Medical device, medical device assembly including the same, and method of reconstitution of pharmaceutical composition

Abstract

To provide a method of reconstitution of a pharmaceutical composition.SOLUTION: A medical device includes a tubular body that defines a container for containing a composition, a spike that extends from a distal end of the body and comes into fluid communication with the container, and an adapter that is connected with a vial and includes a wall extending distally from the body and integrated with it, an annular-shaped base portion, and attachment portions extending from the base portion to the wall, where the base portion surrounds the spike. The adapter is connected to the vial so that the spike pierces a septum of the vial. The vial contains a solid drug. A diluent is injected from the body into the vial, the diluent in the vial is mixed with the solid drug, and a reconstituted pharmaceutical composition is prepared. The pharmaceutical composition is drawn from the vial into the tubular body. The adapter is rotated relative to the tubular body to irreversibly detach the attachment portions from the wall. After irreversibly detaching the attachment portions, the adapter is separated from the tubular body, while the spike remains extending from the distal end of the tubular body.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates generally to medical devices, and more particularly to medical device assemblies including medical devices. The present disclosure also relates to a method of reconstituting a pharmaceutical composition. [Background technology]

[0002] In the field of pharmaceutical packaging, it is known to store drug contents, for example in the form of lyophilized drugs, power drugs, or active substances of drugs, in medical containers, usually called "vials". The vials are usually made of glass and are sealed with an elastomeric septum crimped with an aluminum cap. The part of the elastomer in the center of the septum is covered with a plastic or aluminum part. This part can be removed by the medical professional before the reconstitution procedure, so that the medical professional can access the rubber central part, which 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 the ampoule or vial into the vial containing the lyophilized drug or potent drug. If the diluent is already stored, usually in a prefilled syringe, the medical professional transfers the diluent directly from the syringe into the vial containing the lyophilized drug. The medical professional uses a needle for this transfer to puncture the rubber septum of the vial.

[0004] However, this process typically 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 the stopper of a vial containing the dry vaccine. Finally, the dry vaccine and diluent are mixed, typically by piercing the needle through the vial stopper, and the solution is withdrawn and returned to the syringe for administration. The aim of the present invention is to improve this technology, which suffers from a number of drawbacks.

[0005] Indeed, throughout the process, the needle tip may be damaged due to removal of the needle shield, piercing the vial septum, and / or misalignment during needle insertion. Thus, a damaged or bent needle, or a needle that may contain a burr, may be significantly less sharp than before piercing the vial stopper during reconstitution and may cause pain to the patient during injection of the drug.

[0006] Another major drawback of the known process is that as the user withdraws the reconstituted drug from the vial through the needle, the user must adjust the length of the portion of the needle inserted into the vial as the amount of drug in the vial decreases. In a practical manner, the user must slowly withdraw the needle from the container by withdrawing the syringe from the vial so that the opening of the needle always remains in contact with the drug, i.e., below the surface of the drug. Not only is this difficult to handle, but such movement of the needle within the vial can lead to the loss of a significant amount of drug remaining in the vial. Summary of the Invention

[0007] In one aspect, a medical device is provided. The medical device is configured for connection to a vial. The medical device includes a tubular body and an adapter. The tubular body defines a vessel for containing a composition and has a spike located at a distal end thereof. The spike has at least one through hole in fluid communication with the container. The adapter is integrally formed with or coupled to the body and is disposed on or about the spike.

[0008] In another aspect, a medical device assembly is provided that includes a plunger and the aforementioned medical device.

[0009] In another aspect, a method of reconstituting a pharmaceutical composition is provided, the method comprising providing the medical device assembly as described above, connecting an adapter to a vial, placing a solid drug in the vial, injecting a quantity of a diluent from the medical device assembly into the vial, mixing the diluent and the solid drug in the vial to generate a reconstituted pharmaceutical composition, aspirating the reconstituted pharmaceutical composition from the vial into the body, and disconnecting the adapter from the body. [Brief description of the drawings]

[0010] The above and other features and advantages of the present disclosure, as well as the manner in which they are accomplished, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is an isometric view of a medical device assembly and medical device therefor shown with a vial spaced apart from the medical device assembly in accordance with one non-limiting embodiment of the disclosed concepts. [Diagram 2] FIG. 2 is another isometric view of the medical device assembly of FIG. 1 and the same medical device, with a vial shown connected to the medical device assembly. [Diagram 3] FIG. 3 is a front isometric view of the medical device of FIG. [Figure 4] FIG. 4 is an enlarged view of a portion of the medical device of FIG. [Diagram 5] FIG. 5 is a cross-sectional view of the medical instrument assembly of FIG. 1 taken along line AA of FIG. 1, but shown with the plunger moved to a fully depressed position. [Figure 6] FIG. 6 is a front isometric view of the medical device of FIG. [Figure 7] FIG. 7 is an enlarged view of a portion of the medical device of FIG. [Figure 8A] FIG. 8A is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8B]FIG. 8B is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8C] FIG. 8C is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8D] FIG. 8D is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8E] FIG. 8E is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8F] FIG. 8F is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8G] FIG. 8G is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8H] FIG. 8H is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8I] FIG. 8I is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 8J] FIG. 8J is a simplified diagram of an aspect of the disclosed concepts used to prepare a reconstituted drug for administration to a patient, according to one non-limiting embodiment of the disclosed concepts. [Figure 9]9 is a cross-sectional view of the medical device assembly of FIG. 2 taken along line BB of FIG. 2, shown with a vial containing mixed and reconstituted medication. [Figure 10] FIG. 10 is a cross-sectional view taken along line CC of FIG. 11, illustrating a medical device assembly with the adapter removed and additional components connected to the medical device in accordance with an embodiment of the disclosed concepts. [Figure 11] FIG. 11 is an isometric view of the medical device assembly and components of FIG. [Figure 12] 12 is an isometric view of another medical device in accordance with another non-limiting embodiment of the disclosed concepts. Corresponding reference characters indicate corresponding parts in the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure in any manner. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0012] For purposes of description hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "longitudinal" and their derivatives refer to the invention as oriented in the drawings. It will be understood, however, that the invention may be subject to various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. As such, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0013] As used herein, the term "distal" shall mean the end of an object that generally contacts the patient. As used herein, the term "proximal" shall mean the location of an object furthest from the distal location.

[0014] As used herein, the term "number" is intended to mean one or an integer greater than one (eg, multiple).

[0015] FIG. 1 is an isometric view of a medical device assembly 2 and a medical device 100 therefor shown with a vial 20 spaced from the medical device assembly 2 according to one non-limiting embodiment of the disclosed concept. In one example 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 be generally described as including a plunger 4 and a medical device 100. The plunger 4 is partially disposed within the medical device 100 and configured to slide within the medical device 100 to move a solution into or out of the medical device 100. FIG. 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 a vial 20, as shown in Figure 2, the solid drug and pharmaceutical composition can be mixed by expelling 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 a patient. This process is described further below, along with benefits associated with using the medical device assembly 2 and the medical device 100 therefor, such as protecting the practitioner from undesirable injury during reconstitution and / or administration of the vaccine.

[0016] FIG. 3 shows an isometric view of the medical device 100, and FIG. 4 shows an enlarged view of a portion of the medical device 100 of FIG. 3. As shown in FIG. 3, the medical device 100 has a tubular body 102 having a distal end 104 and an oppositely spaced proximal end 105. The body 102 further has a spike 106 disposed at the distal end 104, the spike 106 being preferably hollow and having at least one through hole 108, 110 (see also FIG. 5) to allow solution to pass in and out of the body 102. It will be appreciated that in an exemplary embodiment, the manufacture of the medical device 100 is advantageously simplified by the use of 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 and, in one embodiment, disposed generally perpendicular to the body 102. The medical device 100 further includes an adapter 120 formed with or coupled to the body 102. It will thus be appreciated that the body 102 and the adapter 120 may be a single component made from a single piece of material, e.g., an injection molded piece, where the piece of material is formed from one or more polymers. When connecting the medical device 100 with the adapter 120 to a vial, the spike 106 is configured to pierce the septum of the vial to allow for reconstitution of the drug.

[0017] Continuing to refer to FIG. 4, the exemplary adapter 120 is provided with a number of deflector members (eight exemplary deflector members 122, 125, 128, 131, 134, 137, 140, 143 are shown in FIG. 4) each disposed on or around the spike 106 and configured for connection with the vial 20 (FIGS. 1 and 2). The deflector members 122, 125, 128, 131, 134, 137, 140, 143 may be a plurality of deflector members 122, 125, 128, 131, 134, 137, 140, 143 configured to surround the spike 106 and to deflect radially inward and outward with respect to the spike 106. Advantageously, the adapter 120 includes between 2 and 10 deflector members, preferably between 4 and 8 deflector members. Typically, the adapter member includes four, five, six, seven, or eight biasing members. Preferably, each of the biasing members 122, 125, 128, 131, 134, 137, 140, 143 includes an elongated member 123, 126, 129, 132, 135, 138, 141, 144 and teeth 124, 127, 130, 133, 136, 139, 142, 145 extending inwardly from the elongated member toward the longitudinal axis of the body 102 (see, for example, longitudinal axis 103 shown in FIG. 5). Advantageously, each of the elongated members 123, 126, 129, 132, 135, 138, 141, 144 extends parallel to a longitudinal axis, such as axis 103.

[0018] The function of the biasing member 137 will now be described with reference to FIG. 5. While the biasing member 137 is discussed herein, it will be understood that each of the other exemplary biasing members 122, 125, 128, 131, 134, 140, 143 function substantially similarly to the biasing member 137. As shown in FIG. 5, the elongated member 138 of the biasing member 137 has an end 148 located opposite and proximal to the teeth 139 of the biasing member 137. FIG. 5 further illustrates the biasing member 137 in a first position in the solid line illustration and in a second biased position 137' in the dashed line illustration. As shown, the biased position 137' corresponds to the biasing member 137 being biased radially outwardly about the end 148. More specifically, the biased position 137' preferably corresponds to the position of the biasing member 137 when the vial 20 (FIGS. 1 and 2) and the medical device 100 are moved to a position connected to one another. Thus, during this movement, the vial 20 first biases the biasing member 137 radially outward, e.g., to a biased position 137', and then radially inward to a non-biased position as shown in solid line in FIG. 5. In one example embodiment, each of the biasing members 122, 125, 128, 131, 134, 137, 140, 143 is configured to be connectable with the vial 20 via a snap-fit ​​mechanism. Thus, the biasing members 122, 125, 128, 131, 134, 137, 140, 143 are preferably biased toward the non-biased position. Thus, after moving radially inward, the teeth (see teeth 127, 139 in FIG. 9) advantageously maintain a 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 instrument 100, at least a portion of the vial 20 is disposed between the tines 124, 127, 130, 133, 136, 139, 142, 145 and the spike 106 to provide for a relatively secure connection between the adapter 120 and the vial 20. See FIG. 9 for illustration.Although the disclosed concepts have been discussed thus far in conjunction with an adapter 120 having biasing members 122, 125, 128, 131, 134, 140, 143 to enable connection to a vial 20, adapters having suitable alternative connection mechanisms and / or different shapes (not shown) are contemplated herein.

[0019] Further, it will be appreciated that not all of the deflectable members 122, 125, 128, 131, 134, 137, 140, 143 may be configured to have the exact same shape as shown in Figure 5. For example, deflectable member 128 is longer than deflectable member 125 that is disposed adjacent to deflectable member 128.

[0020] 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 of FIG. 6. As shown, the adapter 120 has a base portion 150 that is annular in shape. The adapter 120 further comprises a number of attachment portions 152, 154, 156, 158 (see also FIG. 5) that extend from the base portion 150 to the wall 146. 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 may be attached to the wall 146 at spaced apart, isolated locations. The attachment portions 152, 154, 156, 158 may be formed together, for example, by injection molding. The base portion 150 generally surrounds the spike 106 and is preferably concentric with the wall 146. However, suitable alternative arrangements are contemplated herein. Additionally, the attachment portions 152, 154, 156, 158 are configured to be selectively removed from the wall 146 in response to rotation of the adapter 120 relative to the body 102. Thus, the attachment portions 152, 154, 156, 158 are breakable from the wall 146 to which they were previously attached. Thus, in one embodiment, the entire adapter 120 is removably attached to the wall 146, and grasping and rotating the adapter 120 relative to the tubular body 102 disengages the adapter 120 from the remainder of the medical device 100. Thus, the attachment portions 152, 154, 156, 158 preferably provide only one location at which the adapter 120 is attached to the body 102, and advantageously provide a relatively strong mechanism for attachment, yet are weak enough to selectively allow the entire adapter 120 to be removed from the body 102. Removal of the adapter 120 from the medical device 100 is advantageously irreversible. The purpose of this attribute of the medical device 100 is discussed below.

[0021] In addition to being configured to be connectable with the vial 20, the adapter 120 is configured to be connectable with a needle hub, such as the needle hub 40 shown in FIG. 10. In one example embodiment, to provide this connection, the adapter 120 further includes an annular wall 146 extending distally from the body 102, shown in FIG. 4, through which the spike 106 extends. An exterior surface of the wall 146 can extend distally from the tubular body 102. The wall 146 can have a threaded interior surface 147 configured to be threadably connected with the needle hub 40. However, other suitable connection mechanisms between the adapter and the needle hub are within the scope of the disclosed concepts.

[0022] 8A-8J illustrate one process in which the disclosed concepts may be used. Simplified depictions, not drawn to scale, of plunger 204, vial 220, medical device 300, and additional components are shown. It will be understood that these components function substantially similarly to the medical device assembly 2, vial 20, and components used in combination therewith, and like numbers represent like components. As shown in FIG. 8A, first, spike cap 380 may be removed from spike 306. Next, as shown in FIGS. 8B and 8C, adapter 320 and, for example, biasing members 325, 337 are connected to vial 220. When vial 220 and adapter 320 are connected, spike 306 penetrates vial septum or stopper 221 to provide a fluid pathway between the interior of vial 220 and the interior of medical device 300. Next, as shown in Figure 8D, the plunger 204 was depressed to transfer a quantity of diluent 301 from the medical device 300 into a vial 220 containing a quantity of solid drug 220. Shaking the vial 220 mixes the diluent and solid drug, resulting in a mixed reconstituted pharmaceutical composition 225, as shown in Figure 8E.

[0023] 8F and 8G show the mixed and reconstituted pharmaceutical composition 225 being sucked back into the interior of the medical device 300 by the plunger 204. In FIG. 8H, the adapter 320 and vial 220 are removed from the spike 306, e.g., rotated together from the spike 306. A wall similar to wall 146 described above is not shown in the medical device 300, but it will be understood that removal of the adapter 120 from the wall 146 is accomplished in a similar manner to removal of the adapter 320 from the spike 306. See, e.g., the above discussion of the attachment portions 152, 154, 156, 158 being decoupled from the wall 146 by rotation by the user. With the adapter 320 removed from the spike 306, the needle hub 240 can be readily connected to the spike 306, as shown in FIGS. 8I and 8J. 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 to a suitable alternative portion of the adapter 320, via a suitable alternative coupling mechanism, such as, for example, without limitation, via a threaded connection or snap-fitted to the spike 306. Subsequent removal of the needle shield 250 from the needle hub 240 presents the needle 242 prepared for use with a patient. Because the needle 242 has not previously been used for use in creating the reconstituted pharmaceutical composition 225, e.g., the needle 242 is not inserted into the stopper 221 and is not 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 state for use with a patient. Specifically, the problems with existing methods, such as the needle sticking into the stopper causing burrs and the needle sticking into the stopper causing dullness, are resolved by employing, for example, medical device 300 using spikes 106, 306 for this function, or medical device 100 as described above.

[0024] FIG. 9 shows the medical device assembly 2 connected to the vial 20, where the diluent and solid drug are mixed within the vial 20 to obtain the reconstituted pharmaceutical composition 25. FIG. 10 shows the medical device assembly 2 with the adapter 120 removed and the reconstituted pharmaceutical composition 25 aspirated back into the body 102 in the manner described above. Additionally, the needle hub 40 is threadably connected to the threaded inner surface 147. Thus, the needle 42 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, removal of the needle shield 50 (also shown in FIG. 11) from the needle hub 40 exposes a relatively sharp, substantially burr-free needle 42 for use with a patient.

[0025] In accordance with another exemplary embodiment of the concept, Fig. 12 illustrates another medical instrument 400 that may be used in a medical instrument assembly in substantially the same manner as medical instrument 100 and medical instrument assembly 2. However, as shown, medical instrument 400 differs from medical instrument 100. First, medical instrument 400 has four deflector members (only one deflector member 422 is shown in Fig. 12). Second, deflector member 422 has an elongated member 423 and teeth 424 extending therefrom, but elongated member 422 has a through hole.

[0026] It will be appreciated that the method of 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 quantity 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, aspirating the reconstituted pharmaceutical composition 25 from the vial 20 into the body 102, and removing the adapter 120 from the body 102. The method may also optionally include removing a spike cap from the spike 106, and optionally injecting the reconstituted pharmaceutical composition 25 into a patient.

[0027] The disclosed concepts thus provide improved (e.g., without limitation, better in terms of being safer and less painful to the patient) medical device assemblies 2 and medical devices therefor 100, 300, 400, such that a vaccine or the like can be mixed with a pharmaceutical composition, such as a diluent, such that a reconstituted pharmaceutical composition is obtained and can be administered to a patient using a substantially sharper, relatively burr-free needle 42, 242.

[0028] Elements of one disclosed aspect can be combined with elements of one or more other disclosed aspects to form different combinations, all of which are contemplated within the scope of the present concepts.

[0029] While the present disclosure has been described as having an exemplary structure, the disclosure can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which the disclosure pertains and fall within the scope of the appended claims.

Claims

1. 1. A method for reconstituting a pharmaceutical composition comprising the steps of: a tubular body defining a container for containing the composition; a spike extending from a distal end of the body, the spike having at least one through hole in fluid communication with the container; and 1. An adapter configured to connect to a vial, the adapter including a wall extending distally from and integral with the body, an annular base portion, and a number of attachment portions extending from the base portion to the wall, the base portion surrounding the spike. Providing a medical device comprising: connecting the adapter to the vial such that the spike pierces a septum of the vial, the vial containing a solid pharmaceutical agent; injecting a quantity of diluent through the tubular body into the vial; mixing the diluent and the solid drug in the vial to form 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, the spike remaining extending from the distal end of the tubular body after the attachment portion is irreversibly separated; separating the adapter from the tubular body; A method comprising:

2. The method of claim 1 , wherein the base portion comprises a number of deflection members each configured to be connectable with the vial.

3. The method of claim 2 , wherein the number of biasing members is a plurality of biasing members configured to surround the spike and to bias radially inward and outward relative to the spike.

4. The method of claim 1 , wherein the number of mounting portions is a plurality of mounting portions, each of the plurality of mounting portions being attached to the wall at spaced apart, isolated locations.

5. The method of claim 2 , wherein each of the biasable members is configured to be connectable with the vial via a snap-fit ​​mechanism.

6. The method of claim 1 , wherein the wall is annular in shape and the spikes extend through the annular shaped wall.

7. The method of claim 1 , wherein the wall has a threaded inner surface configured for threaded connection with a needle hub.

8. The method of claim 2 , wherein each of the biasing members comprises an elongated member and teeth extending inwardly from the elongated member toward the longitudinal axis of the body.

9. 9. The method of claim 8, wherein the number of deflectable members comprises a first deflectable member and a second deflectable member disposed adjacent to the first deflectable member, the elongated member of the first deflectable member being longer than the elongated member of the second deflectable member.

10. The method of claim 8 , wherein each of the elongate members has an end disposed opposite and distal to the tines, and each of the elongate members is configured to deflect toward the end.

11. The method of claim 1 , wherein the medical device further comprises a plunger movably disposed within the tubular body.

12. The method of claim 1 , further comprising the step of connecting a needle hub to the tubular body on the spike.

13. The method of claim 12, comprising the step of press-fitting the needle hub into the tubular body.

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