Methods for reconstituting medical devices, medical device assemblies containing the same, and pharmaceutical compositions.
The medical device assembly with a spike and adapter addresses needle damage and drug loss issues, ensuring a safer and more efficient reconstitution process with a sharper needle for patient administration.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2026-02-24
- Publication Date
- 2026-04-23
AI Technical Summary
The existing process of reconstituting pharmaceutical compositions is marred by needle damage, misalignment, and drug loss due to difficult handling, leading to dull needles and patient discomfort during injection.
A medical device assembly comprising a tubular body with a spike and an adapter featuring deflector members that securely connect to a vial, allowing for safe and efficient mixing and transfer of pharmaceutical compositions without prior needle piercing, ensuring a sharp needle for administration.
The solution provides a safer and more efficient process with reduced needle damage and drug loss, resulting in a sharper needle for patient administration, minimizing pain and improving handling efficiency.
Smart Images
Figure 2026069723000001_ABST
Abstract
Description
Technical Field
[0001] The present disclosure generally relates to medical devices, and more specifically to medical device assemblies including medical devices. The present disclosure also relates to a method for reconstituting pharmaceutical compositions.
Background Art
[0002] In the field of pharmaceutical packaging, it is known to store drug contents in a medical container, usually called a "vial", in the form of, for example, a lyophilized drug, a power drug, or an active substance of a drug. The vial is usually made of glass and is sealed with an elastomeric septum crimped with an aluminum cap. A part of the elastomer in the center of the septum is covered with a plastic or aluminum part. This part can be removed by a medical professional before the reconstitution procedure, so that the medical professional can access the rubber central part that can be pierced by the needle of an injection device such as a syringe.
[0003] To reconstitute the drug, the user typically uses a disposable syringe to transfer the diluent from an ampoule or vial to a vial containing the lyophilized drug or power drug. If the diluent is already stored in a prefilled syringe, the medical professional transfers the diluent directly from the syringe to the vial containing the lyophilized drug. The medical professional uses a needle for this transfer to pierce a hole in the rubber septum of the vial.
[0004] However, this process usually includes several procedures. First, a standard needle can be attached to a syringe prefilled with the diluent. Next, the needle can be used to pierce the stopper of the vial containing the dry vaccine. Finally, the dry vaccine and the diluent are mixed, usually by piercing the vial stopper with the needle, sucking the solution back into the syringe, and administering it. The object of the present invention is to improve this technology, which is troubled by many drawbacks.
[0005] In fact, throughout the entire process, the needle tip can be damaged due to the removal of the needle shield, piercing the vial septum, and / or misalignment during needle insertion. Therefore, a damaged or bent needle, or one that may contain burrs, will be significantly less sharp (duller) than before piercing the vial stopper during reconfiguration, potentially causing pain to the patient during drug injection.
[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 needs to adjust the length of the portion of the needle inserted into the vial as the amount of drug in the vial decreases. In practical terms, the user needs to slowly withdraw the needle from the container by pulling the syringe away from the vial so that the opening of the needle remains in contact with the drug at all times, i.e., below the surface of the drug. Not only is this handling difficult, but such movement of the needle within the vial can lead to the loss of a considerable amount of drug remaining in the vial. [Overview of the project]
[0007] In one embodiment, a medical device is provided. The medical device is configured to be connected to a vial. The medical device includes a tubular body and an adapter. The tubular body defines a container for containing a composition and has a spike located at its distal end. The spike has at least one through-hole for fluid communication with the container. The adapter is formed integrally with the body or coupled to the body and is positioned on or around the spike.
[0008] In another embodiment, a medical device assembly is provided that includes a plunger and the aforementioned medical device.
[0009] In another embodiment, a method for reconstituting a pharmaceutical composition is provided. This method includes providing the aforementioned medical device assembly, connecting an adapter to a vial, placing a solid drug in the vial, injecting a certain amount of diluent from the medical device assembly into the vial, mixing the diluent and solid drug in the vial to produce a reconstituted pharmaceutical composition, aspirating the reconstituted pharmaceutical composition from the vial into the body, and detaching the adapter from the body. [Brief explanation of the drawing]
[0010] The aforementioned and other features and advantages of this disclosure, as well as the methods for achieving them, will become more apparent and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings. [Figure 1] Figure 1 is an isometric view of a medical device assembly and a medical device therefor, shown with a vial spaced apart from the medical device assembly, according to one non-limiting embodiment of the disclosed concept. [Figure 2] Figure 2 shows the medical device assembly from Figure 1 and another isometric view of the same medical device, with the vial connected to the medical device assembly. [Figure 3] Figure 3 is a front isometric view of the medical device shown in Figure 1. [Figure 4] Figure 4 is a magnified view of a part of the medical device shown in Figure 3. [Figure 5] Figure 5 is a cross-sectional view of the medical device assembly of Figure 1, taken along line AA in Figure 1, with the plunger moved to the fully depressed position. [Figure 6] Figure 6 is a front isometric view of the medical device shown in Figure 1. [Figure 7] Figure 7 is a magnified view of a part of the medical device shown in Figure 6. [Figure 8A] Figure 8A is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8B]Figure 8B is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8C] Figure 8C is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8D] Figure 8D is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8E] Figure 8E is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8F] Figure 8F is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8G] Figure 8G is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8H] Figure 8H is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8I] Figure 8I is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 8J] Figure 8J is a simplified diagram of an embodiment of the disclosed concept used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concept. [Figure 9]Figure 9 is a cross-sectional view of the medical device assembly in Figure 2, taken along line BB in Figure 2, with the vial containing the mixed and reconstituted drug. [Figure 10] Figure 10 is a cross-sectional view taken along line CC in Figure 11, showing a medical device assembly in which the adapter has been removed and additional components are connected to the medical device, according to the disclosed embodiment of the concept. [Figure 11] Figure 11 is an isometric view of the medical device assembly and components shown in Figure 10. [Figure 12] Figure 12 is an isometric view of another medical device according to another non-limiting embodiment of the disclosed concept. Corresponding reference numerals indicate corresponding parts in some of the figures. The examples presented herein illustrate exemplary embodiments of the disclosure and should not be construed as limiting the scope of the disclosure in any way. [Modes for carrying out the invention]
[0011] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutes are intended to fall within the spirit and scope of the invention.
[0012] For the purposes of the description below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "uppermost", "lowermost", "lateral", "longitudinal", and derivatives thereof shall relate to the present invention as oriented in the drawings. However, it will be understood that the present invention may contemplate various alternative variations unless explicitly specified to the contrary. Also, it should be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be regarded as limiting.
[0013] As used herein, the term "distal" shall generally mean the end of an object that contacts the patient. As used herein, the term "proximal" shall mean the position furthest from the distal position of the object.
[0014] As used herein, the term "a number" shall mean one or an integer greater than one (e.g., a plurality).
[0015] Figure 1 is an isometric view of a medical device assembly 2 and a medical device 100 therefor, shown with a vial 20 spaced apart from the medical device assembly 2, according to one non-limiting embodiment of the disclosed concept. In one non-limiting embodiment, the medical device assembly 2 is a syringe assembly and the medical device 100 is a syringe barrel. However, it will be understood that suitable alternative medical devices and assemblies are contemplated herein. The medical device assembly 2 can generally be described as comprising a plunger 4 and the medical device 100. The plunger 4 is partially located within the medical device 100 and is configured to slide within the medical device 100 to transfer a solution into and out of the medical device 100. Figure 2 shows the medical device assembly 2 connected to a vial 20. Typically, the vial 20 is closed by a pierceable septum. The vial 20 may initially contain a solid drug, such as a dried vaccine, and the medical device assembly 2 may initially contain a pharmaceutical composition, such as a diluent. When the medical device assembly 2 is connected to the vial 20, as shown in Figure 2, the solid drug and pharmaceutical composition can be mixed by discharging the pharmaceutical composition into the vial 20, and the resulting composition, such as a vaccine, is aspirated back into the medical device assembly 2 for administration to the patient. This process, along with the advantages associated with using the medical device assembly 2 and the medical device 100 for it, such as protecting practitioners from undesirable injuries during vaccine reconstitution and / or administration, will be described further below.
[0016] Figure 3 shows an isometric view of the medical device 100, and Figure 4 shows an enlarged view of a portion of the medical device 100 in Figure 3. As shown in Figure 3, the medical device 100 has a tubular body 102 having a distal end 104 and a proximal end 105 spaced apart on the opposite side. The body 102 further has a spike 106 located at the distal end 104, the spike 106 is preferably hollow and has at least one through-hole 108, 110 (see also Figure 5) to allow a solution to enter and exit the body 102. In exemplary embodiments, it will be understood that the manufacture of the medical device 100 is advantageously simplified by using two or more through-holes 108, 110 in the spike 106. However, suitable alternative embodiments, such as those having a spike with only one single through-hole, are contemplated herein. The medical device 100 also includes a flange 107 extending from the proximal end 105 of the body 102, which in one exemplary embodiment is positioned substantially perpendicular to the body 102. The medical device 100 further includes an adapter 120 formed on or coupled to the body 102. It will be understood that the body 102 and the adapter 120 may be a single component made from a single material piece, for example, an injection-molded piece in which the material piece is formed from one or more polymers. When the medical device 100 with the adapter 120 is connected to a vial, the spike 106 is configured to penetrate the partition of the vial to allow for drug reconstitution.
[0017] Continuing to refer to Figure 4, the exemplary adapter 120 is provided with several deflector members (Figure 4 shows eight exemplary deflector members 122, 125, 128, 131, 134, 137, 140, 143) positioned on or around the spike 106 and configured to be connectable to the vial 20 (Figures 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 deflect inward and outward radially with respect to the spike 106. Advantageously, the adapter 120 may include 2 to 10 deflector members, preferably 4 to 8 deflector members. Typically, the adapter member includes four, five, six, seven, or eight deflection members. Preferably, each of the deflection members 122, 125, 128, 131, 134, 137, 140, and 143 includes elongated members 123, 126, 129, 132, 135, 138, 141, and 144, and teeth 124, 127, 130, 133, 136, 139, 142, and 145 extending inward from the elongated members toward the longitudinal axis of the body 102 (see, for example, the longitudinal axis 103 shown in Figure 5). Advantageously, each of the elongated members 123, 126, 129, 132, 135, 138, 141, and 144 extends parallel to the longitudinal axis, such as axis 103.
[0018] Next, the function of the deflection member 137 will be described with reference to Figure 5. While the deflection member 137 is discussed herein, it will be understood that each of the other exemplary deflection members 122, 125, 128, 131, 134, 140, and 143 functions substantially the same as the deflection member 137. As shown in Figure 5, the elongated member 138 of the deflection member 137 has an end 148 located opposite and proximal to the teeth 139 of the deflection member 137. Figure 5 further shows the deflection member 137 in a first position in the solid line diagram and in a second deflected position 137' in the dashed line diagram. As shown, the deflected position 137' corresponds to the deflection member 137 deflected radially outward around the end 148. More specifically, the deflected position 137' preferably corresponds to the position of the deflection member 137 when the vial 20 (Figures 1 and 2) and the medical device 100 are moved to a position where they are connected to each other. Therefore, during this movement, the vial 20 first deflects the deflection member 137 radially outward, for example, to a deflected position 137', and then moves it radially inward to a non-deflected position as shown in the solid diagram of Figure 5. In one exemplary embodiment, each of the deflection members 122, 125, 128, 131, 134, 137, 140, and 143 is configured to be connectable to the vial 20 via a snap-fit mechanism. Thus, the deflection members 122, 125, 128, 131, 134, 137, 140, and 143 are preferably biased toward the non-deflected position. Thus, after moving radially inward, the teeth (see teeth 127 and 139 in Figure 9) favorably maintain the connection between the vial 20 and the medical device 100, thereby enabling fluid communication 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 teeth 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. See Figure 9 for illustration.The disclosed concept has been discussed in conjunction with an adapter 120 having deflection members 122, 125, 128, 131, 134, 140, 143 to enable connection to vial 20, but suitable alternative connection mechanisms and / or adapters with different shapes (not shown) are contemplated herein.
[0019] Furthermore, as shown in Figure 5, it will be understood that not all deflection members 122, 125, 128, 131, 134, 137, 140, and 143 can be configured to have exactly the same shape. For example, deflection member 128 is longer than deflection member 125, which is positioned adjacent to it.
[0020] Figure 6 is a rear isometric view of the medical device 100, and Figure 7 is an enlarged view of a portion of the medical device 100 in Figure 6. As shown, the adapter 120 has an annular base portion 150. The adapter 120 further comprises several mounting portions 152, 154, 156, 158 (see also Figure 5) extending from the base portion 150 to the wall 146. The adapter may include at least two mounting portions, preferably between two and six, and more preferably the adapter includes four mounting portions 152, 154, 156, 158. The mounting portions 152, 154, 156, 158 may be attached to the wall 146 at spaced-apart, isolated positions. The mounting 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 are intended herein. Furthermore, mounting portions 152, 154, 156, and 158 are configured to be selectively removed from the wall 146 in response to the rotation of the adapter 120 relative to the body 102. Thus, mounting portions 152, 154, 156, and 158 are detachable from the wall 146 to which they were previously attached. Thus, in one exemplary embodiment, the entire adapter 120 is detachably mounted to the wall 146, and when the adapter 120 is gripped and rotated relative to the tubular body 102, the adapter 120 is detached from the rest of the medical device 100. Thus, mounting portions 152, 154, 156, and 158 preferably provide a single position to which the adapter 120 is mounted to the body 102, and advantageously provide a relatively strong mechanism for mounting, but weak enough to selectively remove the entire adapter 120 from the body 102. The removal of the adapter 120 from the medical device 100 is advantageously irreversible. The purpose of this attribute of medical device 100 will be discussed below.
[0021] In addition to being configured to be connectable to vial 20, the adapter 120 is configured to be connectable to a needle hub, such as the needle hub 40 shown in Figure 10. In one exemplary embodiment, to provide this connection, the adapter 120 further includes an annular wall 146 extending distally from the body 102, as shown in Figure 4, through which the spike 106 extends. The outer surface of the wall 146 may extend distally from the tubular body 102. The wall 146 may have a threaded inner surface 147 configured to connect threadlessly with the needle hub 40. However, other suitable connection mechanisms between the adapter and the needle hub are within the scope of the disclosed concept.
[0022] Figures 8A–8J illustrate one process in which the disclosed concepts can be used. Simplified depictions, not drawn to actual size, of the plunger 204, vial 220, medical device 300, and additional components are shown. These components function substantially the same as the medical device assembly 2, vial 20, and the components used in combination with them, and it will be understood that similar numbers represent similar components. As shown in Figure 8A, first, the spike cap 380 can be removed from the spike 306. Next, as shown in Figures 8B and 8C, the adapter 320 and, for example, the deflection members 325, 337 are connected to the vial 220. When the vial 220 and adapter 320 are connected, the spike 306 penetrates the vial's septum or stopper 221, providing a fluid path between the inside of the vial 220 and the inside of the medical device 300. Next, as shown in Figure 8D, the plunger 204 was pushed down to transfer a certain amount of diluent 301 from the medical device 300 into a vial 220 containing a certain amount of solid drug 220. As shown in Figure 8E, the vial 220 was shaken to mix the diluent and solid drug, resulting in a mixed, reconstituted pharmaceutical composition 225.
[0023] Figures 8F and 8G show the mixed and reconstituted pharmaceutical composition 225 being drawn into and returned to the medical device 300 by the plunger 204. In Figure 8H, the adapter 320 and vial 220 are detached from the spike 306, for example, by rotating them together. Although a wall similar to the wall 146 described above is not shown in the medical device 300, it will be understood that the detachment of the adapter 120 from the wall 146 is achieved in a similar manner to the detachment of the adapter 320 from the spike 306. See, for example, the above description of the mounting parts 152, 154, 156, and 158 that are detached from the wall 146 by rotation by the user. With the adapter 320 detached from the spike 306, the needle hub 240 can be easily connected to the spike 306, as shown in Figures 8I and 8J. Although shown in Figures 8I and 8J as being connected to the spike 306 via a press-fit mechanism, it will be understood that the needle hub 240 may be connected to the spike 306 or a suitable alternative part of the adapter 320 via a suitable alternative coupling mechanism, such as, for example, via a threaded connection or by snap-fitting to the spike 306, without limitation. Subsequently, removal of the needle shield 250 from the needle hub 240 presents the needle 242 prepared for use with a patient. Since the needle 242 has not been previously used for the preparation of the reconstituted pharmaceutical composition 225, for example, the needle 242 is not inserted into the stopper 221, nor is it used to inject the diluent and aspirate the reconstituted pharmaceutical composition 225 back into the medical device 300, the needle 242 is in a more favorable and safer state for use with a patient. Specifically, problems with existing methods, such as burrs being generated when the needle pierces the stopper, or the cutting performance deteriorating when the needle pierces the stopper, can be solved, for example, by adopting a medical device 300 that uses spikes 106 and 306 for this function, or the aforementioned medical device 100.
[0024] Figure 9 shows a medical device assembly 2 connected to a vial 20, in which the diluent and solid drug are mixed in the vial 20 to obtain a reconstituted pharmaceutical composition 25. Figure 10 shows the medical device assembly 2 with the adapter 120 removed in the manner described above, and the reconstituted pharmaceutical composition 25 aspirated and returned to the body 102. Furthermore, the needle hub 40 is threaded to the threaded inner surface 147. Thus, the needle 42 connected to the needle hub 40 is in a state that is relatively safe for use on a patient for the same reasons discussed above in relation to Figures 8A-8J. Thus, when the needle shield 50 (also shown in Figure 11) is removed from the needle hub 40, a relatively sharp, substantially burr-free needle 42 for use on a patient is exposed.
[0025] According to another exemplary embodiment of the concept, Figure 12 shows another medical device 400 that can be used in a medical device assembly in substantially the same manner as medical device 100 and medical device assembly 2. However, as shown, medical device 400 differs from medical device 100. Firstly, medical device 400 has four deflector members (only one deflector member 422 is shown in Figure 12). Secondly, deflector member 422 has an elongated member 423 and teeth 424 extending therefrom, but the elongated member 422 has through holes.
[0026] It will be understood that the method for reconstituting a pharmaceutical composition includes providing a medical device assembly 2, the medical device 100 containing a pharmaceutical composition such as a diluent, connecting an adapter 120 to a vial 20, the vial 20 containing a solid pharmaceutical such as a lyophilized pharmaceutical, injecting a certain amount of diluent from the medical device assembly 2 into the vial 20, mixing the diluent and the solid pharmaceutical in the vial to create a reconstituted pharmaceutical composition 25, drawing the reconstituted pharmaceutical composition 25 from the vial 20 into the main body 102, and removing 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.
[0027] Accordingly, the disclosed concepts provide improved (for example, but not limited to, safer and better in terms of causing less pain to the patient) medical device assemblies 2 and medical devices 100, 300, 400 therefor, such as vaccines, which can be mixed with pharmaceutical compositions such as diluents, thereby obtaining a reconstituted pharmaceutical composition that can be administered to a patient using substantially sharper, relatively burr-free needles 42, 242.
[0028] An element of one disclosed aspect may be combined with an element of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of this concept.
[0029] While this disclosure has been described to have an exemplary structure, it is subject to further modification within its spirit and scope. Therefore, this application is intended to encompass any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the scope of the appended claims, provided that such deviations are within the realm of known or customary practices in the relevant art.
Claims
1. A method for reconstituting a pharmaceutical composition, A tubular body that defines a container for containing the composition, A spike extending from the distal end of the main body, the spike having at least one through hole that allows fluid communication with the container, and An adapter configured to connect to a vial, the adapter comprising a wall extending distally from the body and integral with the body, an annular base portion, and several mounting portions extending from the base portion to the wall, the wall having a threaded inner surface configured to connect screw-type to a needle hub, and the base portion surrounding the spike. A process for providing a medical device equipped with, A step of connecting the adapter to the vial such that the spike pierces the partition wall of the vial, wherein the vial contains a solid drug, A step of injecting a certain amount of diluent into the vial from the tubular body, A step of preparing a reconstituted pharmaceutical composition by mixing the diluent and the solid drug in the vial, The steps include drawing the reconstituted pharmaceutical composition from the vial into the tubular body, A step of rotating the adapter relative to the tubular body so that the mounting portion is irreversibly separated from the wall, wherein after the mounting portion is irreversibly separated, the spike remains extending from the distal end of the tubular body. The steps include separating the adapter from the tubular body, Methods that include...
2. The method according to claim 1, wherein the base portion comprises several deflection members, each configured to be connectable to the vial.
3. The method according to claim 2, wherein the number of deflection members is a plurality of deflection members configured to surround the spike and deflect it radially inward and outward relative to the spike.
4. The method according to claim 2, wherein each of the deflection members is configured to be connectable to the vial via a snap-fit mechanism.
5. The method according to claim 1, wherein the number of mounting parts is a plurality of mounting parts, and each of the plurality of mounting parts is attached to the wall at a distance from each other and at isolated positions.
6. The method according to claim 1, wherein the wall is annular in shape, and the spike extends through the annular wall.
7. The method according to claim 2, wherein each of the deflection members comprises an elongated member and teeth extending inward from the elongated member toward the longitudinal axis of the main body.
8. The method according to claim 7, wherein the number of deflection members comprises a first deflection member and a second deflection member arranged adjacent to the first deflection member, and the elongated member of the first deflection member is longer than the elongated member of the second deflection member.
9. The method according to claim 7, wherein each of the elongated members has an end located opposite and distal to the tooth, and each of the elongated members is configured to deflect toward the end.
10. The method according to claim 1, wherein the medical device further comprises a plunger movably disposed within the tubular body.
11. A method for reconstituting a pharmaceutical composition, The medical devices we provide are: A tubular body that defines a container for containing the composition, A spike extending from the distal end of the main body, the spike having at least one through hole that communicates fluidly with the container, An adapter configured to connect to a vial, the adapter comprising a wall extending distally from the main body and integrated with the main body, an annular base portion, and a plurality of mounting portions extending from the base portion to the wall, wherein the base portion surrounds the spike. Includes, The steps include connecting the adapter to the vial, the spike piercing the partition wall of the vial, and the vial containing a solid drug, A step of injecting a certain amount of diluent into the vial from the tubular body, A step of preparing a reconstituted pharmaceutical composition by mixing the diluent and the solid drug in the vial, The steps include drawing the reconstituted pharmaceutical composition from the vial into the tubular body, The adapter is rotated relative to the tubular body so that the mounting portion is irreversibly separated from the wall, and the spike remains protruding from the distal end of the tubular body even after the mounting portion has been irreversibly separated. The steps include separating the adapter from the tubular body, The steps include connecting the spike hub to the aforementioned spike, Methods that include...
12. The method according to claim 11, further comprising the step of press-fitting the needle hub onto the outside of the spike.
13. The method according to claim 11, wherein the base portion comprises a plurality of deflection members, each configured to be connected to the vial.
14. The method according to claim 13, wherein the number of deflection members is a plurality of deflection members surrounding the spike, and is configured to deflect radially inward and outward with respect to the spike.
15. The method according to claim 13, wherein each of the deflection members is configured to be connectable to the vial via a snap-fit mechanism.
16. The method according to claim 11, wherein the number of mounting parts is a plurality of mounting parts, and each of the plurality of mounting parts is attached to the wall at spaced-out, isolated positions.
17. The method according to claim 11, wherein the wall is annular in shape, and the spike extends through the annular wall.
18. The method according to claim 11, wherein each of the deflection members comprises an elongated member and teeth extending inward from the elongated member toward the longitudinal axis of the main body.
19. The method according to claim 18, wherein the plurality of deflection members comprises a first deflection member and a second deflection member arranged adjacent to the first deflection member, and the elongated member of the first deflection member is longer than the elongated member of the second deflection member.
20. The method according to claim 11, wherein the medical device further comprises a plunger movably disposed within the tubular body.