A method of reconstruction of a pharmaceutical composition

Abstract

The medical device is configured to be connected to a vial. The medical device includes a tubular body and an adapter. The tubular body forms a container for holding a composition and has a spike at its end. The spike has one or more through holes that are in fluid communication with the container. The adapter is formed together with the body or coupled to the body and is located on or around the spike.

Description

Technology Field

[0001] The present invention generally relates to medical devices, and more specifically to a medical device assembly comprising a medical device. The present invention also relates to a method for reconstitution of a pharmaceutical composition. Background Technology

[0002] In the field of pharmaceutical packaging, it is known that drug contents in the form of lyophilized drugs, powdered drugs, or active substances are stored in medical containers commonly referred to as "vials." Vials are typically made of glass and sealed with an elastomeric septum compressed by an aluminum cap. A portion of the elastomer in the center of the septum is covered with a plastic or aluminum part. This part can be removed by medical personnel prior to a reconfiguration procedure to allow access to the central section, which is made of rubber and can be punctured by a needle from an injection device such as a syringe.

[0003] To reconstitute a drug, users typically use a disposable syringe to transfer the diluent from an ampoule or vial to a vial containing the lyophilized or powdered drug. When the diluent is already stored in a pre-filled syringe, medical personnel transfer it directly from the syringe to the vial containing the lyophilized drug. Medical personnel use a needle for this transfer to puncture the rubber septum of the vial.

[0004] However, this process generally involves several steps. First, a standard needle is attached to a syringe pre-filled with a diluent. Next, the cap of a vial containing the dry vaccine is punctured using the needle. Finally, the dry vaccine and the diluent are mixed, and the solution is typically drawn back into an administration syringe by puncturing the vial cap with the needle. The object of the present invention is to provide an improvement over this conventional technology, which has many drawbacks.

[0005] In practice, the needle tip may be damaged during the entire process due to the removal of the needle shield, puncture of the vial septum, and / or misalignment during needle insertion. A damaged or bent needle, or one that may contain burs, becomes much less sharp during reconfiguration than before puncturing the vial cap, which can cause pain to the patient during drug administration.

[0006] Another major drawback of the known process is that when the user withdraws the reconstituted drug from the vial through the needle, the user must adjust the length of the needle section inserted into the vial by the amount of drug reduced in the vial. As a practical method, the user pulls the syringe out of the vial and slowly withdraws the needle from the container, keeping the needle opening in continuous contact with the drug—that is, below the surface of the drug. This handling is not only difficult to perform, but this movement of the needle can also result in the loss of a significant amount of the drug remaining in the vial. The problem to be solved

[0007] In one embodiment, a medical device is provided. The medical device is configured to be connected to a vial. The medical device comprises a tubular body and an adapter. The tubular body defines a container for holding a composition and has a spike at its end. The spike has one or more through holes that fluidly communicate with the container. The adapter is formed together with the body or coupled to the body and is located on or around the spike. means of solving the problem

[0008] In another embodiment, a medical device assembly comprising a plunger and the aforementioned medical device is provided.

[0009] According to another embodiment, a method for reconstituted a pharmaceutical composition is provided. The method comprises the steps of providing the aforementioned medical device assembly, connecting an adapter to a vial containing a solid drug, injecting a certain amount of diluent from the medical device assembly into the vial, mixing the diluent and the solid drug in the vial to produce a reconstituted pharmaceutical composition, drawing the reconstituted pharmaceutical composition from the vial into the main body, and separating the adapter from the main body. Brief explanation of the drawing

[0010] The foregoing features, other features and advantages of the present invention, and the manner of achieving them will become clearer and the invention itself will be better understood by referring to the following description of embodiments of the present invention described together with the accompanying drawings. FIG. 1 is an isometric view of a medical device assembly and a medical device thereof, illustrated as a vial spaced apart from the medical device assembly, according to one non-limiting embodiment of the described concept. FIG. 2 is another isometric view of the medical device assembly and the medical device for the same of FIG. 1, and is a drawing in which a vial connected to the medical device assembly is shown. Figure 3 is a front isometric projection of the medical device of Figure 1. Figure 4 is a partial enlarged view of the medical device of Figure 3. FIG. 5 is a cross-sectional view of the medical device assembly of FIG. 1 taken along line AA of FIG. 1, in which the plunger is moved to a fully pressed position. Figure 6 is a rear isometric projection of the medical device of Figure 1. Figure 7 is a partial enlarged view of the medical device of Figure 1. FIGS. 8a through 8j illustrate simplified drawings of embodiments of the described concept used to prepare a reconstituted drug for administration to a patient according to non-limiting embodiments of the described concept. FIG. 9 is a cross-sectional view of the medical device assembly of FIG. 2, taken along line BB of FIG. 2 and illustrated as having a vial containing a mixed and reconstituted drug. FIG. 10 is a cross-sectional view along the CC line of FIG. 11, illustrating a medical device assembly having an additional component in which an adapter is separated and connected to a medical device, according to an embodiment of the described concept. FIG. 11 is an isometric view of the medical device assembly and components of FIG. 10. FIG. 12 is an isometric view of another medical device according to another non-limiting embodiment of the disclosed concept. Specific details for implementing the invention

[0011] The reference numerals indicate the corresponding parts in various drawings. The examples described herein illustrate exemplary embodiments of the invention, and such examples should not be construed as limiting the scope of the invention in any way.

[0012] The following description is provided to enable a person skilled in the art to make and use the described embodiments considered to practice the concept of the present invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to a person skilled in the art. All such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0013] For the purposes of the following description, terms such as "top," "bottom," "right," "left," "vertical," "horizontal," "upper side," "lower side," "lateral," "longitudinal," and terms derived therefrom relate to the concept depicted in the drawings. However, it should be understood that the present invention may accommodate various alternative variations unless otherwise explicitly stated. It should be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the concept. Accordingly, specific dimensions and other physical characteristics associated with the embodiments described herein should not be construed as limiting.

[0014] As used herein, the term "distal" generally refers to the end of an object in contact with a patient. As used herein, the term "proximal" refers to the position furthest from the distal position of the object.

[0015] As used in this specification, the term “number” will mean 1 or an integer greater than 1 (e.g., plural).

[0016] FIG. 1 illustrates an isometric view of a medical device assembly (2) and a medical device (100) for the same, according to one non-limiting embodiment of the described invention, together with a vial (20) spaced apart from the medical device assembly (2). In one exemplary non-limiting embodiment, the medical device assembly (2) is a syringe assembly, and the medical device (100) is a syringe barrel. However, suitable alternative medical devices and assemblies may be considered herein. The medical device assembly (2) may generally be referred to as comprising a plunger (4) and a medical device (100). The plunger (4) is partially located inside the medical device (100) and is configured to slide within the medical device (100) to move a solution inside and outside the medical device (100). FIG. 2 illustrates a medical device assembly (2) connected to a vial (20). Typically, the vial (20) is closed by a perforable diaphragm. The above vial (20) may initially contain a solid drug, such as a dry vaccine, and the above medical device assembly (2) may initially contain a pharmaceutical composition, such as a diluent. When the above medical device assembly (2) is connected to the vial (20), as shown in FIG. 2, the solid drug and the pharmaceutical composition may be mixed by discharging the pharmaceutical composition into the vial (20), and the resulting composition, such as a vaccine, may be reabsorbed into the medical device assembly (2) for administration to a patient. This process will be discussed further below, along with the benefits associated with using the medical device assembly (2) and the medical device (100), such as protecting medical personnel from undesirable injury during the reconstitution and / or administration of the vaccine.

[0017] FIG. 3 shows an isometric view of a medical device (100), and FIG. 4 is an enlarged view of a portion of the medical device (100) of FIG. 3. As illustrated in FIG. 3, the medical device (100) has a tubular body (102) having a distal end (104) and a proximal end (105) spaced apart from it. The tubular body (102) further comprises a spike (106) located at the distal end (104), wherein the spike (106) is preferably hollow and has at least one through hole (108, 110) (see FIG. 5) to allow a solution to escape and enter the body (102). In an exemplary embodiment, it will be understood that the manufacture of the medical device (100) is advantageously simplified by using one or more through holes (108, 110) in the spike (106). However, suitable alternative embodiments, such as having a spike having a single through hole, are considered here. The medical device (100) includes a flange (107) that extends from the proximal end (105) of the main body (102) and is positioned generally perpendicular to the main body (102) in an exemplary embodiment. The medical device (100) further includes an adapter (120) formed together with or coupled with the main body (102). As such, it will be understood that the main body (102) and the adapter (120) may be a single component manufactured from a single piece of material, for example, an injection-molded piece in which the material member is formed from one or more polymers. When the medical device (100) having the adapter (120) is connected to a vial, the spike (106) is configured to penetrate the diaphragm of the vial to allow for the reconstitution of the drug.

[0018] As illustrated in FIG. 4, an exemplary adapter (120) is positioned on or around a spike (106) and has a plurality of deflector members (8 exemplary deflector members (122, 125, 128, 131, 134, 137, 140, 143 shown in FIG. 4)) each configured to be connectable to a vial (20) (Figs. 1 and 2). The deflector members (122, 125, 128, 131, 134, 137, 140, 143) may be a plurality of deflector members (122, 125, 128, 131, 134, 137, 140, 143) configured to surround the spike (106) and deform radially inward and outward with respect to the spike (106). The adapter (120) preferably comprises 2 to 10 deflector members, preferably 4 to 8 deflector members. Generally, the adapter members comprise 4, 5, 6, 7, or 8 deflector members. Preferably, each of the deflector members (122, 125, 128, 131, 134, 137, 140, 143) comprises an elongated member (123, 126, 129, 132, 135, 138, 141, 144) and a toothed portion (124, 127, 130, 133, 136, 139, 142, 145) extending inward from the elongated member toward the longitudinal axis of the main body (102) (e.g., the longitudinal axis (103) shown in FIG. 5). Preferably, each of the above-mentioned elongated members (123, 126, 129, 132, 135, 138, 141, 144) extends parallel to a longitudinal axis such as the axis (103).

[0019] With reference to FIG. 5, the function of the deflector member (137) will now be discussed. While the deflector member (137) is being discussed here, it will be understood that each of the other exemplary deflector members (122, 125, 128, 131, 134, 140, 143) functions substantially the same as the deflector member (137). As illustrated in FIG. 5, the elongated member (138) of the deflector member (137) has an end portion (148) located proximal to the opposite side of the tooth portion (139) of the deflector member (137). FIG. 5 further illustrates the deflector member (137) in a deflected position (137'), which is a first position indicated by a solid line and a second position indicated by a dotted line. As illustrated, the deflected position (137') corresponds to a deflector member (137) that is deflected radially outward with respect to the end portion (148). More specifically, the deflected position (137') preferably corresponds to the position of the deflector member (137) when the vial (20) (Figs. 1 and 2) and the medical device (100) are moved to a position connected to each other. Thus, during this movement, the vial (20) causes the deflector member (137) to initially be deflected radially outward, for example, to the deflected position (137'), and then to move radially inward again to the non-deflected position shown by the solid line in Fig. 5. In an exemplary embodiment, each of the deflector members (122, 125, 128, 131, 134, 137, 140, 143) is configured to be connectable to the vial (20) via a snap-fastening mechanism. Accordingly, it is preferable that the deflector members (122, 125, 128, 131, 134, 137, 140, 143) be deflected toward a non-deflected position. Thus, after moving radially inward, the tooth portion (see tooth portions (127, 139) in FIG. 9) advantageously allows fluid communication between the vial (20) and the medical device (100) by maintaining a connection between the vial (20) and the medical device (100).Specifically, when the vial (20) is connected to the medical device (100), at least a portion of the vial (20) is positioned between the tooth portion (124, 127, 130, 133, 136, 139, 142, 145) and the spike (106) to provide a relatively secure connection between the adapter (120) and the vial (20). Refer to FIG. 9 for illustration. Although the described concept has so far been discussed in relation to an adapter (120) having a deflector member (122, 125, 128, 131, 134, 140, 143) that allows connection to the vial (20), an adapter having a suitable alternative connection mechanism and / or a different geometric structure (not shown) is considered here.

[0020] Additionally, as illustrated in FIG. 5, it will be understood that not all deflector members (122, 125, 128, 131, 134, 137, 140, 143) can be configured to have exactly the same geometric structure. For example, the deflector member (128) is longer than the deflector member (125) located adjacent to the deflector member (128).

[0021] FIG. 6 is a rear isometric view of a medical device (100), and FIG. 7 is a partial enlarged view of the medical device (100) of FIG. 6. As illustrated, the adapter (120) has an annular base portion (150). The adapter (120) further includes a plurality of attachment portions (152, 154, 156, 158) (see FIG. 5) extending from the base portion (150) to a wall (146). The adapter may include at least two attachment portions, preferably two to six attachment portions, and more preferably, the adapter may include four attachment portions (152, 154, 156, 158). The attachment portions (152, 154, 156, 158) may be attached to the wall (146) at spaced-away isolated positions. The attachment portions (152, 154, 156, 158) may be formed together, for example, by injection molding. The base portion (150) generally surrounds the spike (106) and is preferably concentric with the wall (146). However, suitable alternative arrangements may be considered here. Additionally, the attachment portions (152, 154, 156, 158) are configured to be selectively removed from the wall (146) in response to rotation of the adapter (120) relative to the main body (102). Thus, the attachment portions (152, 154, 156, 158) may crumble from the previously attached wall (146). Accordingly, in an exemplary embodiment, the entire adapter (120) is attached to a wall (146) so that gripping and rotating the adapter (120) against the tubular body (102) causes the adapter (120) to be separated from the rest of the medical device (100). Accordingly, the attachment portions (152, 154, 156, 158) preferably provide the only location where the adapter (120) is attached to the body (102) and preferably provide a relatively strong mechanism for attachment, but are weak enough to allow the entire adapter (120) to be selectively removed from the body (102).It is desirable that the detachment of the adapter (120) from the medical device (100) be irreversible. The purpose of this property of the medical device (100) will be discussed below.

[0022] In addition to being configured to be connectable to the above-mentioned vial (20), the adapter (120) is configured to be connectable to a needle hub such as the needle hub (40) shown in FIG. 10. In an exemplary embodiment, to provide such a connection, the adapter (120) further comprises an annular wall (146) that extends distally from the main body (102) as shown in FIG. 4 and through which the spike (106) extends. The outer surface of the wall (146) may extend distally from the tubular main body (102). The wall (146) may have a threaded inner surface (147) that is threadably connected to the needle hub (40). However, other suitable connection mechanisms between the adapter and the needle hub are also within the scope of the described invention.

[0023] FIGS. 8a through 8j illustrate a process in which the disclosed invention may be employed. The plunger (204), vial (220), medical device (300), and additional components are depicted in a simplified manner rather than at scale. These components function substantially identically to the medical device assembly (2), vial (20), and components used in conjunction therewith, and similar reference numerals indicate similar components. As illustrated in FIG. 8a, the spike cap (380) may first be removed from the spike (306). Next, as illustrated in FIGS. 8b and 8c, an adapter (320), for example, a deflector member (325, 337), is connected to the vial (220). When the vial (220) and the adapter (320) are connected, the spike (306) penetrates the partition or stopper (221) of the vial to provide a fluid path between the interior of the vial (220) and the interior of the medical device (300). Next, as shown in FIG. 8d, a plunger (204) is pressed to transfer a certain amount of diluent (301) from a medical device (300) into a vial (220) containing a certain amount of solid drug (220). As shown in FIG. 8e, shaking the vial (220) mixes the diluent and the solid drug to produce a reconstituted mixed pharmaceutical composition (225).

[0024] FIGS. 8f and 8g illustrate a mixed, reconstituted pharmaceutical composition (225) that is reabsorbed into the interior of the medical device (300) by a plunger (204). As illustrated in FIG. 8h, the adapter (320) and the vial (220) are rotated together to separate, for example, from the spike (306). Although a wall similar to the aforementioned wall (146) is not illustrated with the medical device (300), it will be understood that separating the adapter (120) from the wall (146) can be achieved in a similar manner to how the adapter (320) is separated from the spike (306). For example, attachment parts (152, 154, 156, 158) that are separated from the wall (146) by rotation by a user may be referenced in relation to the above description. When the adapter (320) is separated from the spike (306), the needle hub (240) can be easily connected to the spike (306) as shown in FIGS. 8i and 8j. When FIGS. 8i and 8j is connected to the spike (306) via a pressure fastening mechanism, the needle hub (240) can be connected to the spike (306) or a suitable alternative part of the adapter (320) via any suitable alternative coupling mechanism, for example, without limitation via a screw connection or snap-fastened to the spike (306). Subsequently, when the needle shield (250) is removed from the needle hub (240), a needle (242) prepared for use on a patient is revealed. Since the needle (242) has not previously been used to produce the reconstituted pharmaceutical composition (225), for example, the needle (242) has not been inserted into the plug (221) and has not been used to inject the diluent and reabsorb the reconstituted pharmaceutical composition (225) back into the medical device (300), the needle (242) is advantageously in a safer state for use with a patient.Specifically, problems with the existing method, such as burrs caused by piercing the stopper or loss of sharpness of the needle caused by piercing the stopper, are resolved by using, for example, the medical device (300) and medical device (100) discussed above, which use spikes (106, 306) for this function.

[0025] FIG. 9 illustrates a medical device assembly (2) connected to a vial (20), where a diluent and a solid drug are mixed in the vial (20) to produce a reconstituted pharmaceutical composition (25). FIG. 10 illustrates a medical device assembly (2) in which the adapter (120) is separated in the manner described above and the reconstituted pharmaceutical composition (25) is reabsorbed into the main body (102). Additionally, the needle hub (40) is screw-connected to the inner surface (147) of the threads. Thus, the needle (42) connected to the needle hub (40) is in a relatively safe state for use with a patient for the same reasons described above in relation to FIG. 8a through 8j. Therefore, removing the needle shield (50) (shown in FIG. 11) from the needle hub (40) exposes a relatively sharp and substantially burr-free needle (42) for use with a patient.

[0026] According to another exemplary embodiment of the present invention, FIG. 12 illustrates another medical device (400) that can be used in a medical device assembly in substantially the same manner as the medical device (100) and the medical device assembly (2). However, as illustrated, the medical device (400) is different from the medical device (100). First, the medical device (400) has four deflector members (only one deflector member (422) is illustrated in FIG. 12). Second, the deflector member (422) has an elongated member (423) and a toothed portion (424) extending therefrom, but the elongated member (422) has a through hole.

[0027] A method for reconstituting a pharmaceutical composition comprises the steps of: providing a medical device assembly (2) and a medical device (100) containing a pharmaceutical composition such as a diluent; connecting an adapter (120) to a vial (20), wherein the vial (20) contains a solid drug such as a lyophilized drug; injecting a certain amount of diluent from the medical device assembly (2) into the vial (20); mixing the diluent and the solid drug within the vial to produce a reconstituted pharmaceutical composition (25); drawing the reconstituted pharmaceutical composition (25) from the vial into a main body (102); and separating the adapter (120) from the main body (102). The method may also optionally include the step of removing a spike cap from a spike (106), and optionally the step of injecting the reconstituted pharmaceutical composition (25) into a patient.

[0028] Accordingly, the described invention provides an improved (e.g. safer and better in terms of causing less pain to the patient) medical device assembly (2) and a medical device (100, 300, 400) for the same, wherein a solid drug such as a vaccine can be mixed with a pharmaceutical composition such as a diluent, so that a reconstituted pharmaceutical composition is obtained and can be administered to the patient with a substantially sharper and relatively burr-free needle (42, 242).

[0029] The elements of the described embodiment may be combined with elements of one or more other disclosed embodiments to form different combinations, all of which are considered to be within the scope of the present invention.

[0030] Although the present invention has been described as having an exemplary design, the invention may be further modified within its spirit and scope. Accordingly, this application is intended to include all variations, uses, or modifications of the content of the invention by using general principles. Furthermore, this application is intended to include such extensions from the invention that are known or within customary practice in the art to which the invention pertains and fall within the limits of the appended claims. Explanation of the symbols

[0031] 2; Medical device assembly 100: Medical devices 20: Vial 102: Tubular body 108, 110: Through holes 120: Adapter

Claims

Claim 1 A method for reconstituting a pharmaceutical composition, wherein the method for reconstituting the pharmaceutical composition comprises the step of providing a medical device, wherein the medical device comprises: a tubular body forming a container for receiving the composition; a spike disposed at the distal end of the tubular body, wherein the spike has one or more through holes fluidly communicating with the container; and an adapter to be connected to a vial, wherein the adapter comprises a wall extending distally from the tubular body and integral with the tubular body, an annular base portion, and a plurality of attachment portions extending from the base portion to the wall; wherein the base portion surrounds the spike. A method for reconstituting a pharmaceutical composition, characterized by comprising: connecting the adapter to the vial so that the spike perforates the diaphragm of the vial containing the solid drug; injecting a certain amount of diluent from the tubular body into the interior of the vial; mixing the diluent and the solid drug within the vial to produce a reconstituted pharmaceutical composition; drawing the reconstituted pharmaceutical composition from the vial into the interior of the tubular body; rotating the adapter relative to the tubular body so that the attachment portion is irreversibly separated from the wall, wherein the spike is maintained extending from the distal end of the tubular body after the attachment portion is irreversibly separated; and separating the adapter from the tubular body. Claim 2 A method for reconstructing a pharmaceutical composition according to claim 1, wherein the base portion comprises a plurality of deflector members each capable of being connected to the vial. Claim 3 A method for reconstructing a pharmaceutical composition according to paragraph 2, wherein a plurality of deflector members are a plurality of deflector members that surround the spike and deflect radially inward and outward with respect to the spike. Claim 4 A method for reconstructing a pharmaceutical composition according to claim 1, wherein the number of attachment portions is a plurality; and the plurality of attachment portions are each attached to the wall at spaced-apart isolated locations. Claim 5 A method for reconstructing a pharmaceutical composition according to claim 2, characterized in that each deflector member is capable of being connected to a vial through a snap-fastening mechanism. Claim 6 A method for reconstructing a pharmaceutical composition according to claim 1, wherein the wall of the adapter is annular; and the spike extends through the annular wall. Claim 7 A method for reconstructing a pharmaceutical composition according to claim 1, wherein the wall has a screw-type inner surface configured to be screw-fastened with a needle hub. Claim 8 A method for reconstructing a pharmaceutical composition according to claim 2, wherein each of the above-mentioned deflector members comprises an elongated member and a toothed portion extending inwardly from the elongated member toward the longitudinal axis of the tubular body. Claim 9 A method for reconstructing a pharmaceutical composition according to claim 8, wherein a plurality of deflector members include a first deflector member and a second deflector member disposed adjacent to the first deflector member; and wherein the elongated member of the first deflector member is longer than the elongated member of the second deflector member. Claim 10 A method for reconstructing a pharmaceutical composition according to claim 8, wherein the slender member comprises an end portion disposed on the distal portion opposite to the tooth portion; and each of the slender members is configured to be deflected around the end portion. Claim 11 A method for reconstituting a pharmaceutical composition according to claim 1, wherein the medical device comprises a plunger movably disposed inside the tubular body. Claim 12 A method for reconstituting a pharmaceutical composition according to claim 1, further comprising the step of connecting a needle hub to a tubular body on the spike. Claim 13 A method for reconstituting a pharmaceutical composition according to claim 12, characterized in that the needle hub is pressurized and fastened to the tubular body.

Images