Devices and methods for variable locking syringe assemblies

Abstract

This specification discloses exemplary variable-locking syringe assemblies, methods for manufacturing them, and methods for using them. Such variable-locking syringe assemblies are useful in many applications.

Description

Technical Field

[0004] ,

[0001] The present disclosure generally discloses a syringe assembly and related devices and methods. The present disclosure relates to a syringe assembly in which a plunger is lockable in position within a syringe barrel, and related devices and methods for the syringe assembly.

[0002] Related Applications This disclosure is a PCT application claiming the priority and benefit of U.S. Provisional Patent Application No. 63 / 444,605, filed on February 10, 2023, the entire content of which is incorporated herein by reference. All applications in which foreign or domestic priority claims are identified in the application data sheet filed with this application are incorporated herein by reference.

Background Art

[0003] Syringes are used in many medical and non-medical applications, for example, in conjunction with other devices, for blood collection, for drug injection, and for assisting in biopsy procedures and bone marrow transplantation surgeries. A syringe or syringe assembly of a medical device generally includes a barrel and a plunger that is slidable within the barrel and fits to seal within the barrel. The plunger typically has a finger grip accessible at its proximal end for pushing the plunger into or pulling it out of the barrel, and the barrel itself can have opposing finger grips at its proximal end. Medical syringes are manufactured in a variety of sizes and configurations and are well known in the medical and industrial fields. The syringe barrel often includes volume graduations and, in many cases, the barrel is made of a translucent plastic material so that the position of a seal at the end of the plunger can be seen through the barrel wall.

[0004] To control the amount of substance entering and leaving the syringe barrel, a stopcock may be mounted on the distal end of the syringe barrel or fluidly aligned with the syringe's inlet / outlet port. Stopcock valve assemblies have been routinely used for many years in various medical procedures and surgeries, for example, to meter the injection of fluids into the body of a person receiving medical care. Examples of stopcock valve assemblies may include at least three-way valves in which the valve body has three or more ports arranged radially, and an internal directional control member is rotatably positioned within the valve body to selectively close one or more ports while simultaneously opening communication between at least two other ports. When a stopcock is used to control the delivery of substance in a syringe, the possibility of contamination arises, and the operator must consider the position of the stopcock valve handle and the amount of substance in the syringe barrel. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] What is needed is a syringe assembly that can be easily and variably locked to control the amount of substance supplied by the syringe, and that maintains the plunger in a stable position so that pressure from the supplied substance or body tissue does not move the plunger. Providing a syringe assembly that can maintain the plunger in a variable fixed position also helps prevent operator error. [Means for solving the problem]

[0006] This disclosure provides a method for manufacturing and using a device comprising a syringe assembly that is easily and variably lockable so as to control the amount of substance supplied by the syringe, and which can maintain the plunger in a stable position so as not to be moved by pressure from the supplied substance or body tissue. The device disclosed herein provides an element that enables the plunger to be fixed or locked in one or more possible positions within the barrel, and thus the syringe assembly is variably lockable. The device disclosed herein can be locked in one position, unlocked, moved to the next position, and locked again. These steps can be repeated. Maintaining the plunger in a variably fixed position helps prevent operator error by preventing the operator from accidentally pulling the plunger proximal or pushing the plunger distally to supply an excess of substance. In many procedures, care should be taken to prevent the plunger from moving inadvertently while a fluid is in or controlled by the syringe, and the device of this disclosure is useful in such procedures. [Brief explanation of the drawing]

[0007] The embodiments disclosed herein will become more fully apparent from the following description and the appended claims in conjunction with the accompanying drawings. These drawings show only typical embodiments, and those embodiments will be described more specifically and in detail using the accompanying drawings. Alternative configurations of the elements shown herein can be understood from the disclosure and drawings herein.

[0008] [Figure 1] A diagram of an exemplary transparent syringe assembly disclosed herein, with the plunger removed from the barrel, is shown.

[0009] [Figure 2] An exemplary front perspective view of a transparent syringe assembly disclosed herein is shown.

[0010] [Figure 3] An exemplary rear perspective view of a transparent syringe assembly disclosed herein is shown.

[0011] [Figure 4] A diagram of an exemplary transparent syringe assembly disclosed herein is shown, in which the plunger extends proximal to the barrel. [Modes for carrying out the invention]

[0012] Disclosed herein are syringe assembly devices and methods for manufacturing and using such devices. In one embodiment, the devices disclosed herein relate to a syringe assembly comprising at least a syringe barrel and a plunger. Disclosed herein is a syringe assembly device which is a “lockable” syringe assembly, meaning that the plunger in the barrel can be maintained and stationary in one of a plurality of possible longitudinal positions within the barrel. Once the operator of the syringe assembly places the plunger in the locked position within the barrel, the plunger remains in that position without further effort or work by the operator. The locked plunger remains in the desired longitudinal position within the syringe barrel. If it is desired to move the plunger from the locked longitudinal position within the syringe barrel, the operator rotates the plunger in the barrel axially (e.g., clockwise or counterclockwise, around the longitudinal axis of the plunger) until the plunger is in the unlocked position and is no longer locked, thereby moving the plunger longitudinally distally or proximal as desired. When the plunger reaches a second or subsequent longitudinal position, the plunger is rotated axially to the locked position. The syringe assembly can be easily locked, released, moved to another longitudinal position, and relocked, meaning the device is variable lockable. Variable lockable means the syringe's ability to lock the plunger in one of several longitudinal positions across the barrel, the plunger can be positioned or repositioned to different or the same longitudinal position, or the syringe assembly plunger can be unlocked or released by rotating the plunger axially clockwise or counterclockwise, thereby moving the plunger away from the locked position.

[0013] Variable-locking syringe assemblies can be used in known medical applications where a flexible or variable response is required. For example, consider an application where a balloon attached to a syringe assembly needs to be deployed. Depending on the subject, the balloon may be fully deployed (i.e., inflated) without causing pain or injury to the subject. In this case, the disclosed syringe assembly is used to fully inflate the balloon, i.e., to supply air or fluid into the balloon, and then the plunger is locked in a desired longitudinal position within the barrel, maintaining the balloon in its fully inflated state for the desired time required (e.g., for a medical procedure). Once the plunger is locked in place with the balloon fully inflated, the operator no longer needs to manipulate the syringe assembly. If the desired time has elapsed and the balloon needs to be deflated, the plunger is unlocked within the barrel and moved longitudinally to deflate the balloon. For other patients, a fully inflated balloon may be too large and / or overinflated, potentially causing pain and / or injury to the subject. Without the need to switch to a smaller balloon, a variable-lock syringe can be used to supply air or fluid into a balloon and inflate it to the desired inflation level sufficient for the medical procedure being performed. The plunger is then locked in a longitudinal position within the barrel, maintaining the attached balloon at the desired inflation level. Once the plunger is locked in place and the balloon has inflated to a volume smaller than its fully expanded volume, the operator no longer needs to manipulate the syringe assembly. When the desired time has elapsed and the balloon needs to be deflated, the plunger is unlocked within the barrel and moved longitudinally to deflate the balloon. In one embodiment, variable-lock syringes of different sizes may be used for such procedures.

[0014] For example, variable-lock syringe assemblies are also useful in medical applications where fluids, such as drugs or injectable substances, are injected into or supplied to a target or removed from a target in a multi-stage, measured and / or time-controlled manner. For instance, a variable-lock syringe assembly may be useful for withdrawing fluid from a target. The operator can move the plunger in the barrel from a distal longitudinal position to a proximal longitudinal position to create negative gauge pressure or vacuum within the syringe barrel. The operator can then lock the plunger in a desired position within the syringe barrel to maintain the negative gauge pressure and facilitate the withdrawal of fluid from the patient's body. Stepwise, the plunger can be unlocked from a first position, moved longitudinally within the syringe barrel, and relocked in different positions to increase or restore pressure or vacuum, decrease or eliminate pressure or vacuum. Alternatively, fluid can be injected into a target. For example, a variable-lock syringe assembly can be used in procedures that supply a known amount of fluid to a target multiple times. For example, in a procedure to alter a subject's face by delivering an expander such as hyaluronic acid, hydroxyapatite, or fat to one or more locations on the face, the operator can use a variable-lock syringe assembly to ensure that the same amount of expander is delivered to each injection site (e.g., along the length of a wrinkle). The needle attached to the variable-lock syringe assembly is inserted into one site of a wrinkle, and the plunger is moved distally to inject the desired amount of expander into that site. The plunger is locked in that position, the needle is withdrawn from that site, and the needle is inserted again into a second site. At the second site, the plunger is unlocked, the desired amount of expander is injected, the plunger is locked again, and the needle is withdrawn. This step can be repeated once or more times. The desired known amount of substance (e.g., fluid, air, gel) is reliably and reproducibly delivered to the subject without errors due to the operator being unable to maintain the plunger position during injection, after delivery, and / or after needle removal in one or more repeated steps.These examples of use are not intended to limit the disclosed devices and methods, and those skilled in the art will understand and be able to perform procedures in which a variably lockable syringe assembly can be used.

[0015] The embodiments of the disclosed devices are best understood by referring to the drawings, in which similar parts are numbered similarly throughout. It will be readily apparent that the components of the disclosed devices, generally described and illustrated in the drawings herein, can be arranged and designed in a wide variety of different configurations. Accordingly, the following more detailed description of various embodiments as shown in the drawings is not intended to limit the scope of this disclosure, but merely to represent various embodiments. In some cases, well-known structures, materials, or operations are not illustrated or described in detail. Although various embodiments of the disclosed devices are shown in the drawings, the drawings are not necessarily drawn to scale unless otherwise indicated.

[0016] The terms “connected,” “joined,” and “communicated” refer to any form of interaction between two or more real objects, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be joined to each other even if they are not in direct contact with each other. For example, two components can be joined to each other via an intermediate component. The terms “contacting” and “in contact” refer to items that are in direct physical contact with each other, but the items do not necessarily have to be attached.

[0017] The terms “distal” and “proximal” have their usual meanings in the art. That is, the distal end of a medical device refers to the end of the device furthest from the operator during use. The proximal end refers to the opposite end, i.e., the end closest to the operator during use. Particularly when applied to syringe assemblies, the distal end of the syringe assembly refers to the end closest to the inlet / outlet port of the syringe barrel, and the proximal end refers to the opposite end, i.e., the end closest to the plunger head. Furthermore, it will be understood that the term “distal end” always refers to the end closest to the inlet / outlet port, even if the distal end is temporarily closer to the operator at one or more points during the procedure.

[0018] This disclosure can be further understood from the drawings provided herein. Figure 1 shows one embodiment of a syringe assembly, syringe assembly 100. As shown in Figure 1, syringe assembly 100 may comprise a barrel 110 and a plunger 120. The barrel 110 is a cylindrical tube having an internal lumen of the syringe assembly from which the plunger 120 can be pushed (distally) or pulled (proximal). The barrel 110 may be made of any suitable material (e.g., polypropylene). The plunger 120 may be located inside the barrel 110 and may be pushed (distally) or pulled (proximal). When pulled (proximal), a substance such as a liquid, gel, or gas is drawn through the inlet / outlet port 114 and into the internal lumen 111 of the barrel 110. When pushed (distally) by the movement of the plunger 120, the fluid or gas is discharged from the inlet / outlet port 114. As shown in Figure 1 and subsequent figures, the barrel 110 is depicted as transparent so that the plunger is visible within the internal lumen 111 of the barrel 110. Embodiments of the syringe assembly may include a non-transparent barrel and / or plunger. Furthermore, the barrel 110 may have markings or indices that are inside or on the outer surface of the barrel, attached to the outer surface of the barrel 110, or etched on the outer surface of the barrel, although such markings are not shown in the drawings. Such markings or indices may be horizontal lines and / or numbers and may be used, for example, to identify the amount of substance, fluid, liquid, gel, or gas in the barrel. Such markings or indices on the barrel of a syringe assembly are known to those skilled in the art. The barrel 110 is hollow or substantially hollow. In one embodiment, the barrel 110 comprises an elongated cylindrical tube having a through-lumen 111.

[0019] The barrel 110 comprises a distal end 112 and a proximal end 113. The distal end 112 of the barrel 110 may have a distal inlet / outlet port 114, which is an opening that connects to the lumen 111 for fluid connection. The proximal end 113 of the barrel may have a proximal opening 115 through which the shaft 124 of the plunger 120 passes. The distal inlet / outlet port 114 is an opening or passage through which a substance or fluid, such as a liquid, gel, or gas, is drawn into and / or pushed out of the barrel 110. The distal end 112 of the barrel 110 may be configured or shaped so that it can be fitted or coupled to articles, such as catheters, medical devices, tubes, needles, or other devices, which can facilitate the introduction or removal of fluid, attachment for fluid transfer, etc. For example, the distal end 112 of the barrel 110 may be shaped as a fitting or fitted (for example, shaped as a Luer lock fitting) so that the distal end 112 can be mated with a complementary Luer lock fitting on an article (e.g., a catheter, tube, medical device, or needle) to form a fluid connection between the inside of the barrel 110 and the article. The Luer lock fitting may be threaded. Many types of fittings used to join a syringe assembly to an article are envisioned in this disclosure, are known to those skilled in the art, and may be used with the syringe assemblies disclosed herein.

[0020] The proximal end 113 of the barrel 110 is provided with a proximal opening 115 through which the plunger 120 extends and / or is inserted. The proximal end 113 of the barrel 110 may be provided with one or more barrel flanges 117. One or more barrel flanges 117 may extend outward from the barrel 110 as shown in the figures herein and may be useful for the use of the syringe assembly 100. The shape of one or more barrel flanges 117 is not intended to be limited to those shown in the figures herein, and may be different shapes, curved shapes, including ridges or recesses, coated with anti-slip material or coatings, or other designs that would be useful for the use of the disclosed syringe assembly.

[0021] Located inside the barrel 110, close to the proximal opening 115, is the barrel key 118. The barrel key 118 can have any shape that allows it to engage between two plunger teeth 121 (e.g., between teeth 121a and 121b) and "lock" the plunger 120 in a specific longitudinal position. For simplification, only three teeth are identified as plunger teeth 121 in the figure, but it should be understood that the plunger teeth 121 comprises all of each of the plunger teeth shown in the figure. The barrel key 118 is shaped to interact with the plunger 120 and lock it in a specific position. The barrel key 118 is shaped to interact with one or more plunger teeth 121 contained in the plunger 120. For example, the teeth 121 may be beveled or chamfered so that the plunger 120 is fixed and held in that position within the barrel 110, i.e., locked, when the barrel key 118 engages with at least one tooth 121 and edge 128 or edge 129, or with two teeth 121. To clarify the understanding, the plunger 120 is locked in a specific longitudinal position within the barrel 110 by positioning the barrel key 118 between any two teeth 121 or between a tooth and an edge.

[0022] The plunger 120 has a proximal end 122 and a distal end 123 and is generally a solid shaft 124. The solid shaft 124 may be rounded and moves longitudinally within the lumen 111 of the barrel 110. Optionally, the proximal end 122 includes a plunger head 130 and a seal mechanism 131 is disposed at the distal end 123. The seal mechanism is an element, such as a gasket or ring mechanism, that can form a seal so that substances within the lumen 111 of the barrel do not leak in the proximal direction. As shown in FIG. 1, the plunger 120 is removed from within the barrel 110. The plunger head 130 can have any desired shape (e.g., matching or corresponding to the barrel flange 117), or can be different from the barrel flange 117 and is not limited to the shape shown in the figures. The plunger head 130 provides a surface for contact or actuation by an operator when moving the plunger 120 distally or proximally. Optionally, the plunger head 130 can have a diameter larger than the diameter of the barrel 110, such as a shape that complements or engages the barrel flange 117, and the seal mechanism 131 can have a diameter such that the seal mechanism 131 forms a seal for the shaft 124 within the barrel lumen 111.

[0023] As shown in the figure, two structures are formed on the longitudinal shaft 124 of the plunger 120, and each structure exists in an adjacent portion of the longitudinal shaft 124. One structure is a toothed portion having a plurality of teeth 121 and a proximal edge and a distal edge, and is partially shown in FIG. 1. Each of the teeth 121 is herein called the tooth 121 alone and can be denoted by alphabetical symbols such as the tooth 121a or the tooth 121b. As shown in the figure, the teeth 121 are cut into the shaft 124 such that the portion of the shaft 124 having the teeth 121 has the same radius as the shaft 124, and the diameter of the shaft 124 is maintained such that the plunger 120 can easily move within the lumen 111. Optionally, the plunger flange 130 can have a diameter larger than the diameter of the barrel 110, such as a shape that complements or engages with the barrel flange 117, and the seal mechanism 131 can have a diameter such that the seal mechanism 131 forms a seal within the shaft 124.

[0024] The second structure of the shaft 124 is a flat portion 140 that is adjacent to the teeth 121, cut into the shaft 124, and extends longitudinally along the shaft 124. The flat portion 140 can be at least as long as the teeth 121 and can extend from the edge 128 to the edge 129. When the plunger 120 is axially rotated about its longitudinal axis such that the flat portion 140 faces the barrel key 118 and is adjacent to the barrel key 118, the plunger 120 can easily move in the proximal or distal direction within the barrel 110 and cannot be locked. This is the release position. Looking at FIG. 1, when the plunger 120 is inserted distally into the barrel 110, the flat portion 140 faces the barrel key 118 and the plunger 120 is in the release position.

[0025] To lock the syringe assembly, the following steps can be taken. Looking at Figure 1 again, for example, with the plunger 120 inserted into the lumen 111 of the barrel 110, the flat portion 140 facing the barrel key 118, and the plunger 120 in the released position, the plunger 120 is moved distally in the longitudinal direction so that a portion of the flat portion 140 is in the desired longitudinal position, for example, so that a portion of the flat portion 140 located at tooth 121a is adjacent to the barrel key 118. Next, the plunger 120 is rotated axially (for example, about 90 degrees) so that tooth 121a is positioned proximal to the barrel key 118 and tooth 121b is positioned distal to the barrel key 118. The plunger 120 is now fixed longitudinally and cannot be moved proximal or distal. This is the locked position. The locking position can be achieved by positioning the barrel key 118 between any two teeth 121, or between the most proximal tooth 121d and the proximal edge 128, or between the most distal tooth 121c and the distal edge 129. Therefore, since the barrel key 118 can be variably positioned between any two teeth, or between the most proximal tooth 121d and the proximal edge 128, or between the most distal tooth 121c and the distal edge 129, the syringe assembly 100 is variably lockable.

[0026] To unlock the syringe assembly and release the plunger 120, the plunger 120 is rotated to the release position (for example, by about 90 degrees in the opposite direction to the direction used to lock the plunger 120) so that the flat edge 140 faces the barrel key 118 and allows the plunger 120 to move distally or proximal longitudinally as desired.

[0027] The size and dimensions of the barrel 110 and plunger 120 may vary as desired, but they include teeth 121 and a flat section 140, and are shaped to provide a variable locking function for the syringe assembly 100.

[0028] Figure 2 shows a front view of the syringe assembly 200 with the plunger 220 inserted into the lumen 211 of the barrel 210. The barrel 210 comprises a distal end 212 and a proximal end 213. The distal end 212 of the barrel 210 comprises a distal inlet / outlet port 214, which is an opening that makes fluid connection to the lumen 211. The proximal end 213 of the barrel comprises a proximal opening 215 and a barrel flange 217, as described with respect to Figure 1. The distal inlet / outlet port 214 is an opening or passage through which a fluid, such as a substance (e.g., liquid, gel, and gas), is drawn into and pushed out of the barrel 210. The distal end 212 of the barrel 210 can be configured or shaped as described with respect to Figure 1. The proximal end 213 of the barrel 210 comprises a proximal opening 215 through which the plunger 220 extends and / or is inserted.

[0029] The plunger 220 comprises a shaft 224 and has a proximal end 222 and a distal end 223, and is capable of moving longitudinally within the lumen 211 of the barrel 210. Optionally, the proximal end 222 is provided with a plunger head 230, and the distal end 223 is provided with a sealing mechanism 231. The plunger 220 comprises teeth 221 and a flat portion 240 (not shown).

[0030] As shown in Figure 2, the plunger 220 is rotated so that the flat portion 240 is in an open position facing the barrel key 218. In Figure 2, it can be seen that the teeth 221 are formed on the shaft 224 such that the teeth (e.g., teeth 221f) are projections (projections 250 and spaces 251 and 252) with spaces that are open above and below each other. The individual teeth 221 are spaced a distance slightly larger than the diameter of the barrel key 218 so that the barrel key 218 can be positioned between any two teeth 221 or between the most proximal tooth and the edge 228 or between the most distal tooth and the edge 229. The barrel key 218 can have any desired shape, and the teeth 221 can be shaped as appropriate to hold and maintain the barrel key 218 between them or between the teeth and the edge. As shown in Figure 2, the teeth 221 are shaped as chamfered teeth, but this is not limiting, as the teeth 221 can be any shape that allows the barrel key 218 to be placed between them or between the teeth and the edge.

[0031] Figure 3 shows a rear view of the syringe assembly 300, with the flat portion 340 shown. The plunger 320 is inserted into the lumen 311 of the barrel 310 and is shown in the released position rotated so that the flat portion 340 faces the barrel key 318. For example, to lock the syringe assembly 300, the plunger 320 is moved proximal as needed, and then rotated clockwise (or the plunger head 330a is moved toward the observer) so that the barrel key 318 is positioned between two teeth 321, or between a tooth and a rim, for example, between tooth 321c and rim 329. To unlock the syringe assembly 300 and release the plunger 320, the plunger 320 is rotated in the opposite direction (counterclockwise, i.e., the plunger head 330a is moved toward the position shown in Figure 3 so that it faces away from the observer), so that the flat portion 340 faces the barrel key 318 again. In this released or unlocked position, the plunger 320 can move freely within the lumen 311.

[0032] Figure 4 shows a perspective view of a syringe assembly 400 disclosed herein. Figure 4 shows a plunger 420 positioned within the lumen 411 of the barrel 410 in the released position. The flat portion 440 faces the barrel key 418, and the plunger 420 is free to move longitudinally within the lumen 411. In one embodiment, the positioning of the barrel flange and the finger grip of the plunger can provide the operator with a visual indicator of the plunger's position and whether the plunger is in a locked or unlocked position. For example, as shown in Figure 4, the barrel flange 417 and the finger grip 430 are similarly shaped and aligned so that they correspond to (or are mirror images of) each other. This aligned position is a visual cue to the operator that the plunger is unlocked because the flat portion 440 faces or is adjacent to the barrel key 418. When the plunger 420 is rotated axially so that the barrel flange 417 and the finger grip 430 are not aligned, the two teeth 421 grip the barrel key 418. The barrel key 418 is positioned between the two teeth 421 (or teeth and edge), and the plunger 420 is fixed longitudinally and cannot be moved distally or proximal. The misaligned position of the barrel flange and finger grip indicates that the plunger is in the locked position. When the plunger 420 is rotated axially in the opposite direction, thereby realigning the finger grip 430 and the barrel flange 417, the barrel key 418 disengages from between the two teeth 421 (or teeth and edge), the flat portion 440 faces the barrel key 418, and the plunger 420 is released to move freely proximal or distally within the lumen 411. It should be understood that the syringe assemblies disclosed herein do not need to have barrel flanges and finger grips of corresponding shapes to indicate the position of the plunger in either the locked or unlocked (released) position. Barrel flanges and finger grips of corresponding shapes are optionally provided as external indicators of the locked or unlocked state of the plunger.As described above, the barrel flange and finger grip may have corresponding or different shapes, including those known to those skilled in the art.

[0033] One embodiment of a syringe assembly having a plunger having multiple structures consisting of one or more toothed sections and / or one or more flat sections is not shown in the figures. As shown in the figure (e.g., Figure 1), two structures (toothed section 121 and flat section 140) are formed on the longitudinal shaft 124 of the plunger 120, and each structure is located on an adjacent portion of the longitudinal shaft 124. In one embodiment, the plunger has two toothed sections. For example, each of the two toothed sections is located apart around the circumference of the shaft 124 (e.g., 180 degrees apart) and separated by a flat section. Similar to the teeth shown in the figure, the teeth are cut into the plunger shaft such that the toothed section has the same radius as the plunger shaft, and the diameter of the plunger shaft is maintained so that the plunger moves easily within the barrel lumen. The flat section separating the toothed structure is as described above, cut into the plunger shaft, extends longitudinally along the plunger shaft for at least the length of the tooth 121, and extends from the proximal end to the distal end. In one embodiment, the syringe assembly comprises a plunger having a second flat portion located 180 degrees from a first flat portion. By rotating the plunger axially around its longitudinal axis, so that the flat portion faces a barrel key located proximal within the barrel lumen near the proximal opening of the barrel, and the flat portion of the plunger faces and is adjacent to the barrel key, the plunger can move easily proximal or distal within the barrel and cannot be locked. This is the released position.

[0034] In one embodiment, the syringe assembly disclosed herein comprises a second flat portion located 180 degrees from a first flat portion. In one embodiment, the syringe assembly disclosed herein comprises two flat portions located 180 degrees from each other and separated by a tooth structure, so the plunger comprises two tooth structures and two flat portions. For example, when moving the plunger in a 360-degree axial rotation, one can see the teeth, flat portions, teeth and flat portions. Locking the plunger involves moving the plunger in an axial position, for example, by rotating it 90 degrees, so that the barrel key is positioned between two teeth or between the teeth and the edge. Releasing the plunger from the locked position involves moving the plunger in an axial position so that one of the flat portions faces the barrel key of the syringe lumen by releasing the barrel key from the position between the two teeth or between the teeth and the edge. As can be understood from the disclosure herein, the plunger may comprise one or more tooth structures and one or more flat portion structures. For example, a plunger may have two tooth structures and one flat section structure, two tooth structures and two flat section structures, one tooth structure and one flat section structure, one tooth structure and two flat section structures, or three or more or a combination thereof in different parts of the plunger.

[0035] A method of using the syringe assembly disclosed herein is disclosed herein. The method comprises some or all of the following steps, indicated by the reference numerals in Figure 1: Position the plunger 120 longitudinally within the lumen 111 in a position advantageous for either drawing a substance, such as a gas, liquid, or gel, into or out of the lumen 111. Attach the inlet / outlet port 114 to the article before or after positioning the plunger 120 to move the substance in and out of the lumen 111. For example, the inlet / outlet port 114 may be shaped to form a Luer lock when mated with a corresponding shape on the article. The article may be a catheter, balloon fitting, needle, container, or other known article used in a procedure to treat or diagnose a subject. In one embodiment, the plunger 120 is moved proximal to draw air into the lumen 111, and the plunger 120 is rotated so that two teeth 121 grip a barrel key 118, locking the plunger 120 in its longitudinal position within the lumen 111. The inlet / outlet port 114 is fluidly attached to the catheter balloon fitting. The catheter is positioned in the desired location within the object, and the plunger 120 is unlocked (released) by rotating the plunger 120 so that the teeth 121 move away from the barrel key 118 and the flat portion 140 is positioned adjacent to or facing the barrel key 118. Once released / unlocked, the plunger 120 is moved distally, moving air from the lumen 111 to the balloon lumen and inflating the balloon. Once the balloon has been inflated to the desired volume by the movement of the plunger 120 from one longitudinal position to a more distal longitudinal position within the lumen 111 and by the air pushed out from the lumen 111, the plunger 120 is rotated to lock it in its longitudinal position so that the flat portion 140 no longer faces the barrel key 118, and instead the barrel key 118 is sandwiched between the two teeth 121 or the distal edge 129 and the teeth 121c.

[0036] The balloon can be inflated to any desired volume, from only a portion of the volume of the substance contained in the syringe assembly (housed in the lumen 111) to the entire volume, and maintained at that desired volume without further operation by the operator. This is because the syringe assembly 110 can be variably locked in any of the possible longitudinal positions. The syringe assembly 100 can supply all or only a portion of the air from its lumen to the balloon, and then the plunger 120 is locked in the longitudinal position reached when sufficient substance has been discharged from the syringe lumen. The syringe assembly can maintain the longitudinal position of the plunger 120, and thus the inflated balloon, for a desired time without operation, fixing, or movement by the operator. This feature, which allows the syringe assembly to supply a desired and / or variable amount of substance and maintain that state without operation by the operator, distinguishes the disclosed variably lockable syringe assembly from a syringe assembly that does not have a locking capability or has only one locking position. A non-locking syringe assembly may either deliver all or none of the substance into its lumen, and in any amount between all and none, the operator must continue to grip and try to fix the plunger in an intermediate position, and must also deal with the movement of the object and the resistance acting on the syringe assembly and the substance. Furthermore, to meet the need to deliver different amounts of substance to an article or object, operators have relied on having a variety of syringe assemblies available in different capacities and sizes to deliver varying amounts of substance. The disclosed variable locking syringe assembly overcomes the need for many different sized syringe assemblies because it can reliably and accurately deliver variable amounts of substance. In contrast, while unlockable syringes can deliver various amounts, operator error and medical errors can occur because the operator has to rely on accurately and reliably keeping the unlockable syringe plunger in one place.

[0037] To deflate the balloon, the plunger 120 is rotated within the lumen 111 so that the flat portion 140 faces the barrel key 118, i.e., the plunger 120 is released or unlocked, so that the barrel key 118 is no longer pinched by the teeth or by the teeth and edge. In the unlocked position, the plunger 120 is moved proximal to draw the air inside the balloon into the lumen 111 and deflate the balloon.

[0038] The method of supplying a substance to the target is, a. A lockable, variable-lockable syringe assembly comprising a barrel and plunger having inlet / outlet ports, containing a substance within the barrel of the syringe assembly, is positioned at or on the object receiving the substance. b. Unlocking a variable lockable syringe assembly, c. Delivering a desired amount of substance by moving the plunger to a distal position, thereby moving at least a portion of the contained substance from the syringe assembly out of the inlet / outlet port, into or onto the target, d. Locking a variablely lockable syringe assembly, e. Removing a locked, variable-lockable syringe assembly from the object. Includes.

[0039] Steps a) through e) can be optionally repeated one or more times.

[0040] Methods of supplying substances to goods are A lockable, variable-lockable syringe assembly is attached to an article, comprising a barrel and plunger with inlet / outlet ports, and containing a substance within the barrel of the syringe assembly. a. Unlocking a variable lockable syringe assembly, b. Move the plunger to a distal position to move at least a portion of the contained substance out of the inlet / outlet port from the syringe assembly, c. Locking a variable lockable syringe assembly, d. Optionally, unlock the variable lockable syringe assembly and move the plunger proximal to move at least a portion of the discharged material into the barrel through the inlet / outlet port, e. Removing a locked, variable-lockable syringe assembly from the article. Includes.

[0041] Substances that can be supplied by the disclosed devices include solutions, suspensions, liquids, gases, air, saline solutions, drug solutions containing activators, solutions containing biological cells or cellular components, mixtures and combinations thereof, and substances that can be supplied by syringe assemblies known to those skilled in the art.

[0042] The systems disclosed herein include providing a device disclosed herein, or a device disclosed herein comprising a composition disclosed herein. The systems disclosed herein comprise a device disclosed herein and optionally a composition disclosed herein. The systems disclosed herein comprise a device having a plunger comprising at least one tooth structure and at least one flat section structure, and a syringe barrel comprising a barrel key, and optionally a composition disclosed herein. The systems and / or devices disclosed herein can be packaged in sterile containers.

[0043] The kit of the present invention includes the device disclosed herein in a kit container and optionally an instruction manual for using the device. The kit of this disclosure includes a container containing the device disclosed herein, along with the composition disclosed herein, and optionally an instruction manual for using the device. The kit disclosed herein includes a container containing the device disclosed herein, and optionally an instruction manual for using the device, along with the composition disclosed herein. The kit disclosed herein includes a container containing the device disclosed herein, which has a plunger having at least one tooth structure and at least one flat section structure, and a syringe barrel having a barrel key, and optionally an instruction manual for using the device, along with the composition disclosed herein. The kits and / or devices disclosed herein can be packaged in sterile containers.

[0044] definition Where used herein, the nomenclature of compounds, including organic compounds, may be given using a common name or recommendations for IUPAC, IUBMB, or CAS nomenclature. Where one or more stereochemical features are present, the Kahn-Ingold-Prelogue rule for stereochemistry may be used to indicate stereochemical priority, E / Z notation, etc. Those skilled in the art can readily determine the structure of a compound, given its name, either through a systematic classification of compound structures using nomenclature rules or by commercially available software such as CHEMDRAW® (Cambridge Software, USA).

[0045] As used herein and in the appended claims, the singular forms "a," "an," and "the" include multiple references unless the context clearly indicates otherwise. Thus, for example, references to "functional group," "alkyl group," or "residue" include two or more such functional groups, alkyl groups, or mixtures of residues.

[0046] References in parts by weight of a particular element or component in a composition in this specification and the concluding claims indicate the weight relationship between that element or component and any other element or component in the composition or article in which parts by weight are expressed. Thus, in a compound containing 2 parts by weight of component X and 5 parts by weight of component Y, X and Y exist in a weight ratio of 2:5, and such a ratio exists whether or not the compound contains additional components.

[0047] The weight percentage (wt.%) of an ingredient is based on the total weight of the preparation or composition containing that ingredient, unless otherwise specified.

[0048] Where used herein, when a compound is referred to as a monomer or compound, it should be understood that this is not to be interpreted as referring to a single molecule or a single compound. For example, two monomers generally refer to two different monomers, not two molecules.

[0049] As used herein, the terms “optional” or “optional” mean that the event or situation described thereafter may or may not occur, and that the description includes cases in which such event or situation occurs and cases in which it does not occur.

[0050] Where used herein, the terms “about,” “approximately,” and “○○ or about ○○” mean that the quantity or value in question may be a specified exact value or a value that provides an equivalent result or effect to that described in the claims or taught herein. That is, quantities, sizes, formulations, parameters, and other quantities and characteristics are not, and do not need to be, exact, but may be approximately equal and / or greater or less, as desired, to take into account tolerances, conversion factors, rounding, measurement errors, and other factors known to those skilled in the art, so as to yield an equivalent result or effect. In general, quantities, sizes, formulations, parameters, or other quantities or characteristics are “about,” “approximately,” or “○○ or about ○○,” whether explicitly stated as such. Where “about,” “approximately,” or “○○ or about ○○” is used before a quantitative value, the parameter is understood to include the specific quantitative value itself unless otherwise specifically stated.

[0051] As used herein, the term “subject” can be a vertebrate such as a mammal, fish, bird, reptile, or amphibian. Accordingly, the subjects of the methods disclosed herein may be humans, non-human primates, horses, pigs, rabbits, dogs, sheep, goats, cattle, cattle, guinea pigs, or rodents. This term does not imply a specific age or sex. Therefore, adult and neonatal subjects, as well as fetuses, regardless of sex, are intended to be covered. In one embodiment, the mammalian subject is a human. “Patient” refers to a subject suffering from a disease or disorder, or requiring contraception. The term “patient” includes human and veterinary subjects.

[0052] As used herein, the terms “administer” and “dosage” refer to any method of supplying the disclosed composition.

[0053] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “containing,” “characterized by,” “has,” “having,” or any other variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to those elements alone and may include other elements that are not expressly enumerated or are not specific to such process, method, article, or apparatus.

[0054] The transitional phrase "consisting of" excludes any elements, steps, or components not explicitly stated in the claim, and, with the exception of impurities typically associated therewith, closes the claim to the inclusion of materials other than those described. If the phrase "consisting of" appears in a section of the main body of the claim rather than immediately following the preamble, it limits the elements described in that section only, and does not exclude other elements from the claim as a whole.

[0055] The transitional phrase “essentially consisting of” limits the scope of the claim to the specified materials or processes and to those that do not substantially affect the basic and novel features of the claimed invention. “Essentially consisting of” claims occupy an intermediate position between closed claims written in the “consisting of” form and fully open claims written in the “comprising” form. Optional additives (at appropriate levels for such additives) and trace impurities as defined herein are not excluded from the composition by the term “essentially consisting of.”

[0056] Where a composition, process, structure, or part of a composition, process, or structure is described herein using open-ended terms such as “comprising,” unless otherwise specified, such description also includes embodiments that “essentially consist of” or “consist of” elements of the composition, process, structure, or part of the composition, process, or structure.

[0057] The articles “a” and “an” may be used in reference to various elements and components of the compositions, processes, or structures described herein. This is merely for convenience and to give a general meaning to the compositions, processes, or structures. Such descriptions include “one or at least one” of the elements or components. Also, as used herein, the singular articles include descriptions of multiple elements or components unless it is clear from the particular context that the plural is excluded.

[0058] The term “approximately” means that a quantity, size, composition, parameter, and other quantity and characteristic are not, and do not need to be, exact, but may, as desired, be approximately equal to and / or greater than or less than, taking into account tolerances, conversion factors, rounding, measurement errors, and other factors known to those skilled in the art. In general, a quantity, size, composition, parameter, or other quantity or characteristic is “approximately” or “nearly,” whether explicitly stated as such.

[0059] As used herein, the term “or” is inclusive. That is, the phrase “A or B” means “A, B, or both A and B.” More specifically, the condition “A or B” is satisfied by any of the following: A is true (or exists) and B is false (or does not exist), A is false (or does not exist) and B is true (or exists), or both A and B are true (or exist). Exclusive “or” is indicated herein by terms such as “either A or B” and “one of A or B.”

[0060] In addition, the ranges described herein include their endpoints unless otherwise specified. Furthermore, where quantities, concentrations, or other values ​​or parameters are given as ranges, one or more preferred ranges, or lists of preferred upper and lower limits, this should be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, whether such pairs are disclosed separately or not. The ranges of the present invention are not limited to the specific values ​​enumerated in defining the ranges.

[0061] Where a substance, method, or machine is described herein using the terms “known to those skilled in the art,” “conventional,” or synonyms or synonymous phrases, such terms indicate that the description includes substances, methods, and machines that are common at the time of filing of this application. It also includes substances, methods, and machines that are not common at present but are likely to become recognized as suitable for similar purposes in the art.

[0062] Unless otherwise stated, all percentages, parts, ratios, and similar quantities are defined by weight.

[0063] All patents, patent applications, and references included herein are incorporated specifically by reference in their entirety.

[0064] Naturally, it should be understood that the above applies only to embodiments of this disclosure, and that numerous modifications or changes may be made without departing from the intent and scope of the disclosures described herein.

[0065] This disclosure is further illustrated by the examples contained herein, but these examples should not be construed as limiting the scope of the invention. Rather, it should be clearly understood after reading this specification that various other embodiments, modifications, and equivalents thereof that may be obvious to those skilled in the art can be utilized without departing from the spirit of this disclosure and / or the appended claims.

[0066] Exemplary embodiments of the present invention describe in detail methods, syringe assembly devices, delivery systems, and compositions, but the present invention is not limited to these embodiments. Many modifications or changes may be obvious to those skilled in the art for using the methods, delivery systems, and compositions herein for the diagnosis or treatment of various conduits in both human and non-human mammals.

[0067] The present invention is further illustrated by the examples provided herein for clarity. These exemplary embodiments should not be construed as limiting the scope of the invention. Rather, it should be clearly understood after reading this description that various other embodiments, modifications, and equivalents thereof, which may be obvious to those skilled in the art, can be utilized without departing from the spirit of the invention and / or the appended claims.

Claims

1. Syringe assembly a) A barrel having a barrel key positioned within the lumen of the barrel at the proximal end of the barrel, b) A plunger comprising at least one tooth structure and at least one flat structure Equipped with, The plunger is lockable along the lumen of the barrel between the distal end of the lumen and the proximal end of the lumen by positioning the barrel key between two teeth or between a tooth and the edge. A syringe assembly wherein the plunger can be unlocked by moving the flat portion of the plunger so that it faces or is adjacent to the barrel key.

2. The syringe assembly according to claim 1, wherein the tooth structure comprises a plurality of teeth.

3. The syringe assembly according to claim 1, wherein the tooth structure comprises a border structure.

4. The syringe assembly according to claim 1, wherein the tooth structure comprises a plurality of teeth and at least one edge structure.

5. The syringe assembly according to claim 1, wherein the tooth structure comprises a plurality of teeth, a proximal margin structure, and a distal margin structure.

6. The syringe assembly according to claim 1, wherein the plunger comprises two tooth structures.

7. The syringe assembly according to claim 1, wherein the barrel is marked.

8. The syringe assembly according to claim 1, wherein the barrel further comprises a distal inlet / outlet port.

9. The syringe assembly according to claim 8, wherein an article is attached to the distal inlet / outlet port.

10. The syringe assembly according to claim 9, wherein the article is a catheter, tube, needle, or medical device.

11. A method for inflating a catheter balloon, a) comprising attaching a syringe assembly to a port that fluidly connects to a balloon lumen, the syringe assembly comprising: i) a barrel containing a fluid composition, having a proximal end and a distal end, the barrel comprising a barrel key positioned in the lumen of the barrel at the proximal end of the barrel, and an inlet / outlet port at the distal end; and ii) a plunger comprising at least one toothed structure and at least one flat structure, the plunger being lockable along the lumen of the barrel between the distal end of the lumen and the proximal end of the lumen by positioning the barrel key between two teeth or between teeth and a margin, and the plunger being unlockable by moving the flat portion of the plunger to face or be adjacent to the barrel key. b) Moving the plunger distally within the lumen of the barrel to move at least a portion of the fluid through the inlet / outlet port into the balloon lumen, A method optionally comprising c) locking the plunger in a desired position within the lumen of the barrel by rotating the plunger so that the barrel key is positioned between two teeth or between a tooth and a rim.

12. The method according to claim 11, wherein the port that fluidly connects to the balloon lumen is connected to a catheter equipped with the balloon.

13. The method according to claim 11, wherein the port that is fluidly connected to the balloon lumen is connected to a medical device.

14. The method according to any one of claims 11 to 13, further comprising deflating the balloon by unlocking the plunger, wherein the plunger is rotated so that the flat structure faces the barrel key.

15. The method according to claim 14, further comprising moving the plunger in a proximal direction to reduce the volume of the inflated balloon.

16. The method according to claim 11, wherein the fluid is air or liquid.

17. The method according to claim 11, wherein the tooth structure of the syringe assembly comprises a plurality of teeth and at least one edge structure.

18. The method according to claim 11, wherein the tooth structure of the syringe assembly comprises a plurality of teeth, a proximal end structure, and a distal end structure.

19. The method according to claim 11, wherein the plunger of the syringe assembly comprises two tooth structures.

20. A method for injecting a composition into a target, a) comprising attaching a syringe assembly to a needle useful for injection, the syringe assembly comprising i) a barrel comprising a composition having a proximal end and a distal end, the barrel comprising a barrel key positioned in the lumen of the barrel at the proximal end of the barrel and an inlet / outlet port at the distal end, and ii) a plunger comprising at least one tooth structure and at least one flat structure, the plunger being lockable along the lumen of the barrel between the distal end of the lumen and the proximal end of the lumen by positioning the barrel key between two teeth or between teeth and a margin, and the plunger being unlockable by moving the flat portion of the plunger to face or be adjacent to the barrel key. a) Inserting the needle into the target area, b) Moving the plunger distally within the lumen of the barrel by a desired distance, thereby moving at least a portion of the composition through the inlet / outlet port and the needle into the target site, and injecting a desired amount of the composition, c) Locking the plunger at a desired distance within the lumen of the barrel by rotating the plunger so that the barrel key is positioned between two teeth or between a tooth and the edge, d) Withdrawing the needle from the target site A method comprising, optionally, repeating steps a) through d) at a second target site.

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