KR20190013854A - Accurate administration control mechanisms and drug delivery syringes - Google Patents

Abstract

The dosing control mechanisms 510 and 610 for the syringe include an engagement screw thread mechanism between the outer surface of the plungers 514 and 614 and the longitudinal extension channels 520D and 620D of the housings 520 and 620. The engagement screw threading mechanism includes at least one threaded segment 514B, 614B, and pitch guides 520C, 620C that include variable pitch threads. At least a portion of the longitudinally extending channels 520D and 620D of the housings 520 and 620 include one of pitch guides 520C and 620C and at least one threaded piece 514B and 614B and the plungers 514 and 614 Includes one of pitch guide portions 520C and 620C and at least one thread piece 514B and 614B. The plungers 514 and 614 are at least partially disposed within the housings 520 and 620 with at least one threaded piece 514B and 614B associated with the pitch guides 520C and 620C. Accurate dosing drug delivery syringes 500 and 600 may include such dosage control mechanisms 510 and 610, bodies 540 and 640, plunger seals 536 and 636 and body end 452 and needle 454 And a body adapter assembly 450. The syringes 500, 600 may be a filled syringe, a pre-filled syringe, or a safety syringe incorporating a needle retraction or needle shielding safety feature, or a combination thereof, at the time of use. Assembly, fabrication and operation methods are similarly disclosed.

Description

Accurate administration control mechanisms and drug delivery syringes

The present invention relates to a precisely administered drug delivery syringe. More particularly, the invention relates to precise dosing control mechanisms, drug delivery syringes containing such control mechanisms, methods of operation of such devices, and methods of assembling such devices.

In a variety of studies, the dosing method used by the medical practitioner, the ability to accurately read and control the plunger movement during administration, and the dose associated with the prime step used to evacuate air from the syringe prior to the dosing step It has been confirmed that the accuracy of delivery is affected by many factors, including loss. This effect is particularly enhanced by the use of a drug delivery syringe with a large dose volume to axial translation rate (i. E., As in the case of a large diameter syringe, even with a continuation of a small distance of plunger depression Even when a significant amount of drug is dispensed); This problem is more severe when delivering microliter doses. Although the cause of this error is common, accurate dosing syringes are still required. Such syringes are particularly important in sensitive surgery, such as in sensitive intravitreal injections, and may be highly desirable in small administration treatments where incorrect administration can lead to serious errors and potential patient injury.

In the study, the amount of therapeutic delivered was determined by whether the healthcare practitioner selected to deliver 5 μL (5 microliters) of the therapeutic by depressing the syringe plunger from 10 μL to 5 μL or by pressing the syringe from 5 μL to 0 μL It was confirmed that it can be considerably different depending on whether or not it is. In addition, due to the uncertainty of the plunger motion limit, some practitioners can push the syringe past normal exercise limits and deliver excess treatment to the patient, due to mechanical compliance between the stop and the syringe body. For example, given a special syringe torso diameter, a worker can push the plunger beyond the normal stop for 0 μL and misdeliver more doses up to 20% than needed. These errors are magnified due to the low dosage volume requirements for particular therapeutic agents. Because of the small dose and associated plunger movement distance, it is very difficult for the practitioner to gauge the filling of the dosing chamber and to control the dosage when the therapeutic is applied to the patient. The inaccuracy of such administration can result in significant safety-related risks, including increased pressure in the target area and altered (reduced) drug efficacy, among other adverse effects.

The primary cause of dose inaccuracy is the inability to reliably set the plunger motion limit and the inherent variability in the degree to which the plunger seal (or stop) is depressed at the end of delivery during administration. Also, during the manufacture of the syringe, the potential variability in placing the reference marking on the syringe body contributes to the inaccuracy. What is unique to the cause of such inaccuracy is the large sensitivity of the dispensed volume to the axial movement of the plunger, as described above. However, mechanical motion limits are difficult to use in such applications because of the difficulties associated with the user reading and controlling the plunger motion at short dosing distances. Briefly, since the dose is too small, it is difficult for the practitioner to identify the dose measurement in the syringe body and to accurately control the plunger push and dose during injection.

In addition to improving dosing accuracy, it is useful to include in the syringe design the function of the priming step to reduce or eliminate bubbles in the administration chamber. These steps are very useful for minimizing safety hazards, improving surgical hygiene, and reducing pressure within the target site. Minimizing the possibility of bubbling during filling helps to streamline the clinician's drug delivery process. Using pre-filled syringes can help minimize bubbles. However, even in pre-filled syringes, there is no complete trapped air during the filling process.

Thus, a syringe that allows the user to easily identify and control the dose, minimize the presence of bubbles in the dose chamber prior to drug delivery, and ensure the correct delivery of the required drug administration It is quite necessary. With such a syringe, it is desirable that the pre-filling be able to take advantage of the benefits associated with the use of such a product.

In addition, some medications require prior mixing of the two fluids or reconstitution of the dried or lyophilized drug prior to precise dosing. This allows, for example, the diluent to be added to the dehydrated, lyophilized, dried or powdered active material just prior to injection, Lt; / RTI > It also enables the mixing of two liquids to be mixed immediately before injection.

Although it is known to provide a syringe containing a mixing device for mixing deliverable materials prior to injection, such mixed syringes as described above are not commercially available, as they can provide the exact dosage delivery required in some drug treatments. Examples of such mixed syringes are disclosed, for example, in U.S. Patent Application No. 13 / 566,079, assigned to the assignee of the present disclosure and incorporated by reference. In addition to the complexity of its structure, such a design may require complicated assembly, multiple operating steps by the user, or other special subtle differences that make fabrication, assembly or operation difficult. In addition, some mixed syringes must also address factors such as maintenance of container sterility, interaction of components for sealing, ventilation requirements, and distribution of internal forces. Each of these overcomes is further complicated when very high dosing accuracy is required.

The present invention provides an administration control mechanism that enables precise administration and delivery of a drug therapeutic agent, and a drug delivery syringe that includes such a control mechanism. Such a new device allows for identification and control of dosage within a device size similar to the commonly used conventional syringe available on the market and allows the syringe to be "primed" (i.e., To be exhausted), and ensures a precise delivery of a dose of microliter volume. Such new devices are safe and easy to use and aesthetically and ergonomically attractive to clinicians, without significantly altering the technology currently used by clinicians to administer injectable drugs. The novel apparatus of the present invention provides such desirable features without any problems associated with known prior art devices.

In a first embodiment, the present invention provides an administration control mechanism for a syringe. The control mechanism includes a plunger having a coarse pitch screw at the outer surface, a housing having a corresponding coarse pitch guide along the inner surface of the housing, a screw having a fine pitch thread to interface with the fine pitch nut of the adapter, Has an internal annular space in which the screw is at least partially disposed therein. The plunger with coarse pitch can be rotated on the corresponding coarse pitch guide and at least a portion of the plunger is rotatably keyed to and interfaces with the corresponding rotatable keyed portion of the screw. The pitch ratio between the coarse pitch screw and the fine pitch screw is from about 1: 1 to about 20: 1, more specifically from about 2: 1 to about 10: 1, more preferably from about 4: 1 to about 8: 1. In the preferred embodiment, the pitch ratio of coarse pitch screw 14B to fine pitch screw 30B is about 4: 1. The screw may further comprise a screw connection aspect and, optionally, a ring operable to connect the screw directly to the plunger seal or to the plunger rod. In at least one embodiment, the housing has a window that allows the user to see the housing cover at its proximal end and the position of the plunger in the housing. The plunger may have one or more dose markings on the outer surface of the plunger and the housing may have one or more guide markings used to align the plunger dose markings. In use by the user, the plunger translates in a first distance (D1) in the axial direction to translate the screw in a second distance (D2) in the axial direction, and D1 is always D2 Lt; / RTI >

In a second embodiment, the present invention provides a precisely administered drug delivery syringe having an administration control mechanism, a torso, a plunger seal, and a torso adapter assembly having a torso tip and a needle. Such a syringe may further include a plunger rod connected to the screw at one end and connected to the plunger seal at the other end. The syringe may be a use-in-fill syringe, a pre-filled syringe, or a safety syringe, or a combination thereof. The housing of the syringe may have a housing, located at its proximal end, for protecting the medial side of the housing from the environment, and a window that allows the user to see the position of the plunger in the housing. The plunger may have one or more dosing markings on the outer surface of the plunger and the housing may have one or more guiding markings in the window, which are used to align the plunger dosing markings. In use by the user, the plunger translates in a first distance (D3) in the axial direction, causing the threads to translate in the axial direction at a second distance (D4).

The dosage control mechanism may also be designed to provide the desired axial movement of the screw relative to the axial movement of the plunger. In other words, the dosage control mechanism can be configured to provide the user with the desired feel by the plunger, while providing the desired axial movement of the screw and associated drug administration. In an embodiment, the plunger and the housing are coupled together by a variable pitch screw. The pitch may vary over the length of the movement of the plunger relative to the housing, or such movement may include two or more distinct or transitional pitches. However, in any case, the variable pitch will provide at least two pitches.

In an embodiment, for example, the housing includes at least one variable pitch thread along its inner diameter, and the plunger includes at least one thread segment disposed to engage a variable pitch thread of the housing. According to a preferred embodiment, the variable pitch thread of the housing comprises a fine pitch thread toward its proximal end and a coarse pitch thread toward its distal end. Thus, when the user applies a substantially constant speed plunger motion when the plunger is pressed, as the threaded piece of the plunger moves along the fine pitch, the plunger and key engagement screw are rotated at the first speed, The keyed engagement screw will be rotated at a slower speed because the threaded piece of the plunger engages the coarse thread disposed toward the distal end of the housing. In this way, by using a variable pitch screw connection between the plunger and the housing, the rotation of the plunger and associated screw can be configured for a wide range of rotational speeds and, hence, axial movement of the screw.

While the fine portion of the variable pitch thread may have a 1: 1 pitch ratio with the thread of the adapter, the coarse portion of the variable pitch thread may have a ratio of about 20: 1 or less to the thread of the adapter as described above.

Variable pitch threading can provide many advantages. For example, the syringe may be configured to be filled in use. The variable pitch can cause the syringe to fill more quickly.

The housing may be provided with one or more components. By way of example only, the housing may include two or more housing sections that include threads of respective pitches, which may provide advantages with respect to the manufacturing process. As a further example, the housing may include a lower housing section having a coarse pitch and an upper housing section having a fine pitch. The components of the housing can be assembled by any suitable coupling mechanism, including, but not limited to, spin welding, adhesive, or coupling structure such as a thread or engagement latch, or the like.

In another embodiment, the administration control mechanism further comprises a housing comprising first and second housing sections that are moveable relative to one another. For example, a second housing section may be disposed between the first housing section and the plunger. In such an embodiment, the second housing section includes internal threads, which may be constant pitches or variable pitches, configured to engage the external threaded segments of the plunger. The second housing section, in the first configuration, is configured to be axially translational relative to the first housing section. In a second configuration, the second housing section is fixed relative to the first housing section. As described below, this allows the syringe to be quickly filled and primed in a user-friendly manner, while providing precise dosing control during delivery.

According to one aspect of the present invention, there is provided a syringe comprising an administration control mechanism for syringes, such an administration control mechanism. One embodiment of such an administration control mechanism includes a housing, an adapter, a plunger, and a screw. The housing includes a longitudinally extending channel having a medial surface. The adapter includes a channel having fine pitch threads. The plunger having an outer surface and an axially extending channel; The axial extension channel includes a first key configuration. The screw includes a threaded outer surface including a second keyed portion along a proximal portion of the threaded outer surface. The proximal end of the screw is disposed at least partially within the axially extending channel of the plunger. At least a portion of the second key top portion is disposed in the axially extending channel of the plunger and engaged with the first key top portion for sliding movement such that rotational movement of the plunger causes rotational movement of the screw. The distal portion of the threaded outer surface includes a fine pitch thread thread disposed at least partially within and interfacing with the fine pitch thread of the adapter. A mating screw threading mechanism is provided between the plunger and the housing. The engagement screw threading mechanism includes at least one threaded segment, and a pitch guide comprising a variable pitch thread. Wherein at least a portion of the longitudinally extending channel of the housing comprises one of a pitch guide and at least one threaded segment and the plunger includes the other of the pitch guide and at least one threaded segment. The plunger is at least partially disposed within the housing with at least one threaded piece associated with the pitch guide. In at least one embodiment of the dosage control mechanism, the variable pitch threading comprises at least two different thread pitches. In at least an additional embodiment, the variable thread pitch is continuously varied along at least a portion of the variable thread pitch.

At least additional embodiments of such an injection control mechanism include a housing, an adapter, a plunger, and a screw, the housing having a longitudinally extending channel having a medial surface, the telescopically moving relative to each other between a retracted position and an extended position And at least a first housing section and a second housing section arranged to be positioned. The adapter includes a channel having fine pitch threads. The plunger having an outer surface and an axially extending channel; The axial extension channel includes a first key configuration. The proximal end of the screw is disposed at least partially within the axially extending channel of the plunger. The screw has a threaded outer surface that includes a second keyed portion along the proximal portion. At least a portion of the second key top portion is disposed in the axially extending channel of the plunger and engaged with the first key top portion for sliding movement such that rotational movement of the plunger causes rotational movement of the screw. The distal portion of the threaded outer surface includes a fine pitch thread thread disposed at least partially within and interfacing with the fine pitch thread of the adapter. A mating screw threading mechanism is provided between the outer surface of the plunger and the housing. The engagement threaded threading mechanism includes at least one threaded segment, and a pitch guide comprising threads. Wherein at least a portion of the longitudinally extending channel of the housing comprises one of a pitch guide and at least one threaded segment; The plunger includes a pitch guide and at least one other threaded piece. The plunger is at least partially disposed within the housing with at least one threaded piece associated with the pitch guide. According to at least one embodiment, the first housing section and the second housing section are arranged to be moved between the retracted position and the primed position. According to at least one embodiment, as the first and second housing sections are telescopically moved relative to each other between the retracted position and the extended position, rotational movement between the first and second housing sections is permitted.

Also, in at least one embodiment, the administration control mechanism comprises an administration feedback mechanism. The feedback mechanism may, for example, provide the user with tactile feedback on the identification of the desired delivery volume. When the user dials the plunger rod / screw to its desired dosage volume (i.e., when the user sets the desired microliter in the window), the user will feel a tactile notch or a stop-point, You will notice that you have to check to see if you have reached the volume. The feedback mechanism may include a number of volume-based detents, for example, to indicate when the syringe is at 20 microliters, 10 microliters, and 5 microliters delivered volume. In one embodiment, one or more clips may be attached to the housing to engage the plunger rod / screw at an axial position corresponding to one or more desired setpoint / stop points. The clip may have one or more radially inwardly extending prongs through the corresponding opening in the housing, for example, in the thread-threaded portion of the housing. The clip branches are configured to removably engage or contact one or more corresponding depressions, voids, openings, or the like in the plunger rod / screw. When the user rotates the plunger rod / screw in the axial direction to dial the desired delivery volume, the clip branches are in contact / engagement with the screw depression corresponding to the prescribed setpoint / stop point. The setpoint / stop point depressions are dimensioned to correspond to the amount of drug volume in the syringe for drug delivery, respectively. Thus, a plurality of clips including clip branches can be used to engage the housing through the plurality of openings, thereby being associated with the plunger rod / screw at various setpoint depressions along the axial length of the plunger rod / screw One or more tactile feedback associated with the dialed dose volume in the syringe may be provided to the user. In other embodiments, the clip branches may be pre-formed and molded as radially inwardly shaped features on the housing.

In a further embodiment, a method of making a syringe having a control mechanism comprises the steps of: (i) mounting a torso adapter assembly to a distal end of a syringe body; (ii) mounting the plunger seal through the proximal end of the syringe body; And (iii) mounting a control mechanism to the proximal end of the syringe body, wherein the control mechanism may be placed in contact with the plunger seal. The method may further include (ii) at least partially filling the torso with a fluid material prior to mounting the plunger seal through the proximal end of the syringe body. In at least one embodiment, the adapter is a two component adapter having a proximal adapter portion and a distal adapter portion. The proximal adapter portion has one or more connecting branches, the distal adapter portion has a corresponding connecting port, the connecting branch and the corresponding connecting port are mated, occluded, or otherwise connected when received together to form two Integrate the parts. Optional steps of filling steps (i) and (ii), and at least partly the body with the fluid material, may be performed in a sterile environment to maintain vessel integrity and sterility of the syringe.

The present invention further provides a method of assembling an administration control mechanism, a method of manufacturing a syringe having an administration control mechanism, and a method of operating such a mechanism and a syringe. Such novel devices and methods permit identification and control of dosage within a device size similar to the commonly used conventional syringes available on the market and allow the syringe to be "primed" , Bubbles to be evacuated), and ensures a precise delivery of a dose of microliter volume. Throughout this specification, where not otherwise indicated, terms such as " comprise ", and "comprises" or " And the group of integers or integers as described herein may include one or more other unstated integers or groups of integers. As will be described in greater detail below, embodiments of the present invention may include one or more additional components that may be regarded as standard components in the medical device industry. It is to be understood that the components and embodiments including such components are included in the consideration of the present invention and are included within the scope and range of the present invention.

The following non-limiting embodiments of the invention are described herein with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A illustrates a side elevational view of a dosage control mechanism in accordance with at least one embodiment of the present invention.
1B shows a cross-sectional view at a plane ("B") perpendicular to the axis ("A") of the dosage control mechanism of FIG. 1A.
Figure 2 (a) shows a cross-sectional view of the dosage control mechanism shown in Figure 1a, in which the components can be seen in an injection-ready stage of operation.
Figure 2 (b) shows a cross-sectional view of the dosage control mechanism shown in Figure Ia, in which the components can be seen in the dose-ending stage of operation.
Figure 3a shows an exploded view, broken down along the axis ("A") of the dosage control mechanism shown in Figure 1a.
Figure 3B shows a cross-sectional exploded view, broken down along the axis ("A") of the dosage control mechanism shown in Figure 1A.
Figure 4A shows an isometric view of a drug delivery syringe comprising an administration control mechanism, according to a second embodiment of the present invention.
Figure 4b shows an enlarged isometric view of the distal portion of the drug delivery syringe shown in Figure 4a.
Figure 5A shows an isometric view of another drug delivery syringe, including an administration control mechanism, in accordance with another embodiment of the present invention.
Figure 5b shows an enlarged isometric view of the distal portion of the drug delivery syringe shown in Figure 5a.
6A shows an isometric view of another drug delivery syringe comprising an administration control mechanism, in accordance with another embodiment of the present invention.
Figure 6b shows an enlarged isometric view of the distal portion of the drug delivery syringe shown in Figure 6a.
Figure 7 (a) shows an isometric view of an initial assembly stage of a pre-filled drug delivery syringe comprising an administration control mechanism, in accordance with at least one embodiment of the present invention.
Figure 7 (b) shows an isometric view of the pre-filled drug delivery syringe shown in Figure 7 (a) after assembly.
Figure 7 (c) shows an isometric view of the pre-filled drug delivery syringe shown in Figure 7 (a) at the injection-preparation stage of operation.
Figure 7 (d) shows an isometric view of the pre-filled drug delivery syringe shown in Figure 7 (a) at the dosing-end stage of operation.
Figure 8a shows a cross-sectional view of an alternative design of an administration control mechanism such that the components can be seen in an injection-ready stage of operation.
Figure 8b shows a cross-sectional view of the dosage control mechanism shown in Figure 8a, in which the components can be seen in an injection-ready stage of operation.
Figure 8c shows a cross-sectional view of the dosage control mechanism shown in Figure 8a, in which the components can be seen in the dose-ending stage of operation.
Figure 9a shows an exploded view, broken down along the longitudinal axis of the dosage control mechanism shown in Figures 8a-8c.
Figure 9B shows a cross-sectional exploded view, broken down along the longitudinal axis of the dosage control mechanism shown in Figures 8A-8C.
10A is a cross-sectional view of a syringe including another embodiment of a dosage control mechanism in accordance with the present invention, wherein the housing is shown in an extended position;
10B is a side elevational view of the syringe of FIG. 10A.
Figure 10C is a cross-sectional view of the syringe of Figures 10A and 10B at the primed position.
10D is a side elevational view of the syringe of Figs. 10A and 10B at the position shown in Fig.
10E is a cross-sectional view of the syringe of Figures 10A-10D at transfer completion.
10f is a side elevational view of the syringe of Figs. 10a-10d at the position shown in Fig. 10e.
11A is an exploded view of the dosage control mechanism of Figs. 10A-10F, broken down along its longitudinal axis.
11B is a cross-sectional exploded view of the dosage control mechanism shown in Figs. 10A-11A, broken down along the longitudinal axis.
12A is a side elevational view of another embodiment of an administration control mechanism according to the present invention, wherein the housing is shown in the retracted position.
Figure 12B is a side elevational view of the dosage control mechanism of Figure 12A, with the housing shown in an extended position.
Figure 12C is a side elevational view of the dosage control mechanism of Figures 12A and 12B at the primed position.
12D is a side elevational view of the dosage control mechanism of Figs. 12A-12C at the transfer ready position; Fig.
Figure 12E is a side elevation view of the dosage control mechanism of Figures 12A-12D during delivery.
Figure 13A is a partially enlarged view of the engagement portion of the first and second housing sections of Figures 12A-12F in the retracted position shown in Figure 12A, wherein the first housing section is shown partially transparent to show the internal structure. Isometric angle.
Figure 13b shows an enlarged view of an engagement portion of the first and second housing sections of Figures 12a-12f in an extended position shown in Figure 12b, in which the first housing section is shown partially transparent, Isometric angle.
13C shows an enlarged view of an engaging portion of the first and second housing sections of Figs. 12A-12F in the transmission position shown in Fig. 12E, in which the first housing section is shown partially transparent, Isometric angle.
Figure 14 is an enlarged isometric view of a second housing section of the embodiment of Figures 12A-13C.
15 is an enlarged partial cross-sectional view of an embodiment of a coupling structure between a first housing section and a second housing section in accordance with an embodiment of the present invention.
16A is a side elevational view of a syringe including an administration control mechanism according to another embodiment of the present invention including a tactile feedback feature.
16B is a side elevational, partial cross-sectional view of the syringe of FIG. 16B partially cut away to show the tactile feedback feature.
16C is an enlarged view of the cross section of FIG. 16B.

As used herein, the term "axial" or "in the axial direction" generally refers to the direction of motion of the drug delivery syringe, Refers to a longitudinal axis ("A ") in which the control mechanism and the syringe are preferably disposed about, although not necessarily symmetrical around. The term "radial direction " generally refers to a direction perpendicular to the axis (" A "). The terms "proximal", "rearward", "rearward", "rearward", or "backward" generally refer to axial directions along the direction ("P"). The terms "distal", "forward", "forward", "pushed", or "forward" generally refer to axial directions along the direction ("D"). As used herein, the term "glass" generally refers to glass, including, but not limited to, certain non-reactive polymers such as cyclic olefin copolymers (COC), cyclic olefin polymers Reactive materials suitable for use in pharmaceutical grade applications that can be used as a non-reactive material. The term "plastic" may include both thermoplastic and thermoset polymers. The thermoplastic polymers can be re-softened to their original state by heat; The thermosetting polymer can not be softened again. As used herein, the term "plastic" typically includes also other components such as curing agents, fillers, reinforcing agents, colorants, and / or plasticizers, and may be formed or molded under heat and pressure, Mainly refers to moldable thermoplastic polymers such as polyethylene and polypropylene, or acrylic resins. As used herein, the term "plastic" refers to an application that is in direct contact with a therapeutic liquid, which may be degraded by substituents that can interact with the plastic or otherwise enter the liquid from the plastic Non-reactive polymer or elastomer for use in the process of the present invention. The term "elastomer "," elastomeric material ", or "elastomeric material ", although more readily deformable than plastic, is intended for use with medicinal grade fluids, Refers to cross-linked thermoset rubber polymers that are not readily susceptible to movement. "Fluid" refers primarily to a liquid, although such terms may also include a solid that is dispersed in a liquid, and a suspension of gas dissolved in or otherwise co-present in the liquid inside the fluid-containing portion of the syringe. In accordance with various aspects and embodiments described herein, reference is made, for example, in the context of one or more biasing members for retraction of a needle or needle assembly, "biasing member ". It will be appreciated that the biasing member may be any member capable of storing and emitting energy. Non-limiting examples include, for example, a coiled spring, a compression or extension spring, a torsion spring, and a spring such as a leaf spring, an elastically compressible or elastic band, or any other member of similar function. In at least one embodiment of the invention, the biasing member is a spring, preferably a compression spring.

The novel apparatus of the present invention provides an administration control mechanism that enables precise administration and delivery of a drug therapeutic agent, and a drug delivery syringe that includes such a control mechanism. Such devices are safe and easy to use, aesthetically and ergonomically attractive to clinicians. The apparatus described herein includes a feature that allows an untrained user to simply activate, operate, and lock-out the device. The novel apparatus of the present invention provides such desirable features without any problems associated with known prior art devices. Specific non-limiting embodiments of novel delivery control mechanisms, drug delivery syringes, and their respective components are further described herein with reference to the accompanying drawings.

In a variety of studies, it has been found that the accuracy of delivery of a dose with a conventional syringe is affected by a number of factors, including the inability to accurately read and control plunger movement during administration. The use of a conventional drug delivery syringe with a large dose volume versus axial translation rate (i. E., A significant amount of drug, even in the case of a plunger push, even at a small distance, as can occur in the case of large diameter syringes) Distributed) significantly extends this inaccuracy. With the growth of high-cost, small-volume drug therapies entering the market, it is becoming increasingly important to accurately administer and deliver such small-volume therapeutics to patients. Embodiments of the present invention overcome the challenges faced by the use of conventional syringes for administering and delivering small-volume therapeutics, by using novel dosing control mechanisms. As further described herein, the novel administration control mechanism allows the user to accurately read and administer the desired volume of drug treatment for delivery to the patient. Such an arrangement allows the user to have a normal range of motion of the thumb, as can be expected in a conventional syringe, but the range of such motion of the thumb is very limited (e.g., smaller or incremental) To the range of motion of the plunger seal. This relationship allows a user to use a syringe without the need for additional training, but with significant advantages of incremental, small-volume dosing control.

1A illustrates an embodiment of a novel dosing control mechanism for a syringe, in accordance with at least one embodiment of the present invention. The control mechanism 10 includes a plunger 14, a housing 20, an adapter 18, and a screw 30. The plunger 14 may include a button 12 as an integrated or discrete component. For example, the button 12 may be a preformed feature located at the proximal end of the plunger 14. Alternatively, the button 12 may be a separate component that is attached to the proximal end of the plunger 14 by a snap-fit. In a preferred embodiment, the button 12 may be attached to the plunger 14 such that it is freely rotatable axially from the plunger 14, but rotatably secured to the user / clinician's finger. Regardless of the particular configuration and relationship of the button 12 and the plunger 14, the button 12 may include a user interface surface for contact and control by the user (e.g., using a user's thumb or fingertip tip) (12A).

The housing 20 has a substantially cylindrical axial passage through which a substantially cylindrical plunger 14 may be at least partially disposed therein. The distal end of the housing 20 is connected to the proximal portion of the adapter 18 and / or is partially located therein. The proximal and distal portions of the adapter 18 can be separated by an adapter flange 18A that can serve as an additional finger flange for use by a user. The internal shape of this component will be described in more detail herein with reference to Figs. 1B, 2 (A), 2 (B) and 3 (B). Screws 32 may be at least partially disposed within the housing 20 and the plunger 14 and extend distally beyond the flange 18. The screw 30 may have a threaded connection 30A configuration and, optionally, a ring 32, thereby helping to integrate the control mechanism into the drug delivery syringe and centering the plunger rod.

The housing 20 can be used to close the inner portion of the housing 20 from the environment, for example, and / or to axially align the plunger 14 within the housing 20 and by acting as a mechanical stop To prevent removal of the plunger rod, the housing cover 16 may optionally be included at its proximal end. The housing 20 may further include a window 20A, which may be an opening (e.g., an opening) in the housing or may be a transmissive or translucent component. Regardless of the particular configuration of the window 20A, its primary purpose is to allow the user to view the position of the plunger 14 within the housing 20. [ The plunger 14 may include one or more dose markings 14A on the outer surface of the plunger 14. The housing 20 may have at least one reference or guide marking 20B, for example in the window 20A, which is used to align the plunger dose marking 14A. The plunger dose marking 14A may correspond to the relevant dose required by the user. By using the respective plunger and housing markings, as described further herein, the user is able to control the volumetric dose to be delivered to the patient. In another embodiment, the window 20A may be covered by a lens, such as a transparent lens, which provides a visual magnification.

Figures 2 (a) and 2 (b) show a cross-sectional view of an administration control mechanism, in accordance with at least one embodiment of the present invention, in an injection-ready stage and an administration-termination stage, respectively. The cross-sectional view shows another specific aspect of the component within the mechanism. As shown, the plunger 14 has an internal annular space 14C in which the screw 30 is located at least partially inside. In at least one embodiment, the plunger 14 may be provided with a coarse pitch male thread 14B (visible in Figure 3A), such that the pitch on the guide 20C is equal to the pitch on the plunger threads 14B, (20C) on the inner surface of the inner tube (20). Likewise, in at least one embodiment, the screw 30 has a fine pitch 18B interfacing with the fine pitch nut 18B of the adapter 18 so that the pitch on the threaded thread 30B is equal to the pitch on the nut 18B. Thread 30B. 2 (a) and 2 (b), the proximal end 30C of the screw 30 and the jaw 18C of the adapter 18 can be identified. The plunger 14 with coarse pitch 14B is provided with a corresponding (e.g., "female") coarse pitch guide 20C ). ≪ / RTI > The terms "male type" and "female type" are intended to describe corresponding and interfacing threads or surfaces and may be used interchangeably to describe corresponding features as may be readily understood in the art . The screw 30 having the fine pitch screw 30B is engaged with the female pitch fine pitch nut 18B of the adapter 18. [ Thus, the rotation of the plunger 14 results in an axial translational movement of the screw 30, and the resolution of the axial movement is determined by the pitch 30B.

Since the plunger 14 and the screw 30, each having a respective thread pitch, are rotatably key-engaged, the rotational translation of the plunger 14 causes the screw 30 to rotate and translate in the axial direction. The term "key-coupled" is used herein to refer to any number of internal features that removably or slidably couple two or more components (axially). For example, the plunger 14 may be a hollow cylindrical body having a spline design along at least a portion of the coarse pitch screw and inner surface in at least some portion of the outer surface. The spline design is configured to mate with and translate or relay rotation with respect to a complementary spline included in the proximal end of the screw 30. This spline design element ensures that the plunger 14 and the screw 30 are rotatably keyed. The splined or rotatably keyed configuration is formed at the proximal end 30C of the screw 30 of Figure 3a and in its corresponding spline or rotationally keyed configuration 14C in the annular space 14C of the plunger 14 of Figure 3b Together with the department, can be confirmed. The first component can be removably or slidably coupled to the second component in a manner that enables a rotatably keyed relationship and permits axial sliding, so that any number of corresponding features A "keyed" relationship may be entirely given between these components. Alternatively, such components having, for example, a cross or a plus sign, a horizon or minus sign, a star, or a semi-circular shape may be used as a key coupling with a corresponding component having an opposite shape in the inner annular space . 1B shows a cross-sectional view at a plane ("B") perpendicular to the axis ("A") of the dosage control mechanism of FIG. 1A. 1b, in at least one embodiment, the screw 30 has a cross or a plus sign shape in its vertical cross section that is keyed to the plunger 14. As shown in Fig. Such an arrangement or arrangement allows the two components to be rotatably key-engaged while allowing them to slide axially past each other. Both the screw 30 and the plunger 14 are located within the housing 20 at least partially and / or at some operating point.

The screw 30 can be tightened using a fine pitch nut 18B (or simply "nut") having the same fine pitch as the screw 30 and the rotational movement of the plunger 14 can be performed in the axial direction Translational motion. The pitch ratio of the coarse pitch to the fine pitch is determined by the degree or resolution of the axial movement of the screw 30, that is, the distance by which the screw 30 translates axially with respect to each rotation of the plunger 14 . As a result, the healthcare practitioner is provided with an easy operation which enables accurate reading and setting of the dosage. The pitch ratio can be set to enable "fine tuning " of the dose, which is particularly important in small-volume doses where variability is significantly affected by plunger movement.

During operation of the administration control mechanism, the user may rotate the plunger 14 axially or press the button 12 to control the desired dosage volume for injection into the patient. 3A and 3B, the axial rotation of the plunger 14 causes the coarse pitch screw 14B (visible in FIG. 3B) to move in the corresponding coarse pitch guide 20C of the housing 20 Let's exercise. This action causes the plunger 14 to translate axially in the distal direction thereby decreasing the volume of administration within the drug chamber, as will be described in greater detail herein. Due to the rotationally keyed interaction of the plunger 14 and the screw 30 in the annular space 14C, rotation of the plunger 14 causes the screw 30 to rotate and translate in the axial direction. However, due to the pitch ratio between the plunger 14 and the screw 30, each unit measure of the distal translational motion of the plunger 14 is a fractional of the distal screw 30 For example, smaller, more resolved translational motion. This has many advantages for precise control during delivery of small-volume administration. Primarily, the pitch ratio relationship allows the user to precisely control the desired administration and delivery of the drug treatment agent. This pitch ratio relationship also allows the user to operate the syringe in a conventional manner, for example, by pressing the plunger 14 at a perceivable distance, resulting in only a partial or small translation of the screw.

The novel administration control mechanism of the present invention also employs features that provide integrated and adjustable motion-range limits to ensure accurate delivery of small-volume drug therapies. This may include, for example, a feature that prevents variable pushing of the plunger seal (or stop) in the syringe (e. G., Prevents the plunger from "bottoming out" during drug delivery) . Specifically, the dosage control mechanism of the present invention utilizes a mechanical endpoint that is adjustably set for the range of axial motion of the plunger during drug delivery. Such limits may be predefined, i. E., Prior to use by a healthcare professional, integrated or fixed within the syringe configuration, or may be adjustable, i. E., Using an integrated dose setting mechanism, Can be variably controlled by a healthcare practitioner, or by a self-medication patient. Such a mechanical set point allows for a range of axial plunger motions, for example, associated with priming and dosing, but also prevents the user from variably depressing the plunger and plunger seals as part of the administration stroke, Can be prevented from hitting the floor in the administration chamber of the syringe. This new control mechanism greatly enhances the accuracy of administration delivered to the patient. Embodiments of the present invention also allow a user to prime the syringe to evacuate any residual air from the dosing chamber prior to delivering the dose to the patient. The priming step may be a constant amount or a variable amount depending on the composition of the small administration syringe and the variation of the amount of drug or liquid contained / filled in the administration chamber. The configuration of the novel syringe may allow the user to complete the priming step, while maintaining or enabling the ability of the syringe to deliver accurate and precise dosing to the patient.

As discussed above, the mechanical set point limit effectively serves to prevent the user from pressing the plunger and plunger seal variably, or to prevent such components from hitting the floor in the injection chamber of the syringe. This function improves the accuracy of the administration delivered to the patient because such function is prescribed to be delivered to the patient and reduces the variability of delivery delivery from the intended amount. By using the pitch ratio between the plunger 14 having the coarse pitch screw 14B and the screw 30 having the fine pitch screw 30B, the mechanical end point can be easily identified and set easily. For example, in one such embodiment, the pitch ratio between the coarse pitch and the fine pitch may be 4: 1, such that the rotatable "screwing" or rotation of the plunger 14, Which translates the plunger component axially 4 times farther than the axial translation of the plunger component. Thus, the practitioner is provided with a fairly easy operation because the practitioner can more accurately set the required dosage. Such a pitch ratio may range from 1: 1 to 20: 1, for example, as required to achieve the required accuracy of the small-volume dose. The "dialing-in" and "setting" can be aided by the above-described dose marking on the plunger and guidance marking on the housing.

When the user presses the button 12 to set the desired small-volume dose for injection and such a push rotates the plunger 14, the user will perform what is known in the art as the "priming step" . This priming step evacuates any residual bubbles trapped in the administration chamber during pre-filling (if present) from the administration chamber and primes the attached needle (or catheter or extension set) prior to delivery. After completing priming and setting dosing by pressing button 12, button 12 may be further depressed to hit the floor, thereby injecting the desired dose into the patient. In drug delivery delivery, the plunger 14 "bottoms" at the jaw 18C of the adapter 18 (as shown in Figure 2 (b)). Due to the pitch ratio between the plunger 14 and the screw 30, the plunger 14 moves in the distal direction (i.e., in the direction of the solid arrows in Figures 2 (a) and 2 (b) The screw 30 translates axially in the distal direction only a portion of the distance at which the plunger 14 is translationally moved. This difference in axial translational distance between the plunger 14 and the screw 30 can be ascertained by comparing the distance D2 with the distance D1 in Figures 2 (a) and 2 (b) . D1 is the distance that the plunger 14 translates in the axial direction while D2 is the incremental distance that the screw 30 translates in the axial direction. The difference in dimensions D1 and D2 also indicates the relative position of the plunger 14 when comparing the relative positions of the proximal end 30C of the screw 30 (compare Figures 2 (a) and 2 (b) Of the annular space 14C. Thus, the variable annular space 14C of the plunger 14 is associated with the mechanical set point required by the practitioner and provides space for translational motion of the screw 30 during the dose stroke.

In particular, the novel embodiments contemplated by the present invention effectively prevent the plunger seal from "hitting the floor" in the dosing chamber. This ensures that the amount of dosage administered to the patient is correct and minimizes user error by pre-eliminating one aspect of user variability in overdosage by over-depression of the plunger or under-depression of the plunger do. This is particularly important in small doses of the therapeutic agent where user-related errors can cause significant and undesirable fluctuations and inaccuracies in delivery of the drug to the patient. Embodiments in accordance with the present invention serve to prevent the occurrence of such and effectively eliminate administration errors associated with conventional syringe construction and delivery methods. Also, in this embodiment, the plunger push does not reverse-drive the screw.

The novel dosage control mechanism of the present invention can be integrated with a large number of drug delivery syringe configurations to provide users with accurate drug delivery capabilities. For example, the control mechanism may be used in combination with a filled syringe, a pre-filled syringe, or a safety syringe incorporating needle retraction or needle shielding safety features, or combinations thereof. In addition, the administration control mechanism according to the teachings of this disclosure can be used with a so-called mixed syringe, as well as with a conventional syringe. For example, the administration control mechanism may be incorporated into a syringe such as that disclosed in U.S. Patent Application No. 13 / 566,079, the entire disclosure of which is incorporated herein by reference.

An example of such a syringe containing a novel administration control mechanism is provided below. By using each plunger 14 and, optionally, the dose marking 14A and the guidance marking 20B, the user can control the volume dose in the syringe to deliver to the patient. The plunger dose marking 14A may correspond to the relevant dose required by the user. In order to identify and select the desired dose by aligning the desired dose marking 14A with the guide marking 20B, the user may use the plunger initially, e.g., by pressing a button in the axial direction or by rotating the plunger . The axial rotation of the plunger 14 causes the plunger 14 to translate axially in the distal direction and such movement is transmitted to the screw 30 by the mechanism described above. The axial translation of the screw 30 along the distal direction causes the drug fluid contained in the drug chamber of the syringe to be dispensed through the needle of the body adapter assembly. Once the desired dosage is identified and selected by the user, the remaining amount of drug fluid in the drug chamber is substantially the exact amount to be injected. The syringe can then be injected into the patient for drug delivery. After injection of the needle into the patient, the user may further depress the plunger 14 (and / or the button 12) axially in the distal direction to deliver drug administration. Due to the novel aspects of the present invention, including the aforementioned pitch ratio and mechanical stop mechanism, the accuracy of administration is finely controlled and the variability is reduced. In use, the plunger 14 and the screw 30 initially function in the reverse direction (e. G., Translate axially in the proximal direction) in the embodiment of the present invention intended for a filled syringe, Is withdrawn from the bottle or container and the drug chamber of the syringe is filled. In an embodiment of the present invention intended for retractable or safety syringes, the plunger 14 and the screw 30 serve to enable the needle retraction or safety mechanism to initiate or operate after substantially drug administration has been delivered. . In the following, such embodiments of the present invention will be described in more detail with reference to the accompanying drawings.

4A shows an embodiment of the dosage control delivery mechanism 10 as a component of a filled drug delivery syringe 100, i. E., A syringe that can be withdrawn reversibly by a user and filled with a drug treatment agent. As shown, the control mechanism 10 includes a plunger 14, a housing 20, an adapter 18, and a screw 30. As described above, the plunger 14 may include a button 12 as an integrated or discrete component. The housing 20 may be secured to the housing cover 20 at its proximal end, for example to close the interior of the housing 20 from the environment and / or to axially align the plunger 14 within the housing 20. [ 16 < / RTI > The housing 20 may further comprise a window 20A, which may be an opening (e.g., an opening) in the housing or may be a transmissive, translucent, and / or optically expanding component . The plunger 14 may include one or more dose markings 14A on the outer surface of the plunger 14. The housing 20 may have at least one reference or guide marking 20B, for example in the window 20A, which is used to align the plunger dose marking 14A. The control mechanism 10 may be attached, mounted, fixed, or otherwise connected to the proximal end of the body 140 such that at least a portion of the screw 30 is disposed inside the body 140.

Figure 4b shows an enlarged isometric view of the distal portion of the drug delivery syringe shown in Figure 4a. The screw 30 may be connected to the plunger seal 136 either directly or indirectly to drive axial translation of the plunger seal 136. In an indirectly connected configuration, a plunger rod 134 may be used between the screw 30 and the plunger seal 136 to connect these components. The plunger rod 134 can be connected to the screw 30, for example in the form of a threaded connection 30A. Optionally, the ring 32 near the distal end of the screw 30 may be used to assist in the connection of the screw 30, the plunger rod 134, and the plunger seal 136. The threaded connection 30A configuration and ring can be seen in Figures 2 (a), 2 (b), and 3 (b). In at least one embodiment, the threaded connection 30A configuration is connected to the plunger rod 134 through a radial opening in the plunger rod. Additionally or alternatively, such connections may be snap-fit connections, forced fit connections, or any number of other connection methods known in the industry. In at least one other embodiment, the threaded connection feature is connected to the plunger rod through the proximal opening in the plunger rod, such that the threaded connection feature is seated within the proximal pocket within the plunger rod. Preferably, the connection between the screw 30 and the plunger seal 136 or between the screw 30 and the plunger rod 134 (when the plunger rod is used) is such that the plunger rod and / or the plunger seal are rotationally fixed So that the screw can be rotated in the axial direction. When the plunger 14 and the screw 30 of the control mechanism 10 are rotated and translated in the axial direction such movement is relayed to the plunger seal 136 and the plunger seal is also rotated axially do.

The plunger 14 and the screw 30 will initially function in the reverse direction (e.g., translate axially in a proximal direction), and will move the drug fluid from the bottle or container And fills the drug chamber 138 of the syringe 100. As described above, the control mechanism 10 can then be used by the user to identify and select drug administration for delivery. The user can then inject the needle into the patient for drug delivery. The button 12 and / or the plunger 14 can then be pushed by the user to translate the plunger 14 and the screw 30 in the axial direction. Due to the function of the control mechanism and the pitch ratio, any dimension of the distal translational motion of the plunger 14 causes only an incremental dimension of the distal translation of the screw 30, allowing for precise delivery delivery control by the user . Axial translational movement of the screw 30 causes axial translation of the plunger seal 136. This axial movement along the distal direction of the plunger seal 136 may be accomplished by the use of the needle 154 of the body adapter assembly 150 and the drug chamber 138 of the body 140 for injection and delivery to the patient. Thereby urging the drug fluid to the outside.

Similarly, the novel control mechanism of the present invention can be used with a pre-filled syringe, i.e. a syringe filled with a drug treatment by the manufacturer and prepared for injection by the user. FIG. 5A illustrates an embodiment of an administration control mechanism 10 as a component of an exemplary pre-filled drug delivery injector 200. FIG. As shown, the control mechanism 10 includes a plunger 14, a housing 20, an adapter 18, and a screw 30. As described above, the plunger 14 may include a button 12 as an integrated or discrete component. The housing 20 may be configured to axially align the plunger 14 within the housing 20, for example, to close the medial side of the housing 20 from the environment, and / To prevent the plunger 14 from being accidentally removed, it may optionally include a housing cover 16 at its proximal end. The housing 20 may further include a window 20A, which may be an opening (e.g., an opening) in the housing or may be a transmissive or translucent component. The plunger 14 may include one or more dose markings 14A on the outer surface of the plunger 14. The housing 20 may have at least one reference or guide marking 20B, for example in the window 20A, used to align or observe the plunger dose marking 14A. The control mechanism 10 may be attached, mounted, fixed, or otherwise connected to the proximal end of the body 140 such that at least a portion of the screw 30 is disposed inside the body 140.

Figure 5b shows an enlarged isometric view of the distal portion of the drug delivery syringe shown in Figure 5a. The screw 30 may be connected to the plunger seal 236 either directly or indirectly to drive the axial translation of the plunger seal 236. In an indirectly connected configuration, a plunger rod 234 may be used between the screw 30 and the plunger seal 236 to connect these components. The plunger rod 234 may be connected to the screw 30, for example, in the form of a threaded connection 30A. In at least one embodiment, the threaded connection feature is connected to the plunger rod through the proximal opening in the plunger rod, such that the threaded connection feature is seated within the proximal pocket within the plunger rod. Additionally or alternatively, such connections may be snap-fit connections, forced fit connections, or any number of other connection methods known in the industry. In at least one embodiment, the screw, threaded connection portion, and plunger rod are configured such that the drug chamber is filled with the drug fluid and the plunger seal < RTI ID = 0.0 > And the plunger rod is inserted into the proximal end of the body. Preferably, the connection between the screw 30 and the plunger seal 236 or between the screw 30 and the plunger rod 234 (when the plunger rod is used) is such that the plunger rod and / or the plunger seal are rotationally fixed So that the screw can be rotated in the axial direction. When the plunger 14 and the screw 30 of the control mechanism 10 are rotated and translated in the axial direction such movement is relayed to the plunger seal 236 and the plunger seal is also rotated axially do. When used in a pre-filled syringe, the control mechanism 10 is generally attached to the body 240 after the drug chamber 238 of the body 240 is filled with the drug fluid. This is often required so that the syringe 200 can be filled and assembled in a standard medical fill-finish process line. Once the syringe 200 has been filled and assembled, the control mechanism 10 can be used by the user to identify and set the selected medication delivery for delivery. The user can then inject the needle into the patient for drug delivery. The button 12 and / or the plunger 14 can then be pushed by the user to translate the plunger 14 and the screw 30 in the axial direction. Due to the function of the control mechanism and the pitch ratio, any dimension of the distal translational motion of the plunger 14 causes only an incremental dimension of the distal translation of the screw 30, allowing for precise delivery delivery control by the user . The axial translation of the screw 30 causes an axial translation of the plunger seal 236. This axial movement along the distal direction of the plunger seal 236 may be accomplished by the needle 254 of the body adapter assembly 250 and the medicament chamber 238 of the body 240 for injection and delivery to the patient. Thereby urging the drug fluid to the outside.

In addition, the novel control mechanism of the present invention can be used with a safety syringe, such as a retractable needle safety syringe (i.e., a syringe including a needle safety mechanism). FIG. 6A illustrates an embodiment of an administration control mechanism 10 as a component of an exemplary retractable drug delivery syringe 300. As shown, the control mechanism 10 includes a plunger 14, a housing 20, an adapter 18, and a screw 30. As described above, the plunger 14 may include a button 12 as an integrated or discrete component. The housing 20 may be used to axially align the plunger 14 within the housing 20 and / or to allow the plunger 14 to be inadvertently placed in the housing 20, for example, to close the medial side of the housing 20 from the environment. To prevent removal, the housing cover 16 may optionally be included at its proximal end. The housing 20 may further include a window 20A that may be an opening (e.g., an opening) in the housing or may be a component that provides transmissive, translucent, and / have. The plunger 14 may include one or more dose markings 14A on the outer surface of the plunger 14. The housing 20 may have at least one reference or guide marking 20B, for example in the window 20A, used to align or observe the plunger dose marking 14A. The control mechanism 10 may be attached, mounted, fixed, or otherwise connected to the proximal end of the body 140 such that at least a portion of the screw 30 is disposed inside the body 140.

Figure 6b shows an enlarged isometric view of the distal portion of the drug delivery syringe shown in Figure 6a. The screw 30 may be connected to the plunger seal 336 either directly or indirectly to drive the axial translation of the plunger seal 336. In an indirectly connected configuration, a plunger rod 334 may be used between the screw 30 and the plunger seal 336 to connect these components. The plunger rod 334 may be connected to the screw 30, for example in the form of a threaded connection 30A. The screw connection configuration can be connected to the plunger rod in the configuration described above with reference to Figs. 4A and 4B, in the configuration described above with reference to Figs. 5A and 5B, or in many other connection methods known in the industry. Preferably, the connection between the screw 30 and the plunger seal 336 or between the screw 30 and the plunger rod 334 (when the plunger rod is used) is such that the plunger rod and / or the plunger seal are rotationally fixed So that the screw can be rotated in the axial direction. When the plunger 14 and the screw 30 of the control mechanism 10 are rotated and translated in the axial direction such movement is relayed to the plunger seal 336 and the plunger seal is also rotated axially do. The plunger 14 and the screw 30 may function to initiate or actuate a needle retraction or safety mechanism after substantially drug administration has been delivered.

When used within a safety syringe, such as a retractable needle safety syringe, the plunger 14 of the control mechanism 10 may activate or initiate the needle safety mechanism. Suitably, the needle safety mechanism may include a spring, such as a spring, an elastic or other member capable of storing and releasing energy, to assist any method of protecting the needle from retraction, needle shielding, Is assisted by a member. It will be appreciated that the safety syringe may include any needle safety mechanism, such as a needle retraction safety mechanism or a needle safety safety mechanism, which may be operated with the control mechanism and syringe disclosed herein. By way of example, a needle safety mechanism may be used to secure the needle retraction safety as described in non-limiting, International Publication WO2006 / 119570, International Publication WO2006 / 108243, International Publication WO2009 / 003234, International Publication WO2011 / 075760, Mechanism. In at least one embodiment of the present invention, the syringe 300 is a needle retraction safety syringe and includes a needle retraction safety mechanism 356 as disclosed in U.S. Patent No. 8,702,653.

Such a needle retraction safety mechanism 356 may be assembled to the syringe body 340 through the distal end of the body 340, e.g., as part of the body adapter assembly 350. The control mechanism 10 is generally attached to the body 340 after the drug chamber 338 of the body 340 is filled with the drug fluid. This is often required so that the syringe 300 can be filled and assembled in a standard medical fill-finish process line. Once the syringe 300 has been filled and assembled, the control mechanism 10 can be used by the user to identify and set up drug delivery for delivery. The user can then inject the needle into the patient for drug delivery. The button 12 and / or the plunger 14 can then be pushed by the user to translate the plunger 14 and the screw 30 in the axial direction. Due to the function of the control mechanism and the pitch ratio, any dimension of the distal translational motion of the plunger 14 causes only an incremental dimension of the distal translation of the screw 30, allowing for precise delivery delivery control by the user . Axial translational movement of the screw 30 causes axial translation of the plunger seal 336. This axial motion along the distal direction of the plunger seal 336 may be accomplished by the needle 354 of the body adapter assembly 350 and the drug chamber 338 of the body 340 for injection and delivery to the patient. Thereby urging the drug fluid to the outside. At the termination of drug delivery, the plunger seal 336 contacts the elements of the needle retraction safety mechanism 356 to initiate the retraction mechanism whereby the needle 354 retracts into the body 340 of the syringe 300 . Screws 30 and other components or control mechanisms 10 may be configured or adjusted to allow a range of these additional axial translational movements along the distal direction after delivery of the desired drug delivery. Subsequently, as the needle 354 is retracted into the body 340 of the syringe 300, the elements of the needle retraction safety mechanism 356 are placed against the plunger seal 356 in the proximal direction and push it. As such retraction forces continue, the user can controllably reduce the force they apply to the button 12 and / or the plunger 14 when the screw 30 and the plunger 14 are moved in the proximal direction, The retraction rate can be controlled. Accordingly, the needle retraction safety mechanism 356 provides a number of additional desirable features to the novel syringe of the present invention.

As will be readily appreciated by those skilled in the art, the trunk adapter assembly may be attached, mounted, fixed, or otherwise connected to the distal end of the torso by any number of known methods. For example, the body adapter assembly can be connected to the syringe body using a luer connection. The luer connection system is a standard way to attach syringes, catheters, hub-type needles, IV tubes, and others together. The Luer connections consist of a slightly tapered, conical / tubular male and female interlocking component to better maintain coexistence. The luer connection may be a "luer slip" as shown in Figs. 4A and 4B, which is a luer connection with a simple pressure or torsional pit; The luer connection may be "luer lock" as shown in Figs. 5A and 5B, which may have additional outer rims threaded to be more secure. Alternatively, the connection may be assisted by a trunk adapter connection. By way of example, the trunk adapter connection may be, but is not limited to, as described in International Publication No. WO2011 / 137488 and / or US Patent No. 8,702,653. While maintaining within the breadth and scope of the present invention, the trunk adapter assembly can be attached to the trunk using a luer connection, an interference fit connection, a trunk adapter connection, or any number of other known connections. Regardless of the type of body adapter assembly used, the body adapter assembly generally includes body end portions 152, 252, 352 and needles 154, 254, 354, respectively. In some configurations, the bodyside ends 152, 252, 352 may be pre-formed features located at the distal end of the body. Alternatively, the body distal end 152, 252, 352 may be a separate component attached to the distal end of the torso. Needles 154, 254, and 354 can be any type of fluid conduit, including, for example, a flexible cannula or a rigid needle, and can be made of any number of materials including stainless steel. The type of connection described herein can be used regardless of the type of syringe shown together. For clarity, the luer slip connection shown with the filled-in injector in the use of Figs. 4a and 4b may be used with the pre-filled syringe of Figs. 5a and 5b, or any other type of connection May be used with any other type of syringe described herein.

From the foregoing it will be appreciated that the novel dosage control mechanisms and syringes described herein provide an effective and easily operated system for precise administration setting and delivery of drug therapies. Such devices are safe and easy to use, aesthetically and ergonomically attractive to clinicians. Embodiments of the present invention overcome the challenges faced by the use of conventional syringes for administering and delivering small-volume therapeutics, by using novel dosing control mechanisms. The novel administration control mechanism allows the user to accurately read and administer the desired volume of drug treatment for delivery to the patient. Such an arrangement allows the user to have a normal range of motion of the thumb, as can be expected in a conventional syringe, but the range of such motion of the thumb is very limited (e.g., smaller or incremental) To the range of motion of the plunger seal. This relationship allows a user to use a syringe without the need for additional training, but with significant advantages of incremental, small-volume dosing control.

Assembly and / or fabrication of the control mechanism 10, the syringe 100, the syringe 200, or the syringe 300, or any individual component, may utilize any number of known materials and methods in the art. A number of known cleaning fluids, such as, for example, isopropyl alcohol and hexane, can be used to clean components and / or devices. A large number of known adhesives or glue may be similarly used in the manufacturing process. For example, to connect the distal end of the housing 20 to the proximal end of the adapter 18, glue or adhesive may be used. Similarly, glue or glue may be used to connect the distal end of the adapter 18 to the proximal end of the torso. Additionally, known siliconization fluids and processes can be used during the manufacture of the novel components and devices. Also, to ensure sterility of the final product, known sterilization processes may be used in one or more of the manufacturing or assembly stages.

In one embodiment, a method of assembling a control mechanism comprises:

(i) at least partially threading a fine pitch screw through a fine pitch nut of the adapter;

(ii) at least partially threading a coarse pitch screw on the outer surface and a plunger having an annular space in the inner surface through the inner axial passage of the housing, wherein the housing inner side has a corresponding coarse pitch guide;

(iii) inserting at least a proximal portion of the screw through the distal portion of the plunger into the annular space of the plunger; And

(iv) attaching the outer distal portion of the housing to the proximal portion of the adapter.

The plunger may also include a button at its proximal end. The button may be a pre-formed portion of the plunger, or it may be a separate component from the plunger. Preferably, the button is a separate component attached to the plunger, for example by a snap-fit. Similarly, the housing may include a housing cover at its proximal end. The housing cover may be a pre-formed portion of the housing, or it may be a separate component from the housing. As described above, one or more components of the control mechanism can be attached to each other using glue or adhesive. Alternatively, one or more components of the control mechanism may be an integrated component. For example, the housing may be a separate component attached to the adapter by glue, or the adapter may be a glue- Lt; RTI ID = 0.0 > distal < / RTI > Similarly, the housing cover may be attached to the housing by glue. These components can be sterilized separately or together and can be assembled in a sterile environment or sterilized after assembly. The body can be siliconized before or after assembly.

A control mechanism may be used as a component of the syringe. In one embodiment, a method of manufacturing a syringe including a control mechanism comprises:

(i) attaching the trunk adapter assembly to the distal end of the syringe body;

(ii) mounting the plunger seal through the proximal end of the syringe body; And

(iii) mounting a control mechanism to the proximal end of the syringe body, wherein the control mechanism can be placed in contact with the plunger seal.

Such a method may further comprise: (ii) prior to the step of mounting the plunger seal through the proximal end of the syringe body: at least partially filling the body with a fluid material. Step (iii) may further require indirectly connecting the threaded connection form of the screw of the control mechanism either directly to the plunger or through the plunger rod connected to the proximal end of the plunger seal. The connection between the plunger rod and the plunger seal can be any number of connections including, but not limited to, screw-type connection, snap-fit connection, interference fit connection, capture connection, . In at least one embodiment, the threaded connection feature is connected to the plunger rod through a radial opening or proximal opening in the plunger rod, such that the threaded connection feature is seated within the proximal pocket within the plunger rod. Additionally or alternatively, such connections may be snap-fit connections, forced fit connections, or any number of other connection methods known in the industry. Preferably, the connection between the screw and the plunger seal, or between the screw and the plunger rod (when the plunger rod is used) is such that the screw can be rotated axially while the plunger rod and / or the plunger seal are held rotatably fixed .

One preferred method of manufacturing a syringe having an administration control mechanism, according to one embodiment of the present invention, is described herein with reference to Figures 7 (a) to (d). 7A shows a pre-filled syringe, as described above with reference to Figs. 5A and 5B, and the adapter includes two components, a proximal adapter portion 418P and a distal adapter portion 418D, Lt; / RTI > The proximal adapter portion 418P has one or more connecting branches 418E and the distal adapter portion 418D has a corresponding connection port 418F. The connection branch 418E and the corresponding connection port 418F are merged, interlocked, or otherwise connected to integrate the two portions 418P, 418D of the adapter. Initially, the cap 460 may be connected to the distal end of the body 440 of the syringe 400. The distal adapter portion 418D can be slidably mounted on the outer side of the body. The medial side of the body 440, i. E. The medicament chamber 438, can be filled with the drug fluid or material through the open proximal end of the body. The plunger seal 436 may be mounted into the torso through the proximal end to be in fluid contact. The optional plunger rod 434 may be connected to the plunger seal 436 either before or after inserting the plunger seal 436 into the body 440. In order to maintain the integrity of the container and the sterility of the drug treatment, this step may be carried out in a sterile environment.

The remainder of the syringe can then be assembled in a non-sterile or sterile environment. The screw can then be connected to the plunger seal, as a component of the control mechanism, or, if a plunger rod is used. The distal adapter portion 418D can then be slid proximally along the lateral portion of the body to be connected to the proximal adapter portion 418P, as described above. The connection between the distal adapter portion 418D and the proximal adapter portion 418P can capture the shape of the body flange 440A of the body 440 to maintain the control mechanism 10 at the proximal end of the body 440. [ A variety of glue or adhesives may be utilized to assure that such components and connections are maintained in place during assembly, filling, fabrication, transportation, storage, and operation of the novel devices of the present invention. As in the pre-filled syringe 400, final assembly of the syringe may be accomplished as shown in Figure 7 (b). This type of pre-filled syringe can be used when the drug administration can be variably selected by the user, for example, when the syringe is filled with a standard amount of drug fluid by the pharmaceutical company or the contracted drug filler, When the needle length can be variably selected by the user, or in a number of different situations. Figure 7 (c) shows a pre-filled syringe with a selectable needle attached through a luer lock connection, as described above. In such a scenario, the syringe may be maintained such that the distal end of the syringe is pointing upward. The cap 460 (shown in FIG. 7 (b)) can be removed and replaced by the body adapter assembly 450. The torso adapter assembly 450 includes a torso tip portion 452 and a needle 454 that can be selected by the user and attached to a pre-filled syringe immediately prior to use. Drug administration can be identified and selected by the user as described above. From the comparison of the pre-filled syringes of FIGS. 7 (c) and 7 (d), the difference between the pre-filled syringes immediately before and after the injection and delivery of the drug administration to the patient can be clearly seen. Due to the pitch ratio between the plunger 14 and the screw 30, the plunger 14 may be pushed or moved along the axial direction in the distal direction (i.e., in the direction of the solid line arrows in FIGS. 7C and 7D) When translated, the screw 30 translates axially in the distal direction only incrementally or to a lesser extent. This difference in axial translation distance between the plunger 14 and the screw 30 can be confirmed by comparing the distance D3 and the distance D4 in Figs. 7C and 7D. D3 is a distance in which the plunger 14 translates in the axial direction, while D4 is a partial distance in which the screw 30 is translated in the axial direction.

Another embodiment of a syringe 500 including an administration control mechanism 510 is shown in Figures 8a-8c. The embodiment of Figures 8A-8C provides the advantages of the administration control mechanism of the previous embodiments and the advantages of a conventional syringe, as described below. Figures 8a, 8b and 8c show a cross-sectional view of the dosage control mechanism in each of the injection-ready stage, the partially injected stage, and the dose-ending stage, while Figures 9a and 9b show the dosage control 0.0 > 510 < / RTI >

The dosage control mechanism 510 for the syringe 500 includes a plunger 514, a housing 520, an adapter 518, and a screw 530, as in the previous embodiments. The housing 520 has a substantially cylindrical axial passage through which a substantially cylindrical plunger 514 can be at least partially disposed therein. The distal end of the housing 520 includes an adapter 518. The housing 520 and adapter 518 of this embodiment are formed as an integral structure and the adapter 518 provides a finger flange for engagement by a user during operation. It should be noted, however, that as described in connection with other embodiments, the housing 520 and the adapter 518 may be separately formed.

The adapter 518 may couple the dosage control mechanism 510 to the body 540 of the syringe 500 with any suitable structure. The adapter 518 is coupled to the body 540 by an insert 518A that is received within an axially extending opening 518B in the adapter 518. In the illustrated embodiment, While the insert may be of any suitable design, the illustrated insert 518B includes a gasket 518C and a positioning insert 518D. The body 540 of the syringe 500 is received within the opening in the gasket 518C and the body flange 540A is disposed along the upper surface of the gasket 518C. The gasket 518C and the body 540 can be inserted through an opening in the positioning insert 518D that can be slidably received within the laterally extending opening 518B of the adapter 518; The laterally extending flanges 518E may serve to hold the insert 518A and the associated body 540 in place. Thus, within the assembly, the body 540 can be inserted into the openings in the gasket 518C and the positioning insert 518D and then slid into a position in the laterally extending opening 518B in the adapter 518 .

As in the previous embodiment, the screw 530 may be coupled to the plunger rod 534, directly or indirectly, in any suitable manner. For example, as in the embodiment of Figs. 1A-7D, a connecting configuration portion 530A of the screw 530 may be received within the depression 534A at the proximal end of the plunger rod 534 have. In the illustrated embodiment, the distal end of the plunger rod 534 is coupled to the plunger seal 536 by a threaded connection, but other connections known in the art may be provided. Likewise, the plunger seal 536 can be of any suitable design. For example, in the illustrated embodiment, a plurality of ring seals 536A are disposed within a corresponding plurality of peripheral depressions 536B of the plunger seal 536. [

The housing 520 may be used to close the inner portion of the housing 520 from the environment and / or to axially align the plunger 514 within the housing 520 and to act as a mechanical stop, for example, To prevent removal of the plunger rod, it may optionally include a housing cover 516 at its proximal end.

The housing 520 may further include a dose reference mechanism. For example, by viewing the position of one or more dosing markings on the outer surface of the plunger 514, as described above, the user may view the position of the plunger 514 in the housing 520, (520) may have a window 520A (see Figure 9B). Although not specifically illustrated in these embodiments, those skilled in the art will appreciate that the same or similar mechanisms as in the previous embodiments may be provided in such embodiments.

The plunger 514 may include a button 512 that provides a user interface surface 512A for engaging the user to axially translate the plunger 514 within the housing 520. [ Button 512 and plunger 514 may be an integral component, or a separate component. For example, button 512 may be a preformed feature located at the proximal end of plunger 514. Alternatively, the button 512 may be a separate component that is attached to the proximal end of the plunger 514 by a snap-fit. In at least one embodiment, the button 512 is attached to the plunger 514, but may be freely rotated about the proximal end of the plunger 514. In this manner, the button 512 may be rotationally fixed relative to the user / clinician's finger while allowing the plunger 514 to rotate while the plunger is translationally moved in the axial direction.

The plunger 514 may further include a plunger dial 517 that may provide an alternative or additional structure for manipulating the plunger 514. In the illustrated embodiment, for example, the plunger dial 517 is secured together with the plunger 514. As a result, by rotating the plunger dial 517, the user can rotate the plunger 514 directly as desired. In this manner, the plunger dial 517 can be rotated to draw in the medicament or medication medication, depending on the direction in which the plunger is rotated.

Screw 530 is at least partially disposed within axially extending channel 514C in plunger 514, as in the embodiment of Figs. 1A-B (b). 1B, the proximal length 530C of the screw 530 is axially keyed relative to the plunger 514 for relative sliding movement along the axial direction, as shown in Fig. 1B with respect to the screw 30 and the plunger 14. [ do. In this manner, the axial rotation of the plunger 514 results in an axial rotation of the screw 530. As in the previous embodiments, those skilled in the art will appreciate that the axial key engagement may differ from what is specifically illustrated in FIG. 1B.

Threaded portion is formed outside on the distal length 530B of the screw 530 for complementary engagement with the internally threaded portion 518F of the adapter 518, as in the previous embodiment. As a result, rotation of the screw 530 will result in rotation of the screw 530 in the adapter 518, as can result from the rotation of the axially keyed plunger 514. The translational movement of the associated plunger rod 534 and plunger seal 536 is likewise dependent on the rotational direction of the screw 530 as the axial direction in which the screw 530 translates varies with the direction of rotation of the screw 530. [ Will vary.

The plunger 514 is received within the longitudinally extending channel 520D in the housing 520. [ The longitudinal extension channel 520D and the plunger 514 are coupled by a mating screw thread mechanism to provide axial movement and rotational movement of the plunger 514 to and from the housing 520. [ To this end, one of the longitudinal extension channel 520D and the plunger 514 includes the length of the thread, while the other of the longitudinal extension channel 520D and the plunger 514 includes at least Includes one thread segment. In the illustrated embodiment, the longitudinal extension channel 520D includes a thread 520C, while the plunger 514 includes a threaded segment 514B; In this case, the thread 520C of the longitudinal extension channel 520D is double threaded and the plunger 514 includes a pair of threaded segments 514B.

However, those skilled in the art will appreciate that, in at least one embodiment, the configuration of the engagement thread pitch for the plunger 514 and the housing 520 can be reversed. In other words, the outer surface of the plunger 514 may include the length of the coarse thread, while the longitudinally extending channel 520D includes at least one threaded segment disposed to engage the threads of the plunger 514. [ Those skilled in the art will appreciate that a threaded piece along the inner surface of the longitudinally extending channel 520D can include a piece of threaded threaded depression within which the external thread of the plunger 514 is rotated and / When translated, can be positioned on top of it. For the purposes of this disclosure, the term "threaded segment" will include both threaded depressions that can receive threads and threads that can be received within threaded depressions.

8A-9B, the coupling between the plunger 514 and the housing 520 may be varied, as illustrated in connection with the embodiment of Figs. 1A-3B, instead of a uniform coarse pitch thread, Pitch thread 520C. In this manner, the rotation of the plunger 514 relative to the axial translation of the plunger 514 in the housing 520 results in a further rotation and axial translation of the screw 530 relative to the housing 520 Can be precisely configured. Such a mechanism also allows the user to fill the syringe more easily and quickly.

For the purposes of this disclosure, the term "variable pitch thread" 520C means that the threads include at least two thread pitches for engagement by threaded piece (s) 514B (see Fig. 9B). The first thread pitch 520E is disposed toward the distal end of the housing while the second thread pitch 520F is disposed proximal within the housing 520 from the first thread pitch 520E.

In this embodiment, the first thread pitch 520E is a coarse pitch thread, as illustrated in connection with the embodiment of FIGS. 1A-3B, while the second thread pitch 520F is a first thread pitch 520E). ≪ / RTI > As a result, when the plunger 514 is rotated and the threaded piece 514B is engaged with the first pitching thread 520E, the plunger 514 is rotated about the axis < RTI ID = 0.0 >Lt; / RTI > In other words, as the user advances the plunger 520 with the threaded piece 514B engaged with the first threaded pitch 520E, the plunger 520 is moved farther than the keyed relatively short pitch screw 530 Will move along the axial direction to the distance. Conversely, as the user advances the plunger 520 with the threaded piece 514B associated with the second threaded pitch 520F, the thread pitches of the plunger 520 and the thread 530 are more closely aligned. As a result, the zonally anti-motion distance of the plunger 520 and the screw 530 will more closely match. In this manner, when the user moves the plunger 520 in a proximal direction at a relatively constant speed to retract the medicament into the body 540, the medicament is positioned such that the threaded segment 514B is disposed within the first threaded pitch 520E It will be pulled into the body 540 more aggressively at an early stage and more rapidly when the threaded segment 514B is disposed within the second threaded pitch 520F. Thus, the variable pitch thread 520C facilitates the rapid entry of a larger volume of drug than the embodiment of Figs. 1A-3B. Likewise, when the plunger 520 is pressed to prime the syringe or dosing agent, the rate at which the plunger seal 536 moves within the body 40 is at the position of the threaded piece 514B in the variable pitch thread 520C And will therefore allow for earlier priming and slower final drug delivery. In at least one embodiment, upon completion of the priming phase of operation, the thread segment 514B is disposed within the first thread pitch 520E of the variable pitch thread 520C. This allows the medicament to be accurately transferred to the target using the mechanical advantages described above with reference to Figures 1A-3B.

Referring again to FIG. 8A, a syringe 500 is shown with a plunger 514 in its fully retracted position. It should be noted that the thread segment 514B is disposed within the second thread pitch 520F of the variable pitch thread 520C. For example, as the plunger 514 is pressed to primer the syringe 50, the threaded piece (s) 514B traverses the second threaded pitch 520F of the variable pitch thread 520C, As shown in Fig. 4B, into the first thread pitch 520E. During priming, typically air is discharged from the body 540, possibly with a small amount of medicament. It will be appreciated that as the threaded piece 514B enters the first threaded pitch 520E the rotational speed of the screw 530 will be reduced for uniform axial movement of the plunger 514. [ In this manner, the user can precisely prime the injector 500 to the desired dose. When the user presses the plunger 512 or rotates the plunger dial 517 the primed dose may be delivered and the threaded piece 514B may be delivered to the first threaded pitch 520E of the variable pitch thread 520C, To provide a rotational motion for drug delivery to the screw 530 (see FIG. 8C). In this way, the syringe can be quickly filled and primed. For example, the pitch ratio of the first thread pitch 520E to the adapter nut may be 1: 1. The axial translation of the plunger seal 536 will be the same as the axial translation of the plunger 512 when the threaded piece 514B is disposed within the first threaded pitch 520E. This allows the syringe to function like a standard syringe during the filling and priming phases, providing a familiar experience for healthcare professionals. After priming, if threaded piece 514B is disposed within second threaded pitch 520F, the syringe provides fine control over the volume of drug being dispensed as described above with reference to Figures 1-7 (b) .

Thus, those skilled in the art will appreciate that the variable pitch threads 520C can thus be configured to provide the desired rotation of the screw 530 and hence the axial movement for relatively uniform axial movement of the plunger 512 I will understand. It will also be appreciated that the variable pitch thread 520C may include more than two pitches. For example, the variable pitch thread 520C may include three or more different pitches. The pitch can be shifted along its entire length and can progress gradually from one pitch to another, such as a gradual transition from coarse pitch to fine pitch. In addition, the variable pitch thread 520C may include a transitional pitch between different pitches, such as a transition pitch between a coarse pitch and a fine pitch.

Although FIGS. 8A-B show a housing 520 formed in a unitary form, it will be appreciated that the housing 520 may be composed of a plurality of components. Those skilled in the art will further appreciate that a housing comprising a plurality of components can facilitate fabrication and assembly, as well as enhance customized options and functionality of the device.

For example, the housing 520 may include a lower housing and an upper housing. FIG. 15 illustrates an exemplary embodiment of the present invention having a housing 520 including, for example, a lower housing 522 and an upper housing 524. The lower and upper housings 522 and 524 may be formed, for example, by threaded engagement, snap fit, interference fit feet, hooks / branches and window coupling (as shown in cross section in Figure 15) By incorporating known methods of < / RTI > 15, the upper housing 524 may include one or more hooks 524A configured to engage one or more windows 522A of the lower housing 522. As shown in FIG. In another embodiment, the adapter 518 is formed separately from the lower housing and can be assembled to the lower housing 522.

In addition to assisting in the fabrication and assembly of such components, trifurcating the housing 520 with a number of components may have additional functional advantages. For example, the pitch ratios of the individual upper and lower housings 524 and 522 can be varied to provide customized choices, thereby enabling different dosing delivery accuracy or tuning. Thus, the remainder of the device may be a uniform structure, regardless of dosage accuracy parameters, but by altering or selecting the correct lower and upper housings, along with the interfacing screw-portions of the plunger rods, The administration accuracy can be simply changed. Thus, the device may have substantial customizability, minimizing the components that need to be modified to satisfy the exact desired delivery parameters. For example, by changing the pitch of the threads 530 and the internal threaded portion 518F of the adapter 518, additional customization can be provided. In such a mechanism, the adapter 518 may be formed with the lower housing 522 as shown, or formed separately from the lower housing 522 and assembled thereto. In this way, the device can be further customized by changing the adapter 518 and the screws 530. Those skilled in the art will appreciate that such a mechanism can provide an array of wider choices in the customization of the device through the use of a large number of standardized components that can be mixed and matched to provide the desired delivery parameters I will understand. Altering these components may also cause the manufacturer, pharmaceutical company, or user to change other parameters such as drug delivery metering, authorized power, and fill volume, Since it depends on the selected pitch ratio of the component.

Similarly, the functionality of one or more components may be further separated into discrete sub-components. For example, the housing can be further subdivided so that the upper housing has an inner upper housing and an outer upper housing. In such a case, the inner upper housing may include a thread-threaded portion and may interface with the outer upper housing. This may further assist in the fabrication and assembly of the device, and / or may further improve the customization range of the device by replacement of only one sub-component. In this example, the inner upper housing can be easily replaced, in order to modify threaded engagement and, thus, drug delivery accuracy or tuning. Additionally or alternatively, one or more components may be modified to function as a function of other components described herein, a function similar thereto, or a supplement of the function. For example, in at least one embodiment, the cover 516 may be modified to incorporate a thread-threaded portion that replenishes the thread-threaded portion of the upper housing. This may be used to provide additional axial translation of the plunger, and / or may be used to provide other portions of the plunger with a modified pitch ratio. In another embodiment of the present invention, the threaded cover may be elongate and may be combined with the inner upper housing so that the cover has a threaded portion that extends substantially the length of the housing or upper housing. Thus, the threaded portion of the housing may be a separate component from the exterior of the housing. As a result, the threaded portion can be easily replaced.

In addition, the threaded portion of the device and / or its sub-components may have any range of thread profiles or cross-sectional configurations. For example, Figs. 8A to 9B show a configuration using a rectangular thread profile. The embodiment shown in Figs. 10A to 11B shows a configuration using a triangular thread profile. In this sense, the term profile is intended to refer to the cross-sectional shape of each thread of a thread-threaded portion of the device.

A thread profile or shape may be selected to satisfy the desired parameters of the functioning device. For example, the triangular thread profile can reduce the glide force felt by the user and provide less adhesive bonding between corresponding threaded components. This may be because the mating surfaces of the corresponding threaded components are altered or are generated in other planes that are more easily tactilely perceived or operated by the user. In addition, the triangular thread profile can enable more rotation in shorter axial lengths. This can provide the device with finer accuracy, tuning, or volume control. Also, while embodiments of the present invention show a rectangular / square threaded profile or a triangular square profile, within the scope of the claimed invention, a number of thread profiles can be used by the present apparatus. Similarly, within the scope of the claimed invention, the thread direction can be changed.

10A-14, the dosage control mechanism 610 includes at least first and second housings 668, 670 configured to selectively perform telescopic movement relative to each other between a retracted position and an extended position The housing further includes a housing 620. In this manner, an administration control mechanism 610 may be provided at the retracted position and then extended to withdraw the medication into the torso. In at least one embodiment, the first and second housings 668, 670 can then be translated relative to each other in a primed position from which the medicament can be dosed. A first such embodiment is shown in Figs. 10A-11B, and a second such embodiment is shown in Figs. 12A-14. The difference between the first and second such embodiments is a mechanism to control the relative motion between the first and second housing sections 668, 670. Accordingly, like reference numerals are used for like elements between the two embodiments. Those skilled in the art will appreciate that the dosage control mechanism 600 shown in Figures 12A-12E can be coupled to the trunk of the syringe in a manner similar to the embodiment of Figures 10A-10F.

More specifically, in the illustrated embodiment, the second housing section 670 is disposed between the first housing section 668 and the plunger 614. In such an embodiment, the second housing section 670 includes an internal thread 670D, which may be a constant pitch or variable pitch, configured to engage an external threaded piece 614B of the plunger 614. [ The second housing section 670 is configured to be axially translational relative to the first housing section 668 in a first configuration. In the second configuration, the sleeve 670 is fixed relative to the first housing section 668. As will be described below, this provides a user-friendly manner when the first and second housing sections 668, 670 are moved from the retracted position to the extended position and then to the primed position, , Allowing the syringe to be quickly filled and primed.

To fill the syringe, the user pulls the button 612 in the proximal direction. This allows the plunger 614, the second housing section 670, the screw 630, the plunger rod 634 and the plunger seal 636 to move from the retracted position shown in Figures 12a and 13a to Figures 10a, To translate in a proximal direction relative to the first housing section 668 to the extended position shown in Figures 12b, 13b, thereby causing fluid contents to be drawn into the body of the syringe. After filling the syringe, the user can prime the syringe by pressing the button 612 in the distal direction. This allows the plunger 614, the second housing section 670, the screw 630, the plunger rod 634, and the plunger seal 636 to move as a unit and to release a portion of the fluid contained within the torso (These positions are shown in Figures 10c, 10d, and 12c). At the completion of this priming motion, the second housing section 670 is engaged with the first housing section 668 such that the second housing section 670 is rotated or translational relative to the first housing section 668 Can not be. In this configuration, the administration control mechanism functions in a manner similar to that described above with reference to Figs. 1A to 7B.

10A-11B illustrate an embodiment of a locking mechanism for restricting the relative movement of the second housing section 670 relative to the first housing section 668. [ The second housing section 670 may include a guide boss 670A and a locking tab 670B. The first housing section 668 may include a longitudinal slot 668H. As can be seen in Figure 10b, the second housing section 670 is translationally moved for filling the syringe, and both the guide boss 670A and the locking tab 670B are disposed in the longitudinal slot 668H do. Which limits the rotation of the second housing section 670 relative to the first housing section 668. [ As can be seen in FIG. 10D, when the second housing section 670 is translationally moved in the distal direction, for example to prime the syringe, the locking tab 670B contacts the first housing section 668 Thereby limiting the subsequent translational movement of the second housing section 670 relative to the first housing section 668. Additionally or alternatively, the interaction of the guide boss 670A and the longitudinal slot 668H may limit the radial translation of the second housing section 670 relative to the first housing section 668 .

In at least one embodiment, shown in FIGS. 12A-14, the second housing section 670 has a track 672 that engages a guiding feature of the first housing section 668. Initially, the guide configuration portion 668G is disposed within the first portion 672A of the track 672, as shown in Figure 13A. When the plunger 614, the second housing section 670, the screw 630, the plunger rod 634, and the plunger seal 636 are translated in the proximal direction from the retracted position of Figs. 12A and 13A, The interaction of the morphology portion 668G and the track 672 causes the second housing section 670 to be rotated relative to the first housing section 668 to the position shown in Figures 12b and 13b. That is, in addition to axial translation, the second housing section 670 is rotated relative to the first housing section 668. Subsequently, the distal translational movement of the second housing section 670 relative to the first housing section 668 is achieved by the second housing section shown in Figures 12c and 13c from the extended position shown in Figures 12b and 13b Resulting in a guide configuration 668G that traverses the second portion 672B of the track 672 when translating to the primed position. The track 672 may include a locking feature 672C that engages the guide feature to limit additional translational movement of the second housing section 670 relative to the first housing section 668. [

During the filling and priming steps, the rotation of the second housing section 670 and the plunger 614 may be coupled to prevent relative rotation therebetween. For example, as shown in FIGS. 12A-14, the dosage control mechanism 610 may include a coupler 680, which is a key engagement with the plunger 614. The tab 680A of the coupler 680 may be disposed within the notch 670F of the second housing section 670 and thereby the tab 680A of the second housing section 670 relative to the coupler 680 The rotation can be limited. Due to the keyed relationship of coupler 680 and plunger 614, this engagement also prevents rotation of second housing section 670 relative to plunger 614. The user can disengage the tab 680A of the coupler 680 from the notch 670F of the second housing section 670 by translating the coupler 680 in the proximal direction (compare Figures 12C and 12D) . When the coupler 680 is in this position, the dosing control mechanism may be operated as described above and the plunger 614 may be actuated by a tab 680A positioned above the upper ramped surface of the housing 620, Is rotated with respect to the housing 620, thereby rotating the screw 630 to release the contents of the syringe body. The remaining elements of the dosage control mechanism 610 of Figures 12A-14 are substantially as shown in Figures 10A-11B.

In any of the described embodiments, the dosage control mechanism may include one or more additional threaded components. This can provide additional mechanical advantages to the user. For example, the administration control mechanism may include an inner plunger and an outer plunger. The outer plunger has an outer thread associated with the inner thread of the housing and an inner thread associated with the outer thread of the inner plunger. The inner plunger also has internal threads that engage the threads. In this way, the ratio of the displacement between the knob and the plunger seal can be increased.

According to another feature, some embodiments may provide tactile feedback to a user, for example, in connection with identification of a desired delivery volume. In this manner, when the user dials the plunger rod / screw into their desired dosage volume (e.g., when the plunger 514 is rotated until a particular microliter setting is visible in the window 520A) Will feel a tactile notch or breakpoint to signal placement for a preset dose volume. The dosage control mechanism 510 may comprise a number of volume-based detents for indicating various dosage volumes. By way of example only, the dosage control mechanism 510 may include such feedback for a syringe delivery volume of 20 microliters, 10 microliters, and 5 microliters.

While tactile feedback may be provided by any suitable mechanism, one such embodiment is shown in Figures 16a-c. For example, housing 520 and plunger 514 may include a structure that provides tactile feedback when aligned. As best seen in Figure 16c, the housing 520 may include a projection 526 and the plunger 514 may include at least one depression 514B, which, when aligned, And provides the user with a variation in the normal rotation of the plunger 514.

The depression 514B in the plunger 514 may be formed by any suitable method. For example, the depression 514B may be formed by a bore extending through the wall of the plunger 514, or by a bore.

Similarly, the protrusions 526 may be provided by any suitable structure, such as a molded feature on the inner wall of the housing 520. [ However, in the illustrated embodiment, the housing 520 includes at least one radially extending opening 520G through which the branches extend radially inward to provide a projection 526. [ In this embodiment, a pair of openings 520G and a pair of protrusions 526 are provided. The protrusion 526 may extend from a separate clip 528 that may be attached to the exterior surface of the housing 520, as shown in Figures 16A-C.

It will be appreciated that any number of such clips 528 may be provided at locations along the length of the housing 520, in order to identify a corresponding number of desired set points / breakpoints that identify a preset dose volume. Alternatively or additionally, the plunger 514 may have any number of depressions 514B that correspond to a predetermined dose volume. When the user axially rotates the plunger rod / screw to dial the desired delivery volume, the protrusion 526 extending radially from the clip 528 is depressed by a depression 514B corresponding to the prescribed set point / / RTI > The dimples 514B and the protrusions 526 are dimensioned so as to correspond to preset dose volumes in the syringe for drug delivery, respectively.

Any of the administration control mechanisms described above can be used with such a blended syringe. These are particularly well suited for such mixed syringes because the dosage control mechanisms described herein permit proximal translation of the plunger rod to the drug container.

Accordingly, a novel embodiment of the present invention provides an administration control mechanism that enables precise administration and delivery of a drug therapeutic agent, and a drug delivery syringe that includes such a control mechanism. Such a new device allows for identification and control of dosage within a device size similar to the commonly used conventional syringe available on the market and allows the syringe to be "primed" (i.e., To be exhausted), and ensures a precise delivery of a dose of microliter volume. Such new devices are safe and easy to use, aesthetically and ergonomically attractive to clinicians. The novel apparatus of the present invention provides such desirable features without any problems associated with known prior art devices.

In order to complete the filling step of the syringe manufacturing process, a number of known filling processes and equipment may be used. The body assembly, needle, plunger seal, plunger rod, and other components described in this manufacturing and assembly process may be as described above or may be a number of similar components that achieve the same function as these components . Throughout the specification, the purpose was to describe a preferred embodiment of the present invention, without restricting the invention to any one embodiment or set of specific features. Various changes and modifications can be made to the described and described embodiments without departing from the invention. The disclosures of each of the patents and scientific literature, computer programs and algorithms mentioned herein are incorporated by reference in their entirety.

Claims (28)

As an administration control mechanism for a syringe:
A housing having a longitudinally extending channel having a medial surface;
An adapter including a channel having fine pitch threading,
A plunger having an outer surface and an axially extending channel, the axially extending channel comprising a first key configuration;
A proximal end of the thread is disposed at least partially within an axially extending channel of the plunger and the threaded outer surface includes a second keyed portion along a proximal portion of the threaded outer surface, Wherein at least a portion of the second key-shaped portion is disposed in an axially extending channel of the plunger and is engaged with the first key-shaped portion for sliding movement, whereby rotational movement of the plunger causes rotational movement of the screw, Wherein the distal portion of the screw outer surface includes a fine pitch thread thread disposed at least partially within and interfaced with the fine pitch thread of the adapter; And
At least a portion of the longitudinally extending channel of the housing including one of the pitch guide and one of the at least one threaded segment, Wherein the plunger includes at least one of the pitch guide and at least one threaded piece, the plunger being at least partially disposed within the housing, the at least one threaded piece being associated with the pitch guide, An administration mechanism. The method according to claim 1,
Wherein the variable pitch threads comprise at least two different thread pitches. 3. The method according to claim 1 or 2,
Wherein the housing includes the pitch guide and the variable thread pitch is changed from a coarse pitch proximal to the adapter to a relatively fine pitch proximal to the coarse pitch. 4. The method according to any one of claims 1 to 3,
Wherein the variable pitch threads comprise at least three different thread pitches. 4. The method according to any one of claims 1 to 3,
Wherein the variable pitch thread comprises a transition between at least two different thread pitches. 6. The method of claim 5,
The metastasis is progressive, administration control mechanism. The method according to claim 6,
Wherein said transition occurs substantially over the entire length of said pitch guide. 7. The method according to any one of claims 1 to 6,
Wherein the variable pitch threads comprise a length of at least one constant thread pitch. 9. The method according to any one of claims 1 to 8,
Wherein the variable pitch threads comprise distal-positioned coarse pitch threads and proximal-positioned relatively fine pitch threads. 10. The method of claim 9,
Wherein a pitch of the fine pitch thread threads of the variable pitch thread threads is substantially equal to a pitch of the fine pitch thread threads of the adapter. 11. The method according to any one of claims 1 to 10,
Wherein the housing comprises at least a first housing section and a second housing section. 12. The method of claim 11,
Wherein the first housing section is an upper housing and the second housing section is a lower housing and the upper and lower housings are coupled together. 13. The method according to claim 11 or 12,
Wherein the first housing section comprises at least one thread pitch different from the thread pitch of the second housing section. As an administration control mechanism for a syringe:
A housing having a longitudinally extending channel having a medial surface, the housing comprising at least a first housing section and a second housing section arranged to telescopically move relative to each other between a retracted position and an extended position;
An adapter including a channel having fine pitch threads;
A plunger having an outer surface and an axially extending channel, the axially extending channel comprising a first key configuration;
A proximal end of the thread is disposed at least partially within an axially extending channel of the plunger and the threaded outer surface includes a second keyed portion along a proximal portion of the threaded outer surface, Wherein at least a portion of the second key-shaped portion is disposed in an axially extending channel of the plunger and is engaged with the first key-shaped portion for sliding movement, whereby rotational movement of the plunger causes rotational movement of the screw, Wherein the distal portion of the screw outer surface includes a fine pitch thread thread disposed at least partially within and interfaced with the fine pitch thread of the adapter; And
An engagement screw threaded mechanism comprising a pitch guide comprising at least one threaded segment and a thread, wherein at least a portion of the longitudinally extending channel of the housing comprises one of the pitch guide and at least one threaded segment, Wherein the at least one threaded piece is engaged with the pitch guide and the pitch guide and the other one of the at least one threaded piece, the plunger being at least partially disposed within the housing, / RTI > 15. The method of claim 14,
Wherein the first housing section and the second housing section are arranged to be moved between the extended position and the primed position. 16. The method of claim 15,
Wherein the plunger and the first housing section are configured to be decoupled to allow rotational movement relative to each other when the first and second housing sections are disposed in the primed position. 17. The method according to any one of claims 14 to 16,
Wherein said plunger and said first housing section are coupled to prevent rotational movement relative to each other during telescopic movement from said extended position. 18. The method according to any one of claims 14 to 17,
Wherein the first and second housing sections are disposed for controlled rotational movement relative to each other. 19. The method according to any one of claims 14 to 18,
Wherein the first and second housing sections are configured to be coupled together in the primed position to prevent relative movement therebetween. 20. The method according to any one of claims 14 to 19,
Wherein relative movement of said first and second housing sections between said retracted position and said extended position comprises at least one of said first and second housing sections including at least one guide configuration and at least one track Wherein the first and second housing sections are controlled by the other of the first and second housing sections. 21. The method of claim 20,
Wherein motion of the guiding portion in at least a portion of the track provides relative rotational movement between the first and second housing sections. 22. The method according to any one of claims 1 to 21,
Whereby the engagement screw threading mechanism causes rotation of the plunger within the housing when the plunger is translated relative to at least a portion of the housing and rotation of the plunger within the housing causes rotation of the screw And wherein rotation of the thread within the adapter channel and engagement of the first and second key tops provide relative axial sliding between the screw and the plunger and relative axial sliding between the screw and the plunger, And provides motion of the screw in a distal direction and in a proximal direction when the plunger is moved proximally relative to at least a portion of the housing. 23. The method according to any one of claims 1 to 22,
Wherein at least a portion of said variable pitch threads is coarser than a pitch of fine pitch threads of said adapter. 24. The method according to any one of claims 1 to 23,
Further comprising one or more volume based detents. 25. The method of claim 24,
Wherein the at least one volume-based detent comprises a protrusion configured to engage a depression of the plunger. 26. The method according to any one of claims 1 to 25,
Wherein the adapter is configured to be coupled to the body of the syringe and the distal end of the plunger is configured to be coupled to a plunger rod disposed within the body. 27. A precisely dosed drug delivery syringe according to any one of claims 1 to 26, comprising a body, a plunger rod, a plunger seal coupled to the plunger rod and disposed within the body, and a needle, Wherein a proximal end of the rod is coupled to a distal end of the screw and a distal end of the plunger rod is coupled to the plunger seal. 28. The method of claim 27,
Wherein the syringe is at least one of a filling syringe, a pre-filled syringe, and a safety syringe at the time of use.

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