• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
      SAFETY SYRINGES WITH RETRACTABLE NEEDLE.The present invention relates to a safety syringe 10 that includes a barrel 18, plunger assembly 12, and barrel adapter 20. A barrel adapter 20 mountable on a syringe barrel 18 includes a barrel tip 32, barrel assembly. needle 42, and needle retraction mechanism 21. Needle assembly 42 includes a needle hub 24, needle seal 26, and needle 28, which is configured to pass through needle assembly 42, locking mechanism 22, tilt member 30, and the tip of the barrel 32. The needle retraction mechanism 21 includes a tilt member 30 and the locking mechanism 22 so that actuation of the locking mechanism 22 allows the tilt member 30 to cause the retraction of needle 28 at the tip of the drum 32. Methods for assembling, manufacturing and using these syringes 10 are also provided.
    公开号:BR112014020766A2
    申请号:R112014020766-6
    申请日:2012-12-04
    公开日:2020-10-27
    发明作者:Nasoud Samandi；Christian P. Brandt；Paul D. Goebel
    申请人:Unitract Syringe Pty. Ltd.；
    IPC主号:
    专利说明:

    [002] [002] The present invention relates to safety syringes. More specifically, the modalities of the present invention refer to. refer to adaptive drum needle retraction systems, syringes that integrate such safety mechanisms, methods for making such safety syringes, and their methods of use. Background of the Invention
    [003] [003] Pre-filled syringe cartridges manually activated are commercially available from a variety of manufacturers, including the owner and holder of the present invention. Pre-filled syringe cartridges are used to administer drug solutions, drug suspensions, vaccines, medical therapies, and any other liquid medication by parenteral injection.
    [004] [004] Thus, the pre-filled syringe cartridges include a primary medication chamber, a hypodermic needle permanently affixed to or in fluid communication with the medication chamber, and a piston received slidably in the medication chamber. The pistons of the pre-filled syringe cartridges often include a sub-assembly of the plunger, which may include an inner plunger and an outer plunger, to force the liquid medication from the needle. Pre-syringes
    [005] [005] The practice of sharing syringes without adequate sterilization between successive users is the main contributor to the transfer of the Human Immunodeficiency Virus (HIV).
    [006] [006] In addition, healthcare professionals may be exposed to used syringes, which can lead to needle injury "inadvertently and possible exposure to infectious pathogens or other contaminants. In response to this problem, retractable syringes were developed with the aim of preventing reuse and syringes and / or needlestick injuries through used syringes.
    [007] [007] When developing such retractable syringes, retractable needles of relatively complicated assemblies were invented, which are often developed from a specific syringe barrel shape or configuration and cannot be easily assembled to a syringe barrel having a different format or configuration. This is particularly a problem with glass syringe drums, which are generally scarce, many of the glass drums do not have the desired shape or configuration to mount a retractable needle assembly. Accordingly, many existing safety syringes require retraction mechanisms and specifically adapted drum configurations, which may require complex manufacturing processes or operational changes. The materials used in the manufacture of such safety syringes must satisfy criteria
    [008] [008] The modalities of the present invention refer to the retractable systems of adaptable drum needles, syringes that integrate safety mechanisms, methods of manufacturing such safety syringes, and their methods of use. The modalities of this invention provide safe needle retraction, for improved user safety ”, without requiring complex manufacturing processes or operational changes for pharmaceutical companies or contract fillings. In addition, the embodiments of the present invention provide configurations that use materials and components that are easily employable for pharmaceutical use, many of which are increasingly considered ready-to-use or standard components. In addition, the present invention provides components and devices that are aesthetically similar to conventional syringes, which have no needle retraction mechanisms, are ergonomically attractive to end users, such as doctors and self-administration patients, and provide safety features highly desired integrated products. The new drum adapters of the present invention are remarkably able to be adapted to primary medicine drums of varying configurations and materials, such as, preferably, straight glass drums to provide integrated needle assemblies and drum retraction mechanisms. Such modalities can be used by pre-filled or filled injectable syringes at the time of use. As such, the adaptive retraction mechanisms of the present invention can be flexibly attached, affixed, assembled, or else
    [0010] [0010] In another aspect of the modalities of the invention, an automatically retractable safety syringe is provided including a barrel having a distal end and a close end, a plunger assembly adapted to move within the barrel, and a-
    [0011] [0011] In another aspect of the modalities of the invention, a method is provided for assembling an automatically retractable safety syringe. The method includes the steps of disposing a plunger assembly to move within a drum, sealingly engaging a drum tip with a distal end of the drum, providing a needle assembly for moving within the drum tip and the barrel between an injection position where a needle in the needle assembly extends from the tip of the barrel and the retracted position where the needle is disposed within at least one end of the barrel or within the barrel, and having a retraction mechanism
    [0012] [0012] In a specific first embodiment, the present invention provides a barrel adapter that facilitates the assembly of a needle assembly to a syringe barrel and includes a "needle retraction" mechanism. The barrel adapter includes a the tip of the barrel, a tilt member, a locking mechanism, and a needle assembly.The needle assembly can generally include a needle, a needle hub, and a needle seal.The needle is configured to pass through the needle assembly, locking mechanism, tilt member, and barrel tip so that, at one end, the needle is inside the barrel, and at the other end, the needle goes through an opening in the barrel tip In some embodiments, the needle hub and needle seal may be a component, while in other embodiments they may comprise two or more components, for example, in one embodiment the needle hub and needle seal are a unified unit, as a plastic needle hub with double dose and elastomeric needle seal. Aspects of the needle assembly, such as the needle hub and / or the needle seal, can be used to retain the needle. Needle retention can be achieved by mechanical retention, molded retention, as described below, or a number of other retention methods known in the art. Alternatively,
    [0013] [0013] Accordingly, drum adapters include the necessary components for needle retention and retraction, and are configured to attach to standard drums. The drum adapter is configured to attach and be attached, using a number of known methods, to the distal end of a drum.
    [0014] [0014] The drum adapters of the present invention allow the selection and adaptation of variable needle assemblies with standard drums. In other words, the design and configuration of the present invention allows the user to select a needle and / or needle assembly of a specific design or dimensions and adapt it to a syringe barrel for drug delivery. Accordingly, the drum adapters of the present invention also allow customization of the drug delivery device to the user, allowing them to employ the integrated retraction mechanism of the drum adapter to any drum to produce a se-. security ring. For example, drum adapters and needle assemblies can be configured to provide a number of different needle lengths. The user can then select the. barrel adapter with your desired needle lengths and adapt it to a syringe to deliver medicine. This flexibility of the present invention is particularly useful for administering medications that are subcutaneous or intramuscular. The drum adapters of the present invention can be configured to * allow such flexibility. One or more additional components can be used to provide this adaptive feature. For example, one or more connection components can be used to connect the barrel tip of the drum adapter to the drum. In such an embodiment, a connecting component (such as a receiving component) can be fixedly mounted to the distal end of a glass drum. The receiving component can receive directly and attach the tip of the drum to the integrated retraction mechanism. Alternatively, the drum adapter may include one or more additional connection components (such as a coupling component) that are used to couple the receiving component. Other optional components, such as elastomeric seals, which are known to a person skilled in the art, may be required and incorporated into the devices to facilitate the connection between the drum adapter and the drum.
    [0015] [0015] Additionally, the drum adapters of the present invention use materials that are substantially non-reactive with therapeutic fluids or medications, and are suitable for use in pharmaceutical grade applications. The new drum adapters are configured to minimize or eliminate the possibility of contact
    [0016] [0016] Modalities of the present invention also substantially reduce the number of components required for integrated retention and retraction mechanisms. In at least one embodiment of the present invention, for example, the drum adapter does not require a conventional needle holder or needle mold (such as, for example, a material that is formed on a needle to assist in retaining the needle within the needle). drum for injection of drugs
    [0017] [0017] In another embodiment, the present invention provides a safety syringe that includes a drum, a plunger assembly, and a drum adapter. The drum adapter includes a drum tip, a tilt member, a locking mechanism, and a needle assembly. The needle assembly can generally include a needle, the needle hub, and the needle seal. The needle is configured to pass through the needle assembly, locking mechanism, tilt member, and tip of the barrel so that one end of the needle is inside the barrel and the other end of the needle passes through an opening in the tip of the barrel. The drum can be substantially cylindrical, having along its longitudinal axis a distal end for drug injection, a close end for injection control, and at least a part of the internal drum for drug containment. The drum adapter is configured to engage and be attached, using a number of known methods, to the distal end of a drum. The barrel adapter is capable of coupling or assembling, or engaging with, a barrel of the safety syringe. In any of these modes of the drum adapter, the tilt member is mounted, both fixedly and movably, usually within the tip of the drum and the distal end of the drum. The tilt member is polarized to expand proximally and substantially along the longitudinal axis of the drum. The plunger assembly may include a piston rod
    [0018] [0018] One or more embodiments of the present invention can optionally include certain standard components. For example, configurations of the drum adapter and syringe devices of the present invention may include one or more O-rings. In at least one embodiment, one or more O-rings are employed to seal the tip of the drum within the drum. and / or to ensure a sterile environment and the integrity of the container within the medication chamber of the drum. Additionally or alternatively, the drum adapter may include one or more control members to facilitate control of the retraction rate. Similarly, the drum adapter may include one or more needle blocks, such as clips, tabs, flanges, or the like, that work to prevent the needle from being moved or ejected from the drum by opening the end of the drum after half an hour. - retraction cannism has been started or completed. In addition, the
    [0019] [0019] The designs of the drum adapter of the present invention i prevent the need to have a drum shape or configuration. specific for mounting a needle assembly to it. Another desirable feature of the present invention is to provide a relatively simplified needle set comprising few components, thereby providing a user-friendly and retractable syringe while maintaining manufacturing costs in a minimum. and / or facilitating the mass distribution of retractable syringes. Modalities of the present invention also provide configurations, which allow the user of commercially available standard components, which can reduce overall manufacturing costs, streamline assembly processes, and avoid regulatory issues often associated with non-standard materials and components. In addition, the invention provides for the efficient administration of fluid contents, thereby minimizing waste of fluid contents, and / or integrates one or more locking systems to prevent or at least minimize the reuse of syringes and / or needlestick injuries.
    [0020] [0020] Accordingly, yet another embodiment of the present invention provides a method for assembling a safety syringe having a drum adapter, a plunger assembly, and a drum having a longitudinal axis. The method includes the steps of: assembling the drum adapter which includes a drum tip, a tilt member, a locking mechanism, and a needle assembly; mounting the tip of the drum to a distal end of the drum; and assembly of the plunger assembly having a plunger seal and a plunger rod to an end close to the plug.
    [0021] [0021] Another embodiment of the present invention provides a method: manufacturing a safety syringe that includes the steps of: assembling the retraction mechanism that includes a tilt member, a locking mechanism, and a needle assembly through - via an end close to a drum, where the distal end of the retraction mechanism is moved axially to substantially reside within the tip of the drum; and assembly of the plunger assembly having a plunger seal and a plunger rod to an end close to the drum. The plunger assembly can be movably mounted to the distal end of the drum by first inserting a plunger seal into the then inserting the plunger rod into the plunger seal by screw connection or known connection method.The method for making the safety syringe can also include a step for filling the barrel with a medication, after a step for assembling the retraction, but prior to the plunger assembly step. The plunger seal can be mounted prior to, or in connection with, the plunger rod. In at least one embodiment, the retraction mechanism is in a configuration of compression prior to mounting on the drum, for example, the tilt member may be engaged compressedly, as in an energized stage, prior to mounting the retraction mechanism on the drum. these components can be mounted on the drum prior to compression and locking the tilt member in place. In such an embodiment, the tip of the drum is mounted at the distal end of the drum while the rest of the drum adapter components
    [0022] [0022] A drug or pharmaceutical treatment can be filled in a part of the drum between the near end and the distal end constituting a medicine chamber. The drum adapter and plunger assembly can be connected to the drum by a number of known methods. For example, the drum adapter may be fixedly attached by glue or another method of adhesion or connection, such as compression adjustment, to the distal end of the drum. The syringe barrel can then be filled with a desired amount of medication at the end near the barrel. After filling is complete, the plunger assembly can be mounted on the end close to the syringe barrel. As will be noted by a person skilled in the art, this filling and assembly process can be completed under vacuum and / or under a sterile environment to facilitate the aseptic manufacture of the safety syringe. These safety syringes are configured in such a way that they can easily be manufactured individually, or in a group, as in the case of the filling process based on torque.
    [0023] [0023] In another embodiment, the present invention relates to a method of use for a safety syringe having a drum adapter, a plunger assembly, and a drum having a longitudinal axis. The drum adapter, which can be mounted at a distal end of the drum, includes a drum tip, an
    [0024] [0024] Throughout this specification, unless indicated, "comprise," "comprise," and "comprising," or terms related to "includes" or "consists of," are used including and not exclusively, from so that a declared integer or group of integers can include one or more of other integers or a group of undeclared integers. As will be described below, embodiments of the present invention can include one or more additional components that can be considered standard components in the medical device industry. The components, and embodiments containing such components, are within the scope of the present invention and are to be understood within the scope of the present invention. Brief description of the drawings
    [0025] [0025] The following non-limiting embodiments of the invention are described in this document with reference to the following drawings, in which:
    [0026] [0026] FIG. 1 is an isometric view of a first embodiment of a safety syringe according to the present invention;
    [0027] [0027] FIG. 2 is an enlarged view, along a longitudinal axis, of the embodiment shown in FIG. 1;
    [0028] [0028] FIG. 3a shows an enlarged side view of a drum adapter according to an embodiment of the present invention;
    [0029] [0029] FIG. 3b shows a transparent side view of the adapter
    [0030] [0030] FIG. 3c shows a partially enlarged side view of the drum adapter of FIG. 3a, separating the needle assembly from other components of the drum adapter; | [0031] FIG. 3d shows a completely enlarged side view: of the drum adapter of FIG. 3a;
    [0032] [0032] FIG. 4 shows an isometric view of a locking mechanism, according to an embodiment of the present invention;
    [0033] [0033] FIG. 5 shows an isometric view of a tip of the drum with an optional O-ring, according to an embodiment. of the present invention;
    [0034] [0034] FIG. 6 shows a needle seal and needle hub,. according to an embodiment of the present invention;
    [0035] [0035] FIG. 7 shows an optional needle block clamp according to an embodiment of the present invention;
    [0036] [0036] FIGS. 8a-8d show the side views of a syringe including a barrel adapter according to an embodiment of the present invention, as the syringe progresses through the stages of needle injection, drug dose administration, retraction activation, and retraction the needle;
    [0037] [0037] FIGS. 9a-9d show enlarged fragmentary cross-views of the embodiment shown in FIGS. 8a-8d, similarly as the syringe progresses through the stages of: needle injection, medication dose administration, retraction activation, and needle retraction. Detailed description of the invention
    [0038] [0038] The modalities of the present invention provide reliable needle retraction, for improved user safety, without requiring complex manufacturing processes or operational changes for pharmaceutical companies or drug fillers by contract.
    [0041] [0041] In addition, the modalities of the present invention provide efficient administration of the fluid contents, thus reducing the waste of pharmaceutical drugs. They similarly provide configurations that reduce null space, for example, interstitial voids within the syringe barrel, which reduce or eliminate the capture of unwanted air bubbles during the assembly or filling process. These aspects of the present invention can provide highly desired functional and aesthetic characteristics, and can be modified to produce a range of different configurations.
    [0042] [0042] For example, the modalities of the present invention can
    [0043] [0043] The syringes of the present invention allow the administration of the drug with integrated safety as they prevent accidental exposure to the needle, as is common with injuries caused by the needle. As described above and detailed in the figures, a user can use the safety syringes of the present invention to perform the drug administration stages, including: needle injection, drug dose administration, retraction activation, and needle retraction . In particular, the components of the drum adapters of the present invention are maintained substantially in position through the needle injection and drug dose administration stages. This new feature allows the drum to be graduated, that is, marked with volumes, as the reference point for the end of the dose is constant. At the substantially stable and constant position of the needle seal through the needle injection and dose administration stages,
    [0044] [0044] Integrating one or more locking systems to prevent or at least reduce the reuse of the syringe and / or needle injury, the modalities of the present invention provide highly desirable products that are cost-efficient in manufacture and easy for doctors to use and self-administration patients. These locking systems may include, for example, needle retraction mechanisms and / or arrangements that block a retracted needle extending again from the syringe tip. The new features and functionality of the drum adapters and syringes of the present invention provide the user with several safety advantages. For example, the locking mechanism can be configured to provide visual, audible and / or tactile feedback to the user that the dose of medication has been fully administered, the retraction mechanism has been activated, the needle has been retracted, and the syringe is safe for disposal. The components of the present invention are further configured so that there is high destruction of the components, and all of the syringe, at the end of use. This integrated security and destruction
    [0045] [0045] The modalities of the present invention are further detailed in this document with respect to the attached figures. It must be understood
    [0046] [0046] As used in this document to describe the ring, drum, drum adapter, or any of the relative positions of the components of the present invention, the terms "axially" or "axially" refer generally to a longitudinal axis " The "by which the syringe or barrel is preferably formed although not necessarily symmetrically around it. The term "radial" generally refers to a direction normal to the "A" axis. The terms "next",. "rear", "back", "back", or "retraction" generally refer to an axial direction away from the tip of the drum 32. The terms "distal",: "forward", "forward", "depressed" , or "forward" generally refer to an axial direction towards the tip of the drum 32. It should be understood that the term "spring" is used in this document to suggest a sloping member, such as a substantially coiled spiral coil, which can be compressed and allowed to expand in a given direction. While the spring element as the arrangement discussed and used in the modalities detailed in this document can be used, it is within the scope of the present invention that other types of slope members can be readily employed for the same purpose while remaining within the width and scope of the present invention. For example, springs such as compression springs, torsion springs, constant force springs, extension springs, and leaf springs, or combinations of different types of springs can be used within the scope of the present invention, as would be understood by a technician on the subject. In addition or alternatively, slope members other than springs can still be used for similar purposes. Non-limiting examples of the tilt members include a spring, elastic
    [0047] [0047] As used in this document, the term "glass" must | be understood to include other similarly non-reactive materials suitable for use in a pharmaceutical grade application that would normally require glass. The term "plastic" can include both thermoplastic and thermoset polymers. Thermoplastic polymers can be softened again in their original condition by heat; thermosetting polymers cannot. As used in this document, the term "plastic" refers mainly to high moldable thermoplastic polymers such as, for example, polyethylene and polypropylene, or an acrylic resin, which still typically contains other ingredients such as dressings, fillers , reinforcing agents, colorants, and / or plasticizers, etc., and that can be formed or molded under heat and pressure. As used in this document, the term "plastic" does not include glass or rubber elastomers that are approved for use in applications where they are in contact with therapeutic liquids that can interact with plastic or that can degrade by substituents that could enter the liquid from plastic. As used in this document, the term "elasomer", "elastomeric" or "elastomeric material" mainly refers to cross-linked thermoset rubber polymers that are more easily deformable than plastics, but which are approved for use with pharmaceutical grade fluids and are not easily subjected to leaching or gas migration. As used in this document, the term "fluid" refers primarily to liquids, but may still include suspensions of solids dispersed in liquids, and dissolved gases or otherwise prevent present together within liquids within parts containing syringe fluid.
    [0049] [0049] One or more embodiments of the present invention may still include certain standard components. For example, settings
    [0052] [0052] Similarly, while the components of the drum adapter and the safety syringe are described in this document as separate components, it is within the scope of
    [0053] [0053] Furthermore, while the components of the drum adapter are described in this document as separate components, they can be unified components having several functions. As discussed above, the tilt member (for example, spring) can be compressed in its energized state and the locking mechanism engaged either before installation on the tip of the drum or after the components are mounted on the drum. The configuration of the components and their assembly may vary based on the assembly process, the device parameters, and other desired characteristics.
    [0054] [0054] FIG. 1 shows an isometric view of an embodiment of a safety syringe 10, according to the present invention. FIG. 2 shows an enlarged view of the safety syringe 10, and its components, shown in FIG. 1. According to the invention, a barrel adapter 20 is provided for attachment to a syringe barrel 18 having a plunger assembly 12. As an advantage of the embodiments of the present invention, the barrel tip 32 of the
    [0055] [0055] For example, one or more modalities may use - standard components, such as standard plunger rods, plunger seals, and rigid needle guards, thus greatly reducing the need for injection molded or specially manufactured components. For example, FIGS. 1-2 show a modality that uses a standard plunger rod 14, plunger seal 16, and a rigid needle guard 38, among other possible standard components. The plunger seal 16 can be, for example, a tetrafluoroethylene (ETFE) coated with a rubber cap / seal, such as is readily available under the trade name "FluroTec" from West Pharmaceutical Services, Inc., Lionville, Pennsylvania . Other components can be similarly standard, ready-to-use components, providing a great advantage of the modalities of the present invention. This advantage of the modalities of the present invention provides valuable manufacturing efficiencies and operational savings.
    [0056] [0056] The barrel adapter 20 can be mounted on the syringe barrel 18 by any appropriate coupling arrangement, as will be described by those skilled in the art. For example, the barrel adapter 20 can be attached to the syringe barrel 18 by a coupling structure that can be separated from the components of the syringe.
    [0057] [0057] The barrel adapter 20 makes it easier to mount a needle 28 (see FIG. 2) to the syringe barrel 18. The barrel adapter includes a barrel tip 32, a needle assembly 42, and a needle retraction mechanism 21. The barrel tip 32 can be attached to the syringe barrel 18 by any appropriate method, as explained above with respect to attaching the barrel adapter 20 to the syringe barrel 18. The barrel tip 32 typically has one end distal to the safety syringe 10 when coupled to the syringe barrel 18, the needle 28 extending over the distal end of the barrel tip during injection of a medication. The tip of the drum 32 can also include the structure that forms a part of the retraction mechanism of the needle 21, as will be explained below.
    [0058] [0058] Needle assembly 42 can generally include a needle 28, a needle hub 24, and a needle seal 26. Needle 28 is configured to pass through the needle hub 24 and needle seal 26 of the assembly of needle 42, as well as the locking mechanism 22, spring 30, and tip of the barrel 32 so that one end of the needle 28 is inside the barrel 18 and the other end
    [0059] [0059] The needle seal 26 and the needle hub 24 can be configured to remain in a substantially fixed position within the barrel 18 while the needle assembly 42 is at a “. first stage, for injection of a medication into a patient. Alternatively, the needle seal 26 and the needle hub 24 'can be configured to move in an injection position, for example, as the piston rod 14 is pressed.
    [0060] [0060] To prevent inadvertent insertion with needle 28 or reuse of syringe 10 after drug administration, the drum adapter 20 includes the needle retraction mechanism
    [0061] [0061] In this embodiment of a locking arrangement 31, the = tilt member 30 is a compression spring. The ends of the spring 30 are arranged on the adjacent surface 23 of the locking mechanism 22 and surface 25, inside the tip of the drum 32. The relative positions of the surfaces 23, 25 keep the slope member 30 in the energized position compressed before injection, or: allow spring 30 to move to a de-energized position to retract needle 28 after injection. To keep the spring 30 in an energized position, the locking mechanism 22 and the tip of the drum 32 include the joint structure which can be disengaged to allow the spring 30 to move to a de-energized position.
    [0062] [0062] The needle retraction mechanism 21 can be activated by any appropriate trigger. For example, in the illustrated mode, the needle retraction mechanism 21 is triggered by the movement of the plunger seal 16 in contact with the needle assembly
    [0063] [0063] In the junction structure of the needle retraction mechanism 21 illustrated, the locking mechanism 22 is caused to engage and remain connected with one or more corresponding locking aspects 32a of the barrel tip 32. As the mechanism in
    [0064] [0064] The needle hub 24 can function to hold the needle 28 in a substantially fixed position while the tube adapter 20 and the safety syringe 10 are in a first stage, that is, generally configured for drug injection. In addition or alternatively, the locking mechanism 22 can work to retain the needle 28 in a substantially fixed position during this first stage for injecting the drug. Thus, the
    [0065] [0065] On disengaging the locking mechanism 22 and activating the retraction mechanism, the spring 30 is allowed to expand causing the needle assembly 42 to retract in the substantially close direction along a longitudinal axis of the drum 18. In some modalities of the of the present invention, the entire needle assembly 42 is caused to retract, while in other embodiments only certain components thereof, including needle 28, are caused to retract upon release of the locking mechanism 22 and expansion of the closely polarized spring 30 Similarly, in some embodiments of the present invention, the locking mechanism 22 is caused to retract with the needle assembly 42 while in other embodiments the locking mechanism 22 remains substantially stationary, but allows the needle assembly 42, or components of this, move. After needle retraction 28 is initiated or completed, needle block 34 works to prevent needle 28 from passing in the distal direction and out of the barrel tip 32. As stated above, other standard components can be used in assembling syringes for as O-ring 36.
    [0067] [0067] At the end of the medication administration, the force applied by the user to axially move the piston seal 16 and piston rod 14 can be used to disengage the locking mechanism 22 and activate the retraction mechanism. For example, the plunger seal 16 can be made to contact the needle seal 26 so that the force applied to the plunger rod 14 by a user is applied to the plunger seal 16 and transferred, by less in part to the needle seal 26. The force transmitted to the needle seal 26 can similarly be transferred, at least in part, to the needle hub 24. Through this transfer, a component of the hub release ring needle 24, or
    [0070] [0070] FIGS. 4-7 show the components of the drum adapter 20 separately, excluding the needle 28. Figure 4 shows a locking mechanism 22 according to an embodiment of the present invention. Figure 5 shows the tip of the drum 32. The tip of the drum 32 has locking aspects 32a, which are interlockable with the receiving structures of the locking mechanism 22. In this mode, the tip of the drum 32 has two locking aspects 32a which engage with the corresponding locking portals on the
    [0072] [0072] To unlock the locking mechanism 22 and the tip of the drum 32 in the illustrated mode, in addition to polarizing the locking mechanism 22 and the tip of the drum 32, the tilt member 30 provides a relative torsion rotation between the locking mechanism 22 and the tip of the drum 32. This twisting rotation is permitted by the axial movement of the piston seal 16 in the locking mechanism | 22 during, or at the end of, the drug administration. With . In this regard, the compression spring 30 is not only maintained in compression by the engagement between the locking mechanism 22 and the | tip of the drum 32, the spring 30 is additionally maintained in an energized torsion position, that is, it is also mounted as a torsion polarized compression spring. With reference to figure 3C, the spring 30 includes the end 30a, which extends generally radially, and the end 30b, which extends generally longitudinally. The ends 30a, 30b engage the locking mechanism 22 and the tip of the drum 32, which are held in position with respect to the locking aspects 32a by engaging the seat: 22a of the locking portals 46. As can be seen in figure 3B, the end 30b is received in a compartment 33 at the tip of the barrel 32. Although not visible in the figures, the end 30a similarly engages the locking mechanism 22. Thus, when the movement of the seal of the piston 16 together with the outward tilt force of the spring 30 disengages the locking aspects 32a from the seat 22a, the spring 30 causes the locking mechanism 22 to rotate with respect to the locking aspects 32 of the barrel tip 32. When the locking aspects 32a reach compartments 47 (see FIG. 4), the continued outward tilt force of the spring 30 causes the locking element 22 to disengage from the tip of the drum 32.
    [0073] [0073] In other words, as the locking mechanism 22 is pressed by the activation force applied by the user on the piston rod 14 at the end of the medication dose administration, the retraction mechanism is activated. This means that the locking mechanism 22 is allowed to rotate by the torsional tilt of the spring
    [0074] [0074] It will be noted that the locking mechanism 22 is allowed to rotate freely, upon activation of retraction by the user, provided that there is minimal friction between the locking mechanism 22 and the needle hub 24 (shown in FIG . 6). As discussed above. Also, the needle seal 26 and the needle hub 24 can be separate components or a single double dose component. At least in one embodiment, the needle seal 26 and the needle hub 24 are separate components to ensure that the minimum surface friction is present between the needle hub 24 and the locking mechanism 22 for allow the rotation of the substantially free locking mechanism 22 on retraction activation.
    [0075] [0075] According to another aspect of the invention, in some embodiments, after retracting needle 28, the drum adapter 20 may be provided with a block that prevents or inhibits needle 28 from re-projecting from the tip of the drum 32. A Figure 7 shows a modality of a needle block 34, which can reside within the distal end of the barrel tip 32. The illustrated needle block 34 includes a flange 48 having a central opening 50 for the needle passage 28. A pair of arms 52 extends from the flange 48, the distal ends of the arms 52 supporting a pair of clips 54. When the needle block 34 is disposed within the tip of the barrel 32, the arms 52 tilt the clips 54 towards the other. In this way, with the needle 28 extending through the opening 50 of the flange 48, the clips 54 on the distal end of the needle block 34 are
    [0077] [0077] The new barrel adapter and syringe designs of the present invention allow for relatively simplified needle assembly 42 and filling processes. A method for assembling a safety syringe having a barrel adapter 20, a con-. next to the plunger 12, and a drum 18 having a longitudinal axis includes the steps of: mounting the drum adapter 20 which includes a barrel tip 32, a spring 30, a locking mechanism 22, and a needle assembly 42; mounting the tip of the drum 32 on a distal end of the drum 18; and mounting the plunger assembly 12 having a plunger seal 16 and a plunger rod 14 at an end close to the drum 18. The adapter of the drum 20 can be fixedly mounted, as by glue, to the distal end of the drum 18. The assembly the plunger 12 can be movably mounted on the distal end of the barrel 18 by first inserting the plunger seal 16 into the barrel 18 and then inserting the plunger rod 14 into the plunger seal 16 by the threaded connection or other known method of connection. The method for assembling the safety syringe may further include a step to fill the drum 18 with medication, after the step for assembling the tip of the barrel 32, but before the step for assembling the plunger assembly 12.
    [0078] [0078] The seal of the plunger 16 may comprise an elastomeric material and be dimensioned so as to provide a compression fit with an inner diameter of the barrel 18 to maintain the sterility and integrity of the medicine chamber container. THE
    [0079] [0079] At least in one embodiment, the drum adapter 20 is in a compressed configuration before mounting to the drum
    [0080] [0080] The safety syringes of the present invention are configured to be used in a similar manner to conventional syringes. The method of use includes the steps: pressing the
    [0081] [0081] Regardless of the particular components, the methods of use for the safety syringes of the present invention are relatively similar. By releasing the locking mechanism 22 from its engaged condition, the tilt member 30 is allowed to expand causing the needle assembly 42 to retract in the substantially close direction along a longitudinal axis of the drum
    [0082] [0082] FIGS. 8a-8d show a syringe 10 including a barrel adapter 20 according to an embodiment of the present invention, as syringe 10 progresses through the stages of: in-. needle jetting, drug dose administration, retraction activation, and needle retraction. Figures 9a-9d show expanded cross-sectional views of the modality shown in Figures 8a-8d, showing the relationship of components as syringe 10 progresses through the stages of: needle injection, administration of medication dose, activation retraction, and needle retraction.
    [0083] [0083] Figure 8a shows the drum adapter 20 mounted with the drum 18. In the package, the drum adapter 20 may contain a rigid needle guard (RNS - not shown in figures 8-8d) that engages with the tip of the barrel 32 to protect the user from needle 28. Figure 8a shows syringe 10 with the RNS removed and needle 28 exposed for injection into a patient. The medication chamber 60 of the drum 18, between the seal of the plunger 16 and the seal of the needle 26, contains a drug treatment for injection. Figure 8b shows the syringe 10 at the end of the medication dose administration, with the plunger rod 14 pressed axially in the distal direction, the plunger seal 16 in contact with the needle seal 26, and substantially all of the injection drug treatment. - delivered by needle 28 to the patient. Even in the minimal depression of the piston rod 14, the retraction mechanism is activated. As shown
    [0084] [0084] The present invention provides component assemblies, such as barrel adapters, that provide needle retraction, seeds that integrate such safety mechanisms, manufacturing methods such as safety adapters and syringes, and their methods of use. As stated above, the barrel adapters and safety syringes can be used in several different configurations.
    [0086] [0086] The use of terms "one" and "one", "o" and "a" and "at least one" and similar references in the context to describe the invention (especially in the context of the following claims) should be constructed to cover singular and plural, unless otherwise indicated in this document or clearly contradicted by the context. The use of the term "at least one" followed by a list of one or more items (for example, "at least one from A and B") should be constructed to mean an item selected from the items listed (A or B) or any combination of two or more items listed (A and B), unless
    [0088] [0088] Certainly, this disclosure includes all modifications and 'equivalents of the subject recited in the attached claims as permitted by applicable law. In addition, any combination of the elements described above in all possible variations of this is covered by the disclosure unless otherwise stated in this document or otherwise clearly contradicted by the context.
    权利要求:
    Claims (15)
    [1]
    1. Drum adapter (20) for a safety syringe (10) having a drum (18) and a plunger assembly (12) adapted to move inside the drum (18), characterized by the fact that it comprises: a barrel tip (32) adapted to be sealingly engaged with a distal end of the barrel (18), a needle assembly (42) including a needle (28), a needle hub (24) through which the needle (28) extends, and a needle seal (26), the needle assembly (42) being arranged at least partially within the tip of the drum (32), the needle (28) adapted to move from an injection position in which the needle (28) extends from a distal end of the drum tip (32) to a retracted position in which the needle (28) is disposed within at least one of the drum tip (32) or drum (18), and a needle retraction mechanism (21), the needle retraction mechanism (21) including a tilt member (30) and an actionable locking arrangement (31), available actionable locking option (31) including a locking mechanism (22) that releasably engages the tip of the drum (32) to keep the tilt member (30) in an energized position when the locking arrangement ( 31) is locked and releases the tilt member (30) when engaged, the locking arrangement (31) being activated by the depression of the piston assembly (12) to disengage the locking mechanism (22) from the barrel tip (32) to allow the tilt member (30) to at least de-energize, the tilt member (30) being arranged to move the needle (28) from the injection position to the retracted position when the tilt member (30) is released from the energized position.
    [2]
    2. Drum adapter according to claim 1,
    characterized by the fact that the actionable locking arrangement (31) still includes at least one locking aspect (32a) arranged to energize the tilt member (30).
    [3]
    Drum adapter according to claim 2, characterized by the fact that the tilting member (30) is arranged between the tip of the drum (32) and the locking mechanism (22).
    [4]
    Drum adapter according to claim 3, characterized in that at least one of the tips of the drum (32) and the locking mechanism (22) includes at least one locking aspect (32a) and the other the barrel tip (32) and the locking mechanism (22) include at least one corresponding receiving element (46) arranged to freely engage with the locking aspect (32a).
    [5]
    Drum adapter according to claim 4, characterized in that the locking aspect (32a) includes a protrusion and the receiving element 46 includes a portal.
    [6]
    Drum adapter according to claim 1, characterized by the fact that the tilt member is a compression spring mounted on the compression and torsion between the locking mechanism (22) and the tip of the drum (32) so that the movement of the locking mechanism (22) towards the tip of the drum (32) results in the rotational movement of the locking mechanism (22) and disengagement of the locking mechanism (22) and tip of the drum (32).
    [7]
    7. Drum adapter according to claim 1, characterized in that the tilting member (30) includes a torsion-polarized compression spring, and the locking arrangement (31) is operable by at least one between compression or torsion.
    [8]
    8. Drum adapter according to claim 1, characterized by the fact that it still comprises a needle block (34) arranged to block the movement of the needle (28) distally through the tip of the drum (32) when the needle (28) is in the retracted position.
    [9]
    Drum adapter according to any one of claims 1 to 8, characterized in that the needle retraction mechanism (21) is arranged at least partially within the tip of the drum (32).
    [10]
    10. Drum adapter according to claim 1, characterized by the fact that the locking mechanism (22) engages the needle assembly (42).
    [11]
    11. Automatically retractable safety syringe (10) characterized by the fact that it comprises: a barrel (18) having a distal end and a close end, a piston assembly (12) adapted to move inside the barrel (18 ), and the drum adapter (20) as defined in any one of claims 1 to 10, which sealably engages with the distal end of the drum (18).
    [12]
    12. Method for assembling an automatically retractable safety syringe (10) characterized by the fact that it comprises the steps of: arranging a piston assembly (12) to move inside a drum (18); sealingly engage a drum tip (32) with a distal drum end (18), arrange a needle assembly (42) for movement within the drum tip (32) and drum (18) between a position of injected-
    where a needle (28) from the needle assembly (42) extends from the tip of the drum (32) and a retracted position in which the needle (28) is arranged within at least one of the tip of the drum (32 ) or drum (18), and have a needle retraction mechanism (21) including a tilt member (30) and an adjustable locking arrangement (31) inside the drum (18), the locking arrangement will activate - speed (31) including a locking mechanism (22) that releasably engages the tip of the drum (32) to keep the tilting member (30) in an energized position when the locking arrangement (31) is locked and releases the tilt member (30) when engaged, the locking arrangement (31) being operable by depressing the piston assembly (12) to disengage the locking mechanism (22) from the tip of the drum (32) to allow the tilt member (30) to at least de-energize, the tilt member (30) being arranged to move the needle (28) alongside move from the injection position to the stowed position when the tilt member (30) is released from the energized position.
    [13]
    13. Method according to claim 12, characterized by the fact that it also includes the step to assemble a drum adapter (20) comprising the needle assembly (42), the needle retraction mechanism (21 ) and the tip of the drum (32) on the drum (18), and the step for sealingly engaging the tip of the drum (32) with a distal end of the drum (18) includes engaging the tip of the drum ( 32) with the distal end of the drum (18) and seal the tip of the drum (32) at the distal end of the drum (18).
    [14]
    14. Method according to claim 12, characterized by the fact that the step of arranging the needle assembly (42) is carried out before the step for sealingly engaging the tip of the drum (32) with the distal end the drum (18).
    [15]
    15. Method according to claim 12, characterized by the fact that the step for sealingly engaging includes the use of an adapter for sealingly engaging the tip of the drum (32) with the distal end of the drum (18) .
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    同族专利:
    公开号 | 公开日
    JP2018043092A|2018-03-22|
    IL234075D0|2014-09-30|
    ZA201406006B|2017-03-29|
    MX352575B|2017-11-29|
    AU2012370436B2|2017-11-23|
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    US8702653B2|2014-04-22|
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    US10159808B2|2018-12-25|
    JP6587801B2|2019-10-09|
    EP2817046A1|2014-12-31|
    KR20140124861A|2014-10-27|
    CA2865274A1|2013-08-29|
    JP2015511846A|2015-04-23|
    CN104582767A|2015-04-29|
    AU2012370436A1|2014-09-11|
    TW201336540A|2013-09-16|
    CA2865274C|2020-03-24|
    US20130226084A1|2013-08-29|
    TWI587887B|2017-06-21|
    WO2013126118A1|2013-08-29|
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    法律状态:
    2020-11-10| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-11-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-03-02| B11B| Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements|
    2021-12-07| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US201261602277P| true| 2012-02-23|2012-02-23|
    US61/602,277|2012-02-23|
    US201261639898P| true| 2012-04-28|2012-04-28|
    US61/639,898|2012-04-28|
    US201261667010P| true| 2012-07-02|2012-07-02|
    US61/667,010|2012-07-02|
    PCT/US2012/067793|WO2013126118A1|2012-02-23|2012-12-04|Retractable needle safety syringes|
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