U.S. patent application number 17/093323 was filed with the patent office on 2021-02-25 for safety needle assemblies and related methods.
This patent application is currently assigned to B. Braun Melsungen AG. The applicant listed for this patent is B. Braun Melsungen AG. Invention is credited to Soo Yong Tan, Kevin Woehr.
Application Number | 20210052859 17/093323 |
Document ID | / |
Family ID | 1000005207212 |
Filed Date | 2021-02-25 |
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United States Patent
Application |
20210052859 |
Kind Code |
A1 |
Tan; Soo Yong ; et
al. |
February 25, 2021 |
SAFETY NEEDLE ASSEMBLIES AND RELATED METHODS
Abstract
A safety needle assembly having a first hub attached to a
flexible tube and a second hub attached to a needle projecting
through the flexible tube. A needle guard is positioned in an
interior cavity of the first hub. The needle guard has a proximal
wall having an opening and two arms each with an end and wherein
the two ends spaced from and biased toward the needle in a ready
position. In a particular example, a support is located inside the
cavity of the first hub and wherein the two ends of the two arms on
the needle guard rest on the support in the ready position.
Inventors: |
Tan; Soo Yong; (Penang,
MY) ; Woehr; Kevin; (Felsberg, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
B. Braun Melsungen AG |
Melsungen |
|
DE |
|
|
Assignee: |
B. Braun Melsungen AG
Melsungen
DE
|
Family ID: |
1000005207212 |
Appl. No.: |
17/093323 |
Filed: |
November 9, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14536252 |
Nov 7, 2014 |
|
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17093323 |
|
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|
|
61911870 |
Dec 4, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0693 20130101;
A61M 5/3202 20130101; A61M 25/0097 20130101; A61M 5/3273 20130101;
A61M 5/321 20130101; A61M 2005/3247 20130101; A61M 25/0612
20130101; A61M 25/0606 20130101; A61M 25/0618 20130101; A61M
25/0631 20130101; A61M 5/3205 20130101 |
International
Class: |
A61M 25/06 20060101
A61M025/06; A61M 5/32 20060101 A61M005/32; A61M 25/00 20060101
A61M025/00 |
Claims
1-18. (canceled)
19. A safety catheter assembly comprising: a catheter hub
comprising an interior cavity; a valve and a valve opener having a
head sized and shaped for pushing into the valve to open one or
more slits of the valve, said valve and said valve opener being
located in the interior cavity of the catheter hub; a catheter tube
attached to the catheter hub; a needle hub; a needle attached to
the needle hub and projecting through the catheter tube and having
a needle tip extending out of a distal end of the catheter tube in
a ready to use position; a needle guard positioned in an interior
space of a third hub located proximally of the catheter hub;
wherein the needle guard comprises a proximal wall having an
opening and two arms; wherein the needle guard comprises two ends,
one on each of the two arms; wherein a support is formed in an
interior space of the third hub and fixed in the interior space
thereof; and wherein the support comprises surfaces that space the
two ends of the two arms of the needle guard from the needle in the
ready to use position, and the two ends otherwise contact the
needle if not for the support, so as to reduce drag between the
needle and the needle guard when the needle retracts from the
catheter tube and the catheter hub following vascular access.
20. The safety catheter assembly of claim 19, wherein each of the
two ends has a curved lip.
21. The safety catheter assembly of claim 20, wherein the support
is ring shaped and the support is coaxially disposed with the
catheter tube.
22. The safety catheter assembly of claim 19, wherein the support
is located at a distal end of the third hub.
23. The safety catheter assembly of claim 19, wherein the third hub
has a proximal wall with a proximal opening.
24. The safety catheter assembly of claim 19, wherein the third hub
comprises a distal wall and at least one arm extending from the
distal wall and engaging the catheter hub to retain the third hub
in the ready to use position.
25. The safety catheter assembly of claim 24, wherein the third hub
further comprises a second arm and wherein the at least one arm and
the second arm engage a holding portion in the interior cavity of
the catheter hub.
26. The safety catheter assembly of claim 19, wherein the two arms
of the needle guard cross each other forming a cross-section and
the support is spaced from the cross-section.
27. The safety catheter assembly of claim 20, wherein the needle
comprises a change in profile located proximal of the needle tip;
and wherein the change in profile abuts against the proximal wall
of the needle guard before the needle guard separates from the
support.
28. The safety catheter assembly of claim 20, wherein the third hub
comprises a distal wall and an opening formed through the distal
wall of the third hub, the support is centered around the opening
of the distal wall of the third hub, and the needle passes through
the support and the opening of the distal wall of the third
hub.
29. The safety catheter assembly of claim 19, wherein the support
is spaced from the needle.
30. The safety catheter assembly of claim 19, wherein the valve
opener comprises at least one leg.
31. The safety catheter assembly of claim 19, wherein the support
has a body with a ring shape, has a body with a bore, is formed
from two or more ribs, or has multiple sides.
32. A safety catheter assembly comprising: a catheter hub
comprising an interior cavity; a valve having one or more slits and
a valve opener having a head sized and shaped for opening the
valve, said valve and said valve opener being located in the
interior cavity of the catheter hub; a catheter tube attached to
the catheter hub; a needle hub; a needle attached to the needle hub
and projecting through the catheter tube in a ready to use
position, said needle having a needle tip and a shaft; a needle
guard positioned in an interior space of a third hub located
proximally of the catheter hub; wherein the needle guard comprises
a proximal wall having a perimeter defining an opening, two arms,
and two ends, one on each of the two arms; wherein a support
interacts with the needle guard to bias the two ends of the two
arms of the needle guard away from the needle in the ready to use
position, and the two ends otherwise contact the needle if not for
the support, so as to reduce drag between the needle and the needle
guard when the needle retracts from the catheter tube and the
catheter hub following vascular access; and wherein the support is
fixed in the interior space of the third hub, and wherein the
support is spaced from the proximal opening of the proximal wall of
the needle guard and spaced from the needle in the ready to use
position and in a protective position, the needle tip being blocked
from inadvertent needlestick in the protective position.
33. The safety catheter assembly of claim 32, wherein the two arms
of the needle guard are separated from the support when in the
protective position.
34. The safety catheter assembly of claim 32, wherein the support
is fixed to the third hub at a distal end of the third hub.
35. The safety catheter assembly of claim 32, wherein the support
has a body with a ring shape, is a body with a bore, is formed from
two or more ribs, or has multiple sides.
36. The safety catheter assembly of claim 32, wherein the third hub
has a proximal wall with a proximal opening.
Description
FIELD OF ART
[0001] The present invention is generally directed to needle safety
assemblies and related methods and more particularly to needle
safety assemblies and related methods utilizing needle guards
having unique mounting for low friction between the needle guard
and the needle during needle movement, such as during retraction of
the needle relative to the needle guard.
BACKGROUND
[0002] Insertion procedure for an intravenous (IV) catheter
assembly contains four basic steps: (1) the healthcare worker
inserts the needle and catheter together into the patient's vein;
(2) after insertion into the vein with the needle point, the
catheter is forwarded into the vein of the patient by the
healthcare worker pushing the catheter with his or her finger; (3)
the healthcare worker withdraws the needle by grasping the hub end
(opposite the point end) while at the same time applying pressure
to the patient's skin at the insertion site with his or her free
hand to stop the flow of blood through the catheter; and (4) the
healthcare worker then tapes the exposed end of the catheter (the
catheter hub) to the patient's skin and connects it to the source
of the fluid to be administered into the patient's vein.
[0003] One problem is that, immediately after the withdrawal of the
needle from the patient's vein, the healthcare worker, who is at
this time involved in at least two urgent procedures, must place
the exposed needle tip at a nearby location and address the tasks
required to accomplish the needle withdrawal. It is at this
juncture that the exposed needle tip creates a danger of an
accidental needle stick, which, under the circumstances, leaves the
healthcare worker vulnerable to the transmission of various
dangerous blood-borne pathogens, including AIDS and hepatitis.
[0004] Other needle types similarly expose healthcare workers to
risks of accidental needle sticks. For example, a doctor
administering an injection, using a straight needle, a Huber
needle, an epidural needle, etc., may place the used needle on a
tray for subsequent disposal by a nurse. For the period between
placing the used needle on a tray or a work station to the time it
is discarded, the used needle is a potential source for disease
transmissions for those that work near or around the needle.
SUMMARY
[0005] The various embodiments of a needle assembly have several
features, no single one of which is solely responsible for their
desirable attributes. Without limiting the scope of the present
embodiments as set forth in the claims that follow, their more
prominent features now will be discussed briefly.
[0006] Aspects of the present disclosure include an indwelling
needle assembly that includes a first hub, a flexible tube attached
to a distal end of the first hub, a second hub connected to a
proximal end of the first hub, a needle attached to the second hub
and projecting through the flexible tube, and a needle guard
positioned in an interior cavity of the first hub, the needle guard
comprising a proximal wall having an opening and two arms each
comprising an end located opposite the proximal wall, the two ends
being biased away from and spaced from the needle in a ready
position, and the needle passing through the opening of the needle
guard.
[0007] The indwelling needle can further include a support located
inside the interior cavity of the first hub wherein the two ends of
the two arms on the needle guard rest against the support in the
ready position.
[0008] The support can be ring shaped and coaxially disposed with
the flexible tube. The support can also be a projection protruding
from a distal surface of the interior cavity of the first hub. Each
of the two ends of the two arms can have a sharp end contacting the
support. The two arms of the needle guard can cross each other to
form an intersection or a cross-section, and the needle further
passes through the cross-section.
[0009] The needle can include a needle tip and a change in profile
located proximal of the needle tip. When the change in profile
abuts against the proximal wall of the needle guard and the ends of
the arms no longer bias against the support, the two arms close
over the needle tip in a needle protective position.
[0010] The indwelling needle can further include a guide arm
attached to the first hub, wherein the guide arm is configured for
pressing against the flexible tube. The guide arm can include a
guide section configured to press against the flexible tube and a
contact flange extending from the guide section. The guide arm can
be pivotably attached to the first hub.
[0011] Another aspect of the present disclosure includes a safety
catheter assembly that includes a catheter hub comprising a valve
and a valve opener for opening the valve, a catheter tube attached
to the catheter hub, a needle hub, a needle attached to the needle
hub and projecting through the catheter tube, and a needle guard
positioned in an interior cavity of the catheter hub or an interior
cavity of a third hub located proximally of the catheter hub. The
needle guard can include a proximal wall having an opening and two
arms each comprising an end and wherein a support formed with the
catheter hub, the third hub, or a valve opener located inside the
catheter hub spaces the two ends of the needle guard from the
needle in a ready position.
[0012] The safety catheter assembly can further include a support
located inside the cavity of the third hub wherein the two ends of
the two arms on the needle guard rest on the support in the ready
position. The support can be ring shaped and coaxially disposed
with the flexible tube. The support can be located in the interior
cavity of the catheter hub in which the two ends of the two arms on
the needle guard rest on the support. The support can also be
formed with the valve opener.
[0013] The third hub can include a distal wall and at least one arm
extending from the distal wall engaged with the catheter hub to
retain the third hub in the ready position. The third hub can
include two arms engaged with a holding portion of the catheter
hub.
[0014] The two arms of the needle guard can cross each other to
form an intersection or a cross-section. The needle can further
pass through the cross-section. Alternatively the two arms can run
alongside the needle in a ready position and do not intersect. The
guard can have end walls that overlap when in a protective position
over the needle without also incorporating intersecting arms.
[0015] The needle can include a needle tip and a change in profile
located proximal of the needle tip. When the change in profile
abuts against the proximal wall of the needle guard, the ends of
the arms of the needle guard are no longer biasing against the
support in a protective position.
[0016] The third hub can include a distal wall and an opening
defined through the distal wall of the third hub. The distal wall
can abut against the catheter hub, with the support centered around
the opening of the distal wall of the third hub and extending
proximally into a chamber of the third housing. The needle can pass
through the opening of the distal wall of the third hub.
[0017] The third hub can further include a proximal wall and a
sidewall or sidewalls extending between the distal wall of the
third hub and the proximal wall of the third hub. The proximal wall
of the third hub can define an opening. The needle can pass through
the opening of the distal wall of the third hub. The distal wall,
the sidewall, and the proximal wall of the third hub can
cooperatively define an interior cavity. The needle guard can be
positioned in the interior cavity.
[0018] The valve can include a plurality of slits or one slit and
the valve opener at least one leg.
[0019] Yet another aspect of the present disclosure includes a
safety catheter assembly including a catheter tube attached to a
catheter hub, a needle attached to a needle hub and projecting
through the catheter tube and the catheter hub and a needle guard
positioned in an interior cavity of the catheter hub and comprising
a proximal wall having an opening and two arms each comprising an
end biased away from and spaced from the needle and supported by a
support located in the interior cavity of the catheter hub in a
ready position.
[0020] The support can be near a bore at a distal end of the
catheter hub. The support can be provided on a valve opener located
inside the catheter hub. The valve opener can be sized and shaped
to open a valve comprising at least one slit.
[0021] Still yet another aspect of the present disclosure includes
a method of reducing resistance on a needle of a catheter assembly.
The method includes retracting the needle in a proximal direction
through a needle guard and a catheter tube attached to a catheter
hub. The needle guard has a proximal wall having a proximal opening
and two arms each comprising an end. A needle tip of the needle
extends out a distal end of the catheter tube prior to
retracting.
[0022] The method can further include abutting a change in profile
of the needle against the proximal wall. For example, when a change
in profile abuts the proximal wall, it can abut a perimeter
defining a proximal opening of the proximal wall. The proximal wall
prevents the change in profile from passing therethrough.
[0023] The method can further include covering the needle tip of
the needle with at least one end of the arms of the needle
guard.
[0024] The method can further include a support formed with the
catheter hub, a third hub, or a valve opener located inside the
catheter hub that spaces the two ends of the needle guard from the
needle in a ready position.
[0025] The needle can further project through a valve in the
catheter hub, and a valve opener in the catheter hub. The valve
opener can be configured to press against the valve to open the
valve.
[0026] The needle guard can be positioned in an interior cavity of
the catheter hub or located proximally of the catheter hub or
partially in the catheter hub and partially proximal of the
catheter hub.
[0027] The ends of the arms are supported by a support to prevent
the ends from pressing against the needle in the ready
position.
[0028] A yet further aspect of the present disclosure includes a
safety catheter assembly comprising: a catheter hub comprising a
valve and a valve opener for opening the valve; a catheter tube
attached to the catheter hub; a needle hub; a needle attached to
the needle hub and projecting through the catheter tube; a needle
guard positioned in an interior cavity of the catheter hub or an
interior cavity of a third hub located proximally of the catheter
hub; wherein the needle guard comprises a proximal wall having an
opening and two arms each comprising an end and wherein the two
ends are spaced from and biased toward the needle in a ready
position; and wherein a support formed with the catheter hub, the
third hub, or a valve opener located inside the catheter hub biases
the two ends of the needle guard apart in the ready position.
[0029] A still yet further aspect of the present disclosure
includes a method of reducing resistance on a needle of a catheter
assembly. In an example, the method comprises: retracting the
needle held with a needle hub in a proximal direction through a
needle guard and a catheter tube attached to a catheter hub, the
needle guard comprising a proximal wall having a proximal opening
and two arms each comprising an end spaced from and biased towards
the needle in a ready position, a needle tip of the needle
extending out a distal end of the catheter tube prior to
retracting; abutting a change in profile of the needle against the
proximal opening on the proximal wall, the proximal opening of the
proximal wall preventing the change in profile from passing
therethrough; covering the needle tip of the needle with at least
one end of the arms of the needle guard in a protective position;
and wherein a support formed with the catheter hub, a third hub, or
a valve opener located inside the catheter hub biases the two ends
of the needle guard apart in the ready position.
[0030] Yet another feature of the present disclosure includes a
safety catheter assembly comprising: a catheter hub comprising a
valve and a valve opener for opening the valve; a catheter tube
attached to the catheter hub; a needle hub; a needle attached to
the needle hub and projecting through the catheter tube; a needle
guard positioned in an interior cavity of the catheter hub or an
interior cavity of a third hub located proximally of the catheter
hub; wherein the needle guard comprises a proximal wall having an
opening and two arms each comprising an end; and wherein a support
biases the two ends of the needle guard away from the needle in a
ready position and the support is spaced from the proximal opening
of the proximal wall in the ready position and a protective
position.
[0031] Yet another aspect of the present disclosure includes a
method of reducing resistance on a needle of a catheter assembly
comprising: retracting the needle held with a needle hub in a
proximal direction through a needle guard and a catheter tube
attached to a catheter hub, the needle guard comprising a proximal
wall having a proximal opening and two arms each comprising an end,
a needle tip of the needle extending out a distal end of the
catheter tube prior to retracting; abutting a change in profile of
the needle against the proximal opening on the proximal wall, the
proximal opening of the proximal wall preventing the change in
profile from passing therethrough; covering the needle tip of the
needle with at least one end of the arms of the needle guard in a
protective position; and wherein a support biases the two ends of
the needle guard away from the needle in a ready position and the
support is spaced from the proximal opening of the proximal wall in
the ready position and the protective position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] These and other features and advantages of the present
devices, systems, and methods will become appreciated as the same
becomes better understood with reference to the specification,
claims and appended drawings wherein:
[0033] FIG. 1 is a schematic cross-sectional side view of one
embodiment of a safety needle assembly having a guide arm.
[0034] FIG. 2A is a close up view of the assembly of claim 1
showing a needle guard located inside a cavity of a first hub of
the safety needle assembly of FIG. 1.
[0035] FIG. 2B shows a needle guard protecting the needle tip of
the needle.
[0036] FIG. 3 is a schematic cross-sectional view of another
embodiment of a safety IV catheter assembly having a needle guard
located in another embodiment of a third hub.
[0037] FIG. 4 is a schematic cross-sectional view of a needle
assembly coupled to another embodiment of a catheter assembly with
a needle guard support on a valve opener.
[0038] FIG. 5 is a schematic cross-sectional view of the catheter
assembly of FIG. 4 with the needle assembly removed.
[0039] FIG. 6 is a schematic cross-sectional view of the catheter
assembly of FIG. 4 coupled with a syringe.
[0040] FIG. 7 is a cross-sectional view of one embodiment of the
valve opener with the needle guard.
[0041] FIG. 8 is a cross-sectional view of one embodiment of the
valve opener with the needle guard mounted on a support of the
valve opener of FIG. 7.
[0042] FIGS. 9-11 are various end views looking proximal to distal
of embodiments of a valve opener.
DETAILED DESCRIPTION
[0043] The detailed description set forth below in connection with
the appended drawings is intended as a description of the presently
preferred embodiments of safety needle assemblies provided in
accordance with aspects of the present devices, systems, and
methods and is not intended to represent the only forms in which
the present devices, systems, and methods may be constructed or
utilized. The description sets forth the features and the steps for
constructing and using the embodiments of the present devices,
systems, and methods in connection with the illustrated
embodiments. It is to be understood, however, that the same or
equivalent functions and structures may be accomplished by
different embodiments that are also intended to be encompassed
within the spirit and scope of the present disclosure. As denoted
elsewhere herein, like element numbers are intended to indicate
like or similar elements or features.
[0044] FIG. 1 is a schematic cross-sectional side view of one
embodiment of a safety needle assembly 100 provided in accordance
with aspects of the present disclosure, which in the present
embodiment is an indwelling needle. As shown, the needle assembly
100 comprises an outside flexible tube 102 attached to a first hub
104 and a needle 106 disposed internally of the flexible tube 102
and attached to a second hub 108. The needle 106 may be hollow,
such as having a lumen, or solid, such as a stylet, and can be made
of a metal or other biocompatible material. The needle has a needle
tip 110 and a change in profile 112, such as a needle bulge or
crimp, located proximally of the needle tip 110. The second hub 108
can be removably coupled to the first hub 104, but is preferably
only in abutting contact and not friction fit inside the female
Luer taper of the first hub 104.
[0045] The safety needle assembly 100 may be used as a peripheral
vein catheter and therefore normally has a length L of up to about
50.0 cm. At this length, the flexible tube 102 and the needle 106
can flex or bend when attempting to perform a medical procedure by
pushing on the first hub 104, the second hub 108, or both. Thus, a
guide arm 114 is provided having a guide section 116 and a contact
flange 118 to facilitate the process. The guide section 116 is
configured to press against the outer tube 102 while a finger may
push against the contact flange 118 to steady the insertion during
the medical procedure.
[0046] The guide arm 114 can be pivotably connected to the first
hub 104 at the pivot connection point 120. As the needle 106 and
tube 102 penetrate the vein, the guide arm 114 can rotate in a
direction (shown in FIG. 1 as counter-clockwise) to provide the
necessary clearance for the insertion. After successful
catheterization, the second hub 108 and the needle 106 are
retracted away from the first hub 104 and the tube 102.
[0047] A tip protector or needle guard 122 can be provided in the
interior cavity 124 of the first hub 104. The interior cavity is
further provided with a support 126. In the present embodiment, the
support 126 can embody a ring, which is coaxially disposed with the
flexible tube 102. In one example, the support 126 is attached to
the interior of the first hub 104 to provide a support surface for
the needle guard 122, as further discussed below. In another
example, the support 126 is a molded projection, such as a rib, on
the interior of the first hub 104. Further, instead of a continuous
or complete ring, the support 126 may embody two or more separate
sections, such as two or more ribs, formed around the bore inlet
128 to the tube 102. The support 126 can be any structure so long
as it does not interfere with the needle 106 passing through and
can provide a support surface for the needle guard 122.
[0048] With reference now to FIG. 2A, the needle guard 122 is shown
disposed in the interior cavity 124 of the first hub 104. The
needle guard 122 comprises a proximal wall 130 comprising a
proximal opening 132 having the needle passing therethrough and two
arms 134, 136 each having an end 138, 140 biasing against the
support 126 in the ready position in which the needle is ready for
use on a patient. The two arms 134, 136 can have the same length or
different lengths so that the two ends are staggered axially. Each
end 138, 140 can comprise a curved section having a relatively
smooth surface for biasing against or contacting the support 126 so
as to avoid biasing the support with a sharp edge. In other
examples, the ends 138, 140 contact the support 126 by way of a
sharp end edge, which is less preferred. The needle guard 122 can
be made of a metal or other biocompatible material, such as
plastics or a combination of metal and plastic.
[0049] In one embodiment, the needle guard 122 and the needle 106
only contact one another, if at all, at the proximal opening 132 of
the proximal wall 130. In another embodiment, the needle guard 122
and the needle 106 can also contact each other, if at all, at the
cross-section or intersection 142 of the two arms. Thus, during
retraction of the needle 106 from the flexible tube 102, the only
drag experienced or felt, if at all, by the user as the needle is
retracted away is at the opening 132 of the proximal wall. The two
ends 138, 140 are spaced from the needle 106, such as by a gap or
space or the support 126, during most if not all of the retraction
of the needle 106 away from the flexible tube 102 and first hub
104.
[0050] During removal of the needle 106 away from the first hub
104, the change in profile 112 near the needle tip 110 eventually
abuts the perimeter of the proximal opening 132 of the needle
guard. Because the change in profile 112 is physically larger than
the perimeter of the proximal opening 132 on the needle guard at
least along the cross-section, the crimp will engage the opening
132 and will pull the needle guard 122 out of the cavity 124 of the
first hub 104 upon retraction of the second hub 108 and the needle
105 away from the first hub 104. It is understood that when the
crimp or change in profile engages the opening on the proximal
wall, it actually engages a perimeter defining the proximal
opening, or more broadly engages the proximal wall of the needle
guard which has the opening. As the needle guard 122 moves in the
proximal direction with the needle change in profile 112 engaged to
the proximal wall 130, the ends 138, 140 of the two arms 134, 136
on the needle guard 122 slide proximally off of the support 126 to
close over the needle tip 110 to prevent inadvertent needle sticks
with the sharp tip. FIG. 2B illustrates the change in profile 112
contacting the opening 132 at the proximal wall 130 and the two
ends 138, 140 overlap just distal of the needle tip 110.
Alternatively only one arm has the curved end to block the distal
path of the needle tip 110.
[0051] Thus, aspects of the present disclosure is understood to
include an indwelling needle assembly comprising a first hub
attached to a flexible tube and a second hub attached to a needle
projecting through the flexible tube. A needle guard is positioned
in an interior cavity of the first hub. Wherein the needle guard
comprises a proximal wall having an opening and two arms each
comprising an end and wherein the two ends are spaced from the
needle in a ready position and are in tension so as to bias towards
the needle. In a particular example, a support is located inside
the cavity of the first hub and wherein the two ends of the two
arms on the needle guard rest on the support in the ready position.
Thus, upon retraction of the needle and until a change in profile
on the needle engages the proximal wall of the needle guard and
pulls the proximal wall in a proximal direction which then pulls
the two arms from the support, contact between the needle and the
needle guard is minimized.
[0052] In an example, the indwelling needle assembly discussed with
reference to FIGS. 1 and 2 and be adopted for use with a safety
intravenous catheter. For example, the first hub can be a catheter
hub attached to a catheter tube and the second hub can be a needle
hub attached to a needle projecting through the catheter tube. The
guide arm of FIG. 1 can be omitted. A needle guard is positioned in
an interior cavity of the catheter hub. Wherein the needle guard
comprises a proximal wall having an opening and two arms each
comprising a distal end and wherein the two distal ends are spaced
from the needle in a ready position inside the catheter hub. The
two arms are resilient and therefore bias toward the needle. In a
particular example, a support is located inside the cavity of the
catheter hub and wherein the two ends of the two arms on the needle
guard rest on the support in the ready position so that they are
spaced from the needle shaft. Thus, upon retraction of the needle
and until a change in profile on the needle engages the proximal
wall of the needle guard and pulls the proximal wall in a proximal
direction which then pulls the two arms from the support, contact
between the needle and the needle guard is minimized.
[0053] A further aspect of the present disclosure is understood to
include a support formed with a catheter hub, a third hub (as shown
with reference to FIG. 3), or a valve opener located inside the
catheter hub (as shown with reference to FIGS. 4-11) that spaces
the two ends 138, 140 of the needle guard 122 from the needle 158,
such as away from the needle so that the ends do not touch the
needle in a ready position. As the support 126 is formed with the
catheter hub, the third hub, or the valve opener, the support is
spaced from the proximal opening 132 of the proximal wall of the
needle guard in both a ready position, as shown in FIG. 2A, and in
a protective position, as shown in FIG. 2B. In FIG. 2B, the support
126 is located with the first hub and is therefore spaced from the
proximal opening 132 of the proximal wall of the needle guard.
Still further, as the support 126 is formed with the catheter hub,
the third hub, or the valve opener, the support is spaced from the
proximal opening 132 of the proximal wall of the needle guard in
both a ready position, as shown in FIG. 2A, and in a protective
position, as shown in FIG. 2B, and spaced from the needle guard in
the protective position. In FIG. 2B, the support 126 is located
with the first hub and is therefore spaced from the proximal
opening 132 of the proximal wall of the needle guard as well as the
entire needle guard.
[0054] For other safety needle assemblies and safety needle
assembly components disclosed herein below, it is understood that
where a feature is shown but not expressly described and is
otherwise the same or similar to the feature or features described
elsewhere, such as above with reference to FIGS. 1 and 2, the
disclosed part or parts shown in the subsequent drawing figures but
not expressly described because of redundancy and because knowledge
is built on a foundation laid by earlier disclosures may
nonetheless be understood to be described or taught by the same or
similar features expressly set forth in the text for the
embodiments in which the feature or features are described, such as
for the safety needle assembly of FIGS. 1 and 2. Said differently,
subsequent disclosures of the present application are built upon
the foundation of earlier disclosures unless the context indicates
otherwise. The disclosure is therefore understood to teach a person
of ordinary skill in the art the disclosed embodiments and the
features of the disclosed embodiments without having to repeat
similar components and features in all embodiments since a skilled
artisan would not disregard similar structural features having just
read about them in several preceding paragraphs nor ignore
knowledge gained from earlier descriptions set forth in the same
specification. As such, the same or similar features shown in the
following safety needle assemblies incorporate the teachings of
earlier embodiments unless the context indicates otherwise.
Therefore, it is contemplated that later disclosed embodiments
enjoy the benefit of earlier expressly described embodiments, such
as features and structures of earlier described embodiments, unless
the context indicates otherwise.
[0055] With reference now to FIG. 3, a safety IV catheter 150
comprises a first hub or catheter hub 152 having a catheter tube
154 attached thereto, and a second hub or needle hub 156 having a
needle 158 attached thereto and extending partially through the
catheter hub 152. As shown, the needle 158 is in the process of
being removed from the catheter hub 152, such as following
successful venipuncture. The safety IV catheter 150 can further
comprise a valve 160 positioned at a distal end of an interior of
the catheter hub 152, a valve opener 162 positioned proximally of
the valve 160, and a third hub 164, which can also be referred to
as a third housing or a guard housing, positioned proximally to the
catheter hub 152. The third hub 164 can couple directly to the
catheter hub 152, such as having a Luer projection for frictionally
engaging the female Luer of the catheter hub 152. The valve 160 can
be any check valve configured to prevent fluid or blood from
leaking proximally out of the catheter hub. The needle 158 can pass
through the valve 160 in a ready position, such as through one or
more slits provided centrally of the valve.
[0056] The valve opener 162 is configured to press against the
valve 160 and open the valve 160 to allow fluid or solution to pass
distally through the catheter hub 152 and the catheter tube 154.
For example, the valve opener 162 can be advanced distally by a
male medical implement, such as a syringe tip, which presses
against the proximal end of the valve opener 162 to push the nose
section of the valve opener distally forward into the valve to
open, such as by opening one or more slits. In one example, the
valve opener 162 has a wedge shape nose section to press open the
valve 160 and an extension or leg 1622 to be pushed against by a
male medical implement. Although a single extension or leg 1622 is
usable to push the valve opener, two or more extensions are
preferred. The extension 1622 can be one or more separate sections
that can be pressed against by a male medical implement to advance
the valve opener 162 against the valve 160. The valve opener 162
has an opening 1620 defined through a center of the nose section of
the valve opener 162 for the needle 158 to pass therethrough.
[0057] The third hub 164 has a sidewall 167 extending from the
distal wall 165 and a proximal wall 169 such that the sidewall 167
extends between the distal wall 165 and the proximal wall 169 of
the third hub 164. The proximal wall 169 of the third hub 164 has
an opening for the needle 158 to pass therethrough. The needle 158
also passes through the opening 163 of the distal wall 165 of the
third hub 164. The distal wall 165, the sidewall 167, and the
proximal wall 169 of the third hub 164 cooperatively define an
interior cavity or space 170 having a needle guard 122 disposed
therein. The shape of the third hub 164 can be hemispherical,
cylindrical, rectangular, polygonal, or irregular shaped, so long
as the needle 158 can pass through the proximal wall 169 and the
distal wall 165, and the needle guard 122 can fit inside the
interior cavity 170 of the third hub 164. In other words, side wall
167 can be made up of multiple portions each having their own
plane. Accordingly the sidewall 167 can be cylindrical,
rectangular, polygonal, or irregular shaped. In one example, the
sidewall 167 is unitarily formed to the distal wall 165 and the
proximal wall is separately formed and subsequently attached to the
sidewall after the needle guard 122 is placed inside the interior
cavity 170. In another embodiment, the sidewall 167 is unitarily
formed with the proximal wall 169 and the sidewall is attached to
the distal wall 165 after the needle guard 122 is placed into the
interior cavity 170.
[0058] The third hub 164 can be made of metal, plastic, or a
biocompatible material. The distal wall 165 abuts against the
catheter hub 152 such that the third hub 164 is positioned between
the catheter hub 152 and the needle hub 156. The needle 158 passes
through the opening 163 of the distal wall 165 of the third hub
164. The third hub 164 can have at least one arm 166 sized and
shaped to engage the catheter hub 152 in the ready position. As
shown, two arms 166 extend distally and engage the annular
projection or bump 168 inside the catheter hub 152 to retain the
third hub 164 to the catheter hub 152 in the ready position and
during retraction of the needle 106 following successful
venipuncture. The arms 166 and valve opener 162 are sized so as to
avoid interference with the operation of each other. The wall 165
can be a circular plate or any other shape that completely covers
or partially covers the interior of the catheter hub 152.
[0059] A support 126 is provided in the third hub 164. The support
126 can be centered around the opening 163 or near the opening 163
of the distal wall 165 of the third hub 164. As described above for
the support 126 of FIG. 2A, the support 126 can embody a ring,
which is coaxially disposed with the catheter tube 154. In one
example, the support 126 is attached to the third hub 164 to
provide a support surface for the needle guard 122. In another
example, the support 126 is a molded projection, such as a rib, to
the distal wall 165 of the third hub 164. In yet another example,
the support 126 is integrally formed with the third hub 164, such
as by way of glue or detents. Further, instead of a continuous or
complete ring, the support 126 may embody two or more separate
sections, such as two or more ribs, formed around the bore inlet
128 to the tube 102. The support 126 can be any structure so long
as it does not interfere with the needle 106 passing through and
can provide a support surface for the needle guard 122.
[0060] The needle guard 122 shown in FIG. 3 is similar to the
needle guard of FIG. 2A. The two ends 138, 140 of the two arms are
similarly spaced from the needle shaft in the ready position. As
shown, the two ends 138, 140 are biased against the support 126
located inside the third hub 164 and are spaced from the needle
shaft in the ready position and during retraction of the needle 158
from the catheter hub 152. As previously discussed, when the needle
158 is retracted away from the catheter hub 152, the change in
profile 112, such as a needle crimp, abuts a perimeter defining the
opening 132 on the proximal wall of the needle guard and the needle
guard 122 eventually separates from the support 126 to block the
needle tip 110 from inadvertent needle sticks in a similar manner
as previously discussed and as shown with reference to FIG. 2B.
[0061] With reference now to FIGS. 4-6, an alternative catheter
assembly 150 provided in accordance with further aspects of the
present devices, systems, and methods is shown. In the present
catheter assembly, a support for the needle guard can be
implemented directly with a valve opener 162. Furthermore, the
catheter hub 152 can be a single piece or formed from two separate
pieces that are attached together. The valve opener 162 can have a
support 1624 extending from a proximal end of the nose section of
the valve opener 162 to support the needle guard 122. In one
embodiment, the support 1624 is a stub having a bore and is shorter
in height or width than the width of the extension 1622. The needle
guard 122 rests on the valve opener support 1624 until the needle
158 is retracted out of the catheter hub 152 and the needle crimp
abuts the opening on the needle guard 122 as discussed above to
separate the needle guard from the support 1624 to then block the
needle tip 110, similar to that shown in FIG. 2B.
[0062] Specifically, the distal ends 138, 140 of the needle guard
122 are shown rested on the support 1624 and the proximal wall 130
of the needle guard 122 is recessed into the interior of the
catheter hub and the proximal end most part of the catheter hub is
located proximally of the proximal wall 130 so that a nose section
of the needle hub 156 can project into the catheter hub 152 without
interfering with the extension 1622 or the needle guard 122 in a
ready position (FIG. 4). Alternatively the distal portion of the
needle hub 156 can extend around the exterior of the proximal end
portion of catheter hub or there can be a simple abutment without
overlapping of the catheter hub and needle hub. Thus, the height or
width of the extension 1622 and the support 1624 can vary so long
as the needle hub 156 does not interfere with the needle guard 122
or the extension 1622. The valve opener can be made from any
biocompatible material. In the three figures shown, the catheter
assembly 150 is shown in a ready position in FIG. 4, in a used
position shown in FIG. 5, in which the needle guard 122 covers the
needle tip of the needle and the valve is closed, and in valve
opened position in FIG. 6, in which a male Luer taper of a syringe
is inserted into the catheter hub and advances the valve opener
distally forward to open the valve.
[0063] As shown, the support 1624 can be centered around or located
near the opening 1620 through the nose section of the valve opener
162. As described above for the support 126 of FIG. 2A, the support
1624 of the present embodiment can embody many shapes and
configurations to support the needle guard 122. The support 1624
can be any structure so long as it does not interfere with the
needle 106 passing through the valve opener 162 and can provide a
support surface for the needle guard 122. The support 1624 can be a
cylindrical ring, such as a stub, or two separate sections. In some
examples, the support can incorporate exterior surface features to
enable the two ends of the needle guard to easily separate from the
support or to make the separation more difficult. For example, the
exterior surface can be smooth and can even taper inwardly in the
proximal direction to facilitate separation. Alternatively,
gripping features, such as bumps or notches, may be incorporated to
make the separation between the two ends of the needle guard and
the support more difficult by increasing the resistance. The
exterior features discussed herein may be incorporated on any of
the supports discussed elsewhere herein.
[0064] One method for mounting the needle guard 122 onto the
support 1624 comprises a step of sliding the distal end of the
needle guard 122 onto the support 1624 of a valve opener 162 so
that the two arms 134, 136 are spaced from the needle shaft in the
ready position. With reference to FIG. 7, to ensure the needle
guard 122 is able to slide onto the support 1624, the distance x
between the needle shaft and outer surface of the support 1624
should be less than the distance y between the needle shaft and the
transition point of the needle guard 122. The transition point can
be the turning point where the curved section of the ends 138, 140
of the needle guard 122 have reached a maximum and begins to curve
inward thereby allowing the curved surface of the ends 138, 140 to
engage the outer surface of the support 1624 thereby spreading the
ends 138, 140 apart from each other away from the needle shaft and
biasing against the support 1624. If the distance x between the
support 1624 and the needle shaft is greater than the distance y
between the needle shaft and the transition point, then the end of
the support 1624 can be tapered (as shown in FIGS. 7 and 8) until
the distance x between the support 1624 and the needle shaft is
less than the distance y between the needle shaft and the
transition point. In one embodiment, the outer surface of the
support 1624 can be tapered inwardly (as shown in FIG. 8), such as
incorporating recessed sections, from the end of the support 1624
towards the main body of the valve opener 162 so that the two ends
of the needle guard can settle into the space and be more secured
to the support. This helps to prevent the needle guard 122 from
unintended premature separation from the support 1624 of the valve
opener. In another embodiment, the support 1624 has a groove (as
shown in FIG. 8) or other resistant means to prevent unintended
premature separation of the needle guard 122 from the support 1624.
Obviously, the valve opener shown in FIGS. 7 and 8 may be usable
with any of the catheter assemblies disclosed elsewhere herein
having a valve.
[0065] Referring now to FIG. 9, an end view of a valve opener 162
provided in accordance with aspects of the present disclosure is
shown, which has a support 1624 embodied as a ring like structure
located between two extensions 1622 and formed around the opening
1620 of the valve opener 162. The space between the two extensions
1622 allows the ends 138, 140 of the needle guard 122 to be located
there and over the support 1624 in a ready to use position, similar
to that shown in FIGS. 7 and 8.
[0066] With reference now to FIG. 10, an end view of a valve opener
162 provided in accordance with further aspects of the present
disclosure is shown, which has a support 1624 embodied as two or
more separate sections, such as two or more ribs, formed around the
opening 1620 of the nose section of the valve opener 162. The two
or more ribs can be generally rectangular, arc shape, or
combinations thereof. The support 1624 can have a mating surface
for the ends 138, 140 of the needle guard 122 to rest thereon in a
ready to use position.
[0067] FIG. 11 is an end view of a valve opener 162 provided in
accordance with still yet further aspects of the present
disclosure, which has a support 1624 formed by a generally square
shape stub connecting a distal portion of the two extensions 1622.
The depth of the square shape stub determines the height of the
support 1624. Alternatively, the support 1624 can have a flat
surface to engage with the ends 138, 140 of the needle guard
122.
[0068] Although limited embodiments of the safety needle assemblies
and their components have been specifically described and
illustrated herein, many modifications and variations will be
apparent to those skilled in the art. Furthermore, elements and
features expressly discussed for one embodiment but not for another
may equally apply provided the functionality or structures do not
conflict. Thus, unless the context indicates otherwise, like
features for one embodiment are applicable to another embodiment.
Accordingly, it is to be understood that the safety needle assembly
and their components constructed according to principles of the
disclosed devices, systems, and methods may be embodied other than
as specifically described herein. The disclosure is also defined in
the following claims.
* * * * *