U.S. patent application number 17/233270 was filed with the patent office on 2021-07-29 for systems and methods for automatic termination of flow due to needle dislodgement.
This patent application is currently assigned to Hemotek Medical Incorporated. The applicant listed for this patent is Hemotek Medical Incorporated. Invention is credited to Patrick Rousche, Richard A. Scribner, Peter Tek, Charles Ventura.
Application Number | 20210228802 17/233270 |
Document ID | / |
Family ID | 1000005523237 |
Filed Date | 2021-07-29 |
United States Patent
Application |
20210228802 |
Kind Code |
A1 |
Rousche; Patrick ; et
al. |
July 29, 2021 |
SYSTEMS AND METHODS FOR AUTOMATIC TERMINATION OF FLOW DUE TO NEEDLE
DISLODGEMENT
Abstract
Systems and methods for automatic flow termination for fluid
delivery, including a housing configured for coupling a fluid
delivery tube to a needle configured for subcutaneous delivery of
fluid within a tissue of a patient and a spring-loaded activation
mechanism having a first orientation corresponding to a condition
where the housing is disposed substantially adjacent to the tissue
and the needle lodged within the tissue and a second orientation
corresponding to a condition where the housing is disposed away
from the tissue or the needle being dislodged from the tissue. A
flow termination mechanism is coupled to the activation mechanism
and having an open configuration allowing flow from the fluid
delivery tube to the needle when the activation mechanism is in the
first orientation and a closed configuration substantially
terminating flow from the fluid delivery tube to the needle when
the activation mechanism is in the second orientation.
Inventors: |
Rousche; Patrick;
(Healdsburg, CA) ; Tek; Peter; (Orland Park,
IL) ; Ventura; Charles; (Cary, IL) ; Scribner;
Richard A.; (Shingle Springs, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hemotek Medical Incorporated |
Healdsburg |
CA |
US |
|
|
Assignee: |
Hemotek Medical
Incorporated
Healdsburg
CA
|
Family ID: |
1000005523237 |
Appl. No.: |
17/233270 |
Filed: |
April 16, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16244445 |
Jan 10, 2019 |
10994075 |
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17233270 |
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15286274 |
Oct 5, 2016 |
10213548 |
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16244445 |
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PCT/US2014/072573 |
Dec 29, 2014 |
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15286274 |
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61978671 |
Apr 11, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2005/1586 20130101;
A61M 5/16813 20130101; A61M 5/158 20130101; A61M 39/281 20130101;
A61M 2005/1588 20130101; A61M 2205/276 20130101 |
International
Class: |
A61M 5/168 20060101
A61M005/168; A61M 5/158 20060101 A61M005/158; A61M 39/28 20060101
A61M039/28 |
Claims
1. A system, device, and/or method disclosed herein.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 16/244,445 filed Jan. 10, 2019, which is a divisional of U.S.
application Ser. No. 15/286,274 filed Oct. 5, 2016 (now U.S. Pat.
No. 10,213,548), which is a continuation-in-part of International
Application No. PCT/US2014/072573 filed Dec. 29, 2014, which claims
priority to, and the benefit of, U.S. Provisional Application No.
61/978,671 filed Apr. 11, 2014, each of which is herein
incorporated by reference in its entirety for all purposes.
BACKGROUND
1. Technical Field
[0002] This disclosure pertains generally to vascular connections,
and more particularly to detection and interruption of dislodged
vascular connections.
2. Background Discussion
[0003] There are a number of techniques that provide a means by
which to detect an errant flow of fluid through a vascular
connection leading fluid from the outside of the body to the inside
of the body. Common to many of these is the use of a `continuity
sensor` that looks for an interruption of energy-based signal or
some mechanical connection from the tubing to the body. Such
systems often use mechanical connectors, a small electrical
current, a capacitance, a magnet or even ultrasound as a means of
monitoring the fidelity of the connection between the body and the
fluid passing element. Others use techniques designed to look for
`wetness` on the theory that a dislodged needle will leak fluid and
fluid detection can be used as a surrogate marker for needle
dislodgement.
BRIEF SUMMARY
[0004] An aspect of the present disclosure is a needle safety
system or add-on to existing needles/tubing that uses a contact
sensing mechanism on the patient's skin to determine when a given
needle/tubing set that has been inserted into a patient has
potentially become dislodged from that patient. This can occur when
the tape holding a vascular access needle in place fails or the
line is pulled out etc.
[0005] The system of the present disclosure offers important
protection through the use of a fluid stop valve within the device
that automatically deploys to stop the flow of fluid through a
needle/tube when and only when, the needle delivering that fluid
into the body is accidentally dislodged from the patient during
fluid delivery. In hemodialysis that fluid is blood. In other
cases, that fluid may be saline or medications. Vascular access is
routinely performed in hospitals, clinics and other medical
locations as well as the home (during home hemodialysis for
example).
[0006] Another aspect is a device with a pinch valve configured in
such a way that the valve is only activated by a mechanical linkage
to a mechanical `skinsensing` element in a needle system that has
been pre-manufactured to include a compressible segment of
tubing.
[0007] Another aspect is a system for sensing skin contact using a
buttonlike sensor that comes straight out of the bottom of a needle
body and halting flow using a blockage technique that involves
rotating or sliding an opening from close to open within the needle
valve.
[0008] The device of the current disclosure uses no external power,
thus requires no batteries or cables, improving its ability to be
adopted in medical workspaces that are complex and require
simplified solutions. The device of the current disclosure is
completely sterilizable and can be completely disposable. It can be
manufactured relatively inexpensively using high-volume injection
molding processes. It does not require extensive clinical
training.
[0009] Further aspects of the technology will be brought out in the
following portions of the specification, wherein the detailed
description is for the purpose of fully disclosing embodiments of
the technology without placing limitations thereon
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0010] The technology described herein will be more fully
understood by reference to the following drawings which are for
illustrative purposes only:
[0011] FIG. 1A is a perspective view of a sensing mechanism
employing a spring arm and pinching mechanism in accordance with
the present disclosure.
[0012] FIG. 1B is a perspective view of the sensing mechanism of
FIG. 1A in a released orientation.
[0013] FIG. 1A' is a perspective view of a sensing mechanism
employing a spring arm and pinching mechanism in accordance with
the present disclosure.
[0014] FIG. 1B' is a perspective view of the sensing mechanism of
FIG. 1A' in a released orientation.
[0015] FIG. 2A is a cross-sectional view of the sensing mechanism
of FIG. 1A.
[0016] FIG. 2B is a cross-sectional view of the sensing mechanism
of FIG. 1A in a released orientation.
[0017] FIG. 3A is a perspective view of the sensing mechanism of
FIG. 1A with the top cover removed.
[0018] FIG. 3B is a perspective view of an alternative sensing
mechanism of FIG. 1 A with integrated tube and housing.
[0019] FIG. 4 is an exploded perspective view of the sensing
mechanism of FIG. 1A.
[0020] FIG. 5A shows a perspective view of a rotary-valve sensing
mechanism in accordance with the present disclosure.
[0021] FIG. 5B shows a cutout side view of the rotary-valve sensing
mechanism of FIG. 5A in an open configuration.
[0022] FIG. 5C shows a cutout side view of the rotary-valve sensing
mechanism of FIG. 5A in a closed configuration.
[0023] FIG. 6A through FIG. 6C show sectional side views of a
slider valve-based sensing system in accordance with the present
disclosure.
[0024] FIG. 7A shows an exploded perspective view of a preferred
embodiment incorporating a rotary valve mechanism in accordance
with the present disclosure.
[0025] FIG. 7B is a side view of the rotary valve mechanism of FIG.
7A in a closed configuration.
[0026] FIG. 7C is a side view of the sealing mechanism of FIG.
7A.
DETAILED DESCRIPTION
[0027] The sensing systems/mechanisms of the present disclosure are
configured to detect separation of a vascular access needle or the
associated fluid delivery tubing from the patient's skin, and act
to terminate or restrict flow of the delivery fluid to the needle
upon a detection or sensing of a needle
separation/dislodgement.
[0028] For purposes of this disclosure, the term "sensing,"
particularly with respect to sensing needle dislodgement, shall be
defined as a mechanical response or reaction to a needle, or device
of the present disclosure in association with a needle, being
dislodged or separated from the tissue of a patient.
[0029] In normal and successful vascular access, the needle
delivering fluid into the body is taped to rest flat on the skin
surface just behind the access point. Generally, any needle or
associated tubing that is not making immediate flat contact with
the skin is in danger of being dislodged.
[0030] Because the dislodged needle is not in the body, this fluid
may not be reaching its intended destination. If this fluid is
blood, this is a highly dangerous condition and should be treated
immediately by stopping the fluid flow and re-inserting or
replacing the needle.
[0031] The systems of the present disclosure use a skin contact
sensor to detect when a vascular access needle is no longer in
contact with the skin. In some embodiments, activation of the
contact sensor also causes a secondary motion that delivers a
compression lever directly onto the soft section of tubing within
the flow path in the needle body for automatic
restriction/reduction of the fluid flow. With the sensing
mechanisms of the present disclosure, the device or add-on device
can both detect and immediately stop errant fluid flow due to
dislodged access needles.
[0032] FIG. 1 A through FIG. 4 show an embodiment of a sensing
mechanism/system 10 employing a spring arm and pinching mechanism
in accordance with the present disclosure. Standard needle sets may
incorporate sensing mechanism 10 to provide vascular access for
blood or saline/medication delivery, and can be manufactured to
look and feel almost like existing needle sets yet still
incorporate the skin contact sensing mechanism 10 within the needle
20 and tubing 16 set. This sensing mechanism 10 comprises an
activation mechanism 25 in the form of a contact member or
projecting spring-arm 18 or that is located toward the bottom of
housing 12. The spring-arm 18 size can be adjusted before
manufacture to create a device that can precisely determine an
exact height for which the needle body 20 has lifted off the
surface 50 of the skin during needle dislodgement. For purposes of
this disclosure, the term "dislodgement" shall mean a condition
where the needle tip has exited the skin, or the housing has lifted
off a certain distance from the skin.
[0033] The spring-arm 18 is spring-loaded (e.g. with torsion spring
28 shown in FIG. 3A and FIG. 4), and only remains in close
apposition to the bottom of the needle body 20 if the tape 52 used
to secure the needle 20 it can hold the needle 20 flat down against
the skin 50 (see FIG. 1A). The tape 52 can secure the housing 12
and flaps 14, holding the housing 12 and flaps 14 against the skin
50 and/or spring arm 18 (see FIG. 1A'). Housing 12 may also include
a cover 32h, needle guide 44, tubing port 42, and flaps 14.
[0034] Referring to the dislodged/released orientation shown in
FIG. 1 B, when the needle 20 lifts from the body 50, as occurs
during most needle dislodgements, the spring-arm 18 swings
open.
[0035] As seen in the sectional views of FIG. 2A and FIG. 2B, the
spring-arm 18 is coupled mechanically within the interior of
housing 12 to a flow termination mechanism comprising a compression
lever 24 that forms a pinch valve with tube 40 to stop or
significantly limit fluid flow via mechanical disruption of the
flow path, e.g. compression or pinching of a soft section 40 of
tubing within the needle 20 and flow path. A torsion spring 28
translates movement of the spring-arm 18 into movement of the
compression lever 18 via hinge 46 and pins 26 that are disposed in
the housing 12 (see FIG. 4).
[0036] The embodiment shown in FIG. 3A and FIG. 4 shows
compressible tube 40 as a separate structure that is installed into
the housing 12. However, it is contemplated that the housing 12 and
tube 40 may be formed from one integral, contiguous piece, by
forming a tube 40 from the housing 12 using a thin-wall tube 40,
thus making it compliant. Ideally, the compression lever 24 would
be disposed underneath tube 40 and rotate upward to form a pinch
valve, as shown in FIG. 3B. A two-stage molding process using soft
materials for integrated tube section 40 may also be used.
[0037] When tape 52 holds the needle down in the lodged
configuration of FIG. 1A and FIG. 2A, the spring arm 18 is pushed
closed against the housing 12, thus keeping the compression lever
24 off of tubing 40. For purposes of clarity, the tape 52 is shown
disposed over needle 20 in FIG. 1 A. However, it is appreciated
that tape 52 will often be disclosed over the housing 12 and tabs
14.
[0038] When the tape 52 falls off, and the needle tip 22 is
dislodged (configuration of FIG. 1B and FIG. 2B), the needle 20
lifts up, allowing the swing arm 18 to open under the pressure of
the torsion spring 28, thus forcing the compression lever 24
downward, pinching tubing 40 and stopping flow to the needle
20.
[0039] When tape 52 holds the housing 12 down in the lodged
configuration of FIG. 1A' and FIG. 2A', the spring arm 18 is pushed
closed against the housing 12, thus keeping the compression lever
24 off of tubing 40. For purposes of clarity, the tape 52 is shown
disposed over housing 12 in FIG. 1A'.
[0040] When the tape 52 falls off or is removed from the housing 12
and tabs 14 (or the needle tip 22, as shown in FIGS. 1A and 1B),
and the needle tip 22 is dislodged (configuration of FIG. 1B' and
FIG. 2B), the housing 12 lifts up, allowing the swing arm 18 to
open under the pressure of the torsion spring 28, thus forcing the
compression lever 24 downward, pinching tubing 40 and stopping flow
to the needle 20.
[0041] The integrated design of the compression lever 24 and the
spring-arm 18 work synergistically in both detecting problematic
dislodgement and immediately solving it. Importantly, system 10 is
configured to continuously occlude the tubing at all times during
dislodgement. This stops flow and importantly, raises back pressure
high enough that a machine pumping the alarm will be triggered to
automatically stop pumping.
[0042] FIG. 5A through FIG. 5C show an embodiment incorporating a
rotary-valve sensing mechanism/system 150, which includes a housing
152 for receiving tube 16 and needle 20. Housing 152 further
includes a central channel 156 in communication with needle 20 and
tube 16 for allowing delivery of fluid there between. An aperture
154 runs through channel 156 in approximately an orthogonal
orientation, with the aperture 154 configured to receive rod 168 to
form a rotary valve, that is coupled to ratchet wheel 164. Rod 168
comprises a through hole 162 that has a diameter approximately the
size of channel 156, and is located on rod 168 to line up with
channel 156 when in an open configuration, as shown in the side
view of FIG. 5B. A sealing mechanism, such as o-ring 312 shown in
FIG. 7C, may also be disposed on rod 168 to seal the rotary valve
aperture 154.
[0043] One end of rod 168 comprises a ratchet wheel 164, which
along with contact member/button 170 form an activation mechanism
to open and close the rotary valve rod 168. Contact member 170
comprises a compliant, dome-shaped diaphragm that contacts the
patient's skin and acts as a return spring that is loaded when
pressing inward on the patient. The spring-loaded actuation
mechanism of button 170 is further detailed with reference to
button 210 shown in FIG. 6A through 6C, which operates in a
similar, if not identical, manner. Button 170 comprises an elongate
catch 172 that emanates from the bottom of the inside wall of the
button. Catch 172 has a hooked distal end 174 that is configured to
interface with teeth 166 of ratchet wheel 164 of rod 168 to form a
rotary valve-based flow termination mechanism.
[0044] When in the compressed state, the catch 162 of button 170 is
in an extended linear position toward housing 152 and above ratchet
wheel 164. This forms the open state of the rotary valve as seen in
the cut-out side view of FIG. 5B (ratchet wheel 164 and button 170
removed for clarity), with through hole 162 lined up to be
substantially concentric with the central channel 156 of the
housing. Fluid flow is thus allowed between the tube 16 and the
needle 22.
[0045] When needle 20 is dislodged from the patient's skin, button
170 expands downward from the housing body 152 to its biased,
uncompressed state, which causes the catch 172 to move downward
such that distal end 174 catches teeth 166 of ratchet wheel 174 to
rotate rod 162 (e.g. 90) within aperture 154. This results in the
through hole 162 no longer being in alignment with central channel
156, thus terminating or restricting flow through channel 156 from
tube 16 to needle 20 as seen in the cut-out side view of FIG. 5C
(ratchet wheel 164 and button 170 removed for clarity). To reset
the flow to open upon re-insertion of the needle 20 and compression
of the button 170, the ratchet wheel 164 may simply be rotated e.g.
90.degree. clockwise to the original position, such that indicia
167 lines up in the proper position. The rotary valve mechanism 150
thus converts the linear motion of button 170 to a rotational
motion.
[0046] FIG. 6A through FIG. 6C show sectional side views of a
slider valve, or shuttle valve-based sensing system 200 in
accordance with the present disclosure. FIG. 6A shows the system
200 in an open configuration, allowing fluid flow between needle 20
and tube 16. Housing 216 includes a central channel 208 in
communication with needle 20 and tube 16. An aperture 214 runs
through channel 208 in approximately an orthogonal orientation,
with the aperture 214 configured to receive slider pin 202. Slider
pin 202 comprises a through hole 206 that has a diameter
approximately the size of channel 208, and is located to line up
with channel 208 in the open configuration of FIG. 6A. In this
configuration, contact member or button 210, which is coupled to
one end of the slider pin 202, is compressed against the patient's
skin 212. Button 210 comprises a compliant, dome-shaped wall that
acts as a return spring that is loaded when pressing inward on the
patient. Slider pin 202 may be molded with button 210 as one
contiguous piece of material (e.g. silicone), or may be attached to
the button 210 via adhesive or other attachment means.
[0047] As seen in FIG. 6B, which shows the system 200 in a closed
configuration, and FIG. 6C, which shows the system 200 in an open
(dashed line) configuration, the slider pin 202 is configured to
reciprocate within aperture 214 of the housing 216. When needle 20
is dislodged from the patient's skin 212, button 210 expands, which
causes the slider pin 202 to retract out of aperture 214. This
results in the through-hole 206 no longer being in alignment with
central channel 208, thus terminating or restricting flow through
channel 208 from tube 16 to needle 20 to form a shuttle valve/flow
termination mechanism.
[0048] FIG. 7A shows an exploded perspective view of a preferred
embodiment incorporating a rotary valve-sensing mechanism/system
300, which includes a housing 304 for receiving tube 16 and needle
20. Housing 304 further includes tabs 316 and a central channel 308
(FIG. 7B) in communication with needle 20 and tube 16 for allowing
delivery of fluid there between. An aperture 314 runs through
channel 308 in approximately an orthogonal orientation, with the
aperture 314 configured to receive rod 302 that is coupled to
spring-arm/lever 310. Rod 302 comprises a through hole 306 that has
a diameter approximately the size of channel 308, and is located on
rod 302 to line up with channel 308 when in an open configuration,
i.e. rod 302 and spring-arm 310.
[0049] As seen in FIG. 7B, which shows the contact member or
spring-arm 310 of system 300 in a closed configuration (dashed line
open away from housing 304) and open configuration (solid line
against the housing 304), the rod 302 is configured to rotate
within aperture 314 of the housing 304. When needle 20 is dislodged
from the patient's skin, lever 310 retracts outward from the
housing body (e.g. from a biasing member (not shown) such as a
torsion spring or the like), which causes the rod 302 to rotate
within aperture 214. The activation mechanism of spring-arm 310
thus results in the through hole 306 no longer being in alignment
with central channel 308, thus terminating or restricting flow
through channel 308 from tube 16 to needle 20, i.e. forming a flow
termination mechanism.
[0050] As shown in FIG. 7C, the rod 302 may comprise a pair of
o-rings 312 that are disposed on the rod 302 at the periphery of
the openings of aperture 304 to seal aperture 304 from possible
leakage of fluids within the central channel 308.
[0051] From the description herein, it will be appreciated that
that the present disclosure encompasses multiple embodiments which
include, but are not limited to, the following:
[0052] 1. An apparatus for automatic termination of flow for fluid
delivery, the apparatus comprising: a housing configured for
coupling a fluid delivery tube to a needle configured for
subcutaneous delivery of fluid within a tissue of a patient; a
spring-loaded activation mechanism coupled to the housing; wherein
the activation mechanism comprises a first orientation
corresponding to a condition where the housing is disposed
substantially adjacent to the tissue and the needle lodged within
the tissue; wherein the activation mechanism comprises a second
orientation corresponding to a condition where the housing is
disposed away from the tissue or the needle is dislodged from the
tissue; a flow termination mechanism coupled to the activation
mechanism; wherein the flow termination mechanism comprises an open
configuration allowing flow from the fluid delivery tube to the
needle when the activation mechanism is in the first orientation;
and wherein the flow termination mechanism comprises a closed
configuration substantially terminating flow from the fluid
delivery tube to the needle when the activation mechanism is in the
second orientation.
[0053] 2. The apparatus of any preceding embodiment: wherein the
activation mechanism comprises a contact member configured to be
disposed adjacent the patient's skin when the activation mechanism
is in the first orientation; and wherein the contact member
articulates with respect to the housing to the second
orientation.
[0054] 3. The apparatus of any preceding embodiment: wherein the
flow termination mechanism comprises a pinch valve that
substantially terminates flow from the fluid delivery tube to the
needle when the activation mechanism is in the second
orientation.
[0055] 4. The apparatus of any preceding embodiment: wherein the
contact member and flow termination mechanism comprise a spring-arm
and compression lever to form a pinch valve; wherein the spring-arm
is disposed adjacent the housing when positioned in the first
orientation; wherein the spring-arm articulates away from the
housing in the second orientation; and wherein the compression
lever articulates in response to articulation of the swing arm in
the second orientation to pinch-off flow from the fluid delivery
tube to the needle when the activation mechanism is in the second
orientation.
[0056] 5. The apparatus of any preceding embodiment: wherein the
housing comprises a compliant tube coupling the fluid delivery tube
to the needle; and wherein the compression lever articulates
against the compliant tube in the second orientation to terminate
flow from the fluid delivery tube to the needle.
[0057] 6. The apparatus of any preceding embodiment: wherein the
contact member comprises a dome-shaped button that is biased in an
expanded configuration corresponding to the second orientation; and
wherein the button is loaded in a compressed configuration adjacent
the patient's skin in the first orientation.
[0058] 7. The apparatus of any preceding embodiment: wherein the
flow termination mechanism comprises a shuttle valve coupled to the
contact member; and wherein the contact member affects translation
of the shuttle valve from within the housing from the first
orientation to the second orientation.
[0059] 8. The apparatus of any preceding embodiment: wherein the
contact member comprises a dome-shaped button that is biased in an
expanded configuration corresponding to the second orientation; and
wherein the button is loaded in a compressed configuration adjacent
the patient's skin in the first orientation.
[0060] 9. The apparatus of any preceding embodiment: wherein the
flow termination mechanism comprises a rotary valve coupled the
contact member; and wherein the contact member affects rotation of
the rotary valve from within the housing from the first orientation
to the second orientation.
[0061] 10. The apparatus of any preceding embodiment: wherein the
contact member and rotary valve comprise a lever and a rod, the rod
being disposed in an aperture within the housing; the housing
comprising a central channel allowing fluid flow from the fluid
delivery tube to the needle; wherein the rod comprises a
through-hole that is in alignment with the central channel when in
the first orientation; wherein the spring-arm is disposed adjacent
the housing when positioned in the first orientation and
articulates away from the housing in the second orientation; and
wherein the rod rotates in response to articulation of the swing
arm in the second orientation to rotate the through-hole out of
alignment with the central channel to inhibit fluid flow from the
fluid delivery tube to the needle when the activation mechanism is
in the second orientation.
[0062] 11. The apparatus of any preceding embodiment: wherein the
contact member and rotary valve comprise a button and a rod, the
rod being disposed in an aperture within the housing; the housing
comprising a central channel allowing fluid flow from the fluid
delivery tube to the needle; wherein the rod comprises a
through-hole that is in alignment with the central channel when in
the first orientation; wherein the button is adjacent the housing
when positioned in the first orientation and retracts away from the
housing in the second orientation; and wherein the rod rotates in
response to retraction of the button in the second orientation to
rotate the through-hole out of alignment with the central channel
to inhibit fluid flow from the fluid delivery tube to the needle
when the activation mechanism is in the second orientation.
[0063] 12. A system for automatic termination of flow for a fluid
delivery, the system comprising: a fluid delivery tube and a needle
configured for subcutaneous delivery of fluid within a tissue of a
patient; a housing configured for coupling the fluid delivery tube
to the needle; a spring-loaded activation mechanism coupled to the
housing; wherein the activation mechanism comprises a first
orientation corresponding to a condition where the housing is
disposed substantially adjacent to the tissue and the needle lodged
within the tissue; wherein the activation mechanism comprises a
second orientation corresponding to a condition where the housing
is disposed away from the tissue or the needle being dislodged from
the tissue; a flow termination mechanism coupled to the activation
mechanism; wherein the flow termination mechanism comprises an open
configuration allowing flow from the fluid delivery tube to the
needle when the activation mechanism is in the first orientation;
and wherein the flow termination mechanism comprises a closed
configuration substantially terminating flow from the fluid
delivery tube to the needle when the activation mechanism is in the
second orientation.
[0064] 13. The system of any preceding embodiment: wherein the
activation mechanism comprises a contact member configured to be
disposed adjacent the patient's skin when the activation mechanism
is in the first orientation; and wherein the contact member
articulates with respect to the housing to the second
orientation.
[0065] 14. The system of any preceding embodiment: wherein the flow
termination mechanism comprises a pinch valve that substantially
terminates flow from the fluid delivery tube to the needle when the
activation mechanism is in the second orientation.
[0066] 15. The system of any preceding embodiment: wherein the
contact member and flow termination mechanism comprise a spring-arm
and compression lever to form a pinch valve; wherein the spring-arm
is disposed adjacent the housing when positioned in the first
orientation; wherein the spring-arm articulates away from the
housing in the second orientation; and wherein the compression
lever articulates in response to articulation of the swing arm in
the second orientation to pinch-off flow from the fluid delivery
tube to the needle when the activation mechanism is in the second
orientation.
[0067] 16. The system of any preceding embodiment: wherein the
housing comprises a compliant tube coupling the fluid delivery tube
to the needle; and wherein the compression lever articulates
against the compliant tube in the second orientation to terminate
flow from the fluid delivery tube to the needle.
[0068] 17. The system of any preceding embodiment: wherein the
contact member comprises dome-shaped button that is biased in an
expanded configuration corresponding to the second orientation; and
wherein the button is loaded in a compressed configuration adjacent
the patient's skin in the first orientation.
[0069] 18. The system of any preceding embodiment: wherein the flow
termination mechanism comprises a shuttle valve coupled to the
contact member; and wherein the contact member affects translation
of the shuttle valve from within the housing from the first
orientation to the second orientation.
[0070] 19. The system of any preceding embodiment: wherein the
contact member comprises a spring-loaded, dome-shaped button that
is biased in an expanded configuration corresponding to the second
orientation; and wherein the button is loaded in a compressed
configuration adjacent the patient's skin in the first
orientation.
[0071] 20. The system of any preceding embodiment: wherein the flow
termination mechanism comprises a rotary valve coupled to the
contact member; and wherein the contact member affects rotation of
the rotary valve from within the housing from the first orientation
to the second orientation.
[0072] 21. The system of any preceding embodiment: wherein the
contact member and rotary valve comprise a lever and a rod, the rod
being disposed in an aperture within the housing; the housing
comprising a central channel allowing fluid flow from the fluid
delivery tube to the needle; wherein the rod comprises a
through-hole that is in alignment with the central channel when in
the first orientation; wherein the spring-arm is disposed adjacent
the housing when positioned in the first orientation and
articulates away from the housing in the second orientation; and
wherein the rod rotates in response to articulation of the swing
arm in the second orientation to rotate the through-hole out of
alignment with the central channel to inhibit fluid flow from the
fluid delivery tube to the needle when the activation mechanism is
in the second orientation.
[0073] 22. The system of any preceding embodiment: wherein the
contact member and rotary valve comprise a button and a rod, the
rod being disposed in an aperture within the housing; the housing
comprising a central channel allowing fluid flow from the fluid
delivery tube to the needle; wherein the rod comprises a
through-hole that is in alignment with the central channel when in
the first orientation; wherein the button is adjacent the housing
when positioned in the first orientation and retracts away from the
housing in the second orientation; and wherein the rod rotates in
response to retraction of the button in the second orientation to
rotate the through-hole out of alignment with the central channel
to inhibit fluid flow from the fluid delivery tube to the needle
when the activation mechanism is in the second orientation.
[0074] 23. A method for automatic termination of flow for fluid
delivery within a patient, the method comprising: coupling a
housing to a surface of a patient's tissue; the housing configured
for coupling a fluid delivery tube to a needle for delivery of
fluid within the tissue of a patient; preloading a spring-loaded
activation mechanism at a first orientation corresponding to a
condition where the housing is disposed adjacent to the tissue and
the needle lodged within the tissue; wherein a flow termination
mechanism coupled to the activation mechanism is disposed in an
open configuration allowing flow from the fluid delivery tube to
the needle when the activation mechanism is in the first
orientation; upon release of the housing away from the tissue or
the needle being dislodged from the tissue, advancing the
activation mechanism to a second orientation; and switching the
flow termination mechanism to a closed configuration to
substantially terminate flow from the fluid delivery tube to the
needle.
[0075] 24. The method of any preceding embodiment: wherein the flow
termination mechanism comprises a pinch valve; and wherein
switching the flow termination mechanism to a closed configuration
comprises pinching-off flow between the fluid delivery tube and the
needle.
[0076] 25. The method of any preceding embodiment: wherein the
activation mechanism comprises a contact member disposed adjacent
the housing when positioned in the first orientation; wherein the
contact member articulates away from the housing in the second
orientation; wherein the housing comprises a compliant tube
coupling the fluid delivery tube to the needle; and wherein flow
termination mechanism comprises a compression lever that
articulates against the compliant tube in the second orientation to
terminate flow from the fluid delivery tube to the needle.
[0077] 26. The method of any preceding embodiment: wherein the
activation mechanism comprises a contact member disposed adjacent
the housing when positioned in the first orientation; wherein the
contact member articulates away from the housing in the second
orientation; wherein the flow termination mechanism comprises a
rotary valve coupled to the contact member; and wherein the contact
member affects rotation of the rotary valve from within the housing
from the first orientation to the second orientation.
[0078] 27. The method of any preceding embodiment: wherein the
contact member and rotary valve comprise a lever and a rod, the rod
being disposed in an aperture within the housing; the housing
comprising a central channel allowing fluid flow from the fluid
delivery tube to the needle; wherein the rod comprises a
through-hole that is in alignment with the central channel when in
the first orientation; wherein the spring-arm is disposed adjacent
the housing when positioned in the first orientation and
articulates away from the housing in the second orientation; and
wherein the rod rotates in response to articulation of the swing
arm in the second orientation to rotate the through-hole out of
alignment with the central channel to inhibit fluid flow from the
fluid delivery tube to the needle when the activation mechanism is
in the second orientation.
[0079] Although the description herein contains many details, these
should not be construed as limiting the scope of the disclosure but
as merely providing illustrations of some of the presently
preferred embodiments. Therefore, it will be appreciated that the
scope of the disclosure fully encompasses other embodiments which
may become obvious to those skilled in the art.
[0080] In the claims, reference to an element in the singular is
not intended to mean "one and only one" unless explicitly so
stated, but rather "one or more." All structural, chemical, and
functional equivalents to the elements of the disclosed embodiments
that are known to those of ordinary skill in the art are expressly
incorporated herein by reference and are intended to be encompassed
by the present claims. Furthermore, no element, component, or
method step in the present disclosure is intended to be dedicated
to the public regardless of whether the element, component, or
method step is explicitly recited in the claims. No claim element
herein is to be construed as a "means plus function" element unless
the element is expressly recited using the phrase "means for". No
claim element herein is to be construed as a "step plus function"
element unless the element is expressly recited using the phrase
"step for".
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