Medical fluid injection and transfer device and method

Abstract

A medical fluid injection device, a medical fluid transfer device, and a method for administering and transferring medical fluids are disclosed. The device and method may include a compressed gas tank in fluid communication with an expandable elastic bladder positioned within a vial to provide a means of delivering a drug through an injection cannula that can be moved between multiple locations or through a transfer catheter.

Description

[0001] Claiming priority rights

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 878,111, filed on July 24, 2019, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure generally relates to devices for injecting medical fluids into a patient's body and to transfer devices for transferring medical fluids from a container, and more particularly, to a medical fluid injection device or transfer device that uses inflation of a balloon within a medical fluid container to increase the pressure within the container to drive the medical fluid out of the container for injection or transfer. Background Art

[0004] Bottle (vials) is one of the preferred container closure systems used by the pharmaceutical industry, because they have a wide range of clinical history and a long-term stability record for various drugs. Drugs including biopharmaceuticals are usually first introduced into standard containers such as bottles commercially. In addition, the industry has made a large amount of investment in the capital equipment for aseptic bottle filling. In normal use, the bottle often needs to transfer the contained drug from the bottle to another device, such as a syringe and a needle or an injection device, to be delivered to the patient. New container closure systems have been introduced, such as pre-filled syringes and medicine boxes, which allow drugs to be transferred directly from syringes and medicine boxes. Injection devices such as automatic injection devices and barrels have been developed to use these newer forms of container closures. Due to the uncertainty of long-term drug stability, and the manufacturing resources already in place, the device combined with the standard container closure system, such as bottles, pre-filled syringes or medicine boxes, is more preferred for the pharmaceutical industry than the device that requires customized form of drug containment.

[0005] Typical syringes and automatic injection devices are limited by the viscosity of the drug that can be delivered and the forces that can be applied to the glass container closure system. New injection devices have been developed, including pumps for delivering insulin that use custom container closures, but these systems are very expensive, cannot generate high forces or pressures, and are typically reusable and / or refillable.

[0006] Due to factors including stability and time to market, drugs including biologics are usually initially sold in lyophilized or powdered forms or concentrated liquid forms. Such drugs packaged in bottles in liquid and powdered formulations may require a large amount of preparation before application. For the convenience of applying liquid formulations in bottles, the drugs in bottles are usually packaged together with empty syringes and multiple needles for aspirating and injecting from bottles into patients. In the case of powdered formulations, additional diluents or solution bottles can be provided to allow the powdered drug to be reconstituted into injectable solutions. The risks associated with the preparation and application of these drug dosage forms are significant. They include possible needle stick injuries that may occur during reconstruction and application, as well as errors caused by improper mixing and inaccurate dosage volumes or concentrations of the delivered drugs. This is a real challenge for both the trained caregiver and the patient who is receiving medication.

[0007] Similar risk issues can also apply to the transfer of ready-to-use injectable medications that must be transferred from a vial to an injection device. This transfer involves removing the medication from the vial, measuring the appropriate dose, and injecting into the patient using a syringe. Incomplete transfer of the entire volume in the vial requires overfilling the vial by approximately 25-30% and the associated waste. Contamination of the medication by non-sterile ambient air injected into the vial, or improper aseptic technique can result in contamination of injectable medications.

[0008] To overcome the above preparation and administration challenges using bottles, new injection devices have been developed to allow the user to manually and / or automatically transfer the drug from the bottle to a separate injection device at the time of use. However, this can present challenges to the user, including additional steps of use and associated risk of error, as well as additional device materials to dispose of. This can ultimately impact treatment compliance.

[0009] Therefore, there remains a need for new and / or improved devices and methods for injecting a drug into a subject from one or more source vials, or for transferring a drug from one or more source vials. Summary of the invention

[0010] Several aspects of the subject matter of the present invention may be implemented individually or together in the devices and systems described and claimed below. These aspects may be implemented individually or in combination with other aspects of the subject matter described herein, and the description of these aspects together does not mean to exclude the use of these aspects alone, or to claim the rights to these aspects alone or in a combination different from that described in the attached claims.

[0011] In one aspect, an injection device is characterized by: a vial holder configured to hold a vial containing a medical fluid; a canister holder configured to hold a compressed gas canister; and a balloon. The balloon spike is in fluid communication with the balloon and is configured to be inserted into a vial located in the vial holder and selectively communicates with the compressed gas canister located in the canister holder so that the balloon is inflated in the vial to pressurize the medical fluid in the vial. The injection spike is configured to be inserted into the vial positioned in the vial holder. The injection cannula is selectively in fluid communication with the injection spike so that the medical fluid pressurized in the vial by inflation of the balloon flows through the injection cannula.

[0012] In another aspect, a transfer device for transferring a medical fluid from a bottle is characterized by: a bottle holder configured to hold a bottle containing a medical fluid; a canister holder configured to hold a compressed gas canister; and a balloon. The balloon spike is in fluid communication with the balloon and is configured to be inserted into a bottle located in the bottle holder and selectively communicates with the compressed gas canister located in the canister holder so that the balloon is inflated in the bottle to pressurize the medical fluid in the bottle. The injection spike is configured to be inserted into the bottle positioned in the bottle holder. The transfer catheter cannula is selectively in fluid communication with the injection spike so that the medical fluid pressurized in the bottle by the inflation of the balloon flows through the transfer catheter.

[0013] In another aspect, a method for transferring a medical fluid from a bottle containing the medical fluid comprises the steps of inserting a balloon spike into the bottle, inserting an injection spike into the bottle, inserting a balloon into the bottle, inflating the balloon in the bottle, increasing the pressure of the medical fluid in the bottle, and transferring the pressurized medical fluid out of the bottle through the injection spike. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Examples of the subject matter of the present patent application are shown in the accompanying drawings for purposes of illustration only and not limitation, in which:

[0015] Figure 1 is a schematic diagram of a pre-loaded single vial injection system including an embodiment of the present disclosure.

[0016] Figure 2 is a perspective view of a single vial injection device according to an embodiment of the present disclosure.

[0017] Figure 3 yes Figure 2 A perspective view of a single vial injection device with its top cover removed to allow visualization of the internal components.

[0018] Figure 4 yes Figure 3 A top view of the injection device.

[0019] Figure 5 is along Figure 1A cross-sectional view taken along line 5-5 of FIG. 5 shows the compressed gas tank before the injection device button is pressed.

[0020] Figure 6 Shows Figure 5 An injection device of FIG. 1 is shown with the compressed gas tank after the injection device button is pressed.

[0021] Figure 7 is along Figure 1 A cross-sectional view taken along line 7-7 of FIG. 1 shows the retainer driver before the injection device button is pressed.

[0022] Figure 8 Shows the injection device after pressing the button and piercing the vial. Figure 7 injection device.

[0023] Fig. 9 Shown after filling the balloon and starting to dispense drug Figure 8 injection device.

[0024] Fig.10 Shown during further balloon filling and drug dispensing Fig. 9 injection device.

[0025] Fig.11 The diagram shows the end of the drug dispensing and balloon filling. Fig.10 The injection device shown.

[0026] Fig.12 Shows the results after drug dispensing Fig.11 An injection device wherein the button is retracted into a locked position.

[0027] Fig.13A is a cross-sectional view showing the holder driver of the second embodiment of the present disclosure before the injection device button is pressed.

[0028] Fig. 13B Shows the injection device after pressing the button and piercing the vial. Fig.13A injection device.

[0029] Fig.14 is a schematic diagram of another embodiment of the present disclosure.

[0030] Fig.15A The balloon and mandrel are shown in a second embodiment of the present disclosure, with the balloon in a deflated and wrapped configuration.

[0031] Fig. 15B Shows Fig.15A A balloon and a mandrel, wherein the balloon is in an inflated configuration.

[0032] Fig.16AA holding tube in a second embodiment of the present disclosure is shown.

[0033] Fig. 16B Shown is located Fig.16A Keep the tube Fig.15A of the balloon and mandrel.

[0034] Fig.17 The retaining tube, balloon and mandrel of FIG. 16 are shown positioned within the tack after the tack has been inserted into the vial.

[0035] Fig.18A shows when the balloon begins to leave the retaining tube and the nail Fig.17 The nail, retaining tube, balloon and mandrel in the.

[0036] Fig.18B The figure shows the state when the balloon is completely free of the retaining tube and the nail. Fig.18A of nails, retaining tubes, balloons and mandrels.

[0037] Fig. 18C The tack, retaining tube, balloon, and mandrel of FIG. 18 are shown with the balloon partially inflated.

[0038] Fig.19 is a perspective view of an exhaust valve assembly in a second embodiment of the present disclosure.

[0039] Fig. 20 is a bottom perspective partial view of the expansion chamber showing the exhaust port in the second embodiment of the present disclosure.

[0040] Fig.21 is an enlarged view of the pivot plate and piston head of the exhaust valve assembly.

[0041] Fig.22A Is in the initial configuration before the injection device button is pressed Figure 19-21 Cross-sectional view of the exhaust valve assembly and exhaust port.

[0042] Fig. 22B Is in the pressurized configuration after the injection device button is pressed Fig.22A Cross-sectional view of the exhaust valve assembly and exhaust port.

[0043] Fig. 22C Is in decompression configuration after the injection device button is pressed Fig. 22B Cross-sectional view of the exhaust valve assembly and exhaust port.

[0044] Fig.23 is a perspective view of a mechanism for piercing a pressurized gas cartridge in another embodiment of the present disclosure.

[0045] Fig.24 The gas expansion chamber cover is removed Fig.23 A partial view of the structure. DETAILED DESCRIPTION

[0046] Embodiments of the present disclosure relate to devices and methods for administering or transferring the contents of a bottle or other container. The contents of the bottle or container may be any suitable injectable, and for the purposes of this specification and claims, "injectable" includes, but is not limited to, any type of drug, therapeutic or diagnostic agent, antibiotic, biological agent, sedative, sterile water, and other injectable materials, alone or in combination with one or more other injectable materials, whether or not reconstitution or concentration adjustment or other processing is required prior to injection.

[0047] The following description is for illustrative purposes only and is not intended to be limiting. The subject matter of the present invention can be implemented in various devices, systems, and methods not shown below.

[0048] Embodiments of the present disclosure may include an injection device or transfer device with a compressed gas tank, a bottle with a stopper filled with an injectable, a double-chamber bottle nail or a double-bottle nail, an inflatable balloon, an injection sleeve or a transfer catheter, and an actuation button. The gas tank is in fluid communication with the balloon through the inlet side of the double-chamber bottle nail or the double-bottle nail. The balloon is initially folded and positioned within the inlet side of the double-chamber nail or the double-bottle nail to allow the nail to easily pierce the rubber stopper. The outlet side of the double-chamber nail or the double-bottle nail allows the contents of the bottle to be fluidly connected to the injection sleeve or other device via the transfer catheter. In the case of an injection device, the injection button can be mechanically coupled to an injection sleeve that can be moved within the device. In the case of a transfer device, the transfer catheter can be configured to transfer a medical fluid to a filling port of the injection device, such as disclosed in the commonly assigned U.S. Patent No. 9,925,333 issued to Hoovon et al., the contents of which are incorporated herein by reference.

[0049] Embodiments of the present disclosure may include single-use injection device apparatus and methods for administering to a subject such as a human. For example, referring to Figure 1 , which shows a general schematic diagram of a single bottle, pre-loaded or user-loaded injection system, which includes a bottle 1 filled with an injectable 2, a compressed gas tank 3, a balloon spike with an inflatable balloon 5, and an injection sleeve 6. The gas tank 3 is in fluid communication with the balloon 5 through a gas-to-balloon line 4, which has a distal end terminating at the balloon spike. The balloon is initially folded and positioned within the balloon spike to allow the spike to easily pierce the rubber stopper of the bottle 1. The upper end of the injection sleeve includes an injection spike, which pierces the rubber stopper of the bottle 1, as shown in FIG. Figure 1 As shown, to allow the vial 1 to be in fluid communication with the contents 2 of the injection cannula 6. In another embodiment, the balloon tack and injection tack may be combined into a single dual lumen tack with the lumen housing the balloon prior to inflation of the vial.

[0050] Figure 1The injection system can be positioned in a housing that is provided with an adhesive to attach the injection device to a patient or subject. An example of such an injection device is provided in PCT International Patent Application No. PCT / US2018 / 055624, International Publication No. WO2019 / 075337, issued to Bourelle et al., the contents of which are incorporated herein by reference.

[0051] Once the injection device is attached to the subject using an adhesive, the injection device button is activated. The activation of the button causes the balloon nail and the injection nail (or double-chamber nail) to be inserted into the rubber stopper of the bottle, puncture the gas tank and insert the injection sleeve into the subject. The compressed gas leaves the tank to fill the balloon located in the bottle. When the balloon expands in the rigid bottle, the increase in pressure prompts the injectable to enter through the injection nail (or the outlet side of the double-chamber nail) and enter the subject's body through the injection sleeve. The balloon can be designed to fill the internal space of the bottle to fully drive out all medical fluids and minimize residues. The balloon is preferably configured to expand against the farthest side wall and work toward the plug end of the bottle to ensure that there is no retained fluid. The direction of the bottle is not critical. Once all the injectables are dispensed from the bottle, the button is released and the needle is allowed to retract automatically. The injection device can be removed from the patient and discarded.

[0052] If the diameter of the balloon nail and the injection nail (or double-lumen nail) is large, it is difficult for the user to insert the nail into the rubber stopper. In some embodiments, as described below, the actuation of the button releases gas from the canister, which helps the injection nail or double-lumen nail enter and pass through the stopper of the bottle. Once the injection nail or double-lumen nail is fully located in the bottle, the compressed gas begins to fill the balloon.

[0053] Reference Figure 2 , a single bottle, pre-loaded injection device 7 embodiment includes an upper housing 8 and a lower housing 9, an injection device or actuation button 10, and a viewing window 11, wherein the upper housing 8 allows visualization of the bottle 1 ( Figure 3 ), the contents of the bottle 2 and the balloon 5. The viewing window 11 can also be used as an indicator of the state of the injection device 7 during the dispensing process.

[0054] In another embodiment, the injection device may not be pre-loaded with a bottle. In other words, the upper housing 8 is removably fixed to the lower housing 9 so that the bottle can be positioned in the bottle holder 40 by the user.

[0055] Reference Figure 3 and 4 , showing Figure 2Injection device with upper housing 8 removed. Components visible in this view include lower housing 9, vial 1 with injectable 2, vial stopper or cap 21, canister cap 14, button 10, expansion chamber 12, gas to balloon line 4, vial spike holder 18, vial to filter line 15, filter 13, filter to cannula line 17.

[0056] Reference Figure 5 and 7 , Figures 2 to 5 The spray device is shown in a pre-fire state. The compressed gas tank 3 is located in the tank holder 42 ( Figure 5 ) and is sealed in the expansion chamber 12 with a tank cover 14. In another embodiment, when the device is reusable, the tank cover 14 may also be removable so that the compressed gas tank 3 can be replaced after use.

[0057] The can lid 14 and the can nail 20 move with the button 10. The button also interacts with the retainer drive to Figure 7 and Figure 8 The retainer driver 24 is generally indicated by 24. The retainer driver 24 includes a double bottle nail, which includes an injection nail 22 and a balloon nail 23, wherein the balloon nail 23 has a balloon 5 in a deflated state. As mentioned above, in another embodiment, a single double-chamber bottle nail can be used instead of the double bottle nail.

[0058] Reference Figure 7 and 8 In the illustrated embodiment, the retainer driver 24 includes a rack 29 attached to the button 10 so as to move with the button. In addition, the retainer driver 24 includes a gear 32 rotatably mounted in the lower housing, and when the button 10 is pressed and recessed, the gear 32 engages and rotates with the rack 29. The cam 34 is fixedly fixed to the gear 32 so that when the gear rotates via the actuation of the button 10, the gear 32 rotates. Figure 7 and 8 When the cam 34 moves from Figure 7 Move to the position shown Figure 8 In the position shown, it engages with the bottle nail holder 18, which is slidably positioned in the lower housing. When the nail holder 18 slides into the lower housing due to the push of the cam 34, the bottle nail holder 18 is engaged with the bottle nail holder 18, which is slidably positioned in the lower housing. Figure 8 In the position shown, the injection nail 22 and the balloon nail 23 pierce the bottle stopper 21.

[0059] Reference Figure 6 and 8 Once the button 10 is pressed, the sleeve 6 connected to the button 10 extends from the lower housing (eg Figure 8As just one example, commonly assigned U.S. Patent No. 9,925,333 issued to Hoovon et al., the contents of which are incorporated herein by reference, as noted above, provides a means for coupling a button 10 to a sleeve.

[0060] exist Fig.13A and 13B An alternative embodiment of an injection device is shown generally at 100 in which parts common to the previous embodiments are given the same reference numerals. Fig.13A and 13B The injection device works in the same manner as the previous embodiment, except that reference is made to Figures 13A-22C describe.

[0061] exist Fig.13A and 13B In the injection device 100 of the present invention, in order to assist in the movement of the injection cannula 6, the compressed gas from the expansion chamber 12 is optionally introduced to the barrel 101 via a pipeline or a port to move the cannula piston 102 connected to the spring-loaded cannula holder 104, thereby pushing the cannula into the extended position (such as Fig. 13B The compressed gas translates the sleeve piston 102 to the relief 103 (also represented by Fig.14 ), which allows the sleeve piston to stop translating and allows gas to flow around the piston into the barrel 112 to insert the nail into the bottle and then to the balloon nail 23 ( Figure 7 and 8 ) to start inflation of the balloon. In such an embodiment, the button 10 can still be connected to the injection sleeve 6 so that the gas pressure helps the user to deploy the injection sleeve, or the button 10 can be disconnected from the injection sleeve 6 and the gas pressure can provide all the force required to deploy the injection sleeve. Fig. 13B Once in the dispensing position shown, the cannula holder 104 may also act as a valve to allow gas to enter the bladder in the bottle.

[0062] The button 10 is also connected to the can cap 14, and when the button is pressed, the button 10 pushes the can cap toward the can 3, thereby allowing the can nail 20 to pierce the can 3 to allow the flow of compressed gas 19 to fill the expansion chamber 12. As just one example, the pressure in the gas can 3 can be in the range of 500psi to 4000psi. The gas 19 is preferably nitrogen, because many drugs are sensitive to oxidation from the air, so nitrogen is used because it is inert. Once the gas 19 fills the expansion chamber 12, the pressure in the 12 is reduced to about 50psi (just as an example). The purpose of the expansion chamber is to reduce the pressure of the gas into a larger volume as a safety measure without the risk of bursting the bottle.

[0063] In alternative embodiments, expansion chamber 12 may be replaced by an alternative pressure regulating device, many of which are known in the art.

[0064] As described above, the button 10 also interacts with the retainer driver 24 to insert the injection spike 22 and the balloon spike 23 through the vial stopper 21 to access the internal contents 2 of the vial 1 .

[0065] Fig.13A and Fig. 13B An optional embodiment of the injection device 100 uses compressed gas to help the injection nail 22 and the balloon nail 23 move through the bottle stopper 21 to access the internal contents 2 of the bottle 1. More specifically, the compressed gas from the expansion chamber 12 moves the nail piston 110 connected to the bottle nail holder 18 to move the nails 22 and 23 (or double-lumen nails) from the bottle stopper 21. Fig.13A Push to the position shown Fig. 13B The position shown in the figure allows the nail to pass through the bottle stopper 21. The nail piston is slidably positioned in the barrel 112, and the barrel 112 receives compressed gas from the expansion chamber 12 via the injection sleeve to drive the piston release member 103 ( Fig.13A and 13B ) and port 114. Port 114 may be in direct communication with release member 103, or may be in communication with release member 103 via a gas line (not shown). Thus, in embodiments where pressurized gas does not assist in extending injection cannula 6, there is no Fig.13A and 13B The barrel 101 , without the sleeve piston 102 and without the release member 103 , can receive pressurized gas directly from the expansion chamber 12 or through a gas pipeline extending between the expansion chamber 12 and the port 114 .

[0066] In another alternative embodiment, the schematic diagram is shown in Fig.14 , compressed gas can translate the nail piston 110 in the direction of arrow 111 into the release member 113, which allows the piston to stop translating and allows gas to flow around the piston into the side hole 115 in the balloon nail 23 to begin translating the wrapped balloon into the bottle and inflating the balloon.

[0067] Reference Figure 4 and 9, after the distal portion of the nail is positioned in the bottle, the gas 19 in the expansion chamber 12 enters the balloon nail 23 through the gas to balloon line 4. The gas 19 pushes the balloon 5 from the balloon nail 23 to the rear of the bottle 1, and the initial inflation begins. The balloon 5 is designed to be deployed from the balloon nail 23 to the rear of the bottle 1. An example of a device is provided in U.S. Patent No. 7,883,499 issued to Fangrow, which is used to store a folded balloon 5 in the inner cavity of the balloon nail 23 when the balloon nail pierces the bottle stopper, and then deploy and inflate the balloon after being positioned in the bottle, and the contents of the patent are incorporated herein by reference. Optionally, as described below, the balloon can be extended and wrapped around a mandrel located in the balloon nail. The manufacture of the balloon can adopt various dipping techniques to obtain the correct size before and after inflation. Examples of suitable materials for balloons are provided in commonly assigned U.S. Patent Application Publication No. US2015 / 0217058 issued to Hoovon et al., the contents of which are incorporated herein by reference.

[0068] Another embodiment of a device for storing a folded balloon in the cavity of a balloon spike that pierces a bottle stopper and then unfolding and inflating the balloon will be described with reference to FIG. 15A to FIG. 18C Description. Fig.15A As shown, the balloon 122 is in a wrapped or collapsed configuration and is positioned on the distal end of an inflation tube or mandrel 124. Fig.16A The balloon retaining tube generally indicated at 126 includes an enlarged balloon storage portion 128 and a mandrel or inflation tube receiving portion 132, as shown in FIG. Fig. 16B As shown in FIG. 17 , the balloon storage portion 128 of the holding tube 126 is characterized by an open distal end 134. As shown in FIG. 17 , the balloon storage portion 128 of the holding tube 126 contains a wrapped or collapsed balloon and an inflation tube or mandrel ( Fig. 16B ) is positioned in the balloon nail 23. In this configuration, the balloon nail is inserted through the bottle stopper 21 and into the bottle ( Fig.17 (shown by the dashed line 1).

[0069] Fig.17 The deployment of the balloon 122 in the bottle is shown in Figures 18A-18C A gas channel 136 is formed in the bottle; the nail holder 18 is in fluid communication with the cylinder 112 ( Fig.13A and 13B ), so that the pressurized gas flows through the gas passage 136 and at the proximal end ( Fig.18A 138) pushes the balloon so that the balloon 122 moves along Fig.18B Move the retaining tube 126 and the balloon sleeve 23 out of the direction of the arrow 142 and move into Fig.18B Then, as Fig. 18C As shown, due to the pressurized gas (also from Fig.13A and13B The tube 112 in the air tube 124 flows through the inflation tube 124, and the balloon 122 begins to inflate. This continues until the balloon is fully inflated (as shown in Figure 15b or Fig.12 For balloon 5).

[0070] The balloon 5 (or 122) is designed to fill the back of the bottle 1 first and then move forward. This can be achieved by having a thin section at the back of the bottle 1 and a thicker section towards the front of the bottle 1. This has the advantage of allowing the balloon 5 to drive all of the injectable 2 out of the bottle 1 regardless of the orientation of the bottle 1.

[0071] Once the balloon 5 (or 122) begins to fill with gas 19, the increase in the volume of the balloon forces the injectable 2 to leave the bottle 122 through the injection pin. The injectable 2 is pushed through the filter 13 through the bottle-to-filter line 15. The filter 13 is composed of hydrophilic and hydrophobic filter media. The drug 2 is allowed to flow through the hydrophilic but not the hydrophobic filter media. Any gas present in the bottle, which is generally referred to as the head space T, and which is discharged from the bottle during the transfer process or after all the injectables are discharged, is allowed to flow through the hydrophobic but not the hydrophilic filter media. This has the advantage of delivering the injectable 2 to the patient instead of the gas 19 only through the injection cannula 6. An example of such a filtering device is provided in the PCT International Patent Application PCT / US2018 / 056130, International Publication No. WO2019 / 079335, issued to Bourelle et al., which is jointly assigned, and the contents of which are incorporated herein by reference.

[0072] Reference Figure 4 and 10 , pushing the injectable 2 through the filter 13, through the cannula line 17 and into the cannula manifold 25. Within the cannula manifold 25 is the cannula 6. The cannula 6 is sealed with an upper septum 26 and a lower septum 27 to seal around the outside of the cannula 6. The side holes 28 in the cannula 6 allow the injectable to flow from the manifold 25 through the inner diameter of the cannula 6 into the patient's body. An example of such a configuration is provided in commonly assigned U.S. Pat. No. 9,925,333 issued to Hooven et al., the contents of which are incorporated herein by reference as described above.

[0073] Reference Fig.10 As more gas 19 fills the balloon 5 (or 122) in the bottle 1, more injectable material 2 is forced out of the bottle 1 and into the patient's body.

[0074] Reference Fig.11, the balloon 5 (or 122) is almost completely filled within the bottle 1 to expel most of the injectable 2 from the bottle 1 and into the patient's body. As previously described, the preferred method of filling the balloon 5 is from the back of the bottle 1 to the front to ensure that all of the injectable 2 is removed from the bottle 1, thereby minimizing the residual injectable 2 in the bottle 1. The balloon can optionally be provided with an axial groove formed in the outer surface, or the balloon is provided with a small axial thick portion to create a path for fluid flow, thereby minimizing the retained fluid behind the balloon when the balloon is inflated against the inner wall of the bottle.

[0075] Reference Fig.12 Once the balloon 5 (or 122) has almost completely filled the bottle 1 and expelled a substantial amount of the injectable 2 from the bottle 1, the balloon triggers the button release mechanism 39. This allows the button 10 to rise and the sleeve 6 to automatically retract and lock the restart of the injection device by providing notification to the patient that the administration is complete.

[0076] By way of example only, the button release mechanism may include a switch, button, or other member that engages the fully (or nearly fully) inflated balloon 5, and an associated linkage or other mechanism that activates an automatic needle / cannula retraction mechanism, such as disclosed in commonly assigned U.S. Patent No. 9,925,333 issued to Hoovon et al., the contents of which are incorporated herein by reference as described above. Alternatively, the button release mechanism 39 may be triggered, for example, by a reduced fluid flow rate through an injection tack or balloon tack or associated tubing (or a combination thereof). As yet another example, the button release mechanism may be activated by the expansion chamber 12 ( Figure 4 The sensor is triggered by the change of gas pressure inside the sensor.

[0077] The injection device may further include an exhaust valve in fluid communication with the cavity of the balloon spike and the exhaust port. The exhaust valve may be configured to be opened by the button release mechanism 29 after the dispensing / injection of the drug is completed, so that the pressurized gas in the balloon is discharged outside the injection device housing.

[0078] In an optional embodiment, the expansion chamber 12 is provided with an exhaust valve assembly. Figure 3 As described below, after the button is pressed to start the injection, the exhaust valve assembly engages with a locking tab 152 formed on the button 10. Once the expansion chamber 12 is pressurized after the pressurized gas cylinder 19 is pierced, the exhaust valve assembly is activated ( Figure 5 ). The button 10 remains in the lowered or retracted position until all of the medical fluid has been transferred to the patient and the gas begins to be exhausted. Once the pressure in the expansion chamber drops below a predetermined pressure, the exhaust valve assembly opens, allowing the button 10 to be released to Figure 2 and 3 Raised or extended position shown.

[0079] Above Figure 3 One embodiment of the exhaust valve assembly is Fig.19 The pivot plate, generally designated 150, is pivotally attached to a mounting post 156 located on the outer top surface of the expansion chamber 12 adjacent to the exhaust port, as shown in FIG. Fig. 20 158. A torsion spring 162 is also positioned on the mounting post 156 and pushes the pivot plate 154 to rotate in a counterclockwise direction (arrow 164). Fig.19 As shown, the pivot plate includes an arcuate main slot 166. Fig.21 As shown in FIG. 1 , the arcuate slot 166 of the pivot plate has a stop wall 168 , an opposing pair of recesses 172 a and 172 b and an opposing pair of slots 174 a and 174 b .

[0080] like Fig.19 , 21 As shown in Figures 22A-22C, the pressure relief member piston 175 is located within the exhaust port 158 ​​and the arcuate main groove 166 of the pivot link 154. The piston includes a piston head having arms 176a and 176b. Fig.21 As shown, due to Fig.19 and 22A -22C compression coil spring 180 pushes downward ( Fig.22A The piston arms 176a and 176b are initially positioned within the recesses 172a and 172b of the pivot plate 154 (arrow 178). Fig. 20 and 22A -22C, the bottom of the pressure release piston 175 is provided with an annular seal 182, which is positioned in the exhaust hole 158 and closes the exhaust hole 158 when the exhaust valve assembly 150 is in the following configuration: it corresponds to the initial state of the injection device before the pressurized gas cartridge is pierced.

[0081] When the user presses the button 10 and moves it to Fig. 13B After the retracted position shown (injection cannula 6 extended), and the gas cylinder is punctured, Figure 3 The button locking tab 152 and the latch notch 184 of the pivot plate 154 ( Fig.21 ) engages and is locked in the down or retracted position.

[0082] As described above, the action of pressing the button 10 causes the pressurized gas cartridge ( Figure 5 and 6 19) is punctured, thereby filling the pressurized gas expansion chamber 12 with pressurized gas. The pressure in the gas expansion chamber pushes the bottom of the annular seal 182, which overcomes the thrust of the compression spring 180 and forces the pressure release member piston 175 to rise to Fig. 22B Therefore, refer to Fig. 22B , the arms 176a and 176b of the piston head are moved from the grooves 172a and 172b ( Fig.21 ) rises. Then, due to the torsion spring 162 Fig.19 By pushing in the direction of arrow 164, the pivot plate 154 rotates until the piston stop 188 ( Fig.21 ) contacts the stop wall 168 of the pivot plate 154 ( Fig.21 ). At this point, the annular seal 182 is still located within the vent 158 ​​and the vent remains closed while the injection is being made. The tab 152 ( Figure 3 ) is held locked by the pivot plate 154 so that the button remains in the lowered or retracted position.

[0083] When the injection is complete, the balloon expands to its fully inflated (or nearly fully inflated) state. The dimensions of the balloon 5 or 122 and the expansion chamber 12 can be such that full (or nearly full) inflation of the balloon 5 or 122 results in a decrease in the pressure within the expansion chamber 12. Alternatively, or in addition, Figure 4 The exhaust port shown by the dashed line 192 can be formed in the expansion chamber and its size is designed to allow the expansion chamber 12 to be slowly exhausted at a rate that does not interfere with the inflation of the balloon 5 or 122. When the pressure in the expansion chamber 12 is slowly reduced, the compression spring 180 ( Fig.19 and 22A -22C) begins to expand or stretch out, and refer to Fig. 22B and 22C , the annular seal 182 of the pressure release member piston 175 moves downward in the exhaust hole 158. Fig. 20 and 22A -22C, an exhaust notch is formed in the expansion chamber 12. When the annular seal 182 is lowered below the notch, the compressed air from within the expansion chamber 12 bypasses the annular seal and enters the exhaust hole 158. This causes the annular seal 182 to move further downward into the expansion chamber, so that the remaining pressurized air in the expansion chamber is quickly exhausted through the exhaust hole 158 and through the exhaust ports 194 and 196 ( Fig.21 )discharge.

[0084] After the last exhaust stage, the pressure in the expansion chamber 12 is at atmospheric pressure, so there is no pressure to push the bottom of the annular seal 182 of the pressure relief piston 175 upward. Fig. 22C As shown, it is free to expand further and the piston head drops downward relative to the pivot plate 154. When this happens, the stop member 188 ( Fig.21 ) from the pivot plate stop surface ( Fig.21 168) slide down and slide out. Fig.21 and 22C Then, when the compression spring further expands, the piston arms 176a and 176b drop downward through the opposite slots 174a and 174b and leave the pivot plate 154. As the piston arms 176a and 176b leave the pivot plate 154, the pivot plate further moves along the pivot plate due to the push of the torsion spring 162. Fig.19 Rotate in the direction of arrow 164 ( Fig.19 and 22A -22C). Therefore, the latch notch 184 ( Fig.21 ) pivots away from the locking tab 152 of the button 10 ( Figure 3 ), so that the button is released and rises upward or extends backward, and the injection sleeve 6 rises upward or retracts Fig.13A The injection is then complete.

[0085] In short, for Figures 13A-22C In the illustrated embodiment, the use of the injection device can be as follows. The user removes the injection device from the packaging. The safety strip and adhesive pad are in place. The user removes the pad and attaches the device to their skin. The user removes the safety strip and presses the injection device button. Pressing the button punctures the canister. The compressed gas in the canister fills the expansion chamber. When the expansion chamber has 0.75cc-1cc of compressed gas at 150psi-200psi, the gas expands into the expansion chamber, and the volume of the expansion chamber is approximately twice the volume of the bottle. For example, theoretically ignoring losses, at 150psi a 1cc canister will fill a 10cc expansion chamber to 15psi. A 10cc expansion chamber at 15psi will fill a 10ml bottle to a final pressure of approximately 7.5psi. The size and pressure of these expansion chambers limit the pressures to which the user is exposed when the balloon ruptures.

[0086] Once the canister is pierced and the gas fills the expansion chamber and the spring loaded cannula holder is advanced to the locked deployed position from the compressed gas at least partially by piston action. Due to the pressure in the expansion chamber, locking occurs from the exhaust valve assembly. Once the cannula holder reaches the deployed position, this opens the ability for gas to pass through the nail holder. The nail holder is advanced with a piston that interacts with the compressed gas until it reaches the deployed position inside the bottle through the stopper. In the deployed position, the gas pushes the balloon into the bottle and begins to inflate. As the size of the balloon increases, fluid flows out of the bottle. The filter line and the dead space in the filter are discharged through the hydrophobic filter. The fluid from the bottle travels through the filter line through the hydrophobic / hydrophilic filter. The fluid passes through the hydrophilic substance into the cannula line and into the patient's body. Air flows through the hydrophobic substance into the environment. The exhaust valve opens at the end of delivery. This releases the air in the expansion chamber and releases the button to retract the injection cannula, and the button is lifted.

[0087] exist Fig.23 and 24 An alternative arrangement for piercing a pressurized gas canister via actuation of an injection device button is shown in FIG.

[0088] Reference Fig.23 , the gas expansion chamber housing 212 includes a flexible wall portion 214. By way of example only, for flexibility, the flexible wall portion 236 may be constructed of a plastic having a thickness of approximately .030". The expansion chamber 212 is configured to supply pressurized gas to Fig.13A and 13B The tube 101 and / or 110, the balloon 5 ( Figure 9-12 ) or 122( Figure 9-12 ) and any other components of the injection device as described above that receive pressurized gas. The expansion chamber is provided with an exhaust valve assembly 250, which operates in the same manner as Figure 19-22C The exhaust valve assembly 150 in the embodiment of the present invention operates in the same manner as described above.

[0089] The trigger spring, generally indicated at 218, includes a hammer portion 222 and a latch portion 224. Bracket 226 and retaining post 228 cooperate to secure the proximal retaining portion of the trigger spring in place in a fixed manner. The hammer portion 222 is urged by the elastic force of the trigger spring to engage with the flexible wall portion 216 of the gas expansion chamber 212, as shown in FIG. Fig.23 As shown. By way of example only, the trigger spring 218 may be made of metal or steel.

[0090] Continue to refer Fig.23 , the link 232 includes a first notch 234 and a second notch 236. The first notch 234 engages with the latch portion 224 on the distal end of the trigger spring 218. The second notch 236 engages with a link hook 238 formed or fixed on the cam ring 242, and the link hook 238 is rotatably positioned about a button shaft or socket, generally indicated at 246, and fixed to the base 244. By way of example only, the connector can be made of steel, metal, or plastic.

[0091] like Fig.24 As shown, the gas box cap 262 is characterized in that the inner surface of the piercing tip with a sharp tip is retained. Cap 262 keeps the piercing tip in a position relative to the seal of the pressurized gas box 219 located in the gas expansion chamber 212.

[0092] like Fig.23 and 24 As shown in the comparison of FIG. 2 , the cover 262 is positioned adjacent to or engages the flexible wall portion 214 at a position corresponding to the position where the hammer portion 222 of the trigger spring engages with the flexible wall portion. Thus, the flexible wall portion 214 is sandwiched between the pressurized gas tank cover 262 and the hammer portion 222 of the trigger spring 218.

[0093] Reference Fig.23 , cam hooks 264a and 264b are formed on the side of the button 210. Cam slopes 266a and 266b are formed on the rotating cam ring 242. When the button 210 is in the raised or extended position shown, the cam hooks 264a and 264b are located on the top of the cam slopes 266a and 266b.

[0094] When the button 210 is pressed, the button is lowered and retracted into the socket 246, and the cam hooks 264a and 264b travel downward along the corresponding cam slopes 266a and 266b of the cam ring, so that the cam ring moves along Fig.23 The device rotates in the direction of arrow 270 (ie, counterclockwise).

[0095] When the cam ring 242 moves along the direction of arrow 270 ( Fig.23 ), the connecting rod 232 is pulled by the hook 238. As a result, the hammer portion 222 of the trigger spring overcomes the push of the trigger spring and is pulled away from the flexible wall portion 214 of the gas expansion chamber. This occurs until the latch portion 224 of the trigger spring slides out of the first notch 234 of the connecting rod 232, so that the deflected hammer portion 222, which is now spaced apart from the flexible wall portion 214, is released.

[0096] Due to the elastic force acting on the deflected trigger spring, the released hammer portion 222 hits the flexible wall portion when the hammer portion rebounds to its initial position. This forces the central area of ​​the flexible wall portion 214, and thus the piercing tip ( Fig.24 ) moves inwardly and punctures the seal of the pressurized gas cartridge 219. In doing so, the flexible wall portion is elastically deformed in a concave manner into the gas expansion chamber 212. Thus, the pressurized gas from the gas cartridge fills the gas expansion chamber 212 and flows toward the above-mentioned components.

[0097] It should be noted that in alternative embodiments, the flexible wall may be used to push the gas cartridge toward a fixed piercing tip to pierce the seal of the pressurized gas cartridge.

[0098] While preferred embodiments of the present disclosure have been shown and described, it will be apparent to those skilled in the art that changes and modifications may be made thereto without departing from the spirit of the present disclosure, the scope of which is defined by the appended claims.

Claims

1. An injection device, comprising: a. a bottle holder configured to hold a bottle containing a medical fluid; b. a tank holder configured to hold a compressed gas tank; c.Balloon; d. a balloon tack in fluid communication with the balloon and configured to be inserted into a vial located in the vial holder and selectively communicated with a compressed gas tank located in the tank holder so that the balloon is inflated in the vial, thereby pressurizing the medical fluid in the vial; e. an injection spike configured to be inserted into a bottle positioned in the bottle holder; f. an injection cannula selectively in fluid communication with the injection spike so that the medical fluid pressurized in the bottle by inflation of the balloon flows through the injection cannula, The injection device further comprises: a housing in which the bottle holder and the can holder are positioned; as well as an actuation button connected to the injection sleeve and configured to move between a first position and a second position, wherein in the first position, the injection sleeve is retracted into the housing and prevents fluid flow from the injection spike to the injection sleeve, and in the second position, the injection sleeve is extended from the housing and is in fluid communication with the injection spike.

2. The injection device of claim 1, wherein the balloon is configured to be located within a lumen of the balloon spike during insertion into the vial.

3. The injection device of claim 1, further comprising a vial containing a liquid drug positioned within the vial holder.

4. The injection device of claim 1 , further comprising a compressed gas tank positioned in the tank holder.

5. The injection device of claim 1, further comprising a vial containing a medical fluid positioned within the vial holder and a compressed gas canister positioned within the canister holder.

6. The injection device as claimed in claim 5, wherein the bottle includes a bottle stopper, and when the balloon nail and the injection nail are inserted into the bottle, the bottle stopper is pierced by the balloon nail and the injection nail.

7. The injection device according to any one of claims 1 to 6, wherein the balloon nail and the injection nail comprise a single double-lumen bottle nail.

8. The injection device of claim 1 , further comprising a tank spike connected to the actuation button and configured such that when the button is moved to the second position, the tank spike pierces a seal of the compressed gas tank so that compressed gas flows from the compressed gas tank to the balloon.

9. The injection device of claim 8, further comprising: i) a bottle nail holder, wherein the balloon nail and the injection nail are fixed to the bottle nail holder and the bottle nail holder is configured to move from a first position and a second position, wherein in the first position, the balloon nail and the injection nail are separated from the bottle, and in the second position, the balloon nail and the injection nail are inserted into the bottle; and ii) a holder driver, comprising a rack connected to the actuating button, a gear rotatably mounted in the housing, and a cam fixed to the gear, wherein when the actuating button moves from the first position to the second position, the rack meshes with the gear and rotates the gear, thereby causing the bottle nail holder to move from the first position to the second position through the cam.

10. The injection device of claim 8, wherein the housing includes a window through which the vial can be viewed.

11. The injection device as described in claim 4 or 5 further includes a pressure regulating device, which is positioned between the compressed gas tank and the balloon nail and is fluidly connected to the compressed gas tank and the balloon nail so as to receive gas having a first pressure from the compressed gas tank and direct gas having a second pressure to the balloon nail, wherein the second pressure is less than the first pressure.

12. The injection device of claim 11, wherein the pressure regulating device is an expansion chamber.

13. An injection device as claimed in claim 12, wherein the canister holder is positioned within the expansion chamber.

14. The injection device of claim 1, wherein the balloon nail and the injection nail comprise a single double-lumen bottle nail.

15. The injection device of claim 1 , wherein the bottle comprises a distal wall or bottom and a stopper, the stopper being pierced by the injection spike when the injection spike is inserted into the bottle, and the balloon is configured to initially expand against the distal wall or bottom and then expand toward the stopper during inflation.

16. The injection device of claim 1, wherein the balloon comprises an axial groove when inflated.

17. The injection device of claim 1, further comprising a hydrophilic and a hydrophobic filter configured to receive fluid from the injection spike and deliver the filtered fluid to the injection cannula.

18. The injection device of claim 1, further comprising: i. an injection sleeve piston, wherein the injection sleeve is mounted on the injection sleeve piston; j. an injection sleeve barrel, wherein the injection sleeve piston is slidably positioned within the injection sleeve barrel; k. A tank spike, which is operably connected to the actuation button and is configured to pierce the seal of the compressed gas tank when the button is moved to the second position, allowing the pressurized gas from the compressed gas tank to flow to the injection sleeve barrel, thereby extending the injection sleeve from the housing.

19. The injection device of claim 1, further comprising: i. a bottle nail holder, wherein the balloon nail and the injection nail are fixed to the bottle nail holder and the bottle nail holder is configured to move from a first position and a second position, wherein in the first position, the balloon nail and the injection nail are separated from the bottle, and in the second position, the balloon nail and the injection nail are inserted into the bottle; j. a bottle nail holder piston, wherein the bottle nail holder is mounted on the bottle nail holder piston; k. A bottle nail holder cylinder, wherein the bottle nail holder piston is slidably positioned within the bottle nail holder cylinder; 1. A bottle nail, which is operably connected to the actuation button and is configured such that when the button is moved to the second position, the bottle nail pierces the seal of the compressed gas tank so that the pressurized gas from the compressed gas tank flows to the bottle nail holder cylinder, thereby moving the bottle nail holder from the first position to the second position through the bottle nail holder piston.

20. The injection device of claim 1, further comprising: h. a button shaft within which the actuation button moves between the first position and the second position; i. An expansion chamber configured to selectively communicate with the balloon nail; j. A compressed gas tank positioned within the expansion chamber; k.Piercing tip; l. a trigger spring having a hammer portion, wherein the trigger spring is configured to be deflected and released when the actuation button moves from the first position to the second position; as well as m. A flexible wall portion positioned near the compressed gas tank or the piercing tip and configured to be engaged by the hammer portion of the trigger spring when the trigger spring is released after deflection, so that the flexible wall portion causes the piercing tip to pierce the compressed gas tank, thereby pressurizing the expansion chamber.

21. The injection device as described in claim 1 further includes an expansion chamber, which is fluidly connected to the compressed gas tank and the balloon nail so as to receive gas having a first pressure from the compressed gas tank and direct gas having a second pressure to the balloon nail, wherein the second pressure is less than the first pressure, wherein the expansion chamber includes an exhaust hole and an exhaust valve assembly, and the exhaust valve assembly includes a piston spring and an annular seal, wherein the piston spring is constructed to push the seal to a position allowing air to flow through the exhaust hole when the pressure in the expansion chamber drops below a first predetermined level.

22. The injection device of claim 21, further comprising: a tank spike operably connected to the actuation button and configured such that when the button is moved to the second position, the tank spike pierces a seal of the compressed gas tank; as well as a pivot plate, wherein the pivot plate is pivotally mounted to the injection device so as to pivot between a locked position and a released position, wherein in the locked position the pivot plate engages the actuation button when the actuation button is in the second position, and in the released position the actuation button is released to return to the first position, the pivot plate being operatively connected to the exhaust valve assembly so that the pivot plate pivots to the released position when the pressure in the expansion chamber drops below a second predetermined level.

23. The injection device of claim 22, wherein the piston spring is a compression coil spring, and the injection device further comprises a torsion spring configured to urge the pivot plate toward the release position.

24. The injection device as described in claim 1 also includes a core shaft having a distal end and a balloon holding tube, the balloon is wrapped or gathered on the distal end, wherein the wrapped or gathered balloon and the core shaft are received in the balloon holding tube, and the balloon holding tube is received in the balloon nail, and wherein the balloon holding tube is constructed so that when the balloon nail is connected to the compressed gas tank, the wrapped or gathered balloon is pushed out of the balloon holding tube and the balloon nail and then inflated.

25. A transfer device for transferring a medical fluid from a bottle, comprising: a. a bottle holder configured to hold a bottle containing a medical fluid; b. a tank holder configured to hold a compressed gas tank; c.Balloon; d. a balloon tack in fluid communication with the balloon and configured to be inserted into a vial located in the vial holder and selectively communicate with the compressed gas tank located in the tank holder so that the balloon is inflated in the vial to pressurize the medical fluid in the vial; e. an injection spike configured to be inserted into a bottle positioned in the bottle holder; f. a transfer catheter selectively in fluid communication with the injection spike so that the medical fluid pressurized in the bottle by inflation of the balloon flows through the transfer catheter, The transfer device further comprises: a housing in which the bottle holder and the can holder are positioned; as well as an actuation button connected to the transfer conduit and configured to move between a first position in which the transfer conduit is retracted into the housing and prevents fluid flow from the injection spike to the transfer conduit, and a second position in which the transfer conduit is extended from the housing and is in fluid communication with the injection spike.

26. The transfer device of claim 25, wherein the balloon is configured to be positioned within a lumen of the balloon tack during insertion into the vial.

27. The transfer device of claim 25 or 26, wherein the balloon nail and the injection nail comprise a single double-lumen bottle nail.

28. A method for transferring a medical fluid from a bottle containing the medical fluid, comprising the steps of: a. Providing a bottle and a bottle holder, wherein the bottle is held in the bottle holder; b. Providing a compressed gas tank and a tank holder, wherein the compressed gas tank is held in the tank holder; wherein said bottle holder and said can holder are positioned within a housing; c. Providing a balloon and a balloon tack, wherein the balloon is in fluid communication with the balloon tack and is selectively in communication with the compressed gas tank; d. providing an injection spike, an injection sleeve selectively in fluid communication with the injection spike, and an actuation button connected to the injection sleeve, wherein the actuation button is configured to move between a first position and a second position, wherein in the first position, the injection sleeve is retracted into the housing and prevents fluid flow from the injection spike to the injection sleeve, and in the second position, the injection sleeve is extended from the housing and in fluid communication with the injection spike; e. inserting the balloon nail into the bottle; f. inserting the injection nail into the bottle; g. inserting the balloon into the bottle; h. piercing the compressed gas tank and directing the pressurized gas from the compressed gas tank to inflate the balloon in the bottle to increase the pressure of the medical fluid in the bottle; and i. Transferring the pressurized medical fluid out of the vial through the injection spike and the injection cannula selectively in fluid communication with the injection spike.

29. The method of claim 28, wherein the pressurized gas is nitrogen.

30. The method of claim 28, wherein the bottle includes a rubber stopper, and during steps e and f, the balloon tack and the injection tack are inserted through the rubber stopper.

31. The method of any one of claims 28 to 30, wherein during steps e and g, the balloon is positioned within a lumen of the balloon tack.

32. The method of any one of claims 28 to 30, wherein steps e, f and g are performed simultaneously.

Images