MEDICAL DEVICE, MEDICAL DEVICE ASSEMBLY INCLUDING THE DEVICE AND METHOD OF RECONSTITUTING A PHARMACEUTICAL COMPOSITION

Abstract

A medical device is a medical device assembly including the device itself and a method for reconstituting a pharmaceutical composition. A medical device is configured to be connectable to a vial. The medical device includes a tubular body and an adapter. The tubular body defines a container for holding a composition and has a tip located at its distal end. The tip has at least one orifice for fluid communication with the container. The adapter is formed with or coupled to the body and is located at or near the tip.

Description

"MEDICAL DEVICE, ASSEMBLIES OF MEDICAL DEVICES INCLUDING THE DEVICE AND METHOD OF RECONSTITUTING A PHARMACEUTICAL COMPOSITION" STATE OF THE ART Field of invention

[0001] This disclosure relates generally to medical devices and, more specifically, to medical device assemblies, including medical devices. This disclosure also relates to methods of reconstituting a pharmaceutical composition. Description of the Related State of the Art

[0002] In the field of drug packaging, the storage of a drug's contents, in the form of, for example, a lyophilized drug, a powdered drug, or an active substance of a drug, in a medical container generally referred to as a vial is known. A vial is typically made of glass and is sealed by an elastomeric septum that is crimped by an aluminum cap. A portion of the elastomer in the center of the septum is covered by a piece of plastic or aluminum. This part can be removed by a healthcare professional before the reconstitution procedure so that the healthcare professional can access a central portion made of rubber, which can be punctured by a needle from an injection device, such as a syringe.

[0003] To reconstitute the medication, the user generally uses a disposable syringe to transfer the diluent from an ampoule or vial to the vial containing the lyophilized or powdered medication. When the diluent is already stored in a pre-filled syringe, the healthcare professional transfers the diluent directly from the syringe to the vial that Petition 870210122122, dated 12 / 30 / 2021, page 43 / 75 2 / 15 contains the lyophilized medication. The healthcare professional uses a needle for this transfer in order to puncture the rubber septum of the vial.

[0004] However, this process generally involves several steps. First, a standard needle can be attached to a syringe pre-filled with diluent. Second, the needle can be used to pierce a stopper of a vial containing the dry vaccine. Finally, the dry vaccine and diluent are mixed and the solution is drawn back into the syringe for administration, usually by piercing the vial stopper with the needle. It is an object of this invention to provide an improvement over this technique, which has a number of disadvantages.

[0005] In fact, throughout the process, the needle tip can be damaged due to removal of the needle guard, perforation of the vial septum, and / or misalignment during needle insertion. A damaged or bent needle, or a needle that may contain burrs, is therefore significantly less sharp than before piercing the vial cap during reconstitution, which can cause pain to the patient during injection of the medication.

[0006] Another major disadvantage of known processes is that, when the user withdraws the reconstituted medication from the vial using the needle, the user needs to adjust the length of the needle portion inserted into the vial as the amount of medication in the vial decreases. In practice, the user needs to slowly withdraw the needle from the container by pulling the syringe away from the vial, so that the needle opening remains in constant contact with the medication, i.e., below the surface of the medication. This handling is not only difficult to perform, but the movement of the needle in the vial can also lead to the loss of a significant amount of the medication remaining in the vial. Petition 870210122122, dated 12 / 30 / 2021, page 44 / 75 3 / 15 SUMMARY

[0007] In one aspect, a medical device is provided. The medical device is configured to be connectable to a container. The medical device includes a tubular body and an adapter. The tubular body defines a container for holding a composition and has a tip located at a distal end thereof. The tip has at least one passage orifice in fluid communication with the container. The adapter is formed with or coupled to the body and is located at or near the tip.

[0008] In another aspect, a medical device kit is provided including a plunger and the aforementioned medical device.

[0009] In another aspect, a method of reconstituting a pharmaceutical composition is provided. The method includes providing the aforementioned medical device assembly, connecting the adapter to the vial, the vial containing a solid drug, injecting a quantity of diluent from the medical device assembly into the vial, mixing the diluent and the solid drug in the vial to create a reconstituted pharmaceutical composition, aspirating the reconstituted pharmaceutical composition from the vial into the body, and detaching the adapter from the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The aforementioned features and advantages, and other features of this disclosure, and the manner of obtaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of disclosure modalities taken together with the accompanying figures, in which:

[0011] FIG. 1 is an isometric view of a medical device assembly and medical device for it, shown with a spaced vial in Petition 870210122122, dated 12 / 30 / 2021, p. 45 / 75 4 / 15 from the medical device assembly, according to a non-limiting modality of the disclosed concept;

[0012] FIG. 2 is another isometric view of the medical device assembly and medical device for the same as FIG. 1, and shown with the bottle connected to the medical device assembly;

[0013] FIG. 3 is a front isometric view of the medical device in FIG. 1;

[0014] FIG. 4 is an enlarged view of a portion of the medical device in FIG. 3;

[0015] FIG. 5 is a cross-sectional view of the medical device assembly of FIG. 1, taken along line A-A of FIG. 1, but shown with the plunger moved to a fully depressed position;

[0016] FIG. 6 is a rear isometric view of the medical device in FIG. 1;

[0017] FIG. 7 is an enlarged view of a portion of the medical device in FIG. 6;

[0018] FIGS. 8A - 8J show simplified views of aspects of the disclosed concept, employed to prepare a reconstituted medicament for administration to a patient, according to a non-limiting embodiment of the disclosed concept;

[0019] FIG. 9 is a cross-sectional view of the medical device assembly of FIG. 2, shown with the vial containing a reconstituted, mixed, and taken medication along line B-B of FIG. 2;

[0020] FIG. 10, a sectional view taken along line CC of FIG. 11, shows the medical device assembly in which the adapter is highlighted and with additional components connected to the medical device, according to an embodiment of the disclosed concept; Petition 870210122122, dated 12 / 30 / 2021, p. 46 / 75 5 / 15

[0021] FIG. 11 is an isometric view of the medical device assembly and components of FIG. 10; and

[0022] FIG. 12 is an isometric view of another medical device, according to another non-limiting embodiment of the disclosed concept.

[0023] The corresponding reference characters indicate the corresponding parts in the various visualizations. The examples set forth in this document illustrate exemplary aspects of the disclosure and such examples should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0024] The following description is provided to enable those skilled in the art to make and use the contemplated modalities described to realize the concept. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all modifications, variations, equivalents, and alternatives are intended to fall within the object and scope of the present concept.

[0025] For the purposes of the following description, the terms top, bottom, right, left, vertical, horizontal, upper, lower, side, longitudinal and their derivatives relate to the concept as they are oriented in the figures of the drawings. However, it should be understood that the concept may assume several alternative variations, except where expressly specified otherwise. It should also be understood that the specific devices illustrated in the attached drawings and described in the following specification are simply exemplary embodiments of the concept. Therefore, specific dimensions and other physical characteristics related to Petition 870210122122, dated 12 / 30 / 2021, page 47 / 75 6 / 15 of the options disclosed in this document should not be considered as limiting.

[0026] As used in this document, the term distal should generally mean an end of an object in contact with the patient. As used in this document, the term proximal should mean a location further away from a distal location of an object.

[0027] As used in this document, the term number should mean one or an integer greater than one (for example, a plurality).

[0028] FIG. 1 shows an isometric view of a medical device assembly 2 and medical device 100 for the same and shown with a vial 20 spaced from the medical device assembly 2, according to a non-limiting embodiment of the disclosed concept. In a non-limiting embodiment example, the medical device assembly 2 is a syringe set and the medical device 100 is a syringe cylinder. However, it will be appreciated that suitable alternative medical devices and assemblies are contemplated in this document. The medical device assembly 2 can, in general, be stated as including 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 in order to move a solution into and out of the medical device 100. FIG. 2 shows the medical device assembly 2 connected to the vial 20.Normally, vial 20 will be closed by a pierceable septum. Vial 20 may initially contain a solid drug, such as a dry vaccine, and medical device assembly 2 may initially contain a pharmaceutical composition, such as a diluent. When medical device assembly 2 is connected to vial 20, as shown in FIG. 2, the solid drug and the pharmaceutical composition may be... Petition 870210122122, dated 12 / 30 / 2021, p. 48 / 75 7 / 15 mixed, expelling the pharmaceutical composition into vial 20, and the resulting composition, such as a vaccine, can be aspirated back into medical device assembly 2 for administration to a patient. This process will be discussed further below, along with the advantages associated with employing medical device assembly 2 and medical device 100 for the same, such as protecting physicians from unwanted injuries during the reconstitution and / or administration of vaccines.

[0029] FIG. 3 shows an isometric view of medical device 100 and FIG. 4 shows an enlarged view of a portion of medical device 100 from FIG. 3. As shown in FIG. 3. The medical device 100 has a tubular body 102 having a distal end 104 and an opposite, spaced proximal end 105. The body 102 further has a tip 106 located at the distal end 104, and the tip 106 is preferably hollow and has at least one through hole 108, 110 (see also FIG. 5) in order to allow a solution to exit and enter the body 102. In the exemplary embodiment, it will be appreciated that the manufacture of the medical device 100 is advantageously simplified by employing more than one through hole 108, 110 in the tip 106. However, suitable alternative embodiments, such as those with a tip having only a single through hole, are contemplated in this document.The medical device 100 also includes a flange 107 extending from the proximal end 105 of the body 102 and, in an exemplary embodiment, generally located perpendicular to the body 102. The medical device 100 further includes an adapter 120 formed with or coupled to the body 102. Thus, it will be appreciated that the body 102 and the adapter 120 may be a single component made from a single piece of material, for example, an injection-molded part where the material part is formed from one or more polymers. When connecting the device... Petition 870210122122, dated 12 / 30 / 2021, page 49 / 75 8 / 15 medical 100 with adapter 120 to a vial, tip 106 is configured to pierce the vial septum to allow reconstitution of a medication.

[0030] With reference to FIG. 4, the example adapter 120 is located at or around the tip 106 and has a series of deflector members (eight examples of deflector members 122, 125, 128, 131, 134, 137, 140, 143 are shown in FIG. 4) each configured to be connected to the bottle 20 (FIGS. 1 and 2). The deflecting members 122, 125, 128, 131, 134, 137, 140, 143 may be a plurality of deflecting members 122, 125, 128, 131, 134, 137, 140, 143 around tip 106 and configured to deflect radially inward and outward relative to tip 106. Advantageously, adapter 120 includes from two to ten deflecting members, preferably from four to eight deflecting members. Typically, an adapter member will include four, five, six, seven, or eight deflecting members.Preferably, each of the deflecting members 122, 125, 128, 131, 134, 137, 140, 143 includes an elongated member 123, 126, 129, 132, 135, 138, 141, 144 and a tooth 124, 127, 130, 133, 136, 139, 142, 145 that extend inward from the elongated member towards a longitudinal axis (see, for example, longitudinal axis 103 shown in FIG. 5) of the body 102. Advantageously, each of the elongated members 123, 126, 129, 132, 135, 138, 141, 144 extends parallel to a longitudinal axis, such as the axis 103.

[0031] With reference to FIGS. 5, the functionality of deflector member 137 will now be discussed. Although deflector member 137 is being discussed in this document, it will be appreciated that each of the other exemplary deflector members 122, 125, 128, 131, 134, 140, 143 function substantially the same way as deflector member 137. As shown in FIG. 5, the elongated member 138 of deflector member 137 has an end portion 148 located opposite and proximally from tooth 139 of Petition 870210122122, dated 12 / 30 / 2021, page 50 / 75 Figure 5 further shows deflector member 137 in a first position in solid line drawing and in a second deflected position 137' in dashed line drawing. As shown, the deflected position 137' corresponds to the deflector member 137 having been radially deflected outwards around the end portion 148. More specifically, the deflected position 137' preferentially corresponds to the position of the deflector member 137 when the bottle 20 (Figs. 1 and 2) and the medical device 100 are being moved to a connected position relative to each other. Thus, during this movement, the bottle 20 causes the deflector member 137 to initially deflect radially outwards, for example, to the deflected position 137', and then radially inwards to the non-deflected position, shown in continuous line drawing in Figure 9 / 15. 5.In an exemplary embodiment, each of the deflector members 122, 125, 128, 131, 134, 137, 140, 143 are configured to be connectable to the flask 20 by means of a press-fit mechanism. Consequently, the deflector members 122, 125, 128, 131, 134, 137, 140, 143 are preferentially deflected towards the non-deflected positions. Thus, after the radial inward movement, the teeth (see teeth 127, 139 in FIG. 9) advantageously maintain the connection between the bottle 20 and the medical device 100, thereby allowing fluid communication between the bottle 20 and the medical device 100. Specifically, when the bottle 20 is connected to the medical device 100, at least a portion of the bottle 20 is located between the teeth 124, 127, 130, 133, 136, 139, 142, 145 and the tip 106 in order to provide for a relatively secure connection between the adapter 120 and the bottle 20. See FIG. 9 for illustration purposes.Although the disclosed concept has been discussed so far in conjunction with adapter 120 having deflector members 122, 125, 128, 131, 134, 140, 143 to allow connection to bottle 20, it will be appreciated that... Petition 870210122122, dated 12 / 30 / 2021, page 51 / 75 10 / 15 suitable alternative connection mechanisms and / or adapters with different geometries (not shown) are contemplated in this document.

[0032] Furthermore, as shown in FIG. 5, it will be appreciated that not all deflector members 122, 125, 128, 131, 134, 137, 140, 143 can be configured to have exactly the same geometry. For example, deflector member 128 is longer than deflector member 125, which is located adjacent to deflector member 128.

[0033] FIG. 6 is a rear isometric view of the medical device 100 and FIG. 7 is an enlarged view of a portion of the medical device 100 from FIG. 6. As shown, the adapter 120 has an annular base portion 150. The adapter 120 further comprises a series of fixing portions 152, 154, 156, 158 (see also FIG. 5) extending from the base portion 150 to the wall 146. The adapter may comprise at least two fixing portions, preferably between two and six fixing portions, more preferably the adapter comprises four fixing portions 152, 154, 156, 158. The fixing portions 152, 154, 156, 158 may be fixed to the wall 146 at separate spaced locations. The fixing portions 152, 154, 156, 158 can be formed together, for example, by injection molding. The base portion 150 generally surrounds the tip 106 and is preferably concentric with the wall 146.However, suitable alternative arrangements are contemplated in this document. Furthermore, the fixing portions 152, 154, 156, 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. The fixing portions 152, 154, 156, 158 are therefore breakable from the wall 146 from which they were previously fixed. Therefore, the complete adapter 120, in an exemplary embodiment, is removablely fixed to the wall 146, so that gripping and rotating the adapter 120 relative to the tubular body 102 does not work. Petition 870210122122, dated 12 / 30 / 2021, page 52 / 75 11 / 15 with which the adapter 120 separates from the rest of the medical device 100. Thus, the fastening portions 152, 154, 156, 158 preferentially provide the only location where the adapter 120 is attached to the body 102, and advantageously provide a relatively strong fastening mechanism, but weak enough to allow selective removal of the entire adapter 120 from the body 102. The separation of the adapter 120 from the medical device 100 is advantageously irreversible. The purpose of this attribute of the medical device 100 will be discussed below.

[0034] In addition to being configured to be connectable to the bottle 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, in order to provide this connection, the adapter 120 further includes an annular wall 146 extending distally from the body 102, shown in FIG. 4, and through which the tip 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 be threaded into the needle hub 40. However, other suitable connection mechanisms between adapters and needle hubs are within the scope of the disclosed concept.

[0035] FIGS. 8A - 8J show a process by which the disclosed concept can be employed. Simplified representations, not drawn to scale, of a plunger 204, a vial 220, a medical device 300 and additional components are shown. It will be appreciated that these components function substantially in the same way as the medical device assembly 2, vial 20 and components to be used in conjunction therewith, and similar numbers represent similar components. As shown in FIG. 8A, a first tip cap 380 can be removed from the tip 306. A Petition 870210122122, dated 12 / 30 / 2021, p. 53 / 75 12 / 15 Next, as shown in FIGS. 8B and 8C, the adapter 320, for example, and the deflector members 325, 337, are connected to the vial 220. As the vial 220 and the adapter 320 are being connected, the tip 306 pierces a septum or stop 221 of the vial to provide a fluid pathway between an interior of the vial 220 and an interior of the medical device 300. Next, as shown in FIG. 8D, the plunger 204 is pressed in order to move a quantity of diluent 301 from the medical device 300 into the vial 220, which contains a quantity of solid medicine 220. As shown in FIG. 8E, shaking the vial 220 causes the diluent and the solid medicine to mix, resulting in a mixed reconstituted pharmaceutical composition 225.

[0036] FIGS. 8F and 8G represent the reconstituted mixed pharmaceutical composition 225 being aspirated back into the interior of the medical device 300 by the plunger 204. In FIG. 8H, the adapter 320 and the vial 220 together have been rotated outwards, i.e., detached from the tip 306. Although a wall, similar to wall 146 above, has not been shown with the medical device 300, it will be appreciated that the detachment of the adapter 120 from the wall 146 can be achieved in a similar manner to how the adapter 320 is detached from the tip 306. See, for example, the discussion above with reference to the fixing portions 152, 154, 156, 158 being detached from the wall 146 by rotation by a user. With the 320 adapter detached from tip 306, the 240 needle hub can be readily connected to tip 306, as shown in FIGS. 8I and 8J. Although shown in FIGS.8I and 8J being connected to tip 306 by means of a pressure-fit mechanism, it will be appreciated that the needle hub 240 can be connected to tip 306, or a suitable alternative portion of adapter 320, by means of any suitable alternative coupling mechanism, for example, without limiters, by means of a threaded connection or by being fitted to tip 306. Petition 870210122122, dated 12 / 30 / 2021, pp. 54 / 75 13 / 15 Subsequently, removing a needle shield 250 from the needle hub 240 reveals a needle 242 prepared for use with a patient. Since the needle 242 has not been previously employed for use with the creation of the reconstituted pharmaceutical composition 225, for example, the needle 242 has not been inserted into the stop 221 and used to inject diluent and aspirate the reconstituted pharmaceutical composition 225 back into the medical device 300, the needle 242 is advantageously in a safer condition for use with the patient. Specifically, problems of existing methods, such as burrs being created by needles piercing stops and needles losing their sharpness as a result of piercing stops, are solved by employing the medical device 300, for example, and the medical device 100 discussed above, which uses tips 106, 306 for this function.

[0037] FIG. 9 shows the medical device assembly 2 connected to the vial 20, with the diluent and the solid medication mixed in the vial 20, resulting in the reconstituted pharmaceutical composition 25. FIG. 10 shows the medical device assembly 2 with the adapter 120 having been detached, in the manner discussed above, and with the reconstituted pharmaceutical composition 25 having been aspirated back into the body 102. Furthermore, a needle hub 40 has been threaded onto the threaded inner surface 147. Consequently, a needle 42, which is connected to the needle hub 40, is in a relatively safe condition for use with a patient, for the same reasons discussed above in connection with FIGS. 8A - 8J. Thus, removing a needle shield 50 (also shown in FIG. 11) from the needle hub 40 exposes the relatively sharp and substantially burr-free needle 42 for use with a patient.

[0038] According to another exemplary embodiment of the concept, FIG. 12 shows another medical device 400 that can be employed in a Petition 870210122122, dated 12 / 30 / 2021, pp. 55 / 75 Medical device assembly 14 / 15 is substantially the same as medical device 100 and medical device assembly 2. However, as shown, medical device 400 differs from medical device 100. First, medical device 400 has four deflector members (only one deflector member 422 is shown in FIG. 12). Second, although deflector member 422 has an elongated member 423 and a tooth 424 extending from it, the elongated member 422 has a through hole.

[0039] It will be appreciated that a method of reconstituting a pharmaceutical composition includes providing the medical device assembly 2, the medical device 100 containing a pharmaceutical composition, such as a diluent, connecting the adapter 120 to the vial 20, the vial 20 containing a solid drug product, such as a lyophilized pharmaceutical product, injecting a quantity of diluent from the medical device assembly 2 into the vial 20, mixing the diluent and the solid drug product in the vial to create a reconstituted pharmaceutical composition 25, aspirating the reconstituted pharmaceutical composition 25 from the vial 20 into the body 102, and detaching the adapter 120 from the body 102. The method may also optionally include the steps of removing a tip cap from the tip 106 and optionally injecting the reconstituted pharmaceutical composition 25 into a patient.

[0040] Therefore, the disclosed concept provides a set of medical devices 2 and medical devices 100, 300, 400 for the same improved (e.g., without limitations, safer, better in terms of transmitting less pain to a patient), wherein a solid medicine, such as a vaccine, can be mixed with a pharmaceutical composition, such as a diluent, and thus a reconstituted pharmaceutical composition can be obtained and administered to a Petition 870210122122, dated 12 / 30 / 2021, pp. 56 / 75 15 / 15 patient with a 42, 242 needle which is substantially sharper and relatively free of burrs.

[0041] The elements of a disclosed aspect may be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the present concept.

[0042] Although this disclosure has been described as having exemplary designs, the present disclosure may be further modified within the purpose and scope of this disclosure. This application is therefore intended to cover any variations, uses or adaptations of the disclosure using its general principles. In addition, this application is intended to cover such deviations from the present disclosure as come within known or customary practice in the art to which this disclosure belongs and which fall within the limits of the appended claims.

Claims

CLAIMS 1. Medical device (100, 300) configured to be connected to a bottle (20, 200), the medical device characterized in that it comprises: a tubular body (102) defining a container for containing a composition (222, 225), a tip (106, 306) extending from a distal end (104) of the body (102), the tip (106, 306) having at least one passage orifice (108) in fluid communication with the container; and an adapter (120, 320) for connecting the medical device (100, 300) to the bottle (20, 220), wherein the adapter (120, 320) comprises a wall (146) extending distally from the body, an annular base portion (150) and a series of fixing portions (152, 154, 156, 158) extending from the base portion to the wall; wherein the base portion (150) generally encloses the tip (106, 306);and wherein the fastening portions (152, 154, 156, 158) are configured to be irreversibly separated from the wall in response to rotation of the adapter relative to the body, thus allowing the adapter to be removed from the body.

2. Medical device (100, 300), according to claim 1, characterized in that the base portion (150) comprises a series of deflector members (325, 337), each configured to be connectable with the bottle (220).

3. Medical device (100, 300), according to claim 2, characterized in that the series of deflector members (325, 337) is a plurality of deflector members around the tip (106, 306) and being configured to deflect radially inward and outward relative to the tip (106, 306).

4. Medical device (100, 300), according to claim 1, characterized in that the number of fixing portions Petition 870260040910, dated 04 / 30 / 2026, page 10 / 15 2 / 3 (152, 154, 156, 158) is a plurality of fixing portions; and in that the plurality of fixing portions are each fixed to the wall at spaced isolated locations.

5. Medical device (100, 300), according to claim 1, characterized in that the body (102) and the adapter (120, 320) have a unitary construction.

6. Medical device (100, 300), according to claim 1, characterized in that the body (102) and the adapter (120, 320) are formed separately and subsequently assembled.

7. Medical device (100, 300), according to claim 2, characterized in that each of the deflector members (325, 337) is configured to be connectable to the bottle by means of a press-fit mechanism.

8. Medical device (100, 300), according to claim 1, characterized in that the wall is annular in shape; and in that the tip (106, 306) extends through the annular wall.

9. Medical device (100, 300), according to claim 1, characterized in that the wall has a threaded inner surface configured to be threaded connected to a needle hub (40).

10. Medical device (100, 300), according to claim 2, characterized in that each of the deflector members (325, 337) comprises an elongated member and a tooth extending inward from the elongated member towards a longitudinal axis of the body (102).

11. Medical device (100, 300), according to claim 10, characterized in that the number of deflector members (325, 337) comprises 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.

12. Medical device (100, 300), according to claim 10, characterized in that each of the elongated members (325, 337) has an end portion disposed opposite and distal to the tooth; and wherein each of the elongated members is configured to deviate around the end portion.

13. Medical device assembly (2), characterized in that it comprises: a plunger (204); and the medical device (100, 300) defined according to any of the preceding claims.

14. Method of using the medical device defined in any one of claims 1 to 12 for reconstituting a pharmaceutical composition, characterized in that it comprises: connecting the adapter (120, 320) to the vial (20, 200), the vial containing a solid medicine; injecting a quantity of diluent from the medical device assembly into the vial; mixing the diluent and the solid medicine in the vial (20, 200) to create a reconstituted pharmaceutical composition; aspirating the reconstituted pharmaceutical composition from the vial (20, 200) into the body; and detaching the adapter (120, 320) from the body (102).

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