart from the lumen 44 of the catheter adapter
In some embodiments, the extension 20 may include a lumen 54 extending
therethrough. In further detail, the lumen 54 of the extension 20 may extend through the insertion
feature 24 of the distal end of the extension 20 to a proximal end of the extension 20. The
extension 20 may be integrally formed or include separate components. In some embodiments,
the connector element 22 may be coupled with a tubular element 56 of the extension 20. In other
embodiments, the tubular element 56 and the connector element 22 may be integrally formed. In
some embodiments, the tubular element 56 may have a uniform inner diameter, which may be
greater than an inner diameter of the insertion feature 24.
Referring now to Figure 4, in some embodiments, a shape of the stabilization
platform 48 may be generally planar or flat, which may allow the stabilization platform 48 to
have a low-profile. In some embodiments, a distal end of the stabilization platform 48 may
include a gradual taper. In some embodiments, the stabilization platform 48 may include a push
tab 58 disposed on an upper surface of the stabilization platform 48. In some embodiments, the
push tab 58 may be integrally molded from a same material as the stabilization platform 48. In
some embodiments, the upper surface of the stabilization platform 48 may be smooth except for
the push tab 58. In some embodiments, a bottom surface of the stabilization platform 48, or a
surface of the stabilization platform 48 closest to skin of the patient, may be smooth. In some
embodiments, the catheter adapter 12 and/or the extension 20 may be free of protruding edges
that may irritate the skin of the patient.
In some embodiments, the separator elements 28 may complete a geometric shape
of the catheter adapter 12 when the connector element 22 is secured to the catheter adapter 12. In
these and other embodiments, a width of the separator elements 28 may be approximately equal
to a width of the catheter adapter 12 such that the separator elements 28 do not protrude above or
below the catheter adapter 12 and irritate the skin of the patient, as illustrated in Figure 4.
In some embodiments, the stabilization platform 48 may support one or more
digits of the user as the user inserts the catheter 16 at the insertion site, hoods the needle 18, or
moves the catheter assembly 12 from an insertion configuration to a fluid delivery configuration.
In some embodiments, the user may pinch or grip the stabilization platform 24, which may
extend outwardly from the longitudinal axis 50.
The securement platform 48 may optionally be “soft,” i.e., formed of a relatively
compliant material that conforms easily to the skin of the patient. In some embodiments, the
securement platform 48 may be formed of a soft plastic, an elastomer such as silicone rubber,
and/or the like.
As illustrated in Figure 5A, a conventional catheter adapter 59 may be directly
connected to the male luer fitting 60, which may increase a gap or distance between the catheter
adapter 59 and the skin 61 of the patient due to threading between the catheter adapter 59 and the
male luer fitting 60. The male luer fitting 60 directly connected to the conventional catheter
adapter 59 may also increase an angle of the catheter adapter 59 with respect to the skin 61.
As illustrated in Figure 5B, in some embodiments, the extension 20 may be
secured to the catheter adapter 12 without any turning or twisting, which may allow the catheter
adapter 12 and the extension 20 to maintain a low-profile. Thus, the catheter adapter 12 may sit
closer to the skin 61 than the conventional catheter adapter 59, maximizing a catheter insertion
depth and stability of the catheter 16. Also, a side of the catheter adapter 12 may be allowed to
contact the skin 61, further increasing the stability of the catheter 16. In these and other
embodiments, an outer diameter of the catheter adapter 12 may be decreased or tapered at a tip or
nose of the catheter adapter 12 compared to the conventional catheter adapter 59, which may
allow the catheter adapter 12 to maintain a low-profile.
In some embodiments, the male luer fitting 60 may include one or more
protruding sharp edges, which may more easily contact the skin 61 in absence of the extension
, as illustrated in Figure 5A. Advantageously, in some embodiments, the extension 20 may
allow for remote manipulation of the male luer fitting 60 and luer connection, which may reduce
a risk of disturbing an insertion site of the catheter 16.
Referring now to Figure 6, in some embodiments, the catheter adapter 12 may not
include the blood control septum 46, such as, for example, in neonatal applications. In some
embodiments, a conical seal may be relied upon to provide blood control. In further detail, in
some embodiments, a male conical surface of the insertion feature 24 may wedge into or be
engaged in an interference fit with a female conical surface of the catheter adapter 12. In these
and other embodiments, an outer diameter of the insertion feature 24 and an inner diameter of the
catheter adapter 12 may be approximately the same.
Referring now to Figures 7-8, in some embodiments, the proximal end of the
catheter adapter 12 may include a connector, such as, for example, a female luer-type fitting 62.
In some embodiments, the proximal end of the extension 20 may include another female luer-
type fitting. In some embodiments, the female luer-type fitting 62 and the other female luer-type
fitting may be a same or similar size. In some embodiments, the other female luer-type fitting
may include the female luer fitting 30. In some embodiments, the female luer-type fitting 62 of
the catheter adapter 12 may have a reduced size compared to the female luer fitting 30 of the
proximal end of the extension 20. In further detail, in some embodiments, a proximal end and/or
threads 64 of the female luer-type fitting 62 may have a reduced diameter compared to a
proximal end and/or threads 66 of the female luer fitting 30. Thus, in some embodiments, a
corresponding male luer-type fitting 70 of the distal end of the extension 20 may be reduced in
size compared to the male luer fitting 60, allowing the catheter adapter 12 and the extension 20
to maintain a low-profile. The low-profile of the catheter adapter 12 and/or the extension 20 may
allow the catheter adapter 12 to sit close to the skin 61, which may increase an catheter insertion
depth and stability of the catheter 16. In these and other embodiments, a side of the catheter
adapter 12 may contact the skin 61, increasing the stability of the catheter 16.
In some embodiments, the male luer fitting 60 and/or the female luer fitting 30
may correspond to International Organization for Standardization (“ISO”) 80369-7. In some
embodiments, a cross-sectional diameter at a distal end of a tip of the male luer fitting 60 may be
between about 0.1563 inches (3.970 mm) and about 0.1603 inches (4.072 mm). In some
embodiments, an inner cross-sectional diameter at an open proximal end of the female luer
fitting 30 may be between about 0.1653 inches (4.198 mm) and about .1692 inches (4.298 mm).
In some embodiments, the male luer-type fitting 70 and/or the female luer-type
fitting 62 may be smaller than ISO 80369-7. In some embodiments, a cross-sectional diameter at
a distal end of a tip of the male luer-type fitting 70 may be less than about 0.1545 inches (3.925
mm) for rigid material and less than about 0.1545 inches (3.925 mm) for semi-rigid material. In
some embodiments, an inner cross-sectional diameter at an open proximal end of the female
luer-type fitting 62 may be less than about 0.168 inches (4.270 mm).
In some embodiments, the male luer-type fitting 70, the female luer-type fitting
62, and/or the tubular element 56 may be sized to reduce a priming volume for sensitive
applications such as infusion for neonates. In these and other embodiments, the male luer-type
fitting 70 and the female luer-type fitting 62 may be sized smaller than International
Organization for Standardization (“ISO”) 80369-7, and a size of the tubular element 56 may
correspond to the male luer-type fitting 70. For example, a portion of the lumen 54 of the
extension 62 that extends through the male luer-type fitting 70 and the tubular element 56 may
have a generally uniform diameter.
The present invention may be embodied in other specific forms without departing
from its structures, methods, or other essential characteristics as broadly described herein and
claimed hereinafter. The described embodiments and examples are to be considered in all
respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated
by the appended claims, rather than by the foregoing description. All changes that come within
the meaning and range of equivalency of the claims are to be embraced within their scope.
Claims (13)
1. An extension for a catheter assembly, the extension comprising: a distal end, comprising a connector element, comprising a cantilever arm and a blunt insertion feature spaced apart from the cantilever arm, wherein the blunt insertion feature and the cantilever arm are monolithically formed as a single unit, wherein the blunt insertion feature is configured to insert into a lumen of a catheter adapter to provide a fluid connection between the catheter adapter and the extension, wherein the cantilever arm is configured to engage in a snap- fit with the catheter adapter; a proximal end comprising a female luer fitting; and an elongated tubular element, comprising a distal end and a proximal end, wherein the distal end of the elongated tubular element is integrated with the connector element, wherein the proximal end of the elongated tubular element is integrated with the female luer fitting, wherein the elongated tubular element is constructed of a thermoplastic resin, wherein the cantilever arm is configured to engage in a snap-fit with the catheter adapter, wherein the cantilever arm is configured to be fixed with respect to the catheter adapter when the cantilever arm is engaged in the snap-fit with the catheter adapter.
2. The extension of claim 1, wherein a distal end of the cantilever arm comprises a hook facing inwardly towards the blunt insertion feature.
3. The extension of claim 1 or claim 2, wherein the cantilever arm is a first cantilever arm disposed on a first side of the blunt insertion feature, wherein the connector element further comprises a second cantilever arm spaced apart from the blunt insertion feature and on a second side of the blunt insertion feature opposite the first side of the blunt insertion feature, wherein the blunt insertion feature is spaced apart from the first cantilever arm and the second cantilever arm by a plurality of separator elements that extend outwardly with respect to a longitudinal axis of the extension, wherein each of the plurality of separator elements comprises a proximal surface that is curved and configured to complete a geometric shape of a catheter adapter.
4. The extension of claim 1 or claim 2, wherein the cantilever arm is a first cantilever arm, wherein the extension further comprises a second cantilever arm, and wherein the first cantilever arm opposes the second cantilever arm.
5. The extension of any one of the preceding claims, further comprising a grip portion disposed between the distal end and the proximal end of the extension, wherein the grip portion comprises one or more wings or one or more protrusions.
6. A catheter system, comprising: a catheter adapter, comprising a proximal end, a distal end, and a lumen extending therebetween, wherein the proximal end comprises a plurality of slots and a proximal lumen opening, wherein the lumen comprises a septum, wherein the distal end comprises a catheter configured to be inserted into vasculature of a patient, wherein the catheter comprises a longitudinal axis, wherein the catheter adapter is configured to be selectively coupled with a distal end of a needle shield; and an extension, comprising a distal end, an elongated tubular element, a proximal end, and a lumen extending through the distal end, the elongated tubular element, and the proximal end, wherein a longitudinal axis extending through the distal end, the elongated tubular element, and the proximal end is aligned with the longitudinal axis of the catheter, wherein the distal end of the extension comprises a first cantilever arm, a second cantilever arm, and a blunt insertion feature spaced apart from the first cantilever arm and the second cantilever arm, wherein the blunt insertion feature, the first cantilever arm, and the second cantilever arm are monolithically formed as a single unit, wherein the blunt insertion feature is configured to insert into the lumen of the catheter adapter to open the septum and provide a fluid connection between the catheter adapter and the extension, wherein the first cantilever arm and the second cantilever arm are configured to insert into the plurality of slots to engage in a snap-fit with the catheter adapter, wherein in response to the first cantilever arm and the second cantilever arm being engaged in the snap-fit with the catheter adapter, the extension is fixed with respect to the catheter adapter..
7. The catheter system of claim 6, wherein the proximal end of the extension comprises a female luer fitting.
8. The catheter system of claim 6 or claim 7, wherein the catheter adapter comprises a stabilization platform.
9. The catheter system of claim 8, wherein the plurality of slots are disposed within the stabilization platform.
10. The catheter system of claim 9, wherein the blunt insertion feature is spaced apart from the first cantilever arm and the second cantilever arm by a plurality of separator elements that extend outwardly with respect to a longitudinal axis of the extension, wherein the plurality of separator elements complete a geometric shape of a catheter adapter and are flush with an outer surface of the catheter adapter.
11. The catheter system of claim 10, wherein a width of each of the plurality of separator elements is approximately equal to a width of the stabilization platform.
12. The catheter system of any one of claims 6 to 11, further comprising a first groove proximate a first slot of the plurality of slots and a second groove proximate a second slot of the plurality of slots, wherein a distal end of the first cantilever arm comprises a first hook facing inwardly towards the blunt insertion feature and disposed within the first groove, wherein a distal end of the second cantilever arm comprises a second hook facing inwardly towards the blunt insertion feature and disposed within the second groove.
13. The catheter system of claim 12, wherein the first groove and the second groove comprise an adhesive.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/481,690 | 2017-04-07 | ||
US15/481,690 US11116936B2 (en) | 2017-04-07 | 2017-04-07 | Low-profile extension for a catheter assembly |
PCT/US2018/020947 WO2018186964A2 (en) | 2017-04-07 | 2018-03-05 | Low-profile extension for a catheter assembly |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ758144A NZ758144A (en) | 2021-08-27 |
NZ758144B2 true NZ758144B2 (en) | 2021-11-30 |
Family
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