syringe assembly

专利摘要:
DOUBLE CAMERA SYRINGE WITH RETRACTABLE NEEDLE. It is a syringe assembly that includes a double syringe tube configuration. One or more modalities include reuse prevention features and features that prevent premature activation of the retraction mechanism. Methods for aspirating and expelling liquid from medical devices are also provided.
公开号:BR112013001624B1
申请号:R112013001624-8
申请日:2011-07-21
公开日:2021-02-17
发明作者:Ivan Zivkovic；Christopher A. Battles；James Gleason；Jeffrey Radziunas
申请人:Becton, Dickinson And Company；
IPC主号:

专利说明:

[0001] [001] Aspects of the present invention relate to syringe assemblies that include a retractable needle and reuse prevention features and methods of using such syringe assemblies. Foundations
[0002] [002] Needle retraction features have been incorporated into syringe assemblies to protect users from needlestick injuries. In conventional assemblies, needle connector assemblies, which include a needle cannula, are attached to the syringe cylinder and must be retracted into the syringe cylinder by a user or by means of a retract feature. Alternatively, a needle guard can be placed over the needle cannula by the user or otherwise.
[0003] [003] In conventional syringe assemblies in which the needle connector assemblies are retracted into the syringe cylinder by a retract characteristic, the retract characteristic is often provided within the syringe cylinder and / or the plunger rod disposed within of the syringe cylinder. Specifically, the plunger rod may include a chamber that houses the needle connector after it is retracted. The retraction feature typically includes a cutting element disposed between the plunger rod and the plug that is used to open the plug after the contents of the syringe cylinder are expelled, to expose the plunger rod chamber to receive the plug connector. needle retracted. A spring is often incorporated into the needle connector assemblies to trigger the retraction of the needle connector on the plunger rod.
[0004] [004] Consequently, such retraction characteristics require cutting, rupture, perforation or other mechanical action with intensive force for activation and, thus, increased complexity to allow the sealed plunger and plug to be broken during activation. In addition, as retractable needles designed in a more conventional way are activated after dosing by means of continuous pressure on the back of the piston rod, the inadvertent activation of the retract characteristic can occur since the same forces need to be applied when the contents of the syringe cylinder are expelled. In addition, some devices may be inadvertently activated during dosing if sufficient pressure is generated during the expulsion of the contents of the syringe, for example, when the medication is viscous and requires the user to apply additional force or pressure 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.
[0005] [005] The retraction characteristics of conventional syringe cylinders that are plunger-activated must withstand syringe pressures and the associated increase in force applied to the plunger rod, as described above. This pressure and increased forces lead to a demand for large activation forces that could exceed operating forces in order to avoid premature activation. Since most conventional syringe cylinders employ an additional plunger movement after complete dispensing, and in the same way as the dispensing movement, a threshold force needs to be used to allow the user to differentiate between a plunger completely at the bottom and the activation of the retraction feature. The threshold force can be difficult to check and maintain separately from the force applied to the plunger rod to expel the contents of the syringe cylinder. In addition, proper application of threshold force may require a user to position the syringe cylinder and needle cannula at an increased angle to the patient's skin, rather than positioning the syringe cylinder and needle cannula substantially parallel to the patient's skin. patient. The additional force required to activate the retract feature can cause additional pressure to be generated in the plug or other removable opening in the plunger rod, which may be sufficient to make the plug and / or plunger rod function properly. wrong.
[0006] [006] In conventional retractable syringe assemblies where the retract feature and the subsequent housing of the needle connector are contained within the fluid path, the retract feature and the housing can cause a volume of medication to be captured inside the cylinder syringe, thereby increasing waste and potentially affecting dosing accuracy. In addition, a portion of the captured medication can be expelled during activation of the retraction feature causing splash, if the retraction feature is activated when the needle cannula is out of the patient, or an accidental increase in the dose administered to the patient, if the feature retraction is activated when the needle cannula is in the patient. Placing the retract feature within the syringe cylinder can also cause the captured air to remain in the syringe cylinder when purging or preparing the syringe. This can lead to the possibility of injected air. The size of the syringe cylinder must also accommodate the retract feature and the needle connector assembly that will be housed therein after retraction.
[0007] [007] In syringe assemblies that do not accommodate the retract feature within 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. Such designs may not be ergonomically acceptable for certain users of these syringe assemblies.
[0008] [008] Conventional retracting syringe assemblies often do not incorporate reuse prevention features and, thus, the retracting mechanism can be readjusted, thus 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.
[0009] [009] Consequently, it would be desirable to provide a retractable syringe assembly with a retraction feature that does not interfere with the normal operation of the syringe assembly 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
[0010] [010] One aspect of the present invention relates to a syringe assembly comprising a fluid cylinder that includes a side wall that has an internal surface that defines a fluid chamber to retain fluid and that has a first width in cross section, an open proximal end and a distal end that includes a distal wall; a plunger rod disposed within the fluid chamber comprising a distal end, a proximal end, a plunger body extending from the distal end to the proximal end, and a plug disposed at the distal end of the plunger rod for formation of a fluid tight seal with the inner surface of the cylinder; a retraction cylinder disposed adjacent to the side wall of the fluid cylinder, the retraction cylinder that includes a wall that has an inner surface that defines a needle chamber, an open proximal end, an open distal end that includes a barrier wall, an opening between the wall of the retraction cylinder and the side wall of the fluid cylinder that allows fluid communication between the fluid chamber and the needle chamber and a needle connector assembly comprising a needle connector, a needle cannula attached to the needle connector, with the needle cannula in fluid communication with the opening and oriented to move in a proximal direction; and a firing element disposed within the needle chamber and movable within the retraction cylinder independently from the plunger rod, the firing element that provides a firing force that causes the needle cannula to retract in the firing cylinder. retraction.
[0011] [011] In one or more embodiments of the present invention, the needle connector assembly is arranged at the open distal end of the retraction cylinder, the needle connector assembly which additionally comprises a first fixing part, the firing element which includes a second fastening part for engaging the first fastening part. In one or more embodiments of the present invention, the firing force disengages the second clamping part from the first clamping part, then the needle cannula is retracted into the retraction cylinder. In one or more embodiments of the present invention, the needle cannula is guided by a spring disposed between the needle connector and the retraction cylinder which exerts a force on the needle cannula in a proximal direction. In one or more embodiments of the present invention, the retraction cylinder includes a tapered distal end and the spring is disposed between the needle connector and the tapered distal end of the retraction cylinder.
[0012] [012] In one or more embodiments of the present invention, the first securing part comprises a groove disposed on at least part of an external surface of the needle connector and the second securing element comprises at least one flexible arm that extends distally from the distal end of the firing element, the flexible arm that includes at least one locking element that extends inwardly for engaging the groove disposed in the needle connector. In one or more embodiments of the present invention, the trigger element includes a free proximal end, an open and free distal end that provides the trigger force, and a trigger element body that extends from the proximal end to the distal end and that includes an inner surface that defines a hollow interior. In one or more embodiments of the present invention, the needle cannula is retracted in the retraction cylinder and housed within the hollow interior of the firing element. In one or more embodiments of the present invention, the retraction cylinder wall includes a release opening and the trigger element body includes a release holder disposed adjacent the distal end of the trigger element that engages the retraction cylinder opening. In one or more embodiments of the present invention, the firing force includes applying a force to the firing element in the distal direction that is sufficient to disengage the firing element release holder from the release opening in the cylinder wall. retraction. In one or more embodiments of the present invention, the retraction cylinder includes a rib extending proximally from the barrier wall to retain the flexible arm by applying the firing force. In one or more embodiments of the present invention, upon application of the firing force, the flexible arm is moved in a proximal direction to disengage the locking element from the groove of the needle connector and slides over the rib to allow the cannula to needle retracts in the retraction cylinder.
[0013] [013] In one or more embodiments of the present invention, the needle connector assembly is removably attached to the retraction cylinder. In one or more embodiments of the present invention, the needle connector assembly is permanently attached to the retraction cylinder. In one or more embodiments of the present invention, the firing force is at least 4 lbf (1.8 kgf).
[0014] [014] In one or more embodiments of the present invention, prior to the application of the firing force, the proximal end of the firing element is aligned with the proximal end of the piston rod. In one or more embodiments of the present invention, after application of the firing force, the proximal end of the firing element is no longer aligned with the proximal end of the piston rod. In one or more embodiments of the present invention, the alignment of the firing element and plunger rod provides visual indication of retraction of the needle cannula.
[0015] [015] In one or more embodiments of the present invention, the inner surface of the sidewall of 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 protrusion which has a width in cross-section greater than the width in cross-section of the cylinder in the rib and a frangible part. In one or more embodiments of the present invention, the contact between the plug and the distal wall of the cylinder causes a protrusion to proceed distally beyond the rib in the cylinder and lock the plunger rod 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 plug engaging part and the plug is attached to the plug engaging part of the plunger rod, the plug being movable proximally and distally in relation to the plug engagement part 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 plug is in contact with the distal wall of the cylinder, the protrusion is allowed to advance distally beyond the rib on the cylinder and lock the plunger rod on the cylinder to prevent reuse of the syringe assembly. In one or more embodiments of the present invention, the continuous application of a force on the plunger rod in the proximal direction after the protrusion has advanced distally beyond the rib causes the frangible part to break. In one or more embodiments of the present invention, the continuous application of a force on the plunger rod in the proximal direction after the protrusion has advanced distally beyond the rib causes the frangible part to break.
[0016] [016] Another aspect of the present invention relates to a syringe assembly comprising a fluid cylinder that includes a side wall that has an internal surface that defines a fluid chamber to retain fluid and that has a first width in cross section, an open proximal end and a distal end that includes a distal wall; a plunger rod disposed within the fluid chamber comprising a distal end, a proximal end, a plunger body extending from the distal end to the proximal end, and a plug disposed at the distal end of the plunger rod for formation of a fluid tight seal with the inner surface of the cylinder; a retraction cylinder disposed adjacent to the side wall of the fluid cylinder, the retraction cylinder that includes a wall that has an inner surface that defines a needle chamber, an open proximal end, an open distal end that includes a barrier wall, an opening between the wall of the retraction cylinder and the side wall of the fluid cylinder that allows fluid communication between the fluid chamber and the needle chamber and a needle connector assembly comprising a needle connector, a needle cannula attached to the needle connector, with the needle cannula in fluid communication with the opening and oriented to move in a proximal direction; and a firing element disposed adjacent the distal end of the fluid cylinder to provide a firing force that causes the needle cannula to retract in the retraction cylinder.
[0017] [017] Another aspect of the present invention relates to a syringe assembly comprising a cylinder comprising comprising an open proximal end, the side wall having an internal surface that defines a fluid chamber for retaining fluid and having a first width in cross section and a needle chamber for housing a needle connector assembly, the fluid chamber and the needle chamber being bounded by a common wall and divided into separate chambers in fluid communication; a needle connector assembly disposed within the needle chamber, the needle connector assembly comprising a needle connector, a needle cannula supported within the needle connector, the needle cannula in fluid communication with the first opening and oriented to move in a proximal direction; a plunger rod disposed within the fluid chamber comprising a distal end, a proximal end, a plug disposed at the distal end of the plunger rod for forming a fluid tight seal with the inner surface of the cylinder and a rod body of plunger extending from the distal end to the proximal end; and a retraction element disposed within the needle chamber, the retraction element which includes a proximal end and an open distal end to cause the needle cannula to retract and be retracted within the retraction element.
[0018] [018] Another aspect of the present invention relates to a syringe assembly comprising a cylinder comprising comprising an open proximal end, the side wall having an internal surface that defines a fluid chamber for retaining fluid and having a first cross-section width and a needle chamber to accommodate a needle connector assembly, the fluid chamber and the needle chamber being bounded by a common wall and divided into separate chambers in fluid communication; a needle connector assembly disposed within the needle chamber, the needle connector assembly comprising a needle connector, a needle cannula, the needle cannula in fluid communication with the first opening and oriented to move in one direction proximal; a piston rod disposed within the fluid chamber comprising a distal end, a proximal end, a plug disposed at the distal end of the piston rod for forming a fluid tight seal with the inner surface of the cylinder and a rod body of plunger extending from the distal end to the proximal end; and a firing element adjacent to the distal end of the plunger rod to provide a force to cause the needle cannula to retract and retract within the needle chamber. Brief description of the drawings Figure 1 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments of the present invention; Figure 2 illustrates a side view of the syringe assembly shown in Figure 1; Figure 3 shows a view of the syringe assembly shown in Figure 1 from the proximal end of the syringe assembly; Figure 4 illustrates a side cross-sectional view of the syringe assembly shown in Figure 1, in which the retraction cylinder is located outside the fluid cylinder; Figure 5 illustrates a cross-sectional view of the fluid cylinder and the retraction cylinder taken along lines 5-5, with the firing element and piston rod removed from the assembly; Figure 6 illustrates a side cross-sectional view of the syringe assembly according to one or more embodiments, in which the retraction cylinder is nested within the fluid cylinder; Figure 7 illustrates a cross-sectional view of the fluid cylinder and the retraction cylinder taken along lines 7-7; Figure 8 illustrates a partial perspective view of the plunger rod, needle connector assembly and trigger element of Figures 4 and 6 before the needle connector assembly retracts; Figure 9 illustrates a partial perspective view of the plunger rod, needle connector assembly and the firing element shown in Figure 8 after applying force to the firing element in the distal direction; Figure 10 illustrates a partial perspective view of the plunger rod, needle connector assembly and the firing element shown in Figure 9, after the firing element breaks the frangible element; Figure 11 illustrates a partial perspective view of the plunger rod, needle connector assembly and firing element shown in Figure 10 after a part of the needle connector assembly begins to retract in the retraction cylinder; Figure 12 illustrates a partial perspective view of the plunger rod, needle connector assembly and firing element shown in Figure 11 after the needle connector assembly part is more fully retracted in the retraction cylinder; Figure 13 illustrates a perspective view of the assembly of a needle connector assembly according to one or more embodiments; Figure 14 illustrates the needle connector assembly of Figure 13 as the needle cannula and needle cannula holder are being inserted into the needle connector; Figure 15 illustrates the needle connector assembly according to claim 14, as the needle connector is being formed around the needle cannula and the needle cannula holder; Figure 16 illustrates the needle connector assembly according to claim 15, as the needle connector is being more fully formed around the needle cannula and the needle cannula holder; Figure 17 illustrates the assembled needle connector assembly according to claim 16; Figure 18 illustrates a perspective view of a needle connector assembly being mounted on a retraction cylinder, according to one or more embodiments; Figure 19 illustrates the needle connector assembly shown in Figure 18 attached to a needle guard as it is placed on the retraction cylinder also shown in Figure 18; Figure 20 illustrates the needle connector assembly and the needle guard shown in Figure 19 after the needle guard engages the needle connector assembly; Figure 21 illustrates the needle connector assembly and the needle guard shown in Figure 20 after rotation with respect to the retraction cylinder; Figure 22 illustrates the needle connector assembly and the needle guard shown in Figure 21 after alignment of the open conduit of the needle connector assembly and the retraction cylinder opening; Figure 23 illustrates the needle connector assembly and the needle guard shown in Figure 22 after removing the needle guard; Figure 24 illustrates a cross-sectional side view of a retractable syringe assembly, according to one or more embodiments; Figure 25 illustrates an enlarged partial cross-sectional view of the retractable syringe assembly shown in Figure 24; Figure 26 illustrates an enlarged partial cross-sectional view of the retractable syringe assembly shown in Figure 25 after applying the triggering force to the needle connector assembly; Figure 27A illustrates a top cross-sectional view of the double-chamber syringe cylinder shown in Figure 24; Figure 27B illustrates a cross-sectional side view of the double-chamber syringe cylinder shown in Figure 27A; Figure 27C illustrates a cross-sectional view of the double-chamber syringe cylinder shown in Figure 27A taken from the proximal end; Figure 27D illustrates a cross-sectional side view of the double-chamber syringe cylinder shown in Figure 27A taken from the distal end; Figure 28 illustrates a side view of the needle connector assembly shown in Figure 24; Figure 28A illustrates a cross-sectional view of the needle connector assembly shown in Figure 28 taken along line AA; Figure 29 illustrates a partial cross-sectional view of a retractable syringe assembly showing the proximal end according to one or more embodiments; Figure 30 illustrates the proximal end of a retractable syringe assembly according to one or more embodiments; Figure 31 illustrates the proximal end of a retractable syringe assembly shown in Figure 30 after applying force to the plunger rod in the distal direction; Figure 32 illustrates the proximal end of a retractable syringe assembly shown in Figure 31, the firing element locked within the retraction cylinder after applying force to the firing element in the distal direction; Figure 33 illustrates a partial perspective view of a plunger rod, firing element and needle connector assembly according to one or more embodiments; Figure 34 illustrates a partial perspective view of a plunger rod, firing element and needle connector assembly shown in Figure 33, after applying force to the firing element in the distal direction; Figure 35 illustrates a partial perspective view of a plunger rod, firing element and needle connector assembly shown in Figure 34 while applying force to the firing element in the distal direction as the firing element contacts the needle connector assembly; Figure 36 illustrates a partial perspective view of a plunger rod, trigger element and needle connector assembly shown in Figure 35, after the trigger element comes into contact with the needle connector assembly as the firing element exerts a firing force on the needle connector assembly; Figure 37 illustrates a partial perspective view of a plunger rod, firing element and needle connector assembly shown in Figure 36, after a part of the needle connector assembly is retracted in the firing element; Figure 38 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 38A illustrates a side view of the retractable syringe assembly shown in Figure 38; Figure 38B shows a view of the retractable syringe assembly shown in Figure 38 taken from the proximal end; Figure 39 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 39A illustrates a side view of the retractable syringe assembly shown in Figure 39; Figure 39B shows a view of the retractable syringe assembly shown in Figure 39 taken from the proximal end; Figure 40 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 41 illustrates a side view of the retractable syringe assembly shown in Figure 40; Figure 42 illustrates a view of the retractable syringe assembly shown in Figure 40 taken from the proximal end; Figure 43 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 43A illustrates a side view of the retractable syringe assembly shown in Figure 43; Figure 43B illustrates a view of the retractable syringe assembly shown in Figure 43 taken from the proximal end; Figure 44 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 44A illustrates a side view of the retractable syringe assembly shown in Figure 44; Figure 44B illustrates a view of the retractable syringe assembly shown in Figure 44 taken from the proximal end; Figure 45 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 46 illustrates a side view of the retractable syringe assembly shown in Figure 45; Figure 47 illustrates a view of the retractable syringe assembly shown in Figure 45 taken from the proximal end; Figure 48 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 49 illustrates a side view of the retractable syringe assembly shown in Figure 48; Figure 50 illustrates a view of the retractable syringe assembly shown in Figure 48 taken from the proximal end; Figure 51 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 52 illustrates a side view of the retractable syringe assembly shown in Figure 51; Figure 53 illustrates a view of the retractable syringe assembly shown in Figure 52 taken from the proximal end; Figure 54 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 54A illustrates a side view of the retractable syringe assembly shown in Figure 54; Figure 54B shows a view of the retractable syringe assembly shown in Figure 54 taken from the proximal end; Figure 55 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 56 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 56A illustrates a side view of the retractable syringe assembly shown in Figure 56; Figure 56B shows a view of the retractable syringe assembly shown in Figure 56 taken from the proximal end; Figure 57 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments; Figure 57A illustrates a side view of the retractable syringe assembly shown in Figure 57; Figure 57B shows a view of the retractable syringe assembly shown in Figure 57 taken from the proximal end; Figure 58 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments; Figure 59 illustrates a perspective view of the proximal end of a retractable syringe assembly shown in Figure 58, after rotation of the trigger element to prevent movement of the trigger element in the distal direction; Figure 60 illustrates a perspective view of the proximal end of a retractable syringe assembly shown in Figure 59, after rotation of the firing element to allow movement of the firing element in the distal direction; Figure 61 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments; Figure 62 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments; Figure 63 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments; Figure 64 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments; Figure 65 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments; and Figure 66 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments. Detailed Description
[0019] [019] Before describing the various exemplifying embodiments of the invention, it should be understood that the invention is not limited to the details of construction or process steps presented in the following description. The invention is capable of other modalities and can be practiced or carried out in different ways.
[0020] [020] In this description, a convention is followed in which the distal end of the device consists of the end closest to a patient and the proximal end of the device consists of the end furthest from the patient and closest to a professional.
[0021] [021] Aspects of the invention relate to retractable syringe assemblies and methods of aspirating and expelling a liquid from a syringe assembly.
[0022] [022] A first aspect of the present invention relates to a retractable syringe assembly that has a retract feature that is activated by the user to retract a needle connector assembly, which includes a needle cannula, in the syringe assembly.
[0023] [023] In the embodiment shown in Figures 1 to 5, the retractable syringe assembly includes a double syringe cylinder 101 that includes fluid cylinder 110 and a retraction element or retraction cylinder 120. The retractable syringe also includes a connector assembly needle 140, plunger rod 160, plug 170 and trigger element 190. The fluid cylinder shown in Figure 4 includes a distal end 111, an open proximal end 119, a side wall 112 that extends from the distal end 111 and proximal end 119 which includes 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 which encloses the distal end 111. In the embodiment shown, the side wall 112 includes a first opening 123 to allow fluid communication between the fluid cylinder and the retraction cylinder. As will be discussed in more detail below, the first opening 123 also allows fluid communication between a needle cannula disposed within the retraction cylinder 120 and the retraction cylinder 120 and the fluid cylinder 110.
[0024] [024] The fluid cylinders shown in Figures 1 to 7 may include a reuse prevention feature. Specifically, the fluid cylinder 110 may include a retaining element 109 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 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, flaps or optional detectors can be used to create a region of the fluid cylinder 110 that has a width in cross section that is less than the first width in cross section of the fluid cylinder 110. The retaining element it can also be conformed to facilitate the 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 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 diameter transition region 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 the modalities of retractable syringe assembly that use a reuse prevention feature, the prevention feature fluid cylinder 110 reuse cooperates with the corresponding reuse prevention features on the plunger rod 160 to lock the plunger rod 160 into the fluid cylinder 110 and / or to disable the plunger rod 160 from further use.
[0025] [025] An alternative embodiment is shown in Figures 6 to 7, in which the retractable syringe assembly can include a single cylinder 200. In such embodiments, a portion of the cylinder is divided by a common wall or dividing wall 201 in a cylinder fluid 210 and the remainder of the cylinder houses the retract feature and the needle connector assembly and is referred to as the retraction cylinder 220. The dividing wall 201 may include an opening 232 to allow fluid communication between the displacement cylinder fluid 210 and the retraction cylinder 220. The single cylinder 200 of figures 6 to 7 provides an ergonomic design that improves grip by providing a large diameter for small syringe sizes.
[0026] [026] In the embodiments shown in Figures 1 to 5, the retraction cylinder 120 is disposed adjacent to the side wall 112 of the fluid cylinder 110 in the embodiment shown in Figure 4. The retraction cylinder 120 is configured to accommodate a connector assembly of needle 140 in it 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 that defines needle chamber 125 extends from distal end 121 to an open proximal end 129. A wall 122 of the retraction chamber is adjacent to side wall 112 of the fluid cylinder 110. In one or more embodiments, wall 122 may extend around parts 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 internal surface 114 of the retraction cylinder 120 along the part of the retraction cylinder 120 which is in direct contact with the fluid cylinder 110.
[0027] [027] Needle chamber size 125 can be modified to accommodate needle connector 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 about 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, provide ergonomic and functional advantages. For example, the overall appearance and handling of the double-cylinder syringe is more interesting to the user. In certain embodiments, the retraction cylinder can be nestled within the fluid cylinder. For example, both the retraction cylinder and the fluid cylinder can be surrounded or limited by a common wall, and the retraction cylinder can be partially or completely disposed within the fluid cylinder or, alternatively, a partition wall can separate a single cylinder in two separate cylinders, a fluid cylinder and a retraction cylinder.
[0028] [028] The open distal end 121 of the retraction cylinder 120 in the embodiment can be completely open or partially closed, for example, by a barrier wall (not shown) that partially encloses the open distal end 121. The open distal end 121 can be free of a barrier wall and can be completely opened. In such embodiments, the needle connector assembly forms a closure around the open distal end 121 in such a way that there is fluid communication between the needle cannula and the opening 123 that allows fluid communication between the fluid cylinder 110 and the cylinder retraction 120. In one embodiment, as shown in Figure 5, wall 122 may include a second opening (not shown) that allows fluid communication with fluid chamber 115 and needle chamber 125. The second wall opening also it can allow fluid communication between the fluid chamber 115, the needle chamber 125 and the needle cannula. Fluid communication between the fluid cylinder 110 and the retraction cylinder 120 can be provided by a first conduit (not shown) extending from a first opening (not shown) of the fluid cylinder 110 and the second opening (not shown). shown) of the retract cylinder.
[0029] [029] Described otherwise, the retractable syringe assembly includes a cylinder that includes an open proximal end 119, a side wall 112 that has an internal surface that defines a fluid chamber 115 for retaining fluid and that has a first width in cross section and a needle chamber 125 to house a needle connector assembly, the fluid chamber and the needle chamber being bounded by a common wall (side wall 112) and divided into separate chambers (fluid chamber 125 and needle chamber 125) in fluid communication.
[0030] [030] According to one or more modalities, the retraction cylinder has a cross-sectional dimension that is smaller than the cross-sectional dimension of the fluid cylinder. In specific embodiments, the cross section dimension of the retraction cylinder is less than about 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the cross section dimension of the retraction cylinder. fluid. Such designs, in which the cross-sectional dimension of the retraction cylinder is smaller than the cross-sectional dimension of the fluid cylinder, provide ergonomic and functional advantages. For example, the overall appearance and handling of the double-cylinder syringe is more pleasant for the user.
[0031] [031] The needle connector assembly may include a second conduit (not shown) that extends from an open end of the needle cannula to the second opening (not shown) of the retraction cylinder. The second conduit may include an opening (not shown) that needs to be aligned with the second opening to allow fluid communication between the needle cannula and the fluid cylinder.
[0032] [032] The needle connector assembly 140 is disposed within the retraction cylinder 120 and includes a needle connector 142 and a needle cannula 150 attached to needle connector 142. Needle connector 142 includes a distal end 141 and a proximal end 149. Needle cannula 150 includes an open, free distal end 151 and an open proximal end 159 that is attached to distal end 141 of the needle connector. The needle connector 142, shown in Figures 4 and 8, includes a needle connector body 143 and a needle cannula holder 146 distally disposed within the needle connector body 143. The needle cannula holder 146 includes a recessed portion (not shown) to partially accommodate one end of the needle cannula. The recessed portion may include a portion of the second conduit (not shown) that extends through the needle connector 142 to the second opening (not shown) of the retraction cylinder to allow fluid communication between the needle cannula 150 and the fluid cylinder 110.
[0033] [033] The needle cannula 150 of the needle connector assembly 140 is oriented to move in the proximal direction. In the modality shown, the needle connector assembly 140 is oriented to move in the proximal direction, thus orienting the fixed needle cannula 150. In the modality shown, the needle connector assembly 140 is oriented to move in the proximal direction by a guide element 152 disposed between the needle connector body 143 and the needle cannula holder 148. As shown more fully in Figures 13 to 17, the guide element 152 is shown as surrounding the needle cannula holder 146. To mount the needle connector assembly 140 with the guide element 152, the guide element 152 is initially placed on the needle cannula holder 146 and compressed, as shown in Figure 13. The needle connector body 143 includes a distal end 144, a proximal end 145, distal part 147 disposed adjacent to the distal end and proximal part 148 disposed adjacent to the proximal end. The distal part 147 may include a conical fitting with an opening (not shown) through it to receive the needle cannula 150. The proximal end 148 includes two hinged closing walls 155, 156. The closing walls 155, 156 surround the the needle cannula holder and the guide element 152 as they are assembled with the needle connector body 143. Specifically, the needle cannula 150 is inserted into the opening of the distal part 147, as shown in Figure 14. The width in cross section of the opening increases from the proximal end of the distal part 147 to the distal end of the distal part 147, so that the needle cannula 150 extends through the opening, while the needle cannula holder 146 remains within the distal part 147. The two hinged closing walls 155, 156 of Figures 15 to 16 are moved inward until they surround the needle cannula support 146 and the guide element 152, as shown in Figure 17.
[0034] [034] In the embodiment shown, the guide element 152 engages the needle cannula holder 146. The guide element 152 can include a spring, which can consist of a compression spring that applies a constant force on the connector body. needle 143 in the proximal direction. In alternative embodiments, the guiding element 152 can be provided in another way, for example, a lever arm (not shown) can be arranged between the needle connector and the barrier wall. The needle connector body 143 includes a frangible element 153 that supports the guide element 152, the needle cannula holder 146 and the needle cannula 150 of movement in the proximal direction. As will be explained in more detail below, the rupture of the frangible element 153 will allow the oriented needle connector 142 and the needle cannula 150 attached to it to retract in the retraction cylinder 120.
[0035] [035] In one or more variations, the entire needle connector assembly 140 can be oriented. For example, the needle connector body 143, needle cannula holder 146 and needle cannula 150 can be provided as an integral unit that is oriented and the retraction cylinder can include a support element (not shown) that is frangible and applies force to the needle connector assembly 140 in the distal direction. The guide element 152 can be located between the needle connector assembly 140 and the distal end 121 of the retraction cylinder 120. The force applied by the support element to the needle connector assembly 140 in the distal direction acts against the force applied to the needle connector assembly 140 through the guiding element 152 in the proximal direction. Once the support member is broken, the needle connector assembly 140 can be retracted on the retraction cylinder 120.
[0036] [036] The frangible element 153 is shown in Figures 8 to 12 as a partially extended shoulder wall 154 that is arranged along parts of the inner surface of the needle connector body 143. The shoulder wall 154 extends radially inward to form a support barrier that is positioned adjacent to the guiding element 152 surrounding the needle cannula support, which prevents movement or expansion of the guiding element 152. Once the frangible element 153 is broken, for example, by moving the firing element 190 in the distal direction, engagement between the guide element 152 and the needle cannula holder 146 causes the guide element 152 to move the needle cannula holder 146 and the needle cannula 150 attached to the same in the firing element 190 and / or in the retraction cylinder 120. Specifically, the expansion of the guiding element 152 directs the needle cannula holder 146 and the needle cannula 150 to the element trigger 190 and / or retraction cylinder 120.
[0037] [037] The needle connector assembly is dimensioned movable inside the needle chamber. The size and shape of the needle connector assembly can be modified to allow movement in needle chambers that have different sizes. In the assembled state, prior to use, the needle connector assembly is positioned at the open distal end of the retraction cylinder.
[0038] [038] A plunger rod 160 is disposed within the fluid cylinder 110 and includes a plug 170 attached to it to form a fluid tight seal with the inner surface 114 of the fluid cylinder 110. The plunger rod 160 may include a reuse prevention feature that locks the plunger rod 160 inside the fluid cylinder 110 or otherwise disables the plunger rod 160. The plunger rod may include a reuse prevention feature that cooperates with a reuse prevention feature reuse arranged on the fluid cylinder 110. In one or more embodiments, the plunger rod may include a protrusion 113 that 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 on the retaining element (not shown). As discussed above, the retaining element forms a smaller cross-section width than at other locations along the length of the fluid cylinder 110. Consequently, when the plunger rod protrudes distally beyond the fluid cylinder retaining element. 110, the smaller cross-sectional width of the retaining element prevents movement of the protrusion in the proximal direction. Consequently, the plunger rod 160 is locked into the fluid cylinder 110 by the retaining element. In one or more embodiments, the plug 170 and / or the plunger rod 160 may have a structure to allow relative movement of the plunger rod 160 relative to the plug 170. For example, the plug 170 may have an internal recess that allows that the distal end of the plunger rod 160 moves in the distal and proximal directions within the internal recess, thereby lengthening or shortening the length of the plunger rod and the plug. The plunger rods and exemplary plugs that allow the relative movement of the plunger rod in relation to the plug are presented in patent applications nos. serial numbers US 12 / 137,732 (published as United States patent application publication number 20090048560) and 12 / 262,836 (published as United States patent application publication number 20090131869), each of these applications is incorporated herein by reference, in its entirety.
[0039] [039] The plug 170 can also include reuse prevention features that also cooperate with the reuse prevention features arranged on the fluid cylinder 110. For example, plug 160 can include a sealing part (not shown) that has a cross-section width which is greater than the cross-section width of the inner surface 114 of the fluid cylinder 110 in the retaining element. In such embodiments, the removal of the plug 170 is avoided due to the fact that the smaller cross-sectional width of the fluid cylinder retaining ring 110 prevents the plug 170 from being removed. The plunger rod 160 and the plug 170 can be joined by a frangible connection 172 which can cause the plunger rod 160 to be disconnected from the plug 170, while the plug 170 remains locked inside the fluid cylinder 110 by the retaining element . Exemplified plugs that include a reuse prevention feature and plunger rods and plugs joined by a frangible connection are shown in orders nos. U.S. 12 / 137,732 and 12 / 262,836, mentioned above.
[0040] [040] The retractable syringe assembly 101 also includes a firing element 190 that includes a distal end 191 and a proximal end 199. The firing element 190 is movable independently of the plunger rod 160 and extends into the needle chamber 125 of the retraction cylinder 120. In the embodiment shown in Figure 4, the firing element 190 includes a firing support 194 on which the user applies a force in the distal direction to activate the syringe assembly retraction mechanism.
[0041] [041] The firing element 190 is dimensioned, shaped and positioned to provide a firing force on the frangible element 153 of the needle connector body 143 to release the guiding element 152, thus the needle cannula 150 retracts and is housed in the retraction cylinder. The firing element 190 includes a firing element body 192 extending from the distal end 191 to the proximal end 199. The firing element body 192 is shaped to have a cylindrical 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 connector 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 connector 142 within the hollow interior 193 after the needle connector 142 and the needle cannula 150 are retracted in the retraction cylinder. The needle cannula support 146 can also include the structure for retaining the needle cannula support 146 and the needle cannula 150 retracted within the firing element 190.
[0042] [042] The open distal end 191 of the firing element can have a beveled edge that breaks the frangible element 153 more effectively by concentrating the force applied to the frangible element 153. Breaking the frangible element 153 releases the force applied to the element guide 152 and the needle cannula support 146 in the distal direction. After releasing this driving force distally, the force applied to the needle cannula support 146 by the guiding element 152 in the proximal direction remains due to the compression of the guiding element 152. The expansion of the guiding element 152 or the presence the force directed proximally on the needle cannula support 146 by the guide element 152 causes the needle connector 142 to retract or move in the retraction cylinder 120 or, specifically, into the hollow interior 193 of the firing element.
[0043] [043] In use, as shown in Figures 8 to 10, the user is free to aspirate the liquid or fluid in the fluid cylinder 110 and expel the fluid without inadvertently activating the retraction mechanism and retracting the needle cannula. After the user has aspirated and expelled the liquid as desired, the user can activate the retraction mechanism by applying force to the trigger element 190 in the distal direction. The separate retraction cylinder 12 and needle chamber 125 allows the use of a constant or reliable activation force to activate the retraction mechanism. Specifically, the activation force is not more dependent on the viscosity of the liquid that fills the fluid chamber 115. In addition, the activation force has no hands to compensate for the risk of accidental activation during normal syringe assembly operation and therefore , the activation force can be adjusted to a low level. In addition, due to the fact that the retract feature no longer has to cut through a plug, as required by some retractable syringe assemblies, the activation force can be optimized to only activate the retract feature, rather than being also optimized to penetrate the plugs.
[0044] [044] Furthermore, the separation of the retraction mechanism from the fluid cylinder 110 also reduces the accidental activation rich due to the fact that it is no longer coupled with the aspiration and injection of the fluid with the use of the plunger rod. Consequently, there is no risk of premature activation of the retraction mechanism by applying high force during high-speed injections. In use, after the finger or thumb is used to apply force to the plunger rod 160 to expel the contents of the fluid cylinder 110, the user simply moves the finger or thumb to the firing support 194 disposed adjacent to the base. thumb support 164 on the proximal end of the retraction cylinder 120. The user does not need to modify his grip or use two hands to activate the retraction mechanism, as is required in known modalities of retractable syringe assemblies.
[0045] [045] The separation of the retraction cylinder, needle connector assemblies and the retraction characteristic of the syringe assemblies presented in this document also allow the use of interchangeable needles for all dimensions of the retractable syringe. The asymmetric orientation of the needle connector assembly, relative to the entire syringe assembly, facilitates low angle injections (ie, subcutaneous injections). In addition, the asymmetric orientation also allows the user to retain the needle cannula orientation by simply holding the syringe assembly.
[0046] [046] In one or more embodiments, the needle connector assembly can be attached to the retraction cylinder to provide a leak-tight trajectory for the liquid. In one or more embodiments, this is accomplished by using a needle connector assembly that includes a sealing element, which is activated by the pressure and rotation required to assemble the needle connector assembly. Pressing and rotating movements are achieved by incorporating slightly cuneiform surfaces on the needle connector assembly that attach to the corresponding structures on the retraction cylinder. The needle connector assembly can also be designed to be rotated and fixed in one direction. This allows the needle connector assembly to be locked in a defined position, while the applied torque is rotated at sealing pressure.
[0047] [047] In the embodiment shown in Figures 18 to 23, the needle connector assembly 200 can be shaped and sized to cooperate with the retraction cylinder 220 and a needle guard 240 to provide sealing pressure for the retraction cylinder. In the embodiment shown, the retraction cylinder 220 includes a wall 223 extending from an open distal end 221. The wall includes a fastening element 222 disposed at the distal end 221 to secure the needle connector assembly 200 to the cylinder. retraction. The fastener 222 is integrally formed with the side wall of the cylinder, as shown in Figure 18. In the embodiment shown, the fastener 222 includes at least one indentation or opening 224 for receiving a finger element or other corresponding protrusion. on the needle connector assembly. In the embodiment shown, opening 224 extends in a distal direction from the open distal end 221. The fixing element also includes at least one inwardly protruding 226 that is arranged adjacent to opening 224. Protrusion 226 extends inwardly at the open distal end 221 of the retraction cylinder.
[0048] [048] The retraction cylinder 220 is attached to a fluid cylinder 230 with a fluid chamber (not shown) that includes an opening 232 to allow fluid communication between the needle connector assembly 200 and the fluid chamber. The opening 232 is arranged on the opposite side of the open distal end 221 of the retraction cylinder from the protrusion 226. The retaining element 222 of the retraction cylinder may include an alternative structure that cooperates with the needle connector assembly 200 to secure mounting of needle connector 200 to the retraction cylinder.
[0049] [049] As shown in Figure 19, the needle connector assembly 200 is mounted with a needle guard 240 prior to attachment to the retraction cylinder. As shown in Figure 23, the needle connector assembly includes a needle connector body 202 that has a distal end 203 and a proximal end (not shown). The distal end 203 includes an opening 204. A needle cannula 205 is disposed within the needle connector body 202 and extends through opening 204 of the needle connector body. A guiding element (not shown) can be disposed within the needle connector body 202, as otherwise described, for example, with reference to Figures 8 to 17. The needle connector body 202 includes an outer surface 206 that includes a fastening element 208 that engages the fastening element 222 of the retraction cylinder 220. The outer surface 206 has a generally round tapered shape or a curved tapered shape. In the embodiment shown, the fastener 208 of the needle connector assembly includes at least one radially extending flap 210 disposed on the outer surface 206 of the needle connector body. The flap 210 engages the protrusion 226 by sliding under the protrusion 226 in such a way that the protrusion 226 exerts a force in the proximal direction on the flap 210, when the needle connector assembly 200 is attached to the retraction cylinder.
[0050] [050] The needle connector body 202 also includes an open conduit 212 to allow fluid communication between the needle cannula 205 and the opening 232 of the fluid cylinder. In the embodiment shown, the position and location of the fastening element 208 and the fastening element 222 allows the alignment of the open conduit 212 and the opening 232. In addition, the proper engagement of the fastening element 208 and the fastening element 222 ensures fluid communication between the fluid cylinder 230 and the needle cannula 205.
[0051] [051] In the embodiment shown, the needle connector body 202 also includes at least one finger element 214 disposed along the outer surface 206. Specifically, the finger element 214 has a distal end 215 that is attached to the outer surface 206 and the proximal end 216 which is free and not attached to the outer surface 206 of the needle connector body 202. In the embodiment shown in Figure 23, the finger element 214 is flexible to extend outwardly from the outer surface of the needle body. connector. The application of a radially directed outward force on the finger elements 214 causes the proximal end 216 to lift the outer surface 206 of the needle connector body. The finger element 214, in the embodiment shown, has an elongated shape that extends a distal ring 217 that is distally disposed adjacent to the central point between the distal end 203 and the proximal end (not shown) of the needle connector body 202 The distal ring 217 in the embodiment shown forms an indentation on the outer surface 206 of the needle connector body 202 that extends along the perimeter of the outer surface 206. And a variation, the distal ring may form a rib that extends to out from the outer surface 206.
[0052] [052] The finger element 214 has a round distal end 215, in the embodiment shown, but can include a distal end 215 that has a different shape. The finger element 214 forms a raised platform in relation to the outer surface 206 of the needle connector body 202. From the distal end 215 to a curved part 218, the finger element 214 extends substantially parallel to the tapered outer surface 206 of the needle connector body 202. From the curved portion 218 to the proximal end 216, the finger element 214 extends substantially parallel to the retraction cylinder 220. The outer surface 206 also includes a notched portion 207 adjacent the finger element 214. The notched part 207 does not have a curved conical shape, similar to the remaining parts of the outer surface 206, but preferably has a surface that is parallel to the retraction cylinder or is inwardly curved with respect to the retraction cylinder. The finger element 214 and the notched part 207 are disposed adjacent the flap 210. In the embodiment shown, the needle connector body 202 includes two flaps 210 located through the needle connector body 202 opposite each other and the notched part 207 and the finger element 214 disposed between them. Open conduit 212 is disposed on the opposite side of flap 210 from finger element 214 and notched part 207.
[0053] [053] Needle guard 240 is arranged over the needle connector body 202 in such a way that it closes the needle cannula 205. The needle guard 240 provides protection for the user against the needle cannula 205 and prevents contamination of the needle. needle cannula 205. Needle guard 240 also activates the engagement of needle connector assembly 200 and retainer 222 of the retraction cylinder. In the embodiment shown, the needle guard 240 has a structure that engages the needle connector body 202 and facilitates its rotation in relation to the retraction cylinder 220 in such a way that the needle connector assembly 200 is properly fixed to the cylinder retraction. In the embodiment shown, needle guard 240 includes a closed distal end (not shown), an open proximal end 249 and a hollow body 242 that defines a cavity 243 for receiving needle connector body 202 and needle cannula 205. Hollow body 242 includes an inner surface 242. Inner surface 242 includes a structure that allows needle guard 240 to engage needle connector body 202 and facilitate attachment of needle connector assembly 200 to the retraction cylinder.
[0054] [054] The inner surface 242 includes a plurality of holders 244 that extend inwardly and engage at least one finger element 214 of the needle connector body 202. Holders 244 engage finger element 214 to rotate the body of needle connector 202 in relation to the fastener 222 to place the needle connector assembly 200 at the open distal end of the retraction cylinder.
[0055] [055] As shown in Figure 20, as the needle connector assembly 200 and the needle guard 240 are placed inside the open distal end 221 of the retraction cylinder, the finger element 214 flexes as it moves on the wall 223 of the retraction cylinder. As the user rotates needle guard 240 and needle connector assembly 200 attached thereto, holders 244 engage finger element 214 and apply rotational force on finger element 214 to rotate the finger connector body. needle 202 and needle connector assembly 200 until flap 210 engages protrusion 226 of the retraction cylinder and finger element 214 engages opening 224 of wall 223 of the retraction cylinder. Under the engagement of the flap 210 and protrusion 226 and the finger element 214 and the opening 224, the opening 232 is aligned with the open conduit 212 of the needle connector assembly. In other words, the engagement of the fastener 222 and the fastener 208 allows fluid communication between the opening and the needle cannula. After proper engagement of the fastener 222 and the fastener 208, the needle guard can be removed from the needle connector body 202.
[0056] [056] To remove needle connector assembly 200 from the retraction cylinder, the user places needle guard 240 over needle connector body 202 and needle cannula 205 and applies rotational force to the needle guard 240, which in turn causes holders 244 to apply rotational force on finger element 214 and causes needle connector body 202 to rotate in the opposite direction to disengage this flap 210 from protrusion 226 and the finger element 214 from the opening.
[0057] [057] A second aspect of the present invention relates to a retractable syringe assembly that provides a separate containment of the retraction mechanism and the needle cannula in a needle chamber. The assembly also includes an activation button, located at the proximal end of the syringe assembly, which extends into the needle chamber and is located adjacent to the plunger rod used to aspirate and expel fluid from a separate fluid chamber disposed adjacent to the needle chamber. Upon activation of the button, the needle connector is released in the needle chamber.
[0058] [058] The modalities according to the second aspect provide an alternative mechanism for a retractable needle syringe. Retractable needle syringes provide a chamber inside the plunger rod to house the needle cannula and other associated components after the retraction mechanism is activated. This requires increased component complexity to enable the sealed plunger and plug to be broken during activation. The double cylinder design of the modalities according to the second aspect moves the retraction mechanism to a dedicated region that allows a conventional plunger and plug to be used.
[0059] [059] Retractable needles designed in a more conventional manner (single cylinder designs with piston-activated retraction) are activated after dosing by continuous pressure on the rear of the piston rod. As there are the same forces that need to be applied when dispensing medication, inadvertent activation can occur. Specifically, such devices can be inadvertently activated during dosing if sufficient pressure is generated, that is, during the expulsion of a viscous medication from the cylinder, which requires greater forces to be applied and such forces may exceed the forces necessary to activate the retraction mechanism. In other known devices, the pressure generated in the plug may be sufficient to cause failure of the plug or any removable opening in the plunger rod.
[0060] [060] The conventional-type plunger-activated safety syringe retraction mechanisms must withstand increased syringe pressures and the associated large plunger forces, as described above. This leads to a requirement for large activation forces that exceed operating forces by some safety margin in order to avoid premature retraction. Additionally, since most devices of this type employ an additional plunger movement after complete dispensing, and in the same direction as the dispensing movement, a threshold force needs to be employed to allow the user to differentiate between a plunger completely at the bottom and the activation operation.
[0061] [061] By incorporating a separate release mechanism, different from the plunger rod, this limitation is removed in the double cylinder design, and the release activation force can be specified arbitrarily based on user requirements, considerations safety and ergonomic features. In addition, decoupling the retraction activation from the plunger rod allows a separate and separate control to be used for the retraction of the needle that gives the operator greater control over when the needle retraction occurs and removes the possibility of inadvertent actuation. In addition, since the plunger rod and plug are no longer used with the retraction mechanism, existing plunger rods and plugs from existing devices can be used in the manner described in this document.
[0062] [062] A retractable syringe assembly 300 according to one or more embodiments of the second aspect is shown in Figures 24 to 29. The syringe assembly 300 includes a double syringe cylinder that includes fluid cylinder 310 and a retraction cylinder 320 The retractable syringe also includes a needle connector assembly 340, a plunger rod 360, plug 370 and a firing element 390. The fluid cylinder shown in Figures 27A to D includes a distal end 311, an open proximal end 319 , a side wall 312 extending from the distal end 311 and the proximal end 319 which includes an inner surface 314 that defines 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 includes a distal wall 317 which encloses the distal end 311. In the embodiment shown, the side wall 312 includes a first opening 330 to allow fluid communication between the fluid cylinder and the retraction cylinder. As will be discussed in more detail below, the first opening 330 also allows fluid communication between a needle cannula disposed within the retraction cylinder 320 and the fluid cylinder 310.
[0063] [063] The fluid cylinders shown in Figures 24 to 29 may include a reuse prevention feature. Specifically, the fluid cylinder 310 may include a retaining element 309 that extends around the entire circumference of the inner surface 314 of the fluid cylinder 310 at a location adjacent to the proximal end 319 of the fluid cylinder. The cross-section width of the inner surface 314 on the retaining element is less than the first cross-section width or the cross-section width of the inner surface 314 at the remaining locations along the length of the fluid cylinder. In one or more embodiments, flaps or optional detectors can be used to create a region of the fluid cylinder 310 that has a width in cross section that is less than the first width in cross section of the fluid cylinder 310. The retaining element it can also be conformed to facilitate the activation of the reuse prevention feature. For example, the fluid cylinder 310 may also include a proximally arranged diameter transition region adjacent the retaining element at the proximal end 319 of the fluid cylinder 310. The width in cross section of the inner surface 314 of the fluid cylinder at diameter transition region increases from the distal end 311 to the proximal end 319 of the fluid cylinder 310. As will be described in greater detail below, in the modalities of the retractable syringe assembly that use a reuse prevention feature, the prevention feature fluid cylinder 310 reuse feature cooperates with the corresponding reuse prevention features on the plunger rod 360 to lock the plunger rod 360 into the fluid cylinder 310 and / or to disable the plunger rod 360 from further use.
[0064] [064] As more clearly shown in Figures 27A to D, the retraction cylinder 320 is disposed adjacent to the side wall 312 of the fluid cylinder 310. The retraction cylinder 320 is configured to accommodate a needle connector assembly 340 therein and the retraction characteristic. The retraction cylinder 320 includes the distal end 321 and an open proximal end 329. The distal end includes a tapered wall segment 232 that houses the needle connector assembly 340 therein. A wall 322 having an inner surface 324 defining the needle chamber 325 extends from the open distal end 321 to the open proximal end 329. The wall 322 of the retraction chamber is adjacent to the side wall 312 of the fluid cylinder 310. In one or more embodiments, the wall 322 can extend around the parts of the retraction cylinder 320 that are not in direct contact with the fluid cylinder 310 and the side wall 312 can form the barrier between the retraction cylinder 320 and the fluid cylinder 310. In other words, the outer surface of the sidewall 312 can form the inner surface 324 of the retraction cylinder 320 along the part of the retraction cylinder 320 that is in direct contact with the fluid cylinder 310.
[0065] [065] The size of the needle chamber 325 can be modified to accommodate the needle connector assembly 340 and / or the retract 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 inner surface 324 of the retraction cylinder is less than about 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the width in cross section of the inner 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 interesting to the user. In certain embodiments, the retraction cylinder can be nestled within the fluid cylinder. For example, both the retraction cylinder and the fluid cylinder can be surrounded or limited by a common wall, and the retraction cylinder can be partially or completely disposed within the fluid cylinder or, alternatively, a partition wall can separate a single cylinder in two separate cylinders, a fluid cylinder and a retraction cylinder.
[0066] [066] The wall 322 can include a second opening 332 that allows fluid communication with the fluid chamber 315 and the needle chamber 325. The second opening in the wall can also allow fluid communication between the fluid chamber 315, the chamber needle 325 and the needle cannula.
[0067] [067] According to one or more modalities, the retraction cylinder has a cross-sectional dimension that is smaller than the cross-sectional dimension of the fluid cylinder. In specific embodiments, the cross section dimension of the retraction cylinder is less than about 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the cross section dimension of the retraction cylinder. fluid. Such designs, in which the cross-sectional dimension of the retraction cylinder is smaller than the cross-sectional dimension of the fluid cylinder, provide ergonomic and functional advantages. For example, the overall appearance and handling of the double-cylinder syringe is more pleasant for the user.
[0068] [068] The needle connector assembly may include a fluid path 354 that extends from an open end of the needle cannula to the second opening 332 of the retraction cylinder. The second conduit may include an opening (not shown) that needs to be aligned with the second opening to allow fluid communication between the needle cannula and the fluid cylinder.
[0069] [069] Referring to Figures 28 and 28A, the needle connector assembly 340 is disposed within the retraction cylinder 320 and includes a needle connector 342 and a needle cannula 350 attached to the needle connector 342. The needle connector 342 includes a distal end 341 and a proximal end 349. The needle cannula 350 includes an open and free distal end 351 and an open proximal end 359 that is attached to the distal end 341 of the needle connector. The needle connector 342 shown in Figures 28 and 28A includes a recessed part 355 for partially housing one end of the needle cannula. The recessed part 355 is in fluid communication with the fluid path 354 to allow fluid communication between the needle cannula 350 and the fluid cylinder 310.
[0070] [070] The needle cannula 350 of the needle connector assembly 340 is oriented to move in the proximal direction. In the embodiment shown, the needle connector assembly 340 is oriented to move in the proximal direction, thus orienting the needle cannula 350 attached. The needle connector assembly 340 is oriented to move in the proximal direction by a guide element 352 disposed between the needle cannula 350 and the tapered wall segment 323 of the retraction cylinder. As shown more fully in Figures 26 to 27, the guiding element 352 is shown as surrounding the needle cannula 350.
[0071] [071] In the embodiment shown, the guide element 352 engages the needle cannula 350. The guide element 352 can include a spring, which can consist of a compression spring that applies a constant force on the needle connector 342 in the proximal direction. In alternative embodiments, the guiding element 352 can be provided in another form, for example, a lever arm (not shown) can be arranged between the needle connector and the barrier wall. The needle connector 342 includes at least one connector seal 343 disposed along the outer surface of the needle connector 342 for forming a fluid tight seal with the tapered wall segment 323 of the retraction cylinder. As will be described in more detail below, the firing element 390 supports the needle connector 342 and prevents the guiding element 352 from moving in the proximal direction. The needle connector 342 includes at least one holder 344 that receives and engages the corresponding structure on the firing element 390 that supports the needle connector 342. As will be explained in more detail below, the disengagement of the holder 344 from the corresponding structure over the firing element will allow the oriented needle connector 342 and the needle cannula 350 attached to it to retract in the retraction cylinder 320.
[0072] [072] In the embodiment shown, for example, in Figures 25, 28 and 28A, the needle connector 342 includes a first fixing part. In the embodiment shown, the first fixing part is provided in the form of at least two holders 344 or grooves 345 arranged at opposite ends of the needle connector 342. The grooves 345 are arranged adjacent to the proximal end 349 of the needle connector assembly. The grooves are shown as including a first portion radially inwardly in the needle connector 342, a second portion that has no inclination and is substantially parallel to the geometrical axis along which the needle connector is arranged, and a third portion that is tilts radially sharply outward. The first fastening part facilitates the engagement of the firing element 390 with the grooves 345. The third part 347 prevents disengagement of the firing element 390 until sufficient force is applied to the firing element 390. Specifically, the steep inclination of the third part 347 prevents the firing element from sliding over and out of detent 344 when engaged with detent 344. Once sufficient force is applied to firing rod 390 to overcome third part 347 of detent 344 mentioned in the present document as the firing force, disengagement of the firing element 390 from the needle connector 342 allows the guiding element 352 to move the needle cannula 350 and the needle connector 342 attached thereto to the firing element 390 and / or in the retraction cylinder 320. Specifically, the expansion of the guiding element 352 leads to the needle cannula 350 and the needle connector 342 to the firing element 390 and / or the retraction cylinder 320.
[0073] [073] The needle connector assembly is dimensioned movable inside the needle chamber. The size and shape of the needle connector assembly can be modified to allow movement in needle chambers that have different sizes. In the assembled state, prior to use, the needle connector assembly is positioned at the open distal end of the retraction cylinder.
[0074] [074] A plunger rod 360 is disposed within the fluid cylinder 310 and includes a plug 370 attached to it to form a fluid tight seal with the inner surface 314 of the fluid cylinder 310. The plunger 360 may include a reuse prevention feature that locks the plunger rod 360 inside the fluid cylinder 310 or otherwise disables the plunger rod 360. The plunger rod may include a reuse prevention feature that cooperates with a reuse prevention feature reuse disposed on the fluid cylinder 310. In one or more embodiments, the plunger rod may include a protrusion 313 that has a width in cross section that is greater than the width in cross section of the inner surface 314 of the fluid cylinder 310 on the retaining element (not shown). As discussed above, the retaining element forms a smaller cross-section width than at other locations along the length of the fluid cylinder 310. Consequently, when the plunger rod protrudes distally beyond the fluid cylinder retaining element. 310, the cross-sectional width minus the retaining element prevents movement of the protrusion in the proximal direction. Consequently, the plunger rod 360 is locked into the fluid cylinder 310 by the retaining element. In one or more embodiments, the plug 370 and / or the plunger rod 360 may have a structure to allow relative movement of the plunger rod 360 relative to plug 370. For example, plug 370 may have an internal recess that allows that the distal end of the plunger rod 360 moves in the distal and proximal directions within the internal recess, thereby lengthening and shortening the length of the plunger rod and the plug. The plunger rods and exemplary plugs that allow the relative movement of the plunger rod in relation to the plug are shown in orders nos. U.S. 12 / 137,732 and 12 / 262,836, mentioned above and are incorporated herein by reference.
[0075] [075] Buffer 370 may also include reuse prevention features that also cooperate with reuse prevention features arranged on the fluid cylinder 310. For example, buffer 370 may include a sealing part (not shown) that has a cross-sectional width that is greater than the cross-sectional width of the inner surface 314 of the fluid cylinder 310 in the retaining element. In such embodiments, removal of the plug 370 is avoided due to the fact that the smaller cross-sectional width of the fluid cylinder retaining element 310 prevents the plug 370 from being removed. Plunger rod 360 and plug 370 can be joined by a frangible connection 372 which causes plunger rod 360 to be disconnected from plug 370, while plug 370 remains locked within the fluid cylinder 310 by the retaining ring. Exemplary plugs that include a reuse prevention feature and plunger rods and plugs joined by a frangible connection are shown in orders nos. U.S. 12 / 137,732 and 12 / 262,836 and are hereby incorporated by reference.
[0076] [076] The retractable syringe assembly 300 also includes a firing element 390 which includes a distal end 391 and a proximal end 399. The firing element 390 is movable independently of the plunger rod 360 and extends into the needle chamber 325 of the retraction cylinder 320. In the embodiment shown, the firing element 390 includes a firing support 394 on which the user applies a force in the distal direction to activate the syringe assembly retraction mechanism.
[0077] [077] The firing element 390 includes a firing element body 392 extending from the distal end 391 to the proximal end 399. The firing element body 392 is shaped to have a cylindrical shape and is elongated. In the embodiment shown, the firing element 390 has an open distal end 391 and the firing element body 392 has a hollow interior 393 for housing the needle connector 342 and the needle cannula 350. The proximal end 399 of the firing element it is closed and can be tapered to retain the needle connector 342 within the hollow interior 393 after the needle connector 342 and the needle cannula 350 are retracted in the retract cylinder. Needle cannula 350 can also include the structure for retaining retracted needle cannula 350 within firing member 390.
[0078] [078] The distal end 391 of the firing element 390 includes a second fastening part 394 for engaging the first fastening part. In the embodiment shown, the second securing part includes at least one flexible arm 395 that extends distally from the trigger element body 393. The flexible arm 395 includes a release element 396 that is shaped, sized and positioned to engaging the grooves 345 of the needle connector 342. Specifically, the holder includes a first segment 346 that is inclined radially inward, a second portion that has no inclination and is substantially parallel to the geometry axis along which the firing element 390 is disposed and a third segment 347 that slopes out radially sharply. It should be understood that the release element 396 may have another shape or size that does not reproduce the shape and size of the grooves 345.
[0079] [079] The inner surface 324 of the retraction cylinder may include a capture rib 380 for capturing or retaining the flexible arm 395 of the firing element 390 by applying the firing force. Specifically, the capture rib 380 is disposed adjacent to the tapered wall segment 323 and extends in the needle chamber 325. The capture rib has a distal end that is fixed to the inner surface of the retraction cylinder and a free proximal end that extends in the needle chamber 325. The capture rib 380 is profiled to facilitate the distal end 391 of the trigger element 390 to slide or move over the capture rib 380 by applying a trigger force that allows the release element 396 disengagement from grooves 345 the firing rod moves in the distal direction. As shown more clearly in Figure 26, as the flexible arm 395 of the firing element 390 slides over the catch rib 380, the flexible arm 395 flexes or moves outward. The capture rib 380 holds the flexible arm 395 in the flexed position and allows the needle connector 342, the needle cannula 350 and the guide element 352 to move proximally beyond the release element 396 to the hollow interior 393 of the trigger element.
[0080] [080] The retraction cylinder 320 includes a release opening 383 disposed adjacent to the proximal end of the retraction cylinder. The release opening 383 can be closed to form an indentation in the wall 322 of the retraction cylinder. The trigger element 390 includes a release stop 397 disposed on the trigger element body 392 which engages the release opening 383. The release opening 383 and the release stop 397 provide an indication to the user of how much force is sufficient to overcome the grooves 345 of the needle connector 342. This indication can be a visual indication, a tactile indication or a combination of visual and tactile indication. Specifically, the force required to disengage release holder 397 from release opening 383 is equal to or substantially equal to the firing force. The height of the release stop 397 can be modified to require more or less force to disengage the release stop 397 from the release opening 383. In addition, the release opening 383 can be modified to have curved inlets to decrease the angle between the inner surface of the wall 322 and the release opening 383. In embodiments where the release opening 383 is open and not closed, the release opening 383 and the release stop 397 provide visual indication of whether the firing force has been applied . Specifically, the user can view whether the release stop 397 is engaged with the release opening 383 and whether the firing force has been applied.
[0081] [081] In one or more embodiments, the firing force, which consists of the force required to disengage release holder 397 from release opening 383 and / or to disengage release element 396 from slot 345 is at least about 4 pounds of force (lbf) (1.8 kgf). In one or more variations, the firing force is about 4 lbf (1.8 kgf). In another variation, the firing force may include 2 lbf (0.9 kgf), 3 lbf (1.4 kgf), 4 lbf (1.8 kgf), 5 lbf (2.3 kgf) or 6 lbf (2 , 7 kgf). In a more specific mode, the firing force is in the range from about 3.5 lbf (1.6 kgf) to about 4.5 lbf (2.0 kgf).
[0082] [082] In the mode shown, the needle connector assembly is permanently attached to the retraction cylinder 320 due to the fact that it is enclosed within the retraction cylinder. In one or more alternative embodiments, the needle connector assembly can be removably attached to the retraction cylinder 320 or can be attached by the user to the open distal end 321 of the retraction cylinder.
[0083] [083] With reference to Figure 29, the length of the plunger rod 360, the firing element 390 and the syringe cylinder 301 can be modified so that the plunger rod 360 aligns with the firing element by expelling all the contents of the syringe, as shown in Figure 29. The alignment of the plunger rod 360 and the firing element 390 provides one or more of the visual indication and the tactile indication that the contents of the fluid cylinder 310 have been expelled and the cannula needle 350 can be retracted in the retract cylinder. In addition, such alignment of the firing element 390 and the plunger rod 360, after the plug 370 comes into contact with the distal wall 317 of the fluid cylinder 310, requires that the firing element 390 is not aligned with the plunger rod. 360 when the fluid cylinder is filled. Specifically, the firing element 390 is located closer to the proximal end 329 of the retraction cylinder and to the proximal end 319 of the fluid cylinder than the plunger 360. This alignment, when retraction of the needle cannula is not desired, reduces the chance of inadvertent activation of the retraction mechanism.
[0084] [084] A third aspect of the present invention concerns a retractable syringe assembly that incorporates the structure to prevent premature activation of the retraction mechanism. The retractable syringe assembly is shown in Figures 30 to 32. In the embodiments shown in Figures 30 and 32, the syringe assembly 400 includes a double syringe cylinder, as described elsewhere in this document, which includes a retraction cylinder 420 and a fluid cylinder 410. A firing element 490 is disposed within the retraction cylinder 420 and a plunger rod 460 is disposed within the fluid cylinder 410. The plunger rod 460 and firing element 490 have characteristics that avoid that the plunger rod interacts with firing element 490 and accidentally activates firing element 490. In addition, plunger rod 460 and firing element 490 have reuse prevention features that prevent the user from reusing syringe assembly 400. These characteristics of preventing premature activation and characteristics of preventing reuse of the firing element 490 and piston rod 460 described in relation to the third aspect can be incorporated with other firing elements and piston rods described in this document.
[0085] [085] The firing element 490 includes a distal end (not shown) and a proximal end 499 and a firing element body 492 extending from the distal end to the proximal end 499. A socket 494 is disposed adjacent the end proximal 499. In the modality shown, the socket 494 is located between the firing element 490 and the piston rod 460. The socket 494 engages the retraction cylinder and the engagement between them prevents or prevents the movement of the firing element 490 in the distal direction. As shown in Figure 30, the socket 494 is shown as a radially outward extension extending from the firing element body 492. The socket 494 includes a distal end 495 and a proximal end 496. The socket 494 has a height which extends from the proximal end 496 to the distal end 495 to allow or facilitate movement of the plunger rod 460 beyond the socket 494. The distal end 495 of the socket 494 is shown to be substantially perpendicular to the firing element body.
[0086] [086] The plug-in element 494 is depressible by applying a force in the distal direction. The locking element 494 cannot be depressed by applying force in the proximal direction. Consequently, the engagement of the locking element 494 with the retraction cylinder 420 applies a force on the locking element 494 in the proximal direction, which prevents the locking element from depressing and prevents the movement of the firing element 490 in the distal direction. . When the piston rod 460 is moved in the distal direction, it depresses the locking element 494 and allows movement of the firing element 490 in the distal direction. The plunger rod 460 can include a contact surface, shown in Figures 30 to 32 as a flat radial ring 462, which deflects the locking element 494, then the firing element 494 can be moved in the distal direction and the activation of the retraction mechanism can proceed.
[0087] [087] In use, as shown in Figures 31 to 32, movement of the plunger rod in the distal direction to expel all the contents of the fluid cylinder 410 depresses the locking element 494. When the plunger rod touches the bottom or when all the contents of the fluid cylinder 410 are expelled and the plug is in contact with the distal end of the fluid cylinder, the plunger rod continues to depress the locking element 494. The depression of the locking element 494 allows the movement of the locking element trigger 490 only after the contents of the syringe are expelled. Consequently, premature activation of the retraction mechanism is avoided.
[0088] [088] The underlying principle of the locking element 494 is the fact that the inclusion of a steep angular surface, which can be a maximum of 90 degrees), engages the retraction cylinder and prevents the distal movement of the firing element. The locking element 494 may have sufficient stiffness in the axial direction, but it can be easily deflected in the radial direction. This ensures smooth deflection when the plunger rod engages the locking element 494.
[0089] [089] In one or more embodiments, the locking element 494 can be rotatable, thus, it can be turned during transport and storage, as shown in Figures 58 to 60. Before use or before activation, as shown in Figure 58 , the firing element 490 can be turned or rotated in such a way that the locking element 494 is positioned to prevent movement of the firing element 490 in the distal direction, as shown in Figure 59. Later, when the activation of the retraction mechanism it is desired, for example, when the contents of the fluid cylinder 410 have been expelled, the firing element 490 can be rotated in such a way that the locking element 494 is positioned to allow movement of the firing element 490 in the distal direction, as shown in Figure 60.
[0090] [090] The firing element 490 and the retraction cylinder 420 include a reuse prevention feature. The retraction cylinder 420 includes a first locking element 440 disposed adjacent to its proximal end which engages with a second locking element 450 disposed on the firing element body 492. The first locking element 440 is shown as an opening 442 on the wall 422 of the retraction cylinder 420. It should be understood that the opening can be provided in other ways. The second locking element 450 is shown as an outward projection 452 arranged on the trigger element body 492. The projection 452 has a proximally facing stop face 454 that prevents movement of the trigger element 492 in the proximal direction. and prevents disengagement of the first locking element 440 and the second locking element 450.
[0091] [091] The first locking element and the second locking element 450 are positioned on the retraction cylinder 420 and the firing element 490, thus, they can engage when a force is applied to the firing rod in the distal direction to activate the mechanism retraction. As shown in Figure 32, by applying force on the firing element 490 in the distal direction, the projection 452 engages the opening 442.
[0092] [092] A trigger element reuse prevention feature can be designed to be easily deflected in the radial direction when the trigger element comes into contact with the inner surface of the retraction cylinder 420. At the end position of the first and second locks 440, 450, the projection 452 of the firing element 490 should reach the opening 442 where the projection 452 can expand again and lock the back movement of the firing element 490. This will prevent the firing element 490 from being removed from the cylinder retraction 420 and activated for multiple activations of the retraction mechanism. By adding this reuse feature to the device, the retraction mechanism can only be activated once, thus preventing reuse after, for example, changing the retraction needle.
[0093] [093] A fourth aspect of the present invention relates to a retractable syringe assembly 500 that includes an alternative retraction mechanism. The retractable syringe assembly 500 is shown in Figures 33 to 37. The syringe assembly 500 includes a double-chamber syringe cylinder, as described elsewhere in this document, which includes a needle chamber and a fluid chamber. A needle connector assembly 540 according to the needle connector assembly described with reference to Figures 8 to 17, wherein a needle connector 542 encloses a needle cannula holder 546, a needle cannula 550 that is attached to the needle cannula holder and guide element 552 disposed between needle cannula holder 546, needle cannula 550 and needle connector 542. Needle connector 542, as shown in Figures 33 to 37, includes an end distal 553 and a proximal end 554. The distal end 553 can include a body part 545 that has a tapered shape and that includes an opening (not shown) through it to receive the needle cannula 550. The proximal end 554 includes a first retraction part 555 which extends in the proximal direction from the body 545 and defines a connector cavity for housing the needle cannula holder 546, the guide element 552 and the needle cannula, as described above but with reference to Figures 8 to 17. The first retraction part 554 includes a distal end 557 attached to the body part 545 and a free proximal end 556. The first retraction part 555 also includes at least one flexible part 558 which has a engagement flap 559 at the proximal end thereof. The engagement tab 559 engages the needle cannula support 546 and exerts a force on the needle cannula support 546 in the distal direction to act against the force applied by the guide element 552 in the proximal direction on the needle connector assembly 540 .
[0094] [094] The firing element 590 includes a distal end 591 and a proximal end (not shown). The firing element 590 also includes a firing element body 592 extending from the distal end 591 to the proximal end, as otherwise described herein, which may include a hollow interior 593 for housing the needle cannula. retracted. The trigger element body 592 includes a rib 594 that extends radially outwardly to disengage the engagement flap 559 from the needle cannula holder 546 and release the force applied by the engagement flap 559 on the needle connector assembly. 540. The firing element 590 disengages the flap 559 and the needle cannula holder 546 by applying the firing force to the firing element, which provides sufficient force in the distal direction on the coupling flap 559 and / or the flexible part 558 to cause the flexible part 558 to move into shape, thus, the engagement tab 559 is no longer engaged with the needle cannula support 546 and the force applied by the guiding element is no longer neutralized. Specifically, the removal of the force applied by the engagement tab 559 on the needle cannula support 546 in the distal direction allows the force applied by the guide element 552 to move the needle cannula support 546 and needle cannula 550 to the firing.
[0095] [095] The modalities described in this document may include alternative retraction mechanisms that are presented in provisional application for reference number US P-8842, provisional application for the United States, serial number 61/366749, incorporated by reference, in their entirety. . Specifically, the retraction mechanisms shown in Figures 7 to 11, 18 to 22 and 24 to 27 of the provisional U.S. reference number application P-8842.
[0096] [096] The alternative modes of the firing element are shown in Figures 38 to 57, 57A, 57B and Figures 61 to 66, which can be used with the syringe assemblies described in this document.
[0097] [097] In Figures 38, 38A, 38B, 39, 39A, 39B and 54, 54A, 54B and 55, the proximal end of the firing element has a circular firing support that substantially surrounds or surrounds the plunger rod at the proximal end open the fluid cylinder. The trigger element can be coded by signals, such as one or more of indentations, markings or color codes. By activating the firing element by applying distal force to the piston rod, the proximal end or thumb support of the piston rod can be completely nested within the firing support.
[0098] [098] Figures 40 to 42 show a design in which the plunger rod engages the firing element shaped like a semicircular element or element in increasing shape. The thumb support base of the piston rod can be up to its most distal position and the user can then activate the firing element by applying force to the firing element.
[0099] [099] Figures 43 to 47 show a design in which the proximal end of the firing element has a firing support in substantially rectangular shape with curved edges and the plunger rod can nest within the firing support. In Figures 48 to 50, the firing support has a substantially oval shape. In Figures 51 to 53, the firing support is aligned with the needle cannula on one side of the finger flange of the syringe assembly. In Figures 56, 57, 57A and 57B, the firing element has a firing support which is aligned with the needle cannula and the needle chamber, and the firing support extends outwardly from the body of the needle chamber . Figure 61 shows a configuration in which the firing element consists of a small flap at the end of the needle chamber. Figure 62 shows a trigger element such as a flap that can be activated by applying a force in the distal direction. The firing element has a gripping surface in the form of a plurality of spaced ribs. Figure 63 shows an alternative trigger element design, in which the trigger element is in the form of a block that can be activated by the user. Figure 64 shows a button embedded in the proximal end of the needle cylinder that can be activated by the user by pressing or pressing the button to cause the needle to retract.
[0100] [0100] Figure 65 shows a support base for a piston rod thumb that articulates part that can be moved by applying force distal to the articulated part to activate a retraction mechanism of the firing element. Figure 66 shows a firing element that is somewhat similar to Figure 64, except that the firing element is in the form of an articulated type element that can be moved radially to activate the retract mechanism.
[0101] [0101] In another embodiment of the present invention, a method is provided for aspirating and expelling a liquid from a syringe assembly of the present invention which comprises aligning the trigger guard to prevent movement of the trigger member in the distal direction. A pre-selected amount of liquid is then aspirated into the fluid chamber by inserting the needle cannula into the liquid and applying force to the plunger rod in a proximal direction. The liquid from the fluid chamber is expelled by applying force to the piston rod in the distal direction. The needle cannula is retracted in the retraction cylinder by aligning the firing guard to allow the firing element to move in the distal direction and applying a force to the firing guard in the distal direction to provide the firing force that causes the needle cannula to retract in the retraction cylinder.
[0102] [0102] In another embodiment of the present invention, a method is provided for aspirating and expelling a liquid from a syringe assembly of the present invention which comprises aspirating a pre-selected amount of liquid into the fluid chamber by inserting the cannula needle in the liquid and applying a force on the plunger rod in a proximal direction. The liquid from the fluid chamber is then expelled by applying force to the piston rod in the distal direction. The plunger rod is locked into the fluid cylinder by applying continuous force to the plunger rod in the distal direction, which causes the plunger rod protrusion to move distally beyond the fluid cylinder retaining ring. . The needle cannula is retracted in the retraction cylinder by aligning the firing guard to allow the firing element to move in the distal direction and applying a force to the firing guard in the distal direction to provide the firing force that causes the needle cannula to retract in the retraction cylinder.
[0103] [0103] In another embodiment of the present invention, a method is provided for aspirating and expelling a liquid from a syringe assembly of the present invention which comprises providing a syringe cylinder that includes a fluid cylinder and a retracting cylinder in communication fluid, the fluid cylinder that includes a plunger rod attached to a plug for aspirating and expelling liquid from the fluid cylinder and a retraction cylinder that includes a needle connector, needle cannula with an opening and a firing element to provide a firing force that causes the needle cannula to retract into the retract cylinder. The opening of the needle cannula is submerged in a liquid and the fluid cylinder of the syringe is filled with the liquid by applying force to the plunger rod in a proximal direction. The liquid from the fluid cylinder is expelled by applying force to the plunger rod in a distal direction. The needle cannula is then retracted in the retraction cylinder by applying force to the firing element in the distal direction to provide the firing force.
[0104] [0104] In another embodiment of the present invention, a method is provided for aspirating and expelling a liquid from a syringe assembly of the present invention which further comprises locking the plunger rod in the fluid cylinder after expelling the liquid from of the fluid cylinder.
[0105] [0105] In another embodiment of the present invention, a method is provided for aspirating and expelling a liquid from a syringe assembly of the present invention, in which the force applied to the plunger rod is oriented along a geometric axis that is parallel to the geometric axis along which the force applied to the firing element is oriented.
[0106] [0106] In another embodiment of the present invention, a method of aspirating and expelling a liquid from a syringe assembly of the present invention, wherein the force applied to the plunger rod to expel the liquid is less than the force applied to the trigger element.
[0107] [0107] The reference throughout this specification to “one (1) modality”, “certain modalities”, “one or more modalities” or “a modality” means that a particular characteristic, structure, material or resource described in connection with the embodiment is included in at least one embodiment of the invention. Thus, the appearances of the phrases, such as "in one or more modalities", "in certain modalities", "in one (1) modality" or "in a modality" in several places throughout this specification, do not refer necessarily to the same modality as the invention. In addition, the particular characteristics, structures, materials or resources can be combined in any suitable way in one or more modalities.
[0108] [0108] Although the invention in the present document has been described with reference to particular modalities, it should be understood that these modalities are only 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 the modifications and variations that are within the scope of the appended claims and their equivalents.

权利要求:
Claims (22)
[0001]
Syringe assembly (300) comprising: a fluid cylinder (310) including a side wall (312) having an inner surface (314) defining a fluid chamber (315) for holding fluid and having a first cross-section width, an open proximal end (319) and a distal end (311) including a distal wall (317); a plunger rod (360) disposed within the fluid chamber (315) comprising a distal end, a proximal end, a plunger body extending from the distal end to the proximal end, and a plug (372) disposed in the distal end of the plunger rod (360) to form a fluid tight seal with the inner surface (314) of the cylinder (310); a retraction cylinder (320) disposed adjacent to the side wall (312) of the fluid cylinder (310), the retraction cylinder (320) including a wall (322) having an inner surface (324) defining a needle chamber (325 ), an open proximal end (329), an open distal end (321) including a barrier wall, an opening (330) between the wall (322) of the retraction cylinder (320) and the side wall (312) of the cylinder fluid (310) allowing fluid communication between the fluid chamber (315) and the needle chamber (325) and a needle connector assembly (340) comprising a needle connector (342), a needle cannula (350) attached to the needle connector (342), the needle cannula (350) being in fluid communication with the opening (330) and oriented to move in a proximal direction; and a firing element (390) disposed within the needle chamber (325) and movable within the retraction cylinder (320) independently of the piston rod (360), the firing element (390) providing a firing force making with which the needle cannula (350) retracts into the retraction cylinder (320) and where the firing element (390) includes a free proximal end (399), CHARACTERIZED by understanding: a guide element (352) disposed between the needle cannula (350) and the wall (322) of the retraction cylinder (320); and an open and free distal end (391) that provides the firing force, and a trigger element body (392) extending from the proximal end (399) to the distal end (390) and including an inner surface defining an interior hollow (393).
[0002]
Syringe assembly (300) according to claim 1, CHARACTERIZED by the fact that the needle connector assembly (340) is arranged at the open distal end (321) of the retraction cylinder (320), the needle connector assembly (320) needle (340) further comprising a first fastening part (344, 345), the firing element (390) including a second fastening part (394) for engaging the first fastening part (344, 345).
[0003]
Syringe assembly (300) according to claim 2, CHARACTERIZED by the fact that the firing force disengages the second fixing part (394) from the first fixing part (344, 345) so that the needle cannula ( 350) is retracted into the retraction cylinder (320).
[0004]
Syringe assembly (300), according to claim 3, CHARACTERIZED by the fact that the needle cannula (350) is guided by a spring arranged between the needle connector (342) and the retraction cylinder (320) that it exerts a force on the needle cannula (350) in a proximal direction.
[0005]
Syringe assembly (300) according to claim 4, CHARACTERIZED by the fact that the retraction cylinder (320) includes a tapered distal end (323) and the spring is disposed between the needle connector (342) and the end distal taper (323) of the retraction cylinder (320).
[0006]
Syringe assembly (300) according to claim 3, CHARACTERIZED by the fact that the first fixing part comprises a groove (345) arranged on at least a part of an external surface of the needle connector (342) and the second The fixing element (394) comprises at least one flexible arm (395) extending distally from the distal end (391) of the firing element (390), the flexible arm (395) including at least one locking element (396) extending inwardly to engage the groove (345) disposed in the needle connector (342).
[0007]
Syringe assembly (300) according to claim 1, CHARACTERIZED by the fact that the needle cannula (350) is retracted in the retraction cylinder (320) and housed within the hollow interior (393) of the firing element (390 ).
[0008]
Syringe assembly (300) according to claim 1, CHARACTERIZED by the fact that the wall (322) of the retraction cylinder (320) includes a release opening (383) and the firing element body (392) includes a release stop (397) disposed adjacent the distal end (391) of the firing element (390) which engages the opening of the retraction cylinder (320).
[0009]
Syringe assembly (300) according to claim 8, CHARACTERIZED by the fact that the firing force includes applying a force on the firing element (390) in the distal direction that is sufficient to disengage the release holder (397 ) of the firing element (390) from the release opening (383) in the wall (322) of the retraction cylinder (320).
[0010]
Syringe assembly (300) according to claim 9, CHARACTERIZED by the fact that the retraction cylinder (320) includes a rib (380) that extends proximally from the barrier wall to retain the flexible arm ( 395) by applying the firing force.
[0011]
Syringe assembly (300) according to claim 10, CHARACTERIZED by the fact that, by applying the firing force (390), the flexible arm (395) is moved in a proximal direction to disengage the locking element (396 ) from the groove (345) of the needle connector (342) and slides over the rib (380) to allow the needle cannula (350) to retract in the retraction cylinder (320).
[0012]
Syringe assembly (300) according to claim 2, CHARACTERIZED by the fact that the needle connector assembly (340) is removably attached to the retraction cylinder (320).
[0013]
Syringe assembly (300) according to claim 2, CHARACTERIZED by the fact that the needle connector assembly (340) is permanently attached to the retraction cylinder (320).
[0014]
Syringe assembly (300) according to claim 9, CHARACTERIZED by the fact that the firing force is at least 4 lbf (1.8 kgf).
[0015]
Syringe assembly (300), according to claim 10, CHARACTERIZED by the fact that the firing force is 4 lbf (1.8 kgf).
[0016]
Syringe assembly (300) according to claim 11, CHARACTERIZED by the fact that, prior to the application of the firing force, the proximal end (399) of the firing element (390) is aligned with the proximal end of the firing rod plunger (360).
[0017]
Syringe assembly (300) according to claim 16, CHARACTERIZED by the fact that after the application of the firing force, the proximal end (399) of the firing element (390) is no longer aligned with the proximal end of the rod piston (360).
[0018]
Syringe assembly (300) according to claim 16, CHARACTERIZED by the fact that the alignment of the firing element (390) and the plunger rod (360) provides visual indication of the retraction of the needle cannula (350).
[0019]
Syringe assembly (300) according to claim 3, CHARACTERIZED by the fact that the inner surface (314) of the fluid chamber side wall (315) includes a retaining ring (309) adjacent to the proximal end defining a second cross-section width that is less than the first cross-section width and the piston rod body includes a flexible protrusion (313) having a cross-section width greater than the cross-section width of the cylinder (310) in the rib (309) and a frangible part.
[0020]
Syringe assembly (300) according to claim 19, CHARACTERIZED by the fact that the contact between the plug (372) and the distal wall (317) of the cylinder (310) causes the protrusion (313) to proceed distally beyond the rib (309) on the cylinder (310) and lock the plunger rod (360) on the cylinder to prevent reuse of the syringe assembly (300).
[0021]
Syringe assembly (300) according to claim 19, CHARACTERIZED by the fact that the distal end of the plunger rod (360) includes a plug engaging part and the plug is attached to the plug engaging part of the plunger rod plunger (360), the plug (372) being movable proximally and distally with respect to the plug engaging part by a preselected axial distance such that when a force is applied to the plunger rod (360) in the distal direction and the distal end of the plug (372) is in contact with the distal wall (317) of the cylinder (310), the protrusion (313) is allowed to advance distally beyond the rib (309) in the cylinder (310) and lock the stem plunger (360) in the cylinder (310) to prevent reuse of the syringe assembly (300).
[0022]
Syringe assembly (300) according to claim 20 or 21, CHARACTERIZED by the fact that continuous application of a force on the piston rod in the proximal direction after the protrusion has advanced distally beyond the rib makes the part frangible break.

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JP6240250B2|2017-11-29|

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法律状态:
2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-09-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-05-19| B07A| Technical examination (opinion): publication of technical examination (opinion)|

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2020-09-15| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|

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2021-01-12| B09A| Decision: intention to grant|

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2021-02-17| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/07/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US36687410P| true| 2010-07-22|2010-07-22|

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US61/366,874|2010-07-22|

---

US13/187,136|US8556855B2|2010-07-22|2011-07-20|Dual chamber syringe with retractable needle|

---

US13/187,136|2011-07-20|

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PCT/US2011/044841|WO2012012631A1|2010-07-22|2011-07-21|Dual chamber syringe with retractable needle|

---