U.S. patent application number 13/773586 was filed with the patent office on 2014-08-21 for bottle spike with wide-bore introducer.
This patent application is currently assigned to MEDRAD, INC.. The applicant listed for this patent is MEDRAD, INC.. Invention is credited to David A. MISHLER, Mark TROCKI.
Application Number | 20140230368 13/773586 |
Document ID | / |
Family ID | 51350104 |
Filed Date | 2014-08-21 |
United States Patent
Application |
20140230368 |
Kind Code |
A1 |
TROCKI; Mark ; et
al. |
August 21, 2014 |
BOTTLE SPIKE WITH WIDE-BORE INTRODUCER
Abstract
Systems and methods for enabling high fluid rate injections are
disclosed. The system includes a hollow dip tube, an introducer and
a sharp tip-end. The introducer has a hollow sleeve that includes
an opening at a proximal end. The sharp-tip end is located at a
distal end of the introducer and is configured to pierce a septum
of a container. The introducer is configured to receive the dip
tube through the opening. Fluid may be withdrawn from the container
through the dip tube upon insertion. In some cases, the dip tube
separates the tip-end from the introducer when it is inserted
through the opening. In other cases, the tip-end remains seated in
the introducer and allows fluid to pass through it as it is
withdrawn from the container.
Inventors: |
TROCKI; Mark; (Cheswick,
PA) ; MISHLER; David A.; (Slippery Rock, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDRAD, INC. |
Indianola |
PA |
US |
|
|
Assignee: |
MEDRAD, INC.
Indianola
PA
|
Family ID: |
51350104 |
Appl. No.: |
13/773586 |
Filed: |
February 21, 2013 |
Current U.S.
Class: |
53/381.2 |
Current CPC
Class: |
A61J 2200/10 20130101;
G01F 23/24 20130101; A61J 1/201 20150501; G01F 23/268 20130101;
A61J 1/1475 20130101; A61J 1/1406 20130101; G01F 23/0038
20130101 |
Class at
Publication: |
53/381.2 |
International
Class: |
B65B 69/00 20060101
B65B069/00 |
Claims
1. A system for enabling high fluid rate injection, the system
comprising: a hollow dip tube; an introducer having a hollow
sleeve, wherein the hollow sleeve comprises an opening at a
proximal end, wherein the introducer is configured to receive the
hollow dip tube through the opening; and a sharp tip-end located at
a distal end of the introducer, wherein the sharp tip-end is
configured to pierce a septum of a container.
2. The system of claim 1, wherein the introducer comprises a
surface configured to seal against a lip of a container surrounding
a septum pierced by the sharp tip-end.
3. The system of claim 1, wherein the introducer comprises an air
filter surrounding the opening of the hollow sleeve.
4. The system of claim 1, wherein a distal end of the hollow dip
tube is configured to receive the sharp tip-end when the introducer
receives the hollow dip tube through the opening.
5. The system of claim 1, wherein the sharp tip-end is separable
from the introducer.
6. The system of claim 5, wherein the sharp tip-end is further
configured to separate from the introducer upon receiving a distal
end of the hollow dip tube through the opening.
7. The system of claim 5, wherein the sharp tip-end comprises a
buoyant material.
8. The system of claim 5, wherein a distal end of the hollow dip
tube is configured to receive the sharp tip-end when the sharp
tip-end separates from the introducer.
9. The system of claim 1, wherein: the hollow dip tube has an outer
surface, and one or more sensors are located on the outer surface
of the hollow dip tube.
10. The system of claim 9 wherein the one or more sensors comprise
a temperature sensor.
11. The system of claim 9, wherein the one or more sensors comprise
a resistance detector having a resistive element on the outer
surface of the hollow dip tube, a current source electrically
connected to a first end of the resistive element, and a current
detector electrically connected to a second end of the resistive
element.
12. The system of claim 9, wherein the one or more sensors comprise
a first capacitor element on a first side of the outer surface and
a second capacitor element on a second side of the outer
surface.
13. A method of enabling high fluid rate injection, the method
comprising: inserting at least a portion of an introducer into a
septum of a container containing a fluid, wherein the introducer
comprises a hollow sleeve, wherein the hollow sleeve has an opening
at a proximal end, wherein a sharp tip-end is located at a distal
end of the introducer; inserting a hollow dip tube into the opening
of the hollow sleeve; and withdrawing at least a portion of the
fluid in the container through the hollow dip tube.
14. The method of claim 13, wherein the introducer further
comprises an air filter surrounding the opening of the hollow
sleeve.
15. The method of claim 13, further comprising: sensing one or more
properties of the fluid using one or more sensors located at least
in part on an outer surface of the hollow dip tube.
16. The method of claim 15, wherein: the one or more sensors
comprise a temperature sensor, and sensing one or more properties
comprises sensing a temperature of the fluid using the temperature
sensor.
17. The method of claim 15, wherein: the one or more sensors
comprise a resistance detector having a resistive element on the
outer surface of the hollow dip tube, a current source electrically
connected to a first end of the resistive element, and a current
detector electrically connected to a second end of the resistive
element, and sensing one or more properties comprises sensing a
resistance as the fluid is withdrawn from the container to
determine a fluid level in the container.
18. The method of claim 15, wherein: the one or more sensors
comprise a first capacitor element on a first side of the outer
surface and a second capacitor element on an second side of the
outer surface, and sensing one or more properties comprises sensing
a capacitance using the first and second capacitor elements to
determine a fluid level in the container.
19. The method of claim 13, wherein: the sharp tip-end is separable
from the introducer, and inserting the hollow dip tube into the
hollow sleeve of the introducer comprises inserting the hollow dip
tube through the hollow sleeve of the introducer thereby causing
the sharp tip-end to separate from the introducer.
20. The method of claim 19, wherein the sharp tip-end is buoyant,
and further comprising: determining a fluid level in the container
by identifying the location of the separated sharp tip-end in the
container.
21. The method of claim 13, wherein: the sharp tip-end is separable
from the introducer, and inserting the hollow dip tube into the
hollow sleeve of the introducer comprises inserting the hollow dip
tube through the hollow sleeve of the introducer thereby causing
the sharp tip-end to become lodged in the hollow dip tube.
Description
BACKGROUND
[0001] Typically, bulk supplies of a contrast solution and/or a
saline flush solution used in radiological procedures are provided
to an injector from a fluid bag, a bottle or some other type of
container that is hung from a pole near the injector. The fluid in
the container is accessed through a spike connected to a fluid line
that supplies the injector.
[0002] Conventional spikes and tubing tend to be narrow because
they can alternatively be used to supply fluids for intravenous
drips for patients, which typically require a low fluid flow rate.
In some cases, however, high fluid flow rates are required for
injectors. For example, radiological procedures may require
injectors that have high capacity or high fluid injection rates. As
such, standard spike and tubing sets are often too narrow to
provide sufficient fluid flow for these procedures.
SUMMARY
[0003] The invention described in this document is not limited to
the particular systems, methodologies or protocols described, as
these may vary. The terminology used herein is for the purpose of
describing particular embodiments only, and is not intended to
limit the scope of the present disclosure.
[0004] It must be noted that as used herein and in the appended
claims, the singular forms "a," "an," and "the" include plural
reference unless the context clearly dictates otherwise. Unless
defined otherwise, all technical and scientific terms used herein
have the same meanings as commonly understood by one of ordinary
skill in the art. As used herein, the term "comprising" means
"including, but not limited to."
[0005] In an embodiment, a system for enabling high fluid rate
injection may include a hollow dip tube, an introducer having a
hollow sleeve, and a sharp tip-end located at a distal end of the
introducer. The hollow sleeve comprises an opening at a proximal
end. The introducer is configured to receive the hollow dip tube
through the opening. The sharp tip-end is configured to pierce a
septum of a container.
[0006] In an embodiment, a method of enabling high fluid rate
injection may include inserting at least a portion of an introducer
into a septum of a container containing a fluid. The introducer
comprises a hollow sleeve. A sharp tip-end is located at a distal
end of the introducer. The hollow sleeve has an opening at a
proximal end. The method further includes inserting a hollow dip
tube into the opening of the hollow sleeve and withdrawing at least
a portion of the fluid in the container through the hollow dip
tube.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIGS. 1A-C depict an illustrative introducer and dip tube
according to an embodiment. The sequence of illustrations in FIGS.
1A-C also discloses an illustrative operation of inserting the
introducer into a container and the dip tube into the introducer
according to an embodiment.
[0008] FIGS. 2A-C depict illustrative introducers having differing
sharp tip-ends according to embodiments.
[0009] FIGS. 3A-C depict illustrative dip tubes according to
embodiments.
[0010] FIG. 4 depicts an illustrative system for using a combined
dip tube and introducer according to an embodiment.
[0011] FIG. 5 depicts a flow diagram of an illustrative method of
enabling high fluid rate injection according to an embodiment.
DETAILED DESCRIPTION
[0012] This disclosure discloses a spike and tubing set designed to
handle large flow and/or high capacity injection procedures. In
particular, this disclosure discloses embodiments directed to high
capacity spike and tubing sets for use with bottled contrast
solutions and/or saline solutions, a system incorporating the spike
and tubing set, and methods for their use.
[0013] FIGS. 1A-C depict an illustrative introducer and dip tube
according to an embodiment. The sequence of illustrations in FIGS.
1A-C also discloses an illustrative operation of inserting the
introducer into a container and the dip tube into the introducer
according to an embodiment. As shown in FIG. 1A, a dip tube 100 and
an introducer 110 may be used to withdraw a fluid 130 from a
container 120. The container 120 may include a septum (not shown)
forming a sterile seal for the fluid 130 within. The introducer 110
may have a sharp tip-end 140 located at a distal end.
[0014] As shown in FIG. 1B, the sharp tip-end 140 is configured to
pierce the septum so that the tip-end extends through the septum
and into the interior space of the container 120. The introducer
110 and/or the tip-end 140 may be formed so that the interior of
the container 120 remain sterile after the tip-end pierces the
septum. For example, the introducer 110 may seal the location at
which the septum is pierced to maintain sterility.
[0015] As shown in FIG. 1C, at the time of fluid delivery, the dip
tube 100 may be fed through the introducer 110 to allow the dip
tube to enter the container 120 and contact the fluid 130. In an
embodiment, the tip-end 140 of the introducer 110 may detach from
the sleeve of the introducer when the dip tube 100 is fed through
the introducer. In one embodiment, the tip-end 140 may be made of a
material that will sink to the bottom of the fluid 130 upon
detachment from the introducer 110. In an alternate embodiment, the
tip-end 140 may be made of a buoyant material that can float on the
surface of the fluid 130. In such an embodiment, a detector system
may determine the amount of fluid 130 in the container 120 by
monitoring the vertical displacement of the tip-end 140 on the
meniscus of the fluid. In an embodiment, a buoyant tip-end 140 may
be configured to be easily detectable within the container 120 in
order to assist in determining a level of the fluid 130 within the
container. For example, the buoyant tip-end 140 may be
fluorescent.
[0016] In an embodiment, the tip-end 140 may be a separate
detachable piece that is inserted into the distal end of the
introducer 110 prior to use. The tip-end 140 may be seated, for
example, by an interference fit within the introducer 110. Other
methods of fitting a separate tip-end 140 within the introducer 110
may be performed within the scope of this disclosure.
[0017] In an alternate embodiment, the tip-end 140 may be formed as
part of the introducer 110. In such an embodiment, the tip-end 140
may be configured to be separable from the remainder of the
introducer 110. For example, the introducer 110 may be scored when
manufactured to identify a location at which the tip-end 140 is to
separate from the remainder of the introducer upon the application
of a force through the introducer towards the tip-end.
[0018] In an embodiment, the tip-end 140 may be substantially or
completely solid to prevent fluid from passing therethrough. In
such an embodiment, the tip-end 140 may prevent fluid from being
withdrawn from a container 120 until the tip-end is separated from
the introducer 110.
[0019] In an embodiment, the tip-end 140 may be configured to
separate from the introducer 110, but remain lodged in the end of
the dip tube 100. In such an embodiment, the tip-end 140 may be
hollow and allow fluid to pass through to the dip tube 100. In such
an embodiment, the tip-end 140 may operate as a filter for the
fluid entering the dip tube 100 to prevent impurities or other
materials from passing through.
[0020] FIGS. 2A-C depict illustrative introducers having differing
sharp tip-ends according to embodiments. FIG. 2A depicts various
projections of a first embodiment of an introducer 210 and sharp
tip-end 250a. The introducer 210 may include an opening 211 through
which a dip tube may be placed. The introducer 210 may also include
a sleeve 216 to help guide the dip tube through the introducer. The
sleeve 216 may be fabricated so as to form an air-tight seal
against the dip tube.
[0021] The introducer 210 may have a top surface (not labeled) and
a bottom surface 214. The bottom surface 214 may be configured so
that it forms, for example, an air-tight seal against a lip of a
container.
[0022] As a fluid is withdrawn from a container, replacement air
must be supplied to equalize the pressure within the container. To
maintain fluid sterility, an air filter 212 may also be
incorporated into the introducer 210 thereby permitting sterile
filtered air to enter the container and equalize pressure during
fluid withdrawal.
[0023] Several embodiments are possible for the tip-end 250a-c. As
shown in FIG. 2A, a first embodiment for the tip-end 250a may be
hollow and may have a number of fins capable of piercing the bottle
septum. Tip end 250a may be useful in an embodiment in which the
tip-end is retained on the end of the dip tube, the fluid being
drawn through the hollow tip-end and through the dip tube. As shown
in FIG. 2B, a second embodiment for the tip-end 250b may be sealed
and separable from the introducer 210. The tip-end 250b may be
seated within the introducer via an interference fit with the
sleeve 216. The tip-end 250b may be buoyant and float on the fluid
in the container after it is separated from the introducer 210. As
shown in FIG. 2C, a third embodiment for the tip-end 250c may be
sealed and separable from the introducer 210. The tip-end 250c may
be seated within the introducer via an interference fit with the
sleeve 216. The tip-end 250c may be configured to sink to the
bottom of a container upon separation from the introducer 210.
[0024] In an embodiment, the tip-ends 250b,c may be substantially
or completely solid to prevent fluid from passing therethrough. In
such an embodiment, the tip-ends 250b,c may prevent fluid from
being withdrawn from a container until the tip-end is separated
from the introducer 210.
[0025] FIGS. 3A-C depict illustrative dip tubes according to
embodiments. As shown in FIG. 3A, the dip tube 300 may incorporate
one or more sensor components and/or one or more detector
components. For example, the dip tube 300 may incorporate one or
more temperature sensors, such as 302, along its length. Such
temperature sensors 302 may provide information to an operator
regarding the temperature of a fluid in a container in which the
dip tube is present. This may be especially useful for a container
that is undergoing a heating process because it may permit an
operator to assess temperature gradients within the fluid in the
container. In an embodiment, the one or more temperature sensors
302 may include an electronic device. In an embodiment, the one or
more temperature sensors 302 may include a strip of thermochromic
material covering at least a portion of the length of the dip tube
300. The thermochromic material may change color based on the
temperature of the fluid located in close proximity to the
material. Additional and/or alternative temperature sensors may be
used within the scope of this disclosure.
[0026] In an embodiment, one or more sensors may be used to
determine the amount or level of fluid in the container. In an
embodiment, a resistive level detector 304 may cover at least a
portion of the length of the dip tube 300. The resistive level
detector 304 may have a current source located towards one end (for
example, a distal end) of the dip tube 300 and a current detector
located towards an opposing end (for example, a proximal end) of
the dip tube. The current through the resistive element 304 may be
measured, for example, as the fluid within the container is
withdrawn. If the fluid is ionic and capable of carrying charge, a
charge through the fluid may migrate in parallel with the charge
through the resistive element 304. As such, the measured current
may be greater when the fluid level covers more of the resistive
element 304. As fluid is withdrawn from the container, the fluid
level drops, and the fluid-based charge path parallel to the
resistive element 304 decreases. This results in a decrease in
measured current flow because the current path is primarily through
the resistive element 304 alone.
[0027] In an embodiment, one or more fluid level detection sensors
306a,b may be capacitive. For example, the dip tube 300 may include
a pair of parallel capacitor elements 306a,b. The fluid between the
capacitor elements 306a,b may act as a dielectric component. As a
result, as the fluid level falls, the capacitance between the
capacitor elements 306a,b may change, and the change in capacitance
may be measured by any conventional detection method. Capacitor
elements, such as 306a,b, may be particularly useful for solutions
having non-conductive fluids.
[0028] In an embodiment, the one or more sensors may be connected
to one or more fluid monitoring device to determine how much fluid
is available in a container. The fluid monitoring device may
indicate whether the container has sufficient fluid volume for an
injection procedure, whether the container has a low volume,
whether a user should change the container to a new container or
the like. In an embodiment, the one or more sensors may be coupled
wirelessly or via a wired connection to a hospital monitoring
system. In an embodiment, the one or more sensors may identify one
or more of a temperature of the fluid, a weight of the fluid, a
level of the fluid, or a bar code associated with the fluid.
[0029] FIG. 4 depicts an illustrative system for using a combined
dip tube and introducer according to an embodiment. As shown in
FIG. 4, a dip tube 400, an introducer 410, and a fluid container
420 are shown in an exploded configuration. The components are
illustrated in relation to a stand 460. The stand 460 may include
an upright portion 470 and a base 480. As shown in FIG. 4, the
container 420 is positioned such that its bottom situated against
the base 480. It may be appreciated that the base 480 may be used
for container 420 support. In an embodiment, the base 480 may
include a heating element to maintain the container 420 at a
constant temperature. In an embodiment, the base 480 may include a
temperature sensor to detect the temperature of the container 420
and its contents. In an embodiment, the base 480 may include a
scale capable of weighing the container 420. The weight of the
container may be monitored during fluid withdrawal to detect the
amount of fluid remaining in the container 420.
[0030] In an embodiment, a user may manually force the tip-end of
the introducer 410 through the septum of the container 420, and
manually force the dip tube 400 through the sleeve of the
introducer. In an alternate embodiment, an automated system may
include a stabilizing mechanism (such as a clamp, not shown) that
stabilizes the container 420 against the upright portion 470. The
tip-end of the introducer 410 may be forced through the septum by
an automated presser (not shown) that moves along the upright
portion 470. Similarly, the dip tube 400 may be mounted on an
insertion device (not shown) that similarly moves along the upright
portion 470 and forces the dip tube through the introducer 410. The
upright portion 470 may also include one or more electronic devices
that mate with one or more temperature sensors, such as 302, one or
more resistive elements, such as 304, and/or one or more capacitive
elements, such as 306a,b, for fluid detection within the container
420.
[0031] FIG. 5 depicts a flow diagram of an illustrative method of
enabling high fluid rate injection according to an embodiment. As
shown in FIG. 5, at least a portion of an introducer may be
inserted 505 into a septum of a container containing a fluid. The
introducer may include a hollow sleeve and a sharp tip-end at a
distal end of the hollow sleeve. The hollow sleeve has an opening
at a proximal end. In an embodiment, the introducer may further
include an air filter surrounding the opening of the hollow sleeve
to allow for sterile filtered air to enter the container and
equalize pressure during fluid draw.
[0032] A hollow dip tube may be inserted 510 into the opening of
the hollow sleeve. In an embodiment, the sharp tip-end is separable
from the introducer and is buoyant. In such an embodiment, the
operation of inserting 510 the hollow dip tube into the hollow
sleeve of the introducer may cause the sharp tip-end to separate
from the introducer. In such an embodiment, a fluid level in the
container may be determined 525 by identifying the location of the
separated sharp tip-end in the container.
[0033] At least a portion of the fluid in the container may be
withdrawn 515 through the hollow dip tube. In an embodiment, the
fluid may comprise a contrast solution, a saline flush solution or
the like. In an embodiment, the fluid may be useful for completing
a medical imaging procedure.
[0034] In an embodiment, the fluid may be withdrawn 515 from the
container by siphoning the fluid from the container. In an
embodiment, the fluid may be withdrawn 515 from the container by
suctioning the fluid from the container. In an embodiment, the
fluid may be stored at pressure within the container and withdrawn
515 from the container based on the pressure differential. In an
embodiment, the fluid may be withdrawn 515 from the container using
gravity. The container may be pierced on an upper side or a lower
side of the container. The selection of the type of method by which
the fluid is withdrawn 515 may be dependent upon the position of
the septum when it is pierced. Alternate methods of withdrawing 515
the fluid may be performed within the scope of this disclosure. In
addition, one or more devices, if any, used to withdraw 515 the
fluid will be known to those of ordinary skill in the art based on
the teachings herein.
[0035] In an embodiment, one or more properties of the fluid may be
sensed 520 using one or more sensors located at least in part on an
outer surface of the hollow dip tube. In an embodiment, the one or
more sensors may include a temperature sensor. In such an
embodiment, sensing 520 the one or more properties may comprise
sensing a temperature of the fluid using the temperature
sensor.
[0036] In an alternate embodiment, the one or more sensors may
include a resistance detector. The resistance detector may include
a resistive element, a current source and a current detector. The
resistive element may be located on the outer surface of the hollow
dip tube. The current source may be electrically connected to a
first end of the resistive element. In an embodiment, the current
source may be located on the outer surface of the hollow dip tube.
In an alternate embodiment, the current source may be remote from
the hollow dip tube. The current detector may be electrically
connected to a second end of the resistive element. In an
embodiment, the current detector may be located on the outer
surface of the hollow dip tube. In an alternate embodiment, the
current detector may be remote from the hollow dip tube. In such
embodiments, sensing 520 the one or more properties may comprise
sensing a resistance as the fluid is withdrawn from the container.
The resistance level may be used to determine 525 a fluid level in
the container, such as in the manner described above in reference
to FIG. 3B.
[0037] In yet another embodiment, the one or more sensors may
include a first capacitor element on a first side of the outer
surface and a second capacitor element on a second side of the
outer surface. In an embodiment, the first side and the second side
may be opposing sides of the outer surface. In such embodiments,
sensing 520 the one or more properties may comprise sensing a
capacitance using the first and second capacitor elements. The
capacitance may be used to determine 525 a fluid level in the
container, such as in the manner described above in reference to
FIG. 3C.
EXAMPLES
Example 1
Siphon-Based Injection with Buoyant Tip-End
[0038] A bottle or other container having a septum and containing a
fluid will be placed with the septum facing in an upward direction.
The septum will be pierced by an introducer having a sharp tip-end
configured to be buoyant with respect to the fluid in the
container. A dip tube will be inserted through the tip-end, whereby
the tip-end will be separated from the introducer. The tip-end,
once separated from the introducer, will float to the top of the
fluid in the container. The fluid will be siphoned or suctioned out
of the container to provide the fluid to a fluid administration
location, such as a point of injection into a patient, via the dip
tube. The fluid level remaining in the container at any given time
will be observable based on the position of the separated tip-end
within the container.
Example 2
Siphon-Based Injection with Filtering Tip-End
[0039] A bottle or other container having a septum and containing a
fluid will be placed with the septum facing in an upward direction.
The septum will be pierced by an introducer having a sharp tip-end.
A dip tube will be inserted through the tip-end, whereby the
tip-end will be separated from the introducer and lodged within the
dip tube. The fluid will be siphoned or suctioned out of the
container through the tip-end and the dip tube to provide the fluid
to a fluid administration location, such as a point of injection
into a patient, via the dip tube. The tip-end will be used to
filter the fluid and/or to sense one or more characteristics of the
fluid.
Example 3
Gravity-Based Injection
[0040] A fluid bag or other container having a septum and
containing a fluid will be placed with the septum facing in a
upward direction. The septum will be pierced by an introducer
having a sharp tip-end. A dip tube will be inserted through the
tip-end, whereby the tip-end will be separated from the introducer.
The bag will then be inverted to cause the septum to face in a
downward direction. The tip-end, once separated from the
introducer, will float to the top of the fluid in the container.
The fluid will be withdrawn from the container via a gravity-based
feed to provide the fluid to a fluid administration location, such
as a point of injection into a patient, via the dip tube. A hook
will be used to hold the bag in a suspended position. The hook will
be part of a weighing mechanism used to determine an amount of
fluid remaining in the bag by determining the weight of the bag and
a density of the fluid. The density of the fluid in the bag will be
determined by scanning a drug code from the bag which indicates the
type of fluid in the bag. A database will then be accessed to
identify the density of the particular fluid.
[0041] It will be appreciated that various of the above-disclosed
and other features and functions, or alternatives thereof, may be
desirably combined into many other different systems or
applications. It will also be appreciated that various presently
unforeseen or unanticipated alternatives, modifications, variations
or improvements therein may be subsequently made by those skilled
in the art which alternatives, variations and improvements are also
intended to be encompassed by the following claims.
* * * * *