Improvements in or relating to closed-type transfer devices

Abstract

In the field of methods and apparatus for administering drugs, there is a demand for improved closed-loop transfer devices. A closed-loop transfer device (10) comprises a syringe (12) having an elongated hollow syringe body (14), in which a plunger (16) is slidably housed, defining a drug chamber (18) whose size changes depending on the degree of insertion of the plunger (16) within the syringe body (18). The closed-loop transfer device (10) also comprises a needle assembly (28;300) having a needle assembly body (30), to which a subcutaneous injection needle (32) is fixedly attached. The needle assembly body (30) is coupled to the syringe body (14) and maintains fluid communication between the internal conduit (40) of the subcutaneous injection needle (32) and the drug chamber (18). In addition, the closed-loop transfer device (10) also comprises a shield assembly (42) having a shield body (44). The shield body (44) is movably coupled to the syringe body (14), thereby allowing the shield assembly (14) to selectively operate to surround the needle (32). The shield body (44) and the syringe body (14) are provided with mutually cooperative forming parts for restricting the movement of the shield assembly (42) relative to the syringe (12) through a series of positions (200, 210, 220, 230, 240, 250, 260) corresponding to different operating states of the device (10).

Description

Detailed description of the invention

[0001] The present invention relates to a closed-system transport device (CSTD) and a method for using such a device. Closed-loop transfer systems allow for the preparation, transport, and administration of substances, primarily potentially hazardous drugs, while mechanically preventing both the transfer of ambient contaminants into the system and the leakage of drugs or their vapor concentrations outside the system. Such systems, especially those intended for drug transport, are sometimes also known as closed-loop drug transport systems.

[0002] According to a first aspect of the present invention, a closed-type transfer device, A syringe having an elongated, hollow syringe body, wherein a plunger is slidably housed within the syringe body, defining a drug chamber whose size changes depending on the degree of insertion of the plunger within the syringe body, and A needle assembly having a needle assembly body to which a subcutaneous injection needle is fixedly attached, wherein the needle assembly body is coupled to a syringe body and maintains fluid communication between the internal conduit of the subcutaneous injection needle and the drug chamber, A shield assembly comprising a shield body movably coupled to a syringe body, wherein the shield assembly is selectively operable to surround the needle, A closed transfer device is provided, in which the shield body and syringe body are equipped with mutually cooperative forming parts for restricting the movement of the shield assembly relative to the syringe through a series of positions corresponding to different operating states of the device.

[0003] Providing a shield body and syringe body with mutually cooperative forming parts that constrain relative movement between the shield assembly and the syringe through the aforementioned series of positions corresponding to different operating states of the device helps to guide the user of the device favorably through each operating state, thereby reducing the risk of malfunction and significantly improving the usability of the device.

[0004] Optionally, the shield body may be movably coupled to the syringe body for linear axial movement along the length of the syringe body and rotational circumferential movement around the outer circumference of the syringe body.

[0005] Such relative linear and rotational movements can be easily constrained, while maintaining the necessary distinctions between each of the positions in the sequence. Preferably, the series of positions are A first main position corresponding to the prepared state of the device, in which one or more drugs can be aspirated from the vial into the drug chamber, A second primary position corresponding to the transport state of the device, in which the shield assembly surrounds the needle and its movement relative to the syringe is suppressed, preventing the needle from being exposed beyond the shield assembly, and The device includes two or more third primary positions corresponding to the administration state of the device, where a needle can be inserted into a subject and some or all of the contents of the drug chamber can be injected into the subject.

[0006] By constraining the relative movement between the shield assembly and the syringe to two or more of the indicated first, second, and third primary positions, it is possible to guide the user through the primary operating states of the device, i.e., the most important and critical operating states of the device, thereby ensuring easy and reliable use of the device by such a user. Useful.

[0007] The position of the shield assembly relative to the syringe may be selectively restricted to only one of the first primary position, the second primary position, or the third primary position. These limitations present an opportunity to provide a simplified version of the device with limited operating modes.

[0008] The mutually cooperative forming parts of the shield body and syringe body may further be configured to allow movement between a series of main positions in only a single sequence. Preferably, a single sequence includes a first principal position followed by a third principal position.

[0009] Optionally, a single sequence includes a first primary position, followed by a second primary position, followed by a third primary position. By such a configuration of the mutually cooperating formations and restricting the relative movement through a series of primary positions to only a single sequence, the user is forced to follow the optimal sequence of the main operating states of the device, thereby further serving to ensure the correct use of the device by the user.

[0010] Preferably, at least one one-way mutually cooperating formation is interposed between at least two primary positions. By providing at least one such one-way mutually cooperating formation, preferably, respective mechanical barriers against unwanted movement in an incorrect sequence between respective primary positions are provided. Such mechanical barriers are difficult (if not impossible) to overcome without permanently damaging the device, and also provide options to convey tactile and / or auditory feedback to the user of the device when they are correctly traversed.

[0011] In a preferred embodiment of the present invention, the series of positions further a first secondary position corresponding to the shipped state of the device, where the shield door assembly surrounds the needle and is movable towards the first primary position, a second secondary position corresponding to the ready state of the device, where the drug chamber contains one or more drugs and the shield door assembly surrounds the needle and is movable towards the second primary position, a third secondary position corresponding to the inserted state of the device, where the needle can be located inside the recipient, and a fourth secondary position corresponding to the locked state of the device, where the shield door assembly surrounds the needle and is immovable relative to the syringe, includes one or more of these.

[0012] The advantage of including a first secondary position corresponding to the device's shipping state is that, for example, to prevent needle stick injuries during shipment of the device from the manufacturer or distributor to the intended user, such as a healthcare professional or other medical expert, the needle is preferably surrounded, i.e., properly enclosed or covered, while the device is also ready to be inserted into a drug vial, for example, with the shield assembly movable to a first primary position corresponding to the device's prepared state.

[0013] The device has a second secondary position corresponding to a ready state, in which the drug chamber contains one or more drugs and the shield assembly surrounds the needle, which is advantageous in that the needle is ensured to be surrounded, i.e., the needle is properly enclosed or covered to prevent needle stick injuries, while the shield assembly is ready to move toward the second primary position, i.e., the device is ready to assume a transport state that allows for the safe and mechanically closed transport of the device, for example, from the preparation area to the administration area to the patient. It's done.

[0014] By including a third secondary position corresponding to the insertion state of the device, in which the needle may be located inside the subject, the device is fortunately able to adopt a configuration in which the needle may be located inside the subject, while the shield assembly can be continuously in contact with the subject's body, for example, during needle insertion, thereby maintaining the mechanical closure of the device.

[0015] It is particularly advantageous to include a fourth secondary position corresponding to the locked state of the device, in which the shield assembly surrounds the needle and makes it immovable relative to the syringe. This is because, for example, following the use of the device, i.e., following the injection of one or more drugs from the drug chamber into the recipient, the needle is completely and permanently disabled in a safe manner that prevents both needle stick injuries and reuse of the device.

[0016] In another preferred embodiment of the apparatus, if the set of positions includes a fourth secondary position corresponding to a locked state of the apparatus in which the shield assembly surrounds the needle and is immovable relative to the syringe, the shield assembly further comprises an elastically biased latching member which is biased to contact the tip of the needle when the shield assembly moves to the fourth secondary position relative to the syringe, thereby the cooperative forming portions of the shield body and the syringe body further cooperate with the latching member to restrict the linear movement of the shield assembly relative to the syringe.

[0017] By suppressing the relative axial movement between the shield assembly and the syringe in this way, the shield assembly is advantageously held in an axial position relative to the syringe, where relative rotational movement between the shield assembly and the syringe is also suppressed, and thus the shield assembly becomes immovable relative to the syringe.

[0018] The mutually cooperative forming parts of the shield body and the syringe body may be a male forming part and a female forming part, or may include both. This arrangement allows for easy and reliable collaboration in a form that is also easily manufactured.

[0019] Optionally, the male mold forming section is or comprises an elastically biased claw member, and the female mold forming section is or comprises a plurality of slots into which the claw member is biased inward.

[0020] By providing a claw member, a highly reliable follow-up element is provided, while by having a female mold forming section in the form of multiple slots, preferably one or more paths for the claw to follow can be provided, thereby guiding the user of the device through a series of relative positions between the shield assembly and the syringe corresponding to each operating state of the device. In another preferred embodiment of the present invention, the female mold forming section comprises a first slot extending in the axial direction, a circumferentially extending slot extending from one end of the first slot extending in the axial direction, and a second axially extending slot intersecting the end of the circumferentially extending slot opposite to the end of the first slot extending in the axial direction.

[0021] Preferably, The first end of the first slot extending in the axial direction is the end from which the circumferentially extending slot extends, defining both the first secondary position and the second secondary position. The second end of the first slot, which extends in the axial direction, is on the opposite side from the first end and defines the first principal position. The second primary location is situated along a slot that extends circumferentially. The second end of the circumferentially extending slot is the end that intersects with the second axially extending slot, defining a third principal position. The first end of the second slot, which extends axially, is the end closest to the opening end of the syringe body, defining a third secondary position, and The second end of the second slot, which extends in the axial direction, is on the opposite side from the first end and defines a fourth secondary position, satisfying one or more of the following conditions.

[0022] The aforementioned arrangement preferably allows for the mapping of various primary and secondary positions of the shield assembly to the syringe, thereby guiding the user of the device to the corresponding operating states of the device.

[0023] The needle assembly may include an actuator module configured to selectively bias the shield assembly relative to the syringe from a third secondary position corresponding to an insertion state of the device in which the needle may be located inside the recipient, to a fourth secondary position corresponding to a locked state of the device in which the shield assembly surrounds the needle and is immovable relative to the syringe.

[0024] By providing such an actuator module, and by the resulting biasing of the shield assembly from a third secondary position relative to the syringe to a fourth secondary position relative to the syringe, the shield assembly is advantageously maintained in contact with the patient's skin, for example, during the withdrawal of the needle following drug administration, thereby assisting in the mechanical prevention of any leakage of hazardous drugs or vapors that might otherwise leak from the patient or the needle when the needle is withdrawn.

[0025] Optionally, the actuator module includes an actuator valve that is movable between a closed position in which the gas is held pressurized in the gas storage space and an open position in which the gas is released from the gas storage space, biasing the shield assembly from a third secondary position to a fourth secondary position.

[0026] Preferably, the movement of the actuator valve to the open position causes the gas storage space to be in fluid communication with a vent, thereby releasing the gas from the gas storage space, the vent being in fluid communication with a foldable chamber sealed and fixed between the needle assembly and the shield assembly, the release of gas from the gas storage space through the vent into the foldable chamber causing the chamber to expand axially, and this expansion biases the shield assembly from a third secondary position to a fourth secondary position.

[0027] By providing such an actuator valve, particularly by using pressurized gas to bias the shield assembly toward a fourth secondary position, i.e., the locked state of the device, it is preferable that the shield assembly is provided with appropriate power, but that power increases progressively from an initial low level to a higher level. This provides a gentle bias with some elasticity to accommodate the device's potential oscillating axial movement, for example, when withdrawn from a patient by a medical professional, while still maintaining the shield assembly in contact with the patient's skin. This is in contrast to purely mechanical actuators such as springs, which typically have far less tolerable operating modes, as these often transition from an initial high force to a lower force. Furthermore, such mechanical actuators are susceptible to mechanical creep over time, which can lead to decreased effectiveness and reliability over time.

[0028] In addition, the progressively increasing power supply allows the shield assembly to perform a fourth secondary action. When biased toward the target position, the possibility of unintentional displacement of residual drug from the internal conduit of the device's needle is reduced, that is, the risk of drug "scattering" that would otherwise tend to occur when transitioning to a locked state in devices with mechanical actuators that typically cause sudden movement and have much higher acceleration, such as needle-retractable devices.

[0029] The actuator valve of the present invention allows for easy adjustment of both the overall magnitude and speed of the power applied to the shield assembly by changing the stored enthalpy, i.e., the initial internal energy of the pressurized gas.

[0030] Preferably, the actuator valve is a valve member slidably housed within the needle assembly body and formed to define a gas storage space, or comprises such a valve member.

[0031] This valve component configuration allows for adjustment of the size of the gas storage space according to the requirements of the device and / or the characteristics of the gas held therein. Preferably, the valve member itself defines the gas storage space.

[0032] By having the valve component itself define the gas storage space, the number of seal-forming parts required to maintain the airtight integrity of the gas storage space is limited, and therefore advantageously, the risk of leakage occurring through one or more such seal-forming parts is considerably reduced.

[0033] In addition, by reducing the number of seal-forming sections, the magnitude of the force required to operate the valve member, that is, to move it against the resistance that such seal-forming sections might otherwise impose, is also reduced.

[0034] Optionally, the valve member includes an external support forming portion having a hollow interior that defines a gas storage space. This arrangement allows the valve components to provide the aforementioned advantages, while also enabling easy manufacturing, and allowing the gas storage space to be pre-filled once the needle assembly is assembled.

[0035] The valve component may work in cooperation with the needle assembly body to define a gas storage space between them. This configuration provides further options for adjusting the size of the gas storage space.

[0036] In a further preferred embodiment of the present invention, the valve member comprises a first seal-forming portion and a second seal-forming portion that are spaced apart in the axial direction, with an annular gas storage space formed between them. By providing an annular gas storage space, further size adjustment options are offered, while the gas storage space can be more easily and reliably positioned to fluidly communicate with one or each vent when the actuator valve, i.e., the valve member, moves to the open position.

[0037] The actuator module may further include an elongated actuator member that is slidably housed within the needle assembly body and fixedly attached to the actuator valve to move the actuator valve from its closed position to its open position, wherein one end of the actuator member defines a contact forming portion to which the syringe plunger can make contact, so that in the later stages of inserting the plunger into the hollow syringe body, the actuator member is driven axially by the continued insertion of the plunger, thereby moving the actuator valve from its closed position to its open position, and by this movement the shield assembly It is biased from the third secondary position toward the fourth secondary position.

[0038] Having such an actuator member is advantageous in that the continuous insertion of the plunger within the syringe body is converted into the opening of the actuator valve, thereby releasing gas from the gas storage space and consequently biasing the shield assembly to a fourth secondary position. Thus, such an actuator member preferably provides the option to influence the operation, i.e., the opening of the actuator valve, by utilizing the continuous operation of the device, for example, the continuous infusion of a drug into a patient, thereby further ensuring the correct sequencing of the operating states of the device.

[0039] Preferably, the needle assembly body is movably coupled to the syringe body, and the selective movement of the needle assembly body relative to the syringe body causes the contact-forming portion of the actuator member to move into the drug chamber of the syringe.

[0040] This movement of the needle assembly body relative to the syringe body allows for the selective placement of either the contact forming portion to be preferably located outside the drug chamber when, for example, unintended or undesirable opening of the actuator valve needs to be prevented, or the contact forming portion to move into the drug chamber so that the actuator valve can be opened when, for example, the actuator valve is desired to be operated. Thus, this feature ensures that the actuator valve is "armed," i.e., can be operated, only when desired, thereby ensuring the safe and correct operation of the device.

[0041] The selective movement of the needle assembly body relative to the syringe body may further move either or both of the following: (i) the inclined opening plane, which is coplanar with the inclined opening of the subcutaneous injection needle, and (ii) the graduation markings, to align with the natural use axis of the flange defined by the syringe body.

[0042] The alignment of the inclined opening plane with the axis of the flange during natural use is beneficial, as it ensures that the inclined opening is optimally oriented relative to the flange, thereby assisting the user in correct insertion of the needle into the recipient (especially in the case of subcutaneous injection) as the device moves between the administration and insertion states.

[0043] In another preferred embodiment of the present invention, the needle assembly body is helically coupled to the syringe body and constrained to rotate by the shield body, thereby achieving, or both, one of the following: movement of the shield assembly from a second secondary position to a second primary position, and movement from the second primary position to a third primary position, into the drug chamber, and movement of the inclined opening plane and / or scale markings to align with the axis of natural use of the flange.

[0044] This configuration advantageously ensures that the sequence of changes in the operating state of the device is linked to the arming of the actuator valve in an automatic manner, and thus ensures that such operations can only be performed when correctly intended, through the movement of the actuator valve to the open position and the subsequent biasing of the shield assembly to a fourth secondary position.

[0045] In addition, this configuration also automatically sequences the changes in the operating state of the device to help the user correctly insert the needle into the patient, including the optimal orientation of the inclined opening of the needle relative to the flange, i.e., the chisel tip, and / or the information on the syringe body, which can be easily read by healthcare workers, other medical professionals, or other users. The scale markings are aligned to the desired orientation and are synchronized with it.

[0046] A second aspect of the present invention is provided, a method for using a closed transfer device described in any of the preceding claims, comprising the step of moving a shield body relative to a syringe body between at least one position corresponding to an operating state of the device and another position corresponding to a different operating state of the device.

[0047] The method of the present invention shares the advantages of the corresponding features of the apparatus of the present invention. It will be understood that the use of terms such as "first," "second," etc. in this patent specification is intended merely to help distinguish similar features, and, unless otherwise specified, is not intended to indicate the relative importance of one feature to another.

[0048] Within the scope of this application, the various aspects, embodiments, examples and alternatives described in the preceding paragraph, as well as the claims and / or the following description and drawings, in particular their individual features, are expressly intended to be adopted independently or in any combination. That is, all embodiments and all features of any embodiment can be combined in any way and / or in any combination, unless each feature is incompatible with the others. The applicant reserves the right to amend any of the initially filed claims or to file new claims, including the right to modify any of the initially filed claims to depend on and / or incorporate any feature of any of the other claims, even if such a claim was not initially made.

[0049] Hereinafter, preferred embodiments of the present invention will be briefly described with reference to the following drawings as non-limiting examples. [Brief explanation of the drawing]

[0050] [Figure 1A] Figure 1(a) shows an isometric view of the closed-seat transport device (CSTD) according to the first embodiment of the present invention in its shipping state. Figure 1(b) shows a plan cross-sectional view of the CSTD shown in Figure 1(a). [Figure 1B] Figure 1(c) shows an enlarged view of a portion of Figure 1(b). Figure 1(d) shows an axial cross-sectional view through a circumferentially extending slot in the syringe body of the syringe that forms part of the CSTD shown in Figure 1(a). [Figure 2] Figure 2 shows an isometric view of the syringe that forms part of the CSTD shown in Figure 1(a). [Figure 3] Figure 3 shows a plan view of the syringe shown in Figure 2. [Figure 4] Figure 4 shows an axial cross-sectional view through the circumferentially extending slot of the syringe shown in Figure 2. [Figure 5] Figure 5 shows the first elevation view of the syringe shown in Figure 2. [Figure 6]Figure 6 shows a second elevation view of the syringe shown in Figure 5, rotated 120° clockwise in the circumferential direction. [Figure 7] Figure 7 shows an isometric view of the first needle assembly, which forms part of the CSTD shown in Figure 1(a). [Figure 8] Figure 8 shows a plan cross-sectional view of the first needle assembly shown in Figure 7. [Figure 9] Figure 9 shows a plan cross-sectional view of the first needle assembly shown in Figure 7, coupled to the syringe shown in Figure 2. [Figure 10] Figure 10(a) shows a plan cross-sectional view of the shield assembly that forms part of the CSTD shown in Figure 1(a). Figure 10(b) shows a first isometric view of the shield assembly shown in Figure 10(a). Figure 10(c) shows a second isometric view of the shield assembly shown in Figure 10(a). [Figure 11] Figure 11(a) shows a first isometric view of the seal-forming portion that forms part of the shield assembly shown in Figure 10(a). Figure 11(b) shows a second isometric view of the seal-forming portion shown in Figure 11(a). [Figure 12] Figure 12 shows an isometric view of a sealing member that forms part of the seal-forming portion shown in Figures 11(a) and 11(b). [Figure 13] Figure 13(a) shows an isometric view of the CSTD in the ready state shown in Figure 1(a). Figure 13(b) shows an enlarged plan section of the CSTD shown in Figure 13(a). Figure 13(c) shows an axial section of the CSTD shown in Figure 13(a) through a slot extending in the circumferential direction. [Figure 14A] Figure 14(a) shows an isometric view of the CSTD shown in Figure 1(a) in its prepared state before processing. Figure 14(b) shows an enlarged plan cross-sectional view of the CSTD shown in Figure 14(a). Figure 14(c) shows an axial cross-sectional view of the CSTD shown in Figure 14(a) through a slot extending in the circumferential direction. [Figure 14B] Figure 14(d) shows an isometric view of the CSTD shown in Figure 1(a) in its prepared state after preparation. Figure 14(e) shows an enlarged plan cross-sectional view of the CSTD shown in Figure 14(d). [Figure 15]Figure 15(a) shows an isometric view of the CSTD in the transport state shown in Figure 1(a). Figure 15(b) shows an enlarged plan cross-sectional view of the CSTD shown in Figure 15(a). Figure 15(c) shows an axial cross-sectional view of the CSTD shown in Figure 15(a) through a slot extending in the circumferential direction. [Figure 16] Figure 16(a) shows an isometric view of the CSTD in the administration state shown in Figure 1(a). Figure 16(b) shows an enlarged plan cross-sectional view of the CSTD shown in Figure 16(a). Figure 16(c) shows an axial cross-sectional view of the CSTD shown in Figure 16(a) through a slot extending in the circumferential direction. [Figure 17A] Figure 17(a) shows an isometric view of the CSTD shown in Figure 1(a) in its inserted state before administration. Figure 17(b) shows an enlarged plan cross-sectional view of the CSTD shown in Figure 17(a). Figure 17(c) shows an axial cross-sectional view of the CSTD shown in Figure 17(a) through a slot extending in the circumferential direction. [Figure 17B] Figure 17(d) shows an isometric view of the CSTD shown in Figure 17(a) in its insertion state just before the end of administration. Figure 17(e) shows an enlarged plan cross-sectional view of the CSTD shown in Figure 17(d). [Figure 18] Figure 18(a) shows an isometric view of the CSTD in the locked state shown in Figure 1(a). Figure 18(b) shows an enlarged plan cross-sectional view of the CSTD shown in Figure 18(a). Figure 18(c) shows an axial cross-sectional view of the CSTD shown in Figure 18(a) through a slot extending in the circumferential direction. [Figure 19] Figure 19(a) shows an isometric view of a portion of the actuator module forming part of the CSTD shown in Figure 1(a) in an extended configuration. Figure 19(b) shows the actuator module shown in Figure 19(a) in a retracted configuration. [Figure 20] Figure 20 shows axial views of the shield assembly and needle assembly that form part of the CSTD shown in Figure 1(a). [Figure 21] Figure 21 shows an exploded isometric view of a component of the second needle assembly that can alternatively form part of the CSTD shown in Figure 1(a). [Figure 22]Figure 22(a) shows an isometric section view of the second needle assembly shown in Figure 21, with the associated actuator valve in the closed position. Figure 22(b) shows an isometric section view of the second needle assembly shown in Figure 21, with the associated actuator valve in the open position. [Figure 23] Figure 23(a) shows an enlarged plan cross-sectional view of the second needle assembly shown in Figure 21, located within the type of CSTD shown in Figure 1(a) and in the insertion state near the end of administration. Figure 23(b) shows an enlarged plan cross-sectional view of the second needle assembly shown in Figure 21, located within the type of CSTD shown in Figure 1(a) and in the locked state. [Modes for carrying out the invention]

[0051] A closed-system transport device (CSTD) according to the first embodiment of the present invention is generally designated by reference numeral 10, as shown in Figure 1(a), for example. The device 10 includes a syringe 12 having an elongated, hollow syringe body 14, as shown in Figure 3, for example, and a plunger 16 is slidably housed inside the syringe body 14 to define a drug chamber 18.

[0052] More specifically, the plunger 16 comprises a piston end 20 that defines a drug chamber 18 together with a hollow syringe body 14, and an actuator end 22 that, together with a flange 24 on the open proximal end 26 of the syringe body 14, can be used by a user of the device 10, such as a healthcare worker or other medical professional, to selectively insert the plunger 16 into the syringe body 14 or to pull the plunger 16 within the syringe body 14 in a substantially conventional manner.

[0053] The size of the drug chamber 18, and therefore the amount of drug contained within it (not shown in Figure 3), i.e., the amount of drug, medicine, or other substance that has a physiological effect when introduced into the human body, changes depending on the degree to which the plunger 16 is inserted into the syringe body 14.

[0054] Furthermore, as shown in Figures 7 and 8, the device 10 includes a first needle assembly 28 having a needle assembly body 30, and a subcutaneous injection needle 32 is fixedly attached to the needle assembly body 30 at the distal portion 34 of the needle assembly body 30, for example by welding or other fixing means.

[0055] The needle assembly body 30 is coupled to the syringe body 14, for example, as shown in Figure 9, more specifically to be movably coupled, and even more specifically, in the illustrated embodiment, to be spirally coupled.

[0056] Such a helical connection is achieved by a female helical thread forming portion 36 formed within the needle assembly body 30 and a complementary male helical thread forming portion 38 formed on the syringe body 14. However, in different embodiments of the present invention, the connection may be made in a different manner, for example, the male helical thread forming portion may instead be formed on the needle assembly body and the female helical thread forming portion may be formed on the syringe body.

[0057] In any case, by connecting the needle assembly body 30 to the syringe body 14, the internal conduit 40 of the needle 32 is maintained in fluid communication with the drug chamber 18. In addition to the above, the device 10 further includes a shield assembly 42, as shown in the cross-sectional view in Figure 10(a), for example. As also shown in Figures 10(b) and 10(c), the shield assembly 42 includes an elongated, hollow shield body 44.

[0058] The shield assembly 42 further includes a seal-forming portion 46 fixedly attached to the distal end 48 of the shield body 44, as shown in Figures 11(a) and 11(b). The seal-forming section 46 includes a seal member 50 that is attached to the seal support 52 and fixedly attached to the shield body 44.

[0059] The sealing member 50 is formed of a flexible and elastic material, which may be an elastomer or silicone rubber. The sealing member 50 has an opening 54 formed through the sealing member 50 and located in the center of the sealing member 50 in the illustrated embodiment. The opening 54 is self-sealing; that is, for example, the opening 54 can be forcibly opened by deforming the sealing member 50 by pushing a needle 32 through the opening 54, but the opening 54 closes when the sealing member 50 returns to its original deformed state.

[0060] On the other hand, the seal support 52 is formed from a substantially rigid material such as a plastic material. The seal support 52 has two identical tapered tab-forming portions 56, each tab-forming portion 56 which is slidable through complementary guide channels 58 formed in the shield body 44 during the assembly of the shield assembly 42. Preferably, the tab-forming portions 56 and the guide channels 58 are spaced 180° apart from each other in the circumferential direction, but this is not necessarily required.

[0061] In the shield body 44, complementary locking portions 60 are formed near the distal end of each guide channel 58 in the form of elastically deformable catches 62 (only one of the multiple catches 62 is shown, for example, in Figure 10(b)). When each tapered tab-forming portion 56 slides into engagement with the corresponding catch 62, the seal support 52 is fixedly attached to the shield body 44, i.e., in a snap-fit ​​manner.

[0062] In the illustrated embodiment, the opening 54 forms an airtight seal when closed. Thus, the distal end 48 of the shield assembly 42 is mechanically closed, i.e., airtightly sealed, by the seal-forming portion 46 unless the opening 54 is forcibly opened, for example, by a needle 32.

[0063] In addition to the matters described above, the shield body 44 is positioned along the length of the syringe body 14 in the axial direction, i.e., the proximal axial direction A P and distal axis A DThe shield body 44 is designed to move linearly in each direction, and the shield body 44 moves circumferentially around the outer surface of the syringe body 14, i.e., clockwise circumferentially C CW and counterclockwise circumferential direction C CCW It is movably connected to the syringe body 14 so that it can rotate in each direction.

[0064] More specifically, the hollow shield body 44 is sized to slide in a tightly fitted position over the syringe body 14. The movement of the shield body 44 relative to the syringe body 14 allows the shield assembly 42 to be selectively actuated to surround the needle 32. That is, the distal end 48 of the mechanically closed and hermetically sealed shield assembly 42 can selectively enclose or cover the needle, for example, as shown in Figures 1(a) to 1(c). This encirclement of the needle 32 helps prevent needle stick injuries and also prevents both the inflow of substances into the device 10 and the outflow of substances from the device 10.

[0065] In addition, the shield body 44 and the syringe body 14 are equipped with mutually cooperative forming parts 64 and 66 that restrain the movement of the shield assembly 42 relative to the syringe 12 through a series of positions corresponding to different operating states of the device 10.

[0066] More specifically, the shield body 44 includes a male mold forming section 68, and more specifically, an elastically biased claw member 70. On the other hand, the syringe body 14 includes a female mold forming section 72 which has a plurality of slots into which the biased claw member 70 enters.

[0067] Other embodiments of the present invention (not shown) may include different, mutually cooperative forming parts, in which the syringe body may instead have a male forming part, or the shield body may instead have a female forming part.

[0068] Returning to the illustrated embodiment, the female mold forming portion 72 of the syringe body 14 is A first axially extending slot 74 having a first end 76 and a second end 78 opposite to the first end 76, Extending from the first end 76 of the first slot 74 which extends in the axial direction, a first end 82 which is in the same position as the first slot 74 which extends in the axial direction, and a second end on the opposite side of the first end 82 A slot 80 extending in the circumferential direction, having a portion 84, The syringe body 14 comprises a second axially extending slot 86, to which the second end 84 of the circumferentially extending slot 80 intersects, the second axially extending slot 86 having a first end 88 closest to the open proximal end 26 of the syringe body 14 and a second end 90 on the opposite side of the first end 88, located beyond the circumferentially extending slot 80.

[0069] As described above, the movement of the shield assembly 42 relative to the syringe 12 is constrained by the mutually cooperative forming parts 64 and 66 of the shield body 44 and the syringe body 14, namely the claw member 70 and the combination of the axially extending first slot 74, the circumferentially extending slot 80, and the axially extending second slot 86 into which the claw member 70 is biased and inserted, through a series of positions corresponding to different operating states of the device 10.

[0070] More specifically, a series of relative positions and corresponding operating states of the device 10 are defined as follows: The first end 76 of the axially extending first slot 74 defines both the first secondary position 230 and the second secondary position 240 when the claw member 70 of the shield body 44 is positioned there.

[0071] The first secondary position 230 corresponds to the shipping state of the device 10, as shown in Figures 1(a) to 1(d), in which the shield assembly 42 surrounds, i.e., covers and protects, the needle 32, but is movable toward the first primary position 200 (described later). In the illustrated embodiment, this allows the shield assembly 42 to move toward the syringe 12 in the axial direction, more specifically in the proximal axial direction A PIt becomes possible to move to this location, but this is not necessarily the only option.

[0072] On the other hand, the second secondary position 240 is similar to the first secondary position 230, but instead corresponds to the ready state of the device 10, as shown in Figures 13(a) to 13(c), for example. In this ready state, the drug chamber 18 contains one or more drugs 92 (this is confirmed by the plunger 16 in the syringe body 14 being pulled back significantly, as shown in the figures, and will be further detailed in the description of the use of the device 10), and the shield assembly 42 surrounds the needle 32, but is movable toward the second primary position 210 (described later). In the illustrated embodiment, the shield assembly 42 is thus positioned relative to the syringe 12 in the circumferential direction, more specifically in the clockwise circumferential direction C CW This allows for movement to a specific location, but other embodiments of the present invention are not necessarily limited to this.

[0073] The second end 78 of the first slot 74, which extends in the axial direction, defines the first main position 200 corresponding to the prepared state of the device 10, as shown in Figures 14(a) to 14(e), for example. In this prepared state, one or more drugs 92 can be drawn from the vial 94 (circumstantial illustration) into the drug chamber 18, which will also be described in more detail in the explanation of the use of the device 10.

[0074] The second principal position 210 described above is located along the circumferentially extending slot 80, more specifically located midway along the circumferentially extending slot 80, and even more specifically, in the illustrated embodiment, located 60° in rotational direction from each end 82, 84 of the circumferentially extending slot 80. In other embodiments of the present invention (not shown), the second principal position may be located at different positions within the circumferentially extending slot 80.

[0075] In any case, the second main position 210 corresponds to the transport state of the device 10, as shown in Figures 15(a) to 15(c), for example. In this transport state, the shield assembly 42 surrounds the needle 32, and the linear movement of the shield assembly 42 relative to the syringe 12, In other words, proximal axis A P and distal axis A D Movement in each direction is suppressed to prevent the needle 32 from being exposed beyond the shield assembly 42. This will also be described in more detail in the description of the use of the device 10.

[0076] On the other hand, the second end 84 of the circumferentially extending slot 80 defines a third main position 220 corresponding to the administration state of the device 10, as shown, for example, in Figures 16(a) to 16(c). In this administration state, the needle 32 can be inserted into the recipient, for example, a patient, and some or all of the contents of the drug chamber 18, i.e., one or each of the drugs 92 contained therein, can be injected into the recipient. This will also be described in more detail in the description of the use of the device 10.

[0077] The first end 88 of the axially extending second slot 86 defines a third secondary position 250 corresponding to the insertion state of the device 10, as shown, for example, in Figures 17(a) to 17(e). In this insertion state, the needle 32 can be positioned inside the recipient. This will also be described in more detail in the description of the use of the device 10.

[0078] Finally, the second end 90 of the axially extending second slot 86 defines a fourth secondary position 260, which corresponds to a locked state of the device 10, as shown in Figures 18(a) to 18(c), for example. In this locked state, the shield assembly 42 surrounds the needle 32 and is immovable relative to the syringe 12.

[0079] To assist in making the shield assembly 42 non - movable relative to the syringe 12, the shield assembly 34, and more particularly the seal - forming portion 46, further includes an elastically biased latch member 96 that is biased to abut against the tip 98 of the needle 32 when the shield assembly 42 moves to a fourth secondary position 260 relative to the syringe 12, as shown, for example, in FIG. 18(b).

[0080] In such a fourth secondary position 260, the mutually cooperating formations 64, 66 of the shield body 44 and the syringe body 14, namely the claw member 70 and the second end 90 of the axially extending second slot 86, cooperate with the latch member 96 to inhibit linear movement of the shield assembly 42 relative to the syringe 12, i.e., proximal axial direction A P and distal axial direction A D in each direction.

[0081] More particularly, when the latch member 96 abuts against the needle tip 98, the claw member 70 is restricted from moving in the proximal axial direction A along the axially extending second slot 86, and by the claw member 70 abutting against the second end 90 of the axially extending second slot 86, movement of the shield assembly 44 away from the syringe 12 is inhibited, i.e., movement of the shield assembly 44 relative to the syringe 12 in the distal axial direction A P is inhibited. D As a result, the claw member 70 is captured at the second end 90 of the axially extending second slot 86 where it cannot move in either the clockwise circumferential direction C

[0082] or the counter - clockwise circumferential direction C, CW and thus the shield assembly 42 becomes completely non - movable relative to the syringe 12. CCW

[0083] In the illustrated embodiment, the latch member 96 is positioned within the seal member 50 of the seal forming portion 46, as shown, for example, in Figures 10(a) and 12. The latch member 96 is elastically biased by a biasing finger 100 that protrudes close to the opening 54 of the seal member 50, as shown, for example, in Figure 18(b), but the latch member 96 can also be biased by other methods.

[0084] In all designated positions 200, 210, 220, 230, 240, and 250 of the shield assembly 42 relative to the syringe 12, except for a fourth secondary position 260 corresponding to the locked state of the device 10, the latch member 96 is displaced by the needle 32 against the finger 100, as shown in Figures 1(b), 1(c), 13(b), 14(b), 14(e), 15(b), 16(b), 17(b), and 17(e), respectively, so that the needle 32 can move freely in the axial direction relative to the latch member 96.

[0085] However, if there is no influence from the needle 32, the latch member 96 is biased by the finger 100 to a state of contact and engagement with the needle tip 98, that is, the state shown in Figure 18(b), and thus the device 10 is locked.

[0086] The latch member 96 is formed from a substantially rigid material such as metal or ceramic, but it can also be formed from other materials. In addition to the above, the mutually cooperative forming parts 64, 66 of the shield body 44 and the syringe body 14, namely the claw members 70 and slots 74, 80, 86, are further configured to allow movement between a series of main positions, namely the first main position 200, the second main position 210, and the third main position 220, only in a single sequence, more specifically, in a single sequence including the first main position 200, followed by the second main position 210, followed by the third main position 220.

[0087] In the illustrated embodiment, the mutually cooperative forming parts 64, 66, i.e., the claw members 70 and slots 74, 80, 86, are arranged such that a specific ordering of the first main position 200, the second main position 210, and the third main position 220 is achieved by interposing a first unidirectional mutually cooperative forming part 102 between the first main position 200 and the second main position 210, and a second unidirectional mutually cooperative forming part 104 between the second main position 210 and the third main position 220, as shown in Figure 4, for example.

[0088] More specifically, in the illustrated embodiment, the first unidirectional, mutually cooperative forming portion 102 is located between the first end 82 of the circumferentially extending slot 80 and the second main position 210 (the second main position 210 itself is located within the circumferentially extending slot 80), but in other embodiments of the present invention, the first unidirectional, mutually cooperative forming portion may be located at a different position.

[0089] Similarly, in the illustrated embodiment, the second unidirectional, mutually cooperative forming portion 104 is located between the second principal position 210 and the second end 84 of the circumferentially extending slot 80, but other arrangements are also possible.

[0090] Preferably, the first main position 200 and the second main position 210 are spaced circumferentially apart from each other by a first angle α along the circumferentially extending slot 80, and in the illustrated embodiment, this first angle α is 60° (however, it may be any other angle, such as 90° or 120°). Also preferably, the second main position 210 and the third main position 220 are spaced circumferentially apart from each other by a second angle β along the circumferentially extending slot 80, and in the illustrated embodiment, this second angle β is also 60° (however, similarly, it may be any other angle, such as 90° or 120°).

[0091] In addition, the first unidirectional, mutually cooperative forming portion 102 and the second unidirectional, mutually cooperative forming portion 104 each take the form of a first ratchet tooth 106 and a second ratchet tooth 108, respectively, and each operates in a clockwise circumferential direction C within the slot 80 in which the claw member 70 extends in the circumferential direction. CW While movement is permitted, the claw member 70 rotates counterclockwise in the circumferential direction C CCW It is preferable that it be formed in such a way that movement is suppressed. Other forms of the first unidirectional, mutually cooperative forming part and the second unidirectional, mutually cooperative forming part are also possible.

[0092] Furthermore, in the embodiments illustrated and described above, the first needle assembly 28 includes a first actuator module 110 configured to selectively bias the shield assembly 44 relative to the syringe 12 from a third secondary position 250 corresponding to the insertion state of the device 10 to a fourth secondary position 260 corresponding to the locked state of the device 10.

[0093] More specifically, the first actuator module 110 includes a first actuator valve 112 that is movable between a closed position, best shown in Figure 8, and an open position, best shown in Figure 18(b), in which case, in the closed position, gas (not shown) is held pressurized within a first gas storage space 114, and in the open position, the gas storage space 114 is arranged to fluidly communicate with mutually opposing first and second vents 116 and 118 within the needle assembly body 30 in order to release gas from the gas storage space 114. Other embodiments of the present invention may include fewer than two or more vents.

[0094] Preferably, the gas is a hydrofluoroalkane such as Solkane®, but is not necessarily limited to this, and other propellants (which may not be gases) can be used.

[0095] In the illustrated embodiment, the first actuator valve 112 takes the form of a first valve member 120, which is slidably housed within the needle assembly body 30, i.e., within the hollow portion 122 of the needle assembly body 30 through which the needle itself also passes. Through the cooperation of the first valve member 120 and the needle assembly body 30, i.e., the hollow portion 122, a first gas storage space 114 is defined between them.

[0096] More specifically, in the illustrated embodiment, the first valve member 120 includes axially spaced first and second seal-forming portions 124 and 126, between which an annular first gas storage space 114 is formed. The first and second seal-forming portions 124 and 126 themselves also have an annular configuration, and the first seal-forming portion 124 isolates the first gas storage space 114 from the first vent 116 and the second vent 118 while the actuator valve 112 is in the closed position, as shown in Figure 8, for example.

[0097] In addition, the first vent 116 and the second vent 118 are arranged to be in fluid communication with a foldable chamber 128, which in the illustrated embodiment takes the form of a tubular bellows 130, but other forms are also possible.

[0098] The foldable chamber 128, i.e., the tubular bellows 130, is sealed and fixed between the first needle assembly 28 and the shield assembly 42, and more specifically, as shown in Figures 19(a) and 19(b), it is sealed and fixed between the needle assembly body 30 and the seal support 52 of the seal forming portion 46 of the shield assembly 42, i.e., fixed in a substantially permanent and airtight manner. However, in other embodiments of the present invention, the foldable chamber may be provided between the needle assembly and the shield assembly in a different sealed and fixed configuration.

[0099] Due to the foldable nature of the chamber 128, i.e., the tubular bellows 130, the chamber 128 can move between various extended configurations, such as those shown in Figures 19(a), 1(b), 13(b), 15(b), 16(b), and 18(b), and various contracted configurations folded to different degrees, such as those shown in Figures 19(b), 14(b), 14(e), 17(b), and 17(e). ru.

[0100] The foldable chamber 128, i.e., the tubular bellows 130, is positioned to be in fluid communication with the first vent 116 and the second vent 118, respectively. When the first actuator valve 112, i.e., the first valve member 120, moves to the open position, the first gas storage space 114 is in fluid communication with the foldable chamber 128, thereby releasing gas (not shown) from the first gas storage space 114 into the foldable chamber 128, i.e., the tubular bellows 130, through the first vent 116 and the second vent 118.

[0101] As gas is released from the first gas storage space 114 in this manner, the foldable chamber 130, i.e., the tubular bellows 130, moves axially, more specifically in the distal axial direction A relative to the syringe 12. D It expands in the same distal axial direction A. As a result, the seal support 52 expands in the same distal axial direction A. D Pressed by this force, and furthermore, because the seal support 52 is fixedly attached to the shield body 44, the shield assembly 42 is biased from the third secondary position 250 to the fourth secondary position 260, and more specifically, the shield assembly 42 is driven to the fourth secondary position 260, thereby locking the device 10, for example, as shown in Figures 18(a) to 18(c).

[0102] In addition to the above, the first actuator module 110 also includes an elongated actuator member 132 that is slidably housed within the needle assembly body 30 and fixedly attached to the first actuator valve 112, i.e., the first valve member 120 in the illustrated embodiment, thereby enabling the first actuator valve 112, i.e., the first valve member 120, to move from a closed position to an open position, i.e., enabling the selective release of gas from the first gas storage space 114.

[0103] More specifically, in the illustrated embodiment, the actuator member 132 takes the form of a hollow actuator tube 134, dimensioned to slide over the needle 32, which is fixedly attached to the needle assembly body 30 as described above. The hollow actuator tube 134 may be immovably fixed to the first valve member 120 by welding, bonding, or other means. The hollow actuator tube 134 is also preferably movably sealed relative to the needle assembly body 30 by, for example, a first auxiliary seal forming portion 136. Other forms of actuator members are possible, as are different fixing and sealing configurations.

[0104] In the embodiment described above, the actuator tube 134 slides over the needle 30, allowing the actuator tube 134, i.e., the actuator member 132, to move within the needle assembly body 30. On the other hand, because the actuator tube 134, i.e., the actuator member 132, is fixed to the first valve member 120, the first valve member 120 also moves within the needle assembly body 30 due to the relative movement of the actuator tube 134.

[0105] In addition, the proximal end 138 of the actuator tube 134 defines a first contact forming portion 140 to which the syringe plunger 16, and more specifically the piston end 20 of the plunger 16, can come into contact.

[0106] With such a first contact forming portion 140 provided, for example, in the later stages of inserting the plunger 16 into the hollow syringe body 14 as shown in Figure 17(e), the actuator member 132, i.e., the actuator tube 134, moves axially, more specifically in the distal axial direction A, due to the continuous insertion of the plunger 16. D It is driven by.

[0107] As the actuator tube 134 moves in the distal axial direction, for example as shown in Figure 18(b), the first actuator valve 112, i.e., the valve member 120, moves from the closed position to the open position, releasing gas from the first gas storage space 114. This automatically biases the shield assembly 42 from the third secondary position 250 to the fourth secondary position 260, and ultimately to the fourth secondary position 260.

[0108] As described above, the needle assembly body 30 is movably coupled to the syringe body 14, and more specifically, it is spirally coupled to the syringe body 14. In addition to the above, the needle assembly body 30 is constrained to rotate by the shield body 44. In the illustrated embodiment, this is achieved by providing the needle assembly body 30 with a pair of opposing wing-shaped forming portions 142 (for example, those shown in Figures 7, 19(a), and 19(b)), and each wing-shaped forming portion 142 is slidable within the shield body 44 in cooperation with a corresponding guide channel 58, as shown in Figure 20.

[0109] This combination of the helical connection between the needle assembly body 30 and the syringe body 14, and the rotation of the needle assembly body 30 together with the shield body 44 (by the cooperation of each wing-shaped forming portion 142 on the needle assembly body 30 with the corresponding guide channel 58 in the shield body 44), results in rotational motion of the shield body 44 relative to the syringe body 14, particularly in the permissible clockwise circumferential direction C. CW The rotational motion results in linear movement of the needle assembly body 30 relative to the syringe body 14, more specifically, in the proximal axis direction AP This will result in a linear movement to [the specified location].

[0110] Therefore, the above-described combination makes it possible to move the contact forming portion 140 of the actuator member 132, i.e., the actuator tube 134, from a covered position inside the syringe body 14, as shown in Figure 13(b), to an exposed position inside the drug chamber 18 of the syringe body 14, as shown in Figure 16(b), by utilizing the rotational movement of the shield assembly 42 relative to the syringe 12 and the resulting linear movement of the needle assembly body 30 toward the syringe body 14, i.e., the selective movement of the needle assembly body 30 relative to the syringe body 14.

[0111] More specifically, in the illustrated embodiment, as the shield assembly 42 moves from a second secondary position 240 to a second primary position 210, the needle assembly body 30 moves toward the syringe body 14 in the proximal axial direction A P It moves by a first amount. Therefore, as shown in the transition between Figure 13(b) and Figure 15(b), for example, the contact forming portion 140 of the actuator member moves into the drug chamber 18 by the corresponding first amount. Furthermore, as the shield assembly 42 moves from the second principal position 210 to the third principal position 220, the needle assembly body 30 moves toward the syringe body 14 in the proximal axial direction A P It moves by a second amount substantially equal to the first amount (since the first angle α and the second angle β are also equal). Thus, as shown in the transition between Figure 15(b) and Figure 16(b), for example, the contact forming portion 140 moves into the drug chamber 18 by a corresponding further second amount.

[0112] In other embodiments of the present invention (not shown), movement of the contact forming portion 140 into the drug chamber 18 to a desired extent may be achieved by relative rotational motion of different degrees between the shield assembly 42 and the syringe 12, or in fact, by only one of the movement from the second secondary position 240 to the second primary position 210 and the movement from the second primary position 210 to the third primary position 220 described above. This can be achieved, for example, by changing the nature of the coupling between the needle assembly body 30 and the syringe body 14.

[0113] Furthermore, in the illustrated embodiment, the transfer of such contact forming portion 140 into the drug chamber 18 The movement is facilitated by the fact that the sliding movement of the actuator member 132 relative to the needle assembly body 30 has greater frictional resistance than the frictional resistance between the actuator member 132 and the syringe body 14, for example, the frictional engagement between the second auxiliary seal forming portion 144 and the actuator member 132, for example, the frictional engagement between the valve member 12, more specifically the frictional engagement between the first seal forming portion 124 and the second seal forming portion 126 with respect to the hollow interior 122 of the needle assembly body 30.

[0114] In addition to the above, the pair of opposing wing-shaped forming portions 142 of the needle assembly body 30 are, for example, best shown in Figure 7, on the same plane as the inclined opening 148 of the needle 32, i.e., the chisel tip of the needle 32, i.e., on the same inclined opening plane P. BO It is located inside.

[0115] As a result, the aforementioned forced rotation of the needle assembly body 30 by the shield body 44, that is, the rotation caused by the cooperation of each wing-shaped forming portion 142 on the needle assembly body 30 and the corresponding guide channel 58 in the shield body 44, further, the rotational movement of the shield body 44 relative to the syringe body 14, particularly in the permissible clockwise circumferential direction C CW The rotational motion in the same clockwise circumferential direction C relative to the syringe body 14 causes CW Towards, the inclined opening plane P BOThis results in rotational motion of the opening 148 itself.

[0116] In this way, the natural axis A of the flange 24 defined by the syringe body 14 during use relative to the syringe body 14, or more specifically, the axis A of the flange 24 defined by the syringe body 14 during use. NU (This substantially bisects the flange 24, as best shown in Figure 4) the inclined opening 148, i.e., the inclined opening plane P BO The planar orientation is constrained to a desired configuration.

[0117] More specifically, the shield assembly 42 moves clockwise circumferentially C from the second secondary position 240 to the second primary position 210, as shown in the transition between Figure 13(c) and Figure 15(c), and then from the second primary position 210 to the third primary position 220, as shown in the transition between Figure 15(c) and Figure 16(c). CW By rotating, the inclined opening plane P BO It moves, and the shaft A of flange 24 during natural use NU They align as shown in Figure 16(c).

[0118] Axle A during natural use of flange 24 NU The inclined opening plane P BO The alignment is beneficial because it ensures that the inclined opening 148, i.e., the chisel tip, is optimally oriented relative to the flange 24, so as the device 10 transitions between the administration state and the insertion state, the user can correctly insert the needle 32 into the recipient; that is, the inclined opening 148 is optimally oriented relative to the flange 24 when the device 10 is in the administration state (shown in Figure 16(c)) and the insertion state (shown in Figure 17(c)).

[0119] In addition, such alignment provides an option to predetermine the orientation of the scale markings (not shown) on the syringe body 14, which may be created, for example, by overprinting. This ensures that the scale markings are presented facing upwards, for example, when using the syringe, so that they can be easily read by healthcare workers or other medical professionals, for example, when administering a subcutaneous injection.

[0120] During use, the device 10 is configured to operate in the following order: Referring particularly to Figures 1(a) to 1(d), following the manufacture and assembly of the apparatus 10, the apparatus 10 is positioned with the shield assembly 42 in a first secondary position 230 relative to the syringe 12, thereby achieving the desired shipping state, i.e., the needle 32 is safely surrounded by the shield assembly 42.

[0121] Optionally, the plunger 16 is fully inserted into the syringe body 14. This is, for example, to reduce the risk of damage during shipment of the device 10 to the user. However, as shown in Figure 1(c), the needle assembly body 30 is spaced distally from the syringe body 14 to a preset maximum extent, so that the contact forming portion 140 of the actuator member 132 is in a covered position within the syringe body 14. Therefore, the plunger 16 cannot act on the contact forming portion 140, preventing unintended and undesirable activation of the actuator module 110 (and subsequent automatic release of gas from the gas storage space 114) at this stage in the operating sequence of the device 10.

[0122] Following the shipment of the device 10, when it is desired to use the device 10 for administering a drug, the shield assembly 42 can be moved to a first main position 200 relative to the syringe 12 by sliding, for example, the claw member 70 from the first end 76 to the second end 78 of the axially extending first slot 74, as shown in Figures 14(a) to 14(e).

[0123] The sliding of such claw member 70 within the first axially extending slot 74 occurs while the shield assembly 42, more specifically the seal forming portion 46 and associated seal member 50, is held in contact with the vial 94, more specifically the septum (not shown) of such vial or multiple vials, from which one or more drugs 92 will be aspirated (as schematically shown). Thus, the needle 32 is never exposed to the external environment, and the apparatus 10 can take the illustrated preparation state without external contaminants entering the mechanically closed system of the apparatus 10.

[0124] In this preparation state, the plunger 16 is pulled within the syringe body 14 to draw a desired amount of drug into the drug chamber 18. This is as shown in the corresponding transitions from Figures 14(a) and 14(b) to Figures 14(d) and 14(e).

[0125] Once the aspiration of the aforementioned drug is complete, the shield assembly 42 moves to a second secondary position 240 relative to the syringe 12, for example, by sliding the claw member 70 back from the second end 78 to the first end 76 of the first slot 74 that extends in the axial direction, as shown in Figures 13(a) to 13(c).

[0126] Such sliding of the claw member 70 within the first slot 74 extending in the axial direction also occurs while the shield assembly 42, more specifically the seal forming portion 46 and associated seal member 50, is held in contact with the vial 94, thereby avoiding exposure of the needle 32 to the external environment while the shield assembly 42 extends over the needle 32 when the needle 32 is withdrawn from the vial 94.

[0127] Therefore, the device 10 is ready to move to the second main position 210 relative to the syringe 12 in order to assume the transport state shown in Figures 15(a) to 15(c), with the shield assembly 42 surrounding the needle 32.

[0128] Such movement to the second principal position 210 is achieved by sliding the claw member 70 from the first end 82 of the circumferentially extending slot 80, over the first unidirectional, mutually cooperative forming portion 102, i.e., the first ratchet teeth 106, to the stopper 146 formed between the first ratchet teeth 106 and the second ratchet teeth 108, as is most clearly shown in Figure 15(c).

[0129] The shape of the first ratchet teeth 106 prevents the pawl member 70 from moving back along the circumferentially extending slot 80, and thus the shield assembly 42 moves in the opposite direction. Circumferential direction C CCW Movement back to the first primary position is prevented, thereby preventing the user from accidentally moving back from the second primary position 210 to the first primary position 200.

[0130] On the other hand, the arrangement of the claw member 70 within the circumferentially extending slot 80 results in the proximal axial direction A relative to the syringe 12. P and distal axis A D Linear movement of the shield assembly 42 in each of these positions is prevented, and thus, unintentional retraction of the shield assembly 42 from surrounding the needle 32 is also prevented.

[0131] By temporarily "locking" the shield assembly 42 axially to the syringe 12 in this way, the device 10 is ideally suited for movement while in transport, for example, from the drug preparation area to the patient administration area, such as the bedside or other medical setting.

[0132] Furthermore, it should be noted that as the shield assembly 42 moves to the second main position 210, the contact forming portion 140 of the actuator member 132 moves further into the drug chamber 18 of the syringe body 14 by a preset first amount, as best shown in Figure 15(b).

[0133] For example, following the transport of the device 10 to the administration area for the recipient as described above, the shield assembly 42 moves to a third main position 220 relative to the syringe 12 by sliding, for example, the claw member 70 from the stopper 146 in the circumferentially extending slot 80, over a second unidirectional, mutually cooperative forming portion 104, i.e., the second ratchet teeth 108, to the second end 84 of the circumferentially extending slot 80, as is most clearly shown in Figure 16(c), as shown in Figures 16(a) to 16(c). The device 10 is then put into the administration state.

[0134] The shape of the second ratchet teeth 108 similarly prevents the pawl member 70 from moving back along the circumferentially extending slot 80, and thus the shield assembly 42 moves counterclockwise in the circumferential direction C CCW This prevents movement to the third primary position 220, thereby preventing the user from accidentally moving back to the second primary position 210.

[0135] Furthermore, as the shield assembly 42 moves to the third main position 220, the contact forming portion 140 of the actuator member 132 moves further into the drug chamber 18 of the syringe body 14 by a preset second amount, as best shown in Figure 16(b). In addition, this movement causes the inclined opening plane P to move, as shown in Figure 16(c). BO The natural axis A of the flange 24 during use is defined by the syringe body 14. NU Alignment is completed, thereby optimally oriented the inclined opening 148 of the needle 32 (not shown in Figure 16(c)) relative to the flange 24.

[0136] Drug administration can then be initiated by moving the shield assembly 42 to a third secondary position 250 relative to the syringe 12, as shown in Figures 17(a) to 17(e). This is done by sliding the claw member 70 from the second end 84 of the circumferentially extending slot 80 to the first end 88 of the axially extending second slot 86, as shown in Figure 17(c).

[0137] Such sliding of the claw member 70 within the axially extending second slot 86 occurs while the shield assembly 42, more specifically the seal forming portion 46 and associated seal member 50, is held in contact with the subject's body (not shown), for example, the subject's skin. As a result, the needle 32 can be inserted into the recipient and the device 10 can be put into the insertion state without the needle 32 ever being exposed to the external environment, thus preventing external contaminants from entering the mechanically closed system of the device 10.

[0138] In this insertion state, the plunger 16 can be inserted further into the syringe body 14 to inject a desired amount of drug into the recipient, as shown in the corresponding transitions of the plunger 16 in Figures 17(a) and 17(b) through 17(d) and 17(e).

[0139] As shown in Figures 17(d) and 17(e), when the plunger 16 approaches the deepest insertion position within the syringe body 14, the plunger 16 engages with the contact forming portion 140 of the actuator member 132, and as the plunger 16 is continuously inserted, the actuator member moves in the distal axial direction A D Driven by this, the actuator valve 112, i.e., the valve member 120, moves toward and to the open position, as shown in Figure 18(b), for example.

[0140] As described above, when the valve member 120 moves to the open position, gas is released from the gas storage space 114 of the actuator module 110, and the shield assembly 42 is automatically biased from the third secondary position 250 to the fourth secondary position 260.

[0141] The biasing force of the shield assembly 42 allows the shield assembly 42, more specifically the seal-forming portion 46 and associated seal member 50, to remain in gentle contact with the subject's body while the needle 32 is withdrawn from the subject's body. As a result, the needle 32 can be withdrawn without ever being exposed to the external environment, and therefore without any opportunity for external contaminants to enter the mechanically closed system of the device 10, or for any subject's blood, drug, or vapor concentration to leak outside the device 10.

[0142] After the needle has been completely withdrawn, for example, from the subject's body, the continued biasing of the shield assembly 14, brought about by the release of gas into the foldable chamber 128 (i.e., the tubular bellows 130), causes the claw member 70 to be driven further along the axially extending second slot 86 from the first end 88 to the second end 90, thereby moving the shield assembly 42 to a fourth and final secondary position 260, as shown in Figures 18(a) and 18(b).

[0143] During such movement of the shield assembly 42 to the fourth and final secondary position 260, the latch member 96 is biased to contact the tip 98 of the needle 32, and the shield assembly 42 becomes completely immobile relative to the syringe 12, as described above herein.

[0144] The device 10 then assumes its final locked state, in which the needle 32 cannot be exposed and the device 10 cannot be reused without suffering irreparable damage. Figure 21 shows an exploded perspective view of the components of a second needle assembly 300, which may be included in place of the first needle assembly 28 of the first apparatus 10 described herein and which forms a CSTD (not fully shown) according to a second embodiment of the present invention. Where shown, similar features of the apparatus of the second embodiment are given the same reference numerals as those in the first apparatus 10.

[0145] The second needle assembly 300 selectively biases the corresponding shield assembly relative to the corresponding syringe (not shown) from a corresponding third secondary position associated with the insertion state of the second device to a corresponding fourth secondary position associated with the locked state of the second device. It also includes a second actuator module 302 configured similarly.

[0146] More specifically, the second actuator module 302 includes a second actuator valve 304 that is movable between a closed position, as shown, for example, in Figures 22(a) and 23(a), and an open position, as shown, for example, in Figures 22(b) and 23(b). In the closed position, a gas (not shown) is held pressurized within the second gas storage space 306, and in the open position, the second gas storage space 306 is arranged to be in fluid communication with a vent conduit 308 in order to release the gas from the second gas storage space 306 into the interior of the corresponding foldable container 128 coupled to the corresponding shield assembly.

[0147] The ventilation conduit 308 is defined, as shown in the figure, by a hollow conduit member 310 fixedly attached, for example by welding or other fixing configuration, to the corresponding distal portion 34 of the corresponding needle assembly body 30 of the second needle assembly 300. More specifically, the ventilation conduit 308 extends between the hollow conduit member 310 and the corresponding subcutaneous injection needle 32 located within the conduit member 310 and similarly fixedly attached to the distal portion 34 of the needle assembly body 30.

[0148] In addition, the hollow conduit member 310 has an opening 312 formed inside it to define an inlet opening 314 to the ventilation conduit 308. The needle assembly body 30 of the second needle assembly 300 is preferably, here again, coupled to the corresponding syringe body of the second CSTD device, more specifically movably coupled, and even more specifically helically coupled.

[0149] This connection between the needle assembly body 30 and the syringe body ensures that the internal conduit 40 of the needle 32 is maintained in fluid communication with the corresponding drug chamber within the syringe body. On the other hand, the second actuator valve 304 differs from the first actuator valve 112 described herein in relation to the first device 10 in that the second actuator valve 304 takes the form of a second valve member 316 that is movably housed within the needle assembly body 30, i.e., within the hollow interior 122, and defines the second gas storage space 308 by the second valve member 316 itself.

[0150] More specifically, the second valve member 316 includes an external support forming portion 318 having a hollow interior 320 that defines the second gas storage space 306. As best shown in Figures 22(a) and 22(b), the external support forming section 318 is formed from an elongated, hollow central body 322, preferably with a circular cross-section (other cross-sectional shapes are also possible), to which the first end cap 324 and the second end cap 326 are fixed. Preferably, the second end cap 326 is formed integrally with the central body 322, and the first end cap 324 is bonded to the central body 322 using a UV-curing adhesive (not shown), although other fastening methods are also possible.

[0151] In other embodiments of the present invention (not shown), the first end cap and the second end cap may instead extend toward and be fixed toward each other, and a central body may not be required.

[0152] In any case, the first end cap 324 incorporates a third seal-forming portion 328, and the second end cap 326 incorporates a fourth seal-forming portion 330. Both of these, through their sealing cooperation with the first ventilation conduit 308, i.e., the conduit member 310 defining the first ventilation conduit 308, maintain the complete sealing of the second gas storage space 306.

[0153] External support forming portion 318 of the second valve member 316, the first end cap 324 and the second end When combined with the end cap 326, a substantially annular second gas storage space 306 is formed, but other shapes of second gas storage spaces are also possible.

[0154] Preferably, the third seal-forming portion 328 and the fourth seal-forming portion 330 are formed from a relatively soft, elastically deformable material (such as a natural or synthetic elastomer), or include elements (e.g., O-rings or skins) formed from such material. On the other hand, the external support-forming portion 318, for example, the central body 322 and each end cap 324, 326, are formed from (or include) a harder, less deformable material. For example, one or both of the third seal-forming portion 328 and the fourth seal-forming portion 330 may be overmolded with a thermoplastic elastomer, i.e., they may be created as an additional layer of thermoplastic elastomer material on the corresponding end caps 324, 326.

[0155] In addition, the third seal-forming portion 324 and the fourth seal-forming portion 326 are movable relative to the vent conduit 308 (while maintaining airtightness), and more specifically, slidable, thereby allowing the second valve member 316 to move within the needle assembly body 30, and more specifically, to move with a small gap within the hollow, substantially annular interior 122 of the needle assembly body 30. However, the configuration is not necessarily limited to such configurations, and partially hollow shapes or other internal shapes are also possible.

[0156] In this way, the second valve member 316 is movable between a closed position, as shown in Figures 22(a) and 23(a), in which the gas (or other propellant - not shown) is held pressurized within the second gas storage space 306, and an open position, as shown in Figures 22(b) and 23(b), in which the gas is released from the second gas storage space 306 and the shield assembly covers, i.e., completely surrounds or encloses, the needle 30.

[0157] To facilitate such movement of the second valve member 316, a second contact forming portion 332 is similarly defined, to which the corresponding syringe plunger 16 can contact to move the second valve member 316 from a closed position to an open position during use.

[0158] Before the drug is injected into the recipient using the second device, the second valve member 316 is in the closed position, as shown in Figures 22(a) and 23(a), and the gas (not shown) remains pressurized within the second gas storage space 306.

[0159] During the dispensing of the drug from the second device, the plunger 16 of the device comes into contact with the second contact forming portion 332 of the second valve member 316, and as a result, the distal axial direction A of the plunger 16 D Further continued movement to the needle assembly body 30 initiates movement of the second valve member 316 toward the open position.

[0160] This initial movement of the second valve member 316 toward the open position causes the second valve member 316 to move relative to the conduit member 310, and more specifically, the second valve member 316 to slide on the conduit member 310.

[0161] Subsequently, distal axial direction A D Further movement of the plunger causes the second valve member 316 to move to the open position, as shown in Figures 22(b) and 23(b). This positions the second gas storage space 306 in fluid communication with the vent conduit 308, i.e., through the inlet opening 314 formed in the conduit member 310. As a result, gas (not shown) is released from the second gas storage space 306 and flows into the vent conduit 308 in a distal axial direction A, for example, acting on a collapsible container 128 to cause the container 128 to expand. D Guided by this, the shield assembly moves from the corresponding third secondary position toward the corresponding fourth secondary position where the needle 30 is covered by the shield assembly, and Ultimately, it is automatically biased towards a fourth secondary position.

Claims

1. A closed-type transport device, A syringe having an elongated, hollow syringe body, wherein a plunger is slidably housed within the syringe body, defining a drug chamber whose size changes according to the degree of insertion of the plunger within the syringe body; A needle assembly having a needle assembly body to which a subcutaneous injection needle is fixedly attached, wherein the needle assembly body is coupled to the syringe body and holds the internal conduit of the subcutaneous injection needle in fluid communication with the drug chamber, A shield assembly having a shield body movably coupled to the syringe body, wherein the shield assembly is selectively operable to surround the needle, Equipped with, The shield body and the syringe body are provided with mutually cooperative forming parts for restraining the movement of the shield assembly relative to the syringe through a series of positions corresponding to different operating states of the device. Closed transfer device.

2. The closed transfer device according to claim 1, wherein the shield body is movably coupled to the syringe body for linear axial movement along the length of the syringe body and rotational circumferential movement of the outer circumference of the syringe body.

3. The aforementioned series of positions are A first main position corresponding to the prepared state of the apparatus, in which one or more drugs can be drawn from the vial into the drug chamber, The shield assembly surrounds the needle, and the movement of the shield assembly relative to the syringe is suppressed, preventing the needle from being exposed beyond the shield assembly, at a second main position corresponding to the transport state of the apparatus, and A third primary position corresponding to the administration state of the device, in which the needle can be inserted into the recipient and some or all of the contents of the drug chamber can be injected into the recipient, A closed-type transfer device according to claim 1 or claim 2, comprising two or more of the above.

4. The closed transfer device according to claim 3, wherein the position of the shield assembly relative to the syringe is selectively limited to only one of the first principal position, the second principal position, or the third principal position.

5. The closed transfer device according to claim 3, wherein the mutually cooperative forming portions of the shield body and the syringe body are further configured to allow movement between a series of main positions in only a single sequence.

6. The closed transfer device according to claim 5, wherein the single sequence includes the first principal position, followed by the third principal position.

7. The closed transfer device according to claim 6, wherein the single sequence includes the first principal position, followed by the second principal position, followed by the third principal position.

8. A closed-type drug transfer device according to any one of claims 5 to 7, wherein at least one unidirectional, mutually cooperative forming portion is interposed between at least two of the main positions.

9. The aforementioned series of positions further include: The shield assembly surrounds the needle, but is movable toward the first primary position, a first secondary position corresponding to the shipping state of the device, The drug chamber contains one or more drugs, and the shield assembly surrounds the needle, but is movable toward the second primary position, a second secondary position corresponding to the ready state of the apparatus, A third secondary position corresponding to the insertion state of the device, in which the needle can be located inside the person being administered to, and A fourth secondary position corresponding to the locked state of the device, in which the shield assembly surrounds the needle and is immovable relative to the syringe, A closed-type transfer device according to any one of claims 3 to 8, comprising one or more of the above.

10. The closed transfer device according to claim 9, wherein the series of positions includes the fourth secondary position corresponding to a locked state of the device in which the shield assembly surrounds the needle and is immovable relative to the syringe, The shield assembly further comprises an elastically biased latch member which is biased to contact the tip of the needle when the shield assembly moves to the fourth secondary position relative to the syringe, As a result, the mutually cooperative forming portions of the shield body and the syringe body further cooperate with the latch member to suppress the linear movement of the shield assembly relative to the syringe. Closed transfer device.

11. The closed transfer device according to any of the preceding claims, wherein the mutually cooperative forming parts of the shield body and the syringe body are a male forming part and a female forming part, or are provided therewith.

12. The closed transfer device according to claim 11, wherein the male mold forming portion is an elastically biased claw member or comprises such a member, and the female mold forming portion is a plurality of slots into which the claw member is biased inward, or comprises such a plurality of slots.

13. The closed transfer device according to claim 12, wherein the female mold forming section comprises a first slot extending in the axial direction, a slot extending in the circumferential direction extending from one end of the first slot extending in the axial direction, and a second slot extending in the axial direction, the end of the circumferential slot opposite to the end of the first slot extending in the axial direction intersecting with it.

14. The first end of the first slot extending in the axial direction is the end from which the circumferentially extending slot extends, defining both the first secondary position and the second secondary position. The second end of the first slot, which extends in the axial direction, is on the opposite side from the first end and defines the first principal position. The second main position is located along the circumferentially extending slot, The second end of the circumferentially extending slot is the end that intersects with the second slot extending in the axial direction, and defines the third principal position. The first end of the second slot, which extends in the axial direction, is the end closest to the opening end of the syringe body, defining the third secondary position, and The second end of the second slot, which extends in the axial direction, is on the opposite side from the first end and defines the fourth secondary position. A closed-type transfer device according to claim 13, which satisfies one or more of the following conditions.

15. A closed transfer device according to claim 9, or any claim dependent thereon, wherein the needle assembly comprises an actuator module configured to selectively bias the shield assembly relative to the syringe from a third secondary position corresponding to an insertion state of the device in which the needle may be located inside a person to a fourth secondary position corresponding to a locked state of the device in which the shield assembly surrounds the needle and is immovable relative to the syringe.

16. The closed transfer device according to claim 15, wherein the actuator module includes an actuator valve that is movable between a closed position in which gas is held pressurized in a gas storage space and an open position in which the gas is released from the gas storage space and biases the shield assembly from the third secondary position toward the fourth secondary position.

17. The closed transfer device according to claim 16, wherein the movement of the actuator valve to the open position causes the gas storage space to be in fluid communication with a vent, thereby releasing the gas from the gas storage space, the vent is arranged to be in fluid communication with a foldable chamber sealed and fixed between the needle assembly and the shield assembly, thereby causing the chamber to expand axially as the gas is released from the gas storage space through the vent into the foldable chamber, and this expansion biases the shield assembly from the third secondary position toward the fourth secondary position.

18. The closed transfer device according to claim 16 or 17, wherein the actuator valve is a valve member slidably housed within the needle assembly body and formed to define the gas storage space, or comprises the valve member.

19. The closed-type transfer device according to claim 18, wherein the valve member itself defines the gas storage space.

20. The closed-type transfer device according to claim 19, wherein the valve member comprises an external support forming portion having a hollow interior that defines the gas storage space.

21. The closed transfer device according to claim 18, wherein the valve member cooperates with the needle assembly body to define the gas storage space between them.

22. The closed transfer device according to claim 21, wherein the valve member comprises a first seal-forming portion and a second seal-forming portion spaced apart in the axial direction, with an annular gas storage space formed between them.

23. The actuator module further comprises an elongated actuator member slidably housed within the needle assembly body and fixedly attached to the actuator valve to move the actuator valve from its closed position to its open position, wherein one end of the actuator member defines a contact forming portion to which the syringe plunger can contact, thereby driving the actuator member axially by the continued insertion of the plunger in the later stages of inserting the plunger into the hollow syringe body, moving the actuator valve from its closed position to its open position, thereby biasing the shield assembly from the third secondary position to the fourth secondary position, according to any one of claims 16 to 22.

24. The closed transfer device according to claim 23, wherein the needle assembly body is movably coupled to the syringe body, and selective movement of the needle assembly body relative to the syringe body causes the contact forming portion of the actuator member to move into the drug chamber of the syringe body.

25. The closed transfer device according to claim 24, wherein the selective movement of the needle assembly body relative to the syringe body further moves either or both of (i) an inclined opening plane coplanar with the inclined opening of the subcutaneous injection needle, and (ii) a scale mark, to align with the natural use axis of the flange defined by the syringe body.

26. The closed transfer device according to claim 24 or 25, wherein the needle assembly body is spirally coupled to the syringe body and is constrained to rotate by the shield body, thereby achieving one or more of the following by moving the shield assembly from the second secondary position to the second primary position and moving it from the second primary position to the third primary position: moving the contact forming portion of the actuator member into the drug chamber and moving the flange of the inclined opening plane and / or the scale mark to align with the natural axis of use.

27. A method of using a closed-type transfer device according to any of the preceding claims, A method comprising the step of moving the shield body relative to the syringe body between at least one position corresponding to an operating state of the device and another position corresponding to a different operating state of the device.

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