U.S. patent application number 15/623791 was filed with the patent office on 2021-01-07 for dual syringe with funnel feeding kit.
The applicant listed for this patent is Ethicon, Inc., Guangzhou Bioseal Biotech Co., Ltd.. Invention is credited to John Goodman, Michael J. Trezza.
Application Number | 20210001046 15/623791 |
Document ID | / |
Family ID | |
Filed Date | 2021-01-07 |
![](/patent/app/20210001046/US20210001046A9-20210107-D00000.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00001.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00002.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00003.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00004.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00005.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00006.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00007.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00008.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00009.png)
![](/patent/app/20210001046/US20210001046A9-20210107-D00010.png)
View All Diagrams
United States Patent
Application |
20210001046 |
Kind Code |
A9 |
Trezza; Michael J. ; et
al. |
January 7, 2021 |
Dual Syringe with Funnel Feeding Kit
Abstract
The present invention is directed to multi-liquid loading and
delivery kits comprising a first storage vessel for a first active
component, a second storage vessel for a second active component,
at least two transfer syringes, at least two vial adaptors, at
least two cannulas with a through lumen and a multi-liquid delivery
device. The delivery device has dual hollow cartridges, each with
at least one throughbore at one end and plunger access at the
opposing end, a kick stand, a removable dual feed funnel, a spray
or drip manifold and at least one spray or drip tip assembly.
Inventors: |
Trezza; Michael J.; (Long
Valley, NJ) ; Goodman; John; (Ann Arbor, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Guangzhou Bioseal Biotech Co., Ltd.
Ethicon, Inc. |
Guangzhou
Somerville |
NJ |
CN
US |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20180361065 A1 |
December 20, 2018 |
|
|
Appl. No.: |
15/623791 |
Filed: |
June 15, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
29549431 |
Dec 22, 2015 |
|
|
|
15623791 |
|
|
|
|
Current U.S.
Class: |
1/1 |
International
Class: |
A61M 5/19 20060101
A61M005/19; A61M 5/315 20060101 A61M005/315; A61B 17/00 20060101
A61B017/00; A61M 5/32 20060101 A61M005/32 |
Claims
1. A multi-liquid loading and delivery kit comprising: a) A first
storage vessel for a first active component; b) A second storage
vessel for a second active component; c) At least two transfer
syringes; d) At least two vial adaptors; e) At least two cannulas
with a through lumen; and f) a multi-liquid delivery device
comprising a. dual hollow cartridges, each with at least one
throughbore at one end and plunger access at the opposing end; b. a
kick stand; c. a removable dual feed funnel; d. a spray manifold;
and e. at least one spray or drip tip assembly.
2. The kit according to claim 1, wherein each cannula is flexible
and is provided with blunt non-traumatic end tip.
3. The kit according to claim 1, wherein the spray tip assembly
comprises a spray cartridge with a dual path opening, an interior
mixing region, an atomizing insert and flexible spray outlet
cover.
4. The kit according to claim 1, wherein the drip tip assembly
comprises a drip cartridge with a dual path opening in fluid
communication via channels with a flexible drip outlet.
5. The kit according to claim 1, wherein the spray tip assembly is
directly attached to the manifold.
6. The kit according to claim 3 or 4, wherein the spray tip
assembly is connected via a multi-lumen, flexible tube to the spray
manifold.
7. The kit according to claim 1, wherein the first and second
active components are in solid form.
8. The kit according to claim 7, wherein at least the first
component is lyophilized powder.
9. The kit according to claim 1, wherein the first component is
thrombin and the second component is a hemostatically active
extract from blood plasma.
10. The kit according to claim 9, wherein the second component is
fibrinogen.
11. The kit according to claim 1 further comprising at least one
reconstituting vessel containing a solubilizing liquid.
12. The kit according to claim 11, wherein the solubilizing liquid
is an aqueous solution.
13. The kit according to claim 11, wherein the solubilizing liquid
is a buffered solution containing a calcium salt.
14. A method of using the kit according to claim 1 comprising: a)
placing the reconstitution set on a table, b) transferring the
delivery device from the packaging into a sterile field, c)
preparing a first solution by: 1) inserting a first vial adapter
with a first syringe from the reconstitution set into a vial of a
first dissolving solution, 2) drawing the first dissolving solution
into the first syringe, 3) replacing the first dissolving solution
vial on the adapter with a first active vial, 4) injecting the
first dissolving solution into the first active vial, 5)
withdrawing the first active containing solution into the first
syringe, and 6) replacing the vial adapter with a first cannula, d)
preparing a second solution by: 1) inserting a second vial adapter
with second syringe from the reconstitution set into a vial of a
second dissolving solution, 2) drawing the second dissolving
solution into the second syringe, 3) inserting the vial adapter
into a second actives vial, 4) injecting the second dissolving
solution into the second actives vial, 5) withdrawing the second
solution into the second syringe, 6) replacing the vial adapter
with a second cannula, e) retracting the plungers of the
dual-syringe system to a predetermined position, f) rotating the
kick stand into the open position, g) inserting the end of first
and second cannula through first and second funnels of the barrel
for each cartridge in the dual-syringe system, h) replacing the
funnel with a manifold, i) attaching a dispensing tip to the
manifold.
Description
BACKGROUND OF THE INVENTION
[0001] The present disclosure relates to methods, devices and kits
for transferring fluids from storage and reconstitution vessels to
a delivery device in a surgical environment such as an operating
room.
BACKGROUND
[0002] Drip devices for dispensing two or more biocomponents are
known. In the medical device field, such devices are typically used
for applying bioadhesives, polymers and other synthetic material
used in wound closure. Because of the reactant nature of the
biocomponents used to form the bioadhesive, mixing of the
components does not occur until the solution is ready to be
applied. Mixing of the components too soon before application may
result in the premature polymerization reaction or hardening of the
mixture, thereby making application of the solution impossible.
Thus, in known drip devices, the two or more components are
maintained separately until just prior to application. The drip
devices may include one or more pre-mixing means for mixing the two
or more solutions prior to application. The pre-mixing means may be
passive, i.e., spiral configuration in the tubing, or instead may
be active, i.e., mixing blade or impeller. Once mixed, the solution
may be applied through a needle-like output or may instead be
ejected through a spray assembly.
[0003] An exemplary device is taught in U.S. Pat. No. 5,116,315,
entitled "Biological Syringe System", which discloses a system for
delivery two fluids in a mixed composition, comprising a manifold
and a discharge assembly. The discharge assembly mixes fluids in a
mixing space and then atomizes the mixed fluids in a spray
delivered from the assembly. Similarly, the device shown in U.S.
Pat. No. 5,605,255, entitled, "Apparatus for Spraying a mixture of
Two Components`, is an apparatus for spraying a liquid mixture
having two syringes, a connecting piece, a premixing chamber, and a
reduced volume section downstream from premixing chamber, and an
exit aperture for spraying the mixture. The reduced volume section
terminates in a homogenization region. U.S. Pat. No. 6,063,055,
entitled "Turbulence Mixing Head for a Tissue Sealant Applicator
and Spray Head for Same", illustrates a device in which the mixing
is performed in a mixing head.
[0004] U.S. Pat. No. 6,132,396, titled "Apparatus for applying
tissue sealant" discloses a manifold for combining first and second
components of a material, comprising a body having first and second
inlet ports, a tubular dispenser coupled to the body and provided
with an outlet and an internal passageway in fluid communication
with said outlet, said body having first fluid transport means
adapted for transporting said first component from said first inlet
port to said internal passageway and second fluid transport means
adapted for transporting said second component from said second
inlet port to said internal passageway, said first fluid transport
means including a hypodermic needle in fluid connection with said
first inlet port and having an outlet disposed within said internal
passageway, said second fluid transport means including a channel
in the body and in fluid connection with said second inlet port and
provided with an outlet disposed within said internal passageway
the hypodermic needle is located in or able to penetrate the
channel whereby said first and second components are directed by
said first and second transport means into said tubular dispenser
for mixing prior to discharge from the outlet of said tubular
dispenser.
[0005] U.S. Patent Application Publication No. 2013/0325059 titled
"Non-Clogging Airless Spray for High Viscosity, High Surface
Tension Fluids" discloses a medical device for spraying two liquids
comprised of a first and second syringe each syringe having an
outlet for a first and second liquid; a connecting piece having
first and second channels in communication with said syringe
outlets terminating in distal component comprised of a spray cap
which contain independent fluid passages for said first and second
liquids and a first and second exit surface; wherein first and
second exit surfaces of said spray cap contain a plurality of small
exit apertures and said first and second exit apertures create a
spray pattern which combines and mixes said first and second
liquids away from the device.
[0006] U.S. Pat. No. 8,506,547 is directed to a method and device
for transferring fluids from a non-sterile field to a sterile field
within a surgical environment utilizing a device that includes a
main body having a first inlet port that is in communication with a
first outlet port. Fluid is taken from the patient, typically with
a sterile syringe and transferred to the non-sterile field where
the fluid is processed. The processed fluid is then drawn into
another syringe in the non-sterile field and a distal end of the
first syringe is place within the inlet port of the sterile main
body. A distal end of a second sterile syringe is inserted into the
outlet port, where the distal ends of the sterile syringe and the
non-sterile syringe do not make contact. As a plunger is forced
into a chamber of the first non-sterile syringe to force the fluid
out of the first syringe, the plunger of the second sterile syringe
is retracted such that a chamber in the second syringe has a
sufficient volume to store the processed liquid. Since the first
non-sterile syringe and the second sterile syringe do not make
contact during the transfer of the processed fluid, the sterile
field is maintained and the fluid can be utilized in the surgical
procedure.
SUMMARY OF THE INVENTION
[0007] The present invention is directed to multi-liquid loading
and delivery kits comprising a first storage vessel for a first
active component, a second storage vessel for a second active
component, at least two transfer syringes, at least two vial
adaptors, at least two cannulas with a through lumen and a
multi-liquid delivery device. The delivery device has dual hollow
cartridges, each with at least one throughbore at one end and
plunger access at the opposing end, a kick stand, a removable dual
feed funnel, a spray manifold with interchangeable spray tips and
one drip tip assembly. In one embodiment, each cannula is
constructed from flexible material and is provided with blunt
non-traumatic end tip.
[0008] The spray tip assembly can be constructed from multiple
elements including a manifold with a dual path opening, an interior
mixing region and an atomizing insert. Alternatively, the drip tip
assembly can include a manifold with a dual path opening in fluid
communication via channels with a flexible drip outlet. The spray
tip assembly can be directly attached to the manifold or connected
via a multi-lumen, flexible tube to the spray manifold.
[0009] The first and second components are in solid form,
preferably as active ingredients, more preferably as hemostatically
active components. Hemostatically active components means, for
purposes of this application, components that activate clotting
forming agents or once activated by another active component form
clots when exposed to blood or blood plasma derivatives. At least
one of the components can be stored in a vial as a lyophilized
powder. In one embodiment, the first component is thrombin and the
second component is a hemostatically active extract from blood
plasma, more preferably, the second component is fibrinogen. The
reconstituting vials preferably contain a liquid capable of
solubilizing the first and second components, such as an aqueous
solution or a buffered solution containing a calcium salt.
[0010] The present invention also relates to methods for using the
kit described above by placing the reconstitution set on a table,
transferring the delivery device from the packaging into a sterile
field, preparing a first solution, preparing a second solution,
retracting the plungers of the dual-syringe system to a
predetermined position, rotating the kick stand into the open
position, inserting the end of first and second cannula through
first and second funnels of the barrel for each cartridge in the
dual-syringe system, replacing the funnel with a manifold and
attaching a dispensing tip to the manifold. The first and second
solutions are prepared analogously by inserting a vial adapter on a
reconstitution syringe into a vial containing a dissolving
solution, drawing the dissolving solution into a syringe, replacing
the dissolving solution vial on the adapter with a first active
vial, injecting the dissolving solution into the active vial,
withdrawing the active containing solution into the first syringe
and replacing the vial adapter with a first cannula.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1A is a schematic top view of the reconstitution tools
and sterile fluid transfer device.
[0012] FIG. 1B is a perspective view of the reconstitution tools
and sterile fluid transfer device.
[0013] FIG. 2A is a perspective view of the sterile delivery device
in transfer mode as viewed from the top in a filling position with
deployed kickstand, attached funnel, and retracted plungers.
[0014] FIG. 2B is a schematic top view of the delivery device with
funnel attached, non-retracted plungers, a manifold with spray tip,
extra spray tip, and manifold with drip tip.
[0015] FIG. 3 is a perspective view of the sterile delivery device
in transfer mode with deployed kickstand, attached funnel, and
non-retracted plungers.
[0016] FIG. 4 is a perspective view of the sterile delivery device
in transfer mode with retracted kickstand, attached funnel, and
non-retracted plungers.
[0017] FIG. 5 is a perspective view of the sterile delivery device
in drip mode with deployed kickstand, a drip tip, and non-retracted
plungers.
[0018] FIG. 6 is a top view of the sterile delivery device in spray
mode with funnel, a mixing and spraying manifold, and non-retracted
plungers.
[0019] FIGS. 7A-70 are diagrams showing operational process steps
for the inventive kit and devices.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0020] The present invention relates to a method, a device and a
kit for transferring fluids from storage and reconstitution vessels
to a delivery device in a surgical environment such as an operating
room. Reconstitution tools and storage vessels are generally
illustrated in FIGS. 1A and 1B, while delivery device 10 in
transfer mode is shown in FIGS. 2-4 and in delivery or drip mode in
FIGS. 5-6. Delivery device 10 in FIG. 2B has at least two syringes
that are set in a dual syringe configuration, where the delivery
device 10 and the syringes can be packaged individually or together
in a kit with the delivery device 10.
[0021] A set of reconstitution tools are shown in FIG. 1A
consisting of a pair of loading syringes 11, corresponding storage
vials 13 (1-4) and spike adaptors 15. Storage vials 13(1) and (2),
in one embodiment, contain substantially dry active components,
preferably lyophilized proteins or plasma derived components.
Storage vials 13(3) and (4), in the first embodiment, contain
reconstitution solutions, such as saline or buffered aqueous
solutions. Each loading syringe 11 is a hollow cylindrical tube
with handles 17, an outlet 23 at an end distal to handles 17 and a
plunger arm 19 that fits snuggly within the interior space of
loading syringe 11 though an opening 21 in said handle 17.
Retracting plunger arm 19 creates empty space between the base of
plunger arm 19 and outlet 23 for loading syringe 11. Spike adapters
15 are configured to accept vials 13 and simultaneously pierce vial
septum with spikes 9. Sterile, non-metallic cannulas 8 are provided
for subsequent transfer of reconstituted materials drawn into
syringes 11 into delivery device 10.
[0022] Device 10 is shown in the loading configuration in FIGS. 2-4
and in a drip configuration in FIGS. 5 and 6. In either
configuration, device 10 comprises two supply containers provided
as commercially available syringes 12 for solutions of biologic
agents, such as proteins, such as fibrinogen, and of fibrinogen
activators, such as thrombin, of a two-component tissue glue. Each
syringe 12 comprises a hollow cylindrical syringe body 14 having a
front end 16 with ports 18 and connecting pieces 90, and an open
rear end 22 (not shown). Arranged in each syringe body 14 is a
piston or plunger 24 in sealing abutment on the inner surface of
syringe body 14. Piston 24 is held by a piston rod 26 guided out of
syringe body 14 through the rear end 22. The piston rods 26 extend
respectively in the longitudinal direction of the syringe bodies 14
and beyond open rear end 22. The free ends 30 of piston rods 26
facing away from piston 24 have annular flanges 32 formed thereon.
These annular flanges 32 are mechanically connected to each other
by a connecting element 34. Connecting element 34 is formed with
two receiving recesses 36 which are laterally open and suited for
insertion of the annular flanges 32 thereinto. The two syringe
bodies 14 are connected to each other by a clip holding means 38
(hereinbelow referred to as a holding element). The bottom portion
16 of each syringe 12 includes a substantially flat, bottom surface
that includes openings to left and right cavities. The left and
right cavities are separated from each other and include tapered
sidewalls which form frusto-conical cavities. The left inlet port
is in fluid communication with the left outlet port with a left
through bore. The right inlet port is in fluid communication with
the right outlet port with a right through bore.
[0023] In one alternative loading configuration, particularly as
shown in FIGS. 3 and 4, device 10 includes a deployed kick stand 80
and attached funnel 100. Funnel 100 is a dual funnel with two
conical openings 110, 120 joined by connection portion 115 and
configured for attachment to both syringes 14 simultaneously.
Conical openings 110, 120 align to ports 18. Nuts 90 are configured
to releasably attach funnel 100 to the ports. In one embodiment,
funnel 100 is attached by a press fit to an outside surface
corresponding to the tapered interior surface on each syringe 14,
rather than by locking via a screw and/or luer nuts. For initial
liquid transfer into each syringe 14, vial spike adapters 15 from
each reconstitution syringe 11 are replaced with blunt soft cannula
8. Cannulas 8 are used to deliver the liquids into the delivery
device syringe though opening 110, 120 corresponding to each
syringe 14. Dual conical funnel 100 provides larger target for
cannula placement. Each conical opening 110, 120 channels cannula 8
and liquids into each barrel of syringe 14. Blunt tipped soft
cannula 8, particularly when used in association with funnel 100,
provide a safer, easier and faster means of delivering the liquids
into device 10.
[0024] It is to be understood that any type of tips, including
mixing tips, mixing spray tips, mixing drip tips, air-assist,
airless spray, etc. tips can be used in accordance with the present
inventive embodiments. While some drawings show drip tips and other
show spray tips, any tips for mixing and expression of two
components can be utilized in the present systems.
[0025] In one alternative drip configuration, as show in in FIGS. 5
and 6, device 10 includes a manifold 60 includes a substantially
Y-shaped member having a first and a second proximal extension 62,
64 and a distal extension 66. Proximal extensions 62, 64 are
configured for operable engagement with a first and a second source
of component, e.g., syringes 14. Distal extension 66 is configured
for operable engagement with elongated shaft 68, as will be
discussed in further detail below. Manifold 60 further includes
first and second component channels (not shown). First and second
component channels fluidly communicate the first and second sources
of components with a first and a second lumen 73, 75 (not shown)
formed in elongated shaft 68. While manifold 60, as shown, is
configured to receive only two sources of component, it is
envisioned that manifold 60 may be configured to receive more than
two sources of biological/medicinal components. Nuts 90 are
configured to attach and secure manifold 60 to inlet ports 18.
[0026] Elongated shaft 68 may define a substantially solid body of
silicone, plastic, polymer or other flexible material. As noted
above, elongated shaft 68 includes first and second component
lumens 73, 75 extending the length thereof. A wire (not shown)
composed of a malleable material can also extend the length of
elongated shaft 68. Wire 76 can maintain elongated shaft 68 in a
bent or flexed configuration after elongated shaft 68 has been bent
or flexed to accommodate a given procedure. Elongated shaft 68 is
secured to distal extension 66 of manifold 60 such that first and
second component lumens 73, 75 align with first and second
component channels. Alternatively, elongated shaft 68 may be
integrally formed at a distal end of manifold 60. As shown in FIGS.
2A, 5, 6, device 10 can be used with manifold 60 connected to
elongated shaft 68 terminating with spray or drip tip 70, or
alternatively tip 70 can be attached directly to manifold 60 with
no elongated shaft 68.
[0027] FIG. 7 illustrates the primary steps required for
transferring of liquid components into delivery device 10 and then
conversion from a loading configuration to a dispensing or spray
configuration. To begin, a first syringe 11 with a vial adaptor 15
is caused to pierce top barrier layer in storage vial 13(3), which
contains a reconstituting solution, and to withdraw the liquid
therein in conventional fashion. Storage vial 13(3) is replaced on
the end of first syringe 11 with storage vial (1), which preferably
contains, for example, fibrinogen in substantially solid form. The
reconstituting solution is dispensed into storage vial (1) to
dissolve the material therein. The reconstituted liquid is then
drawn back into first syringe 11 and vial adaptor 15 is replaced
with a first cannula 8. These steps are repeated in a second
syringe 11 using storage vials (2) and (4) and a second cannula 8.
In either or both instances, the reconstitution process can be
accelerated with agitation and mild heat.
[0028] For loading purposes, kick stand 80 is deployed on device 10
by rotating about 90 degrees and by pulling (or retracting) the
syringe plungers 30 to a predetermined position. Stand 80 elevates
the inlets of syringes 14 relative to plunger handle 30 which
allows reconstituted liquids to flow fully into each syringe 14. To
prevent stand 80 from swinging shut, detents can be provided to
lock it in the open or closed position. Once the reconstituted
liquids have been transferred into each syringe 14 of device 10,
kick stand 80 is rotated into a locked spray position, preferably
using detents or other securement means, on device 10. Funnel 100
is removed and replaced with manifold 60 and the associated spray
tip elements. Device 10 can now be utilized to spray multi-liquid
components, particularly dual component formulations, such as
fibrinogen and thrombin, in conventional fashion.
* * * * *