Note: Descriptions are shown in the official language in which they were submitted.
CA 02798020 2014-10-16
INTEGRATED VASCULAR DELIVERY SYSTEM WITH SAFETY NEEDLE
TECHNICAL FIELD
[0002] This
invention relates generally to the medical field, and more specifically
to an improved integrated vascular delivery system with safety needle in the
medical
field.
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
BACKGROUND
[0003] Patients undergoing medical treatment often require a form of
intravenous
(IV) therapy, in which a fluid is administered to the patient through a vein
of the
patient. IV therapy is among the fastest ways to deliver fluids and
medications into the
body of the patient. Intravenously infused fluids, which typically include
saline, drugs,
blood, and antibiotics, are conventionally introduced to the patient through a
catheter
positioned at any of several venous routes, such as peripheral veins and
central veins.
Typically, the catheter and associated tubing are secured directly against the
skin of the
patient with tape or similar catheter stabilization devices (CSDs) such as
adhesive
stabilizing pads that restrain the catheter body. However, conventional
devices and
methods for IV therapy have drawbacks. Extension tubing may catch on nearby
obstacles during patient movement or caregiver manipulation, which may cause
painful
vein irritation and compromise the IV. Tape and other existing CSDs are not
optimal for
stabilization because securing the round, rigid and bulky components against
the skin
can be difficult and ineffective. Tape and other existing CSDs do not fully
prevent the
catheter from moving within the vein, which leads to patient-endangering
complications
including catheter dislodgement, infiltration (fluid entering surrounding
tissue instead
of the vein), and phlebitis (inflammation of the vein). Adhesive stabilizing
pads tend to
result in other undesired effects, such as skin irritation and/or breakdown
due to
prolonged concentrated adhesion to the skin. Furthermore, tape and current
CSDs do
2
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
not prevent the catheter from painfully and dangerously pivoting around the
insertion
site and moving within the vein.
[0004] Furthermore, the placement of catheter devices typically utilizes
needles
that are inserted into the patient. By contacting body tissue and fluids such
as blood,
such needles carry biohazard risks including cross-contamination and
transmission of
blood-borne diseases, as well as accidental needle punctures inflicted on a
user of the
medical device.
[0005] Thus, there is a need in the medical field to create an improved
vascular
delivery system and safety needle that overcomes one or more of the drawbacks
of the
conventional vascular delivery systems. This invention provides such an
improved
vascular delivery system with safety needle.
BRIEF DESCRIPTION OF THE FIGURES
[0006] FIGURE 1 is an overview schematic of the integrated vascular
delivery
system with safety needle;
[0007] FIGURES 2-5 are variations of the integrated vascular delivery
system;
[0008] FIGURES 6-14 are variations of means for coupling the catheter hub
and
stabilization hub in the integrated vascular delivery system;
[0009] FIGURES 15-21 are variations of a septum in the integrated
vascular
delivery system with safety needle;
[0010] FIGURES 22-27 are variations of a needle blunter mechanism in the
integrated vascular delivery system;
3
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[001 1] FIGURES 28A and 28B are schematics of the retracted and extended
positions, respectively, of the safety needle system of a first preferred
embodiment
coupled to a catheter hub;
[0012] FIGURES 29-32 are schematics of the housing in the safety needle
system
of a first preferred embodiment;
[0013] FIGURES 33A-33C are variations of the needle in the safety needle
system;
[0014] FIGURES 34A-34F are schematics of the sheath in the safety needle
system of a first preferred embodiment;
[0015] FIGURES 35A-35F are schematics of the slider in the safety needle
system
of a first preferred embodiment;
[0016] FIGURES 36A-36B and 37A-37B are schematics of variations of the
sheath
in the safety needle system of a first preferred embodiment;
[0017] FIGURES 38A-38C are schematics of the coupling between the sheath,
slider, and housing during use of the safety needle system of the first
preferred
embodiment;
[0018] FIGURES 39 and 40 are schematics of the "closed" and "open"
configurations of the jaws in the sheath of a variation of the safety needle
system of the
first preferred embodiment;
[0019] FIGURES 41A-41F are schematics of the slider of a variation of the
safety
needle system of the first preferred embodiment;
4
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0020] FIGURES 42A and 42B are schematics of the retracted and extended
positions, respectively, of the safety needle system of a second preferred
embodiment;
[0021] FIGURES 43A-43C are schematics of the housing of the safety needle
system of a second preferred embodiment;
[0022] FIGURES 44-46 are variations of the sheath in the safety needle
system of
a second preferred embodiment;
[0023] FIGURES 47 and 48 are variations of the locking mechanism in the
safety
needle system of a second preferred embodiment;
[0024] FIGURES 49-50 are schematics of a method of assembling the safety
needle system of a second preferred embodiment;
[0025] FIGURES 51-56 are schematics of a sheath septum in the safety
needle
system;
[0026] FIGURE 57 is a schematic of a vent chamber in the safety needle
system;
[0027] FIGURES 58-60 are schematics of a needle protection cap in the
integrated vascular delivery system with safety needle; and
[0028] FIGURES 61-70 are schematics of a method of stabilizing a catheter
using
the integrated vascular delivery system with safety needle.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] The following description of preferred embodiments of the
invention is not
intended to limit the invention to these preferred embodiments, but rather to
enable any
person skilled in the art to make and use this invention.
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0030] As shown in FIGURE 1., the integrated vascular delivery system 100
with
safety needle of a preferred embodiment includes: a frame 110 having a
catheter hub 120
configured to receive a catheter 122, a stabilization hub 130, and at least
one lateral
member 140 extending between the catheter hub and stabilization hub; a fluidic
channel
150 that fluidically communicates with the catheter; a housing 310 including a
needle
mount; a needle 320 having a distal end insertable through the frame and a
proximal
end coupled to the needle mount; and a sheath telescopically engaged with the
housing.
The catheter hub 120 preferably provides a first anchoring point 112 on the
patient and
is configured to receive a catheter 122 insertable in a patient to transfer
fluid at an
insertion site 102, and the stabilization hub 130 preferably provides a second
anchoring
point 112' on the patient. The frame 110 preferably operates in a folded
configuration 114
in which the catheter and stabilization hubs may be coupled, and in an
unfolded
configuration 116 in which the first and second anchoring points are
distributed around
the insertion site 102 to anchor the frame no to the patient, thereby
stabilizing the
catheter. For instance, in a preferred embodiment the first and second
anchoring points
are on opposite sides of the insertion site, such as proximal and distal to
the side, or on
opposite lateral sides of the insertion site. The sheath operates in a
retracted position in
which the sheath exposes the distal end of the needle and an extended position
in which
the sheath substantially surrounds the distal end of the needle. The sheath is
preferably
coupleable to the frame such that removal of the needle from the frame draws
the
sheath over the needle, thereby transitioning the sheath to the extended
position. The
system 100 preferably includes a catheter 122, such as a catheter embedded in
the
6
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
catheter hub 120, but may the system may alternatively be configured to
receive and/or
couple to a separate catheter before or after insertion into the patient.
[0031] The integrated vascular delivery system may be used to obtain
access to a
blood vessel of a patient, such as one undergoing intravenous (IV) therapy.
The system
may be used to administer drugs, antibiotics, saline, blood, or any suitable
fluid to a
patient, and/or to remove fluid from the patient. The system may be used to
create,
stabilize, and maintain an IV line at an insertion site on a peripheral vein
or artery such
as on the arm, hand, or leg, or for central venous access on the neck, chest,
abdomen, or
any suitable IV location. However, the system may be used to create,
stabilize, and
maintain any suitable catheter-based access to a patient, such as catheters
for transfer of
cerebrospinal fluid. Use of the safety needle may reduce the risk of cross-
contamination
and infection from bodily fluids and other biohazards, and reduce risk of
accidental
needle injuries to a user handling the medical device.
1. Integrated vascular delivery system
[0032] The frame no of the integrated vascular delivery system functions
to
stabilize the system and the catheter on the patient. As shown in FIGURES 2-3,
the
frame no preferably includes a catheter hub 120 that provides a first
anchoring point
112 on the patient, a stabilization hub 130 that provides a second anchoring
point 112' on
the patient, and at least one lateral member 140 that extends between the
catheter and
the stabilization hubs. In alternative embodiments of the frame no, the frame
may
include any suitable number of hubs and any suitable number of lateral
members, such
7
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
that the frame forms an enclosed or partial, non-enclosed perimeter of any
suitable
shape and size around the insertion site 102. The frame preferably allows
visualization
of the insertion site of the catheter, such as by leaving an open uncovered
area around
the catheter, although alternatively the system may include a cover that is
transparent,
translucent, opaque, or any suitable kind of materials, that extends over the
frame to
cover the insertion site and/or catheter.
[0033] The catheter hub 120 is configured to receive a catheter 122,
which may be
embedded in the catheter hub and integrally part of the system, or may be a
separate
catheter that is coupled to the catheter hub 120 before or after insertion
into the patient,
such as with a snap fit into the catheter hub 120. Alternatively, any suitable
portion of
the frame may be configured to receive the catheter. The catheter hub 120
preferably
includes a channel 124, concentrically aligned with the catheter, that may
receive a
needle 320 used during insertion of the catheter into the patient. As shown in
FIGURE
2D, the catheter hub and/or stabilization hub may include a sensor 126 that
measures a
biometric parameter such as temperature, blood pressure, or pulse rate of the
patient.
The sensor 126 may additionally and/or alternatively sense any suitable
parameter such
as one pertaining to the fluid passing through the catheter, such as pH or
flow rate.
[0034] The catheter hub and/or stabilization hub may have a relatively
wide and
thin profile, which may help distribute forces over a greater area on the skin
and
decreases the chances of the patient developing skin irritations, sores, and
other
degradations. The thin profile may help decrease the risk of the risk of the
hub catching
or snagging on bed equipment or other nearby obstacles that could cause the
catheter to
8
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
move within the vein and cause complications such as catheter dislodgement,
infiltration, and phlebitis. However, the catheter and stabilization hubs may
have any
suitable shape. The catheter and stabilization hubs may include a rigid or
semi-rigid
plastic or other suitable material, and/or softer material. For example, one
or both hubs
may include a rigid core overmolded with a softer material such as silicone.
[0035] As shown in FIGURE 2A, the system may further include at least one
extension tube 160 and/or a fluid supply adapter 162, coupled to the catheter
hub 120
and/or stabilization hub 130, that delivers fluid from a fluid supply to the
fluidic channel
150. The extension tube 160, which provides stress relief if the system is
jostled (such as
from patient movement or caregiver manipulations), is preferably made of
flexible
tubing such as polymer tubing, but may alternatively be a passageway made of
any other
suitable material. The extension tube 160 is preferably long enough to provide
stress
relief if needed, but short enough to reduce the chances of the extension tube
catching
or snagging on nearby obstacles. In another variation, the fluidic channel 150
and/or
extension tube 160 may be coiled like a spring to provide stress relief. The
length of the
extension tube may alternatively be any suitable length, and may depend on the
specific
application of the system. Other dimensions of the extension tube, such as
outer
diameter and inner diameter, may also depend on the specific application of
the system.
The fluid supply adapter 162 preferably includes a connector that attaches the
extension
tube to a fluid supply (e.g. pole-mounted IV bag, syringe, or pump that
supplies fluid
through tubing). The connector may be a standard female luer lock connector
(FIGURES 4A and 4B) or Y-connector (FIGURES 4C and 4D) that commonly
interfaces
9
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
with conventional IV bags. Alternatively, the connector may be any suitable
male or
female connector that is adapted to interface with a fluid supply.
Furthermore, the luer
lock connector or other fluid supply adapter may be coupled directly to the
catheter hub
and/or stabilization hub, rather than to an extension tube.
[0036] In alternative versions of the system, the system may include more
than
one extension tube 160 and/or fluid supply adapter 162, to facilitate
delivering fluid
from multiple fluid supplies simultaneously to the system. For example, in an
embodiment of the system that includes two fluidic channels, the system may
include a
first extension tube that delivers a first fluid to a first fluidic channel,
and a second
extension tube that delivers a second fluid to the second fluidic channel.
However, two
extension tubes may useful in applications involving the administering of two
separate
fluids through the same fluidic channel 150 and catheter.
[0037] The lateral member 140 functions to provide structural stability
to the
frame no by stabilizing the catheter hub 120 relative to the stabilization hub
130. As
shown in FIGURES 2-4, the frame preferably includes two lateral members 140
that,
with the catheter and stabilization hubs, form a perimeter around the
catheter. The two
lateral members may be approximately parallel, or may be in any crossed, non-
parallel
or other suitable orientation. However, as shown in FIGURE 3, the frame no may
include only a partial perimeter around the catheter, such as with one lateral
member
instead of two. Each lateral member 140 may be flexible, such as to allow the
catheter
and stabilization hubs to move relative to one another with a significant
number of
degrees of freedom, including displacement in the compression direction (and
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
subsequent displacement in the tension direction) along the axis of the
catheter,
displacement in both directions along the other two axes, twisting in both
directions
along the axis of the catheter, and bending in both directions along the other
two axes.
In particular, the lateral member 140 may be reversibly bendable to allow the
frame no
to be in a folded configuration in which the catheter and stabilization hubs
are
coupleable. One or more lateral members may be tubular. For example, the
lateral
member may be a generally straight, soft, and flexible hollow channel like
medical
tubing, but may be any suitable structure with a lumen.
[0038] The fluidic channel 150 functions to deliver fluid from a fluid
supply to the
catheter, and in some embodiments, deliver fluid to and from the catheter,
such as
transferring fluid removed from the patient through the catheter to an
external
reservoir. As shown in FIGURE 2C, at least a portion of the fluidic channel
150 may be
fixed within at least one of the hubs and/or within a tubular lateral member.
As shown
in FIGURES 5A-5C, at least a portion of the fluidic channel 150 may be
additionally
and/or alternatively be external to the hubs and lateral members. For
instance, at least a
portion of the fluidic channel 150 may be molded to an external surface of the
catheter
hub, the stabilization hub, and/or lateral member. The fluidic channel 150
preferably
includes a turnabout portion 152 in which fluid flows in a direction different
from that
within the catheter 122. In particular, the turnabout portion 152 preferably
directs the
fluid flow to a direction opposite of that within the catheter, or in an
approximately 180-
degree turn. The turnabout portion 152 of the fluidic channel 150 may be fixed
or
embedded within the catheter hub and/or stabilization hub. In one exemplary
11
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
application of the system, the catheter is inserted in the patient such that
its penetrating
end points proximally towards the heart of the patient, and the turnabout
portion of the
fluidic channel 150 allows a stand supporting the IV bag or other fluid supply
to be kept
near the head of a bed, or otherwise proximal to the insertion site as is
typically
practiced in patient treatment settings. The internalized fluid flow turn in
the turnabout
portion 152 of the fluidic channel 150 reduces the number of external
structures that can
get caught or snagged on nearby obstacles and consequently disturb the
catheter and IV
setup. Another effect of the turnabout portion is that if external tubing in
the IV setup is
pulled or caught, the turnabout portion may enable the frame no to stabilize
the
catheter more effectively by causing the catheter to be pulled further into
the patient.
For example, in a common catheter placement in which the catheter is placed on
the
forearm with its distal end pointing proximally toward the elbow of the
patient, if the
external tubing is accidentally pulled posteriorly towards the patient, the
tubing will in
turn pull the turnabout portion of the fluidic channel 150 and the catheter
hub 120
toward the patient, thereby pulling the catheter further into the blood vessel
of the
patient rather than displacing the catheter from the insertion site.
[0039] In some variations, the system may include one, two, or any
suitable
number of fluidic channels. For instance, a second fluidic channel 150 may
pass through
a second lateral member 140. The second fluidic channel 150 preferably
receives a
second fluid, which may be the same or different from the first fluid supplied
to the first
fluidic channel 150. As shown in FIGURES 4A-4C, the system may further include
a
second extension tube 160 that supplies a second fluid to the frame and
catheter.
12
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
However, as shown in FIGURE 4D, the system may include only one extension tube
160
that supplies fluid to one or multiple fluidic channels. The fluidic channels
may have
separate inlets on the stabilization hub 130 (FIGURES 4A and 4C), or may share
the
same inlet on the stabilization hub in which flow may be regulated with valves
or other
fluid control means (FIGURES 4B and 4D). In one variation, the first and
second fluidic
channels preferably fluidically communicate with the same catheter in the
catheter hub
120, coupled to the catheter at the same point (FIGURES 4A and 4B) or
different points
(FIGURE 4C) along the length of the catheter or channel. In this variation,
the system
preferably includes a flow control system 154 that selectively restricts flow
of one or both
of the fluids to the catheter and therefore to the patient. The flow control
system 154
may include one or more valves 156, such as at the extension tubes (FIGURES 4A
and
4B), at the junction between the fluidic channel 150 and the catheter (FIGURE
4C and
4D) or any suitable location. The flow control system may additionally and/or
alternatively use pressure drops, vents, or any suitable technique for
controlling fluid
flow among the fluidic channels and catheter. The flow control system may also
be
present in an embodiment that includes only one fluidic channel 150. In
another
variation, the first and second fluidic channels preferably fluidically
communicate with a
catheter with dual lumens, such that one catheter lumen is coupled to the
first fluidic
channel and another catheter lumen is coupled to a second fluidic channel. In
yet
another variation, the first and second fluidic channels fluidically
communicate with
separate catheters. Additional variations expand on these variations with
three or more
fluidic channels.
13
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0040] As best shown in FIGURE 2D, the frame 110 preferably operates in a
folded configuration 114 in which the catheter hub 120 and stabilization hub
130 may be
coupled to one another and in an unfolded configuration 116 in which the first
and
second anchoring points are distributed around the insertion site. To
facilitate a folded
configuration, the frame 110 preferably allows the catheter hub 120 and
stabilization
hub 130 to move relative to one another with a significant number of degrees
of
freedom. In particular, the frame is preferably reversibly bendable or
foldable to fold the
catheter and stabilization hubs toward each other, or to pass one of the hubs
over
and/or under the other hub.
[0041] In the folded configuration 114, the catheter hub 120 and
stabilization hub
130 may be coupled to one another, thereby securing the frame in a folded
configuration. With the catheter and stabilization hubs coupled, the hubs
experience the
same movement relative to a needle 320 being passed into the catheter hub 120
and
catheter, such as during insertion of the catheter in the patient. In a first
variation, the
catheter hub 120 and stabilization hub 130 may be coupled to one another by
interaction
of the needle 320 with the catheter hub 120 and/or stabilization hub 130. In
one
example of this variation, as shown in FIGURES 6A-6D, the stabilization hub
130
includes an extension 132, and the catheter hub 120 may include a slot 128 or
other
recess that receives the extension 132, although in another example the
catheter hub 120
may include the extension 132 and the stabilization hub 130 may include the
slot 120.
The extension 132 defines a through hole 134, such that when the extension 132
is
inserted into the slot 128, the through hole 134 is substantially aligned with
a need1e-
14
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
receiving channel 124 of the catheter hub 120. In this variation, the frame
110 may be
folded into the folded configuration during catheter insertion into the
patient by a user
(e.g. medical practitioner) who couples the catheter and stabilization hubs
together by
passing the needle 320 through the channel 124 of the catheter hub 120 and
through the
through hole 134 of the extension 132. Alternatively, the frame 110 may be
folded and/or
the needle 320 may be passed through the extension and slot of the hubs during
manufacturing, such as during assembly and/or packaging. When the needle 320
is
withdrawn from the hubs, the hubs may be decoupled and the frame 110 may be
unfolded into the unfolded configuration. As shown in FIGURES 7A and 7B, the
extension 132 may be retractable into the hub when the extension is no longer
needed,
such as when the frame no is in the unfolded configuration and ready for
securement to
the patient. The catheter hub and stabilization hub may include one, two, or
any suitable
number of extensions and/or Mots. However, the catheter hub 120 and/or
stabilization
hub 130 may additionally and/or alternatively interact with the needle in any
suitable
manner (e.g., with a housing that surrounds the needle) to facilitate
selective coupling of
the catheter and stabilization hubs.
[0042] In a second variation, as shown in FIGURE 9, the catheter hub 120
and
stabilization hub 130 may be indirectly coupled to one another by mutually
coupling to
the housing. For example, as shown in FIGURE 9, in the folded configuration of
the
frame, the catheter hub may be coupled to the sheath and indirectly to the
housing, and
the stabilization hub may be coupled to the housing, thereby indirectly
coupling the
hubs and securing the frame in a folded configuration.
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0043] In a third variation, as shown in FIGURES 10-12, the catheter hub
120 and
stabilization hub 130 may be indirectly coupled to one another by mutually
coupling to
the sheath. In a first example, as shown in FIGURES 10A-10D, the catheter hub
may be
coupled to the sheath, and the stabilization hub may include an extension that
is
alignable with the catheter hub and/or the sheath, such that the needle
passing through
the sheath additionally passes through the extension and the catheter hub,
thereby
coupling the catheter hub and stabilization hub, somewhat similar to the first
variation
of hub coupling except the extension is received by the sheath. Like in the
first variation
of hub coupling, the extension may be retractable. In a second example, the
stabilization
hub may couple to the sheath by being press fit or snapped into an external
features of
the sheath, thereby indirectly coupling the catheter hub and stabilization
hub. For
instance, as shown in FIGURE nA-11B, the sheath may include an indentation
having at
least a partial outline of the perimeter of the stabilization hub, such as two
bumps or
pegs between which the stabilization hub fits. To facilitate such a press fit
or snap fit, the
stabilization hub and/or sheath may include an overmold of a soft,
compressible
material such as silicone, isoprene, thermoplastic elastomers, or any suitable
material.
In a third example, as shown in FIGURE 12A-12B, the catheter hub and/or
stabilization
hub may couple to the sheath with a link. In this example, the stabilization
hub has an
extension with a through hole that, when the frame is in the folded
configuration, may
nest within the catheter hub or between the catheter hub and the sheath. The
link may
be a pin that laterally or longitudinally passes through the catheter hub, the
extension in
the stabilization hub, and the sheath and/or housing. However, the link may be
any
16
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
suitable user-controlled latch or other link that provides manual coupling for
securing
the folded configuration of the frame.
[0044] In a fourth variation, the catheter hub, stabilization hub,
sheath, and/or
housing intercouple with a latching system to secure the frame in the folding
configuration and couple the sheath to the frame. For example, each of the
catheter hub
120, stabilization hub 130, and sheath 330 includes at least one extension
(e.g., tab or
arm) or at least one Mot to receive an extension of one of the other pieces
such that the
frame and sheath interlock. For example, as shown in FIGURES 13A-13D, the
catheter
hub 120 includes a slot 172 on its proximal side, the stabilization hub 130
includes a
stabilization hub tab 174 on its distal side and the sheath 330 includes a
sheath tab 176
and/or at least one side arm 178 extending from the distal end of the sheath.
As shown
in FIGURE 14, when the frame is in the folded configuration, the Mot, tabs,
and/or side
arms interlock. In particular, (1) the sheath side arms 178 couple to the
proximal end of
the catheter hub (FIGURES 14A and 14B) such that the catheter hub is seated
within the
sheath, (2) the stabilization hub tab 174 on the inverted stabilization hub
couples to the
catheter hub slot (FIGURE 14C) and (3) the sheath tab 176 on the sheath
couples to the
stabilization hub slot (FIGURES 14D and 14E). In other examples, different
parts of the
frame, sheath, and needle housing may include different combinations of
intercoupling
extensions and Mots, snaps, magnets, latches, and/or any suitable fastening
mechanism.
[0045] In a fifth variation, the catheter hub 120 and stabilization hub
130 may be
coupled to one another by mutually interacting a third structural element,
thereby
indirectly coupling to one another. For example, as shown in FIGURE 8, a block
136
17
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
may couple to both the catheter hub 120 and the stabilization hub 130 when the
frame
110 is in the folded configuration. Although the block 136 is shown in FIGURE
8 to have
a particular geometry, the block may include a switch, latch, plug, and/or any
suitable
fastener or other mechanism. Removal of the block 136 may facilitate the
decoupling of
the catheter hub 120 and stabilization hub, such that frame may be in the
unfolded
configuration. As another example, the needle 320 may couple to both the
catheter hub
120 and the stabilization hub 130 when the frame is in the folded
configuration, such as
during catheter insertion. Following catheter insertion, removal of the needle
may
facilitate the decoupling of the catheter hub 120 and stabilization hub.
[0046] In a sixth variation, the catheter hub 120 and stabilization hub
130 may be
coupled to one another in a slidable manner. For example, one of the hubs may
have
side grooves or channels, and the other hub may have side ridges that
slidingly engage
with the grooves of the other hub when the frame no is in the folded
configuration.
Other examples of this variation may include tabs inserted into slots, or any
suitable
mechanism.
[0047] In a seventh variation, the catheter hub 120 and stabilization hub
130 may
be coupled to one another with snaps, latches, magnets, and/or any suitable
fastener
when the frame no is folded into the folded configuration. The fastener may be
a
separate piece that is mutually coupled to the catheter and stabilization
hubs. Additional
variations of the coupling of the catheter hub and stabilization hub include
various
combinations of the above variations. Furthermore, the catheter hub and
stabilization
18
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
hub may be coupled in any suitable manner, with or without the cooperation of
the
needle to help secure or lock the coupling of the catheter hub and
stabilization hub.
[0048] In the unfolded configuration 116, as shown in FIGURES 2A and 2B,
the
catheter hub 120 and stabilization hub 130 are decoupled such that the frame
no may
be secured to the patient such that the first and second anchoring points 112
and 112' are
distributed around the insertion site 102 of the catheter, thereby stabilizing
the catheter.
The frame no is preferably secured to the patient by securing the catheter hub
120 and
stabilization hub 130 to the patient at the first and second anchoring points,
respectively. However, the frame 110 may additionally and/or alternatively be
secured
by securing only the catheter hub 120, only the stabilization hub 130, the
lateral
members 140 and/or any suitable portion of the frame no. The frame may
alternatively
stabilize the catheter at anchoring points located at any suitable locations
relative to the
catheter insertion site. The frame no, when secured to the patient, enables
the
integrated vascular delivery system to stabilize the catheter more effectively
than
conventional catheter securement devices that stabilize the catheter on only
one side of
the insertion site, because stabilizing the catheter on two different sides of
the insertion
site reduces pivoting motions of the catheter that may occur during normal
patient
movement and/or caregiver manipulates of the IV setup. The frame no is
preferably
secured to the patient with tape, but may additionally and/or alternatively be
secured
with an adhesive located on the underside of the catheter hub and/or
stabilization hub;
an elastic strap; a strap fastened with fasteners such as hooks, hook and
loop, or
magnets; or any suitable securement mechanism.
19
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0049] In one alternative embodiment, as shown in FIGURE 5A-5C, the frame
110
includes one catheter hub, two stabilization hubs located on an opposite side
of the
frame as the catheter hub, two lateral members each connecting the catheter
and a
respective stabilization hub, and a fluidic channel. In this variation, each
hub provides a
respective anchoring point, such that the overall frame 110 includes three
anchoring
points 112, 112' and 112". In other examples, the frame may include any
suitable number
of anchoring points distributed equally or unequally around the insertion site
102. As
shown in FIGURE 5A, the catheter hub 120, stabilization hubs 130, and lateral
members
140 may be integrated in a single piece. The single piece may include a single
kind of
material, or may include a rigid core of a first material (e.g. a rigid
material such as
plastic) and an outer layer of a second material (e.g. soft material such as
silicone)
covering the rigid core.
[0050] Other variations of catheter hub, stabilization hub, and lateral
member
configurations may be similar to that described in U.S. Application number
12/855,013
entitled "Integrated vascular delivery system", which is incorporated in its
entirety by
this reference. Furthermore, the frame may include a catheter hub and a
stabilization
hub, but lack a lateral member; for example, the catheter hub and
stabilization hub may
be coupled together in a hinged manner such that the frame can operate in
folded
("closed hinge") and unfolded ("open hinge") configurations.
1.1 Hub septum
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0051] The catheter hub 120 preferably further includes a catheter hub
septum
200 that functions to seal the internal channel 124 of the catheter hub 120
after
withdrawal of the insertion needle 320 after catheter insertion, to prevent
escape or
leakage of blood and other potential biohazards or other fluids from the
catheter hub
120. The catheter hub septum 200 is preferably coupled to the catheter hub
120,
preferably disposed within an internal channel 124 of the catheter hub, and
may be
concentrically aligned with the catheter. The catheter hub septum 200 is
preferably
coupled to the catheter hub 120 and includes a primary seal 210 and a
secondary seal
212, although a septum 200 may additionally and/or alternatively be coupled to
the
stabilization hub. The primary seal 210 is an inner seal that functions as a
first defense
against fluid escaping, and the secondary seal 212 is an outer seal that
functions as a
second defense against fluid escaping. In some embodiments, the catheter hub
septum
200 may include fewer or more seals similar to the primary and secondary
seals, which
may be suitable for some applications to modify the amount of fluid leakage
protection.
The catheter hub septum preferably defines a catheter hub septum cavity 214
between
the primary and secondary seals that may contain trapped fluid that passes
through the
primary seal. The catheter hub septum cavity 214 may be larger than the
diameter of the
needle 320 to reduce frictional force on the needle during needle insertion
through the
catheter hub septum, thereby increasing the ease of passing the needle through
the
catheter hub septum. However, the cavity may alternatively be closely fit,
and/or may
include a material with a lower friction coefficient and/or fluid absorbent
material.
21
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0052] The catheter hub septum 200 may include an elastomeric material,
and
may have a diameter slightly larger than the channel 124 within the catheter
hub 120,
such that compression of the catheter hub septum 200, when assembled in the
channel,
seals the annular gap between the outer circumferential edges of the catheter
hub
septum and the walls of the channel within the catheter hub 120, thereby
preventing
fluid from escaping through the annular gap, and further maintaining the
coupling
between the catheter hub septum 200 and the catheter hub 120, similar to a
press fit.
The catheter hub septum 200 may additionally and/or alternatively include a
sealant
material applied to the outer edges of the septum to prevent passage of fluid
between
the septum and catheter hub walls, and/or be temporarily or permanently bonded
to the
catheter hub such as with sonic welding, chemical welding, or adhesive.
[0053] As shown in FIGURES 15A-15E, in a preferred embodiment, the septum
200 includes a rigid core 222 and a compressible plug 288 coupled to the rigid
core. The
rigid core is a framework that preferably includes a back wall 224 with
aperture 286 and
wall members 285 extending from the back wall. The back wall 224 may provide a
flange that helps seat the septum 200 within the catheter hub 120. The wall
members
285 are preferably substantially parallel, but may be in any suitable relative
orientation
that defines a gap between the wall members. The compressible plug 228 is
coupled
partially or wholly around the rigid core, covering or filling the aperture
286 and
surrounding the wall members 285 to define a cavity 214 in a central portion
of the
septum. One end of the compressible plug forms the primary seal 210, and the
other end
of the compressible plug covering the aperture of the back wall forms the
secondary seal
22
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
212. The aperture 226 of the back wall allows needle puncture access in and
out of the
septum cavity (and the catheter). The rigid core 222 is preferably made of a
rigid plastic
such as polycarbonate, acrylonitrile butadiene styrene (ABS) or other styrene,
and the
compressible plug 228 preferably includes an elastomeric material such as
isoprene or
silicone. However, the rigid core and compressible plug may include any
suitable
materials. The compressible plug is preferably coupled to the rigid core in an
overmolding manufacturing process, but may additionally and/or alternatively
include
other coupling mechanisms or processes such as adhesive.
[0054] In a first variation, as shown in FIGURES 16A-16C, the septum is a
split
septum 230 that includes a split 232 along a portion of its length. The split
longitudinally divides the septum into approximately two halves or other
multiple
portions. The split may terminate near the inner face of the primary seal 210,
such that
the split 232 travels along at least half of the length of the septum and is
joined near the
primary seal, but the split may alternatively be any suitable length,
including along the
entire length of the septum such that the septum includes two separate
portions. As
shown in FIGURE 16C, when the septum 230 is assembled into the catheter hub
120,
the channel of the catheter hub preferably radially compresses the septum
material to
close the split, thereby forming the cavity 214 and the secondary seal 212.
The split
septum may be manufactured through injection molding, such as with a mold
having a
cavity complementary to the septum shape as shown in FIGURE 16B. In another
example of this variation, the split may begin at the inner primary seal and
continue
23
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
towards the secondary seal. In yet another example of this variation, the
septum may be
split longitudinally along two or more lines, forming three or more split
portions.
[0055] In a second variation, as shown in FIGURES 17A and 17B, the septum
is a
dual grommet septum 240 that includes at least two septum pieces 242 or
"grommets"
placed serially within the catheter hub 120. One of the septum pieces forms
the primary
seal 210 and another septum piece forms the secondary seal 212. The septum
pieces 242
are preferably immediately adjacent to each other such that part of their
interior faces
are contacting and form a fluid-tight seal against the catheter hub wall. The
interior
faces of the septum pieces 242 may be chamfered or radiused to define the
septum
cavity 214 between the septum pieces, but the septum pieces may alternatively
have any
suitable geometry. Alternatively, the septum pieces may be separated by a
distance, such
that the septum cavity is at least partially formed by the walls of the
catheter hub 120. In
other examples of this variation, the septum may includes three or more septum
pieces
placed serially within the catheter hub 120, such as to provide three or more
seals.
[0056] In a third variation, as shown in FIGURES i8A and 18B, the septum
250
includes at least two separate septum pieces 252 and an inner sleeve 254
disposed
between the septum pieces. In this variation, two septum pieces are placed
serially
within the catheter hub 120, either directly adjacent to each other or
separated by a
distance. One of the septum pieces forms the primary seal 210 and another
septum piece
forms the secondary seal 212. The interior faces of the septum pieces 252 are
preferably
adapted to receive the inner sleeve 254, such as by defining axially aligned
recesses. The
inner sleeve 254 may be cylindrical and sized to fit within the recesses of
the septum
24
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
pieces, with an inner diameter large enough to form a cavity 214 that
accommodates the
diameter of the needle 320. The inner sleeve 254 is preferably rigid, and made
of a
thermoplastic material or any other suitable rigid material, although the
inner sleeve
may be made of any suitable material. In other examples of this variation, the
septum
may include more than two septum pieces, such as further including an outer
sleeve-like
septum part surrounding the inner sleeve.
[0057] In a fourth variation, as shown in FIGURES 19A-19E, the septum 260
includes a housing with first and second housing portions 264 and first and
second
septum pieces 262. In this variation, as shown in FIGURE 19E, the septum
includes a
distal half and a proximal half that is substantially a mirrored version of
the distal half,
with each half including a housing portion 264 and a corresponding septum
piece 262.
As shown in FIGURES 19A and 19B, each housing piece includes a tapered,
hourglass-
shaped chamber 266 for receiving a corresponding septum piece. The taper in
the
chamber 266 helps reduce relative movement such as translational movement
between
the septum piece 262 and the housing 264. Each housing piece may further
include an
external annular flange or other protrusion that helps reduce translational
movement
between the housing and the catheter hub 120. The two housing pieces 264 may
be
coupled together and/or to the catheter hub 120 through ultrasonic welding,
epoxy or
other adhesive, threads, and/or any suitable coupling mechanism. As shown in
FIGURE 19C and 19D, each septum piece 262 preferably includes a cavity 263
that
extends inward from one open end of the septum piece, and the septum pieces
are
preferably assembled such that the open ends of the septum pieces abut against
each
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
other. In this manner, the closed ends of the septum pieces form primary and
secondary
seals 210 and 212, respectively, of the septum 260, and the joined open ends
of the
septum pieces form enclosed septum cavity 214. The housing and septum pieces
are
preferably combined, with a corresponding septum portion nested within (e.g.
molded
into or pressed into) each housing portion, and the combined housing and
septum
pieces are preferably mounted within the catheter hub 120.
[0058] In an alternative embodiment, the septum may have only a primary
seal.
In a first alternative variation of this embodiment, the septum 200 is made of
a flexible
material that self-seals to form a hermetic seal on the hub. This self-sealing
septum
prevents fluid from passing out of the catheter hub 120, contributing to a
closed system
in which blood and other fluids will not exit the catheter hub. In a second
alternative
variation, as shown in FIGURES 20 and 21, the septum 200 may be sealed with a
plug,
such as a stopper or sealant material applied to the septum by a user. Before
and during
catheter insertion the back end of the channel of the catheter hub may be left
open
(FIGURES 2oA and 21A). After the catheter is inserted in the patient, the user
may
occlude the blood vessel (such as by applying external direct pressure),
withdraw the
needle 320 from the catheter and catheter hub 120, place a plug on the back
end of the
catheter hub 120 to prevent fluid flow out of the hub (FIGURES 20B and 20B),
and
allow the blood vessel to be in fluid communication with the catheter (such as
by
releasing external direct pressure on the blood vessel). The plug may include
a separate
stopped plug applied to the catheter hub (FIGURE 20), a sliding piece that the
user
slides to gate off the back of the hub (FIGURE 21), a hinged piece that the
user swings to
26
CA 02798020 2014-10-16
the back of the hub, and/or any suitable septum piece. Any of these single
seal variations
of the septum may be repeated serially to form two seals (primary and
secondary) or
more seals.
[0059] The septum may be one or more of the embodiments and variations
described above.
Furthermore, the septum may be
any suitable mechanism that helps prevent escape or leakage of fluid from the
catheter
hub 120.
1.2 Needle shield
[0060] As shown in FIGURES 22-27, the catheter hub 120 and/or stabilization
hub 130 may include a needle shield 190. The needle shield 190 functions to
blunt, or
protect the user from, the distal end of the needle 320 after the needle is
withdrawn
from the catheter and catheter hub after catheter insertion. The needle shield
190 helps
prevent accidental needle sticks to the user and the transfer of biological
hazards. The
needle shield 190 is preferably coupled to the catheter hub 120 and/or
stabilization hub
130, but may additionally and/or alternatively be coupled to any suitable
portion of the
system. The needle shield 190 is preferably a clip such as a spring clip, but
may
alternatively include any suitable blunting mechanism such as a cap. In
general, during
insertion of the catheter into the patient, the needle 320 passes through an
inactive
needle shield 190 and into the catheter (e.g., FIGURE 22A). After the catheter
is placed
27
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
in the patient, the needle 320 is withdrawn from the catheter in a proximal
direction
and engages with the needle shield 190, such as due to interaction with a
needle catch
106 on the needle 320. After the needle catch 106 engages with the needle
shield, the
needle shield is triggered to decouple from the catheter hub and/or
stabilization hub
and cover or blunt the distal end of the needle (e.g., FIGURE 22B). The now
active
needle shield 190 continues to cover the distal end of the needle 320 as the
needle is
further withdrawn and removed from the catheter hub 120. The needle catch 106
that
triggers decoupling of the needle shield 190 from the hub may be one or more
of several
variations. In one variation, the needle catch 106 may be an annular structure
around
the needle body that catches on a portion of the needle shield 190 as the
needle is
withdrawn from the hub. In another variation, the needle catch 106 may include
barbs
that allow free passage of the needle through the needle shield 190 when the
needle
passes into the catheter hub 120, but catch on the needle shield 190 when the
needle
withdraws from the catheter hub 120. Alternatively, the needle catch 106 may
be located
on the needle shield 190. However, any suitable variation of the needle catch
106 that
facilitates the engagement of the needle and the needle shield 190, and the
disengagement of the needle shield from the hub, may be used.
[0061] The needle shield 190 may be configured in one or more of several
arrangements. In a first embodiment, the needle shield 190 is coupled to the
catheter
hub 120. In a first variation of this first embodiment, the needle shield is
removably
coupled to an internal portion of the catheter hub 120. For example, the
needle shield
190 may be coupled to an internal surface of a proximal portion of the
catheter hub 120
28
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
(FIGURES 22 and 24), a distal portion of the catheter hub 120 or any suitable
internal
surface of the catheter hub. As shown in FIGURE 22, the needle shield 190 may
be
coupled to an internal surface of the catheter hub recessed within the
catheter hub, or as
shown in FIGURE 24, the needle shield 190 may be coupled to an internal
surface of the
catheter hub approximately flush with an external surface of the catheter hub,
such as
adjacent to the stabilization hub when the frame is in the folded
configuration. As
another example, the needle shield 190 may be engaged within the catheter hub
120
proximal to the septum 170 (FIGURE 23A), and/or distal to the septum 170. As
another
example, the needle shield is engaged within the septum 170 of the catheter
hub
(FIGURE 23B), such as within the cavity, a slit, or other suitable receptacle
within the
septum. As yet another example, the needle shield 190 may be adjacent to a
flash
chamber 192.
[0062] In a second variation of the first embodiment, the needle shield
190 is
removably coupled to an external portion of the catheter hub 120. For example,
as
shown in FIGURES 25A and 25B, the needle shield may interact with the catheter
hub
120 and/or the needle 320 at at least three points. The needle shield may
couple to the
catheter hub 120 at a first point a, such as to the outside of the hub (e.g.,
FIGURE 25A)
or to notches or other receiving features on the proximal portion of the
catheter hub 120
(e.g., FIGURE 25B). The needle shield 190 closes around the distal end of the
needle
320 at a second point b. The withdrawal of the needle 320 causes disengagement
of the
needle shield from the catheter hub when needle catch 106 engages the needle
shield
190 at a third point c. In this example, the needle shield may be a spring
clip configured
29
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
such that when the needle catch 106 on the needle 320 engages with the needle
shield
during withdrawal, the engagement simultaneously triggers containment of the
needle
tip at point b and the disengagement of the needle shield from the catheter
hub. The
spring clip is preferably dimensioned relative to the needle such that a
distance "x",
defined as the distance between the distal end of the needle 320 and the
needle catch
106, is approximately equal to or less than distance "y", defined as the
distance between
points b and c, although the spring clip may have any suitable geometry.
However, the
needle shield may be any suitable mechanism to blunt the needle tip outside
the
catheter hub.
[0063] In a second embodiment, the needle shield 190 is coupled to the
stabilization hub 130. In a first variation of this embodiment, as shown in
FIGURES 26A
and 26B, the needle shield is removably coupled to an internal portion of the
stabilization hub, in a manner similar to that of the first embodiment. For
example, the
stabilization hub may include a tab that substantially aligns with the
catheter hub 120
when the frame 110 is in the folded configuration. The tab may define a recess
to which
an internal needle shield couples, or an external needle shield may be
externally coupled
to the tab. During catheter placement, the frame 110 is preferably in the
folded
configuration and the needle 320 passes through the tab, through the needle
shield, and
through the catheter hub 120. Upon removal of the needle 320 from the catheter
hub
120, the needle shield disengages from the stabilization hub 130 and covers
the needle.
Following withdrawal of the needle from the catheter hub and disengagement of
the
needle shield from the stabilization hub, the frame 110 may be unfolded into
its
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
unfolded configuration. In a second variation, the needle shield 190 is
removably
coupled to an external portion of the stabilization hub, particularly when the
frame no
is in the folded configuration, similar to the variation in which the needle
shield is
coupled to an external portion of the catheter hub.
[0064] Additional alternative embodiments of the needle shield include
various
combinations of the above variations of the needle shield. In other words, the
needle
shield may be inside and/or outside the catheter hub 120 and/or stabilization
hub. For
example, as shown in FIGURE 27, the needle shield 190 may be coupled directly
to an
internal portion of the catheter hub 120 and indirectly to an external portion
of
stabilization hub 130. As another example, the needle shield may be partially
inside and
partially outside the catheter hub, or the three-point contact needle shield
of the first
embodiment may be coupled to the stabilization hub instead of the catheter hub
120.
Further, the needle shield of any of these variations may be coupled to a
sheath that
covers at least a portion of the needle body, such that the needle blunter and
sheath
combination contains more than solely the distal end of the needle.
[0065] The needle shield may be one or more of the embodiments and
variations
described above, and/or one or more of the embodiments described in U.S.
Provisional
Applications 61/418,358 filed 30-NOV-2010, 61/438,782 filed 02-FEB-2011, and
61/448,318 filed 02-MAR-2011, which are each incorporated in its entirety by
this
reference. Furthermore, the needle shield may be any suitable mechanism that
sufficiently covers and/or blunts the distal end of the needle.
31
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
2. Safety needle system
[0066] In a first preferred embodiment, as shown in FIGURES 28A and 28B,
the
safety needle system 100 operable with the integrated vascular delivery system
or other
medical device includes: a housing 310 having a needle mount 312; a needle 320
having
a distal end insertable through the frame and a proximal end coupled to the
needle
mount 312; a sheath 330 telescopically engaged with the housing 310 and
circumferentially surrounding at least a portion of the needle 320, in which
the sheath
330 operates in a retracted position 332 and an extended position 334; and a
slider 350
longitudinally engaged with the sheath and/or housing and including a
restraint that
selectively engages with the sheath. In the retracted position 332 of the
sheath, the
sheath exposes the distal end of the needle. In the extended position of 334
of the
sheath, the sheath substantially surrounds the distal end of the needle. In
the retracted
position 332 of the sheath, the sheath exposes the distal end of the needle.
In the
extended position 334 of the sheath, the sheath substantially surrounds the
distal end of
the needle. The sheath is coupleable to the medical device such that removal
of the
needle from the medical device draws the sheath over the needle, thereby
transitioning
the sheath from the retracted position to the extended position. In a
preferred
embodiment, the restraint is selectively engaged with the sheath such that (1)
the
restraint is coupled to the sheath when the sheath is in the retracted
position and
coupled to the medical device, and the restraint reinforces the coupling of
the sheath to
the medical device, and (2) the restraint is uncoupled from the sheath when
the sheath
is in the extended position, and the restraint weakens the coupling of the
sheath to the
32
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
medical device, thereby reducing the force required to uncouple the sheath
from the
medial device. In other variations, during removal of the needle from the
medical device
as the sheath is drawn over the needle, the slider automatically triggers the
full
uncoupling of the sheath and the medical device. Removal of the needle is
preferably
performed by pulling the needle away from the medical device, but
alternatively removal
of the needle may be performed by pulling the medical device away from the
needle. In
other words, to draw the sheath from its retracted position to its extended
position and
to decouple the safety needle system from the medical device, the user (e.g.,
medical
practitioner) may pull the needle away in a proximal direction (or pull the
medical
device away in a distal direction away from the safety needle system) thereby
allowing
the sheath to slide from its retracted position to its extended position to
cover the distal
end of the needle. In a preferred embodiment, the slider further includes a
proximal
articulation 364 and a distal articulation 366. When the sheath is in the
extended
position, the proximal articulation of the slider is coupled to the housing
310 and the
distal articulation of the slider is coupled to the sheath, thereby locking
the sheath in the
extended position; however, the system may include any suitable locking
mechanism to
lock the sheath in the extended position.
[0067] The housing 310 functions to support the sheath 330 and the slider
350, to
support the needle and/or to provide a user interface. As shown in FIGURES 29A-
29C,
the housing 310 includes a needle mount 312 to which the needle is coupled.
The needle
mount is preferably on a distal end of the housing and axially centered on the
housing,
but may alternatively be on any suitable portion of the housing. The needle
may be
33
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
molded into the needle mount such that the distal end of the needle extends
out of the
distal end of the housing, but the needle may alternatively be coupled to the
needle
mount with a snap fit, friction fit, threads, epoxy, or in any suitable
manner.
[0068] The housing 310 is slidingly or telescopically engaged with the
sheath 330
and/or slider 350. The housing 310 includes an inner portion that is contained
within
the sheath, such that the housing slides within the sheath. However,
alternatively the
housing may be tubular or otherwise configured such that the sheath slides
within the
housing. The inner portion of the housing may include a track 314 along which
the slider
350 is slidingly engaged. The track is preferably longitudinal along the
housing body,
and may be a projected track such as a ridge (FIGURES 30A and 30D), and/or a
recessed track (FIGURES 30B-30D). In one variation, as shown in FIGURE 29A,
the
housing includes one or more arches 318 that form an outer framework around
the
sheath and/or slider, such as brackets.
[0069] The housing 310 preferably includes a housing stop 316 that is
configured
to abut the proximal articulation of the slider 350 when the sheath is in the
extended
position. In a preferred embodiment, the abutment of the housing stop 316
against the
proximal articulation 364 (or other portion of the slider) functions to fix
the relative
positions of the housing and slider, thereby contributing to locking the
sheath in the
extended position. In one variation, as best shown in FIGURES 29C and 32, the
housing stop 316 includes a snap lock cantilevered arm whose free end abuts
the
proximal articulation of the slider. The housing stop 316 may be biased or
radially
deflected towards the slider such as to allow the slider to pass the housing
stop in one
34
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
direction (e.g. as the slider passes in a distal direction relative to the
housing) but to
prevent the slider from passing the housing stop in the opposite direction
(e.g. as the
slider passes in a proximal direction relative to the housing). Alternatively,
other
housing stop may include a sliding latch, lever, push button, another
protrusion of the
housing that interacts with the slider, or another suitable mechanism that
abuts any
suitable portion of the slider. As another alternative, the housing stop may
include an
aperture that receives the proximal articulation or any suitable portion of
the slider. The
housing stop is preferably integrally formed with the housing, but may
alternatively be a
separate piece coupled to the housing during assembly of the safety needle
device.
[0070] In some embodiments, as best shown in FIGURE 28, the housing 310
may
have one or more handles 311 that a user can grip and manipulate to operate
the safety
needle system. The handle 311 preferably includes two side grips on opposite
sides of the
housing that enable secure grasping with one hand. The handle 311 may include
features
such as ergonomic contours, ridges to improve friction in the grip, cushioning
material
such as silicone, or any suitable additions. Furthermore, other variations of
the handle
may include fewer or more grips (such as a single bulbous handle), and may be
particular for specific applications. In some embodiments, as shown in FIGURE
33, the
handle may further function as a hub cradle, such as for receiving a catheter
hub or
stabilization hub such as that described in U.S. Patent Application number
12/855,013,
or any suitable hub or other portion of a medical device.
[0071] The housing 310 is preferably plastic and may be made of one
singular
piece, such as by an injection molding that forms the needle mount, arches,
and/or
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
handles integrally with the rest of the housing. The housing may alternatively
include
multiple pieces that are separately manufactured and attached to the tubular
portion of
the housing in a secondary process such as with adhesive, locking joints, or
other
fasteners. However, the housing may be in made in any suitable manufacturing
process
such as milling, turning, or stereolithography, and be made of any suitable
material.
[0072] The needle 320 of the safety needle system is preferably a medical
grade
needle with a cannula, such as those used to aid insertion of catheters. The
needle may
have a gauge or size that is selected from a group of available needle gauges,
such as
standard diameter sizes. In one variation, as shown in FIGURE 33A, the needle
320 may
include a notch 322 along a portion of the length of the needle. The notch 322
is
positioned at a notch extent distance 326 defined as the distance between the
distal end
of the needle and the proximal edge of the notch. In an exemplary embodiment
used
with a catheter, during catheter placement within a blood vessel, the needle
320 is
typically telescopically engaged within the catheter, forming an annular space
between
the outer wall of the needle and inner wall of the catheter. When the needle
is placed
within the blood vessel, blood or other fluids pass along the length of the
needle, and the
notch in the needle allows a small amount of the fluid (known as "flash") to
pass into the
annular space between the needle and catheter. This "flash" becomes visible to
the user
through the catheter, and the appearance of the flash signifies needle
placement within
the blood vessel.
[0073] In another variation of the needle 320, as shown in FIGURE 33B,
the
needle may be a substantially solid needle rather than a hollow needle with a
cannula.
36
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
For example, the needle 320 may include a trocar as a catheter introducer. In
this
variation, the needle may include a sharp distal tip and a groove running from
the distal
tip of the needle. The groove 324 preferably receives the flash upon needle
insertion into
the vessel (FIGURE 33C), and the flash may be visible to the user through the
catheter
tubing and/or catheter hub.
[0074] The sheath 330 of the safety needle system preferably functions to
cover
the distal end of the needle 320 after the needle tip is no longer needed, to
help protect
the user from fluid contamination and accidental needle punctures. The sheath
330
operates in a retracted position 332 and an extended position 334, such that
in the
retracted position 332 the sheath exposes the distal end of the needle 320,
and in the
extended position 334 the sheath is extended from the housing and
substantially
surrounds or covers the distal end of the needle 320. In the extended
position, the
sheath may cover the entire needle body, or only a portion of the needle body
including
the distal end.
[0075] As best shown in FIGURE 34F, the sheath 330 preferably includes a
set of
sheath stops including a first stop 336 and a second stop 337. The first stop
336 is
configured to abut the distal articulation of the slider 350 when the
restraint 351 is
engaged with the split portion 340 of the sheath. The second stop 337 is
configured to
abut the distal articulation of the slider 350 when the sheath is in the
extended position,
which prevents substantial relative longitudinal motion of the sheath and
housing,
thereby contributing to locking the sheath in the extended position. The
sheath stops
may additionally and/or alternatively abut against any suitable part of the
slider. In one
37
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
variation, as shown in FIGURE 34E, the sheath stops 336 and 337 may include an
aperture defined in a side wall of the sheath. The aperture may have a partial
perimeter
defined by the gap between two or more split portions 340 in a side wall of
the sheath.
For example, the split portions 340 may be opposing members with each member
having an angled or toothed tip 342. The opposing angled tips 342 define an
aperture
with a surface for abutting the distal articulation of the slider.
Alternatively, the aperture
may be a hole with an enclosed perimeter defined in the side wall of the
sheath. In other
variations, the sheath stop may include a projection or other extension, such
as one
similar to any of the variations of the housing stop, or any suitable portion
of the sheath.
[0076] The sheath 330 may include a mating feature that enables the
sheath to
couple to the frame, or other suitable medical device. In one variation, the
distal end of
the sheath is adapted to mechanically couple to the medical device. In one
preferred
embodiment, as shown in FIGURES 34A-34E, the mating feature includes jaws 342
extending longitudinally from a distal end of the sheath 330. The jaws 342 are
preferably flexible and couple to corresponding mating features (e.g.,
external
articulations, cutouts or pockets) on the medical device. Each jaw may be
coupled to a
split portion 340 of the distal end of the sheath, and preferably couples to
the restraint
tab 351 of the slider. For example, as shown in FIGURE 34F, each split portion
or jaw
may define a restraint Mot 138 that receives a respective restraint tab 351 of
the sheath.
In one variation, the jaws may have an approximately arcuate profile (FIGURE
34A) to
conform to an approximately circular portion of the medical device. In other
variations,
the jaws may include hooked tips 344 (FIGURES 36A and 36B) and/or platforms
346
38
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
(FIGURES 37A and 37B) configured to particular corresponding features on the
medical
device and/or slider 350. In other variations of mechanically coupling to the
medical
device, the sheath 330 may extend beyond the distal end of the housing when
the sheath
is in the retracted position to enable the distal end of the sheath to seat
within a channel
(e.g. a septum or other receptacle) of the medical device. For example, the
medical
device may retain the distal end of the sheath. As another example, the distal
end of the
sheath 330 may include extensions that mate with a corresponding recess in the
medical
device, or the medical device may include extensions that mate with a
corresponding
recess on the sheath 330. The distal end of the sheath 330 may include other
features
for sating within the septum or another receiving portion of the medical
device, such as
having a slight taper to a narrower diameter that fits within the septum,
frictional
features like ribs or ridges that may includes retention of the sheath 330
within the
septum. The distal end of the sheath may additionally and/or alternatively
couple to the
medical device with magnets, adhesive, snap locks, fasteners, or any suitable
mechanical
means.
[0077] In another variation, the distal end of the sheath 330 is adapted
to
manually couple to the frame. For example, as shown in FIGURE 34A, the sheath
may
include a holding tab 348 extending from the distal end of the sheath that
provides a
finger rest for the to press the holding tab against the medical device,
thereby manually
coupling the sheath and the medical device. The holding tab may extend
laterally
outwards or be a projection from the sheath extending in any suitable
direction. The
holding tab 348 may provide assistance for the user to hold the sheath against
the
39
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
medical device as a counterforce while pulling the housing and needle 320 away
from
the medical device. As shown in FIGURE 34D, the holding tab 348 may include a
bridge
that connects the split portions of the sheath stop. Alternatively, the sheath
may include
multiple holding tabs, such as one holding tab 348 extending from each split
portion
340 or jaw 342 of the sheath. The holding tab 348 may include features to help
the user
hold the holding tab against the medical device, such as a lip, ridges that
increase
friction, or a friction coating such as silicone. The holding tab may include
adhesive
and/or a mechanical attachment such as a pin, snap or latch that couples the
holding
tab to the medical device.
[0078] In a preferred embodiment, the slider 350 functions to selectively
modulate the coupling force between the sheath and the medical device. The
slider 350
may further contribute to locking the sheath 330 in the extended position over
the distal
end of the needle. The slider 350 longitudinally extends along at least a
portion of the
sheath 330 and/or housing and is slidingly engaged with the sheath and/or
housing,
such that the housing, sheath and slider are longitudinally movable relative
to one
another. As shown in FIGURES 35A-35E, the slider 350 may include a planar
portion
352 and a sheath insert portion 346. The planar portion is preferably
substantially flat
and is slidingly engaged with the track of the housing, although may
alternatively be
contoured. The planar portion 352 may include a groove 356 (FIGURE 30A) and/or
a
ridge 358 (FIGURE 30B) complementary to the track 314 of the housing 310, or
any
suitable profile. The sheath insert portion 354 is preferably located on a
distal section of
the slider, and is telescopically engaged in the sheath 330. As shown in
FIGURE 35D,
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
the sheath insert portion may have an approximately arcuate cross-section
profile, or
any suitable profile complementary to the cross-sectional profile of the
sheath to allow
the sheath insert portion to be slidingly engaged with the sheath. The sheath
insert
portion 354 preferably defines an aperture 362 that allows the needle 320 to
pass within
the sheath insert. The aperture 362 may be a round hole, a slot, or any
suitable opening
to allow relative longitudinal translation of the slider 350 and the needle
320. In some
embodiments, as shown in FIGURE 41, the slider 350 may include protrusions 356
that
interfere with the flexible jaws of the sheath 330, such that when the slider
is withdrawn
from the medical device the protrusions 368 trigger the jaws into the "open"
configuration, thereby automatically decoupling the sheath 330 and the medical
device.
[0079] The sheath insert portion 354 preferably includes a restraint that
selectively engages with the sheath, such that when the restraint is engaged
with the
sheath, the restraint reinforces the coupling of the sheath to the medical
device, and
when the restraint is disengaged from the sheath, the restraint weakens the
coupling of
the sheath to the medical device. In a preferred embodiment, as shown in
FIGURE 35F,
the slider 350, in particular the sheath insert portion 354, may include at
least one
restraint tab 351 that is insertable into a restraint slot 338 on split
portion 340 or jaw
342 of the sheath. In this embodiment, when the sheath is retracted and jaws
342 are
surrounding and gripping the medical device, the restraint tabs 351 are
coupled to the
restraint slots 338 and the restraint tabs substantially prevent the jaws from
moving
relative to each other, thereby strengthening the grip of flexible jaws 142 on
the medical
device. When the sheath is extended (e.g. the housing is moved in a proximal
direction
41
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
away from the medical device), the restraint tabs become uncoupled from the
restraint
slots 338, leaving the flexible jaws 342 to more freely move relative to
other, thereby
weakening the grip of flexible jaws 342 on the medical device. In other words,
the
selective coupling of the restraint tabs 351 on the slider to the restraint
slots 338 on the
sheath effectively modulates the amount of force required to flex the jaws and
uncouple
the sheath from the medical device.
[0080] The slider 350 preferably includes a proximal articulation 364
that abuts
the housing stop and/or a distal articulation 366 that abuts the sheath stop
when the
sheath 330 is in the extended position. When the sheath 330 is in the extended
position,
the proximal and distal articulations preferably fix the slide position
relative to both the
housing and sheath, respectively, which indirectly fixes the sheath 330
relative to the
housing, thereby locking the sheath 330 in the extended position.
Alternatively, the
system may include any suitable locking mechanism to lock the sheath in the
extended
position. As best shown in FIGURE 35E, the proximal articulation 364 of the
slider 350
is preferably on a proximal portion of the slider and is a laterally outward
extension,
such as a tab, that abuts the housing stop. The proximal articulation 364 may
or may not
include an aperture similar to the aperture 362 of the sheath insert portion
to allow
passage of the needle 320 through the proximal articulation. The distal
articulation 366
of the slider 350 is preferably an extension, such as a nub or catch on the
sheath insert
portion that catches in the aperture 336 of the sheath stop. Alternatively,
the distal
articulation 366 may be on any suitable distal portion of the slider. As shown
in
FIGURES 49 and 41, the proximal and distal articulations may project towards
the
42
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
bottom of the slider 350, although they may project in any suitable direction
corresponding to the locations of the housing stop on the housing and the
sheath stop
on the sheath. In other variations, the proximal and distal articulations may
be in any
suitable locations on the slider and may each be an aperture or extension
corresponding
to the kinds of housing stop on the housing and sheath stop on the sheath.
[0081] Overall in a preferred embodiment, coupling a distal portion of
the sheath
to the portion of the medical device involves coupling flexible jaws (which
are extensions
of split portions on the sheath) around the medical device. As shown in FIGURE
38A,
the sheath is preferably retracted, and restraint tabs 351 on the slider are
inserted in
restraint Mots 338 on the split portions. While the restraint tabs are
inserted the
restraint Mots, the restraint tabs strengthen or lock the coupling between the
jaws and
the medical device, by substantially preventing the jaws from moving laterally
apart.
When the housing and slider are pulled away from the medical device, thereby
drawing
the sheath over the needle, the distal articulation of the slider temporarily
abuts the first
sheath stop 336 so that the restraint tabs 351 remain engaged in restraint
slots 338 and
the sheath remains coupled to the medical device. In this intermediate step,
the
abutment of the distal articulation of the slider against the first sheath
stop is preferably
overcomes the shear force due to friction between the housing and slider. As
shown in
FIGURE 38C, when the housing is further pulled away from the medical device,
the
housing pulls the slider away from the medical device until the distal
articulation 366
overcomes first stop 336 and abuts the second sheath stop 337, while the
proximal
articulation 364 of the slider abuts the housing stop 316. Furthermore, when
the slider
43
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
overcomes the first stop 336, any other portions of the medical device (e.g. a
stabilization hub 130 in the integrated vascular delivery system as described
above) may
be released and decoupled from the safety needle system. Furthermore, as shown
in
FIGURE 38B, when the distal articulation abuts the second sheath stop, the
restraint
tabs 351 disengage from the restraint slots 338, thereby weakening the
coupling
between the jaws and the medical. For instance, after this final step the user
can easily
provide enough force to separate the extended sheath (surrounding the needle)
and the
medical device.
[0082] In an alternative embodiment, as shown in FIGURES 39-41, the
slider
functions to automatically trigger the decoupling between the sheath 330 and
the
medical device when the needle is withdrawn from the medical device. In this
embodiment, as shown in FIGURE 39, the jaws 342 may be biased into a "closed"
configuration 341 in which the jaws tend to grip the mating features on the
medical
device. As shown in FIGURE 40, the jaws 342 may be manipulated to flex, swing,
or
otherwise move into an "open" configuration 343 in which the jaws move
laterally apart,
thereby enabling decoupling of the sheath 330 and medical device 302, such as
after the
sheath has been drawn into its extended position. The jaws 343 may be
manipulated
into the "open" configuration automatically when the housing and/or slider 350
is
pulled in a proximal direction away from the medical device, thereby
automatically
decoupling the sheath 330 from the medical device. In this embodiment, as
shown in
FIGURE 41E, the slider 350 include protrusions 356 that interfere with the
flexible jaws
of the sheath 330, such that when the slider is withdrawn from the medical
device the
44
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
protrusions 368 trigger the jaws into the "open" configuration, thereby
automatically
decoupling the sheath 330 and the medical device.
[0083] In a second preferred embodiment, as shown in FIGURES 42A and 42B,
the safety needle system 400 includes a housing 410 including a needle mount
412
coupled to a setting 414 that approximately axially centers the needle mount
412 within
the housing 410; a needle 412 having a distal end insertable through the frame
or other
suitable medical device and a proximal end coupled to the needle mount 412;
and a
sheath 430 telescopically engaged with the housing 410 and having a distal
wall 444
defining a needle aperture 446 and a longitudinal track 442 that is slidingly
engaged
with the setting 414 of the housing 410. The sheath 430 operates in a
retracted position
432 in which the sheath exposes the distal end of the needle and an extended
position
434 in which the sheath substantially surrounds the distal end of the needle.
Like the
sheath of the first preferred embodient of the safety needle system, the
sheath 430 is
preferably coupleable to the medical device such that removal of the needle
from the
medical device draws the sheath 430 over the needle, thereby transitioning the
sheath
from the retracted position to the extended position. The safety needle system
preferably further includes a locking mechanism 450. In a preferred embodiment
of the
safety needle system, when the sheath is in the extended position, a proximal
portion of
the sheath 430 abuts a housing stop or catch in the housing, and the locking
mechanism
450 restrains the sheath in the extended position. In one variation, the
locking
mechanism 450 is a housing stop including a snap lock cantilevered arm with a
free end
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
that is configured to abut the proximal portion of the sheath when the sheath
is in the
extended position. However, any suitable locking mechanism may be used.
[0084] The housing 410 of the second embodiment of the safety needle
system
functions similarly to the housing of the first embodiment of the system. As
shown in
FIGURES 43A-43C, the housing 410 is preferably tubular, defining a channel 416
that
telescopically engages the sheath 430, and the housing 410 and/or channel 416
is
preferably elongated and cylindrical, but may alternatively have any suitable
cross-
section, such as an oval or an approximate rectangle. Like the housing in the
first
embodiment, the housing 410 of the second embodiment includes a needle mount
412
to which the needle 420 (which is preferably similar to that of the first
embodiment) is
coupled. The housing preferably further includes a setting 414 that anchors
the needle
mount 412 in the housing. The needle mount 412 of the housing is preferably
located on
a distal end of the housing and is preferably approximately axially centered
within the
housing. However, the needle mount may alternatively be offset from the center
of the
housing, or located in any suitable position in or on the housing. The setting
is
preferably a peg, protrusion, or other inwardly, radially extending feature
coupled to an
internal wall of the housing. The setting 414 preferably slidingly engages
with the sheath
430 to facilitate assembly and/or operability of the sheath in the retracted
and extended
positions. The setting 414 may have any suitable cross-sectional shape to
guide the
sliding sheath, such as a square or rectangle. Furthermore, the setting 414
may have a
cross-sectional shape that may particularly help reduce lateral movement of
the sheath
430 within the housing, such as a dovetail. The housing 410 may also have
multiple
46
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
settings arranged within the channel 416 of the housing that slidingly engage
and guide
the sheath. For example, the housing may have a first setting on one side of
the channel
to guide an upper side of the sheath 430, and a second setting on an opposite
side of the
channel relative to the first setting to guide a lower side of the sheath 430.
The needle
mount 412 is preferably coupled to the setting 414 such that the setting
anchors the
needle mount to the housing, but the needle mount and setting may
alternatively be
independent of one another and located in any suitable position in or on the
housing.
For example, the setting 414 may be a guide located along the same
longitudinal line as
the needle mount 412, or on an opposite wall of the needle mount 412, or any
suitable
location. As shown in FIGURE 44C, the relative dimensions of the needle mount
and
setting preferably form an overhang that defines an alcove space 415 or recess
between
the needle mount and the housing. The alcove space 415 is preferably
dimensioned to
accommodate the thickness of the sheath when the sheath is in the extended
mode,
without permitting the sheath to wobble extensively within the housing.
[0085] In some embodiments, the housing 410 further includes one or more
handles 418 that a user can grip and manipulate to operate the safety needle
system.
The handle preferably includes two side grips on opposite sides of the housing
that
enable secure grasping with one hand. The side grips may be relatively short
and narrow
along the length of the housing (FIGURE 43A) or may be relatively wide and
extend
along a substantial length of the housing (FIGURE 45A). Like the handle of the
first
preferred embodiment of the system, the handle 418 may include features such
as
ergonomic contours, ridges to improve friction in the grip, cushioning
material such as
47
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
silicone, or any suitable additions. Furthermore, other variations of the
handle may
include fewer or more grips (such as a single bulbous handle), and may be
particular for
specific applications. In some embodiments, the handle may further function as
a hub
cradle, such as for receiving the catheter hub 120 or stabilization hub 130 or
other
suitable portion of a medical device.
[0086] As shown in FIGURE 43C, the distal end of the housing 410 may
further
include a ledge 417 that helps support the sheath 430 when the sheath is in
the extended
position. The ledge 417 preferably extends beyond the distal end of the
housing,
preferably on at least an underside of the housing to support the extended
sheath
against gravity, and may be flat, curved, or any geometry to support the
sheath. The
ledge may include additional features such as rubberized grips or teeth, or
fasteners
such as magnets, clips, or adhesive to help secure or support the extended
sheath.
Furthermore, the ledge may be hingedly attached to the housing, such as for
folding to
make the system more compact during storage before and/or after use. However,
the
ledge may have any other suitable geometry and/or arrangement.
[0087] The sheath 430 of the safety needle system of the second preferred
embodiment of the safety needle system functions similarly to the sheath of
the first
embodiment of the system. As best shown in FIGURE 45A, the sheath 430 is
preferably
slidably engaged with the housing 410 such that the sheath passes
telescopically within
the channel of the housing. The sheath 430 is operable in at least one of a
retracted
position 432 in which the sheath is at least partially retracted within the
housing 410
and exposes the distal end of the needle, and an extended position 434 in
which the
48
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
sheath 430 is extended from the housing 410 and substantially surrounds the
distal end
of the needle. As shown in FIGURES 44-45, the sheath includes a longitudinal
track 442
that slidingly engages with the setting or other portion of the housing, and a
distal wall
444 that contributes to covering the distal end of the needle when the sheath
is in the
extended position.
[0088] In one preferred embodiment, the sheath 430 is comprised of two
pieces,
including a proximal sheath portion 430a and a distal sheath portion 430b. As
shown in
FIGURES 44A-44E, the proximal sheath portion 430a and the distal sheath
portion
43013 are assembled to form an integrated sheath body. As shown in FIGURE 44E,
the
proximal sheath portion 430a preferably includes snap latches 431a and the
distal
sheath portion preferably includes snap holes 431b that receive snap latches
431a in a
snap fit fastening manner. However, additionally and/or alternatively, the
distal sheath
portion may include snap latches and the proximal sheath portion may include
snap
holes, or the proximal and distal sheath portions may be attached by threads,
an
interference fit, magnets, adhesive, or in any suitable manner. The proximal
and distal
sheath portions are preferably assembled within the housing 410, joined around
the
setting and/or other internal projections inside the housing. During assembly,
the distal
sheath portion may enter the housing 410 from the distal end of the housing
and the
proximal sheath portion may enter the housing from the proximal end of the
housing. In
another variation, the sheath includes one sheath portion and includes
features,
preferably in the longitudinal track as described below, that facilitates
assembly into the
housing.
49
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0089] The longitudinal track 442 of the sheath 430 functions to guide
transition
of the sheath between the retracted and extended positions. The longitudinal
track is
preferably a slot, but may alternatively be a groove that slidingly engages
the setting, or
may include a combination of single or multiple slots and/or grooves. The
longitudinal
track 442 is preferably substantially parallel to a longitudinal axis of the
sheath, from a
proximal end of the sheath towards a distal end of the sheath, and slidingly
engages with
the setting and/or needle mount or another feature of the housing 410.
[0090] As shown in FIGURES 45 and 46, in the one-piece sheath variation,
the
longitudinal track preferably includes a series of arcuately offset, adjacent
slotted
portions, and more preferably two such portions that at least partially
overlap to form a
single track of varying width. In a preferred embodiment, as best shown in the
"unwrapped" view of the track in FIGURE 45C, the first track portion 442a runs
longitudinally along the sheath 430 from the proximal end of the sheath to a
point
partially along the length of the sheath. In this embodiment, the second track
portion
442b is preferably parallel to and circumferentially offset by an offset angle
from the
first track portion and runs along substantially the entire length of the
sheath 430. Each
of the two track portions are preferably approximately as wide, or slightly
wider than,
the width of the setting of the housing, such that as the sheath 430
telescopically moves
within the housing 410 with the setting slidingly engaged with the track 442,
the setting
414 freely passes within the longitudinal track. In a preferred embodiment,
the first
track portion 442a slidingly engages the setting to allow the sheath 430 to
pass in a
proximal direction up to the end of the first track portion, particularly to
at least
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
partially retract the sheath in the housing, such as during assembly of the
safety needle
system. The second track portion 442b preferably slidingly engages the setting
at a
different circumferential angle around the sheath 430, to allow the sheath to
pass
farther in the proximal direction towards the fully retracted position. The
second track
portion 442b preferably also engages the setting 414 to allow the sheath to
pass in a
distal direction towards the extended position of the sheath, such as during
use of the
safety needle system to cover the needle. Although the first and second track
portions
preferably at least partially share an edge, in other variations the track 442
may include
any suitable number of track portions in any suitable arrangement. For
example, the
first and second track portions may be offset by a relatively large offset
angle such that
the first and second track portions do not share an edge. Furthermore, as
shown in
FIGURE 46A, the longitudinal track portions may be joined by a lateral track
442c or
other open passageway (such as an open distal end of the sheath as shown in
FIGURE
46B) so that rotation of the sheath within the housing enables the setting to
travel
between the track portions.
[0091] The longitudinal track 442 and/or other portion of the sheath 430
preferably also defines a catch portion 438 at the proximal portion of the
sheath that
functions to prevent the extended sheath from fully exiting the housing 410.
The catch
438 is preferably arranged at the proximal portion of the sheath and abuts the
setting
and/or needle mount when the sheath is in the extended position. The catch 438
may fit
into the alcove space 415 of the housing. Another catch mechanism, such as
springs or
latches, may additionally and/or alternatively be used to prevent the sheath
from fully
51
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
exiting the housing. In one or more of these variations, the sheath is
preferably
restrained from sliding beyond a particular point in the extension (distal)
direction.
[0092] The distal wall 444 of the sheath 430 functions to substantially
cover the
distal end of the needle when the sheath is in the extended position, and
further
functions as a stop against the needle mount and/or setting when the sheath
430 is in
the retracted position, to prevent the sheath from fully retracting into the
housing 410.
The distal wall 444 forms a substantially full or partial face on the distal
end of the
sheath, and defines a needle aperture 446 or hole large enough to receive and
allow
passage of at least a portion of the needle. The needle aperture 446 may be an
opening
in the distal wall of the sheath (FIGURE 46B) or may be in a guide or partial
needle
covering that extends beyond the distal wall (FIGURE 49). To limit sheath
retraction up
to a point (such as less than fully retracted within the housing 410, such
that the distal
end of the sheath is still extending beyond the distal end of the housing),
the distal wall
444 may abut the needle mount and/or setting when the sheath is in the
retracted
position, or additionally and/or alternatively the proximal end of the sheath
may butt
against a proximal wall or another stop in the housing 410. In at least one of
these
manners, the sheath is preferably retraining from sliding beyond a particular
point in
the retraction (proximal) direction.
[0093] The distal end of the sheath 430 is adapted to mechanically and/or
manually couple to the medical device, similar to the sheath of the first
preferred
embodiment of the system.
52
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[0094] The locking mechanism 450 of the safety needle system functions to
restrain the sheath 430 in the extended position and prevent the sheath from
returning
from the extended position to the retracted position. In some embodiments, the
safety
needle system may include two or more locking mechanisms in the sheath 430
and/or
housing 410. In one variation, as shown in FIGURES 47A-47D, the locking
mechanism
450 may be coupled to the sheath 430 and/or housing 410. For example, the
locking
mechanism 450 may be a tab 452, coupled to the sheath, that engages a
corresponding
catch 454 or other stop in the housing 410 such as near the setting and needle
mount (or
other suitable location in the housing), to substantially lock the sheath in
the extended
position. In a one-piece sheath, the tab 452 is preferably near the proximal
end of the
sheath. In a two-piece sheath, the tab may be located on the proximal sheath
portion or
the distal sheath portion. The tab preferably enables passage of the sheath
430 within
the housing 410 in a proximal direction (e.g. only in assembly), while
substantially
preventing passage of the sheath in the proximal direction when the tab
engages the
catch when the sheath is in the extended position. For instance, as shown in
FIGURE
47B, during assembly when the sheath 430 is passed in the proximal direction
into the
housing 410, the sheath may be rotated to a particular angle such that the
setting and/or
needle mount preferably deflect the tab towards the wall of the housing 410,
enabling
the sheath to free pass in the proximal direction within the housing 410. As
shown in
FIGURES 47C and 47D, during operation of the safety needle system, when the
sheath
is drawn out to its extended position, a barbed end of the tab engages and
stops on the
53
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
catch of the housing, thereby substantially preventing movement of the sheath
in the
proximal direction and restraining the sheath in its extended position.
[0095] In another variation, as shown in FIGURES 48A-48D, the locking
mechanism 450 includes a housing stop coupled to the housing 410. In the
extended
position of the sheath 430, the catch of the sheath preferably abuts the
setting or other
stop of the housing 410 and the housing stop abuts a proximal face of the
catch, thereby
trapping the catch between the setting and the housing stop. The housing stop
is
preferably a snap lock cantilevered arm or tab on a wall of the housing 410
that is
radially deflectable inwards (FIGURE 48A) and/or have a projection that
extends
radially inwards. (FIGURE 48B). In other variations, the locking mechanism 450
may
be a sliding latch (FIGURE 48C), lever, (FIGURE 48D), push button, or another
suitable
mechanism that is engageable to trap the catch of the sheath 430 against the
setting of
the housing, thereby locking the sheath in the extended position. In further
variations,
the locking mechanism 450 may additionally and/or alternatively abut a distal
portion,
central portion, or any suitable portion of the sheath. The locking mechanism
is
preferably integrally formed with the housing 210, but may alternatively be a
separate
piece that is coupled to the housing during assembly of the safety needle
device.
[0096] Preferably, the locking mechanism 450 is disengaged or otherwise
does
not interfere with the ability of the sheath 430 to pass in a proximal
direction to its
retracted position during assembly of the safety needle, or before extended
position of
the sheath 430 is desired for covering the needle tip. For example, the free
end of the
cantilever arm may extend into the alcove space 415 adjacent to the setting of
the
54
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
housing 410 out of the assembly path of the sheath, such that during assembly
the
cantilever arm does not accidentally abut the catch of the sheath 430 and
prematurely
lock the sheath in the extended position. In other variations, the locking
mechanism
may be selectively disengaged according to its mechanical nature, such as by
sliding a
latch or pivoting a lever out of the way of the sheath when the sheath is to
be retracted
(e.g. during assembly or if the needle is to be uncovered).
[0097] As shown in FIGURES 49A-49D, the method of assembling the safety
needle system 500 of the second embodiment includes: inserting a proximal end
of the
sheath into a distal end of the housing S510; engaging the setting of the
housing within
the first track portion of the longitudinal track S520; sliding the sheath
telescopically to
at least a partial retracted position in the housing S530, with the setting of
the housing
traveling within the first track portion of the longitudinal track; rotating
the sheath
within the housing by the offset angle S540 to engage the setting of the
housing within
the second track portion of the longitudinal track; and sliding the sheath
into a full
retracted position in the housing S550, with the setting of the housing
traveling within
the second track portion of the longitudinal track. As shown in FIGURE 49E,
the
method may also include sterilizing the needle and/or placing a protective cap
S560
onto a distal end of the needle that helps maintain sterility and protect
users from
accidental needle pricks during transport and storage. This method may be used
to
assemble an embodiment of the safety needle system with a one piece sheath,
but a
variation 500' may similarly be used to assemble a safety needle system with a
sheath
having two or more pieces. In another variation 500', as shown in FIGURES 50A
and
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
50B, to assemble a two-piece sheath variation of the system, the proximal
sheath
portion and the distal sheath portion are preferably coupled to one another
around the
setting or other housing stop of the housing. For instance, method 500' may
include
inserting the proximal sheath portion into the proximal end of the housing
S570,
inserting the distal sheath portion into a distal end of the housing S580, and
coupling
the proximal sheath portion and distal sheath portion to one another S59o,
preferably
around the setting. After assembly, the sheath is preferably approximately
concentrically nested within the housing. The safety needle system may be
assembled
during manufacture and supplied to the user with the sheath in its retracted
position, or
with the sheath in its extended position. Alternatively, the safety needle
system may be
assembled by the user prior to use.
2.1 Sheath septum
[0098] In either preferred embodiment, the safety needle system may
further
include one or more instances of a sheath septum 200' that functions to seal
any body
fluids, such as blood, or other potential biohazards within the sheath as the
sheath
passes over the needle into the extended position, as the needle is withdrawn
from the
medical device. Although the sheath septum is primarily shown with the safety
needle
system of the first preferred embodiment, the second preferred embodiment of
the
system may also include a sheath septum 200'. The sheath septum 200' is
preferably
coupled to the sheath 330 and more preferably within the sheath. The sheath
septum
200' in the safety needle system is configured to couple to the catheter hub
(or
56
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
alternatively any suitable medical device) in a fluid-tight manner, to help
prevent fluid
leakage through the joint between the catheter hub and the safety needle
system. For
example, the end of the sheath septum may be circumferentially enclosed by the
catheter hub, or the catheter hub may be circumferentially enclosed by the
safety needle
system septum. As another example, the joint between the safety needle system
and the
medical device may include a fluid-tight butt joint and/or a sealant.
[0099] As shown in FIGURE 51, the sheath septum preferably includes a
first seal
210' and a second seal 212'. The first seal 210' is a defense against fluid
escaping from
one end of the sheath septum, and the second seal 212' functions as a defense
against
fluid escaping from another end of the sheath septum. In some embodiments, the
sheath septum 200' may include fewer or more seals similar to the first and
second
seals, which may be suitable for some applications to modify the amount of
fluid leakage
protection. The sheath septum 200' preferably defines a cavity 214' between
the first
and second seals that may contain trapped fluid. The cavity 214' may be larger
than the
diameter of the needle to reduce frictional force as the sheath septum passes
over the
needle. However, the cavity may alternatively be closely fit over the needle,
and/or
include a material with a lower friction coefficient and/or fluid absorbent
material. In
some embodiments, the needle may include additional fluid exit points such as
multiple
notches along its length, and the sheath may include a longer sheath septum or
multiple
sheath septa to contain the multiple fluid exit points on the needle. The
septum 200'
may be similar in structure to one or more of the variations of the catheter
hub septum,
as described above.
57
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[00100] As shown in FIGURES 51-53, in one variation, the sheath septum
length,
and more preferably the sheath septum cavity length, is at least a long as the
notch
extent distance of the needle and positioned as such that when the sheath is
in the
extended mode, the notch is fully contained within the sheath septum. As shown
in
FIGURE 54, in another variation, the catheter hub septum length y and the
sheath
septum length z sum to a sealing length at least as long as the notch extent
distance 326.
In this variation, the catheter hub septum 200 and/or the sheath septum 200'
may
individually be shorter than the notch extent distance, but together the
combination the
catheter hub septum and the sheath septum is preferably equal to or greater
than the
notch extent distance, to fully contain the notch extent distance within at
least one of the
hubs.
[00101] As shown in FIGURES 52A and 52B, the safety needle septum 200' may
be
shorter than the length of the sheath 330, such as near the distal end of the
sheath so
that when the sheath is in the extended position, the septum contains a
portion of the
needle body including the distal end of the needle and the notch.
Alternatively, the
sheath septum may be at least substantially the same length as the sheath. For
example,
as shown in FIGURES 53A and 53B, the septum may be nearly the same length as
the
sheath such that when the sheath is in the extended position, the septum
contains a
large portion needle body. In another example, as shown in FIGURE 54A and 54B,
the
sheath and septum may be at least as long as the notch extent to contain the
notch, but
shorter than the overall needle length.
58
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[00102] Similar to the catheter hub septum, the sheath septum 200' may
include
an elastomeric material, and may have a diameter slightly larger than the
diameter of
the sheath, such that compression of the septum, when assembled in the sheath,
seals
the annular gap between the outer circumferential edges of the septum and the
walls of
the sheath, thereby preventing fluid from escaping through the annular gap,
and further
maintaining the coupling between the septum and the sheath, similar to a press
fit. The
septum may additionally and/or alternatively include a sealant material
applied
between the outer surface of the septum and the sheath, and/or be temporarily
or
permanently bonded to the sheath such as with sonic welding, chemical welding,
or
adhesive.
[00103] In either preferred embodiment, the safety needle system may
further
include a catch 480 that helps lock the septum 200' (or alternatively a
portion of the
sheath 330 without a septum) in place over the notch 122 and/or the distal end
of the
needle 120. The catch 380 may additionally and/or alternatively fix the sheath
in the
extended position. As shown in FIGURES 33A and33B, in one variation the catch
may
be coupled to an internal portion of the septum, such as a spring clip within
the septum
cavity (or other portion of the septum or sheath) that engages the needle once
the sheath
is in its extended position. When the spring clip engages the needle, the
spring clip
prevents movement of the sheath in a proximal direction, thereby locking the
septum in
place. As also shown in FIGURE 56A and 56B, in another variation the catch is
a
compressible ring 484 or nub on an external surface of the needle 120 that
compresses
when the septum 200' passes over the catch in a distal direction, and expands
again
59
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
when the septum covers the notch and/or distal end of the needle, thereby
preventing
movement of the sheath in a proximal direction and locking the septum in
place.
[00104] In either preferred embodiment, as shown in FIGURE 57, the housing
110
may, in addition or an alternative to a sheath septum, include a vent chamber
270 and a
vent cap 272 that seals one end of the vent chamber. The vent chamber 270 may
be
coupled to the needle mount, such that the vent chamber receives blood or
other body
fluids through the needle. In one variation, the vent chamber includes a
recess within
the needle mount of the housing, and the proximal end of the needle is
inserted into an
entrance of the vent chamber to carry fluids into the vent chamber. In this
variation, the
interface between the needle and the vent chamber is sealed to further guard
against
release of fluids, such as with a filter, gasket, 0-ring, epoxy, or any
suitable seal material
or mechanism. Furthermore, the housing may include a vent cap 272 that seals
one end
of the vent chamber to prevent passage of fluid throughout the rest of the
housing and
safety needle system. The vent cap is preferably hydrophobic, preventing fluid
from
exiting the vent chamber while allowing air to exit the vent chamber, thereby
creating a
pressure differential across the needle body due to the difference between
vascular and
atmospheric pressures. This pressure differential causes the blood in the
needle to "flash
back" into the vent chamber. In another variation, the proximal end of the
needle
includes an enlarged needle chamber volume that receives fluids, and the vent
chamber
of the housing receives the needle chamber. In this variation, the fluids are
contained
within the needle structure, which is in turn mounted in the housing.
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
3. Needle protection cap
[00105] The integrated vascular system and/or safety needle system may be
coupled to a needle protection cap 460 that protects the folded or bent
lateral members
prior to insertion of the catheter in the patient, such as during packaging,
shipping, and
storage of the integrated vascular delivery device and/or the safety needle
system. The
needle protection cap 460 may further protect a user or other handlers from
accidental
needle punctures prior to insertion of the needle and/or catheter in the
patient. As
shown in FIGURE 58, the needle protection cap 460 of a preferred embodiment
includes a lumen 462 configured to receive the needle and a recess configured
to receive
the catheter hub. Alternatively, the protective cap may be a sleeve that
surrounds at
least a portion of the exposed needle, and/or include a blunt stopper that
occludes or
blunts the distal end of the needle. However, any other suitable type of cap
may be used.
Furthermore, the cap may be used to protect only the needle; for example, if
the
integrated vascular delivery system is packaged and shipped in the unfolded
configuration, the cap may primarily function to cover the needle, and be
coupled to the
needle (additionally and/or alternatively to any suitable part of the
integrated vascular
delivery device and/or the safety needle system.
[00106] As shown in FIGURES 59A and 59B, the overall body of the needle
protection cap 460 is preferably is at least as high and/or at least as wide
as the
dimensions of at least the folded lateral members and/or the needle, such that
the
needle protection cap 460 bears forces (e.g., forces lateral to the axis of
the needle) that
would otherwise be inflicted on features of the integrated vascular delivery
device, such
61
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
as the folded lateral members. In one aspect, the overall body of the needle
protection
cap is preferably as high as or higher than the height of the folded lateral
members, such
that the needle protection cap bears overhead forces that would otherwise be
inflicted
on the folded lateral members. In another aspect, the overall body, and the
lumen 462,
of the needle protection cap may be as long as or longer than the length of
the exposed
needle extending beyond the housing. In another aspect, as shown in FIGURE
6oA, at
least one point, the overall body of the needle protection cap may be as wide
or wider
than the widest width of the folded lateral members. Furthermore, as shown in
FIGURE
6oB, in an alternative variation the needle protection cap may further cover
some or all
of the folded lateral members and/or catheter hub for greater protection. The
needle
protection cap may further include side walls to bear other forces lateral to
the axis of
the needle.
[00107] The overall body of the needle protection cap 460 may be made of
rigid or
semi-rigid plastic, and/or cushioning elastomer such as silicone, although
soft plastics
or any suitable material may additionally and/or alternatively be used. The
needle
protection cap may be made of a single unitary piece, or may include multiple
coupled
pieces.
[00108] The lumen 462 of the needle protection cap functions to receive
and cover
a needle tip, such as the distal end of a needle of a safety needle system
that is coupled to
an integrated vascular delivery system. In one variation, the lumen is a
through hole
that extends from one end of the cap to an opposite end of the cap. In another
variation,
the lumen is a cavity that is closed on a distal end. In both variations, the
lumen is
62
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
preferably longer than the length of the exposed needle, such that the distal
end of the
needle is contained within the lumen. Furthermore, the lumen may include a
sterilizing
gel or other material that sterilizes and/or further protects against
contamination of the
needle tip prior to insertion in a patient. The lumen may further include
"grips" or other
internal texture to help secure the needle protection cap over the needle.
[00109] The recess 464 that is configured to receive the catheter hub 120
functions
to secure the needle protection cap to the frame. In a preferred embodiment,
the recess
receives the catheter hub and couples the needle protection cap to the
integrated
vascular delivery device with a press fit. In an alternative embodiment, the
needle
protection cap may additionally and/or alternatively include snaps, latches,
catches, or
any suitable coupling mechanisms to secure the needle protection cap to the
integrated
vascular delivery device. However, the needle protection cap may additionally
and/or
alternatively couple to any one or more suitable portions of the frame and/or
safety
needle system, such as the stabilization hub or the flexible lateral members
of the
integrated vascular delivery device, or a sheath, or needle housing of the
safety needle
system.
4. Method for stabilizing a catheter
[00110] In a preferred embodiment, as shown in FIGURES 61-69, a method 600
for stabilizing a catheter around a catheter insertion site on a patient
includes: providing
a frame S6io including a catheter hub, a catheter coupled to the catheter hub,
and
stabilization hub; providing a safety needle system S612 including a housing
with a
63
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
needle mount, a needle coupled to the needle mount, and a sheath
telescopically
engaged with the housing, wherein the sheath operates in a retracted position
that
exposes a distal end of the needle and an extended position that covers the
distal end of
the needle; folding the catheter hub and stabilization hub towards one another
S620,
thereby folding the frame into a folded configuration; coupling the sheath in
the
retracted position to the catheter hub or other portion of the frame S630;
inserting the
catheter S640 into the patient at an insertion site; pulling the housing away
from the
catheter hub S650, thereby drawing the sheath into the extended position S652;
decoupling the extended sheath from the catheter hub S66o and locking the
sheath in
the extended position S662; unfolding the frame S670 such that the frame
surrounds
the insertion site in an unfolded configuration; and securing the frame to the
patient at a
plurality of anchoring points S68o distributed around the insertion site,
thereby
stabilizing the catheter relative to the insertion site.
[00111] The step of folding the catheter hub and stabilization hub towards
one
another S62o functions to expose the end of the catheter, which may help
provide visual
and/or physical clearance for the catheter to be positioned at an insertion
site. As shown
in FIGURE 62, folding the catheter hub and stabilization hub towards one
another
thereby folds the frame into a folded configuration. The folding step S62o may
include
passing the stabilization hub towards a relatively stationary catheter hub,
passing the
catheter hub towards a relatively stationary stabilization hub, or
simultaneously passing
both the catheter and stabilization hubs towards each other. In one
embodiment, the
frame may be folded by the user such as a medical practitioner. In one example
of the
64
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
folding step S620, the stabilization hub is positioned to be a proximal
portion of the
frame (relative to the patient) and the catheter hub is positioned to be a
distal portion of
the frame. Relative to an insertion site on the forearm of a patient, the
stabilization hub
is closer to the elbow and the catheter hub is closer to the hand. In this
example, the
folding step S620 folds the stabilization hub away from the patient towards
the catheter
hub. In another embodiment, the frame may be folded and/or the needle may be
inserted into the catheter prior to use such as during manufacturing (e.g.
during
assembly or packaging). For example, the frame may be shipped and provided to
the
user in folded configuration, with the sheath in the retracted position and
the needle
covered with a needle protection cap that couples to the frame, needle,
sheath, housing.
The needle cap may further assist in the folding step. In alternative
embodiments, the
catheter hub and stabilization hub may be moved in any suitable relative
motion, such
as sliding or twisting relative to each other.
[00112] Folding the catheter hub and stabilization hub S620 may further
include
coupling the catheter hub and the stabilization hub. The catheter hub and
stabilization
hub may be directly coupled to one another, or may be indirectly coupled by
mutual
connection to a third element such as a portion of the safety needle system,
the needle
protection cap, or other piece. For instance, in one embodiment, the method
may
include coupling the sheath and/or housing to the stabilization hub, such that
in
combination with coupling the sheath to the catheter hub, the catheter hub and
stabilization hub are indirectly coupled to one another.
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[00113] Coupling the sheath to the catheter hub S630 may include
mechanically
coupling the sheath to the catheter hub. In one variation, as shown in FIGURE
63A,
mechanically coupling the sheath to the catheter hub includes seating a
portion of the
medical device within the distal portion of the sheath, such as surrounding or
gripping a
portion of the medical device with flexible jaws or receiving a feature of the
catheter hub
in a receptacle of the sheath. In another variation, mechanically coupling the
sheath to
the medical device includes seating the distal end of the sheath in a
receptacle of the
medical device S526. In other variations, mechanically coupling the sheath to
the
medical device includes manipulating snaps, latches, tabs and Mots, magnets,
or any
suitable fastener. Alternatively, as shown in FIGURE 63B, coupling the sheath
to the
portion of the medical device includes manually coupling a distal portion of
the sheath
to the medical device S632, which may include manually pressing a holding tab
(or
other finger rest, extension, or other portion of the sheath) of the sheath
over the
medical device. In other variations manually coupling the sheath to the
medical device
may include any suitable manual coupling step.
[00114] Inserting the catheter into the patient S640 preferably includes
any
suitable steps for particular applications, such as removing a needle
protection cap
(before or after the folding step), threading the catheter over the needle
into a blood
vessel, of drawing blood through the needle. These steps are common and are
familiar to
one skilled in the art, although any suitable insertion step may be used. As
shown in
FIGURE 64, the step of inserting the needle into the patient may further
include
inserting the needle through a portion of the medical device, such as the
catheter hub.
66
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
[001 15] As shown in FIGURE 65, pulling the housing away from the catheter
hub
S650 initiates allowing the sheath to slide in a distal direction towards the
extended
position. Pulling the housing away from the catheter hub includes maintaining
the
coupling between the sheath and catheter hub, although in a preferred
embodiment, the
coupling between the sheath and the medical device may be weakened after the
sheath
is in the extended mode, thereby lowering the required amount of force to
separate or
decouple the sheath and the medical device. Allowing the sheath to slide in a
distal
direction towards the extended position includes drawing the sheath into the
extended
position. In one embodiment, allowing the sheath to slide in a distal
direction includes
drawing a sheath septum over the needle S652, which allows the sheath to
contain fluid
leakage from the needle. When the sheath is in the extended position, the
septum
preferably encloses the distal tip of the needle and the notch (if present).
Steps S65o and
S652 are preferably performed approximately simultaneously, but may
alternatively be
performed separately and sequentially.
[00116] As shown in FIGURES 66A and 66B, uncoupling the distal portion of
the
sheath from the hub S66o includes reversing the mechanical or manual coupling
step
performed when coupling the distal portion of the sheath to the catheter hub.
Uncoupling may include unseating the catheter hub from within the sheath,
unseating
the sheath from the catheter hub, releasing a manual holding force coupling
the catheter
hub and sheath, or any suitable step. In some embodiments, the interaction of
the
sheath, slider, and housing triggers automatic decoupling of the sheath from
the
67
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
catheter hub. Following the uncoupling step, the needle is contained within
the
extended sheath and the safety needle system is fully disengaged from the
catheter hub.
[00117] Locking the sheath in the extended position S662 may be one of
more of
several variations. In one variation, such as with the safety needle system of
the first
embodiment as shown in FIGURES 67A-67C, locking the sheath S662 includes
longitudinally wedging a slider between the extended sheath and the housing
S664.
Wedging the slider S664 preferably includes coupling a proximal end of the
slider to the
housing S666 and coupling a distal end of the slider to the sheath S668,
thereby
preventing relative longitudinal movement between the sheath and the housing.
In
another variation locking the sheath includes allowing a locking mechanism to
abut a
proximal portion of the sheath against a stop. In a third variation, locking
the sheath
includes allowing the sheath and needle to engage with a catch. The catch may
be
coupled to the sheath and engage with the needle (e.g., a spring clip within
the septum
or other portion of the sheath), and/or the catch may be coupled to the needle
and
engage with the sheath (e.g. a compressible ring around an external surface of
the
needle). However, locking the sheath in the extended position may include any
suitable
step.
[00118] Unfolding the frame S67o functions to orient the frame around the
insertion site in an unfolded configuration. As shown in FIGURE 68, unfolding
the
frame S67o preferably reverses the movement performed on the catheter hub and
stabilization hub in the step of folding the frame, but may additionally
and/or
alternatively include other suitable steps such as moving the catheter hub and
68
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
stabilization hub in another direction, twisting a portion of the frame, or
sliding a
portion of the frame.
[00119] Securing the frame to the patient S68o at a plurality of anchoring
points
distributed around the insertion site functions to stabilize the frame, and
thereby the
catheter, relative to the insertion site. Securing the frame includes securing
the catheter
hub at a first anchoring point and securing the stabilization hub at a second
anchoring
point. As shown in FIGURE 69, the first and second anchoring points are
distributed
around the insertion site, preferably on substantially opposite sides of the
insertion site.
More preferably, as shown in FIGURE 70, one of the anchoring points is
proximal to the
insertion site and another anchoring point is distal to the insertion site.
However, the
first and second anchoring points may be distributed around the insertion site
in any
suitable manner. In one variation, securing the frame may further include
securing the
frame at a third anchoring point, such that the first, second and third
anchoring points
are distributed around the insertion site. The frame may also be secured to
the patient at
four or more anchoring points. The multiple anchoring points may be
approximately
equally or unequally distributed around the insertion site. The securing steps
may
include taping the frame to the patient (e.g. with medical tape or sterile
adhesive
dressing), adhering the frame to the patient with adhesive, strapping the
frame to the
patient, or any suitable securing mechanism.
[00120] As shown in FIGURE 69, the method may further include the step of
applying a dressing over the insertion site and the frame S69o. The step of
applying a
dressing functions to protect the insertion site against bacteria, viruses,
and other
69
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
pathogens. The dressing is preferably a breathable, sterile dressing. The
dressing is
preferably transparent to allow visualization of the insertion site, and
includes adhesive
to attach to the skin of the patient and to provide securement of the frame.
The dressing
can be used after the frame has been secured to the patient, or the dressing
can be used
to secure the frame to the patient. However, the dressing can include any
suitable device
or method to assist in the protection of the insertion site.
[00121] In another embodiment, the method may further include applying a
septum plug, preferably to a proximal portion (e.g. needle-receiving channel)
of the
catheter hub, which functions to help prevent escape or leakage of fluids from
the
catheter after the catheter insertion. The septum plug may be applied in one
or more
several manners depending on the nature of the plug, and applying a septum
plug may
include sliding a septum plug over the catheter hub (e.g. septum is a sliding
gate),
stopping a channel in the catheter hub (e.g. septum is a stopper), or any
suitable steps.
[00122] In another embodiment, the method may further include engaging at
least
a distal portion of the needle with a needle shield coupled to the catheter
hub and/or
stabilization hub. The needle shield preferably functions to cover the distal
end of the
needle and may a spring clip, cap, or any suitable mechanism. The needle
shield may be
inside or outside the catheter hub, inside or outside the stabilization hub,
or coupled to
any suitable part of the frame. In this variation, inserting the catheter may
further
include decoupling the needle shield from the catheter hub and/or
stabilization hub
before, simultaneously with, or after, withdrawing the needle from the
catheter hub. The
action of the needle insertion and/or needle withdrawal may trigger the
decoupling of
CA 02798020 2012-10-30
WO 2011/146764 PCT/US2011/037230
the needle shield from the catheter hub and/or stabilization hub. In this
manner, the
needle may be fully withdrawn from the catheter hub while still being engaged
and/or
covered with the needle shield.
[00123] As a person skilled in the art will recognize from the previous
detailed
description and from the figures and claims, modifications and changes can be
made to
the preferred embodiments of the invention without departing from the scope of
this
invention defined in the following claims.
71
