HK40022817B - Dual syringe with funnel feeding kit - Google Patents

Description

Dual injectors with funnel feed kit

Background Technology

This disclosure relates to methods, apparatus, and kits for transferring fluids from storage and recombination containers to delivery devices in surgical environments such as operating rooms.

Background Technology

Infusion devices for dispensing two or more biological components are known. In the field of medical devices, such devices are commonly used to apply bioadhesives, polymers, and other synthetic materials for wound closure. Due to the reactive nature of the biological components used to form the bioadhesive, the components are not mixed until the solution is ready to be applied. Mixing the components too early before application can cause premature polymerization or hardening of the mixture, making it impossible to apply the solution. Therefore, in known infusion devices, the two or more components remain separate until application. Infusion devices may include one or more premixing devices for mixing two or more solutions before application. The premixing device may be passive, i.e., a helical structure in a tube, or conversely, active, i.e., mixing blades or impellers. Once mixed, the solution can be applied via a needle-like output or conversely, sprayed out via a spray assembly.

An exemplary device is taught in U.S. Patent 5,116,315 entitled "Biological Syringe System," which discloses a system for delivering two fluids in a mixed composition, the system including a manifold and a discharge assembly. The discharge assembly mixes the fluids in a mixing space and then atomizes the mixed fluids in a sprayer for delivery from the assembly. Similarly, U.S. Patent 5,605,255 entitled "Apparatus for Spraying a mixture of Two Components" shows a device for spraying a liquid mixture having two syringes, a connector, a premixing chamber and a reduction volume section located downstream of the premixing chamber, and an outlet orifice for spraying the mixture. The reduction volume section terminates in a homogenization zone. U.S. Patent 6,063,055 entitled "Turbulence Mixing Head for a TissueSealant Applicator and Spray Head for Same" illustrates a device in which mixing takes place in a mixing head.

U.S. Patent 6,132,396, entitled "Apparatus for applying tissue sealant," discloses a manifold for mixing a first component and a second component of a material. The manifold includes a body having a first inlet port and a second inlet port, a tubular dispenser connected to the body and having an outlet, and an internal channel in fluid communication with the outlet. The body has a first fluid delivery device adapted to deliver the first component from the first inlet port to the internal channel and a second fluid delivery device adapted to deliver the second component from the second inlet port to the internal channel. The first fluid delivery device includes a hypodermal needle fluidly connected to the first inlet port and having an outlet disposed within the internal channel. The second fluid delivery device includes a channel located within the body and fluidly connected to the second inlet port, having an outlet disposed within the internal channel. The hypodermal needle is located in or can penetrate the channel, thereby guiding the first and second components to the tubular dispenser for mixing, and then discharging from the outlet of the tubular dispenser.

U.S. Patent Application Publication 2013/0325059, entitled "Non-Clogging Airless Spray for High Viscosity, High Surface Tension Fluids," discloses a medical device for spraying two liquids. The device includes: a first syringe and a second syringe, each syringe having an outlet for the first liquid and the second liquid; a connector having a first channel and a second channel communicating with the syringe outlets and terminating in a distal component consisting of a spray cap, the spray cap including separate fluid channels for the first liquid and the second liquid, and a first outlet surface and a second outlet surface; wherein the first outlet surface and the second outlet surface of the spray cap include a plurality of small outlet holes, and the first outlet holes and the second outlet holes form a spray pattern that combines and mixes the first liquid and the second liquid exiting the device.

U.S. Patent 8,506,547 relates to a method and apparatus for transferring fluid from a non-sterile area to a sterile area within a surgical environment using a device comprising a body having a first inlet port communicating with a first outlet port. Fluid is typically drawn from a patient using a sterile syringe and transferred to a non-sterile area where it is treated. The treated fluid is then aspirated into another syringe in the non-sterile area, and the distal end of the first syringe is placed within the inlet port of the sterile body. The distal end of a second sterile syringe is inserted into the outlet port, wherein the distal ends of the sterile and non-sterile syringes do not contact each other. When a plunger is pushed into the chamber of the first non-sterile syringe to force fluid out of the first syringe, the plunger of the second sterile syringe retracts such that the chamber in the second syringe has sufficient volume to store the treated fluid. Because the first non-sterile syringe and the second sterile syringe do not contact each other during the transfer of the treated fluid, the sterile area is maintained and the fluid is available for use in surgical procedures.

Summary of the Invention

This invention relates to a multi-liquid loading and delivery kit, comprising a first storage container for a first active component, a second storage container for a second active component, at least two transfer syringes, at least two vial adapters, at least two cannulas having a through-lumen, and a multi-liquid delivery device. The delivery device includes: dual hollow cartridges, each cartridge having at least one through-hole at one end and a plunger inlet at the opposite end; a support frame; a removable dual-feed funnel; a spray manifold with replaceable spray heads; and a drip head assembly. In one embodiment, each cannula is constructed of a flexible material and is provided with a blunt, non-invasive tip.

The spray head assembly may consist of multiple components, including a manifold with dual openings, an internal mixing zone, and an atomizing insert. Alternatively, the drip head assembly may include a manifold having dual openings in fluid communication with a flexible drip outlet via a channel. The spray head assembly may be directly attached to the manifold or connected to the spray manifold via a multi-lumen, flexible tube.

The first and second components are in solid form, preferably active ingredients, and more preferably hemostatic active components. For the purposes of this patent application, a hemostatic active component refers to a component that activates a coagulating agent upon exposure to blood or plasma derivatives or forms a clot once activated by another active component. At least one of these components may be stored in a vial in the form of a lyophilized powder. In one embodiment, the first component is thrombin and the second component is a hemostatic active extract derived from plasma, more preferably, the second component is fibrinogen. The reconstituted vial preferably contains a liquid capable of dissolving the first and second components, such as an aqueous solution or a buffer solution containing calcium salts.

The present invention also relates to a method of using the above-described kit in the following manner: placing the recombinant component on a table, transferring the delivery device from packaging to a sterile area, preparing a first solution, preparing a second solution, retracting the plunger of the dual-syringe system to a predetermined position, rotating the support bracket to an open position, inserting the ends of the first and second cannulas into the dual-syringe system through a first and second funnel for each cartridge, replacing the funnels with a manifold, and attaching the dispensing head to the manifold. The first and second solutions are prepared similarly by: inserting the vial adapter on the recombinant syringe into a vial containing a dissolving solution, drawing the dissolving solution into the syringe, replacing the dissolving solution vial on the adapter with a first surfactant vial, injecting the dissolving solution into the surfactant vial, drawing the solution containing the surfactant into the first syringe, and replacing the vial adapter with the first cannula.

Attached Figure Description

Figure 1A is a schematic top view of the recombinant tool and the sterile fluid transfer device.

Figure 1B is a perspective view of the recombinant tool and the sterile fluid transfer device.

Figure 2A is a perspective view of a sterile delivery device in transfer mode as seen from top, in the filling position, with deployed support legs, an attached funnel, and a retractable plunger.

Figure 2B is a schematic top view of a delivery device having an attached funnel, an unretracted plunger, a manifold with a spray head, an additional spray head, and a manifold with a drip head.

Figure 3 is a perspective view of a sterile delivery device in transfer mode, which has deployed support legs, an attached funnel, and an unretracted plunger.

Figure 4 is a perspective view of a sterile delivery device in transfer mode, which has retractable support legs, an attached funnel, and an unretractable plunger.

Figure 5 is a perspective view of a sterile delivery device in drip mode, which has deployed support legs, a drip head, and an unretracted plunger.

Figure 6 is a top view of the aseptic delivery device in spray mode, which has a funnel, a mixing and spray manifold, and an unretracted plunger.

Figures 7A-7O are illustrations showing the operation steps of the kit and apparatus of the present invention.

Detailed Implementation

This invention relates to methods, apparatus, and kits for transferring fluid from a storage and recombination container to a delivery device in a surgical environment such as an operating room. The recombination tool and storage container are generally shown in Figures 1A and 1B, while the delivery device 10 is shown in transfer mode in Figures 2-4 and in delivery or infusion mode in Figures 5-6. The delivery device 10 in Figure 2B has at least two syringes configured in a dual-syringe configuration, wherein the delivery device 10 and the syringes can be packaged individually or together in a kit containing the delivery device 10.

Figure 1A shows a set of recombination tools including a pair of loading syringes 11, corresponding storage vials 13 (1-4), and a spike adapter 15. In one embodiment, storage vials 13 (1) and (2) contain substantially dried active components, preferably lyophilized proteins or plasma-derived components. In a first embodiment, storage vials 13 (3) and (4) contain recombination solutions, such as saline or buffered aqueous solutions. Each loading syringe 11 is a hollow cylindrical tube having a handle 17, an outlet 23 at a distal end of the handle 17, and a plunger arm 19 that fits snugly within the internal space of the loading syringe 11 through an opening 21 in the handle 17. Retracting the plunger arm 19 creates an empty space between the base of the plunger arm 19 and the outlet 23 of the loading syringe 11. The spike adapter 15 is configured to receive the vial 13 and simultaneously pierce the vial septum with a spike 9. A sterile, non-metallic cannula 8 is provided for subsequently transferring the recombinant material in the aspiration syringe 11 into the delivery device 10.

The device 10 is shown in a loading configuration in Figures 2-4 and in a drip configuration in Figures 5 and 6. In either configuration, the device 10 includes two supply containers provided in the form of commercially available syringes 12 for solutions of biological agents (such as proteins, such as fibrinogen), and solutions of fibrinogen activators (such as thrombin), and solutions of two-component tissue glue. Each syringe 12 includes a hollow cylindrical syringe body 14 having a front end 16 and an open rear end 22 (not shown), the front end having a port 18 and a connector 90. A piston or plunger 24 is arranged in each syringe body 14 and sealed abuts against the inner surface of the syringe body 14. The piston 24 is held by a piston rod 26 that extends from the syringe body 14 through the rear end 22. The piston rod 26 extends longitudinally along the syringe body 14 and extends beyond the open rear end 22. The free end 30 of the piston rod 26 facing away from the piston 24 has an annular flange 32 formed thereon. These annular flanges 32 are mechanically connected to each other by connecting elements 34. Connecting elements 34 form two receiving grooves 36, which are laterally open and adapted for insertion of the annular flanges 32. The two syringe bodies 14 are connected to each other by clamping retaining members 38 (hereinafter referred to as retaining elements). The bottom portion 16 of each syringe 12 includes a substantially flat bottom surface with openings leading to a left and right cavity. The left and right cavities are separated from each other and include tapered sidewalls forming truncated conical cavities. The left inlet port is in fluid communication with the left outlet port via a left through-hole. The right inlet port is in fluid communication with the right outlet port via a right through-hole.

In an alternative loading configuration, specifically as shown in Figures 3 and 4, the device 10 includes a deployed support frame 80 and an attached funnel 100. The funnel 100 is a double funnel with two tapered openings 110, 120, which engage via a connecting portion 115 and are configured for simultaneous attachment to two syringes 14. The tapered openings 110, 120 are aligned with a port 18. A nut 90 is configured to releasably attach the funnel 100 to the port. In one embodiment, the funnel 100 is attached by pressure fitting to an outer surface corresponding to a tapered inner surface on each syringe 14, rather than by locking via screws and/or Luer nuts. To transfer initial fluid into each syringe 14, a blunt flexible cannula 8 replaces the vial spike adapter 15 of each recombinant syringe 11. The cannula 8 is used to deliver fluid into the delivery device syringe through the openings 110, 120 corresponding to each syringe 14. The double-tapered funnel 100 provides a larger target for cannula placement. Each conical opening 110, 120 guides the cannula 8 and the liquid into each cylinder of the syringe 14. The blunt-tipped soft cannula 8, especially when used in conjunction with the funnel 100, provides a safer, easier, and faster means of delivering liquid into the device 10.

It should be understood that any type of head, including mixing heads, mixing spray heads, mixing drip heads, air-assisted spray heads, airless spray heads, etc., can be used according to embodiments of the invention. Although some figures show drip heads and others show spray heads, any head used for mixing and extruding two components can be used in this system.

In an alternative infusion configuration, as shown in Figures 5 and 6, device 10 includes a manifold 60 comprising a substantially Y-shaped member having a first proximal extension 62, a second proximal extension 64, and a distal extension 66. The proximal extensions 62 and 64 are configured for operatively engaging with a first component source and a second component source (e.g., syringe 14). The distal extension 66 is configured for operatively engaging with an elongated shaft 68, as will be discussed in more detail below. Manifold 60 also includes a first component channel and a second component channel (not shown). The first and second component channels provide fluid communication between the first and second component sources and a first lumen 73 and a second lumen 75 (not shown) formed in the elongated shaft 68. While manifold 60 (as shown) is configured to receive only two component sources, it is contemplated that manifold 60 could be configured to receive more than two biological component sources and/or medical component sources. Nut 90 is configured to attach and secure manifold 60 to inlet port 18.

The elongated shaft 68 may define a substantially solid body made of silicone, plastic, polymer, or other flexible material. As described above, the elongated shaft 68 includes a first component lumen 73 and a second component lumen 75 extending its length. A filament (not shown) made of a malleable material may also extend the length of the elongated shaft 68. A filament 76 may maintain the elongated shaft 68 in a bent or flexed configuration after it has been bent or flexed to accommodate a given surgical procedure. The elongated shaft 68 is secured to the distal extension 66 of the manifold 60 such that the first component lumen 73 and the second component lumen 75 are aligned with the first component channel and the second component channel. Alternatively, the elongated shaft 68 may be integrally formed at the distal end of the manifold 60. As shown in Figures 2A, 5, and 6, the device 10 may be used with a manifold 60 connected to the elongated shaft 68 (which terminates with a spray head or drip head 70), or alternatively, the head 70 may be directly attached to the manifold 60 without having the elongated shaft 68.

Figure 7 illustrates the main steps required to transfer the liquid component into the delivery device 10 and subsequently switch from a loading configuration to a dispensing or spraying configuration. First, a first syringe 11 with a vial adapter 15 is used to puncture the top barrier layer of a storage vial 13(3) containing the recombinant solution, and the liquid is aspirated in a conventional manner. At the end of the first syringe 11, the storage vial 13(3) is replaced with a storage vial (1), which preferably contains, for example, fibrinogen in substantially solid form. The recombinant solution is dispensed into the storage vial (1) to dissolve the material therein. The recombinant liquid is then aspirated back into the first syringe 11, and the vial adapter 15 is replaced using 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 cases, the recombinant process can be accelerated by stirring and gentle heating.

For loading purposes, the support frame 80 is deployed on the device 10 by rotating approximately 90 degrees and by pulling (or retracting) the syringe plunger 30 to a predetermined position. The support frame 80 elevates the inlet of the syringe 14 relative to the plunger handle 30, thereby allowing the reconstituted fluid to flow completely into each syringe 14. To prevent the support frame 80 from swinging and closing, a pawl is provided to lock it in an open or closed position. Once the reconstituted fluid has been transferred into each syringe 14 of the device 10, the support frame 80 is preferably rotated to a locked spray position using the pawl or other securing device on the device 10. The funnel 100 is removed and replaced with a manifold 60 and associated spray head elements. The device 10 can now be used to spray multi-liquid components, especially two-component formulations such as fibrinogen and thrombin, in a conventional manner.

Claims (14)

1. A multi-liquid loading and delivery kit, comprising: a) A first storage container for the first active component; b) A second storage container for the second active component; c) At least two transfer syringes; d) At least two small adapter bottles; e) Having at least two cannulas penetrating the lumen; and f) A multi-liquid delivery device, comprising a. A double hollow barrel, each hollow barrel having at least one through hole at one end and a plunger inlet at the opposite end; b. Rotatable support legs; c. Removable dual-feed funnel; d. Spray manifold; and e. At least one spray or drip head assembly, wherein the removable dual-feed funnel can be replaced using the spray manifold. 2. The kit of claim 1, wherein each cannula is flexible and is provided with a blunt, non-invasive tip. 3. The kit of claim 1, wherein the spray head assembly includes a spray canister with dual openings, an internal mixing zone, an atomizing insert, and a flexible spray outlet cap. 4. The kit of claim 1, wherein the drip head assembly includes a drip cartridge having a dual-way opening in fluid communication with a flexible drip outlet via a channel. 5. The kit of claim 1, wherein the spray head assembly is directly attached to the spray manifold. 6. The kit of claim 3 or 4, wherein the spray head assembly is connected to the spray manifold via a multi-cavity, flexible tube. 7. The kit according to claim 1, wherein the first active component and the second active component are in solid form. 8. The kit according to claim 7, wherein at least the first active component is a lyophilized powder. 9. The kit of claim 1, wherein the first active component is thrombin and the second active component is a hemostatic active extract derived from plasma. 10. The kit of claim 9, wherein the second active component is fibrinogen. 11. The kit of claim 1, further comprising at least one recombination container containing a solution-enhancing liquid. 12. The kit of claim 11, wherein the solution-enhancing liquid is an aqueous solution. 13. The kit of claim 11, wherein the solubilizing solution is a buffer solution containing a calcium salt. 14. A method of using the kit according to claim 1, comprising: a) Place the reassembly components on the table. b) Transfer the multi-liquid delivery device from the packaging to a sterile area. c) Prepare the first solution using the following steps: 1) Insert the first vial adapter with the first transfer syringe from the recombinant component into the vial of the first dissolving solution. 2) The first dissolving solution is drawn into the first transfer syringe. 3) Replace the first dissolving solution vial on the first vial adapter with the first surfactant vial. 4) Inject the first dissolving solution into the first surfactant vial to prepare a first solution containing the surfactant. 5) The first solution containing the active agent is aspirated into the first transfer syringe, and 6) Replace the first vial adapter with the first insertion tube. d) Prepare the second solution by the following steps: 1) Insert the second vial adapter with the second transfer syringe from the recombinant component into the vial of the second dissolving solution. 2) Draw the second dissolving solution into the second transfer syringe. 3) Insert the second vial adapter into the second surfactant vial. 4) Inject the second dissolving solution into the second surfactant vial to prepare a second solution containing the surfactant. 5) The second solution containing the active agent is aspirated into the second transfer syringe. 6) Replace the second vial adapter with the second cannula. e) Retract the plunger of the multi-liquid delivery device to the predetermined position. f) Rotate the support frame to the open position. g) Insert the ends of the first and second cannulas into the multi-liquid delivery device through the first and second funnels of the removable dual-feed funnels for each hollow cylinder. h) Replace the removable dual-feed funnel with a spray manifold. i) Attach the at least one spray or drip head assembly to the spray manifold.