US20210121630A1 - Dual Syringe with Funnel Feeding Kit - Google Patents
Dual Syringe with Funnel Feeding Kit Download PDFInfo
- Publication number
- US20210121630A1 US20210121630A1 US17/143,485 US202117143485A US2021121630A1 US 20210121630 A1 US20210121630 A1 US 20210121630A1 US 202117143485 A US202117143485 A US 202117143485A US 2021121630 A1 US2021121630 A1 US 2021121630A1
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- United States
- Prior art keywords
- delivery device
- liquid delivery
- spray
- drip
- manifold
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
- 230000009977 dual effect Effects 0.000 title claims abstract description 13
- 239000007788 liquid Substances 0.000 claims abstract description 33
- 239000007921 spray Substances 0.000 claims abstract description 32
- 239000012530 fluid Substances 0.000 claims description 27
- 238000002156 mixing Methods 0.000 claims description 18
- 238000004891 communication Methods 0.000 claims description 7
- 241001631457 Cannula Species 0.000 abstract description 4
- 239000000243 solution Substances 0.000 description 16
- 238000000034 method Methods 0.000 description 7
- 239000000463 material Substances 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- 108010049003 Fibrinogen Proteins 0.000 description 5
- 102000008946 Fibrinogen Human genes 0.000 description 5
- 229940012952 fibrinogen Drugs 0.000 description 5
- 238000005507 spraying Methods 0.000 description 5
- 108090000190 Thrombin Proteins 0.000 description 3
- 210000002381 plasma Anatomy 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 229960004072 thrombin Drugs 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 2
- 239000000227 bioadhesive Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 239000000565 sealant Substances 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 206010053567 Coagulopathies Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 239000003124 biologic agent Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 239000008366 buffered solution Substances 0.000 description 1
- 159000000007 calcium salts Chemical class 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000035602 clotting Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000000265 homogenisation Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000008176 lyophilized powder Substances 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 239000000376 reactant Substances 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 230000003381 solubilizing effect Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 239000003106 tissue adhesive Substances 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3286—Needle tip design, e.g. for improved penetration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00495—Surgical glue applicators for two-component glue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00522—Sprayers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/19—Constructional features of carpules, syringes or blisters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/08—Supports for equipment
- A61M2209/084—Supporting bases, stands for equipment
Definitions
- 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.
- Drip devices for dispensing two or more biocomponents are known.
- such devices are typically used for applying bioadhesives, polymers and other synthetic material used in wound closure.
- 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.
- 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.
- the discharge assembly mixes fluids in a mixing space and then atomizes the mixed fluids in a spray delivered from the assembly.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- each cannula is constructed from flexible material and is provided with blunt non-traumatic end tip.
- 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.
- 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.
- 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.
- 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.
- 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.
- FIG. 1A is a schematic top view of the reconstitution tools and sterile fluid transfer device.
- FIG. 1B is a perspective view of the reconstitution tools and sterile fluid transfer device.
- 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.
- 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.
- FIG. 3 is a perspective view of the sterile delivery device in transfer mode with deployed kickstand, attached funnel, and non-retracted plungers.
- FIG. 4 is a perspective view of the sterile delivery device in transfer mode with retracted kickstand, attached funnel, and non-retracted plungers.
- FIG. 5 is a perspective view of the sterile delivery device in drip mode with deployed kickstand, a drip tip, and non-retracted plungers.
- 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.
- FIGS. 7A-70 are diagrams showing operational process steps for the inventive kit and devices.
- 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
- 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 .
- FIG. 1A 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.
- 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 .
- Device 10 is shown in the loading configuration in FIGS. 2-4 and in a drip configuration in FIGS. 5 and 6 .
- 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).
- a piston or plunger 24 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).
- 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.
- 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.
- 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.
- each syringe 14 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 .
- 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.
- device 10 in one alternative drip configuration, as show in in FIGS. 5 and 6 , 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 .
- manifold 60 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 .
- 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.
- elongated shaft 68 may be integrally formed at a distal end of manifold 60 .
- 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 .
- 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.
- 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 .
- steps are repeated in a second syringe 11 using storage vials ( 2 ) and ( 4 ) and a second cannula 8 .
- the reconstitution process can be accelerated with agitation and mild heat.
- 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 .
- detents can be provided to lock it in the open or closed position.
- 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.
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Abstract
Description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
-
FIG. 1A is a schematic top view of the reconstitution tools and sterile fluid transfer device. -
FIG. 1B is a perspective view of the reconstitution tools and sterile fluid transfer device. -
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. -
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. -
FIG. 3 is a perspective view of the sterile delivery device in transfer mode with deployed kickstand, attached funnel, and non-retracted plungers. -
FIG. 4 is a perspective view of the sterile delivery device in transfer mode with retracted kickstand, attached funnel, and non-retracted plungers. -
FIG. 5 is a perspective view of the sterile delivery device in drip mode with deployed kickstand, a drip tip, and non-retracted plungers. -
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. -
FIGS. 7A-70 are diagrams showing operational process steps for the inventive kit and devices. - 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 , whiledelivery device 10 in transfer mode is shown inFIGS. 2-4 and in delivery or drip mode inFIGS. 5-6 .Delivery device 10 inFIG. 2B has at least two syringes that are set in a dual syringe configuration, where thedelivery device 10 and the syringes can be packaged individually or together in a kit with thedelivery device 10. - A set of reconstitution tools are shown in
FIG. 1A consisting of a pair of loadingsyringes 11, corresponding storage vials 13 (1-4) andspike 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. Eachloading syringe 11 is a hollow cylindrical tube with handles 17, anoutlet 23 at an end distal to handles 17 and aplunger arm 19 that fits snuggly within the interior space ofloading syringe 11 though anopening 21 in said handle 17. Retractingplunger arm 19 creates empty space between the base ofplunger arm 19 andoutlet 23 for loadingsyringe 11.Spike adapters 15 are configured to acceptvials 13 and simultaneously pierce vial septum withspikes 9. Sterile,non-metallic cannulas 8 are provided for subsequent transfer of reconstituted materials drawn intosyringes 11 intodelivery device 10. -
Device 10 is shown in the loading configuration inFIGS. 2-4 and in a drip configuration inFIGS. 5 and 6 . In either configuration,device 10 comprises two supply containers provided as commerciallyavailable 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. Eachsyringe 12 comprises a hollowcylindrical syringe body 14 having afront end 16 withports 18 and connectingpieces 90, and an open rear end 22 (not shown). Arranged in eachsyringe body 14 is a piston orplunger 24 in sealing abutment on the inner surface ofsyringe body 14.Piston 24 is held by apiston rod 26 guided out ofsyringe body 14 through the rear end 22. Thepiston rods 26 extend respectively in the longitudinal direction of thesyringe bodies 14 and beyond open rear end 22. The free ends 30 ofpiston rods 26 facing away frompiston 24 haveannular flanges 32 formed thereon. Theseannular flanges 32 are mechanically connected to each other by a connectingelement 34. Connectingelement 34 is formed with two receivingrecesses 36 which are laterally open and suited for insertion of theannular flanges 32 thereinto. The twosyringe bodies 14 are connected to each other by a clip holding means 38 (hereinbelow referred to as a holding element). Thebottom portion 16 of eachsyringe 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. - In one alternative loading configuration, particularly as shown in
FIGS. 3 and 4 ,device 10 includes a deployedkick stand 80 and attachedfunnel 100.Funnel 100 is a dual funnel with twoconical openings connection portion 115 and configured for attachment to bothsyringes 14 simultaneously.Conical openings ports 18.Nuts 90 are configured to releasably attachfunnel 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 eachsyringe 14, rather than by locking via a screw and/or luer nuts. For initial liquid transfer into eachsyringe 14,vial spike adapters 15 from eachreconstitution syringe 11 are replaced with bluntsoft cannula 8.Cannulas 8 are used to deliver the liquids into the delivery device syringe though opening 110, 120 corresponding to eachsyringe 14. Dualconical funnel 100 provides larger target for cannula placement. Eachconical opening channels cannula 8 and liquids into each barrel ofsyringe 14. Blunt tippedsoft cannula 8, particularly when used in association withfunnel 100, provide a safer, easier and faster means of delivering the liquids intodevice 10. - 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.
- 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 secondproximal extension distal extension 66.Proximal extensions syringes 14.Distal extension 66 is configured for operable engagement withelongated 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 inelongated shaft 68. Whilemanifold 60, as shown, is configured to receive only two sources of component, it is envisioned thatmanifold 60 may be configured to receive more than two sources of biological/medicinal components.Nuts 90 are configured to attach andsecure manifold 60 toinlet ports 18. -
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 ofelongated shaft 68. Wire 76 can maintainelongated shaft 68 in a bent or flexed configuration afterelongated shaft 68 has been bent or flexed to accommodate a given procedure.Elongated shaft 68 is secured todistal extension 66 ofmanifold 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 ofmanifold 60. As shown inFIGS. 2A, 5, 6 ,device 10 can be used withmanifold 60 connected toelongated shaft 68 terminating with spray ordrip tip 70, or alternatively tip 70 can be attached directly tomanifold 60 with noelongated shaft 68. -
FIG. 7 illustrates the primary steps required for transferring of liquid components intodelivery device 10 and then conversion from a loading configuration to a dispensing or spray configuration. To begin, afirst syringe 11 with avial 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 offirst 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 intofirst syringe 11 andvial adaptor 15 is replaced with afirst cannula 8. These steps are repeated in asecond syringe 11 using storage vials (2) and (4) and asecond cannula 8. In either or both instances, the reconstitution process can be accelerated with agitation and mild heat. - For loading purposes, kick stand 80 is deployed on
device 10 by rotating about 90 degrees and by pulling (or retracting) thesyringe plungers 30 to a predetermined position.Stand 80 elevates the inlets ofsyringes 14 relative to plunger handle 30 which allows reconstituted liquids to flow fully into eachsyringe 14. To preventstand 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 eachsyringe 14 ofdevice 10, kick stand 80 is rotated into a locked spray position, preferably using detents or other securement means, ondevice 10.Funnel 100 is removed and replaced withmanifold 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.
Claims (13)
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US17/143,485 US20210121630A1 (en) | 2015-12-22 | 2021-01-07 | Dual Syringe with Funnel Feeding Kit |
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US17/143,485 US20210121630A1 (en) | 2015-12-22 | 2021-01-07 | Dual Syringe with Funnel Feeding Kit |
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CN (1) | CN110753518B (en) |
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CN110753518B (en) | 2024-01-02 |
US20180361065A1 (en) | 2018-12-20 |
US20210001046A9 (en) | 2021-01-07 |
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CN110753518A (en) | 2020-02-04 |
US10918790B2 (en) | 2021-02-16 |
WO2018229620A1 (en) | 2018-12-20 |
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