syringe assembly

专利摘要:
NEEDLE SYRINGE WITH PASSIVE DUAL CAMERA RETRACTION. The modalities of a retractable syringe assembly are provided that include a dual syringe cylinder configuration. In one or more embodiments, the assemblies include a fluid cylinder for retaining fluid and a retraction cylinder for housing the retraction feature and the needle hub assembly. Mounts include a firing element that moves with the plunger rod to activate the retract feature on the retract mechanism.
公开号:BR112013001622B1
申请号:R112013001622-1
申请日:2011-07-21
公开日:2021-01-19
发明作者:Ivan Zivkovic；Russell Cole
申请人:Becton, Dickinson And Company；
IPC主号:

专利说明:

Technical field
[001] Aspects of the present invention refer to syringe assemblies that include a retractable needle and reuse prevention features and methods of using such syringe assemblies. Background
[002] Needle retraction features have been incorporated into syringe assemblies to protect users from needle stick injuries. In conventional assemblies, needle hub assemblies, including a needle cannula, are attached to the syringe cylinder and must be removed into the syringe cylinder by a user or by a retraction feature. Alternatively, a needle guard must be placed over the needle cannula by the user or otherwise.
[003] In conventional syringe assemblies in which the needle hub assemblies are retracted into the syringe cylinder by a retract characteristic, the retract characteristic is often provided on the syringe cylinder and / or plunger rod arranged on the cylinder syringe Specifically, the plunger rod may include a chamber that houses the needle hub after being retracted. The retraction feature typically includes a cutting element disposed between the plunger rod and the stopper which is used to open the cork after the contents of the syringe cylinder are expelled, to expose the plunger rod chamber to receive the needle hub retracted. A spring is often incorporated into the needle hub assemblies to trigger the needle hub retraction into the plunger rod.
[004] Consequently, such retraction characteristics require cutting, breaking, drilling or other intense mechanical action in force for activation and thus, increased complexity to allow the sealed plunger and stopper to be violated during activation. In addition, since most conventionally designed retractable needles are activated after continuous pressure dosing at the rear of the plunger rod, inadvertent activation of the retract characteristic can occur since the same forces must be applied when expelling the contents of the cylinder. syringe. In addition, some devices may be inadvertently activated during dosing if sufficient pressure is generated during expulsion of the contents of the syringe, for example, when the medication is viscous and requires the user to apply additional pressure or force to the plunger rod, which exceeds the force required to activate the retract feature. Premature activation is especially problematic in applications where high forces are applied to the piston rod, for example, during high-speed injections.
[005] The retraction characteristics of conventional syringe cylinders that are plunger-activated must withstand increased syringe pressures and associated increase in force applied to the plunger rod, as described above. These increased forces and pressure lead to a requirement for large activation forces that could exceed operating forces to prevent premature activation. Since most conventional syringe cylinders employ an additional plunger movement after full dispensing, and in the same way as the dispensing movement, a limit force must be used to allow the user to differentiate between a plunger fully at the bottom and the activation of the retraction feature. The limit force can be difficult to determine and maintain separately from the force applied to the plunger rod to expel the contents of the syringe cylinder. In addition, proper application of the limit force may require a user to position the syringe cylinder and needle cannula at an increased angle on the patient's skin, rather than positioning the syringe cylinder and needle cannula substantially parallel to the skin. of the patient. The additional force required to activate the retract feature can cause additional pressure to be generated in the stopper or other removable opening in the plunger rod, which may be sufficient to cause the stopper and / or plunger rod to malfunction.
[006] In conventional syringe assemblies where the retraction feature and subsequent housing of the needle hub in conventional retractable syringes are contained in the fluid path, the retraction and housing feature can cause a volume of medication to be retained in the cylinder syringe, thereby increasing waste and potentially affecting dosing accuracy. In addition, a portion of the retained medication may be expelled during activation of the retracting feature causing splashing, if the retracting feature is activated when the needle cannula is out of the patient, or an unintended increase in the dose administered to the patient, if the retraction feature is activated when the needle cannula is in the patient. Placing the retract feature on the syringe cylinder can also cause trapped air to remain in the syringe cylinder when purging or priming the syringe. This can lead to the possibility of injected air. The size of the syringe cylinder must also accommodate the retraction feature and the needle hub assembly that will be housed therein after retraction.
[007] In syringe assemblies that do not accommodate the retract feature in the fluid path, the retract feature is often arranged in a location that requires the user to change their grip on the syringe mount to activate the retract feature.
[008] Conventional retracting syringe assemblies often do not incorporate reuse prevention features and thus the retraction mechanism can be readjusted so that the syringe cylinder can be reused. It is believed that the reuse of syringe assemblies without sufficient sterilization or sterilization facilitates the transfer of contagious diseases. In addition, the retraction characteristics of conventional syringes also often require the user to actively activate the retraction mechanism. Therefore, the chance of human error in failing to activate or properly activate the retraction mechanism can lead to continuous needle exposure.
[009] Therefore, it would be desirable to provide a retractable syringe assembly with a retraction feature that does not interfere with normal syringe assembly operation, is passively activated and reduces the risk of premature activation or the retraction mechanism. It would also be desirable to provide a retractable syringe assembly that incorporates a reuse prevention feature. Summary of the invention
[010] One embodiment of the present invention relates to a syringe assembly comprising a fluid cylinder including a side wall having an internal surface that defines a fluid chamber to retain fluid and having a first width in cross section, an open proximal end and a distal end including a distal wall; a plunger rod disposed in the fluid chamber comprising a distal end, a proximal end, a plunger body extending from the distal end to the proximal end, and a stopper disposed at the distal end of the plunger to form a seal fluid tight with the inner surface of the cylinder; a retraction cylinder disposed adjacent to the side wall of the fluid cylinder, the retraction cylinder including a wall having an inner surface that defines a needle chamber, an open proximal end, an open distal end including a barrier wall, an opening between the fluid cylinder wall and the fluid cylinder side wall such that the fluid chamber and the needle chamber are in fluid communication and a needle hub assembly comprising a needle hub, a fixed needle cannula to the needle hub in fluid communication with the opening, the needle hub assembly tended to move in the proximal direction; and a movable firing element with the plunger rod and extending into the needle chamber of the retraction cylinder, the firing element providing a firing force causing the needle cannula to retract into the retraction cylinder.
[011] In one or more embodiments of the present invention, the wall of a syringe assembly of the present invention includes a support element that engages a needle assembly arranged in the needle chamber and the support element is positioned to apply a force to the distal direction to the needle hub such that the needle cannula extends distally beyond the open distal end of the retraction cylinder in the first position.
[012] In one or more embodiments of the present invention, the firing element provides a firing force on the needle hub to disengage the support element and the needle hub so that the needle cannula is housed in the retraction cylinder.
[013] In one or more embodiments of the present invention, the needle hub is provided by a spring disposed between the needle hub and the barrier wall which exerts a force on the needle hub in the proximal direction.
[014] In one or more embodiments of the present invention, the firing element is attached to the distal end of the piston rod. In one or more embodiments of the present invention, the firing element can include a proximal end attached to the proximal end of the plunger rod, a free and open distal end that provides the firing force, and a firing element body extending from from the proximal end to the distal end and including an inner surface defining a hollow interior.
[015] In one or more embodiments of the present invention, the inner surface of the syringe cylinder includes a retaining ring adjacent to the proximal end that defines a second width in cross section which is less than the first width in cross section and the body piston rod includes a flexible protuberance having a width in cross section greater than the width in cross section of the cylinder in the rib and a frangible portion.
[016] In one or more embodiments of the present invention, the piston rod body comprises a distal portion and a proximal portion, the protuberance disposed between the distal portion and the proximal portion. In one or more embodiments of the present invention, the distal portion of the piston rod body comprises a support element arranged proximally adjacent to the flexible protuberance and at least one frangible portion disposed proximally adjacent to the support element. In one or more embodiments of the present invention, the proximal end of the firing element is attached to the base of the piston rod. In one or more embodiments of the present invention, the distal end of the plunger rod includes a stopper engaging portion and the stopper is attached to the stopper engaging portion of the plunger rod, the stopper being movable distally and proximal to it to the stopper engaging portion by a pre-selected one such that when the distal end of the stopper is in contact with the distal wall of the cylinder, the protrusion is allowed to advance distally beyond the rib in the cylinder and lock the piston rod in the cylinder to avoid reusing the syringe assembly. In one or more embodiments of the present invention, the stopper engaging portion of the plunger rod is connected to the stopper in such a way that after applying a force directed proximally to the plunger rod, while holding the cylinder, causes the plunger rod and firing element move the length of the axial distance in a proximal direction in the cylinder, while the stopper remains stationary. In one or more embodiments of the present invention, the portion of engaging the plunger rod stopper is connected to the stopper in such a way that after applying a force directed proximally to the plunger rod, while holding the cylinder, causes the stopper, the plunger rod and the firing element move together in a proximal direction in the cylinder. In one or more embodiments of the present invention, the stopper engaging portion of the piston rod is connected to the stopper in such a way that the application of an initial distally directed force to the piston rod after application of a directed force proximal to the piston rod, while holding the cylinder, causes the stopper to remain stationary and the piston rod and the firing element move the length of the axial distance in the distal direction in the cylinder. In one or more embodiments of the present invention, the stopper engaging portion of the piston rod is connected to the stopper in such a way that the application of a continuous distally directed force to the piston rod causes the stopper, piston rod and firing element move together in the distal direction on the cylinder until the stopper reaches the distal end of the cylinder. In one or more embodiments of the present invention, the contact between the stopper and the distal wall of the cylinder causes the support element to disengage from the needle hub and the protrusion advances distally beyond the rib in the cylinder and locks the plunger rod in the cylinder to prevent reuse of the syringe assembly. In one or more embodiments of the present invention, the application of a force directed proximally to the plunger, after the protrusion has advanced distally beyond the rib, causes at least a frangible portion of the plunger rod to break. In one or more embodiments of the present invention, the application of a directed proximally directed force to the plunger rod causes the stopper engaging portion to disengage the stopper.
[017] In one aspect of the present invention, the open distal end of the firing element comprises a beveled edge that extends distally.
[018] In one or more embodiments of the present invention, the retraction cylinder is disposed parallel to the fluid cylinder.
[019] Another embodiment of the present invention relates to the assembly of a syringe comprising a cylinder comprising the inclusion of a side wall with an open proximal end having an internal surface that defines a fluid chamber to retain fluid and having a first width in cross section and a needle chamber for housing a needle hub assembly, the fluid chamber and the needle chamber being divided by a barrier wall having a first opening that allows fluid communication between the fluid chamber and the needle chamber, the needle chamber including a flexible tongue that extends into the needle chamber to engage a needle hub assembly disposed thereon; a needle hub assembly disposed in the needle chamber, the needle hub assembly comprising a needle hub, a needle cannula attached to the needle hub in fluid communication with the first opening, the needle cannula intended to move in the proximal direction, the flexible tongue positioned to engage the needle hub and apply force in the distal direction to the needle hub so that the needle cannula extends beyond the open distal end of the retraction cylinder positioned in the first position; and a plunger rod disposed in the fluid chamber comprising a distal end, a proximal end, a stopper disposed at the distal end of the plunger rod to form a fluid-tight seal with the inner surface of the cylinder, a plunger rod body extending from the distal end to the proximal end, and an activation element arranged on the plunger rod to move the flexible tongue and cause the needle cannula to retract and be housed in the retraction cylinder in a second position.
[020] In one or more embodiments of the present invention, the needle cannula is arranged to move in the proximal direction by a spring disposed between the needle hub and the barrier wall which exerts a force on the needle hub and the spring is compressed when the flexible tab engages the needle hub. In one or more embodiments of the present invention, the barrier chamber of the needle chamber further comprises a second opening to allow the flexible tongue to flex inwardly into the needle chamber and an angled portion extending outwardly into the fluid chamber . In one or more embodiments of the present invention, disengagement of the flexible tongue and needle hub allows the spring to expand and causes the needle hub to retract into the hollow interior of the firing element.
[021] In one or more embodiments of the present invention, the firing element is disposed in the piston rod body and extends radially outwardly from the piston rod body. In one or more embodiments of the present invention, the cylinder comprises a dose limit indicator disposed on an external surface of the side wall. In one or more embodiments of the present invention, applying a force in the proximal direction to the plunger rod causes the plunger rod to move in the proximal direction and draw a liquid into the fluid chamber and sequentially applying a force to the plunger. Distal direction causes the plunger rod to engage the ramp and cause the flexible tongue to flex outward into the fluid chamber to release the force applied to the needle hub in the distal direction. The inner surface of the sidewall in the fluid chamber includes a retaining ring adjacent to the proximal end that defines a second width in cross section which is less than the first width in cross section and the piston rod body includes a flexible protuberance having a width in cross section greater than the width in cross section of the cylinder in the rib and frangible portion.
[022] In one or more embodiments of the present invention, the contact between the stopper and the distal wall of the cylinder causes the flexible tongue to disengage from the needle hub and protuberance advancing distally beyond the rib in the cylinder and locking the stem. plunger in the cylinder to prevent reuse of the syringe assembly. In one or more embodiments of the present invention, the distal end of the plunger rod includes a stopper engaging portion and the stopper is attached to the plunger engaging portion of the plunger, the stopper being movable distally and proximal to the portion of engaging the stopper by a pre-selected axial distance such that when a force is applied to the plunger rod in the distal direction and the distal end of the stopper is in contact with the distal wall of the cylinder, the protuberance is allowed to advance distally beyond of the rib on the cylinder and lock the plunger rod on the cylinder to prevent reuse of the syringe assembly.
[023] Yet another embodiment of the present invention relates to a syringe assembly comprising a fluid cylinder including a side wall having an inner surface that defines a fluid chamber to retain fluid and having a first width in cross section, an open end proximal and a distal end including a distal wall; a plunger rod disposed in the fluid chamber comprising a distal end, a proximal end, a plunger body extending from the distal end to the proximal end, and a stopper disposed at the distal end of the plunger to form a seal fluid tight with the inner surface of the cylinder; a retraction cylinder disposed adjacent to the side wall of the fluid cylinder, the retraction cylinder including a wall having an inner surface that defines a needle chamber, an open proximal end, an open distal end including a barrier wall, an opening between the fluid cylinder wall and the fluid cylinder side wall such that the fluid chamber and the needle chamber are in fluid communication and a needle hub assembly comprising a needle hub, a fixed needle cannula to the needle hub in fluid communication with the opening, the needle hub assembly tended to move in the proximal direction; and a retraction mechanism for the needle cannula to retract into the retraction cylinder, where the retraction cylinder is fitted to the fluid cylinder and the retraction cylinder has a cross-sectional dimension that is less than 90% of the cross-sectional dimension of the fluid cylinder. Brief description of the drawings
[024] Figure 1 illustrates a perspective view of a retractable syringe assembly according to one or more modalities; Figure 2 shows a detailed view of the syringe assembly of claim 1; Figure 3 shows a cross-sectional view of the syringe assembly of claim 2; Figure 4 shows a side view in cross section of the fluid cylinder and the retraction cylinder shown in figure 1; Figure 5 illustrates a side cross-sectional view of the plunger rod and stopper shown in Figure 1; Figure 6 shows a cross-sectional side view of the needle hub assembly in Figure 1; Figure 7 illustrates a cross-sectional view of the syringe assembly of figure 1 after a force in the proximal direction has been applied to the plunger rod to fill the fluid chamber with liquid; Figure 8 illustrates a cross-sectional view of the syringe assembly of Figure 7 after a force in the distal direction has been applied to the plunger rod to expel liquid from the fluid chamber; Figure 9 illustrates a cross-sectional view of the syringe assembly of Figure 8 after all liquid has been expelled from the fluid chamber and the stopper is in contact with the distal wall; Figure 10 shows a cross-sectional view of the syringe assembly of claim 9 after the needle hub assembly is retracted into the retraction cylinder. Figure 11 illustrates a cross-sectional view of the syringe assembly of Figure 10 after a force is applied to the plunger rod in the proximal direction, after the plunger rod is locked in the fluid cylinder; Figure 12 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 13 shows a detailed view of the syringe assembly of claim 12; Figure 14 shows a cross-sectional view of the syringe assembly of claim 13; Figure 15 illustrates a cross-sectional side view of the fluid cylinder and retraction cylinder shown in Figure 12; Figure 16 illustrates a side cross-sectional view of the plunger rod shown in Figure 12; Figure 17 illustrates a side cross-sectional view of the needle hub assembly in Figure 12; Figure 18 illustrates a cross-sectional view of the syringe assembly of figure 12 after a force in the proximal direction has been applied to the plunger rod to fill the fluid chamber with liquid; Figure 19 illustrates a cross-sectional view of the syringe assembly of Figure 18 after a force in the distal direction has been applied to the plunger rod to expel liquid from the fluid chamber; Figure 20 illustrates a cross-sectional view of the syringe assembly of figure 19 after all liquid has been expelled from the fluid and stopper chamber in contact with the distal wall; Figure 21 shows a cross-sectional view of the syringe assembly of claim 20 after the needle hub assembly is retracted into the retraction cylinder. Figure 22 illustrates a cross-sectional view of the syringe assembly of Figure 21 after a force is applied to the plunger rod in the proximal direction, after the plunger rod is locked in the fluid cylinder; Figure 23 illustrates a side cross-sectional view of a retractable syringe assembly according to one or more embodiments, with fluid filled in the fluid chamber; Figure 24 illustrates a cross-sectional side view of the retractable syringe assembly shown in Figure 23 after a force is applied to the plunger rod in the distal direction; Figure 25 illustrates a side cross-sectional view of a retractable syringe assembly shown in Figure 24 after the fluid is expelled from the fluid chamber; Figure 26 shows a cross-sectional view of the syringe assembly of claim 25 after the needle hub assembly is retracted into the retraction cylinder; and Figure 27 illustrates a cross-sectional view of the syringe assembly of Figure 26 after a force is applied to the plunger rod in the proximal direction, after the plunger rod is locked in the fluid cylinder. Detailed Description
[025] Before describing several exemplary embodiments of the invention, it should be understood that the invention is not limited to the details of construction or process steps set out in the following description. The invention is capable of other modalities and can be put into practice or carried out in various ways.
[026] In this disclosure, a convention is followed in which the distal end of the device is the end closest to a patient and the end closest to the device is the end furthest from the patient and closest to a doctor.
[027] A first aspect of the present invention relates to a retractable syringe assembly having a passive retraction feature. The retractable syringe assembly 100 of one or more embodiments uses a double syringe cylinder or a syringe cylinder that isolates the fluid chamber from the retraction feature.
[028] In the embodiment shown in figures 1-11, the retractable syringe assembly includes a double syringe cylinder 101 that includes fluid cylinder 110 and a retraction cylinder 120. The retractable syringe also includes a needle hub assembly 140, a plunger rod 160, stopper 170 and a firing element 190. The fluid cylinder shown in figure 4 includes a distal end 111, an open proximal end 119, a side wall 112 extending from distal end 111 and the proximal end 119 including an inner surface 114 that defines a chamber 115. The inner surface 114 defines a width in cross section and may include a reuse prevention feature, which will be discussed in more detail below. The distal end 111 includes a distal wall 117 that encloses the distal end 111. In the embodiment shown, the side wall 112 includes a first opening 118 to allow fluid communication between the fluid cylinder and the retraction cylinder. As will be discussed in more detail below, the first opening 118 also allows fluid communication between a needle cannula disposed in the retraction cylinder 120 and fluid cylinder 110.
[029] The fluid cylinder 110 shown in figures 4, includes a reuse prevention feature. Specifically, the fluid cylinder 110 includes a retaining element 116 shown in the form of a rib that extends around the entire circumference of the inner surface 114 of the fluid cylinder 110 at a location adjacent to the proximal end 119 of the fluid cylinder. The cross-sectional width of the inner surface 114 on the retaining element 116 is less than the first cross-sectional width or the cross-sectional width of the inner surface 114 at the remaining locations along the length of the fluid cylinder. In one or more embodiments, optional tabs or retainers can be used to create a region of the fluid cylinder 110 having a width in cross section that is less than the first width in cross section of the fluid cylinder 110. The retaining ring 116 it can also be shaped to facilitate activation of the reuse prevention feature. For example, the fluid cylinder 110 may also include a proximally arranged diameter transition region adjacent the retaining element 116 at the proximal end 119 of the fluid cylinder 110. The width in cross section of the inner surface 114 of the fluid cylinder in the transition region, the diameter increases from the distal end 111 to the proximal end 119 of the fluid cylinder 110. As will be described in greater detail below, in modalities of the retractable syringe assembly that use a reuse prevention feature, prevention of reuse of the fluid cylinder 110 cooperates with corresponding reuse prevention characteristics on the plunger rod 160 to lock the plunger rod 160 on the fluid cylinder 110 and / or to disable the plunger rod 160 for further use.
[030] In an alternative embodiment, the retractable syringe assembly may include a single cylinder, where a portion of the cylinder is divided by a dividing wall in a fluid cylinder and the remaining portion of the cylinder that houses the retraction feature and the needle hub assembly. The dividing wall may include an opening to allow fluid communication between the fluid cylinder and the remaining portion of the cylinder that houses the retraction feature and the needle hub assembly.
[031] The retraction cylinder 120 is disposed adjacent to the side wall 112 of the fluid cylinder 110 in the manner shown in figure 4. The retraction cylinder 120 is configured to accommodate a needle hub assembly 140 therein and the retraction characteristic . The retraction cylinder 120 includes an open distal end 121 and an open proximal end 129. A wall 122 having an inner surface 124 defining the needle chamber 125 extends from the open distal end 121 to the open proximal end 129. The wall 122 of the retraction chamber is adjacent to the side wall 112 of the fluid cylinder 110. In one or more embodiments, the wall 122 may extend around the portions of the retraction cylinder 120 that are not in direct contact with the fluid cylinder 110 and the side wall 112 can form the barrier between the retraction cylinder 120 and the fluid cylinder 110. In other words, the outer surface of the side wall 112 can form the inner surface 124 of the retraction cylinder 120 along the portion of the retraction cylinder 120 which is in direct contact with the fluid cylinder 110.
[032] Needle chamber size 125 can be modified to accommodate needle hub assembly 140 and / or the retract feature. According to one or more embodiments, the inner surface 124 of the retraction cylinder 120 has a width in cross section that is less than the first width in cross section of the fluid cylinder 110. In specific embodiments, the width in cross section of the inner surface 124 of the retraction cylinder is less than approximately 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the width in cross section of the inner surface 114 of the fluid cylinder. Such designs in which the width in cross section of the inner surface 124 of the retraction cylinder is less than the width in cross section of the inner surface 114 of the fluid cylinder provides ergonomic and functional advantages. For example, the overall appearance and handling of the double-cylinder syringe is more attractive to the user. In certain embodiments, the retraction cylinder can be fitted to the fluid cylinder. For example, both the retraction cylinder and the fluid cylinder can either be limited or circumscribed by a common wall and the retraction cylinder can be partially or completely disposed in the fluid cylinder, or alternatively, a dividing wall can separate a single cylinder in two separate cylinders, a fluid cylinder and a retraction cylinder.
[033] The open distal end 121 of the retraction cylinder 120 in the embodiment shown includes a barrier wall 127 that partially encloses the open distal end 121. The open distal end 121 can be free of a barrier wall 127 and can be fully opened . The wall 122 may include a second opening 128 that allows fluid communication with the fluid chamber 115 and the needle chamber 125. The second opening 128 of the wall may also allow fluid communication between the fluid chamber 115, needle chamber 125 and the needle cannula. The fluid communication between the fluid cylinder 110 and the retraction cylinder 120 can be provided by a first conduit 130 extending from a first opening 118 of the fluid cylinder 110 and second opening 128 of the retraction cylinder. In the embodiment shown, the first conduit 130 extends along the width of the side wall 112 and wall 122.
[034] The needle hub assembly may include a second conduit 132 that extends from an open end of the needle cannula to the second opening 128 of the retraction cylinder. The second conduit 132 may include an opening 133 which must be aligned with the second opening 128 to allow fluid communication between the needle cannula and the fluid cylinder.
[035] The needle hub assembly 140 is arranged on the retraction cylinder 120 and includes a needle hub 142 and a needle cannula 150 attached to needle hub 142. Needle hub 142 includes a distal end 141 and an end proximal 149. The needle cannula 150 includes an open and free distal end 151 and an open proximal end 159 which is attached to the distal end 141 of the needle hub. The needle hub 142 shown in figure 6 includes a needle hub body 144, a needle hub holder 146 distally disposed adjacent the needle hub body and a needle hub extension 148 that extends proximally to from the needle hub body 144. The needle hub holder 146 includes a recessed portion 147 for partially housing the proximal end 159 of the needle cannula. In the embodiment shown, the lowered portion 147 includes a portion of the second conduit 132 that extends through the needle hub 142 to the second opening 128 of the retraction cylinder. In one or more alternative embodiments, the proximal end 159 of the needle cannula can extend through the recessed portion 147 to the second conduit 132, which is located entirely within the needle hub body 144 and does not extend into the cannula support. needle 146. The needle hub extension 148 extends into the needle chamber 125 and forms part of the retractable feature of the retractable syringe assembly 100. The needle hub extension 148, as shown in figure 6, is provided in the form of an elongated stem that is cylindrical in shape. However, the needle hub extension can take other shapes. The needle hub extension 148 includes a locking portion 145 that extends radially outwardly from the needle hub extension 148.
[036] The needle cannula 150 of the needle hub assembly 140 is arranged to move in the proximal direction. In the embodiment shown, the needle hub assembly 140 is arranged to move in the proximal direction, thereby providing the fixed needle cannula 150. In the embodiment shown, the needle hub assembly 140 is arranged to move in the proximal direction by an element. bias 152 disposed between the needle hub 142 and the barrier wall 127 of the retraction cylinder 120. The bias element 152 may include a spring 153, which may be a compression spring that applies constant force to the needle hub 142 in the proximal direction. In alternative embodiments, the bias element 152 can be provided in another form, for example, a lever arm (not shown) can be arranged between the needle hub and the barrier wall. The retraction cylinder 120 includes a support element 134 that prevents the needle hub from moving in the proximal direction. As will be explained in more detail below, releasing support member 134 will allow the bent needle hub 142 and needle cannula 150 attached to it to retract into the retraction cylinder 120. In one or more variants, a portion of the hub needle 142 can be provided. For example, the needle cannula support 146 and the needle hub extension 148 can be provided as separate components from the needle hub body 144 and can be provided in such a way that when the support element 134 is released, the needle hub extension 148 and the needle cannula holder 146 can be retracted with the needle cannula 150 into the retraction cylinder 120, while the needle hub body 144 remains stationary.
[037] The needle hub assembly is dimensioned movable in the needle chamber. The size and shape of the needle hub assembly can be modified to allow movement in needle chambers having different sizes. In the assembled state, prior to use, the needle hub assembly is positioned at the open distal end of the retraction cylinder.
[038] Retraction cylinder wall 122 includes support member 134 that engages at least a portion of the needle hub assembly 140 or interacts with the needle hub assembly 140 to provide a force in the distal direction for the assembly needle hub 140 such that the needle hub assembly 140 is positioned at the open distal end 121 of the retraction cylinder. Specifically, the needle hub assembly 140 is positioned so that the needle cannula 150 extends beyond the open distal end 121 of the retraction cylinder in a first position. In the first position, the support element 134 provides a force on the needle hub 142 in the distal direction that is greater than the force applied to the needle hub 142 in the proximal direction by the propensity element 152. The support element 134 in the embodiment shown it is provided in the form of a flexible arm 135 which is attached to the wall 122 of the retraction cylinder. The wall 122 includes an opening 136 that allows the flexible arm 135 to flex outward. In the embodiment shown, the flexible arm 135 includes a distal end 137 that is attached to the wall 122 and a free proximal end 138 including a tongue 139 that extends radially into the needle chamber 125. The tongue 139 supports the proximal end 149 of the hub and needle for engaging locking portion 145. Latch 139 and flexible arm 135 are dimensioned and molded to engage locking portion 145 and support needle hub 142 and needle cannula 150. Latch 139 and flexible arm 135 are also sized and shaped to compress the bias member 152 so that the needle hub assembly is positioned in the first position. To retract the needle cannula 150 into the retraction cylinder 120, as will be described in more detail below, the flexible arm 135 is moved to release the lock portion 145. In other words, the flexible arm 135 is moved to a position in which the tongue 139 can no longer support the needle hub extension 148 and apply a force to the needle hub extension 148 or needle hub 142 in the distal direction that is greater than the force applied to the needle hub 142 in the proximal direction by the propensity element 152.
[039] In an alternative embodiment, the support element 134 can be provided in the form of a frangible section that extends inwardly from the wall 122 of the retraction cylinder. The frangible section can include a breakable projection that supports the needle hub assembly 140. The frangible section can break to release the needle hub assembly or to no longer apply force to the needle hub extension 148 or needle hub 142 in the distal direction that is greater than the force applied to the needle hub 142 in the proximal direction by the propensity element 152.
[040] A plunger rod 160 is disposed in the fluid chamber 125 and shown more clearly in figure 5. The plunger rod 160 includes a distal end 161 and a proximal end 169. The plunger 160 includes a stopper engaging portion 162 extending from the distal end 161 to a piston rod body 163. In one or more embodiments, the piston rod body 163 can extend from the stopper engaging portion 162 to the proximal end 169 of the piston rod. In the embodiment shown in figure 5, the plunger rod body 163 extends from the stopper engaging portion 162 to a reuse prevention feature that extends from the plunger rod body 163 to a thumb pressure base 164 that it is arranged at the proximal end 169 of the plunger rod. The thumb pressure base 164 can include a thumb pressure base support 184.
[041] The stopper engaging portion 162 includes an annular disk 165 disposed at the distal end of the piston rod and a narrowed portion 166 extending from the annular disk 165 to the piston rod body 163. The annular disk 165 engages a stopper 170 so as to be disposed at the distal end of the plunger rod. In one or more embodiments, the narrowed portion 166 of the plunger rod 160 and the stopper 170 can be shaped to provide relative movement of the plunger rod 160 with respect to the stopper 170. In one or more alternative embodiments, the plunger rod 160 can be fixed to the stopper 170 in a fixed relationship.
[042] As shown in figure 5, the stopper 170 has a distal end 171, a proximal end 179, a stopper body 172 and a peripheral edge 173 that forms a seal with the inner surface 114 of the fluid cylinder 110. In one or more embodiments, the peripheral wedding 173 of the stopper 170 has a width in cross section that allows the stopper 170 to slide in the proximal and distal directions in the fluid cylinder. Stopper 170 may include an optional elongated tip (not shown) at its distal end 171 to facilitate reduction of residual fluid and expulsion of fluid from the fluid cylinder.
[043] The stopper 170 includes a stopper body 174 extending from the peripheral wedding 173 to the proximal end 179. The stopper body 174 includes a recess 175 which is defined by an inner surface 176. The recess 175 includes a portion of neck 177 disposed adjacent to the proximal end 179, where the width in cross-section of the inner surface 176 in the neck portion 177 is less than the width in cross-section of the inner surface 176 in the remaining locations of the recess 175. The recess 175 allows the stopper engaging portion 162 of the plunger rod 160 connects with the stopper 170. The annular disk 165 engages the neck portion 177 to retain the stopper 170 on the plunger stem 160. In one or more alternative embodiments, retainers (not shown) or tongues (not shown) on the stopper 170 and / or the stopper engaging portion 162 can be used to retain the stopper 170 on the plunger rod 160.
[044] In one or more embodiments, the width in cross section of the inner surface 176 can be dimensioned and / or molded to avoid relative movement of the stopper engaging portion 162 in the recess 175. In the embodiment shown in figure 5, the width in section cross section of the inner surface 176 of the stopper is sized and shaped to allow relative movement of the stopper engaging portion 162 in the recess 175. Alternatively, the annular disk 165 and / or the narrowed portion 166 can be shaped and / or sized to allow or prevent movement of the stopper engaging portion 162 in the recess 175.
[045] The stopper is typically made of plastic or other easily disposable and / or recyclable material. It may be desirable to incorporate natural or synthetic rubber into the stopper or to use a natural or synthetic rubber seal with the stopper. It will be understood that the stopper can incorporate multiple seals.
[046] The retractable syringe assembly 100 also includes a firing element 190 that includes a distal end 191 and a proximal end 199. The firing element 190 is movable with the plunger rod 160, but extends into the needle chamber 125 of the retraction cylinder 120. In the embodiment shown, the firing element 190 is attached to the thumb pressure base support 184 of the piston rod. In one or more variants, the firing element 190 can be supplied separately, but configured to move with the piston rod 160 in the distal direction when a distally directed force is applied to the piston rod 160. In such embodiments, the element trigger 190 and piston rod 160 move together in the distal direction when a user applies force to the piston rod 160 in the distal direction.
[047] The firing element 190 is dimensioned, molded and positioned to provide a firing force on the needle hub 142 to disengage the support element 134 and the locking portion 145 so that the needle cannula 150 retracts and is housed in the retraction cylinder. The firing element 190 includes a firing element body 192 which extends from the distal end 191 to the proximal end 199. The firing element body 192 is shaped to be cylindrical in shape and is elongated. In the embodiment shown, the firing element 190 has an open distal end 191 and the firing element body 192 has a hollow interior 193 for housing the needle hub 142 and the needle cannula 150. The proximal end 199 of the firing element it is closed and can be tapered to retain the needle hub 142 in the hollow interior 193 after the needle hub 142 and needle cannula 150 are retracted into the retraction cylinder.
[048] The open distal end 191 of the firing element may have a chamfered edge that flexes or moves the flexible arm 135 radially outward. The movement of the flexible arm 135 radially outward causes the tongue 139 to also move radially outwards so that it no longer engages the locking portion 145 or sustains the needle hub extension 148. The movement of the tongue 139 releases the force applied to the needle hub extension 148 in the distal direction by the tab 139 and, as a result, the force applied to the needle hub 142 by the bias element 152 in the proximal direction, which remains due to compression of the bias element 152, causes that the needle hub 142 retracts or moves into the retraction cylinder 120 or specifically, the hollow interior 193 of the firing element.
[049] The modalities described here use a passive retraction mechanism because the firing element 190 is activated when the user applies a force to the piston rod in the distal direction to expel the contents of the fluid cylinder 110. Specifically, the firing element 190 and the retraction feature are only activated when the total medication dose or the total contents of the fluid cylinder 110 are expelled. Therefore, the retraction syringe sets described here are insensitive to the hydraulic pressure generated during high-speed injections or injections of viscous liquids from the fluid cylinder, which often cause premature activation. In addition, the independent retraction cylinder and the retraction characteristic housing in it allow the retraction syringe cylinder to have a low activation force that is based solely on the movement of the firing element 190 in the distal direction or application of firing on support element 134 to disengage needle hub 142. Therefore, in the modalities described here, retraction of needle hub 142 and needle cannula 150 does not require cutting, breaking, drilling or other intense mechanical action in force, instead it relies on flexing the support element 134 and tongue 139 to release the force applied to the needle hub 142 in the distal direction which neutralizes the force applied to the needle hub in the proximal direction.
[050] In the embodiment shown, the plunger rod 160 includes a reuse prevention feature. Specifically, the plunger rod 160 includes a flexible protrusion 167 arranged approximately adjacent to the plunger rod body 163 and a frangible portion 168 disposed between the flexible protrusion 167 and the thumb pressure base 164. The plunger rod 160 can be characterized such that the piston rod body 163 extends from the stopper engagement portion 162 and includes a distal portion and a proximal portion in which the flexible protuberance 167 is disposed between the distal portion and the proximal portion. The proximal portion includes the frangible portion 168.
[051] The protrusion 167 has a width in cross section that is greater than the width in cross section of the inner surface 114 of the fluid cylinder 110 in the retaining element 116. At least in one embodiment, the retractable syringe assembly is configured to allow the protrusion 167 to advance distally beyond the retaining element 116, to lock the plunger rod 160 in the fluid cylinder 110 when the user touches the bottom of the plunger rod 160 in the cylinder or when the stopper 170 is in contact with the distal wall 117 of the fluid cylinder when all contents of the fluid cylinder 110 have been expelled. Specifically, when the plunger rod 160 is moved distally in the fluid cylinder 110 after a distally directed force is applied to the plunger rod, the protrusion 167 moves distally beyond the retaining element 116. In the embodiment shown, the movement of the protuberance 167 distally beyond the retaining element 116 occurs when the stopper 170 is in contact with the distal wall 117 of the fluid cylinder. The smaller cross-sectional width of the internal surface 114 of the fluid cylinder in the retaining element 116 prevents movement of the plunger rod 160 in the proximal direction after the protrusion 167 has moved distally beyond the retaining element 116. In one or more variants , the protrusion 167 may include a peripheral edge having a tapered portion (not shown) that facilitates distal movement of the protuberance 167 distally beyond the retaining element 116 and into the fluid cylinder 110, as will become evident in the subsequent discussion of syringe operation. The flexible protuberance 167 can also flex in the proximal direction as it moves distally beyond the retaining element 116.
[052] In the embodiment shown, the plunger rod 160 further includes a frangible portion 168 to separate at least a portion of the plunger rod from the remaining portion of the plunger rod 160 when a user applies sufficient proximal force to the plunger rod 160 after being locked in the fluid cylinder 110. In the embodiment shown, the frangible point 168 is located between the protrusion 167 and the thumb pressure base 164. It will be understood that the frangible portion 168 shown is exemplary, and another suitable means for damaging permanently the plunger rod or otherwise separates at least a portion of the plunger rod from the main body can be provided. In the embodiment shown, the frangible portion 168 includes a support element 180 that extends from flexible protuberance 167 to a plurality of point connections 181 that connect support element 180 to inch pressure 164. Support element 180 shown in Figure 5 has a distal end 182 and a proximal end 183. The cross-sectional width of the support element 180 increases from distal end 182, adjacent to the flexible protuberance 167, to the proximal end 183, where the plurality of point connections 181 is willing. The support element 180 is shown to have a circular cross section and the plurality of point connections 181 is arranged at the peripheral edge of the proximal end 183 of the support element 180. The point connections 181 are distinct connections that form a connection point narrowed between the support element 180 and the thumb pressure base 164. It will be understood that a single point connection 181 can also be used to form a narrowed connection point between the support element 180 and the thumb pressure base 164 The thumb pressure base support 184 can additionally support the thumb pressure base and connect the plurality of point connections 181 to the thumb pressure base 164.
[053] In use, when the flexible protrusion 167 has advanced distally beyond the retaining element 116, and the user applies a force in the proximal direction to the plunger rod, the force required for the flexible protrusion 167 to overcome the retaining element 116 exceeds the force required to break the plurality of 181 point connections.
[054] In modalities that use a stopper and plunger rod that allow relative movement of the plunger rod in relation to the stopper, this relative movement allows the stopper to be in contact with the distal wall 117 before use so that air in the cylinder of fluid is minimized, which still allows the flexible protuberance to remain approximately adjacent to the retaining element and thereby allowing movement of the plunger rod in the distal and proximal directions. In that position, the annular disk 165 is disposed adjacent to the neck portion 177 of the stopper and the length of the plunger and stopper stem is maximized. In other words, in such embodiments, when the stopper 170 is attached to the stopper engaging portion 162, and the annular disk 165 engages the neck portion 177, there is a gap between the stopper 170 and the piston rod body 163 defining a preselected axial distance 102. In this position, the user can apply force to the plunger rod in the proximal direction to pull fluid or liquid into the fluid chamber and the stopper and plunger rod will remain in the same position at their combined length maximized. Specifically, when the user applies a force to the plunger rod 160 in the proximal direction, the plunger rod 160 and the stopper 170 move together in the proximal direction, while the stopper engaging portion 162 is connected to the stopper 170 by the neck portion 177. In this configuration, the clearance defined at the preselected axial distance 102 is maintained while the stopper 170 and plunger rod 160 move together in the proximal direction.
[055] As shown in figure 7, the user applies proximal force to the plunger rod until a predetermined or desired amount of liquid is aspirated or pulled into the syringe. During the aspiration step, the plunger rod and the stopper body move in the proximal direction together to pull medication into the syringe, while maintaining the preselected axial distance 102. The firing element 190 does not provide the firing force and the support element 134 and the latch 139 continue to engage the lock portion 145 and support the needle hub extension 148.
[056] When a distal force is applied to the plunger rod 160 during an injection or ejection step to expel the contents of the fluid cylinder 110, the distally directed force closes the gap and causes the plunger rod 160 to move at the preselected axial distance 102, while the stopper 170 remains stationary, as shown in figure 8. Compatible with at least one mode, after the stopper engaging portion 162 has moved distally at the preselected axial distance 102 in the recess 175 , is no longer in contact with the neck portion 177. After this relative movement of the plunger rod 160 with respect to stopper 170, stopper 170 and plunger rod 160 begin to move in tandem in the distal direction. In this position, the length of the plunger and stopper rod is shortened.
[057] In one embodiment, the user can inject a limited amount of the aspirated fluid or exert limited force on the piston rod 160 in the distal direction to discharge or expel some of the aspirated fluid, without locking the piston rod 160 in the cylinder fluid 110, with the proviso that the flexible protuberance 167 remains positioned approximately adjacent to the retaining element 116. However, as will be further described below, a user will typically expel substantially all of the fluid cylinder's contents by touching the bottom of the stopper 170 against the distal wall 117 of the fluid cylinder. As the user applies a force in the distal direction to the plunger rod 160, the firing element 190 moves in the retraction cylinder 120 with the plunger rod 160, as it moves in the fluid cylinder 110 in the distal direction.
[058] As described above and shown in figure 9, when the stopper is in contact with the distal wall 117, the flexible protuberance 167 will have moved distally beyond the retaining element 116, due to the shortened length of the plunger rod 160 and stopper 170 caused by the relative movement of the plunger rod 160 with respect to stopper 170. The firing element 190 applies a firing force to the support element 134 causing the support element 134 to flex radially outward or move radially outward. When the support element 134 moves radially outward, the tongue 139 no longer applies a force to the needle hub extension 148 in the distal direction and the force applied by the bias element 152 in the proximal direction causes the needle hub 142 and the needle cannula 150 move into the retraction cylinder 120, as shown in figure 10.
[059] Referring now to figure 11, which illustrates the syringe assembly after the plunger rod 160 has been locked into the fluid cylinder 110, as a user tries to reuse the retractable syringe assembly by applying force to the stem piston 160 in the proximal direction, the application of a force directed proximally to the piston rod, which is greater than the force required to break the plurality of 181 point connections, causes a portion of the piston rod 160 to separate in the plurality of point connections 181. The plurality of point connections 181 breaks because the force exerted by the retaining element 116 on the flexible protrusion 167 exceeds the breaking force of the plurality of point connections 181.
[060] As the piston rod portion 160 is removed from the remaining piston rod portion, as shown in figure 11, the needle hub assembly 140 remains on the retractable cylinder 120. The needle cannula 150 is fully housed in the retraction cylinder 120. The support element 134 and the latch 139 are no longer flexed because the firing element 190 no longer applies the firing force. In that position, the support element 134 and the latch 139 engage with a portion of the needle hub 142 which prevents removal of the needle hub and cannula from the retraction cylinder. Specifically, the needle hub 142 of one or more embodiments can include a locking portion 145 that engages the tongue 139 to prevent removal of the needle hub. In one or more alternative embodiments, the proximal end 199 of the firing element 199 may have a narrowed cross section portion (not shown) that engages the needle hub extension 148 such that the needle hub 142 is retained inside hollow 193 and the needle cannula 150 is not exposed.
[061] In one or more embodiments, the connection between the stopper engaging portion 162 and the stopper 170 may be frangible. For example, the peripheral edge 173 of the stopper 170 may have a width in cross section that is greater than the width in cross section of the inner surface 114 of the fluid cylinder 110 in the retaining element 116. In such embodiments, after a directed force proximally it has been applied to the plunger rod 160 and the stopper 170 has moved to the proximal end 119 of the fluid cylinder, the retaining element 116 engages the peripheral edge 173 of the stopper 170 and prevents the peripheral edge 173 of the stopper from moving proximally in addition to the retaining element 116. In such embodiments, the continued application of a force in the proximal direction or the application of a proximally directed force causes the connection between the stopper engaging portion 162 and the stopper 170 to break . This break prevents a user from disassembling the parts of the retractable syringe assembly. Without being theoretically limited, it is believed that the force required to break the connection between the stopper engaging portion 162 and the stopper 170 is less than the force exerted by the retaining element 116 at the peripheral edge 173 of the stopper.
[062] In modalities that do not incorporate a reuse prevention feature, the user applies force to the plunger rod 160 in the proximal direction to move the plunger rod 160 and the stopper 170 in the proximal direction. The movement of the plunger rod 160 and stopper 170 in the proximal direction creates a vacuum in the fluid cylinder 110. In this position, the firing element 190 does not apply the firing force to the support element 134 and the support element 134 and the tongue 139 they continue to apply a force to the needle hub 142 in the distal direction that is greater than the force applied to the needle hub 142 by the bias member 152 in the proximal direction. After the desired amount of liquid is aspirated into the fluid cylinder 110, the user applies force to the plunger rod 160 in the distal direction. As the plunger rod 160 and stopper 170 move in the distal direction, the firing element 190 also moves with the plunger rod 160 in the distal direction. Since the entire contents of the fluid cylinder 110 have been expelled through the stopper and the stopper 170 is in contact with the distal wall 117, the firing element 190 applies a firing force to the support element 134 and moves the support element 134 and the tongue 139 radially outwardly so that it no longer applies force to the needle hub 142 in the distal direction and is released. The force applied to the needle hub 142 in the distal direction is released because the support element 134 and the tongue 139 are no longer supporting the needle hub extension 248. The force applied to the needle hub 142 in the proximal direction by the propensity element 152 then drives the needle hub 142 and the needle cannula 150 into the retraction cylinder.
[063] An alternative embodiment of the present invention is shown in figures 1222. Figures 12-22 show a retractable syringe assembly 200 that includes a fluid cylinder 210 and a retraction cylinder 220 as otherwise described herein. The retractable syringe also includes a needle hub assembly 240, a plunger stem 260, stopper 270, and a firing element 290. The fluid cylinder shown in figures 14-15 includes a distal end 211, an open proximal end 219 , a side wall 212 extending from the distal end 211 and the proximal end 219 including an inner surface 214 that defines a chamber 215. The inner surface 214 defines a width in cross section and may include a reuse prevention feature. The distal end 211 includes a distal wall 217 that encloses the distal end 211. In the embodiment shown, the side wall 212 includes a first opening 218 to allow fluid communication between the fluid cylinder and the retraction cylinder. As will be discussed in more detail below, the first opening 218 also allows fluid communication between a needle cannula disposed in the retraction cylinder 220 and the retraction cylinder 220 and the fluid cylinder 210.
[064] The fluid cylinder 210 shown in figures 14-15 includes a reuse prevention feature. Specifically, the fluid cylinder 210 includes a retaining element 216 shown in the form of a rib that extends around the total circumference of the inner surface 214 of the fluid cylinder 210 at a location adjacent to the proximal end 219 of the fluid cylinder, as described above with reference to figure 4.
[065] The retraction cylinder 220 is disposed adjacent to the side wall 212 of the fluid cylinder 210 in the manner shown in figures 14-15. The retraction cylinder 220 is configured to accommodate a needle hub assembly 240 therein and the retraction feature. The retraction cylinder 220 includes an open distal end 221 and an open proximal end 229. A wall 222 having an inner surface 224 defining the needle chamber 225 extends from the open distal end 221 to the open proximal end 229. Wall 222 of the retraction chamber is adjacent to the side wall 212 of the fluid cylinder 210. In one or more embodiments, the wall 222 may extend around the portions of the retraction cylinder 220 that are not in direct contact with the fluid cylinder 210 and the side wall 212 can form the barrier between the retraction cylinder 220 and the fluid cylinder 210. In other words, the outer surface of the side wall 212 can form the inner surface 224 of the retraction cylinder 220 along the portion of the retraction cylinder 220 which is in direct contact with the fluid cylinder 210.
[066] Needle chamber size 225 can be modified to accommodate needle hub assembly 240 and / or retract feature. According to one or more embodiments, the interior surface 224 of the retraction cylinder 220 has a width in cross section that is less than the first width in cross section of the fluid cylinder 210. In specific embodiments, the width in cross section of the inner surface 224 of the retraction cylinder is less than approximately 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the width in cross section of the inner surface 214 of the fluid cylinder. Such designs in which the width in cross section of the inner surface 224 of the retraction cylinder is less than the width in cross section of the inner surface 214 of the fluid cylinder, provide ergonomic and functional advantages. For example, the overall appearance and handling of the double-cylinder syringe is more attractive to the user.
[067] The open distal end 221 of the retraction cylinder 220 in the embodiment shown includes a barrier wall 227 that partially encloses the open distal end 221. The open distal end 221 can be free of a barrier wall 227 and can be fully opened. . The wall 222 may include a second opening 228 that allows fluid communication with the fluid chamber 215 and the needle chamber 225. The second opening 228 of the wall can also allow fluid communication between the fluid chamber 215, the fluid chamber needle 225 and the needle cannula. The fluid communication between the fluid cylinder 210 and the retraction cylinder 220 can be provided by a first conduit 230 extending from a first opening 218 of the fluid cylinder 210 and second opening 228 of the retraction cylinder. In the embodiment shown, the first conduit 230 extends along the width of the side wall 212 and wall 222.
[068] The needle hub assembly may include a second conduit 232 extending from an open end of the needle cannula to the second opening 228 of the retraction cylinder. The second conduit 232 can include an opening 233 that must be aligned with the second opening 228 to allow fluid communication between the needle cannula and the fluid cylinder.
[069] The needle hub assembly 240 is arranged on the retraction cylinder 220 and includes a needle hub 242 and a needle cannula 250 attached to the needle hub 242. The needle hub 242 includes a distal end 241 and an end proximal 249. Needle cannula 250 includes an open, free distal end 251 and an open proximal end 259 that is attached to distal end 241 of the needle hub. The needle hub 242 shown in figure 17 includes a needle hub body 244, a needle hub holder 246 distally disposed adjacent to the needle hub body and a needle hub extension 248 that extends in the proximal direction of the needle hub body 244. The needle hub holder 246 includes a recessed portion 247 for partially housing the proximal end 259 of the needle cannula. In the embodiment shown, the lowered portion 247 includes a portion of the second conduit 232 that extends through the needle hub 242 to the second opening 228 of the retraction cylinder. In one or more alternative embodiments, the proximal end 259 of the needle cannula can extend through the recessed portion 247 to the second conduit 232, which is located entirely within the needle hub body 244 and does not extend into the cannula support. needle 246. The needle hub extension 248 extends into the needle chamber 225 forms part of the retractable feature of the retractable syringe assembly 200. The needle hub extension 248 is shown in figure 17 is provided in the form of a stem elongated which is cylindrical in shape. However, the needle hub extension can take other shapes. The needle hub extension of the embodiments shown in figure 17 includes an outwardly extending latch portion 245 that engages support member 234 of the wall, as will be described in more detail below.
[070] The needle cannula 250 of the needle hub assembly 240 is arranged to move in the proximal direction. In the embodiment shown, the needle hub assembly 240 is arranged to move in the proximal direction. In the embodiment shown, the needle hub assembly 240 is arranged to move in the proximal direction by a bias element 252 disposed between the needle hub 242 and the barrier wall 227 of the retraction cylinder 220. The bias element 252 may include a spring 253, which can be a compression spring that applies a constant force to the needle hub 242 in the proximal direction. In alternative embodiments, the bias element 252 can be provided in another form, for example, a lever arm (not shown) can be arranged between the needle hub and the barrier wall. The retraction cylinder 220 includes a support element 234 that prevents the hub and needle from moving in the proximal direction. As will be explained in more detail below, releasing support member 234 will allow the bent needle hub 242 and the needle cannula 250 attached to it to retract into the retraction cylinder 220. In one or more variants, the portion of the needle hub 242 can be provided. For example, the needle cannula support 246 and the needle hub extension 248 can be provided as separate components from the needle hub body 244 and can be arranged so that when the support element 234 is released, the needle hub extension 248 and needle cannula holder 246 can be retracted with needle cannula 250 into retraction cylinder 220, while needle hub body 244 remains stationary.
[071] The needle hub assembly is dimensioned movable in the needle chamber. The size and shape of the needle hub assembly can be modified to allow movement in needle chambers having different sizes. In the assembled state, prior to use, the needle hub assembly is positioned at the open distal end of the retraction cylinder.
[072] Retraction cylinder wall 222 includes support member 234 that engages at least a portion of the needle hub assembly 240 or interacts with the needle hub assembly 240 to provide a force in the distal direction to the assembly of needle hub 240 such that the needle hub assembly 240 is positioned at the open distal end 221 of the retraction cylinder. Specifically, the needle hub assembly 240 is positioned so that the needle cannula 250 extends beyond the open distal end 221 of the retraction cylinder in a first position. In the first position, the support element 234 engages the locking portion 245 of the needle hub extension 248 and combines a force on the needle hub 242 in the distal direction that is greater than the force applied to the needle hub 242 in the proximal direction by the bias element 252. The support element 234 in the embodiment shown is provided in the form of a flexible arm 235 which is attached to the wall 222 of the retraction cylinder. The wall 222 includes an opening 236 that allows the flexible arm 235 to flex outward. In the embodiment shown, the flexible arm 235 includes a distal end 237 that is attached to the wall 222 and a free proximal end 238 including a tongue 239 that extends radially into the needle chamber 225. The tongue 239 specifically engages the lock portion 245 of the needle hub extension and supports the needle hub extension 248. The tongue 239 and the flexible arm 235 are dimensioned and molded to engage the locking portion 245 of the needle hub extension and compress the bias element 252 so that the needle hub assembly is positioned in the first position. To retract the needle cannula 250 into the retraction cylinder 220, as will be described in more detail below, the flexible arm 235 is moved to release the locking portion 245 of the needle hub assembly 240. In other words, the arm flexible 235 is moved to a position where tongue 239 is no longer engaged with locking portion 245 and support member 234 no longer applies force to the needle hub extension 248 or needle hub 242 in the distal direction that is greater than the force applied to the needle hub 242 in the proximal direction by the propensity element 252.
[073] A piston rod 260 is disposed in the fluid chamber 225. The piston rod 260 includes a distal end 261 and a proximal end 269. The piston rod 260 includes a stopper engaging portion 262 extending from the distal end 261 to a piston rod body 263. In one or more embodiments, the piston rod body 263 can extend from the stopper engaging portion 262 to the proximal end 269 of the piston rod. In the embodiment shown in figure 16, the plunger rod body 263 extends from the stopper engaging portion 262 to a reuse prevention feature that extends from the plunger rod body 263 to a thumb pressure base 264 which is arranged at the proximal end 269 of the plunger rod. The thumb pressure base 264 can include a thumb pressure base support 284.
[074] The stopper engaging portion 262 includes an annular disk 265 disposed at the distal end of the piston rod and a narrowed portion 266 extending from the annular disk 265 to the piston rod body 263. The annular disk 265 engages a stopper 270 so as to be arranged at the distal end of the plunger rod. In one or more embodiments, the narrowed portion 266 of the plunger rod 260 and stopper 270 can be shaped to provide relative movement of the plunger rod 260 with respect to the stopper 270. In one or more alternative embodiments, the plunger rod 260 can be fixed to the stopper 270 in a fixed relationship.
[075] As shown in figure 14, stopper 270 has a distal end 271, a proximal end 279, a stopper body 272 and a peripheral edge 273 that forms a seal with the inner surface 214 of fluid cylinder 210. In a or more embodiments, the peripheral edge 382 of the stopper 270 has a width in cross section that allows the stopper 270 to slide in the proximal and distal directions in the fluid cylinder. Stopper 270 may include an optional elongated tip (not shown) at its distal end 271 to facilitate reduction of residual fluid and expulsion of fluid from the fluid cylinder.
[076] The stopper 270 includes a stopper body 274 extending from the peripheral edge 273 to the proximal end 279. The stopper body 274 includes a recess 275 which is defined by an inner surface 276. The recess 275 includes a portion of neck 277 disposed adjacent to proximal end 279, where the width in cross section of the inner surface 276 in the neck portion 277 is less than the width in cross section of the inner surface 276 in the remaining locations of the recess 275. The recess 275 allows the stopper engaging portion 262 of the plunger stem 260 connect with the stopper 270. The annular disk 265 engages the neck portion 277 to retain the stopper 270 on the plunger stem 260. In one or more alternative modes, retainers (not shown) or tongues (not shown) on the stopper 270 and / or the stopper engaging portion 262 can be used to retain the stopper 270 on the plunger rod 260.
[077] The plunger rod 260 and the stopper 270 have structure to provide relative movement of the plunger rod 26 with respect to the stopper 270, as described above with reference to figures 5 and 7-8. Figures 18-19 illustrate structure to provide relative movement of the plunger rod 260 and stopper 270. Specifically, the stopper engaging portion 262 is capable of moving proximally and distally in the recess 265 of the stopper. When the stopper engaging portion 262 is positioned adjacent to or in contact with the neck portion 278, the length of the plunger and stopper stem is maximized. When the stopper engaging portion 262 is arranged at a distance from the neck portion 278 the length of the plunger and stopper stem is shortened.
[078] The plunger rod 260 may also include a reuse prevention feature, for example, a flexible protuberance 267 as described above with reference to figures 5 and 7-11 that interacts with a retaining element 226 disposed on the inner surface 224 of the fluid cylinder, as described above with reference to figures 4 and 7-11. The plunger rod 260 can also include a frangible portion 268 that breaks after applying force to the plunger rod 260 in the proximal direction after the reuse prevention feature is activated and the plunger rod 260 is locked in the fluid cylinder 210.
[079] In use, as shown in figure 20, the stopper 270 is in contact with the distal wall 217 of the fluid cylinder. In embodiments using a plunger and stopper rod that allow relative movement of the plunger rod with respect to the stopper, the plunger rod is positioned such that the stopper engaging portion 272 is in contact with or adjacent to the neck portion 278. The length of the plunger rod 260 and stopper 270 is maximized in this configuration. As the user applies force to the plunger rod in the proximal direction to fill the fluid cylinder, the plunger rod 260 and stopper 270 move together in the proximal direction. The vacuum created by this movement draws liquid into the fluid cylinder 210. In embodiments that use a reuse prevention feature on the plunger rod and / or fluid cylinder, the reuse prevention feature is not yet activated. In modality using a flexible protrusion on the plunger rod and a retaining element on the syringe cylinder, as described above with respect to figures 7-11, the flexible protuberance 267 remains proximally positioned adjacent to the retaining element 216.
[080] After the desired amount of liquid is pulled into the fluid cylinder 210, the user applies a force to the piston rod 260 in the distal direction. In the embodiment shown, the firing element 290 and the piston rod 260 are fixed as a single unit and therefore the firing element 290 moves with the piston rod 260 in the distal direction.
[081] When the entire contents of the fluid cylinder 210 is expelled and the stopper 270 is in contact with the distal wall 217, the firing element 290 applies a firing force to the support element 234 and causes the support element 234 moves radially outward such that the tongue 239 is no longer engaged with the locking portion 245 and the force applied to the needle hub 242 by the bias member 152 causes the needle hub 242 and the needle cannula 250 retract into the retract cylinder. When the stopper is in contact with the distal wall 217, the protrusion 267 moves distally beyond the retaining element 216 of the fluid cylinder 210 and locks the plunger rod 260 into the fluid cylinder 210. Applying a force in the proximal direction on the piston rod 260 which is greater than the breaking force required to break the frangible portion 268 of the piston rod 260.
[082] A third aspect of the retractable syringe assembly 300 is shown in figures 23-27. The retractable syringe assembly includes a single cylinder 301 with a dividing wall 302 that divides cylinder 301 into a fluid cylinder 310 and a retraction cylinder 320.
[083] In the embodiment shown in figure 23, the retractable syringe assembly includes a fluid cylinder 110 and a retraction cylinder 120. The retractable syringe also includes a needle hub 140 assembly, plunger rod 160, stopper 170 and a trigger element 190.
[084] The fluid cylinder 310 may include a reuse prevention feature that cooperates with the reuse prevention feature on the plunger rod 360. As described above with reference to figures 7-11, stopper 370 and plunger 360 they may have characteristics that allow relative movement of the plunger rod 360 with respect to the stopper 370, as described above with respect to figures 7-11. In one or more alternative embodiments, the plunger rod 360 can be attached to the stopper 370 in a fixed relationship.
[085] Fluid cylinder 310 and retraction cylinder 320 include a distal end 311, an open proximal end 319, a side wall 312 extending from distal end 311 and the proximal end 319 including an inner surface 314 defining a chamber 315. The inner surface 314 defines a width in cross section and may include a reuse prevention feature, which will be discussed in more detail below. The distal end 311 of the fluid cylinder 310 includes a distal wall 317 that encloses the distal end 311, while the distal end 311 of the retraction cylinder includes an opening 322. In the embodiment shown, the dividing wall 302 includes a first opening 318 for allow fluid communication between the fluid cylinder and the retraction cylinder. As will be discussed in more detail below, the first opening 318 also allows fluid communication between a needle cannula arranged in the retraction cylinder 320 and the retraction cylinder 320 and the fluid cylinder 310.
[086] The retraction cylinder 320 is configured to accommodate a needle hub assembly 340 in it and the retraction feature. The retraction cylinder 320 includes an open distal end 321 and a closed proximal end 329. The side wall 312 and the dividing wall 302 form a needle chamber 325 that extends from the open distal end 321 to the open proximal end 329. The size of the needle chamber 325 can be modified to accommodate the needle hub assembly 340 and / or the retraction feature. According to one or more embodiments, the inner surface 324 of the retraction cylinder 320 has a width in cross section that is less than the first width in cross section of the fluid cylinder 310. In specific embodiments, the width in cross section of the surface interior 324 of the retraction cylinder is less than 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the width in cross section of the internal surface 314 of the fluid cylinder. Such designs in which the width in cross section of the inner surface 324 of the retraction cylinder is less than the width in cross section of the inner surface 314 of the fluid cylinder, provides ergonomic and functional advantages. For example, the overall appearance and handling of the double-cylinder syringe is more attractive to the user.
[087] The open distal end 321 of the retraction cylinder 320 in the embodiment shown includes a barrier wall 327 which partially encloses the open distal end 321. In an alternative embodiment, the open distal end 321 can be free from a barrier wall 327 and can be fully opened. The first opening 318 of the wall can also allow fluid communication between the fluid chamber 315, the needle chamber 325 and the needle cannula. The fluid communication between the fluid cylinder 310 and the retraction cylinder 320 can be provided by a first conduit 330 extending from a first opening 318 of the fluid cylinder 310.
[088] The needle hub assembly may include a second conduit 332 that extends from an open end of the needle cannula to the second opening 328 of the retraction cylinder. The second conduit 332 can include an opening 333 which must be aligned with the second opening 328 to allow fluid communication between the needle cannula and the fluid cylinder.
[089] Needle hub assembly 340 is arranged on retraction cylinder 320 and includes a needle hub 342 and a needle cannula 350 attached to needle hub 342. Needle hub 342 includes a distal end 341 and an end proximal 349. Needle cannula 350 includes an open, free distal end 351 and an open proximal end 359 that is attached to distal end 341 of the needle hub. The needle hub 342 shown in figures 23-27 can be the same as described above with reference to figure 17.
[090] The needle cannula 350 of the needle hub assembly 340 is propelled to move in the proximal direction. In the embodiment shown, the needle hub assembly 340 is propelled to move in the proximal direction. In the embodiment shown, the needle hub assembly 340 is arranged to move in the proximal direction by a bias element 352 disposed between the needle hub 342 and the barrier wall 327 of the retraction cylinder 320. The bias element 352 as described otherwise here that applies a constant force to the needle hub 342 in the proximal direction. In alternative embodiments, the bias element 352 can be provided in another form, for example, a lever arm (not shown) can be arranged between the needle hub and the barrier wall. The retraction cylinder 320 includes a support element 334 that prevents the needle hub from moving in the proximal direction. As will be explained in more detail below, the release of the support element 334 will allow the propelled needle hub 342 and the needle cannula 350 attached to it to retract into the retraction cylinder 320. In one or more variants, the portion of the needle hub 342 can be provided.
[091] The needle hub assembly is dimensioned movable in the needle chamber. The size and shape of the needle hub assembly can be modified to allow movement in needle chambers having different sizes. In the assembled state, prior to use, the needle hub assembly is positioned at the open distal end of the retraction cylinder.
[092] In the modality shown in figures 23-27, the retraction mechanism is not driven by a separate firing element, but instead, by the internal structure of the plunger rod 360 and syringe cylinder 301. Specifically, the wall of division 302 includes a support element 303 that engages at least a portion of the needle hub assembly 340 or interacts with the needle hub assembly 340 to provide a force in the distal direction for the needle hub assembly 340 such that the needle hub assembly 340 is positioned at the open distal end 321 of the retraction cylinder. Specifically, the needle hub assembly 340 is positioned so that the needle cannula 350 extends beyond the open distal end 321 of the retraction cylinder in a first position. In the first position, the support element 334 provides a force on the needle hub 342 in the distal direction that is greater than the force applied to the needle hub 342 in the proximal direction by the bias element 352. The support element 334 in the mode shown is provided in the form of a perpendicular tongue 304 which is arranged in the dividing wall 302 and extends into the needle chamber 325 and an inclined portion 307 which is arranged in the dividing wall 302 and extends into the fluid chamber 315. A dividing wall 302 includes an opening 305 that allows perpendicular tongue 304 to flex outwardly into fluid chamber 325 as the plunger rod interacts with the angled portion 307. In the embodiment shown, the portion of the wall division 302 adjacent to perpendicular tongue 304 also flexes inward to move perpendicular tongue 304. Perpendicular tongue 304 is sized and shaped to support needle hub 342 and cannula needle loop and compress the bias element 352 so that the needle hub assembly is positioned in the first position. To retract the needle cannula 350 into the retraction cylinder 320, as will be described in more detail below, the perpendicular tongue 304 is moved to a position where it can no longer support the needle hub 342 and apply force to the needle hub. needle 342 in the distal direction which is greater than force applied to the needle hub 342 in the proximal direction by the propensity element 352.
[093] The retraction mechanisms used in the retractable syringe assemblies 100, 200 and 300 described here can be replaced with the retraction mechanisms described in provisional order P-9275. Specifically, the retraction mechanisms shown in figures 8-12, 24-29 and 33-37.
[094] A plunger rod 360 is arranged in fluid chamber 325. Plunger rod 360 includes a distal end 361 and a proximal end 369. Plunger rod 360 includes a stopper engaging portion 362 extending from the distal end 361 to a plunger rod body 363, which can be shaped and sized as otherwise described herein with respect to retractable syringe assemblies 100 and 200. In one or more embodiments, the plunger rod body 363 may extend from the portion to engage stopper 362 to the proximal end 369 of the plunger rod. In the embodiment shown in figures 23-27, the plunger rod body 363 extends from the stopper engaging portion 362 to a reuse prevention feature that extends from the plunger rod body 363 to a thumb pressure base 364 which is arranged at the proximal end 369 of the plunger rod. The thumb pressure base 364 can include a thumb pressure base support 384.
[095] The plunger rod body 363 includes a projection 306 that extends radially outwardly from the plunger rod body 363. The projection 306 is shaped, sized and positioned to interact with the angled portion 307 of the dividing wall 302 Specifically, the projection 306 applies a distally directed force to the inclined portion 307 to cause the dividing wall 302 and the perpendicular tongue 304 to flex or move into the fluid chamber, thereby releasing the force applied to the hub. needle 342 in the distal direction and allowing the force applied to the needle hub 342 by the propelled member 352 to retract the needle hub and needle cannula into the retraction cylinder. The stopper 370 is attached to the stopper engaging portion 362 and can be shaped and sized as described otherwise with reference to retractable syringe assemblies 100 and 200. The stopper 370 can be shaped and sized and includes features to allow the plunger move in the proximal and distal directions in relation to the stopper.
[096] As shown in figures 24-25, after the desired amount of fluid is aspirated into the fluid cylinder, a force is applied to the plunger rod 360 in the distal direction to expel the contents of the fluid cylinder. As the plunger rod 360 moves in the proximal direction and the projection 306 applies a force to the angled portion 307 in the distal direction that causes the dividing wall 302 and the perpendicular tongue 304 to flex inward and release the needle hub. so that the propensity element causes the needle hub to retract into the retraction cylinder, as shown in figure 26. The reuse prevention features of the retractable syringe cylinder also lock the plunger rod 360 into the retraction cylinder. fluid 310 as otherwise described here and as shown in figure 27.
[097] Reference throughout this specification to "a modality", "certain modalities", "one or more modalities" or "a modality" means that a specific aspect, structure, material or characteristic described in relation to the modality is included in at least one embodiment of the invention. Thus, the appearance of phrases such as "in one or more modalities", "in certain modalities", "in one modality" in several places throughout this specification is not necessarily referring to the same modality of the invention. In addition, specific characteristics, structures, materials or aspects can be combined in any appropriate way in one or more modalities.
[098] Although the invention has been described here with reference to specific modalities, it should be understood that these modalities are merely illustrative of the principles and applications of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention includes modifications and variations that are included in the scope of the appended claims and their equivalents.

权利要求:
Claims (46)
[0001]
1. Syringe assembly (100, 200, 300), comprising: a fluid cylinder (110, 210, 310) including a side wall (112, 212, 312) having an internal surface (114, 214, 314) that defines a fluid chamber (115, 215, 315) for retaining fluid and having a first width in cross section, an open proximal end (119, 219, 319) and a distal end (111, 211, 311) including a distal wall ( 117, 217, 317); a plunger rod (160, 260, 360) disposed in the fluid chamber (115, 215, 315) comprising a distal end (161, 261, 361), a proximal end (169, 269, 369), a rod body plunger (163, 263, 363) extending from the distal end (161, 261, 361) to the proximal end (169, 269, 369), and a stopper (170, 270, 370) arranged at the distal end (161 , 261, 361) of the plunger rod (160, 260, 360) to form a fluid tight seal with the inner surface (114, 214, 314) of the cylinder (110, 210, 310); a retraction cylinder (120, 220, 320) disposed adjacent to the side wall (112, 212, 312) of the fluid cylinder (110, 210, 310), the retraction cylinder (120, 220, 320) including a wall ( 122, 222) having an inner surface (124, 224, 324) that defines a needle chamber (125, 225, 325), an open proximal end (219, 319), an open distal end (221, 321) including a barrier wall (127, 227, 327), an opening (118, 128, 218, 228, 318, 328) between the wall (122, 222) of the fluid cylinder (110, 210, 310) and the side wall ( 112, 212, 312) of the fluid cylinder (110, 210, 310) such that the fluid chamber (115, 215, 315) and the needle chamber (125, 225, 325) are in fluid communication and a needle hub assembly (140, 240, 340) comprising a needle hub (142, 242, 342), a needle cannula (150, 250, 350) attached to the needle hub (142, 242, 342) in fluid communication with the opening (118, 128, 218, 228, 318, 328), the hub assembly needle (140, 240, 340) propelled to move in the proximal direction; and a firing element (190, 290) FEATURED by the fact that the firing element (190, 290) is movable with the piston rod (160, 260, 360) and extending into the needle chamber (125, 225 , 325) of the retraction cylinder (120, 220, 320), the firing element (190, 290) providing a firing force causing the needle cannula (150, 250, 350) to retract into the retraction cylinder ( 120, 220, 320).
[0002]
2. Syringe assembly (100, 200, 300) according to claim 1, CHARACTERIZED by the fact that the wall (122, 222) includes a support element (134, 234, 334) that engages a needle assembly arranged in the needle chamber (125, 225, 325) and the support element (134, 234, 334) is positioned to apply a force in the distal direction to the needle hub (142, 242, 342) in such a way that the the needle cannula (150, 250, 350) extends distally beyond the open distal end (221, 321) of the retraction cylinder (120, 220, 320) in the first position.
[0003]
3. Syringe assembly (100, 200, 300) according to claim 2, CHARACTERIZED by the fact that the firing element (190, 290) provides a firing force on the needle hub (142, 242, 342) to disengage the support element (134, 234, 334) and the needle hub (142, 242, 342) so that the needle cannula (150, 250, 350) is housed in the retraction cylinder (120, 220, 320).
[0004]
4. Syringe assembly (100, 200, 300) according to claim 1, CHARACTERIZED by the fact that the needle hub (142, 242, 342) is provided by a spring arranged between the needle hub (142, 242, 342) and the barrier wall (127, 227, 327) which exerts a force on the needle hub (142, 242, 342) in the proximal direction.
[0005]
5. Syringe assembly (100, 200, 300) according to claim 1, CHARACTERIZED by the fact that the firing element (190, 290) is attached to the distal end (161, 261, 361) of the plunger rod (160, 260, 360).
[0006]
6. Syringe assembly (100, 200, 300) according to claim 5, CHARACTERIZED by the fact that the firing element (190, 290) includes a proximal end (199) attached to the proximal end (169, 269, 369) of the plunger rod (160, 260, 360), a free and open distal end (151, 251, 351) that provides the firing force, and a firing element body (192) extending from the proximal end (199) up to the distal end (191) and including an interior surface (124, 224, 324) defining a hollow interior (193).
[0007]
Syringe assembly (100, 200, 300) according to claim 1, CHARACTERIZED by the fact that the inner surface (114) of the syringe cylinder (101, 301) includes a retaining ring (116) adjacent to the said proximal end (119) which defines a second width in cross section which is less than the first width in cross section and the piston rod body (163, 263, 363) includes a flexible protuberance (167, 267) having a cross-section width greater than the cross-section width of the cylinder (101, 301) in the rib and a frangible portion (168, 268).
[0008]
8. Syringe assembly (100, 200, 300) according to claim 7, CHARACTERIZED by the fact that the piston rod body (163, 263, 363) comprises a distal portion and a proximal portion, the protuberance ( 167, 267) disposed between the distal portion and the proximal portion.
[0009]
9. Syringe assembly (100, 200, 300) according to claim 8, CHARACTERIZED by the fact that the distal portion of the piston rod body (163, 263, 363) comprises a support element (180) disposed proximally adjacent to the flexible protuberance (167, 267) and at least one frangible portion (168, 268) arranged proximally adjacent to the support element (180).
[0010]
10. Syringe assembly (100, 200, 300) according to claim 8, CHARACTERIZED by the fact that the proximal end (199) of the firing element (190, 290) is fixed to the base (164, 264, 364 ) of the plunger rod (160, 260, 360).
[0011]
11. Syringe assembly (100, 200, 300) according to claim 9, CHARACTERIZED by the fact that the distal end (161, 261, 361) of the plunger rod (160, 260, 360) includes a stopper engaging portion (162, 262, 362) and the stopper (170, 270, 370) is attached to the stopper engaging portion (162, 262, 362) of the piston rod (160, 260, 360), the stopper ( 170, 270, 370) being movable distally and proximal to the stopper engaging portion (162, 262, 362) by a pre-selected axial distance (102) such that when the distal end of the stopper (170, 270, 370) is in contact with the distal wall (117, 217, 317) of the cylinder (110, 210, 310), the protuberance (167, 267) is allowed to advance distally beyond the rib in the cylinder (110, 210 , 310) and lock the plunger rod (160, 260, 360) on the cylinder (110, 210, 310) to prevent reuse of the syringe assembly (100, 200, 300).
[0012]
12. Syringe assembly (100, 200, 300) according to claim 11, CHARACTERIZED by the fact that the stopper engaging portion (162, 262, 362) of the plunger rod (160, 260, 360) is connected to the stopper (170, 270, 370) in such a way that after applying a force oriented proximally to the plunger rod (160, 260, 360), while holding the cylinder (110, 210, 310), it makes the plunger rod (160, 260, 360) and the trigger element move the length of the axial distance (102) in a proximal direction in the cylinder (110, 210, 310), while the stopper (170, 270, 370) remains stationary.
[0013]
13. Syringe assembly (100, 200, 300) according to claim 12, CHARACTERIZED by the fact that the portion of engaging the stopper (170, 270, 370) of the plunger rod (160, 260, 360) is connected to the stopper (170, 270, 370) in such a way that after applying a force directed proximally to the plunger rod (160, 260, 360), while holding the cylinder (110, 210, 310), causes that the stopper (170, 270, 370), the plunger rod (160, 260, 360) and the firing element (190, 290) move together in a proximal direction in the cylinder (110, 210, 310).
[0014]
14. Syringe assembly (100, 200, 300) according to claim 13, CHARACTERIZED by the fact that the stopper engaging portion (162, 262, 362) of the plunger rod (160, 260, 360) is connected to the stopper (170, 270, 370) in such a way that the application of a force directed distally, initially, to the piston rod (160, 260, 360) after the application of a force directed proximally to the piston rod ( 160, 260, 360), while holding the cylinder (110, 210, 310), causes the stopper (170, 270, 370) to remain stationary and the piston rod (160, 260, 360) and the firing element (190, 290) move the length of the axial distance (102) in the distal direction in the cylinder (110, 210, 310).
[0015]
Syringe assembly (100, 200, 300) according to claim 14, CHARACTERIZED by the fact that the stopper engaging portion (162, 262, 362) of the plunger rod (160, 260, 360) is connected to the stopper (170, 270, 370) in such a way that the application of a force distally directed continuously to the piston rod (160, 260, 360) causes the stopper (170, 270, 370), piston rod (160, 260, 360) and firing element (190, 290) move together in the distal direction on the cylinder (110, 210, 310) until the stopper (170, 270, 370) reaches the distal end (111, 211, 311) of the cylinder (110, 210, 310).
[0016]
16. Syringe assembly (100, 200, 300), according to claim 15, CHARACTERIZED by the fact that the contact between the stopper (170, 270, 370) and the distal wall (117, 217, 317) of the cylinder (110, 210, 310) causes the support element (134, 234, 334) to disengage the needle hub (142, 242, 342) and the protrusion (167, 267) to advance distally beyond the rib on the cylinder (110, 210, 310) and lock the plunger rod (160, 260, 360) in the cylinder (110, 210, 310) to prevent reuse of the syringe assembly (100, 200, 300).
[0017]
17. Syringe assembly (100, 200, 300), according to claim 16, CHARACTERIZED by the fact that the application of a force directed proximally to the plunger, after the protrusion (167, 267) has advanced distally in addition to the rib, it causes at least one frangible portion (168, 268) of the plunger rod (160, 260, 360) to break.
[0018]
18. Syringe assembly (100, 200, 300), according to claim 11, CHARACTERIZED by the fact that the application of a directed proximally directed force to the plunger rod (160, 260, 360) causes the stopper engaging portion (162, 262, 362) stopper release (170, 270, 370).
[0019]
19. Syringe assembly (100, 200, 300) according to claim 6, CHARACTERIZED by the fact that the open distal end (191) of the firing element (190, 290) comprises a beveled edge that extends distally .
[0020]
20. Syringe assembly (100, 200, 300) according to claim 1, CHARACTERIZED by the fact that the retraction cylinder (120, 220, 320) is arranged parallel to the fluid cylinder (110, 210, 310) .
[0021]
21. Syringe assembly (100, 200, 300) according to claim 1, CHARACTERIZED by the fact that: the needle chamber (125, 225, 325) includes a flexible tongue that extends into the needle chamber ( 125, 225, 325) for engaging a needle hub assembly (140, 240, 340) disposed thereon; the flexible tongue positioned to engage the needle hub (142, 242, 342) and apply force in the distal direction to the needle hub (142, 242, 342) so that the needle cannula (150, 250, 350) extends in addition to the open distal end (221, 321) of the retraction cylinder (120, 220, 320) positioned in the first position; and the activating element moves the flexible tab and causes the needle cannula (150, 250, 350) to retract and be housed in the retraction cylinder (120, 220, 320) in a second position.
[0022]
22. Syringe assembly (100, 200, 300) according to claim 21, CHARACTERIZED by the fact that the needle cannula (150, 250, 350) is propelled to move in the proximal direction by a spring arranged between the hub needle (142, 242, 342) and the barrier wall (127, 227, 327) which exerts a force on the needle hub (142, 242, 342) and the spring is compressed when the flexible tongue engages the needle hub (142, 242, 342).
[0023]
23. Syringe assembly (100, 200, 300) according to claim 22, CHARACTERIZED by the fact that the barrier wall (127, 227, 327) of the needle chamber (125, 225, 325) further comprises a second opening (128, 228, 328) to allow the flexible tongue to flex inwardly into the needle chamber (125, 225, 325) and an angled portion (307) extending outwardly into the fluid chamber (115, 215, 315).
[0024]
24. Syringe assembly (100, 200, 300) according to claim 23, CHARACTERIZED by the fact that the disengagement of the flexible tongue and needle hub (142, 242, 342) allows the spring to expand and causes the needle hub (142, 242, 342) retracts into the hollow interior (193) of the firing element (190, 290).
[0025]
25. Syringe assembly (100, 200, 300) according to claim 23, CHARACTERIZED by the fact that the firing element (190, 290) is arranged on the piston rod body (163, 263, 363) and extends radially outwardly from the piston rod body (163, 263, 363).
[0026]
26. Syringe assembly (100, 200, 300) according to claim 21, CHARACTERIZED by the fact that the cylinder (110, 210, 310) comprises a dose limit indicator disposed on an external surface of the side wall ( 112, 212, 312).
[0027]
27. Syringe assembly (100, 200, 300), according to claim 24, CHARACTERIZED by the fact that after applying a force in the proximal direction to the plunger rod (160, 260, 360) causes the plunger (160, 260, 360) move in the proximal direction and draw a liquid into the fluid chamber (115, 215, 315) and sequentially applying a force in the distal direction causes the plunger rod (160, 260 , 360) engage the ramp and cause the flexible tongue to flex outward into the fluid chamber (115, 215, 315) to release the force applied to the needle hub (142, 242, 342) in the distal direction.
[0028]
28. Syringe assembly (100, 200, 300) according to claim 21, CHARACTERIZED by the fact that the internal surface (110, 210, 310) of the side wall (112, 212, 312) in the fluid chamber ( 115, 215, 315) includes a retaining ring (116) adjacent to the proximal end (119) which defines a second width in cross section which is less than the first width in cross section and the piston rod body (163, 263 , 363) includes a flexible protrusion (167, 267) having a width in cross section greater than the width in cross section of the cylinder (101, 301) in the rib and frangible portion (168, 268).
[0029]
29. Syringe assembly (100, 200, 300), according to claim 28, CHARACTERIZED by the fact that the contact between the stopper (170, 270, 370) and the distal wall (117, 217, 317) of the cylinder (110, 210, 310) causes the flexible tongue to disengage the needle hub (142, 242, 342) and the protrusion (167, 267) to advance distally beyond the rib in the cylinder (110, 210, 310) and lock the plunger rod (160, 260, 360) on the cylinder 110, 210, 310) to prevent reuse of the syringe assembly (100, 200, 300).
[0030]
30. Syringe assembly (100, 200, 300) according to claim 28, CHARACTERIZED by the fact that the distal end (161, 261, 361) of the plunger rod (160, 260, 360) includes a portion of engaging the stopper (162, 262, 362) and the stopper is attached to the stopper engaging portion (162, 262, 362) of the piston rod (160, 260, 360), the stopper (170, 270, 370) being movable distal and proximal in relation to the stopper engaging portion (162, 262, 362) by a pre-selected axial distance (102) such that when a force is applied to the piston rod (160, 260, 360) in the direction distal and distal end (171, 271) of the stopper (170, 270, 370) is in contact with the distal wall (117, 217, 317) of the cylinder (110, 210, 310), the protrusion (167, 267) is allowed to advance distally beyond the rib on the cylinder (110, 210, 310) and lock the plunger rod (160, 260, 360) on the cylinder (110, 210, 310) to prevent reuse of the syringe assembly (100, 200 , 300).
[0031]
31. Syringe assembly (100, 200, 300) according to any one of claims 1 to 19, CHARACTERIZED by the fact that it further comprises a retraction mechanism for the needle cannula (150, 250, 350) to retract for inside the retraction cylinder (120, 220, 320), where the retraction cylinder (120, 220, 320) is fitted to the fluid cylinder (110, 210, 310) and the retraction cylinder (120, 220, 320) ) has a cross section dimension that is less than 90% of the cross section dimension of the fluid cylinder (110, 210, 310).
[0032]
32 .Syringe assembly (100, 200, 300), FEATURED for comprising: a cylinder (110, 210, 310) comprising including an open proximal end (119, 219, 319), a distal end (111, 211, 311) , a side wall (112, 212, 312) extending from a distal end (111, 211, 311) and an open proximal end (119, 219, 319) defining a chamber (115, 215, 315) having a inner surface (114, 214, 314), a dividing wall (302) for dividing the chamber to define a fluid chamber (115, 215, 315) having a first cross-sectional width for retaining fluid, and a needle chamber (125, 225, 325) to house a needle hub assembly (140, 240, 340), the dividing wall (302) having an opening (118, 128, 218, 228, 318, 328) to allow communication of fluid between the fluid chamber (115, 215, 315) and the needle chamber (125, 225, 325); a needle hub assembly (140, 240, 340) disposed within the needle chamber (125, 225, 325), the needle hub assembly (140, 240, 340) comprising a needle hub (142, 242, 342), a needle cannula (150, 250, 350) attached to the needle hub (142, 242, 342) in fluid communication with the first opening (118, 218, 318), a second conduit (132, 232, 332) extending from an open end of the needle cannula (150, 250, 350) to a second opening (128, 228, 328) of the needle chamber (125, 225, 325), the needle cannula (150 , 250, 350) designed to move in the proximal direction by a bias element (152, 252, 352), the dividing wall (302) including a support element (134, 234, 334) that extends into the needle chamber (125, 225, 325) for engaging a needle hub (142, 242, 342) and an inclined portion (307) extending to the fluid chamber (115, 215, 315), the support element (134, 234 , 334) applies a force in the distal direction of the needle hub a (142, 242, 342) so that the needle cannula (150, 250, 350) extends beyond the open distal end (221, 321) of the retraction cylinder (120, 220, 320) in a first position; and a plunger rod (160, 260, 360) disposed in the fluid chamber (115, 215, 315) comprising a distal end (161, 261, 361), a proximal end (169, 269, 369), a stopper ( 170, 270, 370) arranged at the distal end (161, 261, 361) of the plunger rod (160, 260, 360) to form a fluid tight seal with the inner surface (114, 214, 314) of the cylinder (110 , 210, 310), a piston rod body (163, 263, 363) extending from the distal end (161, 261, 361) to the proximal end (169, 269, 369), and a radially extending projection outwardly from the piston rod body (163, 263, 363) to interact with the angled portion (307) of the dividing wall (302) and causes the needle cannula (150, 250, 350) to retract and be housed inside the needle chamber (125, 225, 325) in a second position.
[0033]
33. Syringe assembly (100, 200, 300) according to claim 32, CHARACTERIZED by the fact that the support element (134, 234, 334) in the first position provides a force in the needle hub (142, 242 , 342) in the distal direction that is greater than the force applied to the needle hub (142, 242, 342) in the proximal direction by the propensity element (152, 252, 352).
[0034]
34. Syringe assembly (100, 200, 300) according to claim 32, CHARACTERIZED by the fact that the support element (134, 234, 334) is a perpendicular tongue (304) which is arranged on the partition wall (302).
[0035]
35. Syringe assembly (100, 200, 300) according to claim 34, CHARACTERIZED by the fact that the dividing wall (302) includes an opening (118, 128, 218, 228, 318, 328) that allows that the perpendicular tongue (304) flexes externally to the fluid chamber (115, 215, 315) as the plunger rod (160, 260, 360) interacts with the inclined portion (307) of the dividing wall (302) .
[0036]
36. Syringe assembly (100, 200, 300) according to claim 34, CHARACTERIZED by the fact that a portion of the dividing wall (302) adjacent to the perpendicular tongue (304) also flexes internally to move the perpendicular tongue ( 304).
[0037]
37. Syringe assembly (100, 200, 300), according to claim 34, CHARACTERIZED by the fact that the perpendicular tongue (304) holds the propensity element (152, 252, 352) to maintain the hub assembly needle (140, 240, 340) in the first position.
[0038]
38. Syringe assembly (100, 200, 300), according to claim 34, CHARACTERIZED by the fact that when applying a force in the proximal direction, the tongue (139, 239) is made to move from the first position and allows the bias element (152, 252, 352) to release the needle hub assembly (140, 240, 340) and move the needle hub assembly (140, 240, 340) to the second position.
[0039]
39. Syringe assembly (100, 200, 300) according to claim 32, CHARACTERIZED by the fact that the second conduit (132, 232, 332) includes an opening (118, 128, 218, 228, 318, 328 ) which must be aligned with the second opening (128, 228, 328) to allow fluid communication between the needle cannula (150, 250, 350) and the fluid cylinder (110, 210, 310).
[0040]
40. Syringe assembly (100, 200, 300) according to claim 32, CHARACTERIZED by the fact that the needle chamber (125, 225, 325) has a cross-sectional dimension that is smaller than the first dimension in cross section of the fluid cylinder (110, 210, 310)
[0041]
41. Syringe assembly (100, 200, 300) according to claim 32, CHARACTERIZED by the fact that the internal surface (114, 214, 314) of the fluid cylinder (110, 210, 310) includes a retaining ring (116) adjacent to said proximal end (119) which defines a second width in cross section which is less than the first width in cross section and the piston rod body (163, 263, 363) includes a flexible protuberance (167 , 267) having a cross-section width greater than the cross-section width of the fluid cylinder (110, 210, 310) in the retaining ring (116).
[0042]
42. Syringe assembly (100, 200, 300) according to claim 41, CHARACTERIZED by the fact that the piston rod body (163, 263, 363) comprises a distal portion and a proximal portion, the protuberance ( 167, 267) disposed between the distal portion and the proximal portion.
[0043]
43. Syringe assembly (100, 200, 300) according to claim 42, CHARACTERIZED by the fact that the distal portion of the piston rod body (163, 263, 363) comprises a support element (180) disposed proximally adjacent to the flexible protuberance (167, 267) and at least one frangible portion (168, 268) arranged proximally adjacent to the support element (180).
[0044]
44. Syringe assembly (100, 200, 300) according to claim 43, CHARACTERIZED by the fact that the distal end (161, 261, 361) of the plunger rod (160, 260, 360) includes a portion of engaging the stopper (162, 262, 362) and the stopper (170, 270, 370) is attached to the stopper engaging portion (162, 262, 362) of the plunger rod (160, 260, 360), the stopper (170, 270, 370) being movable distally and proximal to the stopper engaging portion (162, 262, 362) by a pre-selected axial distance (102) such that when the distal end of the stopper (170, 270, 370) is in contact with the distal wall (117, 217, 317) of the cylinder (110, 210, 310), the protuberance (167, 267) is allowed to advance distally beyond the rib in the cylinder (110, 210, 310) ) and lock the plunger rod (160, 260, 360) in the cylinder (110, 210, 310) to avoid reusing the syringe assembly (100, 200, 300).
[0045]
45. Syringe assembly (100, 200, 300), according to claim 44, CHARACTERIZED by the fact that the contact between the stopper (170, 270, 370) and the distal wall (117, 217, 317) of the cylinder (110, 210, 310) causes the support element (134, 234, 334) to disengage the needle hub (142, 242, 342) and the protrusion (167, 267) to advance distally beyond the rib on the cylinder (110, 210, 310) and lock the plunger rod (160, 260, 360) in the cylinder (110, 210, 310) to avoid reusing the syringe assembly (100, 200, 300), in which preferably the application of a force directed proximally to the plunger, after the protrusion (167, 267) has advanced distally beyond the rib, causes at least one frangible portion (168, 268) of the plunger rod (160, 260, 360) break.
[0046]
46. Syringe assembly (100, 200, 300), according to claim 44, CHARACTERIZED by the fact that the application of a directed proximal force to the plunger rod (160, 260, 360) causes the stopper engaging portion (162, 262, 362) stopper release (170, 270, 370).

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法律状态:
2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-09-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2020-08-11| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

---

2020-12-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

---

2021-01-19| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/07/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

---

申请号 | 申请日 | 专利标题

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US36674910P| true| 2010-07-22|2010-07-22|

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US61/366,749|2010-07-22|

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US13/187,045|US8721599B2|2010-07-22|2011-07-20|Dual chamber passive retraction needle syringe|

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US13/187,045|2011-07-20|

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PCT/US2011/044795|WO2012012603A1|2010-07-22|2011-07-21|Dual chamber passive retraction needle syringe|

---