syringe assembly and related method

专利摘要:
DOUBLE CAMERA SYRINGE WITH RETRACTABLE NEEDLE. Modality of a retractable syringe assembly are provided that include a double barrel 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:BR112013001618B1
申请号:R112013001618-3
申请日:2011-07-21
公开日:2020-12-08
发明作者:Ivan Zivkovic；Ulf Handberg；Gert Hanner；Thomas Holma；Ulf Wahlberg；Jorgen Hager
申请人:Becton, Dickinson And Company；
IPC主号:

专利说明:

TECHNICAL FIELD
[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. BACKGROUND
[002] Needle retraction features have been incorporated into syringe assemblies to protect users from needle accidents. In conventional assemblies, needle hub assemblies, including a needle cannula, are attached to a barrel and must be removed from the syringe barrel by a user or by a retraction feature. Alternatively, a needle guard can be placed over the needle cannula by a user or otherwise.
[003] In conventional syringe assemblies in which the syringe hubs are retracted in the syringe barrel by a retraction feature, the retraction feature is generally provided within the syringe barrel and / or the piston rod disposed within the barrel of the syringe. syringe. Specifically, the piston rod may include a chamber that houses the needle hub after it is retracted. The retraction feature typically includes a cutting element disposed between the piston rod and the stop which is used to open the stop after the contents of the syringe barrel are expelled, to expose the piston rod chamber to receive the retracted needle. A spring is generally incorporated into the needle hub assemblies to conduct retraction from the needle hub to the piston rod.
[004] Therefore, such retraction characteristics require cutting, breaking, drilling or other actions of intense mechanical force for activation and, thus, increase the complexity of enabling the sealed piston and the stopper to be violated during activation. In addition, as most conventionally designed retractable needles are activated after dosing by continuous pressure behind the piston rod, accidental activation of the retractable feature can occur since the same forces must be applied when expelling the contents of the syringe barrel. In addition, some devices may be accidentally 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 pressure or force to the piston rod, that exceeds the force required to activate the retractable feature. Premature activation is especially problematic in applications where high forces are applied to a piston rod, for example, during high-speed injections.
[005] The retraction characteristics of conventional syringe drums that are piston-activated must withstand the increased syringe pressures and an increase associated with the force applied to the piston rod, as described above. These increased forces and pressure lead to the requirement for greater activation forces that can exceed operating forces in order to preserve premature activation. Since most conventional syringe drums apply an additional piston movement after complete dispensing, and in the same way as the dispensing movement, a limit force must be used to allow the user to differentiate between a full-bottom piston and the activation of the retraction feature. The limit force can be difficult to check and maintain separately from the force applied to the piston rod to expel the contents of the syringe barrel. In addition, a proper application of the limit force may require a user to position the syringe barrel and needle cannula at a high angle on the patient's skin, rather than positioning the syringe barrel and syringe 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 stopper or another removable opening in the piston rod, which may be sufficient to cause the stopper and / or the piston rod to malfunction.
[006] In conventional retractable syringe assemblies where the retraction feature and the subsequent housing of the needle hub are contained within a fluid path, the retract and housing feature can cause a volume of medication to become stuck inside the syringe barrel, increasing loss there and potentially affecting dosage accuracy. In addition, a portion of the trapped medication can be expelled during activation of the retraction feature causing it to sneeze, if the retraction feature is activated when the needle cannula is out of the patient, or an unintended increase in the dosage administered to the patient , if the retraction feature is activated when the needle cannula is in the patient. Placing the retract feature within the syringe barrel can also cause trapped air to remain in the syringe barrel when purging or starting the syringe. This can lead to the possibility of air injection. The size of the syringe barrel must also accommodate the retraction feature and the needle hub assembly that will be housed there after retraction.
[007] In syringe assemblies that do not harbor the retract feature within the fluid path, the retract feature is usually arranged in a location that requires the user to change their syringe mount control to activate the retract feature. Such designs cannot be ergonomically acceptable for certain users of these syringe assemblies.
[008] Conventional retraction syringe assemblies generally do not incorporate reuse prevention features, so the retraction mechanism can be restarted so the syringe barrel can be reused. It is believed that the reuse of syringe assemblies without sufficient sterilization or sterilization facilitates the transfer of contagious diseases.
[009] Therefore, it should 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 should also be desirable to provide a retractable syringe assembly that incorporates a reuse prevention feature. SUMMARY OF THE INVENTION
[010] One aspect of the present invention pertains to a syringe assembly comprising a fluid drum including a side wall having an inner surface defining a fluid chamber to retain a fluid and have a first cross-section width, an open proximal end and a distal end including a distal wall; a piston rod disposed within the fluid chamber comprising a distal end, and a proximal end, a piston rod body extending from the distal end to the proximal end, and a stop disposed at the distal end of the piston rod to form a watertight fluid sealing with the inner surface of the drum; a retraction drum disposed adjacent to the side wall of the fluid drum, the retraction drum including a wall having an inner surface defining a needle chamber, an open proximal end, a distal end including a barrier wall, a first locking element disposed adjacent to the proximal end, an opening between the wall of the retract drum and the side wall of the fluid drum allowing fluid communication between the fluid chamber and the needle chamber and the assembly of the needle hub comprising a needle hub , a needle cannula attached to a needle cube with a needle cannula being in fluid communication with the opening and prone to move in the proximal direction; and a trigger element disposed within the needle chamber and movable within the retraction drum independently of the piston rod, the trigger element including a second locking element disposed at the proximal end that fits into the first locking element of the retraction drum to prevent movement of the trigger element in a proximal direction after the cannula is retracted in the retract drum, the trigger element providing a trigger force causing the needle cannula to retract into the retraction drum.
[011] In one or more embodiments of the present invention, the first locking element includes at least one opening that receives a second locking element, the second locking element including at least one protrusion extending outwards with a locking face that prevents the protrusion from disengaging from the opening. In one or more embodiments of the present invention, the first locking element includes a plurality of openings and the second locking element includes a plurality of protrusions.
[012] In one or more embodiments of the present invention, after applying a proximally directed force to the piston rod to fill the fluid drum with liquid, the piston rod is movable in the proximal direction while the trigger element remains stationary . In one or more embodiments of the present invention, after applying distally directed force to the piston rod to expel liquid from the fluid barrel, the piston rod is movable in the distal direction to cause the stopper to contact the distal wall of the fluid drum, while the trigger element remains stationary. In one or more embodiments of the present invention, after a distally directed force is applied to the trigger element, the trigger element moves in the distal direction to provide the trigger force and make the second trigger element engage with the first element locking. In one or more embodiments of the present invention, after applying a force to the trigger element in the proximal direction after the second locking element engages with the first locking element, the locking face prevents movement of the locking element. trigger in the proximal direction.
[013] Another aspect of the present invention pertains to a syringe assembly comprising a fluid barrel including a side wall having an inner surface defining a fluid chamber to retain the fluid and having a first cross-section width, an open proximal end and a distal end including a distal wall; a piston rod disposed within the fluid chamber comprising a distal end, a proximal end, a piston rod body extending from the distal end to the proximal end, a stop arranged at a distal end of the piston rod to form a seal fluid-tight with the inner surface of the drum; a retraction drum disposed adjacent the side wall of the fluid drum, the retraction drum including a wall having an inner surface defining a needle chamber, an open proximal end, a distal end including a boundary wall, an opening between the retraction drum wall and the fluid drum side wall allowing fluid communication between the fluid chamber and the needle chamber and the needle hub assembly comprising a needle hub, a needle cannula attached to a hub with a needle, a cannula being in fluid communication with the opening and tending to move in the proximal direction; and a trigger element disposed within a needle chamber and movable within a retraction drum independently of the piston rod, the trigger element including a rupture element disposed at a proximal end which prevents movement of the trigger element in the direction distal, the trigger element providing a trigger force causing the cannula to retract into the retraction drum.
[014] In one or more embodiments of the present invention, the cross section width of the trigger element increases along the rupture element from the proximal end to the distal end and where the retraction drum has a smaller cross section width than the cross section width of the trigger element in the rupture element. In one or more embodiments of the present invention, the rupture element is depressible after applying a force to the rupture element in the distal direction. In one or more embodiments of the present invention, the rupture element is not depressible after applying a force to the rupture element in the proximal direction. In one or more embodiments of the present invention, the rupture element is depressed as the piston rod moves in the distal direction.
[015] In one or more embodiments of the present invention, after applying a proximally directed force to the piston rod to fill the fluid barrel with liquid, the pestle rod is removable in the proximal direction while the trigger element remains stationary . In one or more embodiments of the present invention, after applying a distally directed force to the piston rod, the piston rod moves in a distal direction and provides a force in the rupture element in a distal direction that depresses the rupture element . In one or more embodiments of the present invention, after contact between the stopper and the distal wall, the piston rod applies continuous force to the rupture element to depress the rupture element and allow movement of the trigger element in the distal direction.
[016] In one or more embodiments of the present invention, the inner surface of the sidewall of the fluid chamber includes a retaining ring adjacent 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 having a cross-section width greater than the cross-section width of the drum in the rib and frangible part. In one or more embodiments of the present invention, the contact between the stopper and the distal wall of the barrel causes the protrusion to proceed distally after the rib in the barrel and lock the piston rod in the barrel to prevent reuse of the syringe assembly. In one or more embodiments of the present invention, the distal end of the piston rod includes a stopper part of the stopper is attached to the stopper part of the piston rod, the stopper being distally and proximally movable relative to the stopper of the stopper. stopper for a pre-selected axial distance so that the stopper is in contact with the distal wall of the drum, the protrusion is allowed to advance distally after the rib in the drum and lock the piston rod in the drum to prevent reuse of the assembly syringe
[017] In one or more embodiments of the present invention, the continuous application of a force on the piston rod in the proximal direction after the protrusion has advanced distally after the rib causes the frangible part to break. In one or more embodiments of the present invention, the continuous application of a force to the piston rod in the proximal direction after the protrusion has advanced distally after the rib causes the frangible part to break.
[018] Another aspect of the invention pertains to a syringe assembly comprising a fluid drum including a side wall having an inner surface defining a fluid chamber to retain a fluid and to have a first cross-section width, an open proximal end and a distal end including a distal wall; a piston rod disposed within the fluid chamber comprising a distal end, and a proximal end, a piston rod body extending from the distal end to the proximal end, and a stop disposed at the distal end of the piston rod to form a watertight fluid sealing with the inner surface of the drum; a retraction drum disposed adjacent to the side wall of the fluid drum, the retraction drum including a wall having an inner surface defining a needle chamber, an open proximal end, a distal end including a barrier wall, an opening between and wall from the retraction drum and the side wall to the retraction drum allowing fluid communication between the fluid chamber and the needle chamber and a needle hub assembly comprising a needle hub, a needle cannula attached to the needle hub, the cannula being in fluid communication with the opening and tending to move in a proximal direction; and a trigger element disposed within the needle chamber and rotatable within the retraction barrel independently of the piston rod, the trigger element including a trigger guard that prevents premature retraction of the needle cannula, the trigger element providing a force trigger causing the needle cannula to retract into the retraction drum.
[019] In one or more embodiments of the present invention, the trigger force is provided by a movement of the trigger element in the distal direction and the trigger guard includes a projection extending outward to prevent movement of the trigger element in a distal direction. In one or more embodiments of the present invention, the trigger element is rotatable to align the trigger guard to prevent movement of the trigger element in the distal direction and rotatable to align the trigger guard to allow movement of the trigger element in the direction distal. In one or more embodiments of the present invention, the retraction drum includes a visual indication to indicate whether the trigger guard is aligned to prevent movement of the trigger element in the proximal direction or to allow movement of the trigger element in the distal direction.
[020] Another aspect of the present invention pertains to a syringe assembly comprising a fluid barrel including a side wall having an inner surface defining a fluid chamber to retain a fluid and having a first cross-section width, an open proximal end and a distal end including a distal wall; a piston rod disposed within the fluid chamber comprising a distal end, a proximal end, a piston rod body extending from the distal end to the proximal end, and a stopper disposed at the distal end of the piston rod to form a seal fluid tight with the inner surface of the drum; a retraction drum disposed adjacent the side wall of the fluid drum, the retraction drum including a wall having an inner surface defining a needle chamber, an open proximal end, an open distal end including a barrier wall, an opening between and retraction drum wall and the side wall of the fluid drum allowing fluid communication between the fluid chamber and the needle chamber and a needle hub assembly comprising a needle hub, a needle cannula attached to the needle hub , the cannula being in fluid communication with the opening and tending to move in a proximal direction; and a trigger element disposed within the needle chamber and rotatable within the retraction drum independently of the piston rod, the trigger element including a distal end, the distal end of the trigger element including a trigger pusher with a notch to facilitate the rotation of the trigger element, the trigger element providing a trigger force causing the needle cannula to retract into the retraction drum.
[021] In one or more embodiments of the present invention, the inner surface of the side wall of the retraction chamber includes a retaining ring 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 having a cross-section width greater than the drum cross-section width in the rib and frangible part. In one or more embodiments of the present invention, the contact between the stopper and the distal wall of the barrel causes the protrusion to proceed distally after the rib in the barrel and lock the piston rod in the barrel to prevent reuse of the syringe assembly. In one or more embodiments of the present invention, the distal end of the piston rod includes a stop fitting part and a stop is attached to the piston rod stop fitting part, the stop being distally and proximally movable with respect to the part of parador fitting for a preselected axial distance so that the force applied to the piston rod in the distal direction and at the distal end of the parador is in contact with the distal wall of the drum, the protrusion is allowed to advance distally after the rib on the barrel and lock the piston rod on the barrel to prevent reuse of the syringe assembly.
[022] In one or more embodiments of the present invention, the continuous application of a force on the piston rod in the proximal direction after the protrusion has advanced distally after the rib causes the frangible part to break. In one or more embodiments of the present invention, the continuous application of a force to the piston rod in the proximal direction after the protrusion has advanced distally after the rib causes the frangible part to break.
[023] Another aspect of the present invention pertains to a method comprising providing a syringe assembly comprising a fluid barrel including a side wall having an inner surface defining a fluid chamber for holding a fluid; a piston rod disposed within the fluid chamber comprising a distal end, a proximal end, a piston rod body extending from the distal end to the proximal end, and a stopper disposed at the distal end of the piston rod to form a seal fluid tight with the inner surface of the drum; a retraction drum arranged adjacent to the side wall of the fluid drum, the retraction drum including a wall having an inner surface defining a needle chamber, an opening between the wall of the retraction drum and the side wall of the holding drum allowing for a fluid communication between the fluid chamber and the needle chamber and a needle hub assembly comprising a needle hub, a needle cannula attached to the needle hub, the cannula being in fluid communication with the opening and tending to move in a proximal direction; and a trigger element disposed within the needle chamber and rotatable within the retraction drum and including a trigger guard that prevents premature retraction of the needle cannula; and providing instructions for: aligning the trigger guard to prevent movement of the trigger element in the distal direction; aspirate a pre-selected amount of liquid into the fluid chamber by inserting the needle cannula into a liquid and applying force to the piston rod in a proximal direction; expelling the liquid from the fluid chamber by applying force to the piston rod in the distal direction; and retract the needle cannula in the retraction drum by aligning the trigger guard to allow movement of the trigger element in the distal direction and apply a force to the trigger guard in the distal direction to provide the trigger force causing the needle cannula retracts into the retract drum.
[024] Another aspect of the present invention pertains to a method comprising providing a syringe assembly comprising a fluid barrel including a side wall having an inner surface defining a fluid chamber to retain a fluid and having an open proximal end and an end. distal including a distal wall, the inner surface of the side wall of the fluid chamber including a ring adjacent to the proximal end; a piston rod disposed within the fluid chamber comprising a distal end, a proximal end, a piston rod body extending from the distal end to the proximal end, the piston rod body includes a protrusion and a frangible part, and a stopper arranged at the distal end of the piston rod to form a fluid-tight seal with the inner surface of the drum; a retraction drum arranged adjacent to the side wall of the fluid drum, the retraction drum including a wall having an inner surface defining a needle chamber, a first locking element disposed adjacent to the proximal end, an opening between the drum wall retraction and side wall of the retract drum allowing fluid communication between the fluid chamber and the needle chamber and a needle hub assembly comprising a needle hub, a needle cannula attached to the needle hub, the cannula being in fluid communication with the opening and tended to move in a proximal direction; and a trigger element disposed within the needle chamber and rotatable within the retraction drum independently of the piston rod. The trigger element including a trigger guard that prevents premature retraction of the needle cannula; and providing instructions for: aspirating a pre-selected amount of liquid into the fluid chamber by inserting the needle cannula into a liquid and applying force to the piston rod in a proximal direction; locking the piston rod into the fluid drum by applying continuous force to the piston rod in the distal direction causing the protrusion of the piston rod to move distally after the fluid drum retaining ring; and retract the needle cannula in the retraction drum by aligning the trigger guard to allow movement of the trigger element in the distal direction and apply a force to the trigger guard in the distal direction to provide the trigger force causing the needle cannula retracts into the retract drum.
[025] Another aspect of the present invention pertains to a method comprising providing a syringe barrel including a fluid barrel and a retraction barrel in a fluid communication, the fluid barrel including a piston rod attached to a suction stop and expelling the liquid from the fluid drum and a retraction drum including a needle hub, a needle cannula with an opening and a trigger element to provide a trigger force causing the needle cannula to retract in the retraction drum; providing instructions for: submerging a needle cannula opening in a liquid; fill the fluid drum with liquid by applying force to the piston rod in a proximal direction; expelling the liquid from the fluid chamber by applying force to the piston rod in a distal direction; and retracting the needle cannula in the retract drum by applying force to the trigger element in a distal direction to provide the trigger force.
[026] In one or more embodiments of the present invention, the method comprises providing instructions for locking the piston rod in a fluid drum after expelling the liquid from the fluid drum.
[027] In one or more embodiments of the present invention, the method comprises that force applied to the piston rod is oriented along an axis that is parallel to the axis along which the force applied to the trigger element is oriented. In one or more embodiments of the present invention, the force applied to the piston rod to expel the liquid is less than the force applied to the trigger element. BRIEF DESCRIPTION OF THE DRAWINGS
[028] Figure 1 illustrates a perspective view of a retractable syringe assembly according to one or more embodiments of the present invention,
[029] Figure 2 shows a side view of the syringe assembly of figure 1;
[030] Figure 3 shows a view of the syringe assembly shown in figure 1 of the proximal end of the syringe assembly;
[031] Figure 4 illustrates a cross-sectional view of the syringe assembly shown in figure 1, where the retraction drum is located outside the fluid drum;
[032] Figure 5 illustrates a cross-sectional view of the fluid drum and the retraction drum taken along lines 5-5, with a trigger element and piston rod removed from the assembly;
[033] Figure 6 illustrates a cross-sectional view of the syringe assembly according to one or more modalities, where the retraction drum is nestled within the fluid drum;
[034] Figure 7 shows a cross sectional view of the fluid drum and the retraction drum taken along lines 7-7;
[035] Figure 8 shows a partial perspective view of the piston rod, the needle hub assembly and the trigger element of figures 4 and 6 before the needle hub assembly retracts;
[036] Figure 9 illustrates a partial perspective view of the piston rod, the needle hub assembly and the trigger element shown in figure 8 after applying force to the trigger element in the distal direction;
[037] Figure 10 illustrates a partial perspective view of a piston rod, a needle hub assembly and the trigger element shown in Figure 9, after the trigger element breaks the brittle element;
[038] Figure 11 illustrates a partial perspective view of a piston rod, a needle hub assembly and the trigger element shown in figure 10, after a portion of the needle hub assembly begins to retract into the drum. retractable;
[039] Figure 12 illustrates a partial perspective view of a piston rod, a needle hub assembly and the trigger element shown in figure 11, after the needle hub assembly part is more completely retracted in the barrel retractable;
[040] Figure 13 shows a perspective view of the assembly of a needle hub assembly according to one or more modalities;
[041] Figure 14 illustrates a needle hub assembly of figure 13 while a needle cannula and needle cannula holder are being inserted into the needle hub;
[042] Figure 15 illustrates the needle hub assembly of claim 14 while the needle hub is being formed around the needle cannula and the needle cannula holder;
[043] Figure 16 illustrates the needle hub assembly of claim 15 while the needle hub is being more fully formed around the needle cannula and the needle cannula holder;
[044] Figure 17 the assembly of the assembled needle hub of claim 16;
[045] Figure 18 illustrates a perspective view of the assembly of the needle hub being mounted to a retractable drum according to one or more modalities;
[046] Figure 19 illustrates a needle hub assembly shown in figure 18 attached to a needle guard while being placed on the retractable drum also shown in figure 18;
[047] Figure 20 illustrates a needle hub assembly and the needle guard shown in figure 19 after the needle guard fits into the needle hub assembly;
[048] Figure 21 illustrates a needle hub assembly and the needle guard shown in figure 20 after rotation in relation to the retraction drum;
[049] Figure 22 illustrates a needle hub assembly and the needle shield shown in figure 21 after aligning the open conduit of the needle hub assembly and opening the retract drum;
[050] Figure 23 illustrates a needle hub assembly and the needle guard shown in figure 22 after removing the needle guard;
[051] Figure 24 shows a cross-sectional side view of a retractable syringe assembly according to one or more modalities;
[052] Figure 25 illustrates an enlarged partial cross-sectional view of a retractable syringe assembly shown in Figure 24;
[053] Figure 26 illustrates an enlarged partial cross-sectional view of a retractable syringe assembly shown in figure 25 after applying a trigger force to the needle hub assembly;
[054] Figure 27A illustrates a top cross-sectional view of the barrel of the double chamber syringe shown in figure 24;
[055] Figure 27B shows a side view in cross section of the barrel of the double chamber syringe shown in figure 27A;
[056] Figure 27C illustrates a cross-sectional view of the barrel of the double-chamber syringe shown in figure 27A taken from the proximal end;
[057] Figure 27D illustrates a side cross-sectional view of the barrel of the double-chamber syringe shown in figure 27A taken from the distal end;
[058] Figure 28 shows a side view of the needle hub assembly shown in figure 24;
[059] Figure 28A illustrates a cross-sectional view of the needle hub assembly shown in Figure 28 taken along line A-A;
[060] Figure 29 illustrates a partial cross-sectional view of a retractable syringe assembly showing the proximal end according to one or more modalities;
[061] Figure 30 illustrates the proximal end of a retractable syringe assembly according to one or more modalities;
[062] Figure 31 illustrates the proximal end of a retractable syringe assembly shown in figure 31 after applying force to the piston rod in the distal direction;
[063] Figure 32 illustrates the proximal end of a retractable syringe assembly shown in figure 31 the closed trigger element within the retraction drum after applying force to the trigger element in the distal direction;
[064] Figure 33 illustrates a partial perspective view of a piston rod, a trigger element and a needle hub assembly according to one or more modalities;
[065] Figure 34 illustrates a partial perspective view of a piston rod, a trigger element and a needle hub assembly shown in figure 33 after applying force to the trigger element in the distal direction;
[066] Figure 35 illustrates a partial perspective view of a piston rod, a trigger element and a needle hub assembly shown in figure 34 during the application of a force to the trigger element in the distal direction, while the element trigger contacts the needle hub assembly;
[067] Figure 36 illustrates a partial perspective view of a piston rod, a trigger element and a needle hub assembly shown in figure 35 after the trigger element contacts the needle hub assembly, while the element trigger lever exerts a force on the needle hub assembly;
[068] Figure 37 illustrates a partial perspective view of a piston rod, a trigger element and a needle hub assembly shown in figure 36 after a part of the needle hub assembly is retracted on the trigger element;
[069] Figure 38 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[070] Figure 38A illustrates a side view of a retractable syringe assembly shown in figure 38;
[071] Figure 38B shows a view of a retractable syringe assembly shown in Figure 38 taken from the proximal end;
[072] Figure 39 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[073] Figure 39A illustrates a side view of a retractable syringe assembly shown in figure 39;
[074] Figure 39B shows a view of a retractable syringe assembly shown in figure 39 taken from the proximal end;
[075] Figure 40 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[076] Figure 41 illustrates a side view of a retractable syringe assembly shown in Figure 40;
[077] Figure 42 shows a view of a retractable syringe assembly shown in Figure 40 taken from the proximal end;
[078] Figure 43 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[079] Figure 43A illustrates a side view of a retractable syringe assembly shown in figure 43;
[080] Figure 43B shows a view of a retractable syringe assembly shown in figure 43 taken from the proximal end;
[081] Figure 44 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[082] Figure 44A illustrates a side view of a retractable syringe assembly shown in figure 44;
[083] Figure 44B shows a view of a retractable syringe assembly shown in figure 44 taken from the proximal end;
[084] Figure 45 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[085] Figure 46 illustrates a side view of a retractable syringe assembly shown in figure 45;
[086] Figure 47 illustrates a view of a retractable syringe assembly shown in Figure 45 taken from the proximal end;
[087] Figure 48 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[088] Figure 49 illustrates a side view of a retractable syringe assembly shown in figure 48;
[089] Figure 50 illustrates a view of a retractable syringe assembly shown in Figure 48 taken from the proximal end;
[090] Figure 51 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[091] Figure 52 illustrates a side view of a retractable syringe assembly shown in figure 51;
[092] Figure 53 shows a view of a retractable syringe assembly shown in Figure 52 taken from the proximal end;
[093] Figure 54 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[094] Figure 54A illustrates a side view of a retractable syringe assembly shown in figure 54;
[095] Figure 54B shows a view of a retractable syringe assembly shown in figure 54 taken from the proximal end;
[096] Figure 55 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[097] Figure 56 shows a side view of a retractable syringe assembly according to one or more modalities;
[098] Figure 56A illustrates a side view of the retractable syringe assembly shown in figure 56;
[099] Figure 56B shows a view of a retractable syringe assembly shown in Figure 56 taken from the proximal end;
[0100] Figure 57 illustrates a perspective view of a retractable syringe assembly according to one or more modalities;
[0101] Figure 57A illustrates a side view of a retractable syringe assembly shown in figure 57;
[0102] Figure 57B illustrates a view of a retractable syringe assembly shown in Figure 57 taken from the proximal end;
[0103] Figure 58 illustrates a perspective view of the proximal end of a retractable syringe assembly according to one or more embodiments;
[0104] Figure 59 illustrates a perspective view of a proximal end of a retractable syringe assembly shown in Figure 58 after rotation of the trigger elements to prevent movement of the trigger element in the distal direction;
[0105] Figure 60 illustrates a perspective view of a proximal end of a retractable syringe assembly shown in Figure 59 after the rotation of the trigger elements to prevent movement of the trigger element in the distal direction;
[0106] Figure 61 illustrates a perspective view of the proximal end of the retractable syringe assembly according to one or more embodiments;
[0107] Figure 62 illustrates a perspective view of the proximal end of the retractable syringe assembly according to one or more embodiments;
[0108] Figure 63 illustrates a perspective view of the proximal end of the retractable syringe assembly according to one or more embodiments;
[0109] Figure 64 illustrates a perspective view of the proximal end of the retractable syringe assembly according to one or more embodiments;
[0110] Figure 65 illustrates a perspective view of the proximal end of the retractable syringe assembly according to one or more modalities; and
[0111] Figure 66 illustrates a perspective view of the proximal end of the retractable syringe assembly according to one or more embodiments. DETAILED DESCRIPTION
[0112] Before describing the various exemplary embodiments of the invention, it should be understood that the invention is not limited to the details of the construction or the process steps set out above in the following description. The invention is capable of other modalities and can be practiced or carried out in various ways.
[0113] In this disclosure, a convention is followed where the distal end of the device is one end closer to the patient and the proximal end of the device is the far end of the patient and closer to the doctor.
[0114] Aspects of the invention pertain to assemblies and methods for aspirating and expelling liquid from a retractable syringe and methods for providing syringe assemblies with constructions for aspirating and expelling liquid from a syringe assembly.
[0115] A first aspect of the present invention pertains to a retractable syringe assembly having a retraction feature that is triggered by a user to retract a needle hub assembly, which includes a needle cannula, in a syringe assembly.
[0116] In an embodiment shown in figures 1-5, the retractable syringe assembly includes a double syringe barrel 101 that includes a fluid barrel 110 and a retraction barrel 120. The retractable syringe also includes a hub assembly. needle 140, piston rod 160, stop 170 and trigger element 190. The fluid barrel shown in Figure 4 includes a distal end 111, an open proximal end 119, a side wall 112 extending from distal end 111 and the proximal end 119 including an inner surface 114 defining a chamber 115. The inner surface 114 defines a cross section width and may include a reuse prevention feature, which will be discussed in more detail below. The distal end 111 includes a distal wall 117 covering the distal end 111. In the embodiment shown, the side wall 112 includes a first opening 123 to allow fluid communication between the fluid drum and the retractable drum. As will be discussed in more detail below, first opening 123 also allows fluid communication between the needle cannula disposed within retraction drum 120 and retraction drum 120 and fluid drum 110.
[0117] The fluid drums shown in figures 1-7 may include a reuse prevention feature. Specifically, the fluid drum 110 may include a retaining element 109 that extends around the entire circumference of the inner surface 114 of the fluid drum 110 at a location adjacent to the proximal end 119 of the fluid drum. A cross-section width of the inner surface 114 on the retaining element is less than the cross-section width or cross-section width of the inner surface 114 at the remaining locations along the length of the fluid drum. In one or more embodiments, the flaps or optional holders can be used to create a region of a fluidized drum 110 having a cross-sectional width that is less than the cross-sectional width of the fluid drum 110. The retaining elements it can also be non-formatted to facilitate the activation of the reuse prevention feature. For example, fluid drum 110 may also include a transition region of diameter proximally adjacent to the retaining element at the proximal end 119 of fluid drum 110. The cross-section width of the inner surface 114 of the fluid drum in the transition region in diameter increases from the distal end 111 to the proximal end 119 of the fluid drum 110. As will be described in greater detail below, in the modalities of the retractable syringe assembly that uses a reuse prevention feature, the reuse prevention feature of the drum Fluid 110 cooperates with the reuse prevention features on piston rod 160 to close piston rod 160 within fluid drum 110 and / or to disable piston rod 160 from other use.
[0118] An alternative embodiment is shown in figures 6-7, where a retractable syringe assembly can include a single barrel 200. In such embodiments, a part of the barrel is divided by a wall dividing 201 into a fluid barrel 210 and a remaining part of the drum houses the retraction feature and needle hub assembly and is referred to as a retraction drum 220. The dividing wall 201 may include an opening 232 to allow fluid communication between a fluid drum 210 and the drum shrinkage 220. The single barrel 200 in figures 6-7 provides an ergonomic design that improves grip by providing a larger diameter for smaller syringe sizes.
[0119] In the embodiments shown in figures 1-5, the retraction drum 120 is disposed adjacent to the side wall 112 of the fluid drum 110 in the embodiment shown in figure 4. The retraction drum 120 is configured to house a hub assembly. needle 140 there and the retraction feature. The retract drum 120 includes an open distal end 121 and an open proximal end 129. A wall 122 having an inner surface 124 defining a needle chamber 125 extends from the distal end 121 to an open proximal end 129. The wall 122 of the chamber the retraction drum is adjacent to the side wall 112 of the fluid drum 110. In one or more embodiments, the wall 122 can extend around those parts of the retraction drum 120 that are not in contact with the fluid drum 110 and the side wall 112 can form the barrier between the retract drum 120 and the fluid drum 110. In other words, the outer surface of the sidewall 112 can form the inner surface 114 of the retract drum 120 along the part of the retract drum 120 that is in direct contact with the fluid drum 110.
[0120] Needle chamber size 125 can be modified to accommodate needle hub assembly 140 and / or the retract feature. According to one or more embodiments, the interior surface 124 of the retract drum 120 has a cross-section width that is less than the first cross-section width of the fluid drum 110. In specific embodiments, the width of the cross-section of the fluid drum. inner surface 124 of the retract drum is less than about 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% of the cross section width 114 of the fluid drum. Such designs in which the cross-section width of the inner surface 124 of the retract drum is less than the cross-section width of the inner surface 114 of the fluid drum, provides both functional and ergonomic advantages. For example, the overall appearance and handling of the double barrel syringe is more attractive to the user. In certain embodiments, the retraction drum can be nestled within the fluid drum. For example, both the retraction drum and the fluid drum can both be connected to or surrounded by a common wall, and the retraction drum can be partially or completely disposed within a fluid drum, or alternatively, a dividing wall can separate a single drum in two separate drums, a fluid drum and a retraction drum.
[0121] The open distal end 121 for the retraction drum 120 in the mode can be completely open or partially closed by, for example, a boundary wall (not shown) that partially closes the open distal end 121. The open distal end 121 can be free of a boundary wall and can be completely opened. In such embodiments, the needle hub assembly forms a closure around the open distal end 121 so that there is fluid communication between the needle cannula and the opening 123 that allows fluid communication between the fluid drum 110 and the retraction drum 120. In one embodiment, as shown in figure 5, the wall 122 may include a second opening (not shown) that allows fluid communication with the fluid chamber 115 and the needle chamber 125. The second opening from the wall can also allow fluid communication between the fluid chamber 115, the needle chamber 125 and the needle cannula. Fluid communication between the fluid drum 110 and the retraction drum 120 can be provided by a first conduit (not shown) extending from the first opening (not shown) of the fluid drum 110 and the second opening (not). shown) of the retraction drum.
[0122] According to one or more modalities, the retraction drum has a cross-sectional dimension that is smaller than the cross-sectional dimension of the fluid drum. In specific embodiments, the retraction drum's cross-sectional dimension is less than about 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% of the drum's cross-sectional dimension of fluid. Such designs in which the cross section dimension of the retraction drum is smaller than the cross section dimension of the fluid drum, provide functional and ergonomic advantages. For example, the overall appearance and handling of the double-barrel syringe is more pleasing to the user.
[0123] The needle hub assembly may include a second conduit (not shown) that extends from an open end of the needle cannula to a second opening (not shown) of the retract drum. The second conduit may include an opening (not shown) that must be aligned with the second opening to allow fluid communication between the needle cannula and the fluid barrel.
[0124] The needle hub assembly 140 is disposed within the retract drum 120 and includes a needle hub 142 and a needle cannula 150 attached to needle hub 142. Needle hub 142 includes a distal end 141 and a proximal end 149. The needle cannula 150 includes an open and free distal end 151 and an open proximal end 159 which is attached to the distal end 141 of the needle hub. Needle hub 142, shown in figures 4 and 8, includes a needle hub body 143 and a needle cannula holder 146 disposed within the body of needle hub 143. Needle cannula holder 146 includes an embedded part (not shown) to partially house one end of the needle cannula. The flush part may include a portion of the second conduit (not shown) that extends through the needle hub 142 to the second opening (not shown) of the retract drum to allow fluid communication between the needle cannula 150 and the deflected drum 110.
[0125] The needle cannula 150 of the needle hub assembly 140 is prone to move in the proximal direction. In the embodiment shown, the needle hub assembly 140 tends to move in the proximal direction, there tending to attach the needle cannula 150 therein. In one embodiment shown, the needle hub assembly 140 is tended to move in the proximal direction. by a bias element 152 disposed between the needle hub body 143 and the needle cannula holder 148. As shown more fully in figures 13-17, the bias element 152 is shown as surrounding the needle cannula holder 146. For assemble the needle hub assembly 140 with the bias element 152, the bias element 152 is initially placed on the needle cannula support 146 and compressed, as shown in figure 13. The body of the needle hub 143 includes a distal end 144 , a proximal end 145, a distal part 147 disposed adjacent to the distal end and a proximal part 148 disposed adjacent to the proximal end. The distal part 147 may include a conical fixation with an opening (not shown) through it to receive a needle cannula 150. The proximal part 148 includes two hinged closing walls 155, 156. The closing walls 155, 156 surround the support of the needle cannula and the bias element 152 while being assembled with the body of the needle hub 143. Specifically, the needle cannula 150 is inserted into the opening of the distal part 147 as shown in figure 14. The cross section width 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 support 146 remains within the distal part 147. The two hinged closed walls 155 156 of figures 15-16 are moved inward until they encircle the needle cannula support 146 and the bias element 152, as shown in figure 17.
[0126] In the embodiment shown, bias element 152 engages the needle cannula holder 146. Bias element 152 may include a spring, which may be a compression spring that applies constant force to the body of the needle hub 143 in the direction proximal. In alternative embodiments, the bias element 152 can be provided in another way, for example, a lever arm (not shown) can be arranged between the needle hub and the boundary wall. The needle hub body 143 includes a brittle element 153 that supports the bias element 152, the needle cannula holder 146 and a needle cannula 150 to move in the proximal direction. As will be explained in more detail below, the breaking of the brittle element 153 will allow the biased needle hub 142 and the needle cannula 150 attached thereto to retract within the retraction drum 120.
[0127] In one or more variations, the entire needle hub assembly 140 can be biased. For example, the needle hub body 143, the needle cannula holder 146 and the needle cannula 150 can be provided as an integral unit that is tended and the retraction drum can include a support element (not shown) that it is brittle and applies a force to the needle hub assembly 140 in the distal direction. The bias element 152 can be located between the needle hub assembly 140 and the distal end 121 of the retract drum 120. The force applied by the support element in the needle hub assembly 140 in the distal direction neutralizes the force applied in the assembly of the needle hub 140 by the bias element 152 in the proximal direction. Once the support member is broken, the needle hub assembly 140 can be retracted on the retract drum 120.
[0128] The brittle element 153 is shown in figures 8-12 as a partially extending wall shelf 154 which is arranged along the inner surface parts of the needle hub body 143. The wall shelf 154 extends radially to inside to form a support boundary that is positioned adjacent to the bias element 152 surrounding the needle cannula support, which prevents movement or expansion of the bias element 152. Once the brittle element 153 is broken, for example, by movement of the trigger element 190 in the distal direction, the fit between the bias element 152 and the needle cannula holder 146 causes the bias element 152 to move the needle cannula holder 146 and the needle cannula 150 attached thereto in the element trigger 190 and / or retraction drum 120. Specifically, expansion of the bias element 152 drives the needle cannula holder 146 and the needle cannula 150 on the trigger element 19 0 and / or in the retraction drum 120.
[0129] The needle hub assembly is movably shaped inside the needle chamber. The size and shape of the needle hub assembly can be modified to allow movement in the needle chambers having different sizes. In the assembled state, before use, the needle hub assembly is positioned at the open distal end of the retract drum.
[0130] Piston rod 160 is disposed within fluid drum 110 and includes a stopper 170 attached to it to form a fluid seal with the inner surface 114 of fluid drum 110. Piston rod 160 may include a reuse prevention feature that closes piston rod 160 within fluid drum 110 or otherwise disable piston rod 160. The piston rod may include a reuse prevention feature that cooperates with the reuse prevention feature arranged in the fluid drum 110. In one or more embodiments, the piston rod may include a protrusion 113 that has a cross-section width that is greater than the cross-section width of the inner surface 114 of the fluid drum 110 in the element holding element 109. As discussed above, the holding element forms a smaller cross-section width than the other locations along the length of the fluid drum 110. Therefore, when the protector Piston rod rundown advances distally after the fluid drum retainer 110, a smaller cross-section width of the retainer prevents movement of the protrusion in the proximal direction. Therefore, the piston rod 160 is closed within the fluid drum 110 by the retaining element. In one or more embodiments, the stop 170 and / or the piston rod 160 can have a structure to allow relative movement of the piston rod 160 in relation to the stop 170. For example, the stop 170 can have an interior recess that allows that the distal end of the piston rod 160 moves in the distal and proximal directions within the interior recess, lengthening and shortening the length of the piston rod and the stop. Exemplary piston rods and stoppers that allow relative movement of the piston rod in relation to the stopper are disclosed in U.S. Patent Application Nos. 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 which is incorporated herein by reference in its entirety.
[0131] Parador 170 can also include reuse prevention features which also cooperate with reuse prevention features arranged on fluid drum 110. For example, parador 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 drum 110 in the remaining element. In such embodiments, removal of the stop 170 is prevented because the smaller cross-sectional width of the deflected drum retaining ring 110 prevents the stop 170 from being removed. The piston rod 160 and the stop 170 can be joined by a breakable connection 172 which can cause the piston rod 160 to become disconnected from the stop 170, while the stop 170 remains closed within the fluid drum 110 by the retention. Exemplary stoppers that include a reuse prevention feature and piston rods and stoppers joined by a brittle connection are disclosed in U.S. Orders Nos. 12 / 137,732 and 12 / 262,836, referred to above.
[0132] The retractable syringe assembly 101 also includes a trigger element 190 that includes a distal end 191 and a proximal end 199. Trigger element 190 is movable independently of piston rod 160 and extends into needle chamber 125 retraction drum 120. In the embodiment shown in figure 4, the trigger element 190 includes a trigger pad 194 to which the user applies a force in the distal direction to activate the retraction mechanism of the syringe assembly.
[0133] Trigger element 190 is sized, shaped and positioned to provide a trigger force on the brittle element 153 in the water cube body 143 to release bias element 152 so that the cannula 150 retracts and is housed in the retraction. The trigger element 190 includes a trigger element body 192 that extends from the distal end 191 to the proximal end 199. The body of the trigger element 192 is shaped to have a cylindrical shape and is elongated. In the embodiment shown, the trigger element 190 has an open distal end 191 and the trigger body element 192 has a hollow interior 193 for housing the needle hub 142 and the needle cannula 150. The proximal end 199 of the trigger element it is closed and can be tapered to retain the needle hub 142 inside the hollow interior 193 after the needle hub 142 and the cannula 150 are retracted in the retract drum. The needle cannula holder 146 can also include a structure for retaining the retracted needle cannula holder 146 and a needle cannula 150 within the trigger element 190.
[0134] The open distal end 191 of the trigger element can have a beveled edge that breaks the brittle element 153 more effectively by concentrating the force applied to the brittle element 153. Breaking the brittle element 153 releases force applied to the biased element 152 and the support needle cannula 146 in the distal direction. After the release of this distally direct force, the force applied to the needle cannula support 146 by the bias element 152 in the proximal direction remains due to compression of the bias element 152. The expansion of the bias element 152 or the presence of the proximally direct force in the bias support needle cannula 146 by bias member 152 causes needle hub 142 to retract or move into retraction drum 120 or specifically, the hollow interior 193 of the trigger element.
[0135] In use, as shown in figures 8-10, the user is free to draw the fluid or liquid into the fluid drum 110 and expel the fluid without accidentally triggering 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. A separate retraction drum 120 and a needle chamber 125 allow the use of a constant and reliable driving force to drive the retraction mechanism. Specifically, the actuation force is no longer dependent on the viscosity of the liquid filled within the fluid chamber 115. Furthermore, the actuation force no longer has to compensate for the accidental risk of actuation during normal syringe assembly operation, and therefore, the actuation force can be configured at a low level. In addition, because the retract feature no longer has to cut through a stop, as required by some retractable syringe assemblies, the actuation force can be optimized to only trigger the retract feature, instead of also being optimized to penetrate the paradores.
[0136] In addition, separating the retracting mechanism from the fluid drum 110 also reduces the risk of accidental starting because it is no longer coupled with the aspiration and injection of the liquid using the piston rod. Therefore, there is no risk of premature activation of the drive mechanism by applying high force during high-speed injections. In use, after the finger or thumb used to apply force to the piston rod 160 to expel the contents of the fluid drum 110, the user simply moves the finger or thumb to the trigger pad 194 disposed adjacent to the pressure of the thumb 164 on the adjacent end of the retraction drum 120. The user does not need to modify his grip or use two hands to activate the retraction mechanism, as required in the known modalities of retractable syringe assemblies.
[0137] The separation of the retract drum, the needle hub assemblies and the retraction feature of the syringe assemblies disclosed here also allow the user to change the needles for all dimensions of the retractable syringe. The asymmetric orientation of the needle hub assembly, in relation to the assembly of the whole syringe, facilitates low angle injections (example, subcutaneous injections). In addition, the asymmetric orientation also allows the user to stop the needle cannula orientation simply by tightening the syringe assembly.
[0138] In one or more embodiments, the needle hub assembly can be attached to a retraction drum to provide a leak-proof path for the liquid. In one or more embodiments, this is accomplished using a needle hub assembly that includes a sealing member, which is actuated by pressing and rotating the required to assemble the needle hub assembly. Pressing and turning movements are achieved by lightly incorporating wedge surfaces into the needle hub assembly that attaches to the corresponding structures on the retractable drum. The needle hub assembly can also be designed to be rotated and attached in one direction. This allows the needle hub assembly to be locked in a defined position, while the torque applied is rotated at the sealing pressure.
[0139] In the embodiment shown in figures 18-23, the needle hub assembly 200 can be shaped and sized to cooperate with the retraction drum 220 and a needle guard 240 to provide a sealing pressure for the retraction drum. In the embodiment shown, the retract drum 220 includes a wall 223 extending from an open distal end 221. The wall includes a security element 222 disposed at the distal end 221 to secure the needle hub assembly 200 to the retract drum. Security element 222 is integrally formed with the side wall of the drum, as shown in figure 18. In the embodiment shown, security element 222 includes at least one notch or opening 224 for receiving a corresponding finger element or other protrusion in the assembly needle cube. In the embodiment shown, opening 224 is understood in the distal direction of the open distal end 221. The security element also includes at least one protrusion 226 which is arranged adjacent to opening 224. Protrusion 226 extending inwardly at the open distal end 221 of the retractable drum.
[0140] The retractable drum 220 is attached to a fluid drum 230 with a fluid chamber (not shown) that includes an opening 232 to allow fluid communication between the needle hub assembly 200 and the fluid chamber. The opening 232 is arranged on the opposite side of the open distal end 221 of the retractable drum of the protrusion 226. The security element 222 of the retractable drum may include an alternative structure that cooperates with the needle hub assembly 200 to secure the hub assembly of the hub. needle 200 to the retractable drum.
[0141] As shown in figure 19, the needle hub assembly 200 is mounted with a needle guard 240 prior to attachment to the retract drum. As shown in figure 23, the needle hub assembly includes a needle hub body 202 having a distal end 203 and a proximal end (not shown). The distal end 203 includes an opening 204. The needle cannula 205 is disposed within a needle hub body 202 and extends through opening 204 of the needle hub body. The biased element (not shown) can be disposed within the needle hub body 202 as otherwise described here, for example, with reference to figures 8-17. The body of the needle hub 202 includes an outer surface 206 that includes an attachment element 208 that engages the securing element 222 of the retract drum 220. The outer surface 206 has a generally curved or conical curved shape. In the embodiment shown, the attachment element 208 of the needle hub assembly includes at least one radially extending flap 210 disposed on the outer surface 206 of the needle hub body. The flap 210 engages the protrusion 226 by sliding under the protrusion 226 so that the protrusion 226 exerts a force in the proximal direction on the flap 210, when the needle hub assembly 200 is attached to the retraction drum.
[0142] The needle hub body 202 also includes an open conduit 212 to allow fluid communication between the needle cannula 205 and the opening 232 of the fluid barrel. In the embodiment shown, the position and location of the attachment element 208 and the security element 222 allow the alignment of the open conduit 212 and the opening 232 to be aligned. In addition, an appropriate fit of the attachment element 208 and the security element 222 ensures fluid communication between the fluid drum 230 and the needle cannula 205.
[0143] In one embodiment shown, the needle hub body 202 also includes at least one finger element 214 disposed along the outer surface 206. Specifically, the finger element 213 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 hub body 202. In the embodiment shown in figure 23, the finger element 214 is flexible to extend outwardly from the outer surface of the hub body . The application of an outwardly directed force to the finger elements 214 causes the proximal end 216 to lift from the outer surface 206 of the needle hub body. The finger element 214 in the embodiment shown has an elongated shape that extends a distal ring 217 which is disposed distally adjacent at the midpoint between the distal end 203 and the proximal end (not shown) of the needle hub body 202. The distal ring 217 of the embodiment shown forms a notch on the outer surface 206 of the needle hub body 202 that extends along the perimeter of the outer surface 206. In a variant, the distal ring may form a rib extending outwardly from the outer surface 206 .
[0144] The finger element 214 has a rounded distal end 215 in the embodiment shown, but can include a distal end 215 having a different shape. The finger element 214 forms a raised platform relative to the outer surface 206 of the needle hub body 202. From the distal end 215 to a curved portion 218, the finger element 214 extends substantially parallel to the conically shaped outer surface 206 of the body needle hub 202. From the curved portion 218 to the proximal end 216, the finger element 214 extends substantially parallel to the retract drum 220. The outer surface 206 also includes a notched portion 207 adjacent to the finger element 214. The notched 207 does not have a conical curved shape, like the remaining parts of the outer surface 206, but instead has a surface that is parallel to the retract drum or curved inwardly with respect to the retract drum. The finger element 214 and the notched part 207 are arranged adjacent the flap 210. In the embodiment shown, the needle hub body 202 includes two tabs 210 located through the needle hub body 202 from one to the other and the notched part 207 and finger element 214 disposed between them. Open conduit 212 is arranged on the opposite side of tab 210 of finger element 214 and notched part 207.
[0145] Needle guard 240 is disposed over needle hub body 202 so that it closes needle cannula 205. Needle guard 240 provides protection for needle cannula user 205 and prevents contamination of needle cannula 205 The needle guard 240 also activates the socket of the needle hub assembly 200 and the safety element 222 of the retract drum. In a shown embodiment, the needle guard 240 has a structure that fits the needle hub body 202 and facilitates its rotation, in relation to the retraction drum 220 so that the needle hub assembly 200 is properly attached to the retraction drum. In one embodiment shown, needle guard 240 includes a closed distal end (not shown), an open proximal end 249 and a hollow body 242 defining a cavity 243 for receiving needle hub body 202 and needle cannula 205. The hollow body 242 includes an inner surface 242. The inner surface 242 includes a frame that enables the needle guard 240 to engage the needle hub body 202 and facilitates attachment of the needle hub assembly 200 to the retract drum.
[0146] The inner surface 242 includes a plurality of holders 244 that extend inwardly and engage at least one finger element 214 of the needle hub body 202. Holders 244 engage finger elements 214 to rotate the hub body needle 202 with respect to security element 222 to attach the needle hub assembly 200 to the open distal end of the retract drum.
[0147] As shown in figure 20, while the needle hub assembly 200 and the needle guard 204 are placed inside the distal end 221 of the retract drum, the finger element 214 flexes as it moves over the wall 223 of the retraction drum. While the user rotates the needle guard 240 and the needle hub assembly 200 attached to it, holders 244 engage finger elements 214 and apply rotational force to finger element 214 to rotate needle hub body 202 and the needle hub assembly 200 until the tab 210 engages the protrusion 226 of the retract drum and the finger element 214 engages the opening 224 of the wall 223 of the retract drum. After engaging the flap 210 and the protrusion 226 and the finger element 214 and the opening 224, the opening 232 is aligned with the open conduit 212 of the needle hub assembly. In other words, the engagement of the security element 222 and the attachment element 208 allows fluid communication between the opening and the needle cannula. After proper engagement of the security element 222 and the attachment element 208, the needle guard can be removed from the needle hub body 202.
[0148] To remove the needle hub assembly 200 from the retract drum, the user places the needle guard 240 over the body of the needle hub 202 and the needle cannula 205 and applies rotational force to the needle guard 240, which in turn causes the holders 244 to apply a rotational force to the finger element 214 and causes the needle hub body 202 to rotate in the opposite direction to disengage that flap 210 from the protrusion 226 and the finger element 214 from the opening .
[0149] A second aspect of the present invention pertains to a retractable syringe assembly which provides for the separate contents of the retraction mechanism and the needle cannula in a needle chamber. The assembly also includes a trigger button, located at the proximal end of the syringe assembly, which extends into the needle chamber and is located adjacent to the piston rod used to aspirate and expel fluid from a fluid chamber disposed adjacent to the chamber needle. When the button is pressed, the needle hub is released in the needle chamber.
[0150] The modalities according to the second aspect provide an alternative mechanism for the retractable needle syringe. Typical retractable needle syringes provide a chamber within the piston 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 piston and stopper to be violated during actuation. The double drum design of the modalities according to the second aspect moves the retraction mechanism in a dedicated region allowing a piston and a conventional stopper to be used.
[0151] Most conventionally designed retractable needles (single drum designs with a driven retraction piston) are triggered after dosing by continued pressure behind the piston rod. Since these are the same forces that need to be applied when dispensing medication, accidental triggering can occur. Specifically, such devices can be activated accidentally during dosing if sufficient pressure is generated, that is, during the expulsion of a viscous medicine from the drum, which requires more force to be applied and such forces may exceed the forces necessary to activate the mechanism. retraction. In other known devices, the pressure generated at the stopper may be sufficient to cause a failure of the stopper or any removable opening in the piston rod.
[0152] Conventional retraction mechanisms, piston-driven safety syringes must withstand the increased syringe pressures and associated larger piston forces as described above. This leads to the requirement for larger actuating forces that exceed the operating forces by some safety margin in order to prevent premature retraction. Additionally, since most devices of this type employ an additional piston movement after complete dispensing, and in the same direction as the dispensing movement, a limit force must be employed to allow the user to differentiate between a piston fully tightened and the drive operation.
[0153] Incorporating a separate release mechanism, distinct from the piston rod, this limitation is removed in the double drum design, and the release of the actuation force can be arbitrarily specified based on user requirements, ergonomic and safety considerations. The decoupling of the piston rod retraction drive also allows a separate and distinct control to be used for the retraction of the needle providing the operator with greater control over when the retraction of the needle occurs and remove the possibility of accidental activation. In addition, since the piston rod and stopper are no longer being used with the retraction mechanism, the existing piston rods and stoppers of existing devices can be used with other modalities described here.
[0154] The retractable syringe assembly 300 according to one or more embodiments of the second aspect is shown in figures 24-29. The syringe assembly 300 includes a double barrel that includes a fluid barrel 310 and a retraction barrel 320. The retractable syringe also includes a needle hub assembly 340, a piston rod 360, a stop 370 and a trigger element 390. The fluid drum shown in figures 27A-D includes a distal end 311, an open proximal end 319, a side wall 312 extending from distal end 311 and proximal end 319 including an inner surface 314 defining a chamber 315. A inner surface 314 defines a cross section width and may include a feature of reuse invention, which will be discussed in more detail below. The distal end 311 includes a distal part 317 that closes the distal end 311. In the embodiment shown, side wall 312 includes a first opening 330 to allow fluid communication between the fluid drum and the retraction drum. As will be discussed in more detail below, the first opening 330 also allows fluid communication between the needle cannula disposed within the retraction drum 320 and the fluid drum 310.
[0155] The fluid drums shown in figures 24-29 may include a reuse prevention feature. Specifically, the fluid drum 310 may include a retaining element 309 that extends around the entire circumference of the inner surface 314 of the fluid drum 310 at a location adjacent to the proximal end 319 of the fluid drum. A cross-section width or the cross-section width of the inner surface 314 on the retaining elements 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 barrel . In one or more embodiments, the optional flaps or holders can be used to create a region of the fluid drum 310 having a cross-section width that is less than the first cross-section width of the fluid drum 310. The retaining element can be formatted to facilitate the activation of the reuse prevention feature. For example, the retraction drum 310 can also include a transition region of diameter proximally adjacent to the retaining element at the proximal end 319 of the fluid drum 310. The cross-section width of the inner surface 314 of the flowed drum in the transition region diameter increases from the distal end 311 to the proximal end 319 of the drum 310. As will be described in greater detail below, in the modalities of the retractable syringe assembly that use a reuse prevention feature, the fluid drum reuse prevention feature 310 cooperates with the corresponding reuse prevention characteristics on the piston rod 360 to lock the piston rod 360 inside the fluid drum 310 and / or to disable the piston rod 360 from another use.
[0156] As more clearly shown in figures 27A-D, the retraction drum 320 is disposed adjacent to the side wall 312 of the fluidized drum 310. The retraction drum 320 is configured to house a needle hub assembly 340 and a feature of retraction. The retraction drum 320 includes a distal end 321 and an open proximal end 329. The distal end includes a tapered wall segment 232 that houses the needle hub assembly 340 therein. The wall 322 having an inner surface 324 defining a needle chamber 325 extending from the 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 flow drum 310. In one or more embodiments , the wall 322 can extend around the parts of the retraction drum 320 that are not in direct contact with the fluid drum 310 and the side wall 312 can form a barrier between the retraction drum 320 and the retraction drum 310. In other words, the outer surface of the sidewall 312 can form an inner surface 324 of the retract drum 320 along the part of the retract drum 320 that is directly in contact with the fluid drum 310.
[0157] Needle chamber size 325 can be modified to accommodate needle hub assembly 340 and / or the retract feature. According to one or more embodiments, the inner surface 324 of the retract drum 320 has a cross-section width that is less than the first cross-section width of the fluidized drum 310. In specific embodiments, the cross-section width of the surface interior 324 of the retraction drum is less than about 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% of the cross section width of the internal surface 314 of the fluid drum. Such designs in which the cross-section width of the inner surface 324 of the retract drum is less than the cross-section width of the internal surface 314 of the fluid drum, provides functional and ergonomic disadvantages. For example, the overall appearance and handling of the double-barrel syringe is more pleasurable for the user. In certain embodiments, the retraction drum can be nestled within the fluid drum. For example, both retraction drum and fluid drum can both be connected to or surrounded by a common wall, and the retraction drum can be partially or completely disposed within the fluid drum, or alternatively, a partition wall can separate a simple drum in two separate drums. A fluid drum and a retraction drum.
[0158] The wall 322 can include a second opening 332 that allows communication of the fluid with the fluid chamber 315 and the needle chamber 325. The second opening of the wall can also allow fluid communication between the fluid chamber 315, needle chamber 325 and needle cannula.
[0159] According to one or more modalities, the retraction drum has a cross-section dimension that is smaller than the cross-section dimension of the fluid drum. In specific embodiments, the retraction drum's cross-sectional dimension is less than about 90%, 80%, 70%, 60%, 50%, 40%, 30%, or 20% of the drum's cross-sectional dimension of fluid. Such designs in which the cross section dimension of the fluid drum is smaller than the cross section dimension of the fluid drum, provide functional and ergonomic advantages. For example, the appearance and handling of the double-barrel syringe is more pleasing to the user.
[0160] The needle hub assembly may include a fluid path 354 that extends from the open end of the needle cannula to the second opening 332 of the retract drum. The second conduit may include an opening (not shown) that must be aligned with the second opening to allow fluid communication between the needle cannula and the fluid barrel.
[0161] Referring to figures 28 and 28A, the needle hub assembly 340 disposed within the retraction drum 320 and includes a needle hub 342 and a needle cannula 350 attached to needle hub 342. The needle hub 342 includes a distal end 341 and a proximal end 349. The needle cannula 350 includes an open, free distal end 351 and a proximal end 359 that is attached to the distal end 341 of the needle hub. The needle hub 342 shown in figures 28 and 28A includes a recessed part 355 for partially housing an 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 drum 310.
[0162] The needle cannula 350 of the needle hub assembly 340 is prone to move in the proximal direction. In the embodiment shown, the needle hub assembly 340 is tended to move in the proximal direction, thus tending the needle cannula 350. The needle hub assembly 340 is tended to move in the proximal direction by a bias element 352 arranged between the needle cannula 350 and the tapered wall segment 323 of the retraction drum. As shown more fully in Figures 26-27, the bias element 352 is shown as surrounding the needle cannula 350.
[0163] In the embodiment shown, the tendon element 352 fits into the needle cannula 350. The tendon element 352 can include a spring, which can be a compression spring that applies constant force to the needle hub 342 in the proximal direction . In alternative embodiments, the bias element 352 can be provided in another way, for example, a lever arm (not shown) can be arranged between the needle hub and the boundary wall. The needle hub 342 includes at least one hub seal 343 arranged along the outer surface of the needle hub 342 to form a fluid-tight seal with the tapered wall segment 323 of the retract drum. As will be described in more detail below, trigger element 390 supports needle hub 342 and prevents bias element 352 from moving in the proximal direction. Needle hub 342 includes at least one holder 344 that receives and engages the corresponding frame on trigger element 390 that supports needle hub 342. As will be explained in more detail below, detach holder 344 from the corresponding frame on trigger element will allow the bent needle hub 342 and the needle cannula 350 attached to it to retract in retraction drum 320.
[0164] In the embodiment shown, for example, in figures 25, 28 and 28A, the needle tube 342 includes a first attachment part. In the embodiment shown, the first attachment part is provided in the form of at least two holders 344 or grooves 345 arranged at opposite ends of the needle hub 342. The grooves 345 are arranged adjacent the proximal end 349 of the needle hub assembly. The grooves are shown to include a first part radially outwardly in the needle hub 342, a second part that has no inclination and is substantially parallel to the axis along which the needle hub is arranged, and a third part that tilts clearly radially outward. The first attachment part facilitates the engagement of the trigger element 390 with the grooves 345. The third part 347 prevents disengagement of the trigger element 390 until sufficient force is applied to the trigger element 390. Specifically, the sharp inclination of the third part 347 prevents the trigger element from sliding over and out of holders 344, when engaged with holders 344. Once sufficient force is applied to trigger rod 390 to overcome third part 347 of holder 344, referred to here as the trigger force, the detachment of the trigger element 390 from the needle hub 342 allows the bias element 352 to move in the needle cannula 350 and the needle hub 342 attached thereto to the trigger element 390 and / or the retraction 320. Specifically, expansion of the bias element 352 leads the needle cannula 350 and the needle hub 342 to the trigger element 390 and / or the retraction drum 320.
[0165] The needle hub assembly is movable in the needle chamber. The size and shape of the needle hub assembly can be modified to allow movement in the needle chambers having different sizes. In the assembled state, prior to use, the needle hub assembly is positioned at the open distal end of the retraction drum.
[0166] A piston rod 360 is disposed within the fluid drum 310 and includes a stop 370 attached to it to form a tight fluid seal with the inner surface 314 of the fluid drum 310. The piston rod 360 can include a reuse prevention feature that locks the piston rod 360 inside the fluid drum 310 or otherwise disables the piston rod 360. The piston rod may include a reuse prevention feature that cooperates with the reuse prevention feature arranged in the fluid drum 310. In one or more embodiments, the piston rod may include a protrusion 313 that has a cross-section width that is greater than the cross-section width of the inner surface 314 of the fluid drum 310 in the element retention element 309. As discussed above, the retention element forms a smaller cross-section width than at other locations along the length of the fluid drum 310. Therefore, when the piston rod trusion advances distally after the fluid drum retainer 310, a smaller cross-sectional width of the retainer prevents movement of the protrusion in the proximal direction. Therefore, the piston rod 360 is locked within the fluid drum 310 by a retaining element. In one or more embodiments, the stop 370 and / or the piston rod 360 can have a structure to allow relative movement of the piston rod 360 in relation to the stop 370. For example, the stop 370 can have an interior recess that allows that the distal end of the piston rod 360 moves in the distal and proximal directions within the interior recess, thereby lengthening and shortening the length of the piston rod and the stop. Piston rods and exemplary stoppers that allow relative movement of the piston rod in relation to the stopper are disclosed in U.S. Order Nos. 12 / 137,732 and 12 / 262,836 referred to above and are incorporated herein by reference.
[0167] Parador 370 can also include reuse prevention features that also cooperate with reuse prevention features arranged on fluid drum 310. For example, parador 370 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 314 of the fluid drum 310 in the retaining element. In such embodiments, removal of the stop 370 is prevented because the cross section width of the fluid drum retaining element 310 prevents the stop 370 from being removed. The piston rod 360 and the stop 370 can be articulated by a breakable connection 372 which can cause the piston rod 360 to be disconnected from the stop 370, while the stop 370 remains locked inside the fluid drum 310 by a ring of retention. Exemplary stoppers that include a reuse prevention feature and piston rods and stoppers articulated by a brittle connection are disclosed in U.S. Order Nos. 12 / 137,732 and 12 / 262,836 and are incorporated here for reference.
[0168] The retractable syringe assembly 300 also includes a trigger element 390 that includes a distal end 391 and a proximal end 399. Trigger element 390 is movable independently of piston rod 360 and extends into needle chamber 325 of the retraction drum 320. In the embodiments shown, trigger element 390 includes a trigger pad 394 to which the user applies a force in the distal direction to drive the syringe assembly retraction mechanism.
[0169] Trigger element 390 includes a trigger element body 392 that extends from the distal end 391 to the proximal end 399. The body of the trigger element 392 is shaped to have a cylindrical shape and is elongated. In the embodiment shown, the trigger element 390 has an open distal end 391 and the trigger element body 392 has a hollow interior 393 for housing the needle hub 342 and the needle cannula 350. The proximal end 399 of the trigger element it is closed and can be tapered to retain the needle hub 342 within the hollow interior 393 after the needle hub 342 and the needle cannula 350 are retracted in the retract drum. Needle cannula 350 may also include a structure for retaining retracted needle cannula 350 within trigger element 390.
[0170] The distal end 391 of the trigger element 390 includes a second attachment part 394 for engaging the first attachment part. In the embodiment shown, the second attachment part includes at least one flexible arm 395 that extends distally from the body of the trigger element 393. The flexible arm 395 includes a release member 396 that is sized, shaped and positioned to fit the grooves 345 the needle hub 342. Specifically, the holder includes a first segment 346 that is angled radially inward, a second part that has no inclination and is substantially parallel to the axis along which the trigger element 390 is disposed, and the third segment 347 that clearly slopes radially outward. It will be better understood that the release member 396 may be of another size or shape that does not repeat the size and shape of the grooves 345.
[0171] The inner surface 324 of the retract drum may include a catch rib 380 for capturing or retaining the flexible arm 395 of the trigger element 390 on the application of trigger force. Specifically, the capture rib 380 is disposed adjacent to the conical wall segment 323 and extends in the needle chamber 325. The capture rib has a distal end that is attached to the interior surface of the retraction drum and a free proximal end that extends in the needle chamber 325. The capture rib 380 is limited to facilitate the distal end 391 of the trigger element 390 to slide over or walk over the capture rib 380 after applying a trigger force that allows the release member 396 disengages from grooves 345 and the trigger rod moves in the distal direction. As shown more clearly in figure 26, the flexible arm 395 of the trigger element slides over the catch groove 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 hub 342, the needle cannula 350 and the bias element 352 to move proximally after the release member 396 within the hollow interior 393 of the trigger element.
[0172] The retraction drum 320 includes a release opening 383 disposed adjacent the proximal end of the retraction drum. The release opening 383 can be closed to form a notch in the wall 322 of the retract drum. Trigger element 390 includes a release stop 397 arranged in the body of trigger element 392 that fits release opening 383. Release opening 383 and deliberation stop 397 provide an indication to the user of how much force is sufficient to overcome the grooves 345 of the needle hub 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 the release stop 397 from the release opening 383 is the same or substantially the same as the trigger 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 interior surface of wall 322 and release opening 383. In embodiments where release opening 383 is open and not closed, release opening 383 and release stop 397 provide a visual indication of whether the trigger force has been applied. Specifically, the user can see whether release stop 397 is engaged with release opening 383 and whether trigger force has been applied.
[0173] In one or more embodiments, the trigger force, which is the force required to detach release holder 397 from release opening 383 and / or detach release member 396 from slot 345 is at least about 4 pounds of force (lbf). In one or more variables, the trigger force is about 4 lbf. In another variation, the trigger force may include 2 lbf, 3 lbf, 4 lbf, 5 lbf, or 6 lbf. In a more specific embodiment, the trigger force is in the range of about 3.5 lbf to about 4.5 lbf.
[0174] In the mode shown, the needle hub assembly is permanently attached to the retraction drum 320 because it is closed inside the retraction drum. In one or more alternative embodiments, the needle hub assembly can be removably attached to the retract drum 320 or can be attached by a user to the open distal end 321 of the retract drum.
[0175] Referring to figure 29, the length of the piston rod 360, the trigger element 390 and the syringe barrel 301 can be modified so that the piston rod 360 aligns with the trigger element afterwards of expelling all contents from the syringe, as shown in figure 29. The alignment of piston rod 360 and trigger element 390 provide one or more visual indications and tactile indications and the tactile indication that the contents of the fluid barrel 310 has been completely expelled and the needle cannula 350 can be retracted in the retraction drum. In addition, such alignment of the trigger element 390 and the piston rod 360 after the stop 370 is in contact with the distal wall 317 of the fluidized barrel 310 requires that the trigger element 390 is not aligned with the piston rod 360 when the fluid drum is filled. Specifically, trigger element 390 is located closer to the proximal end 329 of the retract drum and to the proximal end 319 of the fluid drum than to the piston rod 360. This alignment, when retracting the needle cannula is not desired, it reduces the chance of accidental activation of the retraction mechanism.
[0176] A third aspect of the present invention pertains to a retractable syringe assembly that incorporates structure to prevent premature activation of the retraction mechanism. The retractable syringe assembly is shown in figures 30-32. In the embodiments shown in figures 30 and 32, the syringe assembly 400 includes a double syringe barrel as otherwise described here which includes a retraction barrel 420 and a fluid barrel 410. Trigger element 490 is disposed within the barrel retraction 420 and a piston rod 460 is disposed within the fluid drum 410. The piston rod 460 and the trigger element 490 have characteristics that prevent the piston rod from interacting with the trigger element 490 and accidentally triggering the element trigger 490. In addition, piston rod 460 and trigger element 490 have reuse prevention features that prevent the user from reusing syringe assembly 400. These features prevent premature firing and prevent features of reuse of the trigger element 490 and piston rod 460 described in relation to the third aspect can be incorporated with other trigger elements and piston rods described here.
[0177] Trigger element 490 includes a distal end (not shown) and a proximal end 499 and a trigger element body 492 extending from the distal end to the proximal end 499. A rupture 494 is disposed adjacent the proximal end 499. In the embodiment shown, break 494 is located on trigger element 490 and piston rod 460. Break 494 engages the retraction drum and the fit between them hinders or prevents movement of the trigger element 490 in the distal direction. As shown in figure 30, the break 494 is shown as an extension radially outwardly from the body of the trigger element 492. The break 494 includes a distal end 495 and a proximal end 496. The break 494 has a height that increases from the proximal end. 496 to the distal end 495 to allow or facilitate movement of the piston rod 460 after the break 494. The distal end 495 of the break 494 is shown to be substantially perpendicular to the trigger element body.
[0178] The rupture element 494 is pressable under the application of a force in the proximal direction. The rupture element 494 cannot be pressed under the application of a force in the proximal direction. Therefore, the engagement of the rupture element 494 with the retraction drum 420 applies a force to the rupture element 494 in the proximal direction, which prevents the rupture element from pressing movements and hinders the trigger element 490 in the distal direction. When the piston rod 460 is moved in the distal direction, it presses the rupture element 494 and allows the movement of the trigger element 490 in a distal direction. The piston rod 460 can include a contact surface, shown in figures 30-32 as a flat radial ring 462, which deflects the rupture element 494 then the trigger element 494 can be moved in the distal direction and the actuation of the trigger mechanism retraction can proceed.
[0179] In use, as shown in figures 31-32, the movement of the piston rod in the distal direction to expel all the contents of the fluid barrel 410 press the rupture element 494. When the piston rod is tightened or when all the contents of the fluid drum 410 are expelled and the stopper is in contact with the distal end of the fluid drum, the piston rod continues to press the rupture element 494. Pressing the rupture element 494 allows movement of the rupture element trigger 490 only after the contents of the syringe are expelled. Therefore, premature activation of the retraction mechanism is prevented.
[0180] The underlined principle of rupture element 494 is that the inclusion of an abrupt angled surface, which can be as much as 90 degrees, fits the retraction drum and prevents the distal movement of the trigger element. The breaking element 494 may have sufficient stiffness in the axial direction, but it can be easily deflectable in the radial direction. This ensures slight deflection when the piston rod engages the breaking element 494.
[0181] In one or more embodiments, the breaking element 494 can be rotatable so it can be removed during transport and storage, as shown in figures 58-60. Before use or before actuation, as shown in figure 58, trigger element 490 can be turned or rotated so that rupture element 494 is positioned to prevent movement of trigger element 490 in the distal direction, as shown in figure 59. Thereafter, when actuation of the retraction mechanism is desired, for example, when the contents of the fluid drum 410 have been expelled, the trigger element 490 can be rotated so that the rupture element 494 is positioned to allow movement of the trigger element 490 in the distal direction, as shown in figure 60.
[0182] Trigger element 490 and retraction drum 420 include a reuse prevention feature. The retract drum 420 includes a first locking element 440 disposed adjacent to its proximal end which fits with the second locking element 450 disposed in the body of the trigger element 492. The first locking element 440 is shown as an opening 442 in the wall 422 of the retraction drum 420. It should be understood that the opening can be provided in other ways. The second locking element 450 is shown as an outwardly extending projection 452 arranged on the body of the trigger element 492. The projection 452 has a proximally facing back face 454 that prevents movement of the first locking element 440 and the second element locking 450.
[0183] The first locking element and the second locking element 450 are positioned on the retraction drum 420 and the trigger element 490 so they can engage when the force is applied to the trigger rod in the distal direction to activate the retraction mechanism. As shown in figure 32, after applying force to the trigger element 490 in the distal direction, the projection 452 fits the opening 442.
[0184] The trigger element reuse prevention feature can be designed to be easily deflectable in the radial direction when the trigger element contacts the inner surface of the retract drum 420. At the end position of the first and second locking elements 440 , 450, the projection 452 of the trigger element 490 must reach the opening 442 where the projection 452 can re-expand and lock the back movement of the trigger element 490. This will prevent the trigger element 490 from being pulled out of the drum retraction 420 and driven by multiple retraction mechanism drives. Adding this feature to the device, the retraction mechanism can only be activated once, thereby preventing reuse after, for example, changing the retractable needle.
[0185] The fourth aspect of the present invention belongs to a retractable syringe assembly 500 that includes an alternative retraction mechanism. The retractable syringe assembly 500 is shown in figures 33-37. The syringe assembly 500 includes a double syringe barrel as otherwise described herein which includes a needle chamber and a fluid chamber. The needle hub assembly 540 according to the needle hub assembly described with reference to figures 8-17, where the needle hub 542 closes the needle cannula holder 546, a needle cannula 550 that is attached to the holder needle cannula and a bias element 552 disposed between needle cannula holder 546, needle cannula 550 and a needle hub 542. Needle hub 542, as shown in figures 33-37, includes a distal end 553 and a proximal end 554. The distal end 553 can include a body part 545 having a conical shape and includes an opening (not shown) therethrough to receive the needle cannula 550. The proximal end 554 includes a first retraction part 555 which extends in the proximal direction of the body 545 and defines a hub cavity to house the needle cannula support 546, the bias element 552 and the needle cannula, as described above with reference to figures 8-17. 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 includes at least one flexible part 558 having a locking tab 559 at the proximal end thereof. The snap tab 559 engages the needle cannula holder 546 and exerts a force on the needle cannula holder 546 in the distal direction to counteract the force applied by the bias element 552 in the proximal direction in the needle hub assembly 540.
[0186] Trigger element 590 includes a distal end 591 and a proximal end (not shown). Trigger element 590 also includes a trigger element body 592 extending from the distal end 591 to the proximal end, as otherwise described herein, which may include a hollow interior 593 to house the retracted needle cannula. The trigger element body 592 includes a rib 594 that extends radially outwardly to disengage the flap 559 from the needle cannula holder 546 and release the force applied by the snap flap 559 to the needle hub assembly 540. The trigger 590 unsnaps tab 559 and needle cannula holder 546 after applying the trigger force by the trigger element, which provides sufficient distal force on the snap tab 559 and / or the flexible part 558 to cause the flexible part 558 moves outwards so the snap tab 559 is no longer engaged with the needle cannula holder 546 and the force applied to the biased element is no longer neutralized. Specifically, removing the force applied by the snap tab 559 on the needle cannula holder 546 in the distal direction allows the force applied by the bias element 552 to move the needle cannula holder 546 and the needle cannula 550 to the piston element. .
[0187] The modalities described here may include alternative retraction mechanisms that are disclosed in U.S. Interim Order Reference Number P-8842, United States Interim Order Serial Number 61/366749, incorporated by reference in its entirety. Specifically, the retraction mechanisms disclosed in figures 7-11, 18-22 and 24-27 of U.S. Provisional Order Reference Number P-8842.
[0188] Alternative modalities of the trigger element are shown in figures 38-57, 57A-57B and figures 61-66, which can be used with the syringe assemblies described here.
[0189] In figures 38, 38A, 38B, 39, 39A, 39B and 54, 54A, 54B and 55, the proximal end of the trigger element has a circular trigger pad that substantially covers or surrounds the piston rod at the proximal end open of the fluid drum. The trigger element can be coded by indications such as one or more identifications, markings or color codes. After the trigger element is actuated by applying distal force to the piston rod, the proximal end of the piston rod or thumb pressure can be completely nested within the trigger pad.
[0190] Figures 40-42 show a design in which the piston rod fits the trigger element in the shape of a semicircular element or an element in increasing shape. The thumb pressure piston rod can be pressed in its most distal position, and the user can then activate the trigger element by applying force to the trigger element.
[0191] Figures 43-47 show a design where the end of the trigger element has a substantially rectangular trigger pad with curved edges and the piston rod can nest within the trigger pad. In figures 48-50, the trigger pad is substantially oval in shape. In figures 51-53, the trigger pad is aligned with the needle cannula on one side of the syringe assembly finger flange. In figures 56, 57, 57A and 57B, the trigger element has a trigger pad that is aligned with the needle cannula and the needle chamber, and a trigger pad extending outside the body of the needle chamber. Fig. 61 shows a configuration in which the trigger element is a small flap at the end of the needle chamber. Fig. 62 shows a trigger element such as a tab that can be activated by applying a force in the distal direction. The trigger element has a squeezing surface in the form of a plurality of spaced ribs. Fig. 63 shows an alternative trigger element design in which the trigger element is in the form of a user-operated block. Figure 64 shows a button built into the proximal end of the needle barrel that can be triggered by the user by pressing or pressing the button to cause the needle to retract.
[0192] Figure 65 shows a thumb pressing on the piston rod that has an articulated part that can be moved by applying a distal force to the articulated part to activate the trigger element in the retraction mechanism. Figure 66 shows a trigger element that is somewhat similar to figure 64, except that the trigger element is in the form of an alternating type element that can be moved radially to drive the retraction mechanism.
[0193] In another embodiment of the present invention, a method for aspirating and expelling a liquid from the syringe assembly of the present invention is provided comprising aligning the trigger guard to prevent movement of the trigger element 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 piston rod in a proximal direction. The fluid from the fluid chamber is expelled by applying force to the piston rod in the distal direction. The needle cannula is retracted in the retract drum by aligning the trigger guard to allow movement of the trigger element in the distal direction and applying a force to the trigger guard in the distal direction to provide the trigger force causing the needle cannula retracts into the retract drum. The method may include providing the syringe assembly of the present invention and providing instructions for aspirating and expelling the liquid.
[0194] In another embodiment of the present invention. A method of aspirating and expelling a liquid from a syringe assembly of the present invention is provided comprising a pre-selected amount of liquid in the fluid chamber by inserting a needle cannula into the liquid and applying force to the piston rod in a proximal direction. The fluid from the fluid chamber is then expelled by applying force to the piston rod in the distal direction. The piston rod is locked inside the fluid drum by applying continuous force to the piston rod in the distal direction causing the protrusion of the piston rod to move distally after the fluid drum retaining ring. The needle cannula is retracted in the retract drum by aligning the trigger guard to allow movement of the trigger element in the distal direction and applying a force to the trigger guard in the distal direction to provide a trigger force causing the needle cannula retract in the retract drum. The method may include providing the syringe assembly of the present invention and providing instructions for aspirating and expelling the fluid.
[0195] In another embodiment of the present invention, a method for aspirating and expelling a liquid from a syringe assembly of the present invention is provided comprising providing a syringe barrel including a fluid barrel and a retraction barrel in fluid communication, the fluid drum including a piston rod attached to a stopper to suck and expel liquid from the fluid drum and a retraction drum including a needle hub, a needle cannula with an opening and a trigger element to provide a pulling force trigger causing the needle cannula to retract in the retraction drum. The opening of the needle cannula is submerged in a liquid and the fluid barrel of the syringe is filled with the liquid by applying force to the piston rod in a proximal direction. The fluid drum fluid is expelled by applying force to the piston rod in a distal direction. The needle cannula is then retracted in the retract drum by applying force to the trigger element in the distal direction to provide the trigger force. The method may include providing the syringe assembly of the present invention and providing instructions for aspirating and expelling the fluid.
[0196] In another embodiment of the present invention, a method for aspirating and expelling a liquid from a syringe assembly of the present invention is provided further comprising locking the piston rod in the fluid drum after expelling the liquid from the fluid drum. The method may include providing the syringe assembly of the present invention and providing instructions for aspirating and expelling the fluid.
[0197] In another embodiment of the present invention, a method for aspirating and expelling a liquid from a syringe assembly of the present invention is provided where the force applied to the piston rod is oriented along an axis that is parallel to the axis along from which the force applied to the trigger element is oriented. The method may include providing the syringe assembly of the present invention and providing instructions for aspirating and expelling fluid.
[0198] In another embodiment of the present invention, a method for aspirating and expelling a liquid from a syringe assembly of the present invention where the force applied to the piston rod to expel the liquid is less than the force applied to the trigger element. The method may include providing the syringe assembly of the present invention and providing instructions for aspirating and expelling the fluid.
[0199] Reference as a whole in this specification to “a modality”, “certain modalities”, “one or more modalities” or “a modality” means that a characteristic, structure, material or particular feature described in connection with modality is included in at least one modality of the invention. Thus, the appearances of phrases such as "in one or more modalities", "in certain modalities" or "in a modality" in various places throughout this specification are not necessarily referring to the same modalities as the invention. In addition, particular features, structures, materials, or features can be combined in any compatible manner in one or more embodiments.
[0200] Although the invention has described here with reference to particular modalities, it should be understood that these modalities are merely illustrative of the principles and applications of the present invention. It will be apparent to a person skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention includes modifications and variations that are within the scope of the claims and their equivalents.

权利要求:
Claims (36)
[0001]
1. Syringe assembly, comprising: a fluid drum (110) including a side wall (112) having an internal surface (114) defining a fluid chamber (115) for fluid retention and having a first width in cross section , an open proximal end (129) and a distal end including a distal wall; a piston rod (160) disposed within the fluid chamber (115) comprising a distal end, a proximal end, a piston rod body extending from the distal end to the proximal end, and a stop (170) disposed at the end distal from the piston rod (160) to form a fluid-tight seal with the inner surface (114) of the drum (112); a retraction drum (120) disposed adjacent the side wall (112) of the fluid drum (110), the retraction drum (120) including a wall having an inner surface (124) defining a needle chamber (125), a open proximal end (129), an open distal end (121) including a boundary wall, a first closing element (440) disposed adjacent to the proximal end (129), an opening (123) between the wall (122) of the drum retraction (120) and the side wall (112) of the fluid drum (110) allowing fluid communication between the fluid chamber (115) and the needle chamber (125) and a needle hub assembly (140) comprising a needle hub (142), a needle cannula (150) attached to the needle hub (142), the needle cannula (150) being in fluid communication with the opening (123) and being able to move in a proximal direction ; and a trigger element (190) disposed inside the needle chamber (125) and movable inside the retraction drum (120) independently of the piston rod (160), the trigger element (190) including a second lock (450) disposed at its proximal end (199) and which fits into the first locking element (440) of the retraction drum (120) to prevent movement of the trigger element (190) in a proximal direction after the cannula needle (150) is retracted in the retraction drum (120), CHARACTERIZED by the fact that by applying a force directed distally on the trigger element (190), the trigger element (190) moves in the distal direction to provide a trigger force and cause the needle cannula (150) to retract into the retraction drum (120) and cause the second locking element (450) to engage with the first locking element (440).
[0002]
2. Syringe assembly according to claim 1, CHARACTERIZED by the fact that the first locking element (440) includes at least one opening (442) that receives a second locking element (450), the second locking element (450) including at least one protrusion extending outwards (452) with a locking face that prevents the protrusion (452) from disengaging from the opening (442).
[0003]
3. Syringe assembly according to claim 2, CHARACTERIZED by the fact that the opening (442) is closed.
[0004]
Syringe assembly according to claim 2, CHARACTERIZED by the fact that the first locking element (440) includes a plurality of openings (442) and a second locking element (450) includes a plurality of protrusions (452 ).
[0005]
5. Syringe assembly according to claim 2, CHARACTERIZED by the fact that by applying a force directed proximally on the piston rod (160) to fill the fluid barrel (110) with a fluid, the piston rod (160) is movable in the proximal direction, while the trigger element (190) remains stationary.
[0006]
6. Syringe assembly according to claim 5, CHARACTERIZED by the fact that by applying a distally directed force on the piston rod (160) to expel the liquid from the fluid drum (110), the piston rod ( 160) is movable in the distal direction to cause the stopper (170) to contact the distal wall (117) of the fluid drum (110), while the trigger element (190) remains stationary.
[0007]
7. Syringe assembly according to claim 1, CHARACTERIZED by the fact that by applying force to the trigger element (190) in the proximal direction after the second locking element (450) fits into the first locking element locking (440), the locking face prevents movement of the trigger element (190) in the proximal direction.
[0008]
8. Syringe assembly comprising: a fluid drum (110, 410) including a side wall (112) having an internal surface defining a fluid chamber (115) for fluid retention and having a first width in cross section, a open proximal end (119) and a distal end (111) including a distal wall (117); a piston rod (160, 460) disposed within the fluid chamber (115) comprising a distal end, a proximal end, a piston rod body extending from the distal end to the proximal end, and a stop (170 ) arranged at the distal end of the piston rod (160, 460) to form a fluid-tight seal with the inner surface (114) of the drum (110, 410), the piston rod (160, 460) having a contact surface ; a retraction drum (120, 420) disposed adjacent to the side wall of the fluid drum (410), the retraction drum (120, 420) including a wall having an inner surface (124) defining a needle chamber (125), an open proximal end (129), an open distal end (121) including a boundary wall (122), an opening (123) between the wall (122) of the retraction drum (120, 420) and the side wall (112) the fluid drum (110, 410) allowing fluid communication between the fluid chamber (115) and the needle chamber (125) and a needle hub assembly (140) comprising a needle hub (142), a needle cannula (150) attached to the needle hub (142), the needle cannula (150) being in fluid communication with the opening (123) and being able to move in a proximal direction; and a trigger element (190, 490) disposed inside the retraction drum chamber (120, 420) and movable inside the retraction drum (120, 420) independently of the piston rod (160, 460), FEATURED by the element trigger (190, 490) include a distal end (111), a proximal end (199, 499) and a trigger element body (192, 492), the trigger element body (192, 492) extends to from the distal end (111) to the trigger end (199, 499), a rupture element (494) disposed adjacent to the proximal end (199, 499) of the trigger element (190, 490), the rupture (494) having a radially outward extension that extends from the body of the trigger element (192, 492) and prevents movement of the trigger element (190, 490) in the distal direction, the rupture element (494) having a height that increases the from the proximal end (496) to the distal end (495) and where a distal end (495) of the rupture (494) is perpendicular r to the body of the trigger element (192, 492), the rupture element (494) being deflected after contact with the contact surface (462) of the piston rod (460), so that the trigger element (190, 490) can be moved in the distal direction, the trigger element (190, 490) providing a trigger force to cause the needle cannula (150) to retract into the retraction drum (120, 420).
[0009]
9. Syringe assembly according to claim 8, CHARACTERIZED by the fact that the width of the trigger element (190, 490) cross-section increases along the rupture element (494) from the proximal end to the distal end and where the retraction drum (120, 420) has a cross section width that is less than the cross section width of the trigger element (190, 490) in the rupture element (494).
[0010]
10. Syringe assembly according to claim 9, CHARACTERIZED by the fact that the rupture element (494) is compressible after applying force to the rupture element (494) in the distal direction.
[0011]
11. Syringe assembly, according to claim 10, CHARACTERIZED by the fact that the rupture element (494) is not compressible after applying force to the rupture element (494) in the proximal direction.
[0012]
12. Syringe assembly according to claim 10, CHARACTERIZED by the fact that the rupture element (494) compresses as the piston rod (160, 460) moves in a distal direction.
[0013]
13. Syringe assembly according to claim 10, CHARACTERIZED by the fact that by applying a distally directed force on the piston rod (160, 460) to fill the fluid barrel (110, 410) with a liquid, the piston rod (160, 460) is movable in the proximal direction while the trigger element (190, 490) remains stationary.
[0014]
14. Syringe assembly according to claim 13, CHARACTERIZED by the fact that by applying a distally directed force on the piston rod (160, 460), the piston rod (160, 460) moves in the distal direction and provides a force on the rupture element (494) in the distal direction that compresses the rupture element (494).
[0015]
15. Syringe assembly according to claim 14, CHARACTERIZED by the fact that through contact between the stopper (170) and the distal wall (117), the piston rod (160, 460) applies a continuous force to the element rupture element (494) to compress the rupture element (494) and allow movement of the trigger element (190, 490) in the distal direction.
[0016]
16. Syringe assembly according to claim 1, CHARACTERIZED by the fact that the internal surface (114) of the side wall of the fluid chamber (112) includes a retaining ring (109) adjacent to the proximal end (119), defining a second cross-section width that is less than the first cross-section width and a piston rod body includes a flexible protrusion (113) having a cross-section width greater than the drum cross-section width (110) on the retaining ring (109) and a frangible part.
[0017]
17. Syringe assembly according to claim 16, CHARACTERIZED by the fact that the contact between the stopper (170) and the distal wall (117) of the drum (110) causes the protrusion (113) to proceed distally after the retaining ring (109) on the barrel (110) and lock the piston rod (160) on the barrel (110) to prevent reuse of the syringe assembly.
[0018]
18. Syringe assembly according to claim 16, CHARACTERIZED by the fact that the distal end of the piston rod (160) includes a stopper fitting part and a stopper (170) is attached to the stopper fitting part of the piston rod (160), the stopper (170) being distally and proximally movable in relation to the fitting part of the stopper for a pre-selected axial distance, so that when a force is applied to the piston rod (160) in the distal direction and the distal end of the stopper (170) is in contact with the distal wall (117) of the drum (110), the protrusion (113) is allowed to advance distally after the retaining ring (109) in the drum ( 110) and lock the piston rod (160) in the barrel (110) to prevent reuse of the syringe assembly.
[0019]
19. Syringe assembly according to claim 17, CHARACTERIZED by the fact that the continuous application of a force on the piston rod (160) in the proximal direction after the protrusion (113) has been advanced distally after the retaining ring (109) causes the frangible part to break.
[0020]
20. Syringe assembly according to claim 18, CHARACTERIZED by the fact that the continuous application of a force on the piston rod (160) in the proximal direction after the protrusion (113) has been advanced distally after the retaining ring (109) causes the frangible part to break.
[0021]
21. Syringe assembly (400) comprising: a fluid barrel (410) including a side wall having an internal surface defining a fluid chamber for fluid retention and having a first cross-section width, an open proximal end and a distal end including a distal wall; a piston rod (460) disposed within the fluid chamber (410) comprising a distal end, a proximal end, a piston rod body extending from the distal end to the proximal end, and a stopper disposed at the distal end of the rod piston (460) to form a fluid-tight seal with the inner surface of the drum; a retraction drum (420) disposed adjacent the side wall of the fluid drum (410), the retraction drum (420) including a wall having an inner surface defining a needle chamber, an open proximal end, an open distal end including a boundary wall, an opening between the retraction drum wall (420) and the side wall of the fluid drum (410) allowing fluid communication between the fluid chamber and the needle chamber and a needle hub assembly comprising a needle hub, a needle cannula attached to the needle hub, the needle cannula being in fluid communication with the opening and being able to move in a proximal direction; and a trigger element (490) disposed within the needle chamber and rotatable within the retraction drum (420) independently of the piston rod (460), FEATURED by the fact that the trigger element (490) includes a trigger guard (494) which prevents premature retraction of the needle cannula, the trigger element (490) providing a trigger force causing the needle cannula to retract into the retraction drum (420), the piston rod (460) comprising a flat radial ring (462) that deflects the trigger guard (494), so that the trigger element (490) can be moved in a distal direction to retract the needle cannula.
[0022]
22. Syringe assembly (400) according to claim 21, CHARACTERIZED by the fact that the trigger force is provided by the movement of the trigger element (490) in the distal direction and the trigger guard (494) includes a projection extending outwardly (452) to prevent movement of the trigger element (490) in the distal direction.
[0023]
23. Syringe assembly (400) according to claim 22, CHARACTERIZED by the fact that the trigger element (490) is rotatable to align the trigger guard (494) to prevent movement of the trigger element (490) in the distal and rotatable direction to align the trigger guard (494) to allow movement of the trigger element (490) in the distal direction.
[0024]
24. Syringe assembly (400) according to claim 23, CHARACTERIZED by the fact that the retraction drum (420) includes a visual indication to indicate whether the trigger guard (494) is aligned to prevent movement of the element trigger (490) in the proximal direction or allow movement of the trigger element (490) in the distal direction.
[0025]
25. Syringe assembly comprising: a fluid drum (110, 310) including a side wall having an internal surface defining a fluid chamber (115, 315) for fluid retention and having a first width in cross section, one end open proximal and a distal end including a distal wall; a piston rod (160, 360) disposed within the fluid chamber (115, 315) comprising a distal end, a proximal end, a piston rod body (160, 360) extending from the distal end to the proximal end, and a stopper (170, 370) disposed at the distal end of the piston rod (160, 360) to form a fluid-tight seal with the inner surface of the drum; a retraction drum (120, 320) disposed adjacent to the side wall of the fluid drum (110, 310), a retraction drum (120, 320) including a wall having an inner surface defining a needle chamber (125, 325) , an open proximal end, an open distal end including a boundary wall, an opening (123) between the retraction drum wall (120, 320) and the fluid drum side wall (110, 310) allowing for fluid communication between the fluid chamber (115, 315) and the needle chamber (125, 325) and a needle hub assembly (140, 340) comprising a needle hub, a needle cannula attached to the needle hub, the cannula the needle being in fluid communication with the opening (123) and being able to move in a proximal direction; and a trigger element (190, 390) disposed inside the needle chamber (125, 325) and movable inside the retraction drum (120, 320) independently of the piston rod (160, 360), FEATURED by the trigger element (190, 390) include a distal end, the distal end of the trigger element (190, 390) including a trigger press with a notch to facilitate rotation of the trigger element (190, 390), the trigger element (190 , 390) providing a trigger force causing the needle cannula to retract into the retraction drum (120, 320).
[0026]
26. Syringe assembly according to claim 25, CHARACTERIZED by the fact that the inner surface of the side wall of the fluid chamber (115, 315) includes an adjacent retaining ring at the proximal end and defining a second cross section width which is smaller than the first cross-section width and a piston rod body (160, 360) includes a flexible protrusion having a cross-section width greater than the cross-section width of the drum in the rib and a portion frangible.
[0027]
27. Syringe assembly according to claim 26, CHARACTERIZED by the fact that the contact between the stopper (170, 370) and the distal wall (117, 317) of the drum causes the protrusion to advance distally after the rib in the drum and lock the piston rod (160, 360) in the barrel to prevent reuse of the syringe assembly.
[0028]
28. Syringe assembly according to claim 26, CHARACTERIZED by the fact that the distal end of the piston rod (160, 360) includes a stop fitting part and a stop (170, 370) is attached to the piston rod stopper (160, 360), the stopper (170, 370) being distally and proximally movable in relation to the stopper part of the stopper for a pre-selected axial distance, so that when the force is applied to the piston rod (160, 360) in the distal direction and the distal end of the parador (170, 370) is in contact with the distal wall (117, 317) of the drum, the protrusion is allowed to advance distally after the rib on the barrel and lock the piston rod (160, 360) on the barrel to prevent reuse of the syringe assembly.
[0029]
29. Syringe assembly according to claim 27, CHARACTERIZED by the fact that the continuous application of a force on the piston rod (160, 360) in the proximal direction after the protrusion has advanced distally after the rib causes let the frangible part break.
[0030]
30. Syringe assembly according to claim 28, CHARACTERIZED by the fact that the continuous application of a force on the piston rod (160, 360) in the proximal direction after the protrusion has advanced distally after the rib causes the frangible part breaks.
[0031]
31. Method CHARACTERIZED by the fact that it comprises: providing a syringe assembly as defined in claim 1; and providing instructions for: aligning the trigger guard to prevent movement of the trigger element (490) in the distal direction; aspirating a pre-selected amount of liquid into the fluid chamber (115) by inserting the needle cannula (150) in a liquid and applying force to the piston rod (460) in a proximal direction; expelling the liquid from the fluid chamber (115) by applying force to the piston rod (460) in the distal direction; and retract the needle cannula (150) to the retraction drum (420) by aligning the trigger guard to allow movement of the trigger element (490) in the distal direction and applying force to the trigger guard in the distal direction to provide the trigger force causes the needle cannula (150) to retract in the retraction drum (420).
[0032]
32. Method according to claim 31, CHARACTERIZED by the fact that it still comprises: an open proximal end (129) and a distal end (121) including a distal wall, the inner surface of the side wall of the fluid chamber (115 ) including a retaining ring adjacent to the proximal end; and also provide instructions for: locking the piston rod (460) into the fluid drum (410) by applying continuous force to the piston rod (460) in the distal direction, causing the protrusion of the piston rod (460) ) moves distally beyond the fluid drum retaining ring (410) after expelling the liquid from the fluid chamber (115) by applying force to the piston rod (460) in the distal direction and before the cannula retracts needle (150) in the retraction drum (420).
[0033]
33. Method FEATURED by the fact that it comprises: providing a syringe drum (101) including a fluid drum (110, 310, 410) and a retraction drum (120, 320, 420) in a fluid communication, the drum fluid (110) including a piston rod (160, 360, 460) attached to a stopper (170, 370) to aspirate and expel liquid from the fluid drum (110) and a retraction drum (120, 320, 420 ) including a needle hub, a needle cannula (150, 350, 550) with an opening and a trigger element (190, 390, 490, 590) to provide a trigger force causing the needle cannula (150 , 350, 550) retracts to the retraction drum (120, 320, 420); provide instructions for: submerging a needle cannula opening (150, 350, 550) in a liquid; fill the fluid drum (110, 310, 410) with a liquid by applying force to the piston rod (160, 360, 460) in a proximal direction; expelling the liquid from the fluid chamber by applying force to the piston rod (160, 360, 460) in a distal direction; and retract the needle cannula (150, 350, 550) in the retraction drum (120, 320, 420) by applying force to the trigger element (190, 390, 490, 590) in a distal direction to provide the force trigger.
[0034]
34. Method according to claim 33, CHARACTERIZED in that it comprises providing instructions for locking the piston rod (160, 360, 460) in a fluid drum (110, 310, 410) after expelling the liquid from the fluid drum (110, 310, 410).
[0035]
35. Method, according to claim 33, CHARACTERIZED by the fact that the force applied to the piston rod (160, 360, 460) is oriented along an axis that is parallel to the axis along which the force applied to the piston rod trigger element (190, 390, 490, 590) is oriented.
[0036]
36. Method according to claim 33, CHARACTERIZED by the fact that the force applied to the piston rod (160, 360, 460) to expel the liquid is less than the force applied to the trigger element (190, 390, 490 , 590).

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

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

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2020-06-09| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2020-09-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/07/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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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|

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US13/187,200|2011-07-20|

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US13/187,200|US9550030B2|2010-07-22|2011-07-20|Dual chamber syringe with retractable needle|

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PCT/US2011/044834|WO2012012626A2|2010-07-22|2011-07-21|Dual chamber syringe with retractable needle|

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