Medical device, medical device assembly including the medical device, and method of reporting a

Abstract

A medical device is configured to be connectable with 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 staple portion at a distal end thereof. The spike portion has at least one through hole in fluid communication with the container. An adapter is formed with or coupled to the body and is located at or around the staple portion.

Description

[0001] This application is a divisional application of the invention patent application entitled "Medical device, medical device component comprising the same, and method for reconstructing a drug composition", with an international application date of July 2, 2020, an international application number of PCT / IB2020 / 056266, and a national application number of 202080056647.X. Technical Field

[0002] The present disclosure relates generally to medical devices and more particularly to medical device assemblies including medical devices. The present disclosure also relates to methods of reconstituting pharmaceutical compositions. Background Art

[0003] In the field of pharmaceutical packaging, it is known to store drug contents in the form of, for example, lyophilized drugs, powdered drugs or pharmaceutically active substances in medical containers commonly referred to as "vials". Vials are usually made of glass and sealed by an elastic septum, which is crimped by an aluminum cover. The elastomeric part in the center of the septum is covered by a plastic or aluminum part. This part can be removed by a medical professional before a reconstitution procedure, so that the medical professional can access the central part made of rubber, which can be pierced by the needle of an injection device such as a syringe.

[0004] To reconstitute the drug, the user typically uses a disposable syringe to transfer the diluent from the ampoule or vial to the vial containing the lyophilized drug or powdered drug. When the diluent has been stored in a prefilled syringe, the healthcare professional transfers the diluent directly from the syringe to the vial containing the lyophilized drug. The healthcare professional uses a needle for this transfer to pierce the rubber septum of the vial.

[0005] However, the process generally involves many steps. First, a standard needle can be attached to a syringe pre-filled with a diluent. Second, the needle can be used to pierce the 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, which is usually done by piercing the stopper of the vial with a needle. An object of the present invention is to provide an improvement to this technology which has many disadvantages.

[0006] Indeed, during the entire process, the needle tip may be damaged due to removal of the needle shield, piercing of the vial's septum, and / or misalignment during needle insertion. Thus, a damaged or bent needle, or a needle that may contain burrs, is significantly less sharp than before piercing the vial stopper during reconstitution, which may cause pain to the patient during injection of the drug.

[0007] Another major disadvantage of the known method 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 actual operation, the user needs to slowly pull the needle back from the container by pulling the syringe away from the vial so that the opening of the needle always remains in contact with the drug, in other words, so that the opening of the needle always remains below the surface of the drug. This process is not only difficult to perform, but also such movement of the needle in the vial may result in a large amount of drug remaining in the vial and being lost. Summary of the invention

[0008] In one aspect, a medical device is provided. The 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 containing a composition and has a spike portion located at a distal end thereof. The spike portion has at least one through hole in fluid communication with the container. The adapter is formed with or coupled to the body and is located at or around the spike portion.

[0009] In another aspect, a medical device assembly comprising a plunger and the above medical device is provided.

[0010] In another aspect, a method for reconstructing a pharmaceutical composition is provided. The method includes providing the above-mentioned medical device assembly, connecting an adapter to a vial, the 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 reconstructed pharmaceutical composition, aspirating the reconstructed pharmaceutical composition from the vial into a main body, and separating the adapter from the main body. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The above and other features and advantages of the present disclosure and the manner of achieving them will become more apparent, and the present disclosure itself will be better understood, by referring to the following description of the embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0012] Figure 1 is a perspective view of a medical device assembly and a medical device for use therein according to a non-limiting embodiment of the disclosed concept, shown with a vial separated from the medical device assembly;

[0013] Figure 2 yes Figure 1 Another perspective view of a medical device assembly and a medical device for use with the medical device assembly, and shown with a vial connected to the medical device assembly;

[0014] Figure 3 yes Figure 1 A front perspective view of a medical device;

[0015] Figure 4 yes Figure 3 an enlarged view of a portion of a medical device;

[0016] Figure 5 is along Figure 1 The AA line is intercepted Figure 1 A cross-sectional view of a medical device assembly of FIG. 1 , but with the plunger moved to a fully depressed position;

[0017] Figure 6 yes Figure 1 A rear perspective view of a medical device;

[0018] Figure 7 yes Figure 6 an enlarged view of a portion of a medical device;

[0019] Figures 8A-8J shows a simplified view of some aspects of the disclosed concepts for preparing a reconstituted drug for administration to a patient according to one non-limiting embodiment of the disclosed concepts;

[0020] Fig. 9 is along Figure 2 The BB line is intercepted Figure 2 A cross-sectional view of a medical device assembly of FIG. 1 , wherein a vial is shown containing a mixed reconstituted drug;

[0021] Fig.10 is along Fig.11 A cross-sectional view taken along line CC of , showing a medical device assembly according to an embodiment of the disclosed concept, wherein the adapter is separated and an additional component is connected to the medical device;

[0022] Fig.11 yes Fig.10 stereoscopic views of medical device components and parts; and

[0023] Fig.12 is a perspective view of another medical device according to another non-limiting embodiment of the disclosed concept.

[0024] Corresponding reference characters indicate corresponding parts throughout the several views.The examples set out herein illustrate exemplary aspects of the disclosure, and these examples should not be construed as limiting the scope of the disclosure in any way. DETAILED DESCRIPTION

[0025] The following description is provided to enable those skilled in the art to make and use the embodiments contemplated for implementing the concept. However, various modifications, equivalents, variations, and substitutes will still be 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 present concept.

[0026] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the concept as oriented in the accompanying drawings. However, it should be understood that the concept may adopt various alternative variations unless expressly indicated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the concept. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be regarded as limiting.

[0027] As used herein, the term "distal" shall refer to the end of an object that is typically in contact with a patient. As used herein, the term "proximal" shall refer to the location farthest from the distal location of an object.

[0028] As used herein, the term "number" shall mean one or an integer greater than one (eg, a plurality).

[0029] Figure 1 A perspective view of a medical device assembly 2 and a medical device 100 for use therein according to one non-limiting embodiment of the disclosed concept is shown, and is shown with a vial 20 separated from the medical device assembly 2. In an example non-limiting embodiment, the medical device assembly 2 is a syringe assembly, and the medical device 100 is a syringe barrel. However, it should be understood that suitable alternative medical devices and assemblies are contemplated herein. The medical device assembly 2 can generally be stated as including a plunger 4 and a 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 move a solution into and out of the medical device 100. Figure 2 The medical device assembly 2 is shown connected to a vial 20. Typically, the vial 20 will be closed by a pierceable septum. The vial 20 may initially contain a solid drug, such as a dry 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 FIG. Figure 2 As shown, the solid drug and the pharmaceutical composition can be mixed by expelling the pharmaceutical composition into the vial 20, and the resulting composition (such as a vaccine) can be drawn 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 used therein (such as protecting medical practitioners from unwanted injuries during reconstitution and / or vaccination), will be discussed further below.

[0030] Figure 3 A perspective view of the medical device 100 is shown, and Figure 4 Shows Figure 3 An enlarged view of a portion of the medical device 100. Figure 3As shown, the medical device 100 has a tubular body 102 having a distal end 104 and an opposing and spaced proximal end 105. The body 102 also has a spike portion 106 located at the distal end 104, and the spike portion 106 is preferably hollow and has at least one through hole 108, 110 (see also Figure 5 ) to allow solution to exit and enter the body 102. In an exemplary embodiment, it should be appreciated that the manufacture of the medical device 100 is advantageously simplified by employing more than one through hole 108, 110 in the spike portion 106. However, suitable alternative embodiments are contemplated herein, such as embodiments having a spike portion having only a single through hole. The medical device 100 also includes a flange 107 extending from the proximal end 105 of the body 102, and in an exemplary embodiment, the flange is positioned generally perpendicular to the body 102. The medical device 100 also includes an adapter 120 formed with or coupled to the body 102. Therefore, it should be appreciated that the body 102 and the adapter 120 can be an integral component made from a single piece of material, such as an injection molded piece in which the piece of material is formed from one or more polymers. When the medical device 100 having the adapter 120 is connected to a vial, the spike portion 106 is configured to pierce the septum of the vial to allow reconstitution of the drug.

[0031] Continue to refer to Figure 4 , the example adapter 120 is located at or around the nail portion 106 and has a certain number of deflection members ( Figure 4 Eight example deflection members 122, 125, 128, 131, 134, 137, 140, 143 are shown in FIG. 1 ), each of which is configured to be connectable to a vial 20 ( Figure 1 and Figure 2 ). The deflection members 122, 125, 128, 131, 134, 137, 140, 143 can be a plurality of deflection members 122, 125, 128, 131, 134, 137, 140, 143 surrounding the nail portion 106 and configured to deflect radially inward and outward relative to the nail portion 106. Advantageously, the adapter 120 includes two to ten deflection members, preferably four to eight deflection members. Typically, the adapter member will include four, five, six, seven or eight deflection members. Preferably, each of the deflection members 122, 125, 128, 131, 134, 137, 140, 143 includes a slender member 123, 126, 129, 132, 135, 138, 141, 144 and a longitudinal axis from the slender member toward the body 102 (e.g., see Figure 5Advantageously, each of the elongate members 123, 126, 129, 132, 135, 138, 141, 144 extends parallel to a longitudinal axis, such as axis 103.

[0032] Reference Figure 5 , the function of the deflection member 137 will now be discussed. Although the deflection member 137 is discussed herein, it should be understood that the function of each of the deflection members 122, 125, 128, 131, 134, 140, 143 of the other examples is substantially the same as the deflection member 137. Figure 5 As shown, the elongated member 138 of the deflection member 137 has an end portion 148 that is positioned opposite and proximally relative to the teeth 139 of the deflection member 137. Further, Figure 5 The deflection member 137 is shown in a first position in solid lines and in a second deflection position 137' in dashed lines. As shown, the deflection position 137' corresponds to the deflection member 137 having been deflected radially outward about the end portion 148. More specifically, the deflection position 137' preferably corresponds to when the vial 20 ( Figure 1 and Figure 2 ) and the medical device 100 are moved to a connected position relative to each other. Thus, during this movement, the vial 20 causes the deflection member 137 to initially deflect radially outward, e.g., to a deflected position 137', and then move radially inward back to a non-deflected position, e.g. Figure 5 In one example embodiment, each of the deflection members 122, 125, 128, 131, 134, 137, 140, 143 is configured to be connected to the vial 20 via a snap-fit ​​mechanism. Therefore, the deflection members 122, 125, 128, 131, 134, 137, 140, 143 are preferably biased toward a non-deflected position. In this way, after moving radially inward, the teeth (see Fig. 9 The teeth 127, 139 in the adapter 120 advantageously maintain the connection between the vial 20 and the medical device 100, thereby allowing 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 located 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 for illustration purposes Fig. 9While the disclosed concepts have thus far been discussed in conjunction with an adapter 120 having deflection members 122, 125, 128, 131, 134, 140, 143 to allow connection to a vial 20, it should be understood that suitable alternative connection mechanisms and / or adapters having different geometries (not shown) are contemplated herein.

[0033] In addition, if Figure 5 As shown, it should be understood that not all of the deflection members 122, 125, 128, 131, 134, 137, 140, 143 may be configured to have exactly the same geometry. For example, the deflection member 128 is longer than the deflection member 125, and the deflection member 125 is positioned adjacent to the deflection member 128.

[0034] Figure 6 is a rear perspective view of the medical device 100, and Figure 7 yes Figure 6 1 is an enlarged view of a portion of the medical device 100. As shown, the adapter 120 has an annular base portion 150. The adapter 120 also includes a number of attachment portions 152, 154, 156, 158 extending from the base portion 150 to the wall 146 (see also Figure 5 ). The adapter may include at least two attachment portions, preferably between two and six attachment portions, and more preferably, the adapter includes four attachment portions 152, 154, 156, 158. The attachment portions 152, 154, 156, 158 can be attached to the wall 146 at spaced-apart, isolated locations. The attachment portions 152, 154, 156, 158 can be formed together, such as by injection molding. The base portion 150 generally surrounds the nail portion 106 and is preferably concentric with the wall 146. However, suitable alternative arrangements are contemplated herein. In addition, 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 body 102. The attachment portions 152, 154, 156, 158 can thus be disconnected from the wall 146 to which they were previously attached. Thus, in one example embodiment, the entire adapter 120 is removably attached to the wall 146 such that grasping and rotating the adapter 120 relative to the tubular body 102 will cause the adapter 120 to be separated from the remainder of the medical device 100. Thus, the attachment portions 152, 154, 156, 158 preferably provide a unique location for the adapter 120 to be attached to the body 102, and advantageously provide a relatively strong mechanism for attachment, while being weak enough to allow the entire adapter 120 to be selectively removed from the body 102. Advantageously, the separation of the adapter 120 from the medical device 100 is irreversible. The purpose of this attribute of the medical device 100 will be discussed below.

[0035] In addition to being configured to connect to the vial 20, the adapter 120 is also configured to connect to a needle hub, such as Fig.10 In one exemplary embodiment, in order to provide such a connection, the adapter 120 further includes an annular wall 146 extending distally from the body 102, such as Figure 4 146, and the spike portion 106 extends through the annular wall. The outer surface of the wall 146 can extend distally from the tubular body 102. The wall 146 can have a threaded inner surface 147 that is configured to be threadedly 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 disclosed concept.

[0036] Figures 8A-8J One process in which the disclosed concepts may be employed is shown. A simplified depiction of the plunger 204, vial 220, medical device 300, and additional components is shown, not drawn to scale. It should be understood that the functions of these components are substantially the same as the medical device assembly 2, vial 20, and components to be used in conjunction therewith, and like numbers refer to like components. Fig. 8A As shown, the spike cap 380 may first be removed from the spike 306. Next, as shown in FIG. Figure 8B and 8C As shown, the adapter 320 (e.g., deflection members 325, 337) is connected to the vial 220. When the vial 220 and the adapter 320 are connected, the spike 306 pierces the septum or stopper 221 of the vial to provide a fluid passage between the interior of the vial 220 and the interior of the medical device 300. Next, as shown in FIG. Fig.8D As shown, the plunger 204 has been depressed in order to move a certain amount of diluent 301 from the medical device 300 into the vial 220 containing a certain amount of solid medicine. Fig. 8E As shown, shaking of the vial 220 causes the diluent to mix with the solid drug, thereby producing a mixed reconstituted drug composition 225 .

[0037] Figure 8F and 8G The mixed reconstituted drug composition 225 is depicted being drawn back into the interior of the medical device 300 through the plunger 204. Figure 8H306, the adapter 320 and the vial 220 have been unscrewed together from the spike 306, e.g., separated from the spike 306. Although a wall similar to the wall 146 above is not shown with the medical device 300, it should be understood that separation of the adapter 120 from the wall 146 can be achieved in a similar manner to separating the adapter 320 from the spike 306. See, e.g., the above discussion of the separation of the attachment portions 152, 154, 156, 158 from the wall 146 by the user by rotation. With the adapter 320 separated from the spike 306, the needle hub 240 can be easily connected to the spike 306, as shown. Fig.8I and 8J As shown. Fig.8I and 8J 306, but it should be understood that the needle hub 240 can be connected to the spike 306 or a suitable alternative portion of the adapter 320 by any suitable alternative coupling mechanism, such as, but not limited to, by threading or snap-fitting onto the spike 306. Subsequently, removing the needle shield 250 from the needle hub 240 provides the needle 242 ready for use by the patient. Because the needle 242 has not been previously used in the production of the reconstituted drug composition 225, for example, the needle 242 has not been inserted into the stopper 221 and is not used to inject the diluent and aspirate the reconstituted drug composition 225 back into the medical device 300, the needle 242 is advantageously in a safer state for use by the patient. Specifically, the problems of the prior art methods, such as burrs generated by the needle piercing the stopper and the needle losing its sharpness due to piercing the stopper, are solved by adopting the medical device 300 (e.g., the medical device 100 discussed above), which uses the spike 106, 306 for this function.

[0038] Fig. 9 The medical device assembly 2 is shown connected to a vial 20 , wherein a diluent and a solid drug are mixed in the vial 20 , thereby producing a reconstituted drug composition 25 . Fig.10 The medical device assembly 2 is shown in which the adapter 120 has been separated in the manner described above, and in which the reconstituted drug composition 25 has been sucked back into the body 102. In addition, the needle hub 40 has been threadedly connected to the threaded inner surface 147. Therefore, the needle 42 connected to the needle hub 40 is in a relatively safe state for use by a patient, for reasons related to the above. Fig. 8A - 8J. Therefore, remove the needle shield 50 (also in Fig.11 ) exposes a relatively sharp and substantially burr-free needle 42 for use by the patient.

[0039] According to another exemplary embodiment of this concept, Fig.12Another medical device 400 is shown 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 is different from medical device 100. First, medical device 400 has four deflection members ( Fig.12 ). Secondly, the deflection member 422 has an elongated member 423 and teeth 424 extending therefrom, and the elongated member 422 has a through hole.

[0040] It should be understood that the method of reconstituted drug composition includes providing medical device assembly 2, medical device 100 containing a drug composition such as a diluent, connecting adapter 120 to vial 20, vial 20 containing a solid drug such as a lyophilized drug, injecting a certain amount of diluent from medical device assembly 2 into vial 20, mixing the diluent and solid drug in the vial to produce a reconstituted drug composition 25, aspirating the reconstituted drug composition 25 from vial 20 into body 102, and separating adapter 120 from body 102. The method may also optionally include the step of removing the spike cap from spike 106, and optionally the step of injecting the reconstituted drug composition 25 into the patient.

[0041] Thus, the disclosed concept provides an improved (e.g., but not limited to, safer, better in terms of causing less pain to the patient) medical device assembly 2 and medical devices 100, 300, 400 for use therein, wherein a solid drug such as a vaccine can be mixed with a pharmaceutical composition such as a diluent and thereby a reconstituted pharmaceutical composition can be obtained and administered to a patient through a substantially sharper and relatively burr-free needle 42, 242.

[0042] Elements of one disclosed aspect may be combined with elements of one or more other disclosed aspects to form various combinations, all of which are considered to be within the scope of the present concept.

[0043] Although the present disclosure has been described as having an exemplary design, the present disclosure can be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any variant, use or adaptive change of the present disclosure using its general principles. In addition, the present application is intended to cover the deviation from the present disclosure that enters into the known or customary practice scope belonging to the field to which the present disclosure belongs and falls within the limitations of the appended claims.

Claims

1. A method for reconstructing a pharmaceutical composition, comprising: A medical device is provided, the medical device comprising: a tubular body defining a container for containing the composition; a spike portion extending from a distal end of the body, the spike portion having at least one through hole in fluid communication with the container; an adapter configured to connect to a vial, wherein the adapter includes a wall integral with the body and extending distally from the body, an annular base portion, and a number of attachment portions extending from the base portion to the wall, wherein the base portion surrounds the spike; connecting the adapter to a vial such that the spike pierces a septum of the vial, the vial containing a solid drug; injecting a certain amount of diluent from the tubular body into the vial; mixing a diluent and a solid drug in the vial to produce a reconstituted pharmaceutical composition; aspirating the reconstituted pharmaceutical composition from the vial into the tubular body; rotating the adapter relative to the tubular body such that the attachment portion is irreversibly separated from the wall, wherein the spike portion remains extending from the distal end of the tubular body after the attachment portion is irreversibly separated; and The adapter is separated from the tubular body.

2. The reconstruction method according to claim 1, wherein: The base portion includes a number of deflection members, each deflection member being configured to be connectable with the vial.

3. The reconstruction method according to claim 2, wherein: The number of deflection members is a plurality of deflection members surrounding the spike portion and configured to deflect radially inwardly and outwardly relative to the spike portion.

4. The reconstruction method according to claim 1, wherein: The certain number of attachment portions is a plurality of attachment portions; And wherein each of the plurality of attachment portions is attached to the wall at spaced apart, isolated locations.

5. The reconstruction method according to claim 2, wherein: Each of the deflection members is configured to be connectable with the vial via a snap-fit ​​mechanism.

6. The reconstruction method according to claim 1, wherein: The wall is annular.

7. The reconstruction method according to claim 6, wherein: The spike portion extends through the annular wall.

8. The reconstruction method according to claim 1, wherein: The wall has a threaded inner surface configured to threadably engage a needle hub.

9. The reconstruction method according to claim 2, wherein: Each of the deflection members includes an elongated member and teeth extending inwardly from the elongated member toward a longitudinal axis of the body.

10. The reconstruction method according to claim 9, wherein: The number of deflection members includes a first deflection member and a second deflection member disposed adjacent to the first deflection member; and wherein the elongated member of the first deflection member is longer than the elongated member of the second deflection member.

11. The reconstruction method according to claim 9, wherein: Each of the elongated members has an end portion disposed opposite and distally relative to the teeth; and wherein each of the elongated members is configured to deflect about the end portion.

12. The reconstruction method according to claim 1, wherein: The medical device also includes a plunger movably positioned within the tubular body.

13. The reconstruction method of claim 1, further comprising connecting a needle hub to the tubular body over the spike.

14. The reconstruction method of claim 13, wherein the needle hub is press-fit into the tubular body.

15. The reconstitution method of claim 1, wherein the medical device is a syringe.

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