Improvements in or relating to closed system transfer devices

Abstract

In the field of drug delivery methods and devices, improved closed system transfer devices are required. A closed system transfer device (10) includes a syringe (12) having an elongate hollow syringe body (14) within which a plunger (16) is slidably received to define medicament chambers (18) of different sizes depending on the extent of insertion of the plunger within the syringe body (18). The closed system transfer device (10) also includes a needle assembly (28; 300) having a needle assembly body (30) to which the hypodermic needle (32) is securely secured. The needle assembly body (30) is coupled with the syringe body (14) to maintain an internal conduit (40) of the hypodermic needle (32) in fluid communication with the drug chamber (18). In addition, the closure system transfer device (10) also includes a shroud assembly (42) having a shroud body (44). The shroud body (44) is movably coupled with the syringe body (14), whereby the shroud assembly (14) is selectively operable to enclose the needle (32). The shroud body (44) and the syringe body (14) include mutually cooperating formations to constrain movement of the shroud assembly (42) relative to the syringe (12) through a series of positions (200, 210, 220, 230, 240, 250, 260) corresponding to different operating conditions of the device (10).

Description

Technical Field

[0001] The present invention relates to a closed system transfer device (CSTD) and a method of using such a device. Background Technology

[0002] Closed-system transfer devices allow the preparation, transfer, and administration of substances (primarily pharmaceuticals, including potentially hazardous drugs) while mechanically preventing the transfer of environmental contaminants into the device and mechanically preventing the escape of the drug or its vapor concentration from the device. Such devices, specifically designed for drug transfer, are sometimes referred to as closed-system pharmaceutical transfer devices. Summary of the Invention

[0003] According to a first aspect of the present invention, a closed system transfer device is provided, comprising:

[0004] A syringe having a slender, hollow syringe body with a plunger slidably received within the syringe body to define drug chambers of different sizes depending on the degree of plunger insertion within the syringe body;

[0005] The needle assembly includes a needle assembly body, a hypodermic needle securely fixed to the needle assembly body, and the needle assembly body connected to a syringe body to maintain fluid communication between the internal catheter of the hypodermic needle and the drug chamber; and

[0006] A protective cover assembly having a protective cover body that is movably connected to the syringe body, thereby selectively operable to enclose the needle.

[0007] The protective cover and the syringe body include mutually cooperating forming portions to restrict the movement of the protective cover assembly relative to the syringe through a series of positions corresponding to different operating states of the device.

[0008] The device provides a cover and syringe body with mutually mating forming parts. These mating forming parts constrain the relative movement between the cover assembly and the syringe through a series of positions corresponding to different operating states of the device. This advantageously helps guide the user of the device through each operating state, thereby greatly improving the usability of the device and reducing the risk of erroneous operation.

[0009] Optionally, the protective cover body is movably connected to the syringe body to move linearly along the length of the syringe body in the axial direction and rotate around the outside of the syringe body in the circumferential direction.

[0010] This relative linear and rotational motion can be easily constrained, while also providing the necessary distinction between each position in a series of positions.

[0011] Preferably, the series of positions includes two or more of the following:

[0012] The first primary position corresponds to the preparation state of the device, in which one or more drugs can be drawn from the vial into the drug chamber;

[0013] The second primary position corresponds to a transfer state of the device, in which the sheath assembly encloses the needle, and movement of the sheath assembly relative to the syringe is suppressed to prevent the needle from being exposed outside the sheath assembly; and

[0014] The third principal position corresponds to the application 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 are injected into the recipient.

[0015] Restricting the relative movement between the protective assembly and the syringe to two or more of the indicated first, second, and third primary positions ideally allows the user to be guided through the device’s primary operating states, i.e., the most prominent and important operating states of the device, thereby helping to ensure that the user can reliably use the device at any time.

[0016] The position of the protective assembly relative to the syringe can be selectively restricted to a single position among the first primary position, the second primary position, or the third primary position.

[0017] Such limitations create opportunities to provide simplified versions of devices with limited operating modes.

[0018] The mating portions of the protective cover and the syringe body can be further configured to allow movement between the series of main positions in a single sequence.

[0019] Preferably, the single sequence includes a first principal position followed by a third principal position.

[0020] Optionally, the single sequence includes a first principal position, then a second principal position, and then a third principal position.

[0021] This mutually cooperating formation and the structure that restricts the relative movement of a series of main positions to a single sequence forces the user to operate the device in the optimal sequence of its main operating states, thereby further helping to ensure that the user uses the device correctly.

[0022] Preferably, at least two main positions are inserted by at least one unidirectionally cooperating forming part.

[0023] Including at least one such unidirectionally cooperating forming part, ideally providing a corresponding mechanical barrier for unnecessary movement between the various key positions in an incorrect sequence. In turn, such a mechanical barrier is difficult (or even impossible) to overcome without permanently damaging the device, and also provides the option to convey tactile and / or auditory feedback to the device user when correctly traversing the device.

[0024] In a preferred embodiment of the invention, the series of positions further includes one or more of the following:

[0025] The first primary position corresponds to the transport state of the device, in which the cover assembly encloses the sealing needle but can move toward the first primary position;

[0026] The second-level position corresponds to the ready state of the device, in which the drug chamber contains one or more drugs and the protective assembly encloses the needle, but can be moved toward the second primary position;

[0027] The third-level position corresponds to the insertion state of the device, in which the needle may be located within the recipient; and

[0028] The fourth secondary position corresponds to the locked state of the device, in which the protective assembly encloses the needle and is immobile relative to the syringe.

[0029] The advantage of including a first primary position corresponding to the transport status of the device is that the needle is ideally enclosed, i.e., properly sealed or shielded, to prevent needlestick injuries during transport of the device, such as from the manufacturer or distributor to the intended user of the device (such as a medical person or other healthcare professional), while the device is also ready to be inserted into a medication vial, for example when the protective assembly can also be moved to the first primary position corresponding to the preparation status of the device.

[0030] It has a second-level position corresponding to the ready state of the device, in which the drug compartment contains one or more drugs and the cover assembly encloses the needle, advantageously ensuring the encapsulation of the needle, that is, ensuring that the needle is properly sealed or shielded to prevent needlestick injury, while the cover assembly is ready to move toward the second primary position, that is, the device is ready to adopt the transport state to allow safe and mechanically enclosed transport of the device, for example from the preparation area to the patient administration area.

[0031] This includes a third-level position corresponding to the insertion state of the device, in which the needle can be located within the recipient. This advantageously allows the device to be constructed such that the needle can be located within the recipient while the protective assembly can, for example, continuously abut against the recipient's body during needle insertion, thereby maintaining the mechanical closure of the device.

[0032] Including a fourth secondary position corresponding to the locked state of the device is particularly advantageous, in which the protective assembly encloses the needle and is immobile relative to the syringe, because this means that, for example after use of the device, i.e. after one or more drugs are injected from the drug chamber into the recipient, the needle is safely and permanently disabled, thereby preventing needlestick injuries and reuse of the device.

[0033] In another preferred embodiment, the series of positions includes a fourth secondary position corresponding to a locked state of the device, in which the protective assembly encloses the needle and is immovable relative to the syringe. The protective assembly also includes a resiliently biased latching member that is pushed to abut the tip of the needle when the protective assembly moves relative to the syringe to the fourth secondary position. Thereby, the mutually cooperating formations of the protective body and the syringe body further cooperate with the latching member to suppress linear movement of the protective assembly relative to the syringe.

[0034] This suppression of relative axial movement between the shield assembly and the syringe advantageously holds the shield assembly in an axial position relative to the syringe, in which relative rotational movement between the shield assembly and the syringe is also suppressed, thus rendering the shield assembly immobile relative to the syringe.

[0035] The mutually mating portions of the protective body and the syringe body can be male and female portions or include both male and female portions.

[0036] This arrangement provides readily available and reliable interoperability in a form that is easy to manufacture.

[0037] Optionally, the male portion is an elastically biased claw member or includes an elastically biased claw member, and the female portion is a plurality of slots or includes a plurality of slots, into which the claw member is biased.

[0038] The addition of the claw component provides a reliable follower element, while the multiple slotted female forming portion ideally allows for one or more paths to be provided for the claw, thereby guiding the user of the device through a series of relative positions between the cover assembly and the syringe corresponding to the respective operating states of the device.

[0039] In another preferred embodiment of the present invention, the female forming portion includes a first axial extending groove, a circumferential extending groove extending from one end of the first axial extending groove, and a second axial extending groove intersecting with the end of the circumferential extending groove opposite to the end that coincides with the end of the first axial extending groove.

[0040] Preferably, it is one or more of the following:

[0041] The first end of the first axial extension groove defines the first stage position and the second stage position, and the first end is the end from which the circumferential extension groove extends.

[0042] The second end of the first axial extension groove, opposite to the first end, defines the first principal position;

[0043] The second principal position is located along the circumferential extension groove; the second end of the circumferential extension groove defines the third principal position, and the second end of the circumferential extension groove is the end that intersects with the second axial extension groove;

[0044] The first end of the second axial extension groove defines the third stage position, and the first end of the second axial extension groove is the end closest to the opening end of the syringe body; and

[0045] The second end of the second axial extension groove, opposite to the first end, defines the fourth secondary position.

[0046] The above arrangement ideally allows for mapping various primary and secondary positions of the protective assembly relative to the syringe, thereby enabling the user of the device to be guided to each corresponding operating state of the device.

[0047] The needle assembly may include an actuator module configured to selectively push a sheath assembly from a third-level position corresponding to an insertion state of the device to a fourth-level position corresponding to a locked state of the device, wherein in the insertion state the needle is located within the receiver and in the locked state the sheath assembly encloses the needle and is immobile relative to the syringe.

[0048] Including such an actuator module, and the push it provides to move the protective assembly from a third-level position relative to the syringe to a fourth-level position relative to the syringe, advantageously helps to keep the protective assembly in contact with the recipient's skin, for example, during needle withdrawal after drug administration, thereby helping to mechanically prevent the escape of any dangerous drugs or vapors that might otherwise be expelled from the recipient or the needle upon needle withdrawal.

[0049] Optionally, the actuator module includes an actuator valve that is actuable between a closed position and an open position. In the closed position, gas is held under pressure in a gas storage volume, and in the open position, gas is released from the gas storage volume to push the protective assembly from a third-stage position to a fourth-stage position.

[0050] Preferably, the actuator valve moves to the open position to fluidly communicate the gas storage volume with the vent port to release gas from the gas storage volume. The vent port is in fluid communication with the foldable chamber that is sealed between the needle assembly and the cover assembly. Thus, gas is released from the gas storage volume through the vent port into the foldable chamber, causing the chamber to expand in the axial direction, thereby pushing the cover assembly from the third-stage position to the fourth-stage position.

[0051] Such actuator valves, particularly those using pressurized gas to push the protective assembly to a fourth secondary position—the locked state of the device—ideally provide a suitable prime mover for the protective assembly, but this prime mover gradually increases from an initial low level to a higher level in order to apply a moderately resilient thrust to accommodate potential oscillating axial movements of the device, such as when it is removed from the recipient by medical personnel, while maintaining contact between the protective assembly and the recipient's skin. This contrasts with individual mechanical actuators such as springs, which typically have less tolerant operating modes because they frequently transition from high initial forces to lower initial forces. Such mechanical actuators are also prone to mechanical creep over time, which makes them less efficient and potentially even unreliable over time.

[0052] Furthermore, as the protective assembly is pushed to the fourth secondary position, the gradually increasing force reduces the likelihood of any residual medication unintentionally shifting from the internal conduit of the device's needle, i.e., reducing the risk of medication "splashing" when the device transitions to its locked state, which tends to occur in devices with mechanical actuators that typically cause sudden movements and have higher rates of acceleration (e.g., retractable needle devices).

[0053] The actuator valve of the present invention also allows the prime mover applied to the protective assembly to be adjusted at any time in terms of overall size and application rate by modifying the stored enthalpy of the pressurized gas, i.e., the initial internal energy.

[0054] Preferably, the actuator valve is or includes a valve member slidably housed within the needle assembly body and is configured to define a gas storage volume.

[0055] This valve component design allows for adjustment of the gas storage volume size according to the requirements of the device and / or the characteristics of the gas thus held.

[0056] Preferably, the valve component itself defines the gas storage volume.

[0057] By limiting the gas storage volume by the valve component itself, the number of sealing formations required to maintain the sealing integrity of the gas storage volume is restricted, thus advantageously reducing the risk of leakage via one or more such formations.

[0058] Furthermore, the reduction in the number of seal formations also ideally reduces the amount of force required to move (i.e. operate) the valve components to resist the resistance that such seal formations may exert.

[0059] Optionally, the valve component includes an external support forming portion having a hollow interior that defines a gas storage volume.

[0060] This arrangement allows the valve components to provide the aforementioned benefits while being easy to manufacture, and the gas storage volume can be pre-filled once the needle assembly is assembled.

[0061] The valve component can mate with the needle assembly body to define a gas storage volume therebetween.

[0062] This arrangement provides further options for adjusting the size of the gas storage volume.

[0063] In another preferred embodiment of the invention, the valve component includes a first sealing forming portion and a second sealing forming portion spaced apart axially, forming an annular gas storage volume therebetween.

[0064] The annular gas storage volume provides further sizing options while also helping to ensure that the gas storage volume can be easily fluidly connected to the vent or each vent, for example, when the actuator valve (i.e., valve component) is moved to its open position.

[0065] The actuator module may also include an elongated actuator member slidably received within the needle assembly body and securely fixed to the actuator valve to move the actuator valve from its closed position to its open position. The end of the actuator member defines an abutment formation that the syringe plunger can abut against. Thus, in the later stage of plunger insertion into the hollow syringe body, the continued insertion of the plunger drives the actuator member axially, thereby moving the actuator valve from its closed position to its open position, which in turn pushes the protective assembly from a third-stage position to a fourth-stage position.

[0066] Such an actuator component advantageously converts the continuous insertion of the plunger within the syringe body into the opening of the actuator valve, thereby releasing gas from the gas storage volume and pushing the protective assembly to a fourth secondary position. Therefore, this actuator component ideally provides the option of utilizing continuous operation of the device, such as the continuous injection of medication into the receptor, to influence the operation (i.e., opening) of the actuator valve, thereby further contributing to ensuring the correct sequencing of the device's operating states.

[0067] Preferably, the needle assembly body is movably connected to the syringe body, and selective movement of the needle assembly body relative to the syringe body moves the actuator member abutment forming portion into the drug chamber of the syringe.

[0068] This movement of the needle assembly body relative to the syringe body selectively allows the adjacent forming portion to be ideally located outside the drug chamber, for example, to prevent the actuator valve from opening unintentionally or undesirably, or, for example, to be moved into the drug chamber when it is necessary to operate the actuator valve, i.e., to enable the opening of the actuator valve. Therefore, this feature helps ensure that the actuator valve is only equipped when needed, i.e., only operable, thereby contributing to the safe and correct operation of the device.

[0069] The selective movement of the needle assembly body relative to the syringe body may additionally move one or both of the following: (i) the bevel opening plane coplanar with the bevel opening of the hypodermic needle; and (ii) the scale markings, to be aligned with the natural use axis of the flange defined by the syringe body.

[0070] This alignment of the bevel opening plane with the natural use axis of the flange advantageously ensures that the bevel opening is optimally oriented relative to the flange, thereby helping the user to correctly insert the needle into the recipient (especially for subcutaneous injection) when the device is moved between its application and insertion states.

[0071] In another preferred embodiment of the invention, the needle assembly body is helically connected to the syringe body and constrained to rotate by the cover body, thereby enabling the movement of the cover assembly from at least one of the secondary position to the second primary position and from the second primary position to the third primary position to achieve one or more of the movement of the actuator member adjacent forming portion into the drug chamber, and the movement of the inclined opening plane and / or the scale markings and the flange to be naturally aligned using the axis.

[0072] This configuration advantageously coordinates the sequence of changes in the device's operating state with the release mechanism of the actuator valve in an automatic manner, thereby helping to ensure that the actuator valve moves to its open position and thus pushes the protective assembly to the fourth secondary position, which can only occur if such operation is correctly anticipated.

[0073] In addition, it also automatically coordinates the sequence of changes in the device's operating state to align with the optimal orientation of the needle's bevel opening (i.e., the tip) relative to the flange, to help the user correctly insert the needle into the recipient and / or the desired orientation of the graduations on the syringe body so that they are easy for medical personnel, other healthcare professionals, or any other user to read.

[0074] According to a second aspect of the invention, a method of using a closed system transfer device according to any one of the preceding claims is provided, comprising the step of moving a protective cover 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.

[0075] The method of the present invention shares the benefits of the corresponding features of the device of the present invention.

[0076] It should be understood that, unless otherwise stated, the use of terms such as “first” and “second” in this patent specification is intended only to help distinguish similar features and is not intended to indicate the relative importance of one feature to another.

[0077] Within the scope of this application, it is expressly intended that the various aspects, embodiments, examples, and alternatives listed in the foregoing paragraphs, as well as the claims and / or the following description and drawings, particularly their individual features, may be employed independently or in any combination. That is, all embodiments and all features of any embodiment may be combined in any manner and / or combination, unless these features are incompatible. The applicant reserves the right to amend any previously filed claims accordingly or to file any new claims, including the right to amend any previously filed claims to make them subordinate to and / or include features of any other claim, even if not originally claimed in that manner. Attached Figure Description

[0078] Preferred embodiments of the invention will now be briefly described with reference to the following accompanying drawings, by way of non-limiting examples, in which:

[0079] Figure 1(a) shows an isometric view of the closed system transfer device (CSTD) according to a first embodiment of the present invention in the transport state;

[0080] Figure 1(b) shows a plan sectional view of the closed system transfer device shown in Figure 1(a);

[0081] Figure 1(c) shows an enlarged view of a portion of Figure 1(b);

[0082] Figure 1(d) shows an axial cross-sectional view of the circumferentially extending groove of the syringe body through the syringe that forms part of the closed system transfer device shown in Figure 1(a);

[0083] Figure 2 An isometric view of a syringe that forms part of the closed system transfer device shown in Figure 1(a) is shown;

[0084] Figure 3 It shows Figure 2 A planar sectional view of the syringe shown;

[0085] Figure 4 It shows crossing Figure 2 An axial cross-sectional view of the circumferential extension groove of the syringe shown.

[0086] Figure 5 It shows Figure 2 The first front view of the syringe shown;

[0087] Figure 6 It shows Figure 5 The syringe shown is rotated 120° clockwise in a second front view.

[0088] Figure 7 An isometric view of the first needle assembly forming part of the closed system transfer device shown in FIG1(a) is shown;

[0089] Figure 8 It shows Figure 7 A planar cross-sectional view of the first needle assembly shown;

[0090] Figure 9 It shows the relationship with Figure 2 The syringe shown is connected Figure 7 A planar cross-sectional view of the first needle assembly shown;

[0091] Figure 10(a) shows a plan sectional view of the protective assembly that forms part of the closed system transfer device shown in Figure 1(a);

[0092] Figure 10(b) shows a first isometric view of the protective assembly shown in Figure 10(a);

[0093] Figure 10(c) shows a second isometric view of the protective assembly shown in Figure 10(a);

[0094] Figure 11(a) shows a first isometric view of a sealing formation that forms a part of the protective assembly shown in Figure 10(a);

[0095] Figure 11(b) shows a second isometric view of the sealing formation shown in Figure 11(a);

[0096] Figure 12 An isometric view of a sealing member forming a portion of the sealing portion shown in Figures 11(a) and 11(b) is shown;

[0097] Figure 13(a) shows an isometric view of the closed system transfer device shown in Figure 1(a) in a ready state;

[0098] Figure 13(b) shows an enlarged plan sectional view of the closed system transfer device shown in Figure 13(a);

[0099] Figure 13(c) shows an axial cross-sectional view through the circumferential extension groove of the closed system transfer device shown in Figure 13(a);

[0100] Figure 14(a) shows an isometric view of the closed system transfer device shown in Figure 1(a) before preparation;

[0101] Figure 14(b) shows an enlarged plan sectional view of the closed system transfer device shown in Figure 14(a);

[0102] Figure 14(c) shows an axial cross-sectional view through the circumferential extension groove of the closed system transfer device shown in Figure 14(a);

[0103] Figure 14(d) shows an isometric view of the closed system transfer device shown in Figure 1(a) in the preparation state after preparation;

[0104] Figure 14(e) shows an enlarged plan sectional view of the closed system transfer device shown in Figure 14(d);

[0105] Figure 15(a) shows an isometric view of the closed system transfer device shown in Figure 1(a) in the transfer state;

[0106] Figure 15(b) shows an enlarged planar cross-sectional view of the closed system transfer device shown in Figure 15(a);

[0107] Figure 15(c) shows an axial cross-sectional view through the circumferential extension groove of the closed system transfer device shown in Figure 15(a);

[0108] Figure 16(a) shows an isometric view of the closed system transfer device shown in Figure 1(a) in the application state;

[0109] Figure 16(b) shows an enlarged plan sectional view of the closed system transfer device shown in Figure 16(a);

[0110] Figure 16(c) shows an axial cross-sectional view through the circumferential extension groove of the closed system transfer device shown in Figure 16(a);

[0111] Figure 17(a) shows an isometric view of the closed system transfer device shown in Figure 1(a) in its insertion state before application;

[0112] Figure 17(b) shows an enlarged planar sectional view of the closed system transfer device shown in Figure 17(a);

[0113] Figure 17(c) shows an axial cross-sectional view through the circumferential extension groove of the closed system transfer device shown in Figure 17(a);

[0114] Figure 17(d) shows an isometric view of the closed system transfer device shown in Figure 1(a) near the end of application in the inserted state;

[0115] Figure 17(e) shows an enlarged plan sectional view of the closed system transfer device shown in Figure 17(d);

[0116] Figure 18(a) shows an isometric view of the closed system transfer device shown in Figure 1(a) in the locked state;

[0117] Figure 18(b) shows an enlarged plan sectional view of the closed system transfer device shown in Figure 18(a);

[0118] Figure 18(c) shows an axial cross-sectional view through the circumferential extension groove of the closed system transfer device shown in Figure 18(a);

[0119] Figure 19(a) shows an isometric view of a portion of the actuator module forming part of the closed system transfer device shown in Figure 1(a) in an expanded configuration;

[0120] Figure 19(b) shows the collapsed structure of the actuator module shown in Figure 19(a);

[0121] Figure 20 An axial view of the cover and needle assembly forming part of the closed system transfer device shown in FIG1(a) is shown;

[0122] Figure 21 An exploded isometric view of the components of the second needle assembly is shown, which may alternatively form part of the closed system transfer device shown in FIG1(a);

[0123] Figure 22(a) shows Figure 21 The isometric partial cross-sectional view of the second needle assembly shown, wherein the associated actuator valve is in the closed position;

[0124] Figure 22(b) shows Figure 21 The image shows an isometric partial cross-sectional view of the second needle assembly, with the associated actuator valve in the open position.

[0125] Figure 23(a) shows Figure 21 The enlarged planar cross-sectional view of the second needle assembly shown in Figure 1(a) within a closed system transfer device of the type shown, in the insertion state, near the end of application; and

[0126] Figure 23(b) shows Figure 21 The enlarged plan view of the second needle assembly shown in Figure 1(a) in a locked state within a closed system transfer device of the type shown. Detailed Implementation

[0127] The closed system transfer device (CSTD) according to the first embodiment of the present invention is generally indicated by reference numeral 10, as shown, for example, in FIG1(a).

[0128] Device 10 includes a syringe 12 having an elongated hollow syringe body 14, and a plunger 16 slidably received within the syringe body 14 to define a drug chamber 18, such as Figure 3 As shown.

[0129] More specifically, the plunger 16 includes a piston end 20 and an actuator end 22, the piston end 20 defining a drug chamber 18 together with the hollow syringe body 14, and the actuator end 22, together with a flange 24 at the open proximal end 26 of the syringe body 14, being usable by a user of the device 10 (e.g., a medical professional or other healthcare professional) to selectively insert the plunger 16 into or withdraw the plunger 16 from the syringe body 14 in a generally conventional manner.

[0130] The size of the drug chamber 18, and therefore the drugs stored therein ( Figure 3 (not shown in the figure), that is, the amount of medicine, agent or other substance that has a physiological effect when introduced into the human body varies according to the degree of insertion of the plunger 16 into the syringe body 14.

[0131] Device 10 also includes a first needle assembly 28, such as Figure 7 and Figure 8 As shown, it has a needle assembly body 30, to which a hypodermic needle 32 is securely fixed, for example by welding or other fixing means in the distal portion 34 of the needle assembly body.

[0132] The needle assembly body 30 is connected to the syringe body 14, more specifically, movably connected, and in the illustrated embodiment, more specifically, helically connected, for example as... Figure 9 As shown.

[0133] This helical connection is achieved via a female helical screw forming portion (structure) 36 formed in the needle assembly body 30 and a complementary male helical screw forming portion 38 formed on the syringe body 14. However, different embodiments of the present invention can be connected in different ways; for example, a male helical screw forming portion can be formed on the needle assembly body, while a female helical screw forming portion is formed on the syringe body.

[0134] In any case, the connection between the needle assembly body 30 and the syringe body 14 maintains fluid communication between the internal conduit 40 of the needle 32 and the drug chamber 18.

[0135] In addition to the above, the device 10 also includes a cover assembly 42, as shown in the cross-sectional view of FIG10(a), which includes an elongated hollow cover body 44, as shown in FIG10(b) and FIG10(c).

[0136] The cover assembly 42 also includes a sealing forming portion 46, as shown in Figures 11(a) and 11(b), which is securely attached to the distal end 48 of the cover body 44.

[0137] The sealing forming part 46 includes a sealing member 50 mounted on a sealing support 52, which is in turn firmly fixed to the cover body 44.

[0138] The sealing member 50 is formed of a flexible, elastic material, which may be an elastomer or silicone rubber. The sealing member 50 includes an orifice 54 formed therethrough, which, in the illustrated embodiment, is located at the center of the sealing member 50. The orifice 54 is self-sealing; that is, it can be forced open by twisting the sealing member 50, for example by pushing a needle 32 through the orifice 54, but closes when the sealing member 50 is released from such torque.

[0139] Meanwhile, the sealing support 52 is formed of a fundamentally rigid material such as plastic. It includes two identical tapered tab forming portions 56, each of which can slide through a complementary guide channel 58 formed in the cover body 44 during assembly of the cover assembly 42. Preferably, the tab forming portions 56 and the guide channels 58 are circumferentially spaced 180° apart from each other, but this is not required.

[0140] In the cover body 44, complementary fixing portions 60 are formed near the distal end of each guide channel 58, which take the form of elastically deformable snaps 62 (for example, only one snap 62 is shown in FIG. 10(b)). After each tapered tab forming portion 56 slides into contact with the corresponding snap 62, the sealing support 52 is securely fixed to the cover body 44 in a snap-fit ​​manner.

[0141] In the illustrated embodiment, the orifice 54 forms an airtight seal when closed, so the distal end 48 of the cover assembly 42 is mechanically closed by the seal forming portion 46, i.e., an airtight seal, until the orifice 54 is forcibly opened, for example by needle 32.

[0142] In addition to the above, the protective body 44 allows the protective body 44 to extend along the length of the syringe body 14 in the axial direction (i.e., in the proximal axial direction A). P and distal axial direction A D Each of the upper parts is linearly connected to the syringe body 14 in a manner that allows for movable movement around the outside of the syringe body 14 in the circumferential direction (e.g., in the clockwise circumferential direction C). CW and counterclockwise circumferential C CCW Each of the elements in the middle rotates and moves.

[0143] More specifically, the hollow protective body 44 is sized to slide on the syringe body 14 in a tightly fitted alignment manner.

[0144] This permissible movement of the sheath body 44 relative to the syringe body 14 allows the sheath assembly 42 to be selectively operable to enclose the needle 32, that is, to selectively enclose or cover the distal end 48 of the sheath assembly 42, which is mechanically and gas-tight, as shown, for example, in Figures 1(a) to 1(c). This enclosure of the needle 32 helps prevent needlestick injuries and the entry / exit of substances into / out of the device 10.

[0145] In addition, the protective body 44 and the syringe body 14 include mutually cooperating forming portions 64 and 66, which constrain the movement of the protective assembly 42 relative to the syringe 12 through a series of positions, which correspond to different operating states of the device 10.

[0146] More specifically, the protective body 44 includes a male forming portion 68, and more specifically, it also includes a resiliently biased claw member 70, while the syringe body 14 includes a female forming portion 72, which includes a plurality of grooves into which the claw member 70 is biased.

[0147] Other embodiments of the invention (not shown) may include different cooperating forming portions, in which the syringe body may be modified to include a male forming portion and the shield body may be modified to include a female forming portion.

[0148] Returning to the illustrated embodiment, the female portion 72 of the syringe body 14 includes:

[0149] A first axially extending groove 74 has a first end 76 and a second end 78 opposite to the first end 76;

[0150] A circumferentially extending groove 80 extends from a first end 76 of a first axially extending groove 74 and has a first end 82 coinciding with the first axially extending groove 74 and a second end 84 opposite to the first end 82; and

[0151] The second axial extension groove 86 intersects with the second end 84 of the circumferential extension groove 80, and has a first end 88 closest to the opening proximal end 26 of the syringe body 14, and a second end 90 opposite to the first end 88 and positioned beyond the circumferential extension groove 80.

[0152] As described above, the mutually cooperating forming portions 64 and 66 of the cover body 44 and the syringe body 14, namely the combination of the claw member 70 and the first axial extension groove 74, the circumferential extension groove 80 and the second axial extension groove 86 in which the claw member 70 is biased, constrain the movement of the cover assembly 42 relative to the syringe 12 through a series of positions, which correspond to different operating states of the device 10.

[0153] More specifically, the relative positions and corresponding operating states of the device 10 are defined as follows.

[0154] The first end 76 of the first axial extension groove 74 simultaneously defines the first stage position 230 and the second stage position 240 when the claw member 70 of the cover body 44 is located there.

[0155] The first primary position 230 corresponds to the transport state of the device 10, as shown in Figures 1(a) to 1(d), where the protective assembly 42 encloses, i.e., covers and protects the needle 32, but is movable toward the first primary position 200 (described below). In the illustrated embodiment, this means that the protective assembly 42 is movable relative to the syringe 12 in the axial direction, more specifically, in the proximal axial direction A. P It can move upwards, but it is not necessary to do so.

[0156] Meanwhile, the second primary position 240 is similar to the first primary position 230, but instead corresponds to the ready state of the device 10, as shown in Figures 13(a) to 13(c), where the drug chamber 18 contains one or more drugs 92 (as evidenced by the substantial withdrawal of the plunger 16 within the syringe body 14, which will be further explained in the context of the use of the device 10), and the sheath assembly 42 encloses the needle 32, but is movable toward the second primary position 210 (described below). In the illustrated embodiment, this means that the sheath assembly 42 is movable relative to the syringe 12 in a circumferential direction, more specifically, in a clockwise circumferential direction C. CW Movement is possible, but similarly, it is not necessary in other embodiments of the invention.

[0157] The second end 78 of the first axial extension groove 74 defines the aforementioned first primary position 200, which corresponds to the preparation state of the device 10, as shown in Figures 14(a) to 14(e), in which one or more drugs 92 can be drawn from the vial 94 (schematically shown) into the drug chamber 18, which will be further explained in the context of the use of the device 10.

[0158] The aforementioned second principal position 210 is located along the circumferentially extending groove 80, more specifically, at the midpoint of the circumferentially extending groove 80, and more specifically, in the illustrated embodiment, it is 60° circumferentially rotated away from the two ends 82, 84 of the circumferentially extending groove 80. In other embodiments of the invention (not shown), the second principal position may be located differently within the circumferentially extending groove 80.

[0159] In any case, the second primary position 210 corresponds to the transition state of the device 10, as shown in Figures 15(a) to 15(c), where the sheath assembly 42 encloses the needle 32, and the sheath assembly 42 moves linearly relative to the syringe 12, i.e., along the proximal axial direction A. P and distal axial direction A DThe movement of each of them is suppressed to prevent the needle 32 from being exposed outside the cover assembly 42, which will be further explained in the context of the use of the device 10.

[0160] Meanwhile, the second end 84 of the circumferential extension groove 80 defines a third main position 220, which corresponds to the application state of the device 10, as shown in Figures 16(a) to 16(c), wherein the needle 32 can be inserted into a recipient, such as a patient, and some or all contents of the drug chamber 18, i.e., the drug 92 contained therein or each drug 92, can be injected into the recipient, which will be further explained in the context of the use of the device 10.

[0161] The first end 88 of the second axial extension groove 86 defines a third stage position 250, which corresponds to the insertion state of the device 10, for example as shown in Figures 17(a) to 17(e), where the needle 32 can be located within the recipient, which will be further explained in the context of the use of the device 10.

[0162] Finally, the second end 90 of the second axial extension groove 86 defines a fourth secondary position 260, which corresponds to the locked state of the device 10, as shown in Figures 18(a) to 18(c), in which the cover assembly 42 encloses the needle 32 and is immovable relative to the syringe 12.

[0163] To help keep the shield assembly 42 immovable relative to the syringe 12, the shield assembly 34, and more specifically its sealing forming portion 46, also includes a resiliently biased latch member 96 that is pushed to abut 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 FIG18(b).

[0164] In this fourth secondary position 260, the mating portions 64, 66 of the protective body 44 and the syringe body 14, namely the second end 90 of the claw member 70 and the second axial extension groove 86, engage with the latch member 96 to suppress linear movement of the protective assembly 42 relative to the syringe 12, i.e., along the proximal axial direction A. P and distal axial direction A D The movement of each of them.

[0165] More specifically, the abutment of the latch member 96 with the pin tip 98 inhibits the claw member 70 from extending along the second axial groove 86 in the proximal axial direction A. P The movement of the upper part, while the claw member 70 abuts against the second end 90 of the second axial extension groove 86, inhibits the separation of the cover assembly 44 from the syringe 12, that is, inhibits the cover assembly 44 relative to the syringe 12 in the distal axial direction A. D The movement on the surface.

[0166] Therefore, the claw member 70 is engaged at the second end 90 of the second axial extension groove 86, where it cannot rotate clockwise in the circumferential direction C. CW Or counterclockwise circumferential direction C CCW The protective assembly 42 is movable, therefore it is completely immovable relative to the syringe 12.

[0167] In the illustrated embodiment, the latching member 96 is disposed within the sealing member 50 of the sealing forming portion 46, as shown in FIG10(a) and Figure 12 As shown. The resilient bias of the latch member 96 is provided by the bias finger 100, which protrudes adjacent to the orifice 54 of the sealing member 50, as shown, for example, in FIG18(b), but other biasing methods of the latch member 96 are also possible.

[0168] In all designated positions 200, 210, 220, 230, 240, 250 of the protective assembly 42 relative to the syringe 12, except for the fourth secondary position 260 corresponding to the locked state of the device 10, the latching member 96 is displaced by the needle 32 against the finger 100, as shown in each of Figures 1(b), 1(c), 13(b), 14(b), 14(e), 15(b), and 16(b), so that the needle 32 can move freely in the axial direction relative to the latching member 1996.

[0169] However, without the influence of the needle 32, the finger 100 pushes the latch member 96 to engage with the needle tip 98, as shown in FIG18(b), and the device 10 is thus locked.

[0170] The latching member 96 is formed of a fundamentally rigid material such as metal or ceramic, but other materials are also possible.

[0171] In addition to the above, the mutually cooperating forming portions 64, 66 of the protective body 44 and the syringe body 14, namely the claw members 70 and the grooves 74, 80, 86, are also configured to allow movement in a single sequence between a series of primary positions, namely the first primary position 200, the second primary position 210 and the third primary position 220, more specifically, in a single sequence including the first primary position 200, followed by the second primary position 210 and then the third primary position 220.

[0172] In the illustrated embodiment, the mutually cooperating forming portions 64, 66, namely the claw members 70 and the slots 74, 80, 86, achieve this specific order of the first main position 200, the second main position 210, and the third main position 220 by inserting a first unidirectional mutually cooperating forming portion 102 between the first main position 200 and the second main position 210, and inserting a second unidirectional mutually cooperating forming portion 104 between the second main position 210 and the third main position 220. For example, Figure 4 As shown.

[0173] More specifically, in the illustrated embodiment, the first unidirectionally interoperable forming portion 102 is located between the first end 82 of the circumferential extension groove 80 and the second main position 210 (which itself is located within the circumferential extension groove 80), but in other embodiments of the invention, the first unidirectionally interoperable forming portion may be located elsewhere.

[0174] Similarly, in the illustrated embodiment, the second unidirectionally interoperable forming portion 104 is located between the second primary position 210 and the second end 84 of the circumferential extension groove 80, but other positioning is also possible.

[0175] Preferably, the first principal position 200 and the second principal position 210 are circumferentially spaced apart from each other along the circumferential extension groove 80 by a first angle α, which is 60° in the illustrated embodiment (but this could be any other angle, such as 90° or 120°), and the second principal position 210 and the third principal position 220 are circumferentially spaced apart from each other along the circumferential extension groove 80 by a second angle, which is also 60° in the illustrated embodiment (but this could be any other angle, such as 90° or 20°).

[0176] Furthermore, the first unidirectionally interoperable forming portion 102 and the second unidirectionally interoperable forming portion 104 preferably take the form of corresponding first ratchet teeth 106 and second ratchet teeth 108, each ratchet tooth being shaped to allow the pawl member 70 to move in the clockwise circumferential direction C within the circumferential extension groove 80. CW Move, but prevent the chuck component 70 from rotating counterclockwise in the circumferential direction C. CCW Movement. However, other forms of unidirectional, mutually interoperable components are also possible.

[0177] Furthermore, in the embodiments shown and described above, the first needle assembly 28 includes a first actuator module 110 configured to selectively push the cover assembly 44 from a third-level position 250 corresponding to the insertion state of the device 100 to a fourth-level position 260 corresponding to the locking state of the device 100 relative to the syringe 12.

[0178] More specifically, the first actuator module 110 includes a first actuator valve 112, which can, for example, Figure 8 The device moves between the optimal closed position and, for example, the open position shown in FIG18(b), in which gas (not shown) is maintained at pressure in a first gas storage volume 114, and in the open position, the gas storage volume 114 is in fluid communication with a first vent port 116 and a second vent port 118 opposite each other in the needle assembly body 30 to release gas from the gas storage volume 114. Other embodiments of the invention may include fewer or more than two vent ports.

[0179] Preferably, the gas is hydrofluoroalkyl, such as Solkane®, but it is not necessary and other propellants (which may not be gases) may also be used.

[0180] In the illustrated embodiment, the first actuator valve 112 takes the form of a first valve member 120, which is slidably received within the needle assembly body 30, i.e., within the hollow interior 122 through which the needle itself of the needle assembly body 30 also passes. The first valve member 120 and the needle assembly body 30, i.e., its hollow interior 122, cooperate with each other to define a first gas storage volume 114 therebetween.

[0181] More specifically, in the illustrated embodiment, the first valve member 120 includes an axially spaced first sealing forming portion 124 and a second sealing forming portion 126, forming an annular first gas storage volume 114 between them. The first sealing forming portion 124 and the second sealing forming portion 126 themselves also have annular structures, and when the actuator valve 112 is in its closed position, the first sealing forming portion 124 isolates the first gas storage volume 114 from the first vent port 116 and the second vent port 118, for example as... Figure 8 As shown.

[0182] Furthermore, the first vent port 116 and the second vent port 118 are in fluid communication with the foldable chamber 128. In the illustrated embodiment, the foldable chamber is in the form of a tubular corrugated pipe 130, but other forms are also possible.

[0183] The foldable chamber 128 (i.e., the tubular bellows 130) is sealed between the first needle assembly 28 and the protective cover assembly 42. More specifically, as shown in Figures 19(a) and 19(b), it is sealed between the needle assembly body 30 and the sealing support 52 of the sealing forming portion 46 of the protective cover assembly 42, i.e., sealed in a substantially permanent airtight manner. However, other embodiments of the invention may have sealing structures with different foldable chambers between the needle and the protective cover assembly.

[0184] The foldable nature of chamber 128 (i.e., tubular bellows 130) means that it can move between various expansion configurations, such as shown in Figure 19(a) and each of Figures 1(b), 13(b) and 15(b), and can also move between various contraction configurations to which the device can be folded to different degrees, such as shown in Figures 19(b) and 14(b), 14(e), 17(b) and 17(e).

[0185] The arrangement in which the collapsible chamber 128 (i.e., the tubular bellows 130) is in fluid communication with each of the first vent port 116 and the second vent port 118 means that when the first actuator valve 112 (i.e., the first valve member 120) is moved to its open position, the first gas storage volume 114 is in fluid communication with the collapsible chamber 128, thereby releasing gas (not shown) from the first gas storage volume 114 into the collapsible chamber 128 (i.e., the tubular bellows 130) via the first vent port 116 and the second vent port 118.

[0186] This release of gas from the first gas storage volume 114 causes the collapsible chamber 130 (i.e., the tubular bellows 130) to expand in the axial direction, more specifically, in the axial direction A relative to the distal end of the syringe 12. D Upward expansion. This occurs in the same distal axial direction A. D The sealing support 52 is pushed upward, and since the sealing support 152 is firmly fixed to the cover body 44, the cover assembly 42 is pushed from the third position 250 to the fourth secondary position 260. More specifically, the cover assembly 42 is driven to the fourth secondary position 260, thereby putting the device 10 into its locked state, as shown, for example, in Figures 18(a) to 18(c).

[0187] In addition to the above, the first actuator module 110 also includes an elongated actuator member 132, which is slidably received within the needle assembly body 30 and securely fixed to the first actuator valve 112, i.e., the first valve member 120 in the illustrated embodiment, so that it can move the first actuator valve 112, i.e., the first valve member 120, from its closed position to its open position, i.e., selectively release gas from the first gas storage volume 114.

[0188] More specifically, in the illustrated embodiment, the actuator component 132 takes the form of a hollow actuator tube 134, sized to slide on the needle 32, which, as described above, is securely fixed to the needle assembly body 30. The hollow actuator tube 134 may be welded, adhered, or otherwise immovably fixed to the first valve component 120. It is also preferably movably sealed relative to the needle assembly body 30, for example, by means of a first auxiliary seal formation 136. However, other forms of actuator components are possible, as are different fixing and sealing arrangements.

[0189] In the manner described above, the sliding of the actuator tube 134 on the needle 30 allows the actuator tube 134 (i.e., actuator member 132) to move within the needle assembly body 30, while fixing the actuator tube 134 (i.e., actuator member 132) to the first valve member 120 means that this relative movement of the actuator tube 134 causes the first valve member 130 to also move within the needle assembly body 30.

[0190] Furthermore, the proximal end 138 of the actuator tube 134 defines a first abutment formation 140, the syringe plunger 16, and more specifically, the piston end 20 of the plunger 16 is capable of abutting the first abutment formation 140.

[0191] Providing this first abutment formation 140 means that, in the later stages of the insertion of the plunger 16 into the hollow syringe body 14, for example as shown in FIG17(e), the continued insertion of the plunger 16 is along the axial direction, more specifically along the distal axial direction A. D Drive actuator component 132 (i.e. actuator tube 134).

[0192] This distal axial movement of the actuator tube 134 causes the first actuator valve 112 (i.e., valve member 120) to move from its closed position to its open position, as shown, for example, in FIG18(b), which in turn releases gas from the first gas storage volume 114, thereby causing the automatic push-back assembly 42 to move from the third stage position 250 toward and eventually into the fourth stage position 260.

[0193] As described above, the needle assembly body 30 is movably connected to the syringe body 14, and more specifically, is helically connected to the syringe body 2014.

[0194] In addition to the above, the needle assembly body 30 is restricted from rotation by the protective body 44. In the illustrated embodiment, this is achieved by configuring the needle assembly body 30 to have a pair of opposing wing-shaped forming portions 142 (e.g., as shown in the figure). Figure 7 As shown in Figures 19(a) and 19(b), each wing-shaped forming part mates with a corresponding guide channel 58 in the cover body 44 and can slide therein, as... Figure 20 As shown.

[0195] This combination of the helical connection between the needle assembly body 30 and the syringe body 14, and the forced rotation of the needle assembly body 20 with the protective cover body 44 (via the engagement of the corresponding wing-shaped portion 142 on the needle assembly body 40 with the corresponding guide channel 58 in the protective cover body 44), means that the rotational movement of the protective cover body 44 relative to the syringe body 14, particularly along the permissible clockwise circumferential direction C, is subject to rotational movement. CW The rotational motion causes linear motion of the needle assembly body 30 relative to the syringe body 14, and more specifically, causes motion along the proximal axial direction A.P Linear motion.

[0196] Therefore, the above combination allows 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 20 relative to the syringe body 14, to move the adjacent forming portion 140 of the actuator member 132 (i.e., the actuator tube 134) from a shielded position (e.g., as shown in FIG. 13(b)) within the syringe body 14 to an exposed position (e.g., as shown in FIG. 16(b)) in the drug chamber 18 of the syringe body 14.

[0197] More specifically, in the illustrated embodiment, the movement of the shield assembly 42 from the second primary position 240 to the second major position 210 causes the needle assembly body 30 to move in the proximal axial direction A. P The upper part moves towards the syringe body 14 by a first amount, thereby moving the actuator member adjacent forming portion 140 into the drug chamber 18 by a corresponding first amount, as shown, for example, in the transition between Figures 13(b) and 15(b). The movement of the shield assembly 42 from the second main position 210 to the third main position 220 causes the needle assembly body 30 to move along the proximal axial direction A. P The syringe body 14 is moved by a second amount, which is substantially equal to the first amount (since the first angle and the second angle a are also equal), so the adjacent forming portion 140 is moved into the drug chamber 18 by another corresponding second amount, as shown, for example, in the transition between Figures 15(b) and 16(b).

[0198] In other embodiments of the invention (not shown), the abutment forming portion 140 can be moved toward the drug chamber 18 to the desired extent by varying degrees of relative rotational movement between the cover assembly 42 and the syringe 12, or by a single action of moving from the second primary position 240 to the second primary position 210 and from the second primary position 210 to the third primary position 220, for example by a single action caused by changing the connection nature between the needle assembly body 30 and the syringe body 14.

[0199] Furthermore, in the illustrated embodiment, the sliding motion of the actuator member 132 relative to the needle assembly body 30 facilitates the movement of the adjacent forming portion 140 into the drug chamber 18. This sliding motion has a greater frictional resistance than the frictional resistance generated between the actuator member 132 and the syringe body 14, for example, the frictional resistance provided by the frictional engagement of the valve member 12, more specifically its first sealing forming portion 124 and second sealing forming portion 126, with the hollow interior 122 of the needle assembly body 20, for example, the frictional resistance provided by the lighter frictional engagement between the second auxiliary sealing forming portion 144 and the actuator member 132.

[0200] In addition to the above, the pair of opposing wing-shaped forming portions 142 of the needle assembly body 30 are arranged in a coplanar manner, that is, they are located on the same inclined open plane P. BO Inside, needle 32 has a beveled opening 148, which is the chisel tip of needle 32, such as... Figure 7 As shown in the best example.

[0201] Therefore, the aforementioned forced rotation of the needle assembly body 30 via the protective body 44 (i.e., the engagement of the corresponding wing-shaped forming portion 142 on the needle assembly body 30 with the corresponding guide channel 58 in the protective body 44) also implies a rotational movement of the protective body 44 relative to the syringe body 14, particularly along the permissible clockwise circumferential direction C. CW The rotational motion also causes the inclined plane opening plane P to... BO The rotational motion and the inclined opening 148 itself relative to the syringe body 4 in the same clockwise circumferential direction C CW Rotational motion.

[0202] In this way, the plane orientation of the inclined plane opening 148 is determined, i.e., the inclined plane opening plane P. BO Relative to the syringe body 14, and more specifically relative to the natural use axis A of the flange 24 defined by the syringe body 14 NU (like Figure 4 As best shown, the plane orientation of the axis that essentially divides the flange 24 in two is constrained in the desired manner.

[0203] More specifically, the protective assembly 42 in the clockwise circumferential direction C CW The rotational movement from the second primary position 240 to the second primary position 210 (as shown in the transition between Figures 13(c) and 15(c), and then from the second primary position 210 to the third primary position 220 (as shown in the transition between Figures 15(b) and 16(c)) will open the inclined plane P. BO Move to the natural use axis A of flange 24 NU Alignment, as shown in Figure 16(b).

[0204] Inclined opening plane P BO With the natural use axis A of flange 24 NU This alignment is beneficial because it ensures optimal orientation of the beveled opening 148 (i.e., the chisel tip) relative to the flange 24, thereby helping the user to correctly insert the needle 32 into the recipient when the device 10 moves between its application and insertion states, i.e., ensuring optimal orientation of the beveled opening 148 relative to the flange 24 when the device 10 is in its application state (as shown in FIG. 16(c)) and insertion state (as shown in FIG. 17(c)).

[0205] Furthermore, this alignment provides the option to predetermine the orientation of the graduation marks (not shown) on the syringe body 14, for example, by overprinting, to ensure that the graduation marks are presented upwards during use, so that they are easy to read by medical personnel or other healthcare professionals when performing subcutaneous injections.

[0206] In use, the device 10 is configured to operate in the following sequence.

[0207] Referring in particular to Figures 1(a) to 1(d), after the manufacture and assembly of the device 10, it is arranged together with the protective assembly 42 in the primary position 230 relative to the syringe 12, so that it adopts the desired transport state, i.e., the needle 32 is securely encased by the protective assembly 42.

[0208] Optionally, the plunger 16 is fully inserted into the syringe body 14, for example, to reduce the risk of damage during transport of the device 10 to the user. However, as shown in FIG1(c), the needle assembly body 30 and the syringe body 14 are spaced apart at the distal end by a predetermined maximum extent, such that the abutment formation 140 of the actuator member 132 is located in a shielded position within the syringe body 14. Therefore, the plunger 16 cannot act on the abutment formation 140, and at this stage of the operating sequence of the device 10, unintentional and unnecessary activation of the actuator module 110 (and subsequent automatic release of gas from the gas storage volume 114) is prevented.

[0209] After the device 10 is transported, when the device 10 is needed for application, the protective assembly 42 can be moved relative to the syringe 12 to a first primary position 200, as shown in Figures 14(a) to 14(e), for example by sliding the claw member 70 from the first end 76 of the first axial extension groove 74 to its second end 78.

[0210] This sliding of the claw member 70 within the first axial extension groove 74 occurs when the cover assembly 42, more specifically its sealing forming portion 46 and associated sealing member 50 remain in contact (as schematically shown) with the vial 94, and more specifically with the diaphragm (not shown) of the one or more vials, from which the drug 92, or each drug 92, is withdrawn. Therefore, the needle 32 is never exposed to the external environment, and the device 10 can be used in the prepared state shown without external contaminants entering the mechanically closed system of the device 10.

[0211] In this preparation state, the plunger 16 is retracted into the syringe body 14 to draw the required amount of drug into the drug chamber 18, as shown in the corresponding transition from Figures 14(a) and 14(b) to Figures 14(d) and 14.

[0212] Once the drug aspiration is complete, the protective assembly 42 moves relative to the syringe 12 to a second-stage position 240, as shown in Figures 13(a) to 13(c), for example by sliding the claw member 70 back from the second end 78 of the first axial extension groove 74 to its first end 76.

[0213] This sliding of the claw member 70 within the first axial extension groove 74 occurs again, while the cover assembly 42, more specifically its sealing forming portion 46 and associated sealing member 50, remains in contact with the vial 94, so that the needle 32 is similarly prevented from being exposed to the external environment when the cover assembly 42 extends over the needle 32 and when the needle 32 is withdrawn from the vial 94.

[0214] Therefore, the device 10 adopts its ready state, in which the cover assembly 42 encloses the needle 32 and is "ready" to move relative to the syringe 12 to its second primary position 210, thereby adopting its transfer state, as shown in Figures 15(a) to 15(c).

[0215] This movement to the second primary position 210 is achieved by sliding the pawl member 70 from the first end 82 of the circumferential extension groove 80 onto the first unidirectional interlocking forming portion 102 (i.e., the first ratchet tooth 106) and into the locking portion 146 formed between the first ratchet tooth 106 and the second ratchet tooth 108, as most clearly shown in FIG15(c).

[0216] The shape of the first ratchet tooth 106 prevents the pawl member 70 from moving backward along the circumferential extension groove 80, thereby preventing the cover assembly 42 from moving in the counterclockwise circumferential direction C. CCW The device moves backward, which prevents the user from accidentally moving back to the first main position 200 from the second main position 210.

[0217] Meanwhile, the position of the claw member 70 in the circumferential extension groove 80 prevents the protective assembly 42 from being positioned relative to the syringe 12 in the proximal circumferential direction A. P and distal axial direction A D Linear movement in every direction, thus similarly preventing the cover assembly 42 from accidentally retracting and enclosing the needle 32.

[0218] This temporary “locking” of the protective assembly 42 relative to the axis of the syringe 12 advantageously means that, in its transport state, the device 10 is ideally suited for movement, for example from the drug preparation area to the recipient administration area, such as the bedside or other medical environment.

[0219] It should also be noted that the movement of the protective assembly 42 to the second main position 210 will also move the adjacent forming portion 140 of the actuator component 132 into the drug chamber 18 of the syringe body 14 by a preset first amount, as best shown in FIG15(b).

[0220] After the device 10 is transferred to, for example, the recipient administration (application) area described above, the protective assembly 42 moves relative to the syringe 12 to its third main position 220, as shown in Figures 16(a) to 16(c), for example by sliding the claw member 70 from the claw 146 in the circumferential extension groove 80 across the second unidirectionally interoperable forming portion 104 (i.e., the second ratchet tooth 108) to the second end 84 of the circumferential extension groove 80, as... Figure 16c As is most clearly shown in the diagram. Thus, device 10 is in its operational state.

[0221] The shape of the second ratchet tooth 108 prevents the pawl member 70 from moving backward along the circumferential extension groove 80, thereby preventing the cover assembly 42 from rotating counterclockwise in the circumferential direction C. CCW The device moves backward, which prevents the user from accidentally moving back to the second main position 210 from the third main position 220.

[0222] Furthermore, the movement of the protective assembly 42 to the third main position 220 also moves the adjacent forming portion 140 of the actuator member 132 into the drug chamber 18 of the syringe body 14 by a predetermined second amount, as best shown in FIG16(b). Furthermore, as shown in FIG16(c), this movement completes the inclined opening plane P. BO The natural use axis A of the flange 24 defined by the syringe body 14 NU The alignment is such that the beveled opening 148 of the needle 32 (not shown in FIG16(c)) is optimally oriented relative to the flange 24.

[0223] Then, as shown in Figures 17(a) to 17(e), application can begin by moving the protective assembly 42 relative to the syringe 12 to the third stage position 250. This is achieved by sliding the claw member 70 from the second end 84 of the circumferential extension groove 80 to the first end 88 of the second axial extension groove 86, as shown in Figure 17(c).

[0224] This sliding of the claw member 70 within the second axial extension groove 86 occurs when the cover assembly 42, more specifically the seal forming portion 46 and its associated seal member 50, remains in contact with the recipient's body (not shown) (e.g., the recipient's skin). Thus, the needle 32 can be inserted into the recipient, thereby placing the device 10 in the inserted state, and the needle 32 is never exposed to the external environment, thus preventing external contaminants from entering the mechanical closure system of the device 10.

[0225] In this inserted state, the plunger 16 can be further inserted into the syringe body 14 to inject the required amount of drug into the recipient, i.e., as shown by the corresponding transition of the plunger 16 from Figures 17(a) and 17(b) to Figures 17(d) and 17(e).

[0226] As the plunger 16 approaches its furthest insertion depth within the syringe body 14, as shown in Figures 17(d) and 17(e), it engages with the abutment formation 140 of the actuator member 132, and the continued insertion of the plunger 16 proceeds along the distal axial direction A. D Drive the actuator component to move the actuator valve 112 (i.e., valve component 120) toward and into its open position, as shown, for example, in FIG18(b).

[0227] As described above, when the valve component 120 moves to its open position, it releases gas from the gas storage volume 114 of the actuator module 110, and causes the protective assembly 42 to be automatically pushed from the third-stage position 250 to the fourth-stage position 260.

[0228] When the needle 32 is withdrawn from the recipient's body, this pushing of the protective assembly 42 allows the protective assembly 42, more specifically the sealing formation 46 and its associated sealing member 50, to maintain gentle contact with the recipient's body. Therefore, this withdrawal of the needle 32 can be performed without exposing it to the external environment, thus preventing external contaminants from entering the mechanical enclosure system of the device 10, and preventing the escape of the recipient's blood, medication, or vapor concentration from the device 10.

[0229] After the needle is fully withdrawn, for example, from the recipient body, the protective assembly 14 is continuously pushed by releasing gas into the collapsible chamber 128 (i.e., the tubular bellows 130), thereby driving the claw member 70 to move further along the second axial extension groove 86 from its first end 88 to its second end 90, thereby moving the protective assembly 42 to its fourth and final secondary position 260, as shown in Figures 18(a) and 18(b).

[0230] During the movement of the shield assembly 42 to the fourth and final secondary position 260, the latching member 96 is pushed to abut the tip 98 of the needle 32, and as described above, the shield assembly 42 is completely immobile relative to the syringe 12.

[0231] Thus, the device 10 is in its final locked state, in which the needle 32 cannot be exposed, the device 10 cannot be reused, and it will not suffer irreparable damage.

[0232] Figure 21 An exploded isometric view of components of a second needle assembly 300 according to a second embodiment of the present invention is shown. Alternatively, the second needle assembly 300 may be included in the first device 10 described above, replacing the first needle assembly 28, thereby forming a closed system transfer device (not fully shown). As shown, similar features of the device of the second embodiment are indicated using the same reference numerals as those in the first device 10.

[0233] The second needle assembly 300 includes a second actuator module 302, which is similarly configured to selectively push the corresponding protective assembly from a corresponding third-level position associated with the insertion state of the second device to a corresponding fourth-level position associated with the locking state of the second device relative to the corresponding syringe (not shown).

[0234] More specifically, the second actuator module 302 includes a second actuator valve 304 movable between a closed position (e.g., as shown in Figures 22(a) and 23(a)) and an open position (e.g., as shown in Figures 22(b) and 23(b)). In the closed position, gas (not shown) is pressurized in a second gas storage volume 306. In the open position, the second gas storage volume 306 is arranged in fluid communication with a vent duct 308 to release gas from the second gas storage volume 306 and into the interior of a corresponding collapsible container 128 coupled to a corresponding protective assembly.

[0235] As shown in the figure, the ventilation conduit 308 is defined by a hollow conduit member 310, which is securely fixed, for example by welding or other fixing arrangements, in 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 hypodermal injection needle 32 located within the conduit member 310, and is similarly securely fixed at the distal portion 34 of the needle assembly body 30.

[0236] In addition, the hollow duct member 310 has an opening 312 formed therein to define an inlet orifice 314 leading to the ventilation duct 308.

[0237] The needle assembly body 30 of the second needle assembly 300 is preferably connected again to the corresponding syringe body of the second closed system transfer device, more specifically, movably connected, and even more specifically, spirally connected.

[0238] This connection between the needle assembly body 30 and the syringe body similarly maintains fluid communication between the internal conduit 40 of the needle 32 and the corresponding drug chamber within the syringe body.

[0239] Meanwhile, the second actuator valve 304 differs from the first actuator valve 112 described above in conjunction with the first device 10 in that, although the second actuator valve 304 takes the form of a second valve member 316 movably received within the needle assembly body 30 (i.e., within its hollow cavity 122), the second valve member 316 itself defines a second gas storage volume 308.

[0240] More specifically, the second valve member 316 includes an external support forming portion 318 having a hollow interior 320 defining a second gas storage volume 306.

[0241] As best shown in Figures 22(a) and 22(b), the outer support forming portion 318 is formed of an elongated hollow central body 322, preferably having a circular cross-section (but other cross-sectional profiles are also possible), and a first end cap 324 and a second end cap 326 are fixed to the central body 322. Preferably, the second end cap 326 is integrally formed with the central body 322, and the first end cap 324 is bonded to the central body 322 using a UV-curable adhesive (not shown), but other fixing methods are also possible.

[0242] In other embodiments of the invention (not shown), the first end cap and the second end cap may be modified to extend toward each other and be fixed to each other, thereby eliminating the need for a central body.

[0243] In any case, the first end cap 324 is combined with the third sealing forming part 328, and the second end cap 326 is combined with the fourth sealing forming part 330. Both of these sealing forming parts are sealed to the first venting conduit 308, that is, sealed to the conduit member 310 that defines the first venting conduit 308, in order to maintain the sealing integrity of the second gas storage volume 306.

[0244] The first end cap 324 and the second end cap 326 of the external support forming portion 318 and the second valve member 316 are thus combined to form a generally annular second gas storage volume 306, but other shapes of the second gas storage volume are also possible.

[0245] Preferably, each of the third sealing forming portion 328 and the fourth sealing forming portion 330 is formed of (or includes elements formed thereof, such as O-rings or skins) of a relatively soft, elastically deformable material (e.g., natural or synthetic elastomers), while the outer support forming portions 318, such as the central body 322 and each end cap 324, 326, are formed of or include a harder, less deformable material. For example, one or both of the third sealing forming portion 328 and the fourth sealing forming portion 330 may be overmolded onto the corresponding end caps 324, 326 with a thermoplastic elastomer, i.e., an additional layer of thermoplastic rubber material is created.

[0246] Furthermore, the third sealing forming portion 324 and the fourth sealing forming portion 326 are movable relative to the vent duct 308, and more specifically, are slidable (while maintaining seal integrity), so that the second valve member 316 is movable within the needle assembly body 30, and more specifically, is able to move with a small gap within the hollow, substantially annular interior 122 of the needle assembly body 30. However, similarly, this is not necessary; interiors of other shapes and interiors that are only partially hollow are also possible.

[0247] In this manner, the second valve component 316 can move between a closed position (as shown in Figures 22(a) and 23(a)) and an open position (as shown in Figures 22(b) and 23(b)). In the closed position, gas (or other propellant, not shown) is held under pressure in the second gas storage volume 306. In the open position, gas is released from the second gas storage volume 306 so that the needle 30 is shielded by the protective assembly, i.e., completely enclosed or sealed by the needle 30.

[0248] To facilitate this movement of the second valve member 316, a second abutment forming portion 332 is similarly defined, in which the corresponding syringe plunger 16 can abut against the second abutment forming portion 332 in order to move the second valve member 316 from its closed position to its open position.

[0249] Before the drug is injected into the receptor using the second device, the second valve member 316 is in its closed position, as shown in Figures 22(a) and 23(a), and the gas (not shown) is maintained under pressure in the second gas storage volume 306.

[0250] During drug dispensing from the second device, the plunger 16 of the device abuts against the second abutment formation 332 of the second valve member 316, such that the plunger 16 is positioned in the distal axial direction A. D The continued further movement on the upper part additionally begins to move the second valve member 316 relative to the needle assembly body 30 and toward its open position.

[0251] This initial movement of the second valve member 316 toward its open position causes the second valve member 316 to move relative to the conduit member 310, and more specifically, causes the second valve member 316 to slide on the conduit member 310.

[0252] Subsequently, the plunger moves in the distal axial direction A D Further movement of the valve component 316 moves the second valve member 316 to its open position, as shown in Figures 22(b) and 23(b). This puts the second gas storage volume 306 into fluid communication with the vent duct 308, i.e., via the inlet orifice 314 formed in the duct member 310, allowing gas (not shown) to be released from the second gas storage volume 306 and guided in the distal axial direction A. D The airflow into the ventilation duct 308, for example, acts on the collapsible container 128 to expand the container 128, thereby automatically pushing the protective assembly from the corresponding third-level position to and ultimately into the corresponding fourth-level position, in which the needle 30 is shielded by the protective assembly.

Claims

1. A closed-system transfer device, comprising: A syringe having an elongated, hollow syringe body, wherein a plunger is slidably received within the syringe body to define a drug chamber of different sizes depending on the degree of insertion of the plunger within the syringe body; A needle assembly comprising a needle assembly body, a hypodermic needle securely fixed to the needle assembly body, and the needle assembly body being connected to a syringe body to maintain fluid communication between the internal conduit of the hypodermic needle and the drug chamber; and A protective cover assembly having a protective cover body movably connected to the syringe body, thereby allowing the protective cover assembly to be selectively operated to enclose the needle. The protective cover and the syringe body include mutually cooperating forming portions to restrict the movement of the protective cover assembly relative to the syringe through a series of positions corresponding to different operating states of the device.

2. The closed system transfer device according to claim 1, characterized in that, The protective cover is movably connected to the syringe body so as to move linearly along the length of the syringe body in the axial direction and rotate around the outside of the syringe body in the circumferential direction.

3. The closed system transfer device according to claim 1 or 2, characterized in that, The series of locations includes two or more of the following: The first primary position corresponds to the preparation state of the device, in which one or more drugs can be drawn from the vial into the drug chamber; The second primary position corresponds to the transfer state of the device, in which the protective assembly encloses the needle and the movement of the protective assembly relative to the syringe is suppressed to prevent the needle from being exposed outside the protective assembly; as well as The third principal position corresponds to the application state of the device, in which the needle can be inserted into the receptor and some or all of the contents of the drug chamber are injected into the receptor.

4. The closed system transfer device according to claim 3, characterized in that, The position of the protective assembly relative to the syringe is selectively restricted to a single position among the first primary position, the second primary position, or the third primary position.

5. The closed system transfer device according to claim 3, characterized in that, The mating portions of the protective cover and the syringe body are also configured to allow movement between the series of main positions in a single sequence only.

6. The closed system transfer device according to claim 5, characterized in that, The single sequence includes the first primary position, followed by the third primary position.

7. The closed system transfer device according to claim 6, characterized in that, The single sequence includes the first primary position, followed by the second primary position, and then the third primary position.

8. The closed-system drug transfer device according to any one of claims 5 to 7, characterized in that, At least two main positions are formed by at least one unidirectionally cooperating part.

9. The closed system transfer device according to any one of claims 3 to 8, characterized in that, The series of locations also includes one or more of the following: The first primary position corresponds to the transport state of the device, in which the protective assembly encloses the needle but can move toward the first primary position; The second-level position corresponds to the ready state of the device, in which the drug chamber contains one or more drugs, and the protective assembly encloses the needle but is movable toward the second primary position; The third-level position corresponds to the insertion state of the device, in which the needle is located within the recipient. as well as The fourth secondary position corresponds to the locked state of the device, in which the protective assembly encloses the needle and cannot move relative to the syringe.

10. The closed system transfer device according to claim 9, characterized in that, The series of positions includes a fourth secondary position corresponding to the locked state of the device, in which the protective assembly encloses the needle and is immobile relative to the syringe. The protective assembly further includes a resiliently biased latching member that is pushed to abut the needle tip when the protective assembly moves relative to the syringe to the fourth secondary position. Thereby, the mutually cooperating portions of the protective body and the syringe body further engage with the latching member to suppress linear movement of the protective assembly relative to the syringe.

11. The closed system transfer device according to any one of the preceding claims, characterized in that, The mutually cooperating forming parts of the protective cover body and the syringe body are male forming parts and female forming parts, or include male forming parts and female forming parts.

12. The closed system transfer device according to claim 11, characterized in that, The male forming portion is an elastically biased claw member or includes an elastically biased claw member, and the female forming portion is a plurality of grooves or includes a plurality of grooves, wherein the claw member is biased into the grooves.

13. The closed system transfer device according to claim 12, characterized in that, The female forming portion includes a first axial extending groove, a circumferential extending groove extending from one end of the first axial extending groove, and a second axial extending groove intersecting with the end of the circumferential extending groove opposite to the end that coincides with the end of the first axial extending groove.

14. The closed system transfer device according to claim 13, characterized in that, One or more of the following: The first end of the first axial extension groove defines the first stage position and the second stage position, the first end being the end from which the circumferential extension groove extends; The second end of the first axially extending groove, opposite to the first end, defines a first principal position; The second principal position is located along the circumferential extension groove; the second end of the circumferential extension groove defines the third principal position, and the second end of the circumferential extension groove is the end that intersects with the second axial extension groove; The first end of the second axial extension groove defines the third stage position, and the first end of the second axial extension groove is the end closest to the opening end of the syringe body; and The second end of the second axially extending groove, opposite to the first end, defines a fourth secondary position.

15. The closed system transfer device according to claim 9 or any one of the claims dependent on claim 9, characterized in that, The needle assembly includes an actuator module configured to selectively push the protective assembly from a third-level position corresponding to an insertion state of the device to a fourth-level position corresponding to a locked state of the device, wherein in the insertion state the needle is located within the recipient, and in the locked state the protective assembly encloses the needle and is immobile relative to the syringe.

16. The closed system transfer device according to claim 15, characterized in that, The actuator module includes an actuator valve that is actuable between a closed position and an open position, wherein in the closed position, gas is held under pressure in a gas storage volume, and in the open position, gas is released from the gas storage volume to push the protective assembly from the third-level position toward the fourth-level position.

17. The closed system transfer device according to claim 16, characterized in that, The actuator valve moves to the open position to fluidly communicate the gas storage volume with the vent port to release gas from the gas storage volume. The vent port is in fluid communication with a foldable chamber that is sealed between the needle assembly and the cover assembly. Thus, gas is released from the gas storage volume through the vent port into the foldable chamber, causing the chamber to expand in the axial direction, thereby pushing the cover assembly from the third-stage position to the fourth-stage position.

18. The closed system transfer device according to claim 16 or 17, characterized in that, The actuator valve is a valve member or includes a valve member that is slidably accommodated within the needle assembly body and is formed to define the gas storage volume.

19. The closed system transfer device according to claim 18, characterized in that, The valve component itself defines the gas storage volume.

20. The closed system transfer device according to claim 19, characterized in that, The valve component includes an external support forming portion having a hollow interior that defines the gas storage volume.

21. The closed system transfer device according to claim 18, characterized in that, The valve component mates with the needle assembly body to define the gas storage volume therebetween.

22. The closed system transfer device according to claim 21, characterized in that, The valve component includes a first sealing portion and a second sealing portion that are axially spaced apart, forming an annular gas storage volume between the sealing portions.

23. The closed system transfer device according to any one of claims 16 to 22, characterized in that, The actuator module further includes an elongated actuator member slidably received within the needle assembly body and securely attached to the actuator valve to move the actuator valve from its closed position to its open position. The end of the actuator member defines an abutment formation that the syringe plunger can abut against. Thus, in a later stage of plunger insertion into the hollow syringe body, continued insertion of the plunger drives the actuator member axially, thereby moving the actuator valve from its closed position toward its open position, which in turn pushes the protective assembly from the third-stage position to the fourth-stage position.

24. The closed system transfer device according to claim 23, characterized in that, The needle assembly body is movably connected to the syringe body, and selective movement of the needle assembly body relative to the syringe body moves the actuator member abutment forming portion into the drug chamber of the syringe body.

25. The closed system transfer device according to claim 24, characterized in that, The selective movement of the needle assembly body relative to the syringe body also moves one or both of the following: (i) the plane of the bevel opening coplanar with the bevel opening of the hypodermic needle; (ii) Scale markings aligned with the natural use axis of the flange defined by the syringe body.

26. The closed system transfer device according to claim 24 or 25, characterized in that, The needle assembly body is helically connected to the syringe body and constrained to rotate by the cover body, thereby enabling the movement of the cover assembly from at least one of the second primary position to the second primary position and from the second primary position to the third primary position to achieve one or more of the movement of the actuator member adjacent forming portion into the drug chamber, and the movement of the inclined opening plane and / or the scale markings aligned with the natural use axis of the flange.

27. A method of using a closed system transfer device according to any one of the preceding claims, comprising the step of moving the protective 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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