Device and method for reconstituting a lyophilized product, system for injecting a medicine

Abstract

Apparatus and method for reconstructing lyophilized products, and a system for injecting pharmaceutical products. The apparatus for reconstructing lyophilized products includes: a housing including a vial socket; a vial holder configured to connect to the vial socket of the housing and hold a first vial containing lyophilized product and a second vial containing diluent; a pressurized fluid supply system configured to deliver diluent from the second vial to the first vial; and a motor configured to connect to the vial holder when the vial holder is connected to the vial socket and to vibrate the first vial such that the lyophilized product in the first vial is reconstructed with diluent delivered from the second vial to the first vial.

Description

[0001] This application is a divisional application of the applicant’s patent application No. 201880029571.4 (PCT / US2018 / 021811) entitled “Reconfiguration apparatus, system and method”, filed on March 9, 2018. Technical Field

[0002] This invention generally relates to a delivery device for mixing, diluting or reconstituted drugs and delivering the resulting liquid drug into an injection device. Background Technology

[0003] Injection devices, whether worn temporarily or for extended periods by a patient, are well-known in the medical field. The subject matter of this invention relates particularly, but not exclusively, to a delivery device used with the injection device described in PCT Publication Application No. WO 2014 / 204894, published on December 24, 2014, and hereby incorporated herein by reference in its entirety. This injection device includes an internal elastic sac that, when worn by a patient, can be filled for subcutaneous injection, typically a bolus injection, into the patient any suitable injectable agent, pharmaceutical, antibiotic, biologic, or other injectable substance.

[0004] This injection device must be filled (completely or partially) with the required injection solution before being administered to the patient. In some cases, the injection solution must be diluted or reconstituted.

[0005] The use of these injection devices has increased due to the growing number of therapeutic biological agents administered subcutaneously (SC) rather than intravenously (IV). Injection allows for greater flexibility for patients / caregivers and improves their overall quality of life.

[0006] However, injectable formulations are often unstable at room temperature for extended periods. For example, high-protein formulations that are freeze-dried or lyophilized have become attractive. However, such methods require manual reconstitution of the product prior to application.

[0007] The processing of reconstituted lyophilized medications involves several steps required by the user. For example, processing is typically performed using two separate vials (one filled with diluent, the other with the lyophilized medication). The user must use a syringe to retrieve the diluent from the first vial and transfer it to the second / lyophilized vial. The user must then manually shake / roll the second vial for an extended period, after which he or she must visually inspect the vial and determine if the medication has been adequately reconstituted. The overall complexity and time consumption of the processing raise questions about patient / caregiver compliance, safety, and ease of administration. Summary of the Invention

[0008] Several aspects of this subject matter exist that can be implemented separately or together in the apparatuses and systems described and claimed below. These aspects may be used individually or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to exclude the separate use of these aspects or the requirement for the separate or combined use of these aspects as set forth in the appended claims.

[0009] In one aspect, a disposable fluid delivery device includes: a syringe support surface configured to receive an injection device thereon; a fluid delivery port extending upward from the support surface for delivering liquid into the injection device upon receipt on the support surface; a lyophilized drug vial connector configured to receive a vial containing lyophilized drug, and a diluent vial connector configured to receive a vial containing diluent; and a syringe connector configured to receive a syringe. A fluid flow path communicatively disposed between the lyophilized drug vial connector and the syringe connector, between the diluent vial connector and the syringe connector, and between the syringe connector and the fluid delivery port. A manual valve in the fluid flow path selectively positions the diluent vial connector in communication with the syringe connector, the lyophilized drug vial connector in communication with the syringe connector, or the syringe connector in communication with the fluid delivery port.

[0010] In another aspect, an apparatus for reconstituted lyophilized product includes a housing having a vial socket. A vial holder is configured to connect to the vial socket of the housing and hold a first vial containing the lyophilized product and a second vial containing diluent. A pressurized fluid supply system is configured to deliver diluent from the second vial to the first vial. A motor is configured to connect to the vial holder when the vial holder is connected to the vial socket. The motor causes the first vial to vibrate, such that the lyophilized product in the first vial is reconstituted with the diluent delivered from the second vial to the first vial.

[0011] In another aspect, a system for injecting a pharmaceutical product includes an injection device and a device for reconstituted lyophilized pharmaceutical product. The device for reconstituted the lyophilized pharmaceutical product includes a vial holder configured to hold a first vial containing the lyophilized pharmaceutical product and a second vial containing a diluent. A pressurized fluid supply system is configured to deliver the diluent from the second vial to the first vial and to deliver the reconstituted pharmaceutical product from the first vial to the injection device. A motor is connected to the vial holder and configured to vibrate the first vial, such that the lyophilized pharmaceutical product in the first vial is reconstituted using the diluent delivered from the second vial to the first vial.

[0012] On another front, a method for reconstructing a pharmaceutical product includes the steps of: providing a first vial containing a lyophilized pharmaceutical product and a second vial containing a diluent, transferring the diluent from the second vial to the first vial, and vibrating the first vial such that the lyophilized pharmaceutical product in the first vial is reconstructed using the diluent from the second vial.

[0013] On another front, an apparatus for reconstituted lyophilized product includes a vial holder configured to hold a first vial containing the lyophilized product and a second vial containing a diluent. A pressurized fluid supply system is configured to transfer the diluent from the second vial to the first vial. A motor is configured to vibrate the first vial when it is held by the vial holder, such that the lyophilized product in the first vial is reconstituted with the diluent transferred from the second vial to the first vial. Attached Figure Description

[0014] Figure 1 This is a perspective view of the injection device.

[0015] Figure 2 This is a top view showing the filling injection device with the delivery indicator in a full state.

[0016] Figure 3 This is a top view showing the filling injection device with the delivery indicator in an empty state.

[0017] Figure 4 It is a perspective view showing the lower side of the injection device with attachment tape and filling port.

[0018] Figure 5 It is a perspective view showing the lower side of the injection device with the strip disassembled and the filling and dispensing ports exposed.

[0019] Figure 6 It is the cross-section of the injection device on the conveying equipment.

[0020] Figure 7 This is a perspective view of an injection device attached to the skin with safety devices installed.

[0021] Figure 8 This is a perspective view of the injection device attached to the skin with the safety device removed and the button facing upwards in the pre-launch state.

[0022] Figure 9 This is a perspective view of the injection device attached to the skin with the safety device removed and the button down in the firing position.

[0023] Figure 10This is a cross-sectional view of the injection device attached to the skin with the button facing upwards in the pre-launch state.

[0024] Figure 11 This is a cross-sectional view of the injection device attached to the skin when the button is down in the first firing state.

[0025] Figure 12 This is a cross-sectional view of the injection device attached to the skin with the button down in the dispensing state.

[0026] Figure 13 This is a cross-sectional view of an injection device attached to the skin, showing the termination of the delivery indicator when it is not triggered.

[0027] Figure 14 This is a cross-sectional view of an injection device attached to the skin, showing the termination of the delivery indicator.

[0028] Figure 15 This is a cross-sectional view of the injection device attached to the skin with the button locked in the post-firing state.

[0029] Figure 16 This is a perspective view of an injection device being removed from the skin while the bandage remains on the skin.

[0030] Figure 17 This is a perspective view of the injection device with the top shell removed while it is in a filled state.

[0031] Figure 18 yes Figure 17 The top view of the injection device shown.

[0032] Figure 19 This is a perspective view of the injection device with the top casing removed in an empty state.

[0033] Figure 20 yes Figure 19 The top view of the injection device shown.

[0034] Figure 21 This is a perspective view of an injection device used for temporary connection to devices such as those shown in the figures above, for manipulating / mixing / transferring injectables from multiple vials into the injection device.

[0035] Figure 22 Obtained from different angles Figure 21 A perspective view of the conveyor system.

[0036] Figure 23 yes Figure 21 A top view of the conveyor system.

[0037] Figure 24 yes Figure 21 A bottom view of the conveyor system.

[0038] Figure 25 In cases where some parts are removed, look directly at the syringe adapter. Figure 21 An end view of the conveying device.

[0039] Figure 26 yes Figure 21 A side view of the conveyor.

[0040] Figure 27 yes Figure 21 A relative side view of the conveying device.

[0041] Figure 28 It's about looking directly at a pair of small bottle connectors. Figure 21 An end view of the conveying device.

[0042] Figure 29 This is a perspective view of an injection system, which generally comprises as described above. Figure 1-20 The injection device shown, and the temporary connection to the injection device, as shown. Figure 21-28 The device includes a conveyor, a pair of standard vials, and a standard syringe.

[0043] Figure 30 yes Figure 29 A top view of the system.

[0044] Figure 31 yes Figure 29 A bottom view of the system.

[0045] Figure 32 It is in the first valve position Figure 29 A schematic diagram of the flow arrangement of the system.

[0046] Figure 33 It is in the second valve position. Figure 29 A schematic diagram of the flow arrangement of the system.

[0047] Figure 34 yes Figure 29 A schematic diagram of an alternative flow arrangement for the system.

[0048] Figure 35 This is a perspective view of a transfer device used for temporary connection to an injection device to manipulate / mix / transfer injectables from multiple vials into the injection device.

[0049] Figure 36 yes Figure 35 A schematic diagram of an embodiment of the conveying device.

[0050] Figure 37 It is suitable for Figure 36 and 37 A perspective view of the eccentric reciprocating mass motor used in the conveying device.

[0051] Figure 38 This is an example Figure 35 and 36 A flowchart of the operation of the conveying device. Detailed Implementation

[0052] Injection device

[0053] This application Figure 1-20 The relevant description extending from this paragraph to the section entitled “Transmission Device” is derived primarily from jointly owned previously published PCT application WO 2014 / 204894 A2, filed on 17 June 2014, which is hereby incorporated herein by reference in its entirety.

[0054] refer to Figure 1-3 The injection device 7 may have any suitable configuration, but as illustrated, it has a generally low-profile, disc-shaped housing 74 with an upper surface 75 and a lower surface 76 through which the injection needle or cannula protrudes when actuated by the user. The upper surface 75 has an actuator or button 77 for initiating injection and a transparent section 80 of the housing 74 that allows the subject or medical professional to view the expandable member 78 to determine the amount of injectable fluid 79 in the device 7. For example, the user can determine whether the injection has begun or ended. More preferably, the expandable member 78 and / or the transparent section 80 of the housing 74 may be scaled, such as by line marking 127, so that the patient or medical professional can visually determine more accurately the amount of remaining injectable fluid 79—e.g., approximately 50% complete or approximately 75% complete. Additionally, the expandable member 78 may include or interact with features on the outer shell 74 to reveal the amount of remaining injectable fluid 79.

[0055] It should be noted that the terms “injectable fluid,” “injection,” “drug,” “pharmaceutical,” and similar terms are used interchangeably herein. For example, when the injection device 7 is filled with drug 79, the transparent segment 80 may display a color, such as, but not limited to, green. When the injection device 7 is empty of drug 79, the transparent segment 80 may display a different color, such as, but not limited to, red. In the middle of the dispensing process, the transparent segment 80 may display a combination of colors.

[0056] refer to Figure 4-6The lower surface 76 of the injection device 7 includes a filling port 81 and a dispensing port 82. The filling port 81 is an interface that allows the delivery device filling tube 83 to deliver liquid 79 to the injection device 7. The dispensing port 82 also contains an internal path 84 between the dispensing injection 79 from the expandable member 78 and the needle 85. The filling port 81 and the dispensing port 79 can be in direct fluid communication via the internal path 86, or they can be combined into a single port.

[0057] refer to Figure 4-6 The injection device may preferably include a filling port 81, which includes a check valve 87 for preventing the pressurized injection 79 from leaking out of the injection device 7 when the injection device 7 is removed from the delivery device 6 and the filling port 81 is removed from the filling tube 83.

[0058] refer to Figure 4-6 The injection device 7 may also have a filling port 81 configured to accept the insertion of a syringe. This syringe may be configured with a Luer connector fitting or a needle. This filling port 81 configuration allows for manual filling of the injection device by the user. The delivery device 6 can still be used, but it will not be required in this configuration.

[0059] refer to Figure 4-6 The injection device 7 may also have a dispensing port 82, which is configured to be directly connected to the intravenous cannula via an attached tubing or a standard needle port.

[0060] refer to Figure 4-6 The lower surface 76 of the injection device 7 carries an adhesive 88 for temporarily securing the injection device 7 to the subject's skin until the injection is complete. During removal of the injection device 7, the adhesive strip liner 89 can be automatically removed, thereby exposing the adhesive surface 88 on the lower surface 76 of the injection device 7, which can be used to adhere the injection device 7 to the patient's skin. Alternatively, the strip liner 89 may have a tab 90 that the user can pull to manually remove before adhering the injection device 7 to the skin. Alternatively, this tab may be attached to the surface of the delivery device 4 so that the strip liner is automatically removed when the injection device 7 is removed.

[0061] refer to Figure 4-6The injection device 7 may have an adhesive tape flange 91 that extends beyond the lower surface base 76. This flange 91 of the adhesive tape 88 acts as a strain relief element between the injection device 7 and the skin surface, thereby reducing the risk of accidental detachment of the injection device 7 from the skin. In other words, similar to the tapered strain relief element on the wire at its location in the connector, the extended adhesive flange 91 acts to distribute the load on both sides of the connection point between the adhesive tape 88 and the lower surface base 76 of the injection device 7, reducing any stress riser at the interface between the adhesive tape 88 and the skin.

[0062] refer to Figure 4-6 The injection device 7 can be configured to have a tapered lower surface 98 that presses against the adhesive flange 91 when the user presses the injection device 7 against the skin to securely attach the adhesive tape 88 to the skin without further user intervention. By utilizing the compliance of human skin when the injection device 7 is pressed against the skin, the tapered lower surface 98 of the injection device 7 effectively presses the flange 91 of the adhesive tape 88 against the skin, but the upper exposed surface of the flange 91 portion does not have exposed adhesive and therefore is not attached to that portion of the tapered lower surface 98. This eliminates the need for the user to move their fingers around the flange 91 to secure the injection device 7 to the skin, making it a much simpler method for attaching the adhesive tape 88.

[0063] refer to Figure 4-6 The injection device 7 may have a lower surface 76, which is flexible or compliant rather than rigid, to allow for improved adhesion through the conformation of the injection device 7 to the skin during application.

[0064] refer to Figure 7-9 After the injection device 7 is placed against or adhered to the skin 99, the safety mechanism or locking mechanism can be automatically released and the injection device 7 is ready to fire (inject). In other words, the injection device 7 is prevented from being actuated (the injection device is locked) until it is placed against the skin. Alternatively, the user can manually remove the safety device 100, such as a safety needle, safety sleeve, or collar, to release the injection device to prepare for firing (injection). The injection device 7 is preferably not allowed to fire until the safety mechanism 100 is released. The safety mechanism 100 can be passive or active and can be triggered manually by the user or automatically by the injection device 7.

[0065] refer to Figure 7-9The injection device 7 can utilize an actuator or button 77 and a visual indicator 101 in combination to define the state of the injection device after it has been removed from the delivery device. For example, when the button 77 is in the up position and the indicator 101 has a color such as, but not limited to, green, this indicates that the injection device 7 is ready to begin injection. Additionally, the button 77 may have a sidewall 102 that is a different color relative to the top 103 of the button. When the button 77 is pressed, the user cannot see the sidewall 102 of the button 77; this indicates that the injection device 7 is in use. When the injection of the medication is complete, the injection device 7 can issue an alarm to the user. This alarm may be in the form of a visual indicator, an audible sound, a mechanical movement, or a combination thereof. The button 77 is ideally designed to provide the user with auditory, visual, and tactile feedback when the button 77 "pops up" to the locked position. The injection device 7 can indicate to the user that it has been dispensed and the full dose has been delivered to the patient when the button 77 is in the up position, and the indicator window 101 of the injection device is empty. For example, when the button 77 is in the up position and the indicator 101 displays a different color such as, but not limited to, red, this can indicate that the injection device 7 has completed the injection.

[0066] refer to Figure 10-12 The injection device 7 may have an actuator or button 77 that a user presses on the injection device 7 to begin injection. The button 77 may be configured as an on / off switch, i.e., having only two states, open and closed, such as a light switch. This prevents the user from pushing the button 77 halfway without actuating the injection device 7. Once activated, this "light switch" type button 77 will rapidly insert the needle 85 into the skin 99 independently of user operation of the button 77. Alternatively, the button 77 may have continuous motion, allowing the user to slowly insert the needle 85 into the skin 99. The button 77 may preferably be directly attached to the needle 85 via an adhesive 104, thus creating a button 77 and a needle 85.

[0067] refer to Figure 10-12 The injection device 7 can advance the needle 85 into the skin 99 when the button 77 is actuated, the button initially advancing to such a position as Figure 30 The first position or depth shown, and preferably automatically slightly retracted as... Figure 31 The second position shown. Figure 30 The first depth shown is reached from the overtravel of button 77 during actuation. The first depth can be controlled by direct contact between feature 105 in button 77 and the base 106 of injection device 7. The final depth of needle 85 is suitable for subcutaneous injection. Alternatively, the final depth of needle 85 can be reduced for intradermal injection. Alternatively, the final depth of needle 85 can be increased for intramuscular injection. Upon reaching the first depth, needle 85 retracts back as shown. Figure 31The second depth is shown in the diagram. The retraction distance of the needle to the second depth is in the range of 0.1-2 mm. This retraction feature is preferred for preventing the needle 85 from being blocked by tissue during the initial insertion process. This tissue blockage may require very high pressure to overcome and prevent the injection device 7 from delivering the drug. The retraction of the needle 85 from the first position to the second position creates an open pocket in front of the needle tip 107, thereby reducing the pressure required to initiate drug flow from the needle 85. This reduced pressure used to initiate drug flow from the needle is preferred for the injection device 7 to maintain a relatively constant pressure during injection.

[0068] refer to Figure 10-12 The injection device 7 may include a needle 85 having a side hole 108. For example... Figure 31 As shown, once the button 77 on the injection device 7 is fully pressed, the needle 85 will be fully inserted into the skin 99 through the dispensing port 82 and the injection device 7 will begin dispensing the injection. The side hole 108 and therefore the internal lumen of the needle 85 are not in communication with the fluid passage 86 of the dispensing port 82 until the button 77 is fully pressed. Both the side hole 108 and the needle tip 107 remain within the diaphragm 109. With the side hole 108 and the needle tip 107 remaining within the diaphragm 109, the entire drug pathway remains sterile until the time of use. When the button 77 is fully pressed and the needle 85 is in the dispensing position, the side hole 108 in the needle 85 becomes connected to the fluid passage 86 of the dispensing port 82 and the injection of the liquid begins.

[0069] refer to Figure 10-12 Before and after dispensing, the septum 109 provides the advantage of sealing the injection needle tip 107 and side holes 108 relative to the injection. Sealing the needle tip 107 and side holes 108 of the needle 85 at the end of injection has the specific advantage of preventing dripping of the injection from the injection device after dispensing is terminated and / or after the injection device 7 is removed from the skin surface. It also prevents contaminants from entering the hollow needle before being actuated into the skin. The septum 109 can be made of any suitable material to allow sealing once the needle 85 has pierced the septum. The material composition of the septum 109 is preferably silicone. Alternatively, the material composition of the septum can also be a blend of different materials, including but not limited to bromobutyl, chlorobutyl, isoprene, polyisoprene, SBR, polybutadiene, EPDM, natural rubber, and silicone. Alternatively, the fluid path 86, including the dispensing port 82, can be a rigid plastic with silicone that is injection-molded to produce the septum described above.

[0070] refer to Figure 10-12The diaphragm 109 at the dispensing port 82 may protrude slightly from its lower surface into the skin surface 99 of the injection device 7 to provide pressure on the skin surface 99 at the injection site. This pressure on the skin surface 99 via the dispensing port 82 after needle retraction repels the injected fluid from the injection site, a process commonly referred to as backflush.

[0071] refer to Figure 10-12 The injection device 7 may include a set of spring tabs 110 that engage with a button 77 for a locking function. The spring tabs 110 are biased to lock into an undercut 111 in the button 77 to hold the button 77 in place. Figure 29 In the first upper position or pre-launch position shown. The geometry of the undercut 111 and the spring tab 110 helps generate the previously described lamp switch actuation force. This lamp switch actuation is achieved by the translation of the button 77 relative to the spring tab 110 and the engagement of the geometry of the undercut 111 surface.

[0072] refer to Figure 10-12 The injection device 7 may include a spring tab 112 that interacts with a button 77 in the injection device 7 to perform a locking function, such that when the button 77 is actuated to a first depth and slightly retracted to a second depth or dispensing position, the undercut feature 113 in the button 77 allows the spring tab 112 to hold the button 77 in the dispensing position until the injection device 7 has completed dispensing.

[0073] refer to Figure 13-14 The injection device 7 may include a delivery termination indicator or empty indicator 114 for sensing when all fluid 79 has been discharged from the expandable member 78 and when the injection device 7 has completed dispensing. The empty indicator 114 may be configured to have a slot or other opening 115 to slide on the expandable member 78 at the outlet port when the expandable member 78 is in a contracted state after all fluid has been discharged. The empty indicator may have two states. Figure 32 As shown, when the expandable member 78 is filled with fluid 79 at that segment and is not contained within the slot or opening 115, the empty indicator can be in a first position or a deflected-out state. This first position shifts to a non-empty state of the expandable member 78 when the diameter of the expandable member 78 exceeds its minimum diameter due to the residual fluid 79 contained therein. Figure 33 As shown, when the expandable member 78 is partially or completely contained within the slot or opening 115, the empty indicator 114 can be in a second position or offset state. When the diameter is at its minimum, this second position will shift to the empty state of the expandable member 78.

[0074] refer to Figure 13-14The injection device 7 may include an automatic needle retraction mechanism upon dispensing termination. This mechanism includes the direct connection between the previously mentioned spring tab 112, the button undercut feature 113, and the empty indicator 114. When the inflatable member 78 is filled with the injection fluid 79 and the button 77 is pressed from the first pre-dispensing position to... Figure 33 In the second dispensing position shown, the undercut feature 113 in button 77 allows the spring tab 112 to hold button 77 in the dispensing position until the injection device 7 has completed dispensing. This spring tab 112 can also be directly coupled to the empty indicator 114, which is naturally in the first position or off-center state. Movement of button 77 to the second or dispensing position allows the post feature 116 in button 77 to provide bias or pretension on the spring tab 112 to advance the empty indicator 114 into its second position or off-center state. However, because the expandable member 78 is initially filled with the injection fluid 79 in a large diameter, the empty indicator 114 cannot move as shown in the image. Figure 32 The second position or biased state is shown. After button 77 is pressed, fluid 79 begins to be discharged through the needle from the expandable member 78, as described above. Once the expandable member 78 has discharged all fluid 79 and is at its minimum diameter, the empty indicator 114 (under pre-tension from the spring tab 112) will move to the position shown. Figure 33 The second position or biased state is shown. The spring tab 112, directly coupled to the empty indicator 114, also moves along with the empty indicator 114. After dispensing is complete, this movement releases the spring tab 112 from the undercut feature 113 in the button 77 to allow the button 77 (and the pin) to move upwards to the final position or post-firing position, as shown. Figure 34 As shown in the image.

[0075] refer to Figure 15 The locking spring tab 117 can also interact with the button 77 in the injection device 7 to perform a locking function, such that when injection is complete, the button 77 is released and pushed upward by the return spring 118 to the final upper position or the post-emission position. (In the final upper position or post-emission position) Figure 34 As shown in the diagram, the button height 77 relative to the top of the injection device 7 can be higher than the pre-ejection position. Figure 29 (As shown in the diagram). The end of the locking spring tab 117 moves outward within the housing 74 to the outer diameter surface 119 of the button 77 to lock the button 77 in the upper position or the post-launch position and to prevent the button 77 from being actuated again.

[0076] refer to Figure 15The injection device 7 may include a return spring 118 that interacts with a button 77 to bias the button 77 into a first upper position or pre-firing position. When the button is actuated downwards to a second depth or dispensing position, the return spring 118 is compressed, resulting in a greater bias or preload. At the end of the dispensing cycle, the button 77 is removed from the second depth or dispensing position after dispensing is complete. Figure 31 (As shown) Unlocks to move upwards to the final position or post-fire position, as previously mentioned. The bias of the reset spring 118 pushes the button 77 upwards to the final position or post-fire position.

[0077] refer to Figure 15-16 After the injection device 7 is removed from the skin 99, it is preferably locked to prevent non-destructive contact with the needle or reuse of the injection device 7. The injection device 7 can indicate to the user that the full dose has been delivered. This indication can be in the form of a visual indicator, audible sound, mechanical movement, or a combination thereof.

[0078] refer to Figure 16 After the injection device 7 is removed from the skin 35, the bandage 120 can be released from the injection device 7 and remain on the skin surface 35. This is achieved by an adhesive on the bandage portion that adheres the bandage to the skin more strongly than the adhesive used to attach the bandage to the injection device 7. Thus, when the housing is lifted from the skin, the bandage 120 is properly retained at the injection site, as described in U.S. Patent No. 7,637,891 and U.S. Patent Application No. 12 / 630996, filed December 4, 2009, which are incorporated herein by reference.

[0079] refer to Figure 17-20The injection device 7 may preferably include a manifold 121 assembled to both the expandable member 78 and the filling port 81 and dispensing port 82, providing direct fluid communication between the expandable member 78 and the filling port 81 and dispensing port 82 of the injection device 7. The manifold 121 may be configured with a large diameter at its end assembled to the expandable member 78 to facilitate filling and discharging all fluid 79 from the expandable member 78, as discussed above. The manifold 121 may preferably include an internal passage 122 to allow fluid inflow and outflow from the expandable member 78. The manifold 121 may be configured to have a filter 123 in the injection fluid path 122 for filtering the injection 79 to remove particulates before and after its introduction into the expandable member 78. The filter 123 may be a membrane, a depth filter, or other suitable filter media having a sufficiently small pore size or effective pore size to remove harmful particulates, including but not limited to undissolved injection 79 in cases where the injection 79 is reconstituted by the delivery device. Manifold 121 may also be configured to have a filter 123 for removing air. Such an air eliminator filter 123 may include a bubble trap, air gap, or other construction in the injection fluid path 122 that removes air from the injection fluid path 122 before it is introduced into the expandable member 78. This air eliminator filter 123 may be constructed using a hydrophobic filter or a combination of hydrophobic and hydrophilic filters. A hydrophobic filter would allow venting of air from the delivery device but not the passage of liquid. A hydrophilic filter would allow the passage of liquid but not the passage of particles or air. The air eliminator filter 123 may also have a check valve to allow venting of the trapped air. Alternatively, the air eliminator and filter 123 may be located at any point in the fluid path from the fill port 81 to the needle 85. For example, the most downstream point in the fluid path is the distal end 128 of the expandable member 78. An internal mandrel 124 may be connected to the distal end 128 of the expandable member 78. An air remover or filter 123 may be integrated into this downstream point to allow the venting of trapped air during filling of the injection device 7. Additionally, the mandrel 124 may include a slot along its length that communicates with the downstream filter 123 to assist in the venting of air during the filling process.

[0080] refer to Figure 17-20The injection device 7 may include an elastic expandable member 78, such as an elastomeric balloon or pouch. The material composition of the expandable member 78 is preferably silicone. Alternatively, the material composition of the expandable member 78 may be a blend of different materials, including but not limited to bromobutyl, chlorobutyl, isoprene, polyisoprene, SBR, polybutadiene, EPDM, natural rubber, and silicone. Additionally, the expandable member 78 may be coated to improve its surface properties. The coating may include parylene, silicone, polytetrafluoroethylene, and fluorinated materials. Alternatively, the expandable member 78 may be made of a thermoplastic elastomer.

[0081] refer to Figure 17-20 The injection device 7 may include an elastically expandable member 78 on which the injection 79 is delivered under pressure. This causes the expandable member 78 to enlarge, and the elasticity of the expandable member 78 generates pressure that tends to expel the injection 79. The pressure chamber of the delivery device described above (or other pumps or pressurizing means such as those used in the delivery device) delivers the injection 79 under pressure to the injection device 7. The injection 79 is introduced into the expandable member 78 under pressure, causing the expandable member to stretch and expand in diameter and length. An example of this would be the inflation of a long, thin balloon. The volume of the injection device 7 may range from 0.5 to 30 ml. When inflated, the elastically expandable member 78 applies a jet pressure in the range of 1 psi to 200 psi to the injection 79 contained in the expandable member 78, such that the injection device 7 is ready to administer the injection 79 when triggered by a user by pressing a button as described above.

[0082] Conveying device

[0083] Figure 21-34 This relates to an embodiment of a delivery device 250 particularly suitable for injectable solutions requiring reconstitution or dilution. This delivery device includes two vial connectors and a corresponding flow path arrangement described below. For example... Figure 31 As seen, the delivery device 250 includes a base 252 on which the injection device 7 rests when coupled. The base forms a support surface 254 from which a fluid delivery port 254 extends for insertion into the filling port 81 of the injection device. Lifting peripheral walls 258 extend upward from the support surface, and together they define a nesting or mating portion for receiving the injection device.

[0084] The conveyor can be made from a single-piece molded plastic structure for low cost and disposableness. Alternatively, one or more features of the conveyor can be separately formed and assembled together to provide a complete conveyor.

[0085] The injection device can be held on the delivery device in a connected position by opposing flexible hooks 260, which bend outward to receive the injection device and hook onto the peripheral edge of the disc-shaped injection device to removably hold the disc-shaped injection device on the delivery device. Alternatively or additionally, a harness arrangement can be used to temporarily connect the delivery device to the injection device. More specifically, to hold the delivery device temporarily connected to the syringe, such a harness can be pivotally attached to one side of the base and pivotally across the associated injection device to hold the injection device in place. The free end of the harness may include manually engageable and releasable clips or connectors for securing the harness to the injection device and against the base of the delivery device to hold the injection device and for releasing the harness and injection device when fluid delivery to the injection device is complete. To help prevent lateral displacement of the injection device when connected to the delivery device, the harness may have an intermediate loop extending around or external to the actuator button of the syringe.

[0086] The delivery device 250 includes a pair of vial connectors 262, a syringe connector 264, a fluid flow control valve 266, and an associated flow path segment.

[0087] The syringe adapter 264 may optionally include a standard hollow concave Luer lock adapter (not shown) of a standard size, which is designed to interfit with a commonly used standard convex Luer port located at the discharge end of a standard syringe. In such an embodiment, the radial protrusion or lug of the Luer connector engages with a threaded collar located around the convex Luer of the standard syringe, such that relative rotation secures the convex and concave Luer portions together and prevents accidental or premature disconnection.

[0088] refer to Figure 22 Each vial connector has an outer collar 268 that flares outward at an open end for guiding reception at the end of a standard vial for injection, and a hollow piercing pin or cannula 270 for piercing a septum sealing the open end of a standard medical vial. Each vial connector may include a venting feature that allows displaced air to enter or leave the vial, and such venting feature may be provided, for example, as an additional lumen in the piercing pin 270 or as an additional hollow piercing pin specifically for movement of vented air to and from the vial and to the atmosphere. Figure 28 This is a view showing the vial connector 262 with puncture nails, each having two lumens 278, 280 – one for liquid introduction and extraction and one for venting.

[0089] An example of the fluid flow path arrangement for this conveying device can be found in... Figure 24middle, Figure 24 This is a view of the lower side of the delivery device 250. As shown, a fluid flow path segment 274, such as a section of plastic tubing, extends between the flow control valve 266 and the syringe connector 264. Fluid flow path segment 276 extends between the flow control valve and the fluid delivery port 256. Fluid flow path segment 278 extends between the flow control valve and the diluent vial connector 262A, and fluid flow path segment 280 extends between the flow control valve and the injection vial connector 262B.

[0090] When the injection requires reconstitution or dilution, the fluid flow arrangement here allows for immediate use of the delivery device. Injection vials can be attached to one vial connector, and the diluent used for reconstitution or dilution is attached to the other. After the diluent, injection vial, and syringe are attached to the delivery device, a flow control valve is positioned to allow flow between the diluent vial connector and the syringe. Retracting the syringe plunger draws the diluent from the diluent vial into the syringe. The flow control valve is then repositioned to position the syringe and injection vial in flow communication, and the diluent is injected into the injection vial to reconstitute the injection. As described above, reconstitution can be facilitated by manually shaking the entire assembly and / or by repeatedly drawing fluid from and injecting it into the injection vial, causing agitation and mixing of the diluent and injection. The reconstituted injection is then collected in the syringe. These steps can be performed before or after the connection of the delivery device to the injection device 7, and can be repeated as necessary with additional vials of injection and diluent to increase the dosage. If performed before the attachment of the injection device, the injection device is then connected to the delivery device and the valve is repositioned to place the syringe (containing the reconstituted injection) and the fluid delivery port in fluid communication, and the pressing of the syringe plunger pushes the reconstituted injection into the injection device 7 through the fluid delivery port 256 and the filling port 81, thereby inflating the elastic expandable member or sac 78 and preparing the injection device for use.

[0091] A two-vial system is shown, comprising an injection device 7, a delivery device 250, a standard injection container 240, a standard diluent container 240, and a standard syringe 242. The vials and / or syringes can be attached to the delivery device before or after it is secured to the syringe 7. This arrangement allows the user to easily reconfigure or dilute the injection and deliver it into the injection device.

[0092] The device described above thus provides a handheld reconfigurable syringe delivery system that allows for the reconfiguration of lyophilized drugs, the removal of drugs from vials into syringes, and then a compact and efficient method for delivering the drugs into syringes.

[0093] In principle, the user attaches lyophilized medicine and diluent vials to the assembly using vial adapters (multiple). Each medicine and diluent vial can have a capacity of 1-50 mL with a 13-20 mm mouth. Syringe capacity is 1-50 mL. The syringe capacity is 1-50 mL.

[0094] Users can attach multiple vials of lyophilized medicines and diluents to a vial adapter, which is then attached to the system. Alternatively, the vial adapter will be part of the system, and the user will insert multiple vials into the system.

[0095] The vial connectors (multiple) contain puncture pins for insertion into the vial via a rubber stopper and have two fluid paths. The first vial connector has one venting to the atmosphere and the other connected to the fluid path. This allows for easy extraction of fluid from the vial without creating a vacuum. The second vial puncture pin will allow for connection of two independent sources.

[0096] The syringe is connected to the other side to draw fluid from each of the diluent vials and / or reconstitution vials and deliver the fluid to the syringe.

[0097] Once the vials (multiple) and syringes are attached to the system, the valve is positioned to state 1, thereby creating a fluid path between the diluent vials and syringes and allowing the diluent to be drawn into the syringe.

[0098] Fluid is drawn from the diluent vial into the syringe by pulling on the syringe plunger. Depending on the patient's dose, the entire contents of the diluent vial may be removed or only partially removed.

[0099] Users can attach multiple diluent vials to fill a syringe to deliver the necessary dose into the syringe.

[0100] The user can then switch the valve to state 2. This creates a fluid path from the filled syringe (with diluent) to the lyophilized vial.

[0101] In an alternative implementation, the diluent is fed into a pre-filled syringe. In this case, the diluent can be directly transferred to the lyophilized vial. (This can also be achieved in a single-vial system).

[0102] Users can push the plunger on the syringe to transfer the contents of the syringe into the lyophilized vial.

[0103] In an alternative embodiment, the lyophilized vial is under vacuum. The vacuum within the lyophilized vial automatically draws the diluent into the vial through the insertion of the diluent vial and the lyophilized vial.

[0104] Once the diluent is transferred to the lyophilized vial, the reconstitution process can begin.

[0105] Users can manually shake the diluent / powder mixture until the powder is completely dissolved in the solution.

[0106] The user can then pull back on the syringe to introduce the entire contents or a portion of the mixed solution, depending on the prescribed dose.

[0107] Some air may be present in the syringe before the final dosage is determined. The user can prepare the syringe by expelling excess air from the syringe back into the vial.

[0108] Once the required amount of fluid has been removed from the vial and transferred to the syringe, switch the valve to state 3. This creates a fluid path between the filled syringe and the syringe.

[0109] The user pushes on the plunger of the syringe to expel the contents of the syringe into the syringe.

[0110] If air is present in the syringe during delivery, the system can filter the air to prevent it from being delivered into the syringe. A filter in the fluid path between the syringe and syringe can filter the air. This can be achieved using a hydrophobic filter or a combination of hydrophilic / hydrophobic filters.

[0111] The retaining strap or belt (if used) can be unlocked and the filled syringe can be removed from the system.

[0112] Figure 32 and 33 This is a schematic flow diagram showing a dual-vial system with a syringe 270, an injection device 272 (OBDD), a three-way valve or stopcock valve 274, a diluent vial 276 (D), and an injection vial 278 (P), the system also using check valves 282a, 282b, 282c, and 282d that restrict flow to only one direction. Figure 33 The valve 274 position is shown for drawing diluent from the diluent vial into the syringe 270, and Figure 33 The valve position is shown after the diluent has been drawn into the syringe for use in injecting the diluent into the vial. Figure 34This is also a flow diagram illustrating a dual-vial system without a stopcock valve and relying solely on one-way valves 284a, 284b, and 284c for flow control. In this system, a vacuum created by pulling back the syringe plunger draws diluent from the diluent vial through the injection vial and into syringe 270. This system can be found for specific applications of injections requiring only dilution or for injections that can be easily reconfigured in the presence of diluent. The one-way valves allow fluid to flow through the system in only one direction—from diluent vial 276 (D) to injection vial 278 (P), from injection vial 278 (P) to syringe 270, and from syringe 270 to injection device 272 (OBDD). In embodiments where the vacuum in the injection vial is used to draw diluent into the injection vial, a check valve may not be necessary. Check valves can be redundant.

[0113] The apparatus for automatically reconstitutes lyophilized drugs and delivers the reconstituted drugs to the injection device is generally located in Figure 35 and 36 The number 300 is indicated in the text. In this embodiment, as explained in more detail below, the user will contain vials containing inverted lyophilized pharmaceuticals and diluents ( Figure 36 304 and 306) in Figure 35 The vial holder, generally indicated by 302, is inserted into the vial socket 308 of the device. Additionally, the device removably receives the injection device 312 within a corresponding recess in the injection device socket 314. As in the previously described embodiment, the bottom of the recess in the injection device socket includes an injection device filling sleeve ( Figure 36 315 in Figure 35 (Not visible in the middle), the filling sleeve of the injection device penetrates the filling port of the injection device.

[0114] By way of example only, the vial holder 302 may be constructed and used as described in jointly owned previously published PCT application WO 2016 / 154413 A1, filed on March 23, 2016, which is hereby incorporated herein by reference in its entirety.

[0115] When device 300 is activated, diluent flows from the diluent vial to the lyophilized drug vial, causing the lyophilized drug vial to vibrate to promote mixing and reconstitution of the drug. The reconstituted drug is then automatically transferred from the (previously) lyophilized drug vial (now the reconstituted drug or product vial) to the injection device 312. The injection device can then be removed from the device's injection device socket 314 and used to inject the drug into the user.

[0116] As just one example, the above about Figure 1-20 The described injection device can be used as Figure 35The injection device 312.

[0117] like Figure 35 and 36 As indicated, the device includes a housing 316, which serves as a base and houses the operating components of the device.

[0118] like Figure 36 As illustrated, the vial socket 308 of the device includes a vial holder bracket 318 positioned within a housing 316. The vial holder bracket 318 includes a socket that removably receives a vial holder 302 and is operatively connected to an eccentric rotating mass (ERM) motor 322. The ERM motor is implemented in… Figure 37 The eccentric rotational mass is generally indicated by 322, and is indicated by 323 and mounted on the shaft of motor 325. Therefore, when the ERM motor is started, the vial holder 318 shakes or vibrates, and vials 304 and 306 also shake or vibrate. The ERM motor 322 is preferably electrically operated, and such motors are known and available in the prior art. Alternatively, alternative motors and vibration systems known in the art can be used instead of the ERM motor.

[0119] In an alternative embodiment of the device, the lyophilized medicine vials and diluent vials can be individually inserted into the vial socket 308 of the device (such as into a separate slot), and only the lyophilized medicine vials are shaken or vibrated by the motor.

[0120] The damper 320 is also connected between the vial holder bracket 318 and the housing and is constructed such that the ERM motor causes the vial to vibrate at the desired frequency.

[0121] like Figure 36 As illustrated, the vial holder 318 also includes product or lyophilized vial puncture pins 324 and diluent vial puncture pins 326. These puncture pins include hollow sleeves that are automatically positioned in fluid communication with the interior of the corresponding vial when the vial holder 302 is inserted into a slot in the vial holder holder. In an alternative embodiment, vial puncture pins 302 and 304 may be configured such that they rise upon activation of the device 300 to position them in fluid communication with vials 304 and 306.

[0122] Further details regarding embodiments of vial puncture nails 302 and 304 are provided in previously published PCT application WO 2016 / 154413 A1, which is jointly owned and incorporated herein by reference and whose international application date is March 23, 2016.

[0123] The vial holder bracket 318 also includes a vial holder retainer mechanism 328, which locks the vial holder 302 into a slot in the vial holder bracket so that the vial holder cannot be removed after the device 300 is started, until the reconstituted drug has been delivered to the injection device.

[0124] like Figure 36 As indicated at location 332, housing 316 contains a canister 332 containing pressurized air. The air canister 332 is preferably a disposable component, and... Figure 36 As illustrated herein, in alternative embodiments, the air canister may be refillable. As will be explained in more detail below, upon activation of device 300, the canister puncture nail 334 is configured to puncture the air canister 332 to pressurize pressure chamber 336 and provide air for the fluid delivery phase of the operation through the puncture nail. Embodiments of the air canister 332 and the canister puncture nail 334 are provided in co-owned previously published PCT application WO 2016 / 154413 A1, which is previously incorporated by reference and has an international application date of March 23, 2016.

[0125] The conveyor 300, vial holder 302 (which may or may not include vials 304 and 306) and injection device 312 may be placed within the package 340 to allow these components to be sold, transported and stored as a single unit.

[0126] The activation of device 300 is triggered by a trigger mechanism 342, which interacts with electronics 344 having a battery 346 for powering and controlling the ERM motor 322 and the electronic valve 352 (the purpose of which will be described below) and an electronic controller or circuit board 348. The trigger mechanism is also mechanically connected to an air canister 332 and a canister puncture stud 334 such that when the trigger mechanism is activated, the canister puncture stud 334 engages the air canister 332.

[0127] By way of example only, trigger mechanism 342 may include a button on the bottom of the slot of the bottle holder socket, or a lever within the slot, the button or lever being configured to engage and hinge or trigger when the bottle holder 302 is inserted into the slot.

[0128] Now refer to Figure 36 and 38 Explain the operation of the device.

[0129] like Figure 38 As shown in boxes 356 and 358, a vial holder 302 accommodates an inverted lyophilized medicine vial 304 and a diluent vial 306. Figure 36Insert the vial holder 318. This places the lyophilized medicine / product vial puncture nail 324 and the diluent vial puncture nail 326 in fluid communication with the interior of vials 304 and 306, and causes the vial retainer retainer 328 to lock the vial retainer in the device.

[0130] The insertion of the vial holder also triggers the trigger mechanism 342, as by Figure 38 As indicated by box 362. When this occurs, as indicated by box 364, air canister 332 is punctured by canister puncture nail 334, causing pressure chamber 336 to be pressurized.

[0131] As indicated by box 365, pressurized air from pressurization chamber 336 passes through... Figure 36 The flow from line 363 to indicator 367 in injection device socket 314. For example... Figure 35 As illustrated, indicator 367 is essentially an arm, which is pivotally attached to the base at its lower or proximal end and has an inverted hook portion at its distal end. The initial position of indicator 367 (such as when the delivery device is packaged in the case of an injection device) is as follows: Figure 35 As shown, and once the mixing and delivery of the fluid to the injection device is complete, the pressure sensing mechanism allows the indicator 367 to swing away from the injection device (i.e., remove). Figure 35 (The location shown).

[0132] In this application Figure 36 In this embodiment, the pressure mechanism of the hook / indicator 367 detects an increase in pressure in the pressure chamber 336 via the line 363, but maintains the hook 367 at a constant pressure. Figure 35 In the position shown. However, when the pressure in pressure chamber 336 decreases after fluid has been delivered to the syringe, the mechanism detects this pressure decrease and removes the hook / indicator 367, allowing the syringe to be removed from the delivery device (as shown by...). Figure 38 (The box 369 represents).

[0133] Additionally, the small canister piercing nail 334, including the sleeve, receives pressurized air from the air canister 332, and the pressurized air passes through the air filter 366. Figure 36 ) and line 368 flow to diluent vials puncture nails 326 and diluent vials 306, as by Figure 38 As indicated by box 366. (As indicated by...) Figure 38 As indicated by box 368, pressurized air enters the diluent vial 306 through line 372 ( Figure 36 The diluent liquid is pushed from vial 306 to lyophilized drug / product vial 304, where the diluent liquid is combined with the lyophilized drug therein.

[0134] It should be noted that the electronic valve 352 is configured to be closed at this time, so that no liquid flows out of the vial 304.

[0135] When the trigger mechanism is activated, the second primary function occurs within device 300. More specifically, refer to... Figure 38 The box 373, Figure 36 Electronic device 344 is activated, causing battery 346 to supply power to ERM motor 322 under the control of circuit board 348, as indicated by block 374. The circuit board can be programmed to provide a slight delay before ERM motor 322 is activated to allow time for diluent delivery to lyophilized pharmaceutical / product vials 304.

[0136] When the ERM motor 322 is powered, as previously described, the ERM motor causes the vial holder bracket 318 to vibrate or shake, and thus causes the vial holder 302 and vial 304 to vibrate or shake. Figure 38 (in box 368) to mix the diluent and lyophilized medicine in vial 304.

[0137] After the predetermined time period has elapsed, circuit board 348 shuts off ERM motor 322 and opens electronic valve 352. This allows reconstituted medicine from vial 304 to pass through tubing 376. Figure 36 The electronic valve 352, filter 378, and filling sleeve 315 proceed in parallel into the injection device 312, as if by Figure 38 As indicated by boxes 368 and 369.

[0138] The mechanism of pressure chamber 336, pipeline 363, or indicator 367 may have an orifice or other feature that allows the pressure within chamber 336 to be relative to... Figure 38 The function is reduced after a sufficient period of time, causing indicator 367 to... Figure 35 The orientation illustrated herein is retracted (e.g., by a spring). This provides an indication that the injection device 312 has been filled and allows the injection device 312 to be removed from the delivery device 300 (as illustrated by a spring). Figure 36 (As indicated by arrow 382).

[0139] It should be understood that Figure 36 The pressure chamber 336, and the associated air canister 332 and canister puncture nail 334 components, may be replaced in alternative embodiments with alternative pressurized air sources, such as air pumps or external pressurized air sources.

[0140] Figures 35-38The technological basis of the automated conveying device is attributed to the enhanced particle and liquid dispersion in lyophilized pharmaceutical / product vials through vibration (agitation energy). The frequency can be relatively low (<500Hz), thereby reducing the risk of cavitation or other high-frequency-induced protein degradation (temperature or bubble formation).

[0141] As explained above, the lyophilized medicine is captured in an inverted position within the vial holder, just as it would be used. The vial holder is coupled to an eccentric rotating mass (ERM) motor. Variations in the pulse width modulation (PWM) signal and the ERM weight allow for adjustment of a wide range of frequencies and amplitudes to which the medicine is exposed. Furthermore, the electronics of the control system (such as...) Figure 36 The circuit board 348 can be adjusted or programmed to provide the required vibration / mixing duration suitable for the reconstructing of lyophilized pharmaceutical products. Due to the flexibility of the variables (amplitude and frequency) inherent in the technology, it can be adapted to a wide range of pharmaceutical products.

[0142] By way of example only, the frequency of an ERM motor can range from 5,000 rpm (83.3 Hz) to 20,000 rpm (333.3 Hz), while the amplitude can range from 0.38 G to 10 G.

[0143] Figures 35-38 The automated delivery system offers several advantages, including the use of standard sealed vials, automatic mixing of the contents of two vials, a mixing process that can be customized for specific medications, a validated and repeatable mixing process, automatic loading of syringes when mixing is complete, and syringes ready for use immediately after mixing and delivery. Furthermore, the delivery system offers simple operation, as the user simply inserts the vial holder into the system to start the device.

[0144] aspect

[0145] This invention includes various aspects other than those described above, such as:

[0146] Aspect 1. A disposable fluid delivery device, comprising: a syringe support surface configured to receive an injection device thereon; a fluid delivery port extending upward from the support surface for delivering liquid into the injection device when received on the support surface; a lyophilized drug vial connector configured to receive a vial containing a lyophilized drug; a diluent vial connector configured to receive a vial containing a diluent; a syringe connector configured to receive a syringe; a fluid flow path communicatively disposed between the lyophilized drug vial connector and the syringe connector, between the diluent vial connector and the syringe connector, and between the syringe connector and the fluid delivery port; and a manual valve in the fluid flow path for selectively positioning the diluent vial connector in communication with the syringe connector, positioning the lyophilized drug vial connector in communication with the syringe connector, or positioning the syringe connector in communication with the fluid delivery port.

[0147] Aspect 2. A disposable fluid delivery device of aspect 1, comprising a releasable strap for retaining an injection device coupled to the delivery device.

[0148] Aspect 3. A disposable fluid delivery device of aspect 1, comprising an injection device coupled to the disposable fluid delivery device and releasably retained in the coupled position.

[0149] Aspect 4. A disposable fluid delivery device of aspect 3, wherein the injection device includes an internal resilient expandable member and a filling port for introducing liquid into the expandable member, and wherein when the injection device is coupled to the delivery device, the fluid delivery port of the delivery device extends into the filling port.

[0150] Aspect 5. A disposable delivery device of aspect 1, wherein a support has an upper and a lower surface, the injection device can be received against the upper surface, and the valve and fluid flow path are maintained on the lower surface of the support.

[0151] Aspect 6. An apparatus for reconstructing a lyophilized product, the apparatus comprising: a housing including a vial socket; a vial holder configured to connect to the vial socket of the housing and hold a first vial containing the lyophilized product and a second vial containing a diluent; a pressurized fluid supply system configured to transfer the diluent from the second vial to the first vial; and a motor configured to connect to the vial holder when the vial holder is connected to the vial socket and to vibrate the first vial such that the lyophilized product in the first vial is reconstructed with the diluent transferred from the second vial to the first vial.

[0152] The apparatus of aspect 7.6, wherein the freeze-dried product includes pharmaceuticals.

[0153] Aspect 8. The apparatus of any of aspects 6 and 7, further comprising a trigger mechanism and an electronic controller, wherein the electronic controller is configured to control the motor, and the trigger mechanism is connected to the vial socket and the electronic controller.

[0154] Aspect 9. The apparatus of aspect 3 further includes a vial holder bracket configured to receive a vial holder and to activate a trigger mechanism when the vial holder is connected to the vial holder bracket, wherein a motor is configured to vibrate the vial holder bracket.

[0155] The apparatus of aspect 10.9 further includes a vial retainer configured to lock the vial retainer within the vial retainer bracket after the vial retainer is inserted into the vial retainer bracket.

[0156] Aspect 11. An apparatus of any of aspects 6-10, wherein the motor is an eccentric rotary mass motor.

[0157] Aspect 12. The apparatus of any of Aspects 6-11, wherein the housing further includes an injection device socket configured to receive an injection device, and wherein a pressurized fluid supply system is further configured to transfer the reconstituted product from the first vial to the injection device connected to the injection device socket.

[0158] Aspect 13. An apparatus of any of aspects 6-12, wherein a motor is configured to cause the first vial to vibrate at a frequency below 500 Hz.

[0159] Aspect 14. The apparatus of any of Aspects 6-13, further comprising a damper configured to connect to the vial holder when the vial holder is connected to the vial socket of the housing.

[0160] Aspect 15. An apparatus of any of aspects 6-14, wherein a vial holder is configured to hold the first and second vials in an inverted position.

[0161] Aspect 16. A system for injecting a pharmaceutical product, comprising: an injection device; and a device for reconstituted lyophilized pharmaceutical product, the device comprising i) a vial holder configured to hold a first vial containing the lyophilized pharmaceutical product and a second vial containing a diluent; ii) a pressurized fluid supply system configured to transfer the diluent from the second vial to the first vial and to transfer the reconstituted pharmaceutical product from the first vial to the injection device; and iii) a motor connected to the vial holder and configured to vibrate the first vial such that the lyophilized pharmaceutical product in the first vial is reconstituted with the diluent transferred from the second vial to the first vial.

[0162] Aspect 17. A method for reconstructing a pharmaceutical product, comprising the steps of: providing a first vial containing a lyophilized pharmaceutical product and a second vial containing a diluent; transferring the diluent from the second vial to the first vial; and vibrating the first vial such that the lyophilized pharmaceutical product in the first vial is reconstructed using the diluent from the second vial.

[0163] Aspect 18. The method of aspect 17, wherein the vibration occurs at a frequency below 500 Hz.

[0164] Aspect 19. An apparatus for reconstituted lyophilized products includes: a vial holder configured to hold a first vial containing the lyophilized product and a second vial containing a diluent; a pressurized fluid supply system configured to transfer the diluent from the second vial to the first vial; and a motor configured to vibrate the first vial when it is held by the vial holder, such that the lyophilized product in the first vial is reconstituted with the diluent transferred from the second vial to the first vial.

[0165] The apparatus of aspect 20.19 further includes an injection device socket configured to receive an injection device, and wherein a pressurized fluid supply system is further configured to transfer the reconstituted product from the first vial to the injection device connected to the injection device socket.

[0166] While preferred embodiments of the invention have been shown and described, it will be apparent to those skilled in the art that changes and modifications can be made therein without departing from the spirit of the invention, the scope of which is defined by the following claims.

Claims

1. An apparatus for reconstructing a freeze-dried product, the apparatus comprising: a. A housing comprising a vial socket having a vial holder bracket movable relative to the housing; b. A vial holder configured to connect to the vial socket of the housing and hold a first vial containing a lyophilized product and a second vial containing a diluent; c. A pressurized fluid supply system configured to deliver diluent from the second vial to the first vial; d. A motor, located in the housing and configured to connect to the vial holder when the vial holder is connected to the vial socket, and to vibrate the first vial such that the lyophilized product in the first vial is reconstituted with diluent transferred from the second vial to the first vial; e. A trigger mechanism and an electronic controller, wherein the electronic controller is configured to control the motor, and the trigger mechanism is connected to the vial holder bracket and the electronic controller; f. The vial holder bracket is configured to receive the vial holder and to activate the trigger mechanism via the connection between the vial holder and the vial holder bracket, wherein the motor is configured to vibrate the vial holder bracket.

2. The apparatus of claim 1, wherein the freeze-dried product comprises a pharmaceutical product.

3. The apparatus of claim 1, further comprising a vial retainer configured to lock the vial retainer within the vial retainer bracket after the vial retainer is inserted into the vial retainer bracket.

4. The apparatus of claim 1, wherein the motor is an eccentric rotary mass motor.

5. The apparatus of claim 1, wherein the housing further includes an injection device socket configured to receive an injection device, and wherein the pressurized fluid supply system is further configured to transfer the reconstituted product from the first vial to the injection device connected to the injection device socket.

6. The apparatus of claim 1, wherein the motor is configured to cause the first vial to vibrate at a frequency below 500 Hz.

7. The apparatus of claim 1, further comprising a vibration damper configured to connect to the bottle holder when the bottle holder is connected to the bottle socket of the housing.

8. The apparatus of claim 1, wherein the vial holder is configured to hold the first and second vials in an inverted position.

9. The apparatus of claim 1, wherein the vial holder bracket includes a groove, and the trigger mechanism includes a button connected to the groove, wherein the button is engaged and hinged when the vial holder is inserted into the groove, thereby activating the trigger mechanism.

10. The device of claim 9, wherein the button is located within the groove.

11. The apparatus of claim 1, wherein the vial holder bracket includes a groove, and the trigger mechanism includes a lever connected to the groove, wherein the lever is engaged and hinged when the vial holder is inserted into the groove, thereby activating the trigger mechanism.

12. The apparatus of claim 11, wherein the lever is located within the groove.

13. A system for injecting a drug, the system comprising: a. Injection device; b. An apparatus for reconstructing lyophilized pharmaceutical products, comprising: i) A housing, including a vial socket with a vial holder bracket, the vial holder bracket being movable relative to the housing; ii) A vial holder, which is configured to connect to the vial socket of the housing and hold a first vial containing the lyophilized product and a second vial containing the diluent; iii) A pressurized fluid supply system configured to deliver the diluent from the second vial to the first vial; iv) A motor, located in the housing and configured to connect to the vial holder when the vial holder is connected to the vial socket, and to vibrate the first vial such that the lyophilized product in the first vial is reconstituted with diluent transferred from the second vial to the first vial; v) A trigger mechanism and an electronic controller, wherein the electronic controller is configured to control a motor, and the trigger mechanism is connected to the vial holder bracket and the electronic controller; vi) The vial holder bracket is configured to receive the vial holder and to activate the trigger mechanism via the connection between the vial holder and the vial holder bracket, and the motor is configured to vibrate the vial holder bracket; vii) The housing includes an injection device socket configured to receive the injection device, and wherein the pressurized fluid supply system is further configured to transfer reconstituted product from the first vial to the injection device connected to the injection device socket.

14. A method for reconstructing a pharmaceutical product using the apparatus of claim 1, the method comprising the steps of: a. Provide a first vial containing the lyophilized medicine and a second vial containing the diluent; b. Place the first and second vials into the vial holder; c. Connect the vial holder to the vial holder bracket; d. Use a pressurized fluid supply system to transfer the diluent from the second vial to the first vial; e. In step c, the trigger mechanism is activated, thereby starting the motor; f. Use the motor to vibrate the vial holder bracket to vibrate the first vial, such that the lyophilized medicine in the first vial is reconstituted with diluent from the second vial.

15. The method of claim 14, wherein the vibration in step f occurs at a frequency below 500 Hz.

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