Needle assembly with propellant-operated needle shrouding

Abstract

In the field of medical sharps, particularly subcutaneous injection needles, there is a need for improved needle assemblies. A needle assembly (10;80;100;110;120;130) for engaging with a syringe (58;90) having an elongated hollow syringe body (56) in which a plunger (34;88) is slidably received comprises a needle assembly body (12) having a subcutaneous injection needle (14) coupled to the needle assembly body (12) and extending from the distal end (16) of the needle assembly body (12). The needle assembly (10;80;100;110;120;130) also includes an actuator valve (18;132) movably received within the needle assembly body (12) and formed to define a propellant storage space (22;122). The actuator valve (18;132) is movable between a closed position in which the propellant is held under pressure in the propellant storage space (22;122) and an open position in which the propellant is released from the propellant storage space (22;122) and causes the needle (14) to shroud.

Description

Detailed Description of the Invention

[0001] The present invention relates to a needle assembly for engaging with a syringe, a method of using such a needle assembly, and an injection device including such a needle assembly.

[0002] Sharps contaminated with human infected blood, particularly subcutaneous needles, can transmit more than 20 diseases, including hepatitis B, hepatitis C, and the human immunodeficiency virus (HIV). As a result of this transmission risk, needle stick injuries can cause mental labor and stress to thousands of people who have been exposed to them.

[0003] According to a first aspect of the present invention, a needle assembly for engaging with a syringe having an elongated hollow syringe body in which a plunger is slidably received, In a needle assembly body, the needle assembly body having a subcutaneous needle coupled to the needle assembly body and extending from a distal end of the needle assembly body, Active An actuator valve movably received within the needle assembly body and formed to define a propellant storage space, Comprising, The actuator valve is movable between a closed position in which the propellant is held under pressure in the propellant storage space and an open position in which the propellant is released from the propellant storage space to cause shrouding of the needle, A needle assembly is provided. S

[0004] The selective shrouding of the needle, i.e., the shrouding of the needle after movement of the actuator valve to its open position, is highly advantageous because it helps to prevent needle stick injuries, for example, after use of an injection device of which the needle assembly of the present invention forms part, by enclosing or containing the needle in such a manner.

[0005] In contrast, by including an actuator valve of the above type, particularly by using a pressurized propellant to cause needle shrouding, a suitable driving force for achieving such shrouding is preferably provided, provided that the driving force gradually increases from an initial low level to a higher level in order to apply a gentle biasing force using a certain degree of elasticity. This is in contrast to a mere mechanical actuator such as a spring, which typically has an operating mode with much lower tolerance because it often transitions from an initial high force to a lower force over time. Such a mechanical actuator is also prone to mechanical creep over time, which reduces its effectiveness over time and potentially makes it unreliable.

[0006] Additionally, providing a gradually increasing driving force reduces the likelihood that any residual drug will be inadvertently discharged from the internal conduit of the needle as the needle of the assembly is shrouded during use, i.e., it reduces the risk of the drug "spraying" as the needle assembly transitions to a shrouded configuration. Part of this risk typically has a tendency to occur with some devices, such as retractable needle devices, with mechanical actuators that produce sudden movements and much higher accelerations when not providing a gradually increasing driving force.

[0007] The actuator valve of the present invention also allows for easy adjustment in terms of both the overall magnitude and the rate of application of the driving force applied to cause shrouding by modifying the stored enthalpy, i.e., the initial internal energy, of the pressurized propellant.

[0008] Also, by forming the actuator valve to define a propellant storage space, it is allowed to adjust the size of the propellant storage space according to the requirements of the needle assembly and / or the characteristics of the propellant held by the needle assembly.

[0009] Preferably, the actuator valve itself defines the propellant storage space.

[0010] By defining the propellant storage space within the actuator valve itself, the number of sealing structures required to maintain the integrity of the seal of the propellant storage space is limited, thus advantageously resulting in a proportional reduction in the risk of leakage occurring through one or more such structures.

[0011] Additionally, reducing the number of sealing structures preferably also reduces the amount of force required to move, i.e., operate, the actuator valve against the resistance that such sealing structures might otherwise impose.

[0012] Optionally, the actuator valve includes an external support structure having a hollow interior that defines the propellant storage space.

[0013] This arrangement allows the actuator valve to be easily manufactured while providing the aforementioned benefits, and enables the propellant storage space to be pre-filled once the needle assembly of the present invention is assembled.

[0014] The actuator valve may cooperate with the needle assembly body to define a propellant storage space between the actuator valve and the needle assembly body.

[0015] This type of configuration provides further options for adjusting the size of the propellant storage space.

[0016] Preferably, the actuator valve includes a first sealing structure spaced apart in the axial direction and a second sealing structure spaced apart in the axial direction, with a propellant storage space formed between the first sealing structure and the second sealing structure.

[0017] The propellant storage space may have an annular shape.

[0018] These features, for example, provide further size adjustment options while also helping to ensure that the propellant can be easily released from the propellant storage space when the actuator valve moves to its open position.

[0019] Optionally, the actuator valve may have a defined contact structure against which the syringe plunger makes contact during use, moving the actuator valve from its closed position to its open position.

[0020] Having an actuator valve with such a contact structure is advantageous in that, during use, the continuous insertion of the plunger into the syringe body of the syringe engaged with the needle assembly of the present invention is converted into the opening of the actuator valve, thereby allowing the propellant to be released from the propellant storage space and consequently causing the needle to shroud. Thereafter, such an actuator valve provides the option to influence the operation of the actuator valve, i.e., opening and thereby automatic shrouding of the needle, preferably by utilizing the continuous operation of an injection device in which the needle assembly is incorporated, for example, the continuous injection of a drug into a recipient.

[0021] In a preferred embodiment of the present invention, the movement of the actuator valve to the open position is arranged to fluidly communicate with a vent conduit configured to direct the released propellant flow in one or both of the distal axial and proximal axial directions, thereby connecting the propellant storage space to the proximal axial direction.

[0022] The movement of the actuator valve to the open position may be arranged to fluidly communicate with a first vent conduit, which extends the propellant storage space in the proximal axial direction and directs the released propellant flow in the proximal axial direction.

[0023] The movement of the actuator valve to the open position may be arranged to fluidly communicate with a second vent conduit, which extends the propellant storage space in the distal axial direction and directs the released propellant flow in the distal axial direction.

[0024] The ability to direct the released propellant flow distally axially preferably provides a first driving force that enables, for example, extending the shield above the needle to achieve the required shrouding, while the ability to direct the released propellant flow proximal axially preferably provides a second driving force, essentially opposite to the first driving force, that enables retracting the needle into the needle assembly body, thereby shrouding the needle by the aforementioned assembly body.

[0025] Preferably, the second ventilation conduit extends through the needle assembly body.

[0026] Such a configuration preferably achieves the required directionation of the propellant flow in the distal axial direction.

[0027] In another preferred embodiment of this invention, a second vent conduit is additionally arranged to be in fluid communication with the first vent conduit, thereby, when the actuator valve moves to the open position, the propellant storage space is arranged to be in fluid communication with the first vent conduit via the second vent conduit.

[0028] Optionally, the first vent conduit is further configured to extend distally axially, thereby directing the released propellant flow simultaneously in both proximal and distal axial directions when the actuator valve moves to its open position.

[0029] Each of the aforementioned configurations advantageously provides both the first and second driving forces, thereby beneficially creating the option to achieve needle shrouding, for example, by using a combination of shield extension and needle retraction.

[0030] Preferably, when the actuator valve moves to a first open position, the propellant storage space is configured to be in fluid communication with either the first or second vent conduit, and when the actuator valve moves to a second open position, the propellant storage space is configured to be in fluid communication with both the first and second vent conduits.

[0031] The actuator valve has a first open position and a second open position, which preferably provides the option to initiate one shrouding mode first, such as shield extension or needle retraction, before both shrouding modes occur, thus anticipating adjustment of different types of shrouding.

[0032] In a further preferred embodiment of the present invention, the first vent conduit extends between the actuator valve and the needle and terminates at its proximal end, and the first drive member, fixedly attached to the needle, is in a sealed contact state with respect to the proximal end, thereby the propellant released into the first vent conduit and directed to flow in the proximal axial direction acts on the first drive member to move the first drive member and the needle fixedly attached to the first drive member in the aforementioned proximal axial direction.

[0033] Such driving of the needle in the proximal axial direction is desirable because it allows the needle to retract into the needle assembly body.

[0034] In contrast, by including a first drive member configured to be in a sealed contact state at the proximal end of the first vent conduit, it is advantageous to provide a method for converting the flow of the released propellant into the aforementioned first vent conduit into the aforementioned desired movement of the needle in the proximal axial direction.

[0035] The first ventilation conduit may be defined by a hollow conduit member fixedly attached to the needle assembly body at its distal end, within which the needle is axially movable.

[0036] The inclusion of such a hollow conduit member provides a conduit that extends in the proximal axial direction and thus can advantageously direct the released propellant flow in that proximal axial direction.

[0037] Preferably, the hollow conduit member has a first opening formed therein, defining an inlet hole to the first ventilation conduit.

[0038] By providing an inlet hole for the first ventilation conduit, for example, when the actuator valve moves toward the open position, selective introduction of the released propellant into the first ventilation conduit is expected.

[0039] Optionally, the actuator valve is slidable above the conduit member, and the first drive member is spaced inward from the proximal end of the needle to define the proximal needle portion, thereby, the movement of the actuator valve toward the open position additionally exposes the proximal needle portion beyond the actuator valve.

[0040] Such a configuration is beneficial because it anticipates exposure of the proximal needle portion during the operation of the actuator valve, thus providing the proximal needle portion with the option to support the functionality of the needle assembly, such as the continuous movement of the needle in the proximal axial direction.

[0041] In a more preferred embodiment of the present invention, the proximal needle portion cooperates with a second drive member configured to occlude the hollow syringe body of the syringe with which the needle assembly engages during use, thereby, after the initial movement of the first drive member and the needle in the proximal axial direction, a propellant directed to flow proximal through a first conduit additionally acts on the second drive member to continue the movement of the needle in the proximal axial direction.

[0042] The inclusion of a second drive member helps ensure that all of the propellant, which is released into the first vent conduit and directed to flow in the proximal axial direction, can be used to generate movement of the needle, also in the proximal axial direction.

[0043] The needle assembly can engage with a syringe having an improved plunger configured to support the second drive member before it comes into contact with the contact structure of the actuator valve, and to fix the second drive member to the proximal needle portion.

[0044] By providing such an improved plunger, it is desirable to help ensure that the second drive member is fixedly attached to the proximal needle portion only immediately before assisting in moving the needle in the proximal axial direction.

[0045] Preferably, the second drive member and the improved plunger include a mutually cooperative structure for selectively fixing the second drive member and the improved plunger to each other.

[0046] Such a structure also has the advantage of facilitating the desired support of the second drive member by the improved plunger, and, when necessary, the fixing of the second drive member to the proximal needle portion.

[0047] Optionally, at least one of the interconnected structures is elastically deformable.

[0048] By including at least one elastically deformable and cooperative structure, selective separation of the second drive member from the improved plunger is conveniently permitted, for example, when the needle is moved in the proximal axial direction using the second drive member, and it is not desired to move the improved plunger in the same direction.

[0049] In another preferred embodiment of the present invention, the released propellant, directed to flow distally axially, is further directed into a foldable chamber sealed and fixed to the needle assembly body, thereby causing the release of the propellant from the propellant storage space into the foldable chamber to result in the expansion of the chamber in the distal axial direction.

[0050] Such expansion of the chamber in the distal axial direction is desirable because the expansion allows the chamber to extend, at least partially, above the needle, i.e., to shroud the needle.

[0051] Therefore, such a foldable chamber also advantageously provides a method for converting the flow of the propellant in the distal axial direction into the aforementioned desirable movement of the chamber in the distal axial direction.

[0052] The foldable chamber can be sealed and fixed between the needle assembly body and the shield assembly, so that the release of propellant from the propellant storage space into the foldable chamber via the second vent conduit results in distal axial expansion of the chamber, as well as distal axial biasing of the shield assembly above the needle.

[0053] The movement of the shield assembly above the needle, that is, completely surrounding the needle and thereby shrouding it, provides further protection from the needle, for example, from needle stick wounds.

[0054] A second aspect of the present invention provides a method for using the needle assembly described herein, the method comprising moving an actuator valve between a closed position in which the propellant is held under pressure in a propellant storage space and an open position in which the propellant is released from the propellant storage space, causing the needle to shroud.

[0055] According to a third aspect of the present invention, an injection device comprising the needle assembly described above is provided herein.

[0056] The second and third aspects of the present invention share the benefits of the corresponding features of the assembly of the present invention.

[0057] It should be recognized that the use of terms such as “first” and “second” in this patent specification is intended merely to aid in distinguishing between similar features, and is not intended to indicate the relative importance of one feature to another unless otherwise specified.

[0058] Within the scope of this application, the various aspects, embodiments, examples, and alternatives presented in the preceding paragraphs, the claims, and / or the following specification and drawings, and in particular their individual features, are expressly intended to be dealt with individually or in any combination. That is, all embodiments, and all features of all embodiments, can be combined in any manner and / or combination, provided that such features are not incompatible. The applicant reserves the right to modify any of the original claims or to file any new claims accordingly, including the right to amend any of the original claims, even if not originally claimed in that manner, to make them dependent on any other claim and / or to incorporate any features of any other claim.

[0059] Next, a brief description of preferred embodiments of the present invention follows below, with reference to the following figures, in non-limiting examples. [Brief explanation of the drawing]

[0060] [Figure 1] A perspective view of a needle assembly according to a first embodiment of the present invention is shown. [Figure 2] Figure 1 shows a schematic cross-sectional view of a needle assembly as part of an injection device according to another embodiment of the present invention. [Figure 3A] Figures 3(a) to 3(c) show enlarged schematic cross-sectional views of a portion of the needle assembly shown in Figure 1. [Figure 3B] Figures 3(d) to 3(e) show enlarged schematic cross-sectional views of a portion of the needle assembly shown in Figure 1. [Figure 4] Figures 4(a) to 4(c) show enlarged schematic cross-sectional views of a portion of a needle assembly according to a second embodiment of the present invention. [Figure 5A] Figures 5(a) and 5(b) show enlarged schematic cross-sectional views of a portion of a needle assembly according to a third embodiment of the present invention. [Figure 5B] Figures 5(c) to 5(d) show enlarged schematic cross-sectional views of a portion of a needle assembly according to a third embodiment of the present invention. [Figure 6A] Figures 6(a) and 6(b) show enlarged schematic cross-sectional views of a portion of a needle assembly according to a fourth embodiment of the present invention. [Figure 6B] Figures 6(c) to 6(d) show enlarged schematic cross-sectional views of a portion of a needle assembly according to a fourth embodiment of the present invention. [Figure 7A] Figures 7(a) to 7(c) show enlarged schematic cross-sectional views of a portion of a needle assembly according to a fifth embodiment of the present invention. [Figure 7B] Figures 7(d) to 7(e) show enlarged schematic cross-sectional views of a portion of a needle assembly according to a fifth embodiment of the present invention. [Figure 8] Figures 8(a) and 8(b) show schematic cross-sectional views of a portion of a needle assembly according to a sixth embodiment of the present invention. [Figure 9] Figures 8(a) and 8(b) show exploded views of the actuator valve, which forms part of the needle assembly shown. [Modes for carrying out the invention]

[0061] A needle assembly according to a first embodiment of the present invention is generally referred to by reference numeral 10, as shown in Figure 1 and in Figures 2 and 3(a) to 3(e).

[0062] The first needle assembly 10 is a needle assembly body 12, which is coupled to the needle assembly body 12 and extends distally axially A from the distal end 16 of the needle assembly body 12 D It includes a needle assembly body 12 having subcutaneous injection needles 14 extending thereto (not all of which are shown in Figures 3(a) to 3(e)).

[0063] The needle assembly 10 also includes a first actuator valve 18, which is movably received within the needle assembly body 12, more specifically, slidably received within a hollow, substantially annular interior 20 of the needle assembly body 12, provided that the interior 20 does not necessarily have to be hollow and substantially annular, but may be of other shapes, or partially hollow.

[0064] In any case, the actuator valve 18 works in cooperation with the needle assembly body 12, that is, the hollow interior 20 of the needle assembly body 12, to define the propellant storage space 22 located between the actuator valve 18 and the needle assembly body 12.

[0065] More specifically, the actuator valve 18 includes a first sealing structure 24 spaced axially apart and a second sealing structure 26 spaced axially apart, with a propellant storage space 22 formed between the first sealing structure 24 and the second sealing structure 26. Assuming the needle assembly body 12 has an annular hollow interior 20, the first sealing structure 24 and the second sealing structure 26 are substantially ring-shaped in order to cooperate in a sealing manner with such hollow interior 20, and the resulting propellant storage space 22 is also annular in shape. However, propellant storage spaces of other shapes are possible.

[0066] Preferably, each sealing structure 24, 26 is formed of a relatively flexible and elastically deformable material (e.g., a natural elastomer or a synthetic elastomer) (or includes an element formed of such material (e.g., an O-ring or outer shell 28)), while the needle assembly body 12, or at least the portion of the needle assembly body 12 defining the hollow interior in which the actuator valve 18 resides, is formed of or includes a harder, less deformable material. In such a situation, the internal support structure 30 of the actuator valve 18 may be formed of or include a similar, less deformable material.

[0067] In other embodiments, the needle assembly body, or at least the portion of the needle assembly body defining the hollow interior in which the actuator valve resides, may instead be formed of a relatively flexible and elastically deformable material, or may include such a material, and each sealing structure may be formed of a harder, less deformable material (or may include elements formed of such a material).

[0068] In addition to the foregoing, the actuator valve 18 is movable between a closed position, as shown in Figures 2 and 3(a), in which propellant (not shown) is held under pressure in the propellant storage space 22, and an open position, as shown in Figure 3(d), in which the propellant is released from the propellant storage space 22, resulting in the shrouding, i.e., complete containment or accommodation, of the needle 14, as shown in Figure 3(e) and as will be described in more detail below.

[0069] Preferably, the propellant is a gas, such as a hydrofluoroalkane such as Solkane®, more specifically Solkane® 227ea, but other propellants may be used. Additionally, the propellant, such as a gas, may be in the liquid or gas phase when held under pressure in the propellant storage space 22, for example, at ambient temperature or room temperature.

[0070] Additionally, the actuator valve 18 defines a structure 32, as will be described in more detail below, and the first syringe plunger 34 can come into contact with the contact structure 32 during use to move the actuator valve 18 from its closed position to its open position.

[0071] The first needle assembly 10 is positioned in the proximal axial direction A P In addition to extending to the aforementioned proximal axial direction A, the released propellant flow is directed towards the same direction as above. P It also includes a first ventilation conduit 36 ​​configured to direct airflow.

[0072] More specifically, the first vent conduit 36 ​​extends between the actuator valve 18 and the needle 14 and terminates at a proximal end 38, and more specifically, in the shown embodiment, is fixedly attached to the needle assembly body 12 at a distal end 42, and the needle 14 is axially oriented within it, for example, at least in the proximal axial direction A P This is defined by a movable, hollow conduit member 40. The hollow conduit member 40 also has a first opening 44 formed therein, which defines the inlet hole 46 of the first ventilation conduit 36.

[0073] However, other types and configurations of the first ventilation conduit are possible.

[0074] Returning to the shown embodiment, the first drive member 48 is fixedly attached to the needle 14 and spaced inward from the proximal end 50 of the needle 14, defining the proximal needle portion 52. The first drive member 48 is in sealed contact with the proximal end 38 of the first vent conduit 36 ​​and is selectively held there by the actuator valve 18, more specifically, in the shown embodiment, by a relatively flexible and elastically deformable outer sheath 28 of the actuator valve 18.

[0075] The proximal needle portion 52 is capable of cooperating with a second drive member 54, which is configured to occlude, i.e., fluid-seal, the hollow syringe body 56 of the first syringe 58 with which the needle assembly 10 engages during use.

[0076] More specifically, the first syringe 58 has a first improved plunger 34 configured to carry a second drive member 54, and more specifically, the first improved plunger 34 and the second drive member 54 include mutually cooperative structures 60, 62 for selectively fixing the second drive member 54 and the first plunger 34 to each other. Each of the mutually cooperative structures 60, 62 is elastically deformable, but is not necessarily required to be so, and in the shown embodiment, when such elastic deformation occurs, it takes the form of chamfered flaps 64, 66, respectively, which are able to slide over each other. However, other types of mutually cooperative structures are possible.

[0077] The use of the first needle assembly 10 in conjunction with the first syringe 58 having a syringe body 56 and a first improved plunger 34 (to define an injection device 150 according to one embodiment of the present invention) is schematically illustrated in Figures 3(a) to 3(e) and described below.

[0078] As shown in Figures 2 and 3(a), before using the first injection device 150, for example, before using the injection device 150 to inject a drug (not shown) into a recipient, the actuator valve 18 is in its closed position, the propellant (not shown) is held under pressure in the propellant storage space 22, and the first improved plunger 34 is separated from the actuator valve 18.

[0079] When it is desired to quantitatively supply a drug from the injection device 150, the user, for example, a medical technician or other healthcare worker, moves the first plunger 34 distally axially A in a known manner. DMove it to drive a drug (not shown) out of the hollow syringe body 56 via the needle 14. In the distal axis direction A of the first plunger 34 D Due to such movement in the distal axis direction A, for example, as shown in FIG. 3(b), the first plunger 34 is brought into contact with the contact structure 32 of the actuator valve 18.

[0080] After that, the continuous further movement of the first plunger 34 in the distal axis direction A D additionally causes the actuator valve 18 to start moving with respect to the needle assembly body 12, as shown in FIG. 3(c), and thus causes the actuator valve 18 to start moving towards its open position.

[0081] Such an initial movement of the actuator valve 18 towards its open position also causes the actuator valve 18 to move with respect to the conduit member 40. More specifically, the actuator valve 18 is slid above the conduit member 40, which means that the first drive member 48 is passed through the actuator valve 18, more specifically, through the flexible outer skin 28 of the actuator valve 18, in the proximal axis direction A to expose the proximal needle portion 52 beyond the actuator valve 18. P Also, in order to fixedly attach the needle 14 and the second drive member 54 to each other, as the proximal needle portion 52 is exposed beyond the actuator valve 18, it is driven to press-fit with the second drive member 54.

[0082] As shown in FIG. 3(d), the further movement of the first plunger 34 in the distal axis direction A D subsequently moves the actuator valve 18 to its open position.

[0083] Such movement of the actuator valve 18 to its open position is arranged so that the propellant storage space 22 is in fluid communication with the first ventilation conduit 36, that is, through the connecting conduit 68 formed in the support structure 30 of the actuator valve 18 and the inlet hole 46 formed in the conduit member 40, thereby releasing the propellant (highlighted in Figure 3(d)) from the propellant storage space 22 and the proximal axial direction A P The air is directed to flow along the first ventilation conduit 36 ​​toward its proximal end 38 and in contact with the first drive member 48.

[0084] Simultaneously, the movement of the actuator valve 18 to its open position separates the second drive member 54 from the first improved plunger 34, that is, by pushing its deformable, chamfered return fins 64, 66 above each other.

[0085] As a result, as shown in Figure 3(e), the released propellant (highlighted) acts upon the first drive member 48, causing the first drive member 48 to move in the proximal axial direction A P It is biased, that is, moved, and then the needle 14, which is fixedly attached to the first drive member 48, also moves in the proximal axial direction A P This will result in initial movement in [location].

[0086] Furthermore, once the first drive member 48 and the needle 14 are in the proximal axial direction A P After this initial movement, if the propellant leaks past the first drive member 48 and beyond the proximal end 38 of the first ventilation conduit 36, the propellant additionally acts on the second drive member 54, causing the needle 14 to move in the proximal axial direction A P The movement in the needle continues, thereby completing the desired degree of retraction (not shown) of the needle 14 within the needle assembly 10 and the associated syringe body 56.

[0087] A needle assembly according to a second embodiment of the present invention is generally referred to by reference numeral 80, as shown in Figures 4(a) to 4(c).

[0088] The second needle assembly 80 shares many features with the first needle assembly 10, and such features are identified by the same reference number.

[0089] However, the second needle assembly 80 differs from the first needle assembly 10 in that it includes a second vent conduit 82 instead of the first vent conduit, and the second vent conduit 82 is located in the distal axial direction A D In addition to extending to the aforementioned distal axial direction A, the released propellant flow is directed towards the distal axial direction A. D It is configured to direct in that direction.

[0090] More specifically, the second vent conduit 82 extends through the needle assembly body 12 and directs the released propellant flow into a foldable chamber 84 sealed and fixed to the needle assembly body 12. The foldable chamber 84 may additionally be sealed and fixed between the needle assembly body 12 and a shield assembly (not shown).

[0091] Additionally, the second needle assembly 80 omits the first drive member and instead includes a plug member 86, which is similarly fixedly attached to the needle 14 and spaced inward from the proximal end 50 of the needle 14 to define the proximal needle portion 52, but does not act to move the needle 14 under the action of the released propellant. Rather, the plug member 86 simply closes the conduit member 40 that houses the needle 14.

[0092] The proximal needle portion 52 in the second needle assembly 80 is also directly compatible with the second improved plunger 88 of the second syringe 90, and the second needle assembly 80 is engageable with the second syringe 90 in use, defining an injection device 160 according to yet another embodiment of the present invention. The second improved plunger 88 differs slightly from the first improved plunger 34 in the first needle assembly 10 in that it merely includes a receiving structure 92 configured to receive the proximal needle portion 52 rather than carrying a second drive member.

[0093] While the operation, i.e., use, of the second needle assembly 80 shares some similarities with that of the first needle assembly 10, there are also differences, as described below in this specification.

[0094] Therefore, as shown in Figure 4(a), before using the second injection device 160 in which the second needle assembly 80 is positioned, the actuator valve 18 is also in its closed position, the propellant (not shown) remains held under pressure in the propellant storage space 22, and the second improved plunger 88 is separated from the actuator valve 18.

[0095] When it is again desired to supply a quantitative amount of drug from the second injection device 160, the user moves the second plunger 88 distally axially A in a known manner. D The second plunger 88 is moved to drive the drug (not shown) out of the hollow syringe body 56 via the needle 14. The distal axial direction A D Due to this movement, for example, as shown in Figure 4(b), the second plunger 88 is brought into contact with the contact structure 32 of the actuator valve 18.

[0096] Subsequently, the distal axis A of the second plunger 34 D Further continuous movement in this position additionally causes the actuator valve 18 to begin moving relative to the needle assembly body 12, and thus causes the actuator valve 18 to begin moving toward its open position.

[0097] Such initial movement of the actuator valve 18 toward its open position also results in movement of the actuator valve 18 relative to the conduit member 40, more specifically, causing the actuator valve 18 to slide again above the conduit member 40, which in turn causes the plug member 86 to move via the actuator valve 18, that is, via the flexible outer casing 28 of the actuator valve, in the proximal axial direction A, in order to expose the proximal needle portion 52 beyond the actuator valve 18. P It is pressed against. Furthermore, as the proximal needle portion 52 is exposed beyond the actuator valve 18, it is received within the receiving structure 92 of the second improved plunger 88.

[0098] As shown in Figure 4(c), the distal axis A of the second plunger 88 D Further movement in this position then moves the actuator valve 18 to its open position.

[0099] Such movement of the actuator valve 18 to its open position positions the propellant storage space 22 in fluid communication with the second vent conduit 82, thereby releasing the propellant (highlighted in Figure 4(c)) from the propellant storage space 22 and the distal axial direction A D The air is directed to flow into the foldable chamber 84 via the second ventilation conduit 82.

[0100] The release of the propellant (highlighted) from the propellant storage space 22 into the folding chamber 84 occurs in the distal axial direction A above the needle 14 of the chamber 84. D This results in expansion, thereby causing the needle 14 to be covered to the desired degree by the foldable chamber 84, i.e., shrouded.

[0101] Furthermore, in an embodiment in which the foldable chamber is sealed and fixed between the needle assembly body and the shield assembly (not shown), the release of the propellant from the propellant storage space into the foldable chamber via the second ventilation conduit is in the distal axial direction A above the needle of the shield assembly. DThis bias also occurs, causing the needle to be shrouded by the shield assembly to the desired degree.

[0102] A needle assembly according to a third embodiment of the present invention is generally referred to by reference numeral 100, as shown in Figures 5(a) to 5(d).

[0103] The third needle assembly 100 shares many features with the first needle assembly 10 and the second needle assembly 80, and such features are identified by the same reference number.

[0104] In this regard, the third needle assembly 100 includes both the first vent conduit 36 ​​and the second vent conduit 82, but differs from the first needle assembly 10 and the second needle assembly 80 in that the second vent conduit 82 is additionally arranged to fluidly communicate with the first vent conduit 36, thereby, when the actuator valve 18 moves to its open position, as shown in Figures 5(c) and 5(d), the propellant storage space 22 is arranged to fluidly communicate with the first vent conduit 36 ​​via the second vent conduit 82. In the shown embodiment, the folding chamber 84 fluidly interconnects the second vent conduit 82 with the open distal end 102 of the first vent conduit 36 ​​via a conduit passage 104 formed within the needle assembly body 12. However, other configurations of fluid interconnection are possible.

[0105] The third needle assembly 100 may be used in conjunction with the first syringe 58 and the associated first improved plunger 34 (to define the injection device 170 according to another embodiment of the present invention), as described below.

[0106] As shown in Figure 5(a), before using the third injection device 170, the actuator valve 18 is again in its closed position, the propellant (not shown) remains held under pressure in the propellant storage space 22, and the first improved plunger 34 is separated from the actuator valve 18.

[0107] For example, the distal axis A of the first plunger 34 for quantitatively dispensing a drug (not shown) from the first syringe 58 D Due to the movement in the first plunger 34, for example, as shown in Figure 5(b), the first plunger 34 is brought into contact with the contact structure 32 of the actuator valve 18.

[0108] Subsequently, the distal axis A of the first plunger 34 D Further continuous movement in this position additionally causes the actuator valve 18 to begin moving relative to the needle assembly body 12, and thus causes the actuator valve 18 to begin moving toward its open position.

[0109] Such initial movement of the actuator valve 18 toward its open position also results in movement of the actuator valve 18 relative to the conduit member 40, causing the actuator valve 18 to slide above the conduit member 40, which in turn causes the first drive member 48 to move via the actuator valve 18, and more specifically via the flexible outer casing 28 of the actuator valve 18, in the proximal axial direction A, in order to expose the proximal needle portion 52 beyond the actuator valve 18. P It is pressed against. In addition, in order to fix the needle 14 and the second drive member 54 to each other, the proximal needle portion 52 is exposed beyond the actuator valve 18 and is similarly driven to press-fit and engage with the second drive member 54.

[0110] As shown in Figure 5(c), the distal axis A of the first plunger 34 D Further movement in this position then moves the actuator valve 18 to its open position.

[0111] Such movement of the actuator valve 18 to its open position positions the propellant storage space 22 to be in fluid communication with the second vent conduit 82, and also to be in fluid communication with the first vent conduit 36, thanks to the fluid interconnections provided by the foldable chamber 84, the conduit passage 104, and the open distal end 102.

[0112] As a result, the propellant released from the propellant storage space 22 (highlighted in Figure 5(c)) enters the foldable chamber via the second ventilation conduit 82, distal axial direction A D And along the first ventilation conduit 36 ​​toward its proximal end 38 and in contact with the first drive member 48, in the proximal axial direction A P The flow is directed to both directions. Simultaneously, the movement of the actuator valve 18 to its open position separates the second drive member 54 from the first improved plunger 34, i.e., by pushing its deformable, chamfered returns 64, 66 above each other.

[0113] As a result, as shown in Figure 5(c), the released propellant (highlighted) acts upon both the folding chamber 84 and the first drive member 48.

[0114] The released propellant acting on the folding chamber 84 is directed distally axially A above the needle 14 of the chamber 84. D This results in expansion, which in turn results in a first degree of covering, i.e., shrouding, of the needle 14 by the foldable chamber 84.

[0115] In contrast, the released propellant acting on the first drive member 48 simultaneously moves the first drive member 48 in the proximal axial direction A P It is biased, that is, moved, and then the needle 14, which is fixedly attached to the first drive member 48, also moves in the proximal axial direction A P Initial movement occurs in [location].

[0116] Furthermore, once the first drive member 48 and the needle 14 are in the proximal axial direction A P After this initial movement, if the propellant leaks past the first drive member 48 and beyond the proximal end 38 of the first ventilation conduit 36, the propellant will again act additionally on the second drive member 54, causing the needle 14 to move in the proximal axial direction A PThe movement in the needle 14 is continued, thereby completing the desired second degree of retraction (not shown) of the needle 14 within the needle assembly 100 and the associated syringe body 56, as shown in Figure 5(d).

[0117] Therefore, the combination of a first degree of shrouding of the needle 14, caused by the released propellant acting to expand the foldable chamber 84, and a second degree of retraction of the needle 14, caused by the released propellant acting on the first drive member 48 and then on the second drive member 54, results in the needle 14 being completely surrounded, i.e., completely shrouded (not shown).

[0118] A needle assembly according to a fourth embodiment of the present invention is generally referred to by reference numeral 110, as shown in Figures 6(a) to 6(d).

[0119] The fourth needle assembly 110 shares many similarities with the third needle assembly 100, and such similar features are identified by the same reference number.

[0120] More specifically, the fourth needle assembly 110 also selectively releases the propellant flow in the distal axial direction A, similar to the third needle assembly 100. D and proximal axis A P Although it is possible to direct the fourth needle assembly 110 in both directions, the fourth needle assembly 110 instead includes only the first vent conduit 36.

[0121] Rather, the first vent conduit 36 ​​in the fourth needle assembly 110 is additionally located in the distal axial direction A D It extends in such a way that when the actuator valve 18 moves to its open position, the first vent conduit 36 ​​releases the propellant flow in the proximal axial direction A D and distal axis A P Configure it to direct both directions simultaneously.

[0122] In the shown embodiment, such a configuration is achieved by extending the first ventilation conduit 36 ​​distally beyond the opening 44 in the conduit member 40, i.e., beyond the inlet hole 46 to the first ventilation conduit 36, to the open distal end 102 of the first ventilation conduit 36, and then extending it into the foldable chamber 84 via the conduit passage 104 within the needle assembly body 12.

[0123] Therefore, as a result, the inlet hole 46 is fluidly connected to both the first drive member 48 and the foldable chamber 84. However, other fluid interconnection configurations are possible.

[0124] The fourth needle assembly 110 may also be used in conjunction with the first syringe 58 and the associated first improved plunger 34 (to define an injection device 180 according to another embodiment of the present invention).

[0125] The functionality of the fourth needle assembly 110 is the same as that of the third needle assembly 100, so that, as shown in Figure 6(a), before using the fourth injection device 180, the actuator valve 18 is again in its closed position, the propellant (not shown) remains held under pressure in the propellant storage space 22, and the first improved plunger 34 is separated from the actuator valve 18.

[0126] For example, the distal axis A of the first plunger 34 for quantitatively dispensing a drug (not shown) from the first syringe 58 D Due to the movement in the first plunger 34, for example, as shown in Figure 6(b), the first plunger 34 is brought into contact with the contact structure 32 of the actuator valve 18.

[0127] Subsequently, the distal axis A of the first plunger 34 D Further continuous movement in this position additionally causes the actuator valve 18 to begin moving relative to the needle assembly body 12, and thus causes the actuator valve 18 to begin moving toward its open position.

[0128] Such initial movement of the actuator valve 18 toward its open position also results in movement of the actuator valve 18 relative to the conduit member 40, causing the actuator valve 18 to slide above the conduit member 40, which in turn causes the first drive member 48 to move via the actuator valve 18, and more specifically via the flexible outer casing 28 of the actuator valve 18, in the proximal axial direction A, in order to expose the proximal needle portion 52 beyond the actuator valve 18. P It is pressed against. In addition, in order to fix the needle 14 and the second drive member 54 to each other, the proximal needle portion 52 is exposed beyond the actuator valve 18 and is similarly driven to press-fit and engage with the second drive member 54.

[0129] As shown in Figure 6(c), the distal axis A of the first plunger 34 D Further movement in this position then moves the actuator valve 18 to its open position.

[0130] Such movement of the actuator valve 18 to its open position positions the propellant storage space 22 in fluid communication with the first vent conduit 36, that is, through the connecting conduit 68 in the actuator valve 18 and the inlet hole 46 in the first vent conduit 36, and simultaneously in fluid communication with the foldable chamber 84, thanks to the fluid interconnection to the foldable chamber 84 provided by the conduit passage 104 and the open distal end 102 of the first vent conduit 36.

[0131] As a result, the propellant released from the propellant storage space 22 (highlighted in Figure 6(c)) travels along the first ventilation conduit 36 ​​toward its proximal end 38 and in contact with the first drive member 48, in the proximal axial direction A P Furthermore, through the open distal end 102 and conduit passage 104 of the first ventilation conduit 36, into the foldable chamber 84, distal axial direction A DThe flow is directed to both directions. Simultaneously, the movement of the actuator valve 18 to its open position similarly separates the second drive member 54 from the first improved plunger 34, i.e., by pushing its deformable, chamfered return 64, 66 above each other.

[0132] Therefore, as shown in Figure 6(c), the released propellant (highlighted) acts on both the first drive member 48 and the foldable chamber 84.

[0133] The released propellant acting on the first drive member 48 moves the first drive member 48 in the proximal axial direction A P It is biased, that is, moved, and then the needle 14, which is fixedly attached to the first drive member 48, also moves in the proximal axial direction A P Initial movement occurs in [location].

[0134] Furthermore, once the first drive member 48 and the needle 14 are in the proximal axial direction A P After this initial movement, if the propellant leaks past the first drive member 48 and beyond the proximal end 38 of the first ventilation conduit 36, the propellant again acts additionally on the second drive member 54, as shown in Figure 6(d), causing the needle 14 to move in the proximal axial direction A P The movement in this position continues, thereby allowing the needle 14 to retract to a desired first degree (not shown) within the needle assembly 110 and the associated syringe body 56.

[0135] In contrast, the released propellant acting on the folding chamber 84 simultaneously moves in the distal axial direction A above the needle 14 of the chamber 84. D This results in expansion, which in turn results in a second degree of covering, i.e., shrouding, of the needle 14 by the foldable chamber 84.

[0136] Therefore, similar to the third needle assembly 100, the combination of a first degree of retraction of the needle 14 caused by the released propellant acting on the first drive member 48 and then on the second drive member 54, and a second degree of shrouding of the needle 14 caused by the released propellant acting on the foldable chamber 84, similarly results in a fourth needle assembly 110 in which the needle 14 is completely enclosed, i.e., completely shrouded (not shown).

[0137] A needle assembly according to a fifth embodiment of the present invention is generally referred to by reference numeral 120, as shown in Figures 7(a) to 7(e).

[0138] The fifth needle assembly 110 shares features with the first needle assembly 10 and the second needle assembly 80, respectively, and such similar features are identified by the same reference number.

[0139] In this regard, the fifth needle assembly 120 includes both the first vent conduit 36 ​​and the second vent conduit 82, and therefore, like the third needle assembly 100 and the fourth needle assembly 110 respectively, selectively releases the propellant flow in the distal axial direction A D and proximal axis A P It is possible to direct it in either direction.

[0140] However, in the fifth needle assembly 120, the improved propellant storage space 122 is configured to be in fluid communication with the second vent conduit 82 when the actuator valve 18 moves to a first open position, for example as shown in Figure 7(c), and the improved propellant storage space 122 is configured to be in fluid communication with both the first vent conduit 36 ​​and the second vent conduit 82 when the actuator valve 18 moves to a second open position, for example as shown in Figure 7(d).

[0141] In other embodiments of the fifth needle assembly (not shown), the propellant storage space may instead be configured to first fluidize only the first vent conduit when the actuator valve moves to a first open position, and then to fluidize both the first and second vent conduits when the actuator valve moves to a second open position.

[0142] Returning to the fifth embodiment shown, the ability to configure the propellant storage space 122 to be in fluid communication with only the second vent conduit 82 in the first open position, and to be in fluid communication with both the first vent conduit 36 ​​and the second vent conduit 82 in the second open position, is achieved by providing the actuator valve 18 with an improved first sealing structure 124. More specifically, by including a tapered profile 126 in the improved first sealing structure 124, the improved propellant storage space 122 can communicate with the second vent conduit 82 more quickly, i.e., in the distal axial direction A of the actuator valve 18, than if the tapered profile 126 were not included, for example, than using each of the second needle assembly 80, the third needle assembly 100, and the fourth needle assembly 110. D After less movement, the improved propellant storage space 122 is fluidly connected to the first ventilation conduit 36, for example, as shown in Figure 7(c).

[0143] Furthermore, the improved first sealing structure 124 maintains fluid communication between the improved propellant storage space 122 and the second vent conduit 82 during continuous distal axial movement of the actuator valve 18 to its second open position, as shown in Figure 7(d), so that when the improved propellant storage space 122 enters fluid communication with the first vent conduit 36, it is already in fluid communication with the second vent conduit 82 as well.

[0144] Consequently, the improved propellant storage space 122 is first fluid-connected to the foldable chamber 84, i.e., via the second ventilation conduit 82, and then, additionally, after a certain delay, fluid-connected to the first drive member 48, i.e., via the first ventilation conduit 36. However, other fluid interconnection configurations are possible.

[0145] The fifth needle assembly 120 may also be used in conjunction with the first syringe 58 and the associated first improved plunger 34 (to define an injection device 190 according to a further embodiment of the present invention).

[0146] The functionality of the fifth needle assembly 120 is also the same as that of the first needle assembly 10 and the second needle assembly 80. As shown in Figure 7(a), before using the fifth injector 190, the actuator valve 18 is again in its closed position, the propellant (not shown) remains held under pressure in the improved propellant storage space 122, and the first improved plunger 34 is separated from the actuator valve 18.

[0147] For example, the distal axis A of the first plunger 34 for quantitatively dispensing a drug (not shown) from the first syringe 58 D Due to the movement in the first plunger 34, for example, as shown in Figure 7(b), the first plunger 34 is brought into contact with the contact structure 32 of the actuator valve 18.

[0148] Subsequently, the distal axis A of the first plunger 34 D Further continuous movement in this position additionally causes the actuator valve 18 to begin moving relative to the needle assembly body 12, and thus causes the actuator valve 18 to begin moving toward its first open position.

[0149] Such initial movement of the actuator valve 18 toward its first open position also results in movement of the actuator valve 18 relative to the conduit member 40, causing the actuator valve 18 to slide above the conduit member 40, which in turn causes the first drive member 48 to move via the actuator valve 18, and more specifically via the flexible outer casing 28 of the actuator valve 18, in the proximal axial direction A, in order to expose the proximal needle portion 52 beyond the actuator valve 18. P It is pressed against. In addition, in order to fix the needle 14 and the second drive member 54 to each other, the proximal needle portion 52 is exposed beyond the actuator valve 18 and is similarly driven to press-fit and engage with the second drive member 54.

[0150] As shown in Figure 7(c), the distal axis A of the first plunger 34 D Further movement in this position then moves the actuator valve 18 to its first open position.

[0151] Such movement of the actuator valve 18 to its first open position positions the improved propellant storage space 122 into fluid communication with the second vent conduit 82, thereby releasing the propellant (highlighted in Figure 7(c)) from the improved propellant storage space 122 and the distal axial direction A D The air is directed to flow into the foldable chamber 84 via the second ventilation conduit 82.

[0152] Such release of the propellant (highlighted) from the propellant storage space 22 into the folding chamber 84 occurs in the distal axial direction A of the chamber 84 above the needle 14. D This results in expansion, thereby producing a desired first degree of covering, i.e., shrouding, of the needle 14 by the foldable chamber 84.

[0153] The continuous further movement of the actuator valve 18 to its second open position additionally arranges the improved propellant storage space 122 to be in fluid communication with the first vent conduit 36, namely the connecting conduit 68 in the actuator valve 18 and the inlet hole 46 in the first vent conduit 36.

[0154] As a result, the additional propellant (highlighted in Figure 7(d)) ​​released from the improved propellant storage space 122 is now released along the first ventilation conduit 36 ​​toward its proximal end 38 and in contact with the first drive member 48, in the proximal axial direction A P It is directed to flow in that direction. Simultaneously, the continuous further movement of the actuator valve 18 to its second open position similarly separates the second drive member 54 from the first improved plunger 34, i.e., by pushing its deformable, chamfered returns 64, 66 above each other.

[0155] Therefore, as shown in Figure 7(d), the released propellant (highlighted) now acts on both of the first drive members 48 of the folding chamber 84 after a certain delay.

[0156] As in other similar embodiments of the present invention, the released propellant acting on the first drive member 48 is directed in the proximal axial direction A P In this case, the first drive member 48 is biased, that is, the first drive member 48 is moved, and then the needle 14 fixedly attached to the first drive member 48, also in the proximal axial direction A P This causes the initial movement in [location].

[0157] Furthermore, once the first drive member 48 and the needle 14 are in the proximal axial direction A P After this initial movement, if the propellant leaks past the first drive member 48 and beyond the proximal end 38 of the first ventilation conduit 36, the propellant again acts additionally on the second drive member 54, as shown in Figure 7(e), to move the needle 14 in the proximal axial direction A PThe movement in this position continues, thereby allowing the needle 14 to retract to a desired second degree (not shown) within the needle assembly 120 and the associated syringe body 56.

[0158] Therefore, the combination of a first degree of shrouding of the needle 14, caused by the released propellant acting to expand the folding chamber 84, and a delayed second degree of retraction of the needle 14, caused by the released propellant acting on the first drive member 48 and then on the second drive member 54, results in a fifth needle assembly 120 having a needle 14 that is similarly fully enclosed, i.e., fully shrouded (not shown).

[0159] A needle assembly according to a sixth embodiment of the present invention is generally referred to by reference numeral 130, as shown in Figures 8(a) and 8(b).

[0160] The sixth needle assembly 130 shares many similarities with the first needle assembly 10 and the fourth needle assembly 110, but not all of these similar features are shown, except for those that share the same reference number.

[0161] In particular, the sixth needle assembly 130 shares with the first needle assembly 10 and the fourth needle assembly 110, respectively, that it includes the first vent conduit 36, and thus, as desired, the released propellant flow is directed distal axial A D and proximal axis A P It is operable to direct to one or both of these directions.

[0162] Such a first ventilation conduit 36 ​​is defined, as shown, by a hollow conduit member 40, which is fixedly attached to the needle assembly body 12 at its distal end 42, and within it, a needle (not shown) is located in the axial direction, for example, at least in the proximal axial direction A P , is movable. The hollow conduit member 40 also has a first opening 44 formed therein, which defines an inlet hole 46 to the first ventilation conduit 36.

[0163] However, other types and configurations of the first ventilation conduit are possible.

[0164] However, the inclusion of the first ventilation conduit 36 ​​means that the sixth needle assembly 130 can operate in any of the following manner: - The first needle assembly 10, i.e., the released propellant flow distal axial A D To direct and act upon the first drive member (not shown) to cause the associated needle (not shown) to retract; or, - The fourth needle assembly 110, i.e., the released propellant flow, in the proximal axial direction A D and distal axis A P By simultaneously directing both, the first drive member (not shown) and the folding chamber (also not shown) act to cause the associated needle (not shown) to retract and the chamber to expand above the needle, respectively.

[0165] However, the sixth needle assembly 130 is different from the first needle assembly 10 and the fourth needle assembly 110 because it includes a second actuator valve 132 which is different from the first actuator valve 18 included in the first needle assembly 10 and the fourth needle assembly 110, respectively.

[0166] More specifically, the second actuator valve 132 itself defines the propellant storage space 22, and more specifically, the second actuator valve 132 itself also includes an external support structure 134 having a hollow interior 136 that defines the propellant storage space 22.

[0167] As best shown in Figure 9, the external support structure 134 is formed by an elongated, hollow central body 138, which preferably has a circular cross-section (although other cross-sectional profiles are also possible), to which a first end cap 140 and a second end cap 142 are fixed. Preferably, the second end cap 142 is integrally formed with the central body 138, and the first end cap 140 is bonded to the central body 138 using a UV-curing adhesive 148, although other fixing methods are also possible.

[0168] In other embodiments of the present invention (not shown), the first and second end caps may instead extend toward and be fixed toward each other in order to eliminate the need for a central body.

[0169] In any case, the first end cap 140 incorporates the third sealing structure 144, and the second end cap 142 incorporates the fourth sealing structure 146, and both the third sealing structure 144 and the fourth sealing structure 146 cooperate in a sealing manner with the first ventilation conduit 36, i.e., the hollow conduit member 40 defining the first ventilation conduit 36, to maintain the integrity of the sealing of the propellant storage space 22.

[0170] The external support structure 134 of the second actuator valve 132, as well as the first end cap 140 and the second end cap 142, thereby combine to create a substantially annular propellant storage space 22, although propellant storage spaces of other shapes are also possible.

[0171] Preferably, each of the third sealing structure 140 and the fourth sealing structure 142 is formed of a relatively flexible and elastically deformable material (e.g., a natural elastomer or a synthetic elastomer) (or includes an element formed of such material (e.g., an O-ring or a skin)), while the external support structure 134, e.g., the central body 138, and each of the end caps 140, 142 are formed of or include a harder, less deformable material. For example, one or both of the third sealing structure 140 and the fourth sealing structure 142 may be overmolded with a thermoplastic elastomer on the corresponding end caps 140, 142, i.e., they may be created as an additional layer of thermoplastic elastomer material.

[0172] In addition, the third sealing structure 144 and the fourth sealing structure 146 are movable, more specifically slidable, with respect to the first vent conduit 36 ​​(while maintaining the integrity of the seal), thereby allowing the second actuator valve 132 to be movable within the needle assembly body 12, more specifically, within the hollow, substantially annular interior 20 of the needle assembly body 12, although the interior 20 does not necessarily have to be hollow and substantially annular, and other shapes of interiors, and partially hollow interiors, are also possible.

[0173] In this configuration, the second actuator valve 132 is movable between a closed position, as shown in Figure 8(a), in which propellant (not shown) is held under pressure in the propellant storage space 22, and an open position, as shown in Figure 8(b), in which the propellant is released from the propellant storage space 22, resulting in shrouding, i.e., complete containment or accommodation, of the corresponding needle (not shown).

[0174] To facilitate such movement of the second actuator valve 132, similarly, a contact structure 32 is defined that can be contacted by the syringe plunger during use in order to move the second actuator valve 132 from its closed position to its open position.

[0175] As shown in Figure 8(a), before using the sixth needle assembly 130, for example, before using an associated injection device (not shown) for injecting a drug into a recipient, the second actuator valve 132 is in its closed position, and the propellant (not shown) remains held under pressure in the propellant storage space 22.

[0176] While the drug is being dispensed quantitatively from the aforementioned associated injection device, the plunger of the device is brought into contact with the contact structure 32 of the second actuator valve 132, thereby controlling the distal axial direction of the plunger A D Further continuous movement in this position additionally causes the second actuator valve 132 to begin moving relative to the needle assembly body 12 and toward its open position.

[0177] Such initial movement of the second actuator valve 132 toward its open position results in movement of the second actuator valve 132 relative to the conduit member 40, and more specifically, causes the second actuator valve 132 to slide above the conduit member 40.

[0178] As shown in Figure 8(b), the distal axis A of the plunger D Further movement in this position then moves the second actuator valve 132 to its open position. This arranges the propellant storage space 22 to be in fluid communication with the first ventilation conduit 36, i.e., through the inlet hole 46 formed in the conduit member 40, thereby releasing propellant (not shown) from the propellant storage space 22 and into the first ventilation conduit 36, optionally in the proximal axial direction A, for example, by acting on the first drive member to cause the associated needle to retract and / or by acting on the folding chamber to cause the chamber to expand above the needle. P and distal axis A D To direct or direct one or both of them in a flowing manner.

Claims

1. A needle assembly for engaging with a syringe having an elongated hollow syringe body in which a plunger is slidably received, A needle assembly body having a subcutaneous injection needle connected to the needle assembly body and extending from the distal end of the needle assembly body, An actuator valve is movably received within the needle assembly body and is formed to define a propellant storage space, Equipped with, The actuator valve is movable between a closed position in which the propellant is held under pressure in the propellant storage space and an open position in which the propellant is released from the propellant storage space, causing the needle to shroud. Needle assembly.

2. The needle assembly according to claim 1, wherein the actuator valve itself defines the propellant storage space.

3. The needle assembly according to claim 2, wherein the actuator valve includes an external support structure having a hollow interior that defines the propellant storage space.

4. The needle assembly according to claim 1, wherein the actuator valve cooperates with the needle assembly body to define the propellant storage space between the actuator valve and the needle assembly body.

5. The needle assembly according to claim 4, wherein the actuator valve includes a first sealing structure spaced apart in the axial direction and a second sealing structure spaced apart in the axial direction, and the propellant storage space is formed between the first sealing structure and the second sealing structure.

6. The needle assembly according to any of the preceding claims, wherein the propellant storage space has an annular shape.

7. The needle assembly according to any of the preceding claims, wherein the actuator valve defines a contact structure, and a syringe plunger contacts the contact structure during use, thereby moving the actuator valve from its closed position to its open position.

8. The needle assembly according to any of the preceding claims, wherein the movement of the actuator valve to the open position is arranged to communicate fluidly with a vent conduit configured to direct the released propellant flow in one or both of the distal axial and proximal axial directions within the propellant storage space.

9. The needle assembly according to claim 8, wherein the movement of the actuator valve to the open position is arranged to communicate fluidly with a first vent conduit, which is configured to extend the propellant storage space in the proximal axial direction and to direct the released propellant flow in the proximal axial direction.

10. The needle assembly according to claim 8, wherein the movement of the actuator valve to the open position is arranged to communicate with a second vent conduit, which extends the propellant storage space in the distal axial direction and directs the released propellant flow in the distal axial direction.

11. The needle assembly according to claim 10, wherein the second ventilation conduit extends through the needle assembly body.

12. The needle assembly according to any one of claims 9, 10, and 11, wherein the second vent conduit is additionally arranged to be in fluid communication with the first vent conduit, so that when the actuator valve moves to the open position, the propellant storage space is in fluid communication with the first vent conduit via the second vent conduit.

13. The needle assembly according to claim 9, wherein the first vent conduit further extends in the distal axial direction, thereby directing the released propellant flow simultaneously in both the proximal and distal axial directions when the actuator valve moves to its open position.

14. The needle assembly according to any one of claims 9, 10, and 11, wherein when the actuator valve moves to a first open position, the propellant storage space is arranged to be in fluid communication with one of the first and second ventilation conduits, and when the actuator valve moves to a second open position, the propellant storage space is arranged to be in fluid communication with both the first and second ventilation conduits.

15. The needle assembly according to claim 9 or any claim dependent on claim 9, wherein the first vent conduit extends between the actuator valve and the needle and terminates at its proximal end, and a first drive member fixedly attached to the needle is in a sealed contact state with respect to the proximal end, thereby causing a propellant released into the first vent conduit and directed to flow in the proximal axial direction to act on the first drive member, thereby moving the first drive member and the needle fixedly attached to the first drive member in the aforementioned proximal axial direction.

16. The needle assembly according to claim 15, wherein the first ventilation conduit is defined by a hollow conduit member fixedly attached to the needle assembly body at its distal end, and the needle is axially movable within the hollow conduit member.

17. The needle assembly according to claim 14, wherein the hollow conduit member has a first opening formed therein, defining an inlet hole to the first ventilation conduit.

18. The needle assembly according to claim 16 or 17, wherein the actuator valve is slidable above the conduit member, and the first drive member is spaced inward from the proximal end of the needle to define the proximal needle portion, thereby the movement of the actuator valve toward the open position additionally exposes the proximal needle portion beyond the actuator valve.

19. The needle assembly according to claim 18, wherein the proximal needle portion cooperates with a second drive member configured to occlude the hollow syringe body of a syringe with which the needle assembly engages during use, thereby, after the initial movement of the first drive member and the needle in the proximal axial direction, the propellant directed to flow in the proximal direction through the first conduit additionally acts on the second drive member to continue the movement of the needle in the proximal axial direction.

20. The needle assembly according to claim 19, which is engaged with a syringe having an improved plunger that supports the second drive member and is configured to be fixedly attached to the proximal needle portion before it comes into contact with the contact structure of the actuator valve.

21. The needle assembly according to claim 20, wherein the second drive member and the improved plunger include a mutually cooperative structure for selectively fixing the second drive member and the improved plunger to each other.

22. The needle assembly according to claim 21, wherein at least one of the mutually cooperative structures is elastically deformable.

23. The needle assembly according to claim 10 or any claim dependent on claim 10, wherein the released propellant, which is directed to flow in the distal axial direction, is further directed into a foldable chamber sealed and fixed to the needle assembly body, so that the release of the propellant from the propellant storage space into the foldable chamber causes the chamber to expand in the distal axial direction.

24. The needle assembly according to claim 23, wherein the foldable chamber is sealed and fixed between the needle assembly body and the shield assembly, so that the release of the propellant from the propellant storage space to the foldable chamber via the second vent conduit results in the distal axial expansion of the chamber, as well as the distal axial bias of the shield assembly above the needle.

25. A method using a needle assembly according to any of the prior claims, comprising the step of moving the actuator valve between a closed position in which the propellant is held under pressure in the propellant storage space and an open position in which the propellant is released from the propellant storage space, causing the needle to shroud.

26. An injection device comprising a needle assembly according to any one of claims 1 to 24.

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