JP6574264B2 - Device for targeted delivery of therapeutic implants - Google Patents

Description

  The present invention relates to a device for targeted delivery of a therapeutic implant. More specifically, embodiments of the present invention have a delivery system that can place a drug implant in a specific location, a retractable cannula that facilitates delivery of the drug implant, beads, pills, or capsules. The invention relates to syringes, methods of manufacturing such devices, and methods of use thereof.

  Recent therapies have revolutionized the treatment of diseases such as age-related macular degeneration, diabetic retinopathy, diabetic macular edema and the like. The aging of the population and the increasing prevalence of diabetes are driving the demand for treatments used in the treatment of eye diseases. Some pharmaceutical companies are actively working on the development of new therapies in this area in addition to therapies with drugs already on the market.

  Currently, the most common drugs used to treat wet age-related macular degeneration are angiogenesis inhibitors. This drug is usually injected into the vitreous part of the eye (a transparent jelly-like substance that fills the eye from the back of the lens to the retina). Most treatments require a monthly infusion. Infusions involve some risk of suffering from infections such as endophthalmitis in addition to patient inconvenience. Also, the increase in the number of patients that the clinician needs to treat becomes a burden on the entire medical system.

  Drug implants or drug depots can increase the time that the drug remains effective within the target site. This reduces the frequency with which the patient needs treatment by infusion, thereby reducing the burden on the medical system and reducing the potential for infusion-related risks to the patient.

  Devices for placement or placement of such implants or depots should ideally be easy to use for the clinician and should minimize patient discomfort, drug implants or The drug delivery kinetics of the depot should not be changed. Current devices used to place / place implants usually require significant training on the part of the clinician and are painful (and in some cases harmful) to the patient. Gives significant shear forces that can damage the surface. Implant physical damage can alter drug delivery kinetics and, consequently, the clinical effectiveness and / or regulatory compliance of the drug. Current devices usually do not take into account the precise positioning of the implant or depot.

  An object of the present invention is to provide a device for target delivery of a therapeutic implant that can solve the above-mentioned problems.

  In accordance with an aspect of the present invention, a barrel adapter for a delivery syringe having a barrel and a plunger assembly adapted to move within the barrel is provided. The barrel adapter includes a barrel tip configured to sealingly engage the distal end of the barrel. The barrel adapter also includes a needle retraction mechanism that includes a needle subassembly, an actuator subassembly, and at least one biasing member. The needle subassembly includes a needle and a needle overmold portion through which the needle extends. The needle has a lumen, the needle subassembly is at least partially disposed within the barrel tip, and from the injection position where the needle extends from the distal end of the barrel tip, the needle is positioned on the barrel tip or barrel. Adapted to move to a retracted position disposed within at least one of them. The actuator subassembly includes a needle overmold retainer connected to the barrel tip, a stylet, and a stylet disk that holds the proximal end of the stylet. The actuator subassembly also includes at least one prong that passes through the stylet disk and reaches the needle overmold holder. At least one prong is operable in response to movement of the plunger assembly within the barrel. The stylet is axially slidable and is at least partially disposed within the needle lumen, and the stylet is disposed proximally and the needle is distant when the needle is in the injection position. Spaced apart from the distal tip. At least one biasing member is disposed between the needle overmold portion and the needle overmold portion holder to bias the needle overmold portion away from the needle overmold portion holder. The barrel adapter is also arranged to maintain at least one biasing member in a biased position when the locking mechanism is locked and to release the biasing member when actuated by the actuator subassembly. Including an operable locking mechanism. The locking mechanism is operable to move at least one prong relative to the needle overmold holder by depressing the plunger assembly. The at least one biasing member is arranged to provide relative movement of the needle and stylet from the injection position to the retracted position when the biasing member is released from the biased position.

  In another aspect of the invention, an automatically retractable implant delivery syringe is provided. The delivery syringe includes a barrel having a distal end and a proximal end, and a plunger assembly configured to move within the barrel. The delivery syringe includes a barrel tip that is sealingly engaged with the distal end of the barrel and a needle retraction mechanism. The needle retraction mechanism includes a needle subassembly, an actuator subassembly, and at least one biasing member. The needle subassembly includes a needle and a needle overmold portion through which the needle extends. The needle has a lumen, the needle subassembly is at least partially disposed within the barrel tip, and from the injection position where the needle extends from the distal end of the barrel tip, the needle is positioned on the barrel tip or barrel. Adapted to move to a retracted position disposed within at least one of them. The actuator subassembly includes a needle overmold retainer connected to the barrel tip, a stylet, and a stylet disk that holds the proximal end of the stylet. The actuator subassembly also includes at least one prong that passes through the stylet disk and reaches the needle overmold holder. At least one prong is operable in response to movement of the plunger assembly within the barrel. The stylet is axially slidable and is at least partially disposed within the needle lumen, and the stylet is disposed proximally and the needle is distant when the needle is in the injection position. Spaced apart from the distal tip. At least one biasing member is disposed between the needle overmold portion and the needle overmold portion holder to bias the needle overmold portion away from the needle overmold portion holder. The delivery syringe is arranged to maintain at least one biasing member in the biased position when the locking mechanism is locked and to release the biasing member when actuated by the actuator subassembly Includes possible locking mechanisms. The locking mechanism is operable to move at least one prong relative to the needle overmold holder by depressing the plunger assembly. The at least one biasing member is arranged to provide relative movement of the needle and stylet from the injection position to the retracted position when the biasing member is released from the biased position.

  In yet another aspect of the invention, a method for assembling an automatically retractable delivery syringe is provided. The method includes positioning the plunger assembly for movement within the barrel and sealingly engaging the barrel tip with the distal end of the barrel and positioning the needle subassembly within the barrel. The needle subassembly includes a needle and a needle overmold portion through which the needle extends. The needle has a lumen, the needle subassembly is at least partially disposed within the barrel tip, and from the injection position where the needle extends from the distal end of the barrel tip, the needle is positioned on the barrel tip or barrel. Adapted to move to a retracted position disposed within at least one of them. The method also includes positioning the actuator subassembly within the barrel. The actuator subassembly includes a needle overmold retainer connected to the barrel tip, a stylet, and a stylet disk that holds the proximal end of the stylet. The actuator subassembly includes at least one prong that passes through the stylet disk and reaches the needle overmold holder. At least one prong is operable in response to movement of the plunger assembly within the barrel. The stylet is axially slidable and is at least partially disposed within the needle lumen, and the stylet is disposed proximally and the needle is distant when the needle is in the injection position. Spaced apart from the distal tip. The method includes the step of disposing at least one biasing member between the needle overmold part and the needle overmold part holder to bias the needle overmold part away from the needle overmold part holder. Including. The method also operably locks the needle overmolded portion to a needle overmolded portion retainer in the locking mechanism to maintain at least one biasing member in the biased position when the locking mechanism is locked. And releasing the biasing member when actuated by the actuator subassembly. The locking mechanism is operable to move at least one prong relative to the needle overmold holder by depressing the plunger assembly. The at least one biasing member is arranged to provide relative movement of the needle and stylet from the injection position to the retracted position when the biasing member is released from the biased position.

  Throughout this specification, unless otherwise indicated, related terms such as “comprise”, “comprises” and “comprising” or “including” or “consisting of” Are used exclusively rather than exclusively. As such, a listed integer or group of integers may include one or more other undescribed integers or groups of integers. As described further below, embodiments of the present invention may include one or more additional components that may be considered standard components in the medical device industry. It is to be understood that components and embodiments including such components are within the spirit and scope of the present invention and are within the scope and scope of the present invention.

  The following non-limiting embodiments of the present invention are described herein with reference to the following drawings.

1 is a side elevation view of a first embodiment of a delivery syringe including a delivery system according to the present invention. FIG. FIG. 2 is an exploded view along the longitudinal axis of the embodiment shown in FIG. 1. FIG. 3 shows an enlarged side view of a barrel adapter according to an embodiment of the present invention. FIG. 3B shows a side cross-sectional view of the barrel adapter of FIG. 3A along the longitudinal axis (cross-hatching has been removed for clarity). FIG. 3B shows a partially exploded side view of the barrel adapter of FIG. 3A with the needle assembly separated from other components of the barrel adapter. FIG. 3 shows an isometric view of a locking mechanism according to one embodiment of the present invention. FIG. 3 shows an isometric view of a barrel tip according to one embodiment of the present invention. FIG. 3 shows an isometric view of an actuation mechanism including a prong base, a stylet disc, and a stylet, according to one embodiment of the invention. FIG. 4 shows a side elevation view of a delivery syringe including a barrel adapter according to an embodiment of the invention as the syringe progresses through the needle injection phase. FIG. 7 shows a side elevation view of a delivery syringe including a barrel adapter according to an embodiment of the present invention as the syringe progresses through the needle retraction operation phase. FIG. 4 shows a side elevation view of a delivery syringe including a barrel adapter according to an embodiment of the invention as the syringe progresses through the implant delivery phase. FIG. 4 shows a side elevation view of a delivery syringe including a barrel adapter according to an embodiment of the invention as the syringe progresses through the stylet retraction phase. Similarly, FIG. 7A shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 7A as the syringe proceeds through the needle injection stage (cross-hatching has been removed for clarity). Similarly, FIG. 7B shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 7B as the syringe progresses through the stage of needle retraction operation (cross-hatching has been removed for clarity). Similarly, FIG. 7C shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 7C as the syringe proceeds through the implant delivery phase (cross-hatching has been removed for clarity). Similarly, FIG. 7D shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 7D as the syringe progresses through the stylet retraction stage (cross-hatching has been removed for clarity). FIG. 6 shows a side elevation view of a delivery syringe including a barrel adapter having a threaded connection according to another embodiment of the present invention. In FIG. 9A housed in a needle cap (shown as a transparent component for clarity), according to another embodiment of the invention, which may be used for packaging, transport and / or assembly, etc. FIG. 4 shows a side elevation view of the barrel adapter shown. 9B shows a side elevation view of the delivery syringe and barrel adapter shown in FIG. 9A in the assembled configuration. FIG. FIG. 4 shows an enlarged side elevation view of a plunger assembly according to at least one embodiment of the invention. FIG. 4 shows an enlarged side elevation view of a stylet assembly having a stylet and a stylet disc, according to at least one embodiment of the invention. FIG. 4 shows an enlarged side elevation view of a stylet guide and one or more protrusions or prongs according to at least one embodiment of the invention. FIG. 4 shows a side elevational view of a plunger rod according to at least one embodiment of the present invention rotated about an axis A at 90 degree intervals as indicated by arrow R. FIG. FIG. 4 shows a side elevational view of a plunger rod according to at least one embodiment of the present invention rotated about an axis A at 90 degree intervals as indicated by arrow R. FIG. FIG. 4 shows a side elevational view of a plunger rod according to at least one embodiment of the present invention rotated about an axis A at 90 degree intervals as indicated by arrow R. FIG. FIG. 9B shows an enlarged partial cross-sectional view of the embodiment of the delivery syringe shown in FIG. 9A (cross-hatching has been removed for clarity). FIG. 9B shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 9A as the syringe progresses through the needle injection stage (cross-hatching has been removed for clarity). FIG. 9B shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 9A as the syringe progresses through the stage of needle retraction operation (cross-hatching has been removed for clarity). FIG. 9B shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 9A as the syringe proceeds through the implant delivery phase (cross-hatching has been removed for clarity). FIG. 9B shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 9A as the syringe progresses through the stylet retraction stage (cross-hatching has been removed for clarity). Figure 2 shows a cross-sectional view of another embodiment of a delivery syringe and delivery system according to the present invention (cross-hatching has been removed for clarity). Figure 2 shows a cross-sectional view of another embodiment of a delivery syringe and delivery system according to the present invention (cross-hatching has been removed for clarity). FIG. 14B shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 14A. FIG. 14B shows an enlarged partial cross-sectional view of the embodiment shown in FIG. 14B. FIG. 15 shows an exploded view of a needle overmold (“NOM”) and NOM retainer according to the embodiment shown in FIGS. 14A and 14B. FIG. 15 shows an exploded view of a needle overmold (“NOM”) and NOM retainer according to the embodiment shown in FIGS. 14A and 14B. FIG. 15 shows an exploded view of a needle overmold (“NOM”) and NOM retainer according to the embodiment shown in FIGS. 14A and 14B.

  Embodiments of the present invention utilize needle retraction to position the implant. The implant can, for example, elute the drug or be a radiation emitting bead. For the purposes of this disclosure, the term “implant” refers collectively or individually to a depot, implant, bead, pill, capsule, blob, drug eluting device, dry or lyophilized drug or therapeutic agent, or others It is used to include implants of the form

  Clinicians are accustomed to the targeting and handling ease provided by conventional syringes. By using such a basic aspect of a syringe and incorporating a retracting mechanism, the inventors of the present invention can use a retractable needle syringe to accurately and safely deliver or place an implant with ease of use. Developed. The implant is placed in the target location at the location where the needle is placed. This allows for precise placement of the implant and makes the needle placement more determinative with respect to the delivery position compared to existing implantable devices. Existing implantable devices generally use a means for pushing the implant out of the cannula for depot or implant delivery. Such devices are often inaccurate because the user habitually desires to place the tip of the cannula at the target location. When the tip of the cannula is placed at the target location, pushing the implant out of the cannula by conventional methods leads to inaccurate delivery of the implant. To compensate for this inaccuracy, if the user chooses to "place" the cannula tip at an estimated distance from the target location so that the implant is pushed closer to the target location There is. Embodiments of the present invention use an essentially different approach. This technique greatly increases the accuracy of target delivery and is easy for the user to operate. By placing the implant at the tip of the syringe needle, the syringe needle is inserted into the desired target position, and then the syringe needle is removed or retracted, and the implant is placed in place, so that the accuracy of implant delivery to the target position is conventional. It is greatly improved compared to the means of implantation. In addition, embodiments of the present invention are simple to operate for the user to eliminate the need for calculation or estimation by the user because the position of the implant does not change throughout the implantation process. Furthermore, embodiments of the present invention provide desirable safety features because the syringe needle is retracted into the barrel of the implant delivery syringe, thereby eliminating the risk of needle stick damage.

  In a first embodiment, the present invention provides a delivery system that includes a needle, a stylet, a retracting mechanism, an actuation mechanism, and an implant for delivery. A stylet that is substantially coaxial with the needle is disposed within the lumen of the needle (eg, a hollow hole in the needle). In one embodiment, the stylet may partially overlap the needle from the non-patient end (ie, proximal end). The implant is placed in the lumen of the needle between the stylet and the patient end (ie, the distal end) of the needle. The retracting mechanism may be operated using an operating mechanism such as a plunger rod to retract the needle. First, the stylet is stationary with respect to the needle, and the needle is retracted by the retracting mechanism to expose the implant in the target area of delivery. The stylet prevents the implant from following the needle as the needle retracts. The stylet retracts with the needle only after the distal end of the stylet has passed the distal end of the retracting needle. The order and timing of the stylet retraction is such that the stylet retraction is activated or activated after the needle retraction, but the same retraction mechanism may be used to retract both components. A stylet disk proximal to the retract mechanism may be used to ensure the desired retract order. Depending on the distance between the retraction mechanism and the stylet disc, the timing of retreating the stylet relative to the needle is set.

  Embodiments of the present invention provide an accurate implant placement mechanism that utilizes needle retraction without the need for complex manufacturing processes. Embodiments of the present invention provide a relatively simplified syringe assembly that includes fewer components, thereby making the implant placement syringe easy to use and safe for the user while keeping manufacturing costs to a minimum. I will provide a. The novel barrel adapter of the present invention is preferably a primary in various configurations and materials, such as straight-barrel glass or plastic barrels, preferably for providing a built-in needle assembly and retract mechanism to the barrel. Can be adapted to drug barrel. Thus, the adaptable implant placement and needle retraction mechanism of the present invention can be flexibly mounted, fixed, mounted or otherwise coupled to a standard barrel such as a straight glass barrel. May be. The barrel adapter may be configured to couple with the barrel in a number of different ways, but in a preferred embodiment the barrel adapter is attached at least with a proximal connection to the inner diameter of the distal portion of the barrel, And it is comprised so that it may become a shape arrange | positioned in it. Thus, the barrel adapter must be inserted into a standard straight barrel syringe, with at least the proximal portion of the adapter inserted into the distal end of the barrel, attached to, secured to, or attached to the distal end of the barrel. If connected, they may be connected. The barrel adapter may be connected to the barrel by, for example, an interference fit assembly, a snap fit assembly, and / or a screw fit assembly. As will be appreciated by those skilled in the art, any of these connection methods, for example, to inform the user that a connection has been made and to prevent the barrel adapter from being removed from the delivery syringe during or after use. A locking function may also be included. In at least one embodiment of the present invention, the barrel adapter may be connected to the barrel by a screw-fit assembly, as described in further detail herein. Thus, the novel barrel adapter design of the present invention eliminates the need to have a specific barrel shape or configuration to attach the needle assembly to the barrel. Thereby, the manufacturing cost, particularly the cost associated with the manufacture of a specially produced glass barrel can be significantly reduced. The novel barrel adapter of the present invention can be attached to, for example, a straight glass or plastic barrel, thereby simplifying the manufacturing process and costs associated with the production of more complex barrel shapes.

  The barrel adapter of the present invention may be selectable in use or may be pre-attached to the barrel during manufacture. In a selectable option, the design and configuration of the present invention allows a user to select a needle and / or needle assembly of a particular design or size and adapt it to the syringe barrel for drug depot or implant delivery. Enable. For example, the barrel adapter and needle assembly may be configured to provide several different needle lengths or thicknesses. Thus, the user may select a barrel adapter according to the desired needle size and adapt this barrel adapter to a syringe for delivering the implant. In the embodiment shown in FIGS. 1 and 2, the barrel adapter is attached directly to the barrel. One or more additional components may be used to provide the functionality of this adapter. For example, one or more connection components may be used to connect the barrel tip of the barrel adapter to the barrel. In one such embodiment, one connecting component (such as a receiving component) may be fixedly attached to the distal end of the barrel. The receiving component may directly receive the barrel tip and engage the barrel tip with a built-in retract mechanism. Alternatively, the barrel adapter may include additional connection components (such as coupling components) that are used to engage the receiving component. As described above and as further detailed herein, in at least one embodiment of the present invention, the barrel adapter may be connected to the barrel by a screw-fit assembly, both the barrel adapter and the barrel being Corresponding male and female thread pitch portions or components. To facilitate the connection between the barrel adapter and the barrel, other optional components such as elastomer seals well known to those skilled in the art are required and may be incorporated into the device. The barrel adapter may be customized to facilitate implant placement and complete retraction of the needle and stylet into the barrel while including substantially the same components regardless of needle size. As will be readily appreciated by those skilled in the art, longer biasing members (eg, longer springs) may necessarily be selected or adjusted, for example, to facilitate retracting longer needles. Similarly, longer or thicker stylets may be required if longer or thicker needles are used. Such dimensions may also be adjusted to facilitate delivery of longer or shorter implants that are initially held in the needle for delivery, for example.

  Embodiments of the present invention provide configurations that can also utilize materials and components that are readily available for pharmaceutical applications. Many of these are increasingly considering off-the-shelf or standard components. In particular, the material used may have a low extract content. This reduces overall manufacturing costs, simplifies the assembly process, and often avoids unnecessary regulations associated with the use of non-standard materials and components. In addition, the present invention provides components and devices that are aesthetically similar to conventional syringes that do not have a needle retraction mechanism and are ergonomically attractive to medical personnel and end users such as self-administered patients. Along with it, it provides a highly desirable built-in safety function. Accordingly, these embodiments provide new and cost effective components and devices that are easily incorporated into existing manufacturing processes. These aspects of the invention may provide highly desired functional and aesthetic features and may be modified to create a variety of different configurations.

  The syringe of the present invention incorporates safety features to allow targeted delivery of drug implants and to prevent accidental exposure to common needles in needle stick injury. As described above and as detailed in the figures, the user may perform the stage of drug implant delivery using the delivery syringe of the present invention. Stages include needle injection, needle retract actuation, implant delivery, and stylet retract. By incorporating one or more locking systems to prevent, or at least minimize, syringe reuse and / or needle stick damage, embodiments of the present invention are cost effective to manufacture and medical personnel and self-administered Provides a highly desirable product that is easy to use by the patient. Such a locking system may include, for example, a needle retraction mechanism and / or arrangement that prevents the retracted needle from extending again from the end of the syringe. The novel features and functions of the barrel adapter and syringe of the present invention provide several safety benefits to the user. For example, the locking mechanism may provide the user with a visual, auditory and / or visual indication that the drug dose has been completely delivered, the retracting mechanism has been activated, the needle has retracted, and the syringe is safe to dispose It may be configured to provide haptic feedback.

  The components of the present invention may also be configured to increase destruction of the components and the entire syringe at the end of use. This integration of safety and destruction hinders syringe reusability and increases the safety profile of the device. For example, an optional needle block may be configured to prevent the needle from exiting the barrel tip and translating proximally after needle retraction. In this configuration, when a force is applied by the user by depressing the plunger rod and axial translation of the needle in the proximal direction, the needle will bend in the barrel.

  Another safety feature enabled by the present invention is the ability to control the speed of needle retraction. Controlled needle retraction prevents patient injury after a drug dose has been delivered. This can be facilitated by active components such as one or more friction members that limit the rate of extension of the biasing member during retraction, or by passive components such as selecting a biasing member that extends slower. In the embodiment shown in FIGS. 1 and 2, the retraction is controlled by a plunger rod and a prong base. When the needle retract is actuated, the user is still in contact with and applying force to the proximal end of the plunger rod. As the biasing member is extended, the biasing member applies an axial force in the proximal direction to retract the needle and / or needle assembly. This action transfers force to the prong base (which is in contact with the needle hub during retraction) and the plunger rod. The friction generated inside the barrel by the needle hub and prong base limits the rate of retraction of the needle assembly. If the force applied by the user to the plunger rod is reduced, the reverse speed can also be controlled. This controlled retraction is highly desired by syringe users because it increases safety and reduces the pain felt by the patient.

  Embodiments of the present invention with reference to the accompanying drawings are described in further detail herein. It should be understood that these are merely non-limiting embodiments, and other similar embodiments are within the scope of the present disclosure and the disclosure.

  As used herein to describe any of the relative positions of the delivery system, syringe, barrel, barrel adapter or components of the present invention, the term “axial” or “axially” generally refers to a syringe. Or it means a longitudinal axis “A” that is preferably formed around the barrel, but not necessarily symmetrically around it. The term “radial direction” generally means a direction perpendicular to the axis A. The terms “proximal”, “rear”, “rear”, “rear” or “rear” are generally axially away from the end of the needle that is injected into the patient (generally indicated as “P” in FIG. 1). Means. The terms “distal”, “front”, “forward”, “pressed” or “forward” generally refer to an axial direction (generally “D” in FIG. 1) toward the needle end to be injected into the patient. Means). The term “spring” as used herein is understood to indicate a biasing member, such as a substantially helically wound coil, that can be compressed and stretched in a given direction. Should. Although springs such as the arrangements described and used in the embodiments detailed herein may be used, other types of biasing members can be readily used for the same purpose. On the other hand, still within the scope of the invention is within the spirit of the invention. As understood by those skilled in the art, for example, compression springs, torsion springs, constant load springs, tension springs, leaf springs, and the like, and combinations of the same or different types of springs or other structures are within the scope of the present invention May be used. In addition or alternatively, biasing members other than springs may be used for similar purposes. Non-limiting examples of biasing members include springs, resilience or other devices for storing releasable energy. However, in at least one embodiment, the biasing member is preferably a spring, such as a compression spring.

  As used herein, the term “glass” should be understood to include other similar non-reactive materials suitable for use in pharmaceutical grade applications that typically require glass. The term “plastic” may include both thermoplastic and thermosetting polymers. Thermoplastic polymers can be softened again to their original state by heat, and thermosetting polymers cannot be softened again. As used herein, the term “plastic” mainly includes other components, such as usually hardeners, fillers, reinforcing agents, colorants and / or plasticizers, and is formed or formed under heat and pressure. It means moldable thermoplastic polymers that can be molded, for example polyethylene and polypropylene or acrylic resins. As used herein, the term “plastic” is used in direct contact with a therapeutic fluid that may interact with the plastic or otherwise be degraded by substituents that may enter the fluid from the plastic. Does not contain either glass or rubber-based elastomers approved for use in As used herein, the terms “elastomer”, “elastomeric” or “elastomeric material” are primarily more easily deformable than plastics, but are approved for use in pharmaceutical grade fluids. It means a crosslinked thermosetting rubber-based polymer that is not easily affected by leaching or gas transfer. As used herein, the term “fluid” primarily refers to a liquid, but dissolved or otherwise dissolved in a solid suspension dispersed in the liquid and the internal liquid of the portion containing the fluid of the syringe. And may also contain a gas present in the liquid.

  In addition, the devices of the present invention use materials that are substantially non-reactive with therapeutic fluids or drugs and that are suitable for use in pharmaceutical grade applications. Such novel configurations and delivery syringes of the present invention provide increased stability and shelf life parameters for implants and drug delivery devices. In addition, the drug implant may be held in place using known methods and materials during storage and transport. For this purpose, for example, microdeposition of polymers (PLGA, CAHP, etc.) may be used. The nature of the polymer used depends on the target site, for example, a water-soluble polymer is selected at a site that is water-like or contains water. In general, a variety of biodegradable materials, including polymers, may be used to plug the distal end of the needle to hold the implant prior to needle injection and implant placement. If it is necessary to facilitate assembly and manufacture of the barrel adapter and delivery syringe, the implant may be placed in the needle before or after plugging the distal tip of the needle. For example, if the device assembly requires implant insertion from the distal end, the implant may be placed in the needle prior to plugging the distal tip of the needle. This may be necessary, for example, if the barrel adapter is secured to the barrel prior to insertion of the implant. Alternatively, the implant may be placed in the needle after plugging the distal tip of the needle. This may be used, for example, when the implant is inserted into the barrel adapter before assembling the barrel adapter to the barrel of the delivery syringe. Similarly, surface treatment of the stylet tip is envisaged to prevent non-specific and specific attachment of the implant to the stylet, and can be performed in any order of operation with respect to assembly and manufacture of the barrel adapter and delivery syringe. Also good. For example, the stylet may be treated and / or coated with a treatment to maximize the hydrophilicity of the stylet tip surface.

  One or more embodiments of the present invention may further include certain standard components. For example, the barrel adapter configuration and syringe device of the present invention may include one or more O-rings. In at least one embodiment, one or more O-rings are used to seal the barrel tip within the barrel and / or to ensure a sterile environment and container integrity within the drug chamber of the barrel. . Additionally or alternatively, the barrel adapter may include one or more control members to facilitate control of the reverse speed. Similarly, the barrel adapter can be used to prevent the needle and stylet from translating or protruding from the barrel through the barrel tip aperture after completion of the retract mechanism, such as clips, flaps, flanges, etc. One or more needle blocks may be included.

  In addition, the delivery syringe may include one or more components for aesthetics, ease of use, or other purposes. For example, as will be appreciated by those skilled in the art, one or more embodiments of the present invention may include a finger flange. The finger flange may be pre-formed along any portion of the barrel or delivery syringe, or may be a separate component connected or secured to the barrel or delivery syringe. In at least one embodiment, the finger flange is a pre-formed component at the proximal end of the barrel. The finger flange may be configured to allow the user to place his index finger and middle finger on the flange and when the user presses the plunger with his thumb to inject medication. A leverage interface may be provided. As will be readily appreciated by those skilled in the art, the location, shape, number and material of such components may vary to meet any number of desired features.

  Similarly, although the barrel adapter and delivery syringe components are described herein as separate components, certain groups of these components may be combined to perform the functions of the individual components. It is within the contemplation of the present invention that possible single components may be formed. As described above, for example, in at least one embodiment, where a needle seal is provided, the needle hub and needle seal may be one integral component that provides a dual function. In addition, as will be appreciated by those skilled in the art, the components of the delivery syringe may be manufactured as an integrally formed component or as individual or single components. As mentioned above, the finger flange may be a component that is preformed as part of the barrel itself during the manufacturing process. Thus, in at least one embodiment, the finger flange may be a glass finger flange extension of the barrel. Furthermore, although the components of the barrel adapter are described as separate components herein, they may be integrated components having multiple functions. For example, the prong base may be part of the plunger or a separate component from the plunger. Similarly, as further described herein, the protrusion or prong may be a prong-based extension or a separate component from the prong base. The configuration of the components and their assemblies may vary based on the assembly process, device parameters, and other desired characteristics.

  FIG. 1 shows an isometric view of one embodiment of a delivery syringe 10 according to the present invention. FIG. 2 shows an exploded view of the delivery syringe 10 and its components shown in FIG. In accordance with the present invention, a barrel adapter 20 is provided for attachment to a syringe barrel 18 having a plunger assembly 12. As an advantage of embodiments of the present invention, the barrel tip 32 of the barrel adapter 20 may be configured to couple to any standard barrel 18 by any suitable method. Barrel 18 may be a plastic barrel, a glass barrel, or made of any other known material used in medical devices. The barrel 18 may be tapered, non-cylindrical, or substantially straight. In an embodiment suitable for manufacturing purposes, the barrel 18 is a straight barrel glass cylinder. In one or more embodiments, the barrel 18 may be, for example, standard commercially available components that provide valuable manufacturing efficiency and reduced operating costs. In addition, a barrel cap 16 may be provided that may prevent or prevent the plunger assembly 12 from separating from the barrel 18 after the delivery syringe 10 is assembled. Barrel 18 or barrel cap 16 (as shown) may include finger flanges.

  Embodiments of the present invention also allow other significant advantages in the delivery syringe market. For example, one or more embodiments can use standard components such as standard plunger rods, barrels, barrel caps and hard needle shields, thereby being specially made or injection molded. Significantly reduces the need for components. For example, in some embodiments, the delivery syringe 10 may use a standard plunger rod 14 and a hard needle shield (not shown), among other possible standard components. Where a seal is provided, the seal used herein may be obtained from West Pharmaceutical Services, Inc. of Lionville, Pennsylvania under the trade designation “FluroTech” ( Coated with ethylene tetrafluoroethylene (ETFE), such as those readily available under the trade name "Omniflex" from Datwiller Pharma Packaging, Belgium It may be a rubber stopper / seal. Other components may be standard commercial components as well, providing the superior advantages of embodiments of the present invention. This advantage of embodiments of the present invention results in valuable manufacturing efficiency and reduced operating costs.

  As will be appreciated by those skilled in the art, barrel adapter 20 may be attached to syringe barrel 18 by any suitable coupling mechanism. For example, the barrel adapter 20 may be coupled to the syringe barrel 18 by a coupling structure, and the coupling structure may be separate from the barrel adapter 20 and the syringe barrel 18 components. 18 may be integrated. Further, the barrel adapter 20 may be coupled to the syringe barrel 18 during the syringe manufacturing process or just prior to use. By way of example only, the syringe adapter 20 may be coupled to the syringe barrel 18 by an interference fit, adhesive, snap fit assembly and / or screw fit assembly, etc. during the syringe manufacturing process. Alternatively, the syringe barrel 18 and barrel adapter 20 may include a mating thread or luer lock mechanism so that, for example, the barrel adapter 20 can be coupled to the syringe barrel 18 immediately prior to use. In at least one embodiment of the present invention, the barrel adapter may be connected to the barrel by a screw fit assembly, both the barrel adapter and the barrel having corresponding male and female thread pitches or components. In another embodiment, one or more coupling structures may be provided to couple the barrel adapter 20 to the barrel 18. One or more O-rings 36 may be provided for placement between the barrel adapter 20 and the barrel.

  Barrel adapter 20 facilitates attachment of needle 28 (see FIG. 2) to syringe barrel 18. Barrel adapter 20 includes a barrel tip 32, a needle assembly 42, and a needle retraction mechanism 21. As described above with respect to attachment of the barrel adapter 20 to the syringe barrel 18, the barrel tip 32 may be coupled to the syringe barrel 18 by any suitable method. The barrel tip 32 is typically the distal end of the safety syringe 10 when coupled to the syringe barrel 18 and the needle 28 extends into the distal end of the barrel tip 32 during injection for delivery of the implant. . The barrel tip 32 may further include one or more structures that form part of the needle retraction mechanism 21, as will be described below.

  Needle assembly 42 may generally include needle 28 and needle hub 24. An O-ring 36 may be provided around the needle hub 24 to facilitate disposal of the needle assembly 42. The needle 28 passes through the needle retraction mechanism 21 and the barrel tip 32 so that one end of the needle 28 is in the barrel and the other end of the needle 28 passes through the aperture 33 of the barrel tip 32 (see FIG. 3B). It is configured. Various needle retraction mechanisms may be used to facilitate needle retraction within the present invention. For example, the needle retraction mechanism is described in International Application PCT / US Patent Application Publication No. 2012/066793 and US Patent Application No. 13 / 693,915 published as WO2013126118A1 (for all purposes). It may be similar to that disclosed in (herein incorporated by reference in its entirety). In at least one embodiment, the needle retraction mechanism 21 is an actuable locking mechanism that maintains the biasing member 30 in the biased position until the biasing member 30 and the needle 28 of the needle assembly 42 are retracted into the barrel adapter 20. 31. The locking mechanism 31 may be of any suitable design that maintains the biasing member 30 in the biased position until the needle 28 is retracted, but in the illustrated embodiment, as will be described in greater detail below. The locking mechanism 31 includes a locking mechanism 22 and a locking aspect 32a that is coupled to maintain the relative position of the surface that maintains the biasing member 30 in the biased position. When the lock mechanism 31 is operated, the urging member 30 moves the needle 28 back into the barrel tip portion 32.

  In one such embodiment of the locking mechanism 31, the biasing member 30 is a compression spring. The end of the spring 30 is disposed adjacent to the surface 23 and the surface 35 of the locking mechanism 22 in the barrel tip 32. The relative position of the surfaces 23, 35 ensures that the biasing member 30 is compressed and maintained in the biased position prior to injection, or after injection, the spring 30 moves to the depressed position to retract the needle 28. to enable. In order to maintain the spring 30 in the biased position, the locking mechanism 22 and barrel tip 32 include a mating structure. The mating structure may be separated to allow the spring 30 to move to the de-energized position. The structure and operation of the needle retraction mechanism 21 will be described in more detail below.

  The embodiment shown in FIGS. 1 to 5 includes a configuration in which the locking mechanism 22 is independent from the barrel tip 32. However, the locking mechanism 22 may be configured to be part of or attached to the barrel tip 32. As described above, the locking mechanism 22 may be a separate component or a dual-purpose component such as a dual-purpose locking mechanism 22 and a needle block. In other words, the locking mechanism 22 may include or function to prevent the needle 28 from being axially translated distally after the retracting mechanism is activated and the needle 28 is retracted. Also good. Alternatively, a separate needle block 34 component may be used as shown in FIGS. 2, 3B and 3C.

  FIG. 3B shows a cross-sectional view of the barrel tip 32 shown in FIG. 3A. However, for clarity, cross-hatching of the various components is omitted. As seen in FIG. 3B, the biasing member 30 is at least partially within the barrel tip 32. When in the compressed state, the biasing member 30 is in the barrel tip 32 at the distal end and in the locking mechanism 22 at the proximal end. The components of the barrel adapter 20 are shown in the exploded view of FIG. 3C. Needle assembly 42 including needle hub 24 and needle 28 may be assembled separately from or in conjunction with other components of barrel adapter 20. For example, all components may be pre-assembled into a complete barrel adapter 20 as shown in FIG. 3A for coupling to a barrel, such as barrel 18 shown in FIGS. Alternatively, the components of needle assembly 42 may be assembled separately from the remaining components of barrel adapter 20. In this second configuration, when assembled, the needle assembly 42 may be attached to the barrel from the proximal end rather than the distal end having the barrel adapter 20.

  Needle retraction mechanism 21 may be actuated by any suitable trigger. For example, in the illustrated embodiment, the needle retraction mechanism 21 is activated by movement of the locking mechanism 22 toward the distal end of the delivery syringe 10. In such a configuration, the needle hub 24 may be forced to contact and / or depress the locking mechanism 22. This contact disengages the locking mechanism 22 and allows the biasing member 30 to extend proximally substantially along the longitudinal axis of the barrel 18, thereby causing the locking mechanism 22 and the needle 28 to move together. The components of the needle assembly 42 that it contains may be retracted into the barrel 18. Generally, the needle hub 24 functions to hold the needle 28 in a substantially fixed position while the barrel adapter 20, delivery system and delivery syringe 10 are in a first stage configured for needle injection and implant delivery. May be. Additionally or alternatively, during this first phase of drug injection, the locking mechanism 22 may function to hold the needle in a substantially fixed position.

  As will be described in more detail below, upon actuation of the locking and disengaging and retracting mechanisms of the locking mechanism 22, the biasing member or spring 30 is extended, causing the needle assembly 42 to be proximally substantially along the longitudinal axis of the barrel. Retreat in the direction. In some embodiments of the invention, the entire needle assembly 42 is retracted, while in other embodiments, only that particular component, including the needle 28, when the locking mechanism 22 is released and the biasing member 30 is extended. Retreat. Similarly, in some embodiments of the invention, the locking mechanism 22 is retracted with the needle assembly 42 while in other embodiments the locking mechanism 22 remains substantially stationary, but the needle assembly 42 or its Allows the component to move.

  In some embodiments, the barrel adapter 20 may be provided with a block that prevents or prevents the needle 28 from translating distally and out of the barrel tip 32 after the needle 28 is retracted. FIG. 3C illustrates one embodiment of a needle block 34 that may be in the distal end of the barrel tip 32. The needle block 34 shown includes a flange 60 having a central aperture for the passage of the needle 28. A pair of arms 62 extends from the flange 60 and the distal ends of the arms 62 support a pair of clips 64. When the needle block 34 is disposed within the barrel tip 32, the arms 62 bias the clips 64 toward each other. In this embodiment, with the needle 28 extending into the aperture of the flange 60, the clip 64 at the distal end of the needle block 34 expands between the clips 64 when the needle 28 is in the infusion and retraction phase. Allows the needle 28 to be placed. However, when the needle 28 is retracted proximally past the clip 64, the arm 62 biases the clip 64 to the closed position and prevents the needle 28 from passing distally. The assembly may be configured in other forms, but in this embodiment, the biasing member 30, ie, the distal end of the spring 30, may be positioned adjacent to the flange 60 during assembly. It will be appreciated that the needle block 34 shown is disclosed by way of example only, and that the block may be of other configurations and structures.

  According to another aspect of the present invention, delivery syringe 10 and / or barrel adapter 20 may be used with syringe barrel 18 for delivery of implant 49. As will be appreciated by those skilled in the art, the implant 49 may be, collectively or individually, a depot, implant, bead, pill, capsule, blob, drug elution device, dry or lyophilized drug or therapeutic agent, Or other forms of implants and the like, and may include drug dispersions, powders, suspensions, etc., or combinations thereof. To allow placement or placement of the implant 49, the barrel adapter 20 further includes a stylet 54 that is disposed within the lumen 29 of the needle 28, and preferably a multi-stage retracting mechanism.

  Referring to FIG. 3B, needle 28 includes a central lumen 29. The needle hub 24 has an aperture 25 that functions as a passage in its center (eg, substantially at the longitudinal axis of these components and the barrel). This aperture 25 has a needle hub 24 so that the needle 28 is held in place during the initial injection phase and can be axially translated proximally when the retracting mechanism is actuated, or You may have a diameter equal to the outer diameter of the needle | hook 28 which does not have. With the needle 28 disposed in the aperture 25 through the needle hub 24, the proximal end of the needle 28 exhibits a central lumen 29. 2 and 6, in operation, the stylet 54 is disposed within the central lumen 29 of the needle 28 and the implant 49 to be implanted is received within the lumen 29 of the needle 28 distal to the stylet 54. May be. Thus, when the needle 28 enters the target (not shown), the needle 28 may be retracted axially over the stylet 54. In this way, the stylet 54 prevents the implant 49 from retracting with the needle 28, leaving the implant 49 in place within the target. If the stylet 54 extends beyond the barrel tip 32, the stylet 54 will also be either with the needle 28 after positioning the implant 49 or separately from the needle 28 after the needle 28 has been retracted. May be retracted from the target. Thus, according to aspects of the present invention, at least the needle 28 is retracted to perform the injection of the implant 49. According to another aspect, in some embodiments, after delivery of the implant 49, the stylet 54 is similarly retracted.

  First referring to the retraction of the needle 28, any suitable actuable locking mechanism 31 may be provided, while one embodiment of the actuatable locking mechanism 31 is shown in FIGS. 3B, 3C, 4 and 5. Indicated. FIG. 4 shows the locking mechanism 22, and FIG. 5 shows the barrel tip 32. The barrel tip portion 32 has a lock portion 32 a that can be engaged with the lock mechanism 22. In this embodiment, the barrel tip 32 has two locking portions 32 a that engage with a receiving structure in the locking mechanism 22. However, it will be appreciated that the barrel tip 32 may have more than one lock 32a.

  As shown in FIG. 4, the receiving structure of the locking mechanism 22 may be in the form of a lock inlet 46, for example. In the illustrated embodiment, the lock inlet 46 is an “L” shaped cutout, although other shapes and arrangements are envisioned. One or more channels 47 within the inner diameter of the lock mechanism 22 allow the lock portion 32a to slide into the lock inlet 46, and the seat 22a of the lock inlet 46 of the lock mechanism 22 when the lock mechanism 22 rotates. Placed inside. Thus, when the urging member 30 of this embodiment urges and releases the lock mechanism 22 and the barrel tip 32, the relative position between the lock mechanism 22 and the barrel tip 32 is maintained. Although the locking mechanism 22 and barrel tip 32 of the illustrated embodiment each include a lock inlet 46 and a locking portion 32a, the locking mechanism 22 and barrel tip 32 can instead engage the associated component by engagement. It will be understood that each may include a lock and a lock inlet or some other combination so long as a mechanism operable to removably couple is provided. Further, as long as the mechanism provides a retractable arrangement of the needle 28 within the syringe and is preferably operable by using the delivery syringe 10 to inject the implant 49, the locking mechanism 22 is completely separate. It will be understood that it may be of a construction.

  In the illustrated embodiment, the needle retraction mechanism 21 is actuated by an axial force applied to the locking mechanism 22. In this embodiment, the contact by the needle hub 24 and the axial movement of the needle hub 24 cause a corresponding movement of the locking mechanism 22 in the axial direction, which may be applied by another structure. In operation, when the locking mechanism 22 is translated distally, such as by contact with the needle hub 24, the locking mechanism 22 can be disengaged from one or more corresponding locking portions 32a of the barrel tip 32 and the spring 30. Extends and allows the retract mechanism to operate. Engagement / disengagement of the lock mechanism 22 from the lock portion 32a may be caused by translation of the lock mechanism 22 in the axial direction. In addition or as an alternative, the engagement / disengagement of the lock mechanism 22 from the lock portion 32a may be caused by rotation of the lock mechanism 22 such as rotation during axial translation. The rotation allows the locking mechanism 22 to disengage from the locking portion 32a by itself or with axial translation. In at least one embodiment, this rotation may occur by urging the compression spring 30 to twist, causing the locking mechanism 22 to rotate in one direction about the axis during compression. In another embodiment, to enable this function, the rotation facilitates the configuration of the locking mechanism 22 itself, eg, the pitched aspect profile of the locking mechanism 22, the shape of the locking part 32a, or this movement. However, it may be caused by an interface between the locking portion 32a and the locking mechanism 22 that enables the engagement and disengagement of the components.

  The force applied by the user to translate the plunger rod 14 in the axial direction similarly activates the actuable locking mechanism 31 to disengage the locking mechanism 22 from the barrel tip 32 and retract the needle 28. May be used for For this purpose, the plunger rod 14 component of the plunger assembly 12 is arranged to allow transmission of the needle retracting force while the stylet 54 is in position for injection and implant delivery. In order to allow transmission of the needle retract actuation force from the plunger assembly 12 to the needle hub 24 and ultimately to the locking mechanism 22, the at least one actuation prong 51 has a stylet 54 within the syringe barrel 18. While the plunger assembly 12 moves, it is arranged to advance longitudinally.

  As seen in FIG. 6, in at least one embodiment of the present invention, the stylet assembly 53 includes a stylet 54 that extends from a support structure in the form of a stylet disk 52. The stylet disc 52 is located within the syringe barrel 18 and substantially maintains the stylet 54 in place. The stylet disk 52 may be maintained in place within the syringe barrel 18 by one or more O-rings. To allow transmission of force from the plunger assembly 12, at least one actuation prong 51 is provided that is disposed longitudinally across the barrel, and the stylet disc 52 includes at least one passage 53. . The passage 53 extends longitudinally through the stylet disc 52 and is arranged to receive at least one actuation prong 51. Although the illustrated embodiment includes two such prongs 51 and passages 53, a larger number may be provided. Further, the illustrated embodiment provides at least one passage 53 spaced from the outer periphery of the stylet disc 52, but the inner wall of the syringe barrel 18 may also form a portion of the passage 53 that also extends longitudinally. Those skilled in the art will appreciate that the at least one passageway 53 may alternatively or additionally be disposed along the outer periphery of the stylet disc 52. Further, it will be appreciated that the number of passages 53 and prongs 51 need not be the same. For example, a single passage 53 may take into account the passages 53 of two or more prongs 51.

  Prongs 51 extend from the base 50. The base 50 is arranged so that it can move in the syringe barrel 18 in the axial direction. The prong base 50 may be maintained in place within the syringe barrel 18 by one or more O-rings. Although the base 50 is shown as having a disk shape, it may have other shapes as long as the base 50 maintains support for the prongs 51 and facilitates movement of the prongs 51 within the barrel 18. Will be understood. In operation, axial movement of the plunger assembly 12 causes movement of the base 50 and corresponding prongs 51, which contact the needle hub 24. Thus, in the illustrated embodiment, the prongs 51 contact the needle hub 24 such that a force applied by the user to the plunger rod 14 is applied to the base 50 and transmitted at least partially to the needle hub 24. You may produce as follows. With this transmission, the surface of needle hub 24 or a similar surface may push locking mechanism 22 or otherwise begin to release locking mechanism 22 from engagement connection with locking portion 32a of barrel tip 32. Also good. By releasing the locking mechanism 22 from the locking portion 32 a of the barrel tip 32, the biasing member 30 (e.g., a spring) is extended, causing the needle assembly 42 including the needle 28 to move substantially along the longitudinal axis of the barrel 18. Retract in the proximal direction along. In such an embodiment of the invention, upon release of the locking mechanism 22 and extension of the biasing member 30, the needle 28, needle hub 24 and locking mechanism 22 are retracted.

  Prong 51, base 50, and plunger assembly 12 may be made separately, or one or more of these aspects may be formed as a unit, formed separately, and later assembled, or It will be appreciated that the separate units that engage one another during assembly or use of the delivery syringe 10 may remain. In the embodiment shown in FIG. 6, the prong 51, the base 50, and the plunger rod 14 are integrally formed, and when the plunger assembly 12 is pressed, the prong 51, the base 50, and the plunger rod 14 are single. Moves axially as a unit. In another embodiment, for example, when the plunger rod 14 is pushed forward within the syringe barrel 18, the plunger 50 engages the base 50 and moves the base 50 and the corresponding prongs 51 to move the base 50 and the prongs 51. 51 may be integrally formed.

  When assembled, a stylet 54 that is substantially coaxial with the needle 28 is disposed within the lumen 29 of the needle 28. In one embodiment, stylet 54 may partially overlap needle 28 from the non-patient end (ie, proximal end P). Implant 49 is placed in lumen 29 of needle 28 between stylet 54 and the patient end of needle 28 (ie, distal end D).

  In use, the needle retraction mechanism 21 may be operated using an operation mechanism such as the plunger rod 14 and the needle 28 may be retracted. First, the stylet 54 is stationary with respect to the needle 28, and the needle 28 is retracted by the needle retracting mechanism 21 to expose the implant 49 in the target region for delivery. The stylet 54 prevents the implant 49 from following the needle 28 as the needle 28 is retracted.

  In accordance with aspects of the present invention, the stylet 54 is retracted only after the distal end of the stylet 54 has passed the distal end of the retracted needle 28 to ensure accurate delivery of the implant 49. . In the illustrated embodiment, the stylet 54 retraction sequence and timing is activated after the mechanism for retraction of the stylet 54 is activated after the distal end of the needle 28 has retracted past the distal end of the stylet 54. Alternatively, although activated, both components may be retracted using the same retracting mechanism. A stylet disk 52 proximal to the needle retraction mechanism 21 may be used to ensure the desired retraction order. The timing of retraction of the stylet 54 with respect to the needle 28 is set according to the distance between the needle retraction mechanism 21 and the stylet disk 52. In the illustrated embodiment, the stylet retraction mechanism is the engagement of the needle hub 24 with the stylet disc 52.

  7A-7D illustrate barrel adapter 20, retraction mechanism 21 and delivery system according to one embodiment of the present invention as syringe 10 proceeds through the steps of needle injection, needle retraction operation, implant delivery and stylet retraction. The delivery syringe 10 containing these is shown. FIG. 7A shows the barrel adapter 20 attached to the barrel 18. At the time of packaging, the barrel adapter 20 may include a rigid needle shield (RNS). The hard needle shield removably engages the barrel tip 32 to protect the user from the needle 28. FIG. 7A shows the syringe with the RNS removed and the needle 28 exposed for infusion into the patient. The lumen 29 of the needle 28 between the stylet 54 and the needle tip includes a drug implant 49 for injection. FIG. 7B shows the syringe after the retracting mechanism 21 is activated, with the plunger rod 14 being pushed axially distally and the prong base 50 in contact with the needle hub 24. When the plunger rod 14 is further pressed down to the minimum, the retracting mechanism 21 is activated, and the lock mechanism 22 can be rotated in the axial direction by, for example, a torsional bias of the biasing member 30. As described above, when the lock mechanism 22 rotates in the axial direction, the lock mechanism 22 can be disengaged from the lock portion 32 a of the barrel tip portion 32.

  As shown in FIG. 7C, the biasing member 30 is allowed to extend in the axially proximal direction. The proximal end of the biasing member 30 pushes the locking mechanism 22 proximally, and the locking mechanism 22 pushes the needle hub 24 and the needle 28 and retracts the needle 28 into the barrel 18. This action, in conjunction with the stylet 54 not moving with the needle 28, exposes the implant 49 for target delivery to the patient. After the implant 49 is fully exposed and delivered, the stylet 54 is retracted with the needle 28. This action is caused by the needle hub 24 coming into contact with the stylet disc 52 and both components retracting together. As noted above, these dimensions are controlled to ensure that the stylet 54 is retracted only after the implant 49 has been delivered. FIG. 7D shows the syringe after the needle 28 and stylet 54 have been retracted. 8A-8D are enlarged cross-sectional views of the embodiment shown in FIGS. 7A-7D showing the relationship of the components as the syringe progresses through the stages of needle injection, needle retraction operation, implant delivery and stylet retraction. Show.

  In another embodiment, the present invention provides a delivery syringe having a barrel adapter that can be attached to the barrel by a screw-fit connection. As described further herein, such a configuration may facilitate an automatic implant insertion process for loading the implant into the barrel adapter needle. FIG. 9A shows a side elevation view of a delivery syringe 100 that includes a barrel adapter 120 with a threaded connection, according to one such embodiment of the present invention. Such a delivery syringe may use a needle cap 170 shown as a transparent component for clarity in FIG. 9B. Needle cap 170 facilitates attachment of barrel adapter 120 containing the implant to barrel 118 of delivery syringe 100. The barrel adapter 120 may be located entirely within the needle cap 170, for example, in a sterile environment sealed by a removable membrane 171 for packaging, shipping and / or assembly. The barrel adapter 120 may be shipped to a filler or pharmaceutical company within the sterile needle cap 170 for, for example, final assembly with the implant 118 and the barrel 118 of the delivery syringe 100. In at least one embodiment, the distal tip of the needle 128 of the barrel adapter 120 includes a biodegradable polymer or the like before the manufacturer transports the sterile needle cap 170 containing the barrel adapter 120 to a filler or pharmaceutical company. Plug with. Upon receipt of the needle cap 170 separate from the barrel 118 and other components of the delivery syringe 100, the filler or pharmaceutical company peels or otherwise removes the removable membrane 171 and proximate the barrel adapter 120. An implant may be inserted through the end. Barrel adapter 120 may then be attached or attached to barrel 118 of delivery syringe 100 with or without the aid of needle cap 170. The delivery syringe has the barrel adapter 120 assembled to the barrel 118 only when the stylet 154 is axially aligned with the proximal end of the needle 128 and is inserted into the proximal end of the needle 128 through the aperture of the needle hub 124. It is configured to be possible. FIG. 9C shows a side elevation view of the delivery syringe and barrel adapter shown in FIG. 9A in such an assembled configuration.

  In particular, these embodiments of the present invention show configurations in which one or more prongs 151 are separated from the prong base 150 or are separate components. In such embodiments, the one or more prongs perform the same relative functions as the prongs used in the delivery syringe described above with reference to FIG. However, in the embodiment shown in FIG. 9C, the prong extends proximally from the stylet guide 155 rather than extending distally from the prong base as shown in FIG. Regardless of configuration, the prong 151 is configured to allow the stylet disc 152 to translate axially on the prong 151 and to control the position of the stylet 154 as the delivery syringe advances through the stages of operation. ing. In either the embodiment shown in FIG. 1 or the embodiment shown in FIG. 9C, the prong 151 also activates the needle retraction mechanism by transmitting the force applied to the plunger rod 114 by the user to the locking mechanism 122. It may be used to make it happen. FIGS. 10B and 10C show enlarged views of the stylet disc 152 and stylet 154 that interact with the stylet guide 155 and prong 151 during operation of the delivery syringe 100.

  As mentioned above, embodiments of the present invention may simplify the assembly, manufacture and operation of an implant delivery syringe. These steps may be facilitated by the use of an optional plunger guide assembly 112 as shown in FIG. 10A. In one embodiment, the plunger guide assembly 112 includes a barrel cap 116 and a plunger rod 114 having a base 150. The barrel cap 116 may have a port 116A, and a guide pin 117 may be disposed in the port 116A. The guide pin 117 may interact with the plunger rod 114 by, for example, the channels, passages and stop members of the plunger rod 114 to guide assembly, manufacture and operation of the delivery device. 11A-11C each show a side elevation of the plunger rod 114 according to at least one embodiment of the invention rotated about the axis A at 90 degree intervals relative to the guide pin 117 as indicated by arrow R, respectively. The figure is shown. FIG. 11A shows a plunger rod 114 having a stop member 114D, a passage 114A, a channel 114E, and a base connection 114C. The base connection mode 114C may be used to connect the plunger rod 114 to the base 150 as shown in FIG. In such a configuration, the pin guide 117 may be in the channel 114E, and the plunger rod 114 may be axially translated until the pin guide 117 contacts the stop member 114D.

  The configuration shown in FIG. 11A may be used, for example, for initial assembly and transportation from the manufacturer to the filler or pharmaceutical company. In this configuration, stop member 114D prevents distal axial translation of the plunger rod. Optionally, the barrel cap 116 may interact with the plunger rod 114 and may be used to prevent proximal axial translation of the plunger rod. FIG. 11B shows plunger rod 114 rotated 90 degrees about axis A in the direction indicated by arrow R to allow guide pin 117 to move between channel 114E and channel 114F through passage 114A. Indicates. In this configuration, the filler or pharmaceutical company may translate the plunger rod 114 to position the stylet disk 152 and stylet 154 for final assembly and operation. The transition from the configuration shown in FIG. 11A to the configuration shown in FIG. 11B may allow for placement of the implant in the barrel adapter prior to attaching the barrel adapter to the barrel of the delivery syringe, for example, as described above. . The delivery syringe may be transported to the user in the configuration shown in FIG. 11B. Prior to use, the user may rotate the plunger rod 114 about axis A in the direction indicated by arrow R an additional 90 degrees. This rotation may allow the guide pin 117 to move between the channel 114F and the channel 114G through the passage 114B (as shown in FIG. 11C). In the configuration shown in FIG. 11C, the plunger rod 114 is free to translate axially freely in the distal and proximal directions to facilitate implant placement and needle and stylet retraction. . FIG. 12 shows an enlarged cross-sectional view of the delivery syringe 100 (with cross-hatching removed for clarity) where the interaction between the guide pin 117 and the plunger rod 114 is visible through the barrel cap 116.

  FIGS. 13A-13D show enlarged cross-sectional views as the delivery syringe 100 proceeds through the stages of needle injection, needle retraction operation, implant delivery, and stylet retraction (cross-hatching has been removed for clarity). . As seen in FIG. 13A, in at least one embodiment of the invention, the stylet assembly includes a stylet 154 that extends from a support structure in the form of a stylet disk 152. The stylet disk 152 is located within the syringe barrel 118 and substantially maintains the stylet 154 in the initial position. The stylet disk 152 may be maintained in place within the syringe barrel 118 by one or more O-rings. In particular, during the initial operational phase, the stylet disk 152 and stylet 154 are held in a substantially fixed position by an O-ring or equivalent means, and the needle 128 is retracted proximally to expose the implant for placement. Until the implant 129 remains in a fixed position. The initial position of the stylet assembly is maintained until the stylet guide 154 contacts the stylet disc 152 when the needle hub 124 and needle 128 are retracted. As shown in FIGS. 13A-13D, actuation of the needle retraction mechanism causes the needle 128 to retract and expose the implant 129 for placement with the stylet 154 and then retract the stylet 154 into the barrel 118. If the plug 127 is used to initially hold the implant 129 in place at the distal tip of the needle 128, the plug 127 may optionally be placed in addition to the placement of the implant 129.

  As shown in FIG. 13A, the stylet guide 155 may contact the needle hub 124 by a force applied to the prongs 151 by the plunger rod 114 and / or the base 150. In the illustrated embodiment, the stylet guide 155 is brought into contact with the needle hub 124 such that a force applied by the user to the plunger rod 114 is applied to the base 150 and is at least partially transmitted to the needle hub 124. May be. This transmission may cause the surface of needle hub 124 or a similar surface to push locking mechanism 122 or otherwise begin to release locking mechanism 122 from engagement connection with the locking portion of barrel tip 132. Good. By releasing the locking mechanism 122 from the locking portion of the barrel tip 132, the biasing member 130 (e.g., a spring) is extended, causing the needle assembly including the needle 128 to move substantially along the longitudinal axis of the barrel 118. Retract proximally. In such an embodiment of the invention, upon release of the locking mechanism 122 and extension of the biasing member 130, the needle 128, needle hub 124 and locking mechanism 122 are retracted. First, the stylet 154 is stationary with respect to the needle 128, and retraction of the needle 128 by the needle retraction mechanism exposes the implant 129 in the delivery target area. The stylet 154 prevents the implant 129 from following the needle 128 as the needle 128 is retracted. To ensure accurate delivery of the implant 129, the stylet 154 is retracted only after the distal end of the stylet 154 has passed the distal end of the retracting needle 128. In the illustrated embodiment, the stylet 154 retraction sequence and timing is activated after the stylet 154 retraction mechanism is retracted after the distal end of the needle 128 is retracted beyond the distal end of the stylet 154. Alternatively, although activated, both components may be retracted using the same retracting mechanism. Similar to the embodiment described above with reference to FIG. 1, the stylet disk 152 may be proximal to the needle retraction mechanism and the stylet disk 152 may be used to ensure the desired retraction sequence. The distance between the needle retraction mechanism and the stylet disk 152 may be used to set the retreat timing of the stylet 154 with respect to the needle 128.

  When the needle retraction mechanism is activated, the needle 128 retracts into the barrel 118 of the delivery syringe 100, thereby exposing the implant 129 for placement at the target location. Retraction of the needle assembly including needle hub 124 and needle 128 causes needle hub 124 to contact stylet guide 155 and retract stylet guide 155. As shown in FIG. 13B, as the needle 128 retracts around the implant 129, the stylet disk 152 and stylet 154 are held in a substantially constant position to hold the implant 129 in a relatively fixed position. The As shown in FIG. 13C, when the implant 129 is exposed from the needle 128 for placement, the stylet guide 155 contacts the stylet disk 152 and thereby retracts the stylet disk 152 and thereby the stylet 154. In particular, the retraction of the needle assembly and stylet guide 155 results in the axial translation of the prong 151 in the proximal direction, so that the plunger rod 114 and / or the base 150 also translate axially in the proximal direction. This allows the user to control needle assembly retraction and implant placement by maintaining contact with the plunger rod 114. As shown in FIG. 13D, at the end of implant placement, the needle 128 and stylet 154 are fully retracted and are safely housed in the barrel 118 of the delivery syringe 100. As described above, an optional guide pin 117 may be used with the plunger rod 114 to control the function of the delivery syringe 100. Thus, embodiments of the present invention allow for accurate delivery of a drug implant to a target location while remaining simple to use and prevent needle stick damage.

  Embodiments of the present invention also provide a configuration that allows the use of standard off-the-shelf components, thereby reducing overall manufacturing costs and simplifying the assembly process, often non- Avoid regulations associated with standard materials and components. For example, the barrel may be made from a particular plastic, glass, or any other material commonly used for medical grade products. One or more components of the present invention may also be a specific such as a polycarbonate plastic sold under the trade name “LEXAN ™” by SABIC Innovative Plastics located in Pittsfield, Massachusetts. It may be made of any plastic. Similarly, a specific elastic polymer or rubber such as a rubber product sold under the trade name “HELVOET” by Datwiller Pharma Packing USA Inc. of Pennsacken, NJ is a needle seal ( And may be used for components such as the prong base 50. As will be appreciated by those skilled in the art, various medical grade metal materials such as stainless steel may be used for the needle. These components, barrel adapter and delivery syringe may be shaped or sized in a variety of different configurations to meet the desired parameters. These components, barrel adapters and syringes may be assembled by a number of processes well known in the art and / or filled with implants. For example, the components of the present invention may be assembled using well-known adhesives or welding methods such as ultrasonic welding.

  The delivery syringe of the present invention is configured to be used in the same manner as a conventional syringe. The method of use includes depressing the plunger assembly 12 to facilitate actuation of the retracting mechanism 21 and delivery of the implant 49 from the needle 28, and actuating the locking mechanism 22 between the biasing member 30 and the needle assembly 42. Releasing the biasing member 30 from its biased state by contact between and retracting the needle assembly 42 into the barrel; delivering the implant 49 to the target position; Retracting 54 into the barrel of the syringe. As described above with respect to the syringe embodiment, the locking mechanism 22, needle hub 24, and other components can be configured to function to allow engagement and release of the biasing member 30. There is. For example, in the syringe 10, the locking mechanism 22 may include an interface that engages the locking mechanism 22 on the barrel tip 32. When actuated by the user, the needle hub 24 may be used to initiate disengagement of the locking mechanism 22 from the barrel tip 32. In another embodiment of the syringe, the lock portion 32 a may be a component different from the barrel tip 32, but may function in the same manner as the component of the syringe 10. The function of the delivery syringe 100 is substantially similar to that described herein with respect to the delivery syringe 10.

  Regardless of the particular component, the method of using the delivery syringe of the present invention is relatively similar. By releasing the locking mechanism 22 from its engaged state, the biasing member 30 is extended and the needle assembly 42 is retracted proximally substantially along the longitudinal axis of the barrel 18. In some embodiments of the invention, the entire needle assembly 42 is retracted, while in other embodiments, only that particular component, including the needle 28, upon release of the locking mechanism 22 and actuation of the biasing member 30. Retreat. Similarly, in some embodiments of the invention, the locking mechanism 22 is retracted with the needle assembly 42 while in other embodiments the locking mechanism 22 remains substantially stationary, but the needle assembly 42 or its Allows the component to move. Optionally, the method of use may include preventing the needle 28 from translating axially distally by the needle block after the needle assembly 42 has been retracted into the barrel 18.

  14A-16C show another embodiment of a delivery syringe 200. FIG. Similar to the delivery syringe embodiment described above, the delivery syringe 200 is configured to place an implant in a target tissue. As described in detail below, however, the delivery syringe 200 uses a different needle retraction mechanism than the embodiment described in FIGS.

  As shown in FIGS. 14A and 14B, the delivery syringe 200 includes a barrel adapter 220 for attachment to a syringe barrel 218 having a plunger assembly 212. It is contemplated that the barrel tip 232 of the barrel adapter 220 may be configured to couple with any standard barrel by any suitable method. Similar to the barrel 18 described above, the barrel 218 may be tapered, non-cylindrical, substantially straight, and formed of any suitable material. In an embodiment suitable for manufacturing purposes, the barrel 218 is a straight barrel glass cylinder. In one or more embodiments, the barrel 218 may be, for example, standard commercial components, resulting in valuable manufacturing efficiency and reduced operating costs. In addition, a barrel cap 208 may be provided that may prevent or prevent the plunger assembly 212 from separating from the barrel 218 when the delivery syringe 200 is assembled. Barrel 218 or barrel cap 208 (as shown) may include finger flanges. The plunger assembly 212 can include a plunger rod 213 and a plunger 215. Plunger 215 may be integrated or connected to the distal end of plunger rod 213, such as by threaded engagement. The plunger 215 operates up and down with respect to the barrel 218 and can follow the plunger rod 213.

  As will be appreciated by those skilled in the art, barrel adapter 220 may be attached to syringe barrel 218 by any suitable coupling mechanism. For example, the barrel adapter 220 may be coupled to the syringe barrel 218 by a coupling structure, and the coupling structure may be separate from the barrel adapter 220 and the syringe barrel 218 components. It may be integral with 218. Further, the barrel adapter 220 may be coupled to the syringe barrel 218 during the syringe manufacturing process or just prior to use. By way of example only, the syringe adapter 220 may be coupled to the syringe barrel 218 by an interference fit, adhesive, snap fit assembly and / or screw fit assembly, etc. during the syringe manufacturing process. Alternatively, the syringe barrel 218 and barrel adapter 220 may include a mating thread or luer lock mechanism so that, for example, the barrel adapter 220 may be coupled to the syringe barrel 218 immediately prior to use. In at least one embodiment of the present invention, the barrel adapter may be connected to the barrel by a screw fit assembly, both the barrel adapter and the barrel having corresponding male and female thread pitches or components. In another embodiment, one or more coupling structures such as adapter collar 233 may be provided to couple barrel adapter 220 to barrel 218. One or more O-rings 236 may be provided for placement between the barrel adapter 220 and the barrel.

  Barrel adapter 220 facilitates attachment of needle 201 to syringe barrel 218. The barrel adapter 220 includes a barrel tip 232 and a needle retraction mechanism 211. Needle retraction mechanism 211 includes actuator subassembly 210 (shown in FIGS. 15A and 15B), needle subassembly 221, internal and external biasing members 240, 241 and biasing members 240, 241 in the biased position. And an actuable locking mechanism arranged to maintain. The barrel tip 232 typically becomes the distal end of the syringe 200 when coupled to the syringe barrel 218, and the needle 201 extends into the distal end of the barrel tip 232 during drug injection. As will be described in more detail below, the barrel tip 232 may further include a structure that forms a portion of the needle retraction mechanism 211 such as the sleeve 250.

  As shown in FIGS. 15A and 15B, the needle subassembly 221 includes a needle overmolded portion (“NOM”) 222, a needle 201, and a needle hub 216. As shown in FIG. 15A, the proximal end 229 of the needle 201 is located within the center of the needle hub 216 and the needle hub is positioned such that upward movement of the NOM causes upward movement of the needle hub relative to the barrel 218. Located adjacent the proximal end 223 of the NOM 222. In some embodiments, the proximal end 223 of the NOM 222 can be connected to the needle hub 216. The NOM 222 can be molded onto the needle 201, can be attached by gluing, can be co-molded, or can be attached to the needle in some manner, mounted or fixed. Alternatively, NOM 222 may be a form of needle 201, as will be readily appreciated by those skilled in the mechanical arts.

  Barrel adapter 220 also includes an operable locking mechanism. The actuatable locking mechanism is arranged to maintain the internal and external biasing members 240, 241 in the biased position until actuated by the actuator subassembly 210 to retract the needle 201. The actuatable locking mechanism includes, in part, a releasable coupling between the NOM 222 and the NOM retainer 224. When assembled as shown in FIGS. 15A and 15B, the NOM 222 fits substantially within the center of the NOM retainer 224 and within the center of the barrel tip 232. In the embodiment shown in FIG. 15A, the NOM retainer 224 is a barrel, such as at the engagement between the sleeve arm 250A and the engagement surface 224A formed by the engagement orifice 225 in the NOM retainer 224. You may engage with the sleeve 250 of the front-end | tip part 232 so that attachment or detachment is possible. The sleeve arm 250A includes a cammed surface that allows the sleeve 250 to be inserted into the end of the NOM retainer 224 and allows the sleeve arm 250A to snap into place within the engagement orifice 225. obtain.

  The NOM 222 and the NOM retainer 224 are shown in an exploded configuration in FIGS. 16A, 16B, and 16C. It will be appreciated that the needle 201 itself is not shown in FIGS. 16A-16C. In the illustrated embodiment, the internal and external biasing members 240, 241 (omitted for clarity in FIGS. 16A-16C) are sandwiched between the retainer protrusion 230 and the NOM protrusion 231. The embodiment of FIGS. 14 and 15 includes both an internal and an external biasing member, but in some embodiments, either a single biasing member or a further biasing member can be used. It should be understood that it is considered. The NOM 222 is centered in the NOM retainer 224 so that at least one retainer arm 234 snaps into place and engages the NOM shelf 235 contained on the NOM 222 to form a releasable coupling of the locking mechanism. Configured to be accepted. The retainer arm 234 can be generally biased inward to maintain engagement with the NOM shelf 235. Contact between the NOM shelf 235 and the retainer arm 234 prevents the NOM 222 from moving upward, and maintains the biasing members 240 and 241 in the biased position. Referring to FIG. 15B, as shown, when the NOM 222 is in place and in the biased position, the sleeve 250 of the barrel tip 232 engages the NOM notch 238 and the NOM and needle 201 for the barrel tip 232. Is prevented from moving further downward. As described further below, the locking mechanism may remain in the biased position until actuated.

  Returning now to FIGS. 15A-15B, the actuator subassembly 210 is arranged to actuate an actuable locking mechanism, de-energize the biasing members 240, 241 and retract the needle 201. In the illustrated embodiment, the actuator subassembly 210 includes a stylet disk 214, a stylet 254, at least one prong 242, and a NOM holder 224. The illustrated embodiment includes a pair of prongs 242 extending from the plunger 215. In this way, plunger 215 functions as a prong retainer and prong 242 moves axially with plunger 215. However, as long as the prong 242 is arranged to move longitudinally distally by depression of the plunger 215, the prong 242 may extend from a separate base that is engaged by the plunger 215 or fixed to the plunger 215. It will be understood that it is good.

  The prong 242 is slidably disposed with respect to the needle hub 216 and the prong working end 243 extends to the center of the NOM retainer 224 and engages the interior portion of the retainer arm 234. A cam can be attached to the working end 243 of the prong 242 to smoothly engage the internal portion of the retainer arm 234.

  Similar to the embodiment described above with respect to FIG. 3, the syringe 200 and barrel adapter 220 shown in FIGS. 14-16 may be used for delivery of the implant. As shown in FIG. 15B, the needle hub 216 has an aperture 227 that functions as a passage in its center (eg, substantially at the longitudinal axis of these components and the barrel). This aperture 227 is with or without the needle hub 216 so that the needle 201 is held in place within the needle hub 216 during the initial injection phase and can be axially translated proximally upon actuation of the retracting mechanism. Without, it may have a diameter equal to the outer diameter of the needle 201. With the needle 201 positioned in the aperture 227 through the needle hub 216, the proximal end 229 of the needle 201 exhibits a central lumen. In operation, the stylet 254 is disposed within the central lumen of the needle 201 and the implant to be implanted may be contained within the lumen of the needle 201 distal to the stylet 254. Thus, when the needle 201 enters the target (not shown), the needle 201 may be retracted axially on the stylet 254. In this way, the stylet 254 prevents the implant from retracting with the needle 201, leaving the implant in place within the target. If the stylet 254 extends beyond the barrel tip 232, the stylet 254 is also either with the needle 201 after implant positioning or separately from the needle 201 after the needle has retracted. It may be retracted from the target. Thus, according to aspects of the present invention, at least the needle 201 is retracted to perform the implant injection. According to another aspect, in some embodiments, the stylet 254 is similarly retracted after delivery of the implant.

  Referring now to FIG. 14A, the stylet disk 214 holds the proximal end 237 of the stylet 254 when the stylet distal end is positioned within the needle 201. The stylet 254 is held in the stylet disk 214 so that the stylet 254 follows such axial translation during the axial translation by the stylet disk relative to the barrel 218. Similarly, the proximal end of the prong 242 causes the prong 242 to move distally downward relative to the barrel 218 and actuator subassembly 210 as shown in FIGS. 14A and 14B during axial translation of the plunger 215. 239 is held in the plunger 215. Accordingly, actuation of actuator subassembly 210 is responsive to downward axial movement of plunger assembly 212 because the working end 243 of prong 242 engages the internal portion of retainer arm 234 of NOM retainer 224. The plunger 215 is moved in the axial direction downward. During actuation of the actuator subassembly 210, the working end 243 of the prong 242 moves the retainer arm 234 outward relative to the NOM 222. When the retainer arm 234 moves outward and away from the NOM shelf 235, the retainer arm is no longer engaged with the NOM shelf, and the NOM retainer 224 is driven by the force of the internal and external biasing members 240, 241 on the NOM 222. No longer prevent moving upwards. The biasing members 240, 241 force the NOM 222 to move upward relative to the NOM holder 224, so that the needle 201 retracts with the NOM to the distal end of the barrel tip 232.

  Similar to the embodiment described above with respect to FIGS. 13A-13D, the plug 127 (shown in FIGS. 13A-13D) is used to initially hold the implant in place on the distal tip of the needle 201. obtain. The plug may optionally be placed in addition to the placement of the implant. In some embodiments, as shown in FIG. 14A, when the plunger rod 213 is actuated toward the barrel 218, the plunger 215 pushes the stylet disc 214, causing the stylet disc and stylet 254 to move relative to the barrel 218. The stylet disk 214 is disposed immediately adjacent to the plunger 215 so as to translate downward. In such an embodiment, just before the actuator subassembly 210 is actuated, this slight downward axial movement of the stylet 254 translates the stylet downward relative to the needle 201. This slight downward movement of the stylet 254 may be sufficient to simply release the plug from the distal end of the needle 201, but not enough to release the implant from the needle. When the actuator subassembly 210 is activated and the NOM 222 and needle hub 216 are retracted axially into the barrel 218, the needle 201 is retracted around the stylet 254, which forces the stylet out of the needle. When the implant is placed out of the needle 201 and the biasing members 240, 241 press the needle hub 216 against the stylet disc 214, the stylet 254 may also retract relative to the barrel 218 and barrel tip 232. it can.

  Thus, in one aspect of the invention, the delivery system is activated by the user pressing the plunger rod 213 axially against the barrel 218. The depression of the plunger rod 213 causes a slight downward axial translation of the plunger 215 and the stylet disk 214. The downward movement of the stylet disc 214 causes the stylet 254 to translate axially within the needle 201 and push the plug from the distal end of the needle without pushing the implant out of the needle. As the plunger 215 continues its downward translation, the plunger pushes the prong 242 downward against the NOM retainer 224. The actuator end 243 of the prong 242 pushes the retainer arm 234 of the NOM retainer 224 outward, releasing the NOM 222 from retention. When the NOM 222 is released, the urging members 240 and 241 can move from the urging position to the erasing position, pushing the NOM 222 axially upward with respect to the NOM holder 224 and the barrel tip 232. The NOM 222 pushes the needle hub 216 and moves the needle hub upward, causing the distal end of the needle 201 to retract to the barrel tip 232. As the needle 201 retracts, the stylet 254 remains in place and pushes the implant out of the distal end of the needle. When the needle hub 216 contacts the stylet disk 214, the stylet disk 214 can be pushed upward and the stylet 254 can also be retracted into the barrel tip 232.

  Embodiments of the present invention also provide a configuration that allows the use of standard off-the-shelf components, thereby reducing overall manufacturing costs and simplifying the assembly process, often non- Avoid regulations associated with standard materials and components. For example, the barrel may be made from a particular plastic, glass, or any other material commonly used for medical grade products. One or more components of the present invention may also be a specific such as a polycarbonate plastic sold under the trade name “LEXAN ™” by SABIC Innovative Plastics located in Pittsfield, Massachusetts. It may be made of any plastic. Similarly, a specific elastomeric polymer or rubber such as a rubber product sold under the trade name “HELVOET” by Datwiller Pharma Packaging USA Inc. of Pennsacken, NJ is needle-sealed ( And may be used for components such as the plunger 215. As will be appreciated by those skilled in the art, various medical grade metal materials such as stainless steel may be used for the needle. These components, barrel adapter and delivery syringe may be shaped or sized in a variety of different configurations to meet the desired parameters. These components, barrel adapters and syringes may be assembled by a number of processes well known in the art and / or filled with implants. For example, the components of the present invention may be assembled using well-known adhesives or welding methods such as ultrasonic welding.

  The present invention provides a barrel adapter, a delivery system and component assemblies such as a retraction mechanism that provides needle retraction, a delivery syringe incorporating such a safety mechanism, a method of manufacturing such a delivery syringe, and methods of their use. To do. As mentioned above, the barrel adapter, delivery system, retraction mechanism and delivery syringe may be used in several different configurations. For example, as described above, the novel barrel adapter of the present invention is configured to mate with, attach to, or otherwise connect to the barrel, any of the components of the barrel adapter. It may be desirable to pre-form the barrel in the barrel. Such modifications are contemplated in the embodiments of the present invention and are encompassed by the embodiments of the present invention. As described in the above embodiments, a component may be a single component, an integral component, or a multipurpose component. In addition, as described herein, the interaction of needles 28, 201, stylets 54, 254, needle hubs 24, 216, stylet disks 52, 214, and prong base 50 and related components may be utilized. There are several different configurations that can use the novel needle retraction mechanism. Thus, similar to the example described above, the barrel adapter and delivery syringe of the present invention are within the scope of the present invention, while initiating drug implant delivery and actuating needle retraction in any number of configurations. It may be configured, modified and used. Thus, it is intended that the present invention cover modifications and variations of this invention provided they are within the scope of the appended claims and their equivalents.

  It will be understood that the foregoing description provides examples of the disclosed system and approach. However, it is contemplated that other implementations of the present disclosure may differ in details from the previous examples. All references to the present disclosure or examples thereof refer to the specific examples discussed at the time, and more generally do not imply a limitation on the scope of the disclosure. Any distinction or condemnation of a particular feature indicates a lack of suitability for that feature, but unless otherwise indicated, such is completely excluded from the scope of this disclosure. Not what you want.

  In connection with the description of the invention (especially in relation to the claims below), the terms “a” and “an” and “the”, and The use of “at least one”, as well as similar referents, is not specifically implyed herein or is intended to encompass both the singular and plural unless the context clearly dictates otherwise. Should. The use of the term “at least one” following a list of one or more articles (eg, “at least one of A and B”) is not otherwise suggested herein or must be clearly contradicted by context. For example, it should be taken to mean one article (A or B) selected from the listed articles, or any combination of two or more of the listed articles (A and B).

  Unless otherwise indicated herein, the description of a range of values herein serves only as a concise way of referring individually to each distinct value within that range, Separate values are incorporated herein as if they were individually listed herein. Any method described herein may be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.

Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

Claims (13)

A barrel adapter (220) for a delivery syringe (200) having a barrel (218) and a plunger assembly (212) adapted to move within said barrel;
A barrel tip (232) configured to sealingly engage the distal end of the barrel;
A needle retraction mechanism (211),
A needle subassembly (221) comprising a needle (201) and a needle overmold portion (222) through which the needle extends, wherein the needle comprises: The needle subassembly is disposed at least partially within the barrel tip, and the needle extends from the injection position where the needle extends from a distal end of the barrel tip. Or a needle subassembly (221) adapted to move to a retracted position disposed within at least one of said barrels;
A needle overmold holder (224) connected to the barrel tip, a stylet (254), a stylet disk (214) holding the proximal end of the stylet, and through the stylet disk And at least one prong (242) reaching the needle overmold retainer, wherein the at least one prong is responsive to movement of the plunger assembly within the barrel The stylet is slidable in an axial direction and is at least partially disposed within the needle lumen, and the stylet is disposed proximally and An actuator sub-unit that is spaced from the distal tip of the needle when the needle is in the injection position; And Nburi (210),
At least one biasing member (between the needle overmold part and the needle overmold part holder) for biasing the needle overmold part away from the needle overmold part holder; 240, 241), a needle retraction mechanism (211),
An actuable locking mechanism that maintains the at least one biasing member in a biased position when the locking mechanism is locked and that is biased when actuated by the actuator subassembly. Arranged to release and operable to move the at least one prong relative to the needle overmold retainer by depressing the plunger assembly, the at least one biasing member comprising: An actuable locking mechanism arranged to provide relative movement of the needle and stylet from an injection position to the retracted position.   The barrel adapter according to claim 1, wherein the locking mechanism includes a releasable coupling between the needle overmold part and the needle overmold part holder.   The releasable coupling is formed between at least one retainer arm (234) of the needle overmolded part retainer and a needle overmolded part shelf (235) of the needle overmolded part. Item 3. The barrel adapter according to Item 2.   The operating end (243) of the at least one prong is adapted to engage and disengage the at least one retainer arm from the needle overmold shelf in response to depression of the plunger assembly. The barrel adapter according to claim 3, which is configured as follows.   The barrel adapter of claim 4 further comprising two prongs and two retainer arms.   The barrel adapter according to any one of the preceding claims, wherein a proximal end (237) of the at least one prong is disposed within the plunger assembly.   The stylet disk is such that the depression of the plunger assembly causes an initial axial movement of the stylet within the needle lumen before the depression of the plunger assembly causes the actuation of the locking mechanism. A barrel adapter according to any preceding claim, disposed adjacent to the plunger assembly.   The needle lumen is configured to receive an implant (129) and a plug (127) disposed distal to the implant, wherein the stylet disc is in the first axial direction of the stylet. 8. A barrel adapter according to claim 7, wherein movement is arranged to push the plug out of the needle without pushing the implant out of the needle.   The needle subassembly further includes a needle hub (216) disposed adjacent to the needle overmold portion, the needle hub configured to engage the stylet disc when the needle is retracted. The barrel adapter according to any one of claims 1 to 8.   The barrel adapter according to claim 1, wherein the needle is disposed in at least one of the barrel tip or the barrel when the needle is disposed in the retracted position.   11. An automatically retractable delivery syringe (200) comprising a barrel adapter according to any one of claims 1-10, comprising a barrel (218) and a plunger assembly configured to move within the barrel. (212) an automatically retractable delivery syringe. A method of assembling an automatic retractable delivery syringe according to claim 1 1,
Disposing the at least one biasing member between the needle overmold holder and the needle subassembly;
The needle overmold part is operably locked with the needle overmold part holder, and is an operable lock mechanism, and when the lock mechanism is locked, the at least one urging member, An actuable locking mechanism is formed that maintains the needle overmolded portion in the biased position biasing away from the needle overmolded portion retainer and releases the biasing member when actuated. Steps,
Positioning at least a portion of the needle subassembly within the barrel tip with the distal end of the needle extending through the barrel tip;
Placing the stylet extending from the stylet disc within the proximal end of the needle;
Positioning the at least one prong through at least one opening in the stylet disc with a distal end of the prong positioned proximal to the actuatable locking mechanism;
Positioning the plunger assembly for movement within the barrel;
Placing the at least one prong in the barrel for axial movement by the plunger;
Placing the stylet disk and the actuatable locking mechanism within the barrel and sealingly engaging the barrel tip with the distal end of the barrel.   The needle lumen is configured to receive an implant and a plug disposed distally of the implant, the method comprising: prior to depression of the plunger assembly causing the actuation of the locking mechanism; The stylet disc is moved so that the depression of the plunger assembly results in an initial axial movement of the stylet within the needle lumen that pushes the plug out of the needle without pushing the implant out of the needle. The method of claim 12, further comprising positioning adjacent to the plunger assembly.

Images