ABSTRACT
Abstract
The present specification discloses a solution delivery device having a container component and a plug component configured for selective engagement with the container component. The container component has an internal cavity including an elongated mixing channel containing a first constituent, and the plug component provides an internal flow path configured for introduction of a second constituent into the mixing channel for mixing with the first constituent. The plug component may be inserted within the container component partially in a first operational mode and fully in a second operational mode. The first constituent may be a drug and the second constituent a diluent, such that the drug may be lyophilized with the device in the first operational mode and reconstituted with the device in the second operational mode. Multiple devices may be employed in tandem for the co-delivery of multiple constituents. The device may be included in a kit or installed within an injector.
Description
This is a continuation application and so claims the benefit pursuant to 35 U.S.C. § 120 of a prior filed and U.S. non-provisional patent application Ser. No. 14/848,062, filed on Sep. 8, 2015, which itself claims priority pursuant to 35 U.S.C. § 119(e) to and is entitled to the filing date of U.S. provisional patent application Ser. No. 62/048,089, filed on Sep. 9, 2014. The contents of the aforementioned applications are incorporated herein by reference.
The invention relates generally to drug delivery and more particularly, to a solution delivery device and method for storing and mixing medications and related chemicals.
Due to continued advances in genetic and cell engineering technologies, proteins known to exhibit various pharmacological actions in vivo are capable of production in large amounts for pharmaceutical applications. However, one of the most challenging tasks in the development of protein pharmaceuticals is to deal with the inherent physical and chemical instabilities of such proteins, especially in aqueous dosage forms. Pre-filled hypodermic syringes in which these protein pharmaceuticals and other medications are stored in aqueous form offer many efficiencies. However, many injectable medications degrade rapidly and lose their effectiveness in solution. Refrigeration and special packaging can increase shelf-life, but add to cost, complicate storage, and offset many efficiencies provided by pre-filled syringes.
Because of the instability associated with the aqueous dosage forms, powder formulations are generally preferred to achieve sufficient stability for the desired shelf-life of a product. Various techniques to prepare dry powders are known and practiced in the pharmaceutical and biotechnology industry. Such techniques include lyophilization, spray-drying, spray-freeze drying, bulk crystallization, vacuum drying, and foam drying. Lyophilization (freeze-drying) is often a preferred method used to prepare dry powders (lyophilizates) containing proteins. Various methods of lyophilization are well known to those skilled in the art. The lyophilization apparatus and process applies a vacuum that converts liquid portions of a medication into a solid which is subject to a sub-atmospheric pressure to create a vapor. The vapor is drawn from the lyophilization chamber through vapor passages and exhausted to regions external of the lyophilizing apparatus. The lyophilizing process reduces the liquid medication to a dried powdery or granular form.
More particularly, freeze drying, or lyophilization, is a dehydration technique. It takes place while a product is in a frozen state (ice sublimation under a vacuum) and under a vacuum (drying by gentle heating). These conditions stabilize the product, and minimize oxidation and other degradative processes. The conditions of freeze drying permit running the process at low temperatures, therefore, thermally labile products can be preserved. Freeze drying has become an accepted method of processing heat sensitive products that require long term storage at temperatures above freezing.
Steps in freeze drying include pretreatment, freezing, primary drying, and secondary drying. Pretreatment includes any method of treating the product prior to freezing. This may include concentrating the product, formulation revision (i.e., addition of components to increase stability and/or improve processing), decreasing a high vapor pressure solvent or increasing the surface area. Methods of pretreatment include: freeze concentration, solution phase concentration, and formulating specifically to preserve product appearance or to provide lyoprotection for reactive products.
The second step is to freeze the product. Freezing the product decreases chemical activity by decreasing molecular movement. Freezing is essentially the dehydration step in freeze drying; once the solvent matrix is in the solid (frozen) state, the solute matrix is âdry,â (although it may contain some amorphous water). A rule of thumb for freezing product is that the product container should preferably not be filled with product to more than half of its total volumetric rating. In practice this may also mean filling the product only to certain depth to facilitate freezing, ice sublimation, and final water/solvent removal. This helps insure, in most cases, that the surface to depth ratio is such that freeze drying is not impeded by the product depth.
Once the product is at the end of its lyophilization cycle it should be removed from the freeze dryer. In a stoppering shelf/tray dryer, an inert gas may be bled into the chamber forming an inert âgas capâ over the product prior to stop. Many products are simply stoppered while under vacuum. The stoppers used most commonly on serum vials/bottles have a vacuum integrity of approximately five years when used in conjunction with tear-off seals. Once the product is stoppered, the system is returned to atmospheric pressure and the lyophilizing shelves are unloaded.
Many devices presently exist in which lyophilized medication is stored in the chamber of a hypodermic syringe. Shortly prior to delivery to a patient, reconstitution is achieved by removing the tip cap from the syringe and placing the sharpened cannula of the syringe into a diluent container such as a vial, ampule, or any other rigid or flexible reservoir which could be engaged to the syringe. The plunger of the syringe is then pulled proximally to draw the diluent into the lyophilized medication chamber for mixing. The diluent reservoir is then removed and discarded. The diluent/powder solution in the syringe is then shaken sufficiently for complete mixing. Unless a sharpened cannula is already attached, one is mounted to the distal end of the syringe and the cannula is used to pierce the patient's skin at an injection site. The syringe plunger is then pushed into the syringe barrel to deliver the mixture to the patient. If necessary, the needle used for reconstitution of the lyophilized medication can be removed and replaced with a cannula more suitable for injection into a patient. An example of a system of this nature is that shown in U.S. Pat. No. 5,752,940 to Grimard.
More complex prior art includes hypodermic syringes made of glass or plastic having multiple chambers; in most cases two chambers. In one particular case, a chamber has a stopper slidably disposed at an intermediate position. A lyophilized medication is stored in the chamber distally located to the stopper, while a selected diluent is stored in the chamber proximally of the stopper. A plunger is slidably disposed in fluid-tight engagement with the chamber wall proximally of the diluent. Movement of the plunger in a distal direction urges both the diluent and the stopper toward the lyophilized medication. The stopper eventually will align with a bypass region formed in the syringe barrel, and further movement of the plunger will cause the diluent to flow through the bypass and into the distal portion of the chamber for fully mixing with the lyophilized medication. An example of a hypodermic syringe similar to the above is shown in U.S. Pat. No. 4,599,082 to Grimard.
The two-component hypodermic syringe assembly described above can function well; however, the need for two axially-spaced chambers along the body of the hypodermic syringe necessitates a longer syringe. In particular, the need for a chamber large enough to mix all of the diluent with all of the lyophilized medication before delivery to the patient dictates a space requirement that makes a container larger than if all the diluent and medication were not mixed before the delivery step. Since the lyophilizing process generally is carried out in the syringe, the lyophilizing apparatus must then be large enough to accommodate the longer syringe. Larger hypodermic syringes and correspondingly larger lyophilizing apparatus are more costly and require more space, which also increases cost.
Currently known devices and methods require thorough reconstitution and mixing of a lyophilized product into a diluent prior to injection, and can typically involve lengthy procedures (in excess of ten steps) in order to reconstitute a solid medication into a liquid formulation prior to administration. Such lengthy reconstitution steps can be complex, arduous, and tedious and may render injection of the lyophilized product unfeasible. Moreover, these complicated procedures present risks of foaming, contamination, and accidental needle pricks to the caregiver.
One of the most important aspects with the distribution of lyophilized product is the reliability of the container. Another important aspect is the control over costs of distribution. Devices used for pharmaceutical products must be disposable but at the same time, of high quality so that the patient is assured of accurately receiving the medication prescribed. Containers for lyophilized medical products should have a low cost, should be reliably usable, and should not negatively affect the shelf life of the product or its quality. Additionally, the container should be easily and safely usable and intuitive to use. Containers having a large number of parts can be less reliable and more expensive to manufacture. Those with movable parts are more so.
By using a diluent from a separate vial or ampule, a separate space for a diluent is not required in the medication container, and it can be more compact. Thus, the syringe barrel can be substantially shorter than prior art two-component syringe assemblies, and a smaller lyophilizing apparatus also can be used. Even better is the use of blunt cannulas to conduct the diluent into the lyophilized medication. Providing a reconstitution container that does not include a movable plunger is even better for reliability and reduced cost.
In prior reconstitution devices and methods, the diluent is fully mixed with the lyophilized medication before delivery to the patient. In such fully mixed form, the concentration of the medication in the patient delivery is constant throughout the entire injection; i.e., there is no gradient. However, it has been found in some therapeutic settings that a gradient delivery of medication would be clinically beneficial to a patient. In particular, a higher concentration of the medication in the initial delivery tapering to a lower concentration during later delivery has been found to provide certain advantages. A device and method that provide such a concentration gradient delivery profile without any separate manipulation would be beneficial.
In other drug or other solution delivery contexts, there are at times needs related to delivering multiple drugs or substances substantially simultaneously as being advantageous in both efficiency in administration and clinical effect. One or more such drugs or substances may be in powder form as having been lyophilized as above-described or may be stored in liquid form, in either case it being desirable not to mix such drugs or substances until administration so as to avoid instability, a premature or unwanted chemical reaction, or other adverse effects; storage of such a combination in mixed form may in cases also simply be prohibited or unsupported by regulatory authorities. Similarly, there may be clinical contexts for on-demand mixing of two liquid drugs or of a liquid drug and other chemical that in any such case would be adversely affected by pre-mixing and would benefit from a substantially simultaneous mixing and delivery step. There is thus a need for a solution delivery device and method that allows for on-demand mixing of drugs and/or chemicals or other substances where prior mixing is undesirable.
Hence those skilled in the art have recognized the need for an improved reconstitution device that facilitates lyophilization, storage, and the rapid reconstitution of dried medications as well as the on-demand mixing and delivery of various combinations of drugs and chemicals stored in solid or liquid form. Another need has been recognized for a reduced size reconstitution device so that costs both in lyophilization and storage are reduced. Another recognized need is for the ability to reduce the number of steps in reconstitution of a dried medication. A further such need has been recognized to be able to quickly and safely administer lyophilized medications âin the fieldâ in emergency situations or otherwise. Reduction in manufacturing complexity and cost are also needs recognized by those of skill in the art. Relatedly, a need has been recognized to enable initial filling of the reconstitution device with the liquid medications pre-lyophilization on a vial fill line or syringe fill line. Yet another need has been recognized to prevent access to the medication within the reconstitution device once lyophilization is completed. An additional need has been recognized for a device that controllably delivers with a gradient concentration. The present invention fulfills these needs and others.
SUMMARY
Aspects of the present invention teach certain benefits in construction and use which give rise to the exemplary advantages described below.
Aspects of the present specification provide a solution delivery device having a container component and a plug component configured for selective engagement with the container component. The container component has an internal cavity including an elongated mixing channel containing a first constituent, and the plug component provides an internal flow path configured for introduction of a second constituent into the mixing channel for mixing with the first constituent. The plug component may be inserted within the container component partially in a first operational mode and fully in a second operational mode.
Other aspects of the present specification provide for the first constituent being a drug and the second constituent a diluent, such that the drug may be lyophilized with the device in the first operational mode and reconstituted with the device in the second operational mode.
Other aspects of the present specification provide for multiple solution delivery devices being employed in tandem for the co-delivery of multiple constituents.
Other aspects of the present specification provide for such a solution delivery device being included in a kit.
Other aspects of the present specification provide for such a solution delivery device being installed within an injector.
Other features and advantages of aspects of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of aspects of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings illustrate aspects of the present invention. In such drawings:
FIG. 1 illustrates an exploded perspective view of an exemplary solution delivery device according to aspects of the present invention;
FIG. 2 illustrates an enlarged perspective view of an exemplary container component thereof;
FIG. 3 illustrates an enlarged perspective view of an exemplary plug component thereof;
FIG. 4 illustrates an exploded side cross-sectional view thereof;
FIG. 5 illustrates an assembled side cross-sectional view thereof in a first mode of operation;
FIG. 6 illustrates an assembled side cross-sectional view thereof in a second mode of operation;
FIG. 7 illustrates an exploded perspective view of an alternative exemplary solution delivery device according to aspects of the present invention;
FIG. 8 illustrates an enlarged perspective view of an exemplary container component thereof;
FIG. 9 illustrates an enlarged perspective view of an exemplary plug component thereof;
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This is a continuation application and so claims the benefit pursuant to 35 U.S.C. § 120 of a prior filed and U.S. non-provisional patent application Ser. No. 14/848,062, filed on Sep. 8, 2015, which itself claims priority pursuant to 35 U.S.C. § 119(e) to and is entitled to the filing date of U.S. provisional patent application Ser. No. 62/048,089, filed on Sep. 9, 2014. The contents of the aforementioned applications are incorporated herein by reference.
The invention relates generally to drug delivery and more particularly, to a solution delivery device and method for storing and mixing medications and related chemicals.
Due to continued advances in genetic and cell engineering technologies, proteins known to exhibit various pharmacological actions in vivo are capable of production in large amounts for pharmaceutical applications. However, one of the most challenging tasks in the development of protein pharmaceuticals is to deal with the inherent physical and chemical instabilities of such proteins, especially in aqueous dosage forms. Pre-filled hypodermic syringes in which these protein pharmaceuticals and other medications are stored in aqueous form offer many efficiencies. However, many injectable medications degrade rapidly and lose their effectiveness in solution. Refrigeration and special packaging can increase shelf-life, but add to cost, complicate storage, and offset many efficiencies provided by pre-filled syringes.
Because of the instability associated with the aqueous dosage forms, powder formulations are generally preferred to achieve sufficient stability for the desired shelf-life of a product. Various techniques to prepare dry powders are known and practiced in the pharmaceutical and biotechnology industry. Such techniques include lyophilization, spray-drying, spray-freeze drying, bulk crystallization, vacuum drying, and foam drying. Lyophilization (freeze-drying) is often a preferred method used to prepare dry powders (lyophilizates) containing proteins. Various methods of lyophilization are well known to those skilled in the art. The lyophilization apparatus and process applies a vacuum that converts liquid portions of a medication into a solid which is subject to a sub-atmospheric pressure to create a vapor. The vapor is drawn from the lyophilization chamber through vapor passages and exhausted to regions external of the lyophilizing apparatus. The lyophilizing process reduces the liquid medication to a dried powdery or granular form.
More particularly, freeze drying, or lyophilization, is a dehydration technique. It takes place while a product is in a frozen state (ice sublimation under a vacuum) and under a vacuum (drying by gentle heating). These conditions stabilize the product, and minimize oxidation and other degradative processes. The conditions of freeze drying permit running the process at low temperatures, therefore, thermally labile products can be preserved. Freeze drying has become an accepted method of processing heat sensitive products that require long term storage at temperatures above freezing.
Steps in freeze drying include pretreatment, freezing, primary drying, and secondary drying. Pretreatment includes any method of treating the product prior to freezing. This may include concentrating the product, formulation revision (i.e., addition of components to increase stability and/or improve processing), decreasing a high vapor pressure solvent or increasing the surface area. Methods of pretreatment include: freeze concentration, solution phase concentration, and formulating specifically to preserve product appearance or to provide lyoprotection for reactive products.
The second step is to freeze the product. Freezing the product decreases chemical activity by decreasing molecular movement. Freezing is essentially the dehydration step in freeze drying; once the solvent matrix is in the solid (frozen) state, the solute matrix is âdry,â (although it may contain some amorphous water). A rule of thumb for freezing product is that the product container should preferably not be filled with product to more than half of its total volumetric rating. In practice this may also mean filling the product only to certain depth to facilitate freezing, ice sublimation, and final water/solvent removal. This helps insure, in most cases, that the surface to depth ratio is such that freeze drying is not impeded by the product depth.
Once the product is at the end of its lyophilization cycle it should be removed from the freeze dryer. In a stoppering shelf/tray dryer, an inert gas may be bled into the chamber forming an inert âgas capâ over the product prior to stop. Many products are simply stoppered while under vacuum. The stoppers used most commonly on serum vials/bottles have a vacuum integrity of approximately five years when used in conjunction with tear-off seals. Once the product is stoppered, the system is returned to atmospheric pressure and the lyophilizing shelves are unloaded.
Many devices presently exist in which lyophilized medication is stored in the chamber of a hypodermic syringe. Shortly prior to delivery to a patient, reconstitution is achieved by removing the tip cap from the syringe and placing the sharpened cannula of the syringe into a diluent container such as a vial, ampule, or any other rigid or flexible reservoir which could be engaged to the syringe. The plunger of the syringe is then pulled proximally to draw the diluent into the lyophilized medication chamber for mixing. The diluent reservoir is then removed and discarded. The diluent/powder solution in the syringe is then shaken sufficiently for complete mixing. Unless a sharpened cannula is already attached, one is mounted to the distal end of the syringe and the cannula is used to pierce the patient's skin at an injection site. The syringe plunger is then pushed into the syringe barrel to deliver the mixture to the patient. If necessary, the needle used for reconstitution of the lyophilized medication can be removed and replaced with a cannula more suitable for injection into a patient. An example of a system of this nature is that shown in U.S. Pat. No. 5,752,940 to Grimard.
More complex prior art includes hypodermic syringes made of glass or plastic having multiple chambers; in most cases two chambers. In one particular case, a chamber has a stopper slidably disposed at an intermediate position. A lyophilized medication is stored in the chamber distally located to the stopper, while a selected diluent is stored in the chamber proximally of the stopper. A plunger is slidably disposed in fluid-tight engagement with the chamber wall proximally of the diluent. Movement of the plunger in a distal direction urges both the diluent and the stopper toward the lyophilized medication. The stopper eventually will align with a bypass region formed in the syringe barrel, and further movement of the plunger will cause the diluent to flow through the bypass and into the distal portion of the chamber for fully mixing with the lyophilized medication. An example of a hypodermic syringe similar to the above is shown in U.S. Pat. No. 4,599,082 to Grimard.
The two-component hypodermic syringe assembly described above can function well; however, the need for two axially-spaced chambers along the body of the hypodermic syringe necessitates a longer syringe. In particular, the need for a chamber large enough to mix all of the diluent with all of the lyophilized medication before delivery to the patient dictates a space requirement that makes a container larger than if all the diluent and medication were not mixed before the delivery step. Since the lyophilizing process generally is carried out in the syringe, the lyophilizing apparatus must then be large enough to accommodate the longer syringe. Larger hypodermic syringes and correspondingly larger lyophilizing apparatus are more costly and require more space, which also increases cost.
Currently known devices and methods require thorough reconstitution and mixing of a lyophilized product into a diluent prior to injection, and can typically involve lengthy procedures (in excess of ten steps) in order to reconstitute a solid medication into a liquid formulation prior to administration. Such lengthy reconstitution steps can be complex, arduous, and tedious and may render injection of the lyophilized product unfeasible. Moreover, these complicated procedures present risks of foaming, contamination, and accidental needle pricks to the caregiver.
One of the most important aspects with the distribution of lyophilized product is the reliability of the container. Another important aspect is the control over costs of distribution. Devices used for pharmaceutical products must be disposable but at the same time, of high quality so that the patient is assured of accurately receiving the medication prescribed. Containers for lyophilized medical products should have a low cost, should be reliably usable, and should not negatively affect the shelf life of the product or its quality. Additionally, the container should be easily and safely usable and intuitive to use. Containers having a large number of parts can be less reliable and more expensive to manufacture. Those with movable parts are more so.
By using a diluent from a separate vial or ampule, a separate space for a diluent is not required in the medication container, and it can be more compact. Thus, the syringe barrel can be substantially shorter than prior art two-component syringe assemblies, and a smaller lyophilizing apparatus also can be used. Even better is the use of blunt cannulas to conduct the diluent into the lyophilized medication. Providing a reconstitution container that does not include a movable plunger is even better for reliability and reduced cost.
In prior reconstitution devices and methods, the diluent is fully mixed with the lyophilized medication before delivery to the patient. In such fully mixed form, the concentration of the medication in the patient delivery is constant throughout the entire injection; i.e., there is no gradient. However, it has been found in some therapeutic settings that a gradient delivery of medication would be clinically beneficial to a patient. In particular, a higher concentration of the medication in the initial delivery tapering to a lower concentration during later delivery has been found to provide certain advantages. A device and method that provide such a concentration gradient delivery profile without any separate manipulation would be beneficial.
In other drug or other solution delivery contexts, there are at times needs related to delivering multiple drugs or substances substantially simultaneously as being advantageous in both efficiency in administration and clinical effect. One or more such drugs or substances may be in powder form as having been lyophilized as above-described or may be stored in liquid form, in either case it being desirable not to mix such drugs or substances until administration so as to avoid instability, a premature or unwanted chemical reaction, or other adverse effects; storage of such a combination in mixed form may in cases also simply be prohibited or unsupported by regulatory authorities. Similarly, there may be clinical contexts for on-demand mixing of two liquid drugs or of a liquid drug and other chemical that in any such case would be adversely affected by pre-mixing and would benefit from a substantially simultaneous mixing and delivery step. There is thus a need for a solution delivery device and method that allows for on-demand mixing of drugs and/or chemicals or other substances where prior mixing is undesirable.
Hence those skilled in the art have recognized the need for an improved reconstitution device that facilitates lyophilization, storage, and the rapid reconstitution of dried medications as well as the on-demand mixing and delivery of various combinations of drugs and chemicals stored in solid or liquid form. Another need has been recognized for a reduced size reconstitution device so that costs both in lyophilization and storage are reduced. Another recognized need is for the ability to reduce the number of steps in reconstitution of a dried medication. A further such need has been recognized to be able to quickly and safely administer lyophilized medications âin the fieldâ in emergency situations or otherwise. Reduction in manufacturing complexity and cost are also needs recognized by those of skill in the art. Relatedly, a need has been recognized to enable initial filling of the reconstitution device with the liquid medications pre-lyophilization on a vial fill line or syringe fill line. Yet another need has been recognized to prevent access to the medication within the reconstitution device once lyophilization is completed. An additional need has been recognized for a device that controllably delivers with a gradient concentration. The present invention fulfills these needs and others.
SUMMARY
Aspects of the present invention teach certain benefits in construction and use which give rise to the exemplary advantages described below.
Aspects of the present specification provide a solution delivery device having a container component and a plug component configured for selective engagement with the container component. The container component has an internal cavity including an elongated mixing channel containing a first constituent, and the plug component provides an internal flow path configured for introduction of a second constituent into the mixing channel for mixing with the first constituent. The plug component may be inserted within the container component partially in a first operational mode and fully in a second operational mode.
Other aspects of the present specification provide for the first constituent being a drug and the second constituent a diluent, such that the drug may be lyophilized with the device in the first operational mode and reconstituted with the device in the second operational mode.
Other aspects of the present specification provide for multiple solution delivery devices being employed in tandem for the co-delivery of multiple constituents.
Other aspects of the present specification provide for such a solution delivery device being included in a kit.
Other aspects of the present specification provide for such a solution delivery device being installed within an injector.
Other features and advantages of aspects of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of aspects of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings illustrate aspects of the present invention. In such drawings:
FIG. 1 illustrates an exploded perspective view of an exemplary solution delivery device according to aspects of the present invention;
FIG. 2 illustrates an enlarged perspective view of an exemplary container component thereof;
FIG. 3 illustrates an enlarged perspective view of an exemplary plug component thereof;
FIG. 4 illustrates an exploded side cross-sectional view thereof;
FIG. 5 illustrates an assembled side cross-sectional view thereof in a first mode of operation;
FIG. 6 illustrates an assembled side cross-sectional view thereof in a second mode of operation;
FIG. 7 illustrates an exploded perspective view of an alternative exemplary solution delivery device according to aspects of the present invention;
FIG. 8 illustrates an enlarged perspective view of an exemplary container component thereof;
FIG. 9 illustrates an enlarged perspective view of an exemplary plug component thereof;
FIG. 10 illustrates an exploded side cross-sectional view thereof;
FIG. 11 illustrates an assembled side cross-sectional view thereof in a first mode of operation;
FIG. 12 illustrates an assembled side cross-sectional view thereof in a second mode of operation;
FIG. 13 illustrates an exploded perspective view of an alternative exemplary drug delivery device according to aspects of the present invention;
FIG. 14 illustrates an enlarged perspective view of an exemplary container component thereof;
FIG. 15 illustrates an enlarged perspective view of an exemplary plug component thereof;
FIG. 16 illustrates an exploded side cross-sectional view thereof;
FIG. 17 illustrates an assembled side cross-sectional view thereof in a first mode of operation;
FIG. 18 illustrates an assembled side cross-sectional view thereof in a second mode of operation;
FIG. 19 illustrates an exploded perspective view of a further alternative exemplary drug delivery device according to aspects of the present invention;
FIG. 20 illustrates an enlarged assembled perspective view thereof in a first mode of operation;
FIG. 21 illustrates an enlarged assembled side cross-sectional view thereof in a second mode of operation;
FIG. 22 illustrates an exploded perspective view of a further alternative exemplary drug delivery device according to aspects of the present invention;
FIG. 23 illustrates an enlarged assembled side cross-sectional view thereof in a first mode of operation;
FIG. 24 illustrates an enlarged assembled side cross-sectional view thereof in a second mode of operation;
FIG. 25 illustrates an exploded perspective view of a further alternative exemplary drug delivery device according to aspects of the present invention;
FIG. 26 illustrates an assembled side cross-sectional view thereof in a first mode of operation;
FIG. 27 illustrates an assembled side cross-sectional view thereof in a second mode of operation;
FIG. 28 illustrates an exploded perspective view of a further alternative exemplary drug delivery device according to aspects of the present invention;
FIG. 29 illustrates a reduced scale assembled side cross-sectional view thereof in a first mode of operation;
FIG. 30 illustrates a reduced scale assembled side cross-sectional view thereof in a second mode of operation;
FIG. 31 illustrates an exploded perspective view of a further alternative exemplary drug delivery device according to aspects of the present invention;
FIG. 32 illustrates a reduced scale assembled side cross-sectional view thereof in a first mode of operation;
FIG. 33 illustrates a reduced scale assembled side cross-sectional view thereof in a second mode of operation;
FIG. 34 illustrates an exploded perspective view of a further alternative exemplary drug delivery device according to aspects of the present invention;
FIG. 35 illustrates an enlarged perspective view of an exemplary container component thereof;
FIG. 36 illustrates an enlarged perspective view of an exemplary plug component thereof;
FIG. 37 illustrates an exploded side cross-sectional view thereof;
FIG. 38 illustrates an assembled side cross-sectional view thereof in a first mode of operation;
FIG. 39 illustrates an assembled side cross-sectional view thereof in a second mode of operation;
FIG. 40 illustrates a perspective view of an exemplary solution delivery device according to aspects of the present invention as in FIGS. 1-6 shown in use in combination with a syringe and cannula;
FIG. 41 illustrates a perspective view of two exemplary solution delivery devices according to aspects of the present invention as in FIGS. 1-6 shown connected in series;
FIG. 42A illustrates a side schematic view, partially in section, of an exemplary solution delivery device according to aspects of the present invention as in FIGS. 13-18 shown operably installed within a medical injector in a first operational mode;
FIG. 42B illustrates a side schematic view, partially in section, of the exemplary solution delivery device shown operably installed within a medical injector as in FIG. 42A , now in a second operational mode;
FIG. 43A illustrates a side schematic view, partially in section, of an alternative exemplary solution delivery device according to aspects of the present invention shown operably installed within a medical injector in a first operational mode; and
FIG. 43B illustrates a side schematic view, partially in section, of the alternative exemplary solution delivery device shown operably installed within a medical injector as in FIG. 43A , now in a second operational mode.
The above described drawing figures illustrate aspects of the invention in at least one of its exemplary embodiments, which are further defined in detail in the following description. Features, elements, and aspects of the invention that are referenced by the same numerals in different figures represent the same, equivalent, or similar features, elements, or aspects, in accordance with one or more embodiments.
DETAILED DESCRIPTION
The present specification relates generally to a solution delivery device configured for delivering a delivery solution comprising at least two constituents without the need for a separate mixing, shaking, reconstituting, or priming step. It should be understood that the word âsolutionâ is to be interpreted broadly as any combination of two substances, whether any such substances begin in solid, semi-solid, liquid, or gaseous phase and whether any such combination ends in solid, semi-solid, liquid, or gaseous phase and further whether the combination is a mechanical mixture, involves a chemical reaction, or both. Such a solution expressly need not be homogeneous. Further, the word âconstituentâ is also to be interpreted broadly as any substance combined with another to form a delivery solution according to aspects of the present invention, such constituents including but not limited to a drug, a chemical, a matrix, an albumin, an antibody fragment, a marker, a carrier, a targeting molecule, a diagnostic, and a diluent or any combination thereof. Those skilled in the art will thus appreciate that while exemplary constituents forming exemplary delivery solutions in cooperation with exemplary solution delivery devices and methods and contexts of use are disclosed herein, the invention is not so limited, but may take numerous other forms in numerous other contexts without departing from the spirit and scope of the invention.
Referring now to FIGS. 1-6 , there is shown a first exemplary solution delivery device 40 according to aspects of the present invention. The device 40 generally comprises a container component 50 and a plug component 130 . The container component 50 has an open proximal end 52 and an opposite distal end 54 at which is formed an external ejection connector port 124 . The container component 50 is formed having a lower base wall 56 and an upper engagement wall 90 , more about which is said below as relating to engagement with the plug component 130 . The base wall 56 has an inner surface 58 and defines an internal cavity 60 with a size selected to contain a predetermined quantity of a first constituent. Within the cavity 60 there is formed or installed an elongated channel wall 62 to form an elongated mixing channel 66 having a substantially open top 68 and a substantially closed bottom 72 . Nearer to the open top 68 of the mixing channel 66 and substantially adjacent the inner surface 58 of the base wall 56 there is formed or defined a channel input end 70 in fluid communication with the plug outlet port 146 when the device 40 is in its second operational mode and an opposite output end 74 in fluid communication with the ejection connector port 124 , more about which is said below, particularly in connection with FIG. 6 . The plug component 130 is generally configured for selective engagement with the container component 50 in at least first and second operational modes, the plug component 130 having a proximal end 132 , an opposite distal end 134 , and a side wall 136 having an outer surface 138 disposed between the ends, the side wall 136 and distal end 134 together defining a plug periphery 140 . The plug component has an external inlet connector port 192 substantially at the proximal end 132 and an internal flow path 144 from the inlet connector port 192 to a plug outlet port 146 intersecting the plug periphery 140 . It will be appreciated by those skilled in the art that while the container and plug components
50 , 130 generally are shown as being annular, the invention is not so limited; rather, the components and their various features can take a variety of other geometric shapes and configurations without departing from the spirit and scope of the invention. Relatedly, and as will be appreciated with reference to the numerous alternative embodiments shown and described herein, the particular configurations of the walls, engagement surfaces and features, and sizes and proportions of any such features are merely illustrative of aspects of the present invention and non-limiting.
Referring to FIG. 2 , there is shown an enlarged perspective view of the exemplary container component 50 . Once more, the container component 50 generally comprises a lower base wall 56 and an upper engagement wall 90 forming its body. In the illustrated embodiment, the container component 50 further comprises an interconnecting groove 76 formed in the inner surface 58 of the base wall 56 so as to be in fluid communication with the input end 70 of the mixing channel 66 . Preferably, the interconnecting groove 76 is substantially lengthwise along the container component base wall 56 , though it will be appreciated that other orientations of the groove 76 may also be employed. The interconnecting groove 76 is of sufficient length to be in fluid communication with the plug outlet port 146 ( FIGS. 3-6 ) upon assembly of the plug component 130 within the container component 50 in the second operational mode, as shown in FIG. 6 , whereby the mixing channel 66 provides an indirect flow path between the plug outlet port 146 and the ejection connector port 124 . The container component 50 further generally comprises a distribution groove 78 formed in the inner surface 58 of the base wall 56 so as to be in fluid communication with the interconnecting groove 76 . In the exemplary embodiment, the distribution groove 78 is configured as an upwardly-opening step 80 in the inner surface 58 of the base wall 56 , such that the base wall 56 has a stepped inner bore. As shown, the step 80 is angled so as to provide a countersink transition to the inner surface 58 of the base wall 56 beneath or proximal of the step 80 . Further, the step 80 has a depth terminating along the inner surface 58 of the base wall 56 proximal of the channel wall top surface 64 , thereby forming a container seating portion 84 of the inner surface 58 between the step 80 and the mixing channel 66 , more about which is said below regarding the device 40 in use. In the exemplary embodiment as shown, once again, the container component 50 being substantially annular, it follows, though not necessarily so, that the distribution groove 78 here defined by the step 80 formed within the container component lower wall 56 is also substantially annular. Furthermore, as illustrated, the distribution groove is substantially continuous, though once more, there are configurations of the device in which there may not be a distribution groove or if there is it may not be continuous. Those skilled in the art will again appreciate that a variety of such components and configurations are possible without departing from the spirit and scope of the invention.
With continued reference to FIG. 2 in conjunction with FIG. 4 , the base wall 56 of the container component 50 is shown as terminating proximally in a substantially radially-outwardly extending container flange 86 that transitions to or terminates radially in the proximally extending engagement wall 90 , which itself terminates proximally in a radially-inwardly projecting engagement lip 92 . In the exemplary embodiment, the radially-inwardly projecting engagement lip 92 is formed on a flexible leg 102 defining a portion of the engagement wall 90 of the container component 50 . More particularly, as illustrated, four such flexible legs 102 are formed spaced about the engagement wall 90 , as by forming opposite and substantially vertical and parallel notches 104 in the wall 90 , with the flexible legs 102 being defined by the upwardly-extending portions of the wall 90 bound by the notches 104 so as to operate like living hinges. It will be appreciated that the container component 50 may thus be configured with virtually any number of flexible legs 102 with proximal, radially-inwardly projecting engagement lips 92 , such as two, three, four as shown, or more. Further, alternatively, the at least one radially-inwardly projecting engagement lip 92 itself may be flexible and configured for shifting relative to the plug component 130 as it is inserted within the container component 50 . For example, and by way of non-limiting illustration, the material from which the container component 50 may be formed, and particularly the legs 102 and/or lips 92 , so as to have the desired flexibility or resiliency, as well as meeting the requirements for medical use, including sterility, may include polyethylene, polypropylene, acrylic, nylon, silicone, or any combinations thereof or any other such materials now known or later developed. Those skilled in the art will appreciate that any such material now known or later developed may be employed in the present invention. As also shown, at least one container vent hole 98 is formed within the container flange 86 radially outwardly of the base wall 56 , whereby in the first operational mode of the device 40 with the plug component 130 partially inserted within the container component 50 , as shown in FIG. 5 , there is fluid communication between the inner cavity 60 of the container component and the surrounding atmosphere at least through the at least one container vent hole 98 . In the exemplary embodiment, the size and locations of the vent holes substantially correspond to the locations of the legs 102 and related lips 92 , as might result from or be accomplished through an injection molding process with a core pull to simultaneously form each vent hole 98 and undercut of the respective engagement lip 92 , though it will be appreciated that a wide variety of configurations and locations of such vent holes is possible without departing from the spirit and scope of the invention.
Turning to FIG. 3 , the exemplary plug component 130 is shown enlarged and inverted relative to FIG. 1 . The outer surface 138 of the side wall 136 of the plug component 130 is formed having a <figure-callout id="154" label="plug seating portion" filenames="US10894152-20210119-D00002.png,US10894152-20210119-D00003.png" state="{{state}}
CLAIMS
Claims ( 20 )
The invention claimed is:
1. A solution delivery device comprising:
a container component having a proximally-extending engagement wall and an internal cavity with a size selected to contain a predetermined quantity of a first constituent, the container component further having a distal end with an external ejection connector port;
a plug component configured for selective engagement with the container component in at least first and second operational modes, the plug component having a proximal end, a distal end, and a side wall having an outer surface disposed between the ends, the plug component further having an external inlet connector port substantially at the proximal end and an internal flow path from the inlet connector port to a plug outlet port, the plug component being formed on the distal end with a plug distal surface; and
an elongated channel wall installed within the internal cavity of the container component to form an elongated mixing channel, the channel wall having a wall top surface and being located within the container component such that the mixing channel has a substantially closed bottom and an open top adjacent the wall top surface, the mixing channel having an input end in fluid communication with the plug outlet port and an output end in fluid communication with the ejection connector port;
wherein in the first operational mode the plug component is partially inserted within the container component such that the plug distal surface is spaced from the wall top surface so as to facilitate the fluid communication between the internal cavity of the container component, and particularly the mixing channel, and the surrounding atmosphere;
wherein the wall top surface of the elongated channel wall is located within the container component facing the plug component so that when the plug component and the container component are fully assembled together in the second operational mode as by a proximal end of the container component engaging the proximal end of the plug component, the plug distal surface contacts the wall top surface and substantially closes the top of the elongated mixing channel so that the only access to the first constituent is provided by the input and output ends of the mixing channel; and
wherein forcing a second constituent through the inlet connector port with the device in the second operational mode causes the second constituent to flow through the internal flow path of the plug component and out the plug outlet port and into the input end of the mixing channel so as to mix with the first constituent, whereby the first and second constituents are sufficiently mixed as together traversing the mixing channel from the inlet end to the outlet end and then out through the ejection connector port as a delivery solution without the need for a separate mixing, shaking, reconstituting, or priming step.
2. The device according to claim 1 , wherein:
the engagement wall of the container component terminates proximally in a radially-inwardly projecting engagement lip; and
the outer surface of the side wall of the plug component is formed with an outwardly-opening engagement groove;
wherein, the plug component and container component are capable of being fully assembled together in the second operational mode by the engagement lip engaging the engagement groove.
3. The device according to claim 1 , wherein the container component further comprises a base wall with an inner surface and an interconnecting groove formed in the inner surface of the base wall so as to be in fluid communication with the input end of the mixing channel.
4. The device according to claim 3 , wherein the interconnecting groove is substantially lengthwise along the container component base wall and of sufficient length to be in fluid communication with the plug outlet port upon assembly of the plug component within the container component in the second operational mode, whereby the mixing channel provides an indirect flow path between the plug outlet port and the ejection connector port.
5. The device according to claim 3 , wherein the container component further comprises a distribution groove formed in one of the inner surface of the base wall or the outer surface of the side wall so as to be in selective fluid communication with the interconnecting groove.
6. The device according to claim 5 , wherein the distribution groove is formed as an upwardly-opening step in the inner surface of the base wall, such that the base wall has a stepped inner bore.
7. The device according to claim 1 , wherein the outer surface of the side wall of the plug component is formed having a plug seating portion configured to seat against a container seating portion of an inner surface of a base wall of the container component distal of the engagement wall upon assembly of the plug component within the container component in the second operational mode.
8. The device according to claim 1 , wherein:
the plug component is formed at the plug distal end with a distally-opening insert receiving cavity in fluid communication with the internal flow path; and
a plug insert is received within the insert receiving cavity, the plug insert formed on a top surface with at least one horizontal groove so as to be in fluid communication with the flow path and on an outer surface with at least one vertical groove intersecting and in fluid communication with the horizontal groove, the vertical groove further intersecting a distally-facing bottom surface of the plug insert, the vertical groove defining the plug outlet port and the lower surface defining the plug distal surface.
9. The device according to claim 1 , wherein:
the container component is formed with a container indexing surface; and
the plug component is formed with a plug indexing surface configured to selectively engage the container indexing surface as the plug component is seated within the container component, whereby in the second operational mode the plug outlet port is positioned substantially adjacent to the input end of the mixing channel.
10. The device according to claim 1 , wherein a container outlet cap is configured for selective sealable engagement with the external ejection connector port, the container outlet cap having an outlet cap wall terminating distally in an outlet cap base defining an outlet cap base surface, the outlet cap base surface being substantially planar and the outlet cap wall defining an outlet cap perimeter such that the device is capable of standing vertically on the container outlet cap.
11. The device according to claim 1 , wherein:
the first constituent is substantially in one of powder form or liquid form; and
the second constituent is substantially in liquid form.
12. A method of employing a solution delivery device as defined in claim 1 , the method comprising the steps of:
filling the predetermined quantity of the first constituent within the internal cavity of the container component;
positioning the plug component in the container component in the first operational mode of the device wherein the plug distal surface is spaced from the first constituent;
acting on the first constituent with the device in the first operational mode;
shifting the plug component to the second operational mode of the device wherein the plug component is fully seated within the container component and the plug distal surface is substantially adjacent to the first constituent; and
flowing the second constituent through an internal flow path formed within the plug component and into the internal cavity of the container component so as to contact the first constituent;
whereby the first and second constituents are sufficiently mixed in forming the delivery solution without the need for a separate mixing, shaking, reconstituting, or priming step.
13. The method according to claim 12 , wherein the step of shifting the plug component to the second operational mode comprises snapping the plug component within the container component.
14. The method according to claim 12 , wherein the step of flowing the second constituent further comprises activating an injector wherein the device is operably installed.
15. A solution delivery device according to claim 1 in combination with an injector.
16. The combination according to claim 15 , wherein the device is slidably installed within a housing of the injector.
17. The combination according to claim 15 , further comprising one of a membrane or a plug temporarily sealing the external inlet connector port of the device.
18. The combination according to claim 17 , wherein a reservoir is engaged with the external inlet connector port of the plug component, the reservoir containing the second constituent.
19. The combination according to claim 18 , wherein a plunger is operable within the reservoir to act on the second constituent, the plunger being biased distally by a plunger spring.
20. The combination according to claim 18 , wherein the device, the reservoir, the membrane or the plug, and a shielded cannula assembly together comprise an injector sub-assembly slidably installed within the housing, the injector sub-assembly being biased distally by an assembly spring anchored against a proximal housing cap engaged with the housing, whereby axial movement of the injector sub-assembly against the assembly spring as when the injector is to be activated by pushing proximally on the shielded cannula assembly compresses the plunger spring and shifts the plunger distally relative to the injector sub-assembly and particularly the reservoir, the membrane or plug being configured to fail upon proximal movement of the injector sub-assembly and distal movement of the plunger under the increased force of the plunger spring, whereby the second constituent stored in the reservoir is freed and forced to flow out of the reservoir and through the external inlet connector port of the plug component into the container component and there mix with the first constituent housed within the internal cavity of the container component to form the delivery solution then expelled through a cannula of the shielded cannula assembly.
US16/230,596
2014-09-09
2018-12-21
Solution delivery device and method
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2036-06-18
US10894152B2
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Solution delivery device and method
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2014-09-09
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Syringe device for mixing two components
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1995-03-22
1996-10-29
Abbott Laboratories
Syringe system accommodating separately storable prefilled containers for two constituents
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1995-02-27
1997-11-11
Schott Parenta Systems, Inc.
Dual chamber internal by-pass syringe assembly
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1992-04-30
1998-02-10
Takeda Chemical Industries, Ltd.
Prefilled syringe
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1994-01-25
1998-05-19
Becton Dickinson And Company
Syringe and method for lyophilizing and reconstituting injectable medication
JP2762088B2
( en )
1987-07-27
1998-06-04
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Self-priming injection site with check valve
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( en )
1995-03-29
1998-07-14
Abbott Laboratories
Syringe barrel for lyophilization, reconstitution and administration
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1995-03-22
1998-07-28
Abbott Laboratories
Pre-filled syringe drug delivery system
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1992-07-07
1998-10-06
Pharmacia & Upjohn Aktiebolag
Dual-chamber injection cartridge
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1996-09-23
1998-11-10
Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg
Prefilled hypodermic syringe
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1995-03-22
1999-03-02
Abbott Laboratories
Syringe system accomodating seperate prefilled barrels for two constituents
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1996-06-28
1999-05-04
Grimard; Jean Pierre
Stopper assembly having bypass features for use in a multi-chamber syringe barrel
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1998-05-08
1999-09-14
Sellars; Andy
Storage, admixing, and dispensing system
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1998-07-20
2000-11-21
Szapiro; Jaime Luis
Syringe with two variable volume chambers for containing and administering mixtures of products provided separately
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1997-11-28
2000-11-28
Pharmacia & Upjohn Ab
Syringe
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1999-10-13
2001-04-19
Societe De Conseils De Recherches Et D'applications Scientifiques (S.C.R.A.S.)
Device for reconstituting a therapeutic solution, suspension or dispersion
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1998-06-05
2001-08-22
Abbott Laboratories
System for storing, mixing and administering a drug
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1998-03-19
2001-11-20
Nihon Chemical Research Co., Ltd.
Injection syringe including device for preparation of injection
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2001-01-03
2002-05-14
Gc Corporation
Capsule for dental restoration material
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1996-06-03
2002-06-06
Applied Research Systems Ars Holding N.V.
Reconstituting device for injectable medication
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1998-12-18
2002-06-18
Biovalve Technologies, Inc.
Injection devices
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1999-03-19
2002-07-16
Arzneimittel Gmbh Apotheker Vetter & Ravensburg
Medical syringe with braked step-advance plunger
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2000-05-31
2002-08-27
Abbott Laboratories
Syringe systems for lyophilized drugs and methods for making the same
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1997-10-22
2002-12-26
3M Innovative Properties Company
Dispenser for an adhesive tissue sealant
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1998-07-20
2003-02-04
Jaime Luis Szapiro
Disposable syringe with single variable volume chamber
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1997-08-06
2003-04-15
Pharmacia Ab
Automated delivery device and method for its operation
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2002-03-15
2003-09-18
Ernst Muhlbauer Gmbh & Co. Kg
Multi-component mixing capsule, in particular for dental purposes
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2002-03-28
2003-10-02
Igal Sharon
Multi-compartment syringe
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1994-09-27
2004-02-17
Ottfried Waldenburg
Dual-chamber syringe and methods
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2000-12-06
2004-06-22
Illbruck Gmbh
Cartridge set for dispensing in-situ foam
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2001-10-11
2004-10-26
Gary J. Pond
Disposable aspirating safety syringe
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2001-08-18
2004-11-16
Arzneimittel Gmbh Apotheker Vetter & Co. Ravensburg
Mixing hypodermic syringe
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1997-12-04
2005-02-08
Baxter International Inc.
Sliding reconstitution device with seal
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2003-10-31
2005-05-05
Adam Hagmann
Laparoscopic spray device and method of use
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2003-12-23
2005-06-23
Fowles Thomas A.
Sliding reconstitution device for a diluent container
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2004-05-26
2005-12-01
Kriesel Marshall S
Fluid delivery apparatus with adjustable flow rate control
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