Vial adapter device

Abstract

A vial adapter is described that is configured to allow a syringe to directly withdraw fluid from a fluid container having a self-healing seal member. The syringe is connected to the vial adapter by a vial adapter connecting member and a corresponding syringe connecting member. During use, the fluid container is pressed against the vial adapter, which releasably locks the fluid container to the vial adapter. When releasably locked, a peg in the vial adapter penetrates the seal member.

Description

Technical Field

[0001] The present disclosure generally relates to a vial adapter device for transferring fluid to and / or from a fluid container having a seal member, and more particularly, the present disclosure relates to a vial adapter for directly withdrawing fluid from a fluid container using a syringe while minimizing damage and buckling of the needle tip.

Background Art

[0002] Pharmaceuticals and solvents are often provided in glass or plastic containers such as vials, bottles, bags, etc., and sealed with rubber, plastic, or elastomeric stoppers, stoppers, membranes, or pierceable caps. Such seal members prevent degradation and contamination of the drug, allow mixing of the contents of the container by shaking, and prevent the contents of the container from leaking and contaminating the surroundings. Conventional hollow needles having a flow channel and an opening communicating with the flow channel are typically inserted through such a seal member to supply fluid to and withdraw fluid from the container.

[0003] To avoid damage and buckling of the needle tip, larger gauge needles are often used to penetrate the seal member because they have greater structural strength than smaller gauge needles. However, larger gauge needles cause larger puncture holes in the patient's epidermis, and thus, when selecting a needle gauge for a given medical application, a practitioner can balance the risk of structural deformation of the needle and the invasiveness to the patient. Separate needles may be used, but this effectively doubles the biological waste for a given application and increases the risk of infection by exposing the tip of the medical syringe to unfiltered air. The unfiltered air may contain undesirable particles such as dust, pollen, or bacteria and microorganisms in the air.

[0004] Furthermore, when the container containing the medical fluid is almost empty, the needle may not be able to completely capture and withdraw the last few drops of the medical fluid from the container (which can be very expensive and / or toxic). To capture the remaining medical fluid, the cannula is slowly and carefully retracted through the seal member while withdrawing the medical fluid remaining in the container. However, the drug, which can be toxic, may leak during such a procedure and contaminate the surroundings, and unfiltered air may be drawn into the cannula and thus contaminate the medical fluid therein.

[0005] Therefore, there is a need to reduce the potential for structural damage to the needle while limiting exposure to a non-sterile environment and unfiltered air.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0006] A first aspect of the present disclosure relates to a vial adapter configured to draw fluid from a fluid container equipped with a syringe. The vial adapter includes a wall having a plurality of protrusions extending distally from the wall, stakes protruding distally from the wall, a lumen extending from at least one inlet through the wall, an inlet extending at least partially along the length of the stakes, and an elongated body extending proximally from the wall and defining a longitudinal cavity.

[0007] At least one of the plurality of protrusions has a protruding inner flange configured to lock onto the neck of the fluid container. The lumen defines an opening within the wall, the lumen is in fluid communication with at least one inlet, the lumen houses the needle cannula of the syringe, and the needle cannula is also in fluid communication with at least one inlet. The cavity of the elongated body is defined by an inner wall and a proximal opening, and the elongated body includes a connecting member configured to connect to a syringe connecting member.

[0008] In one or more embodiments, the cavity of the elongated body further defines an inner tapered surface, and the inner tapered surface forms an interference fit with a hub on the syringe.

[0009] In one or more embodiments, the lumen and the cavity define an inner channel through which the cannula of the syringe passes, and the cannula is not removably press-fitted into the hub of the syringe. In one or more embodiments, the cannula does not extend beyond at least one inlet of the peg.

[0010] In one or more embodiments, when the fluid container is fully pushed down against the wall, at least one inlet of the peg does not extend beyond the seal member of the fluid container, and when the seal member is fully pushed down against the wall, the peg pierces the seal member and causes fluid communication from the fluid container through at least one inlet and the lumen.

[0011] In one or more embodiments, when the fluid container is fully pushed down against the wall, at least one inlet of the peg extends beyond the seal member of the container.

[0012] In one or more embodiments, the inlet exposes an air ventilation channel for normalizing the internal pressure of the vial.

[0013] In one or more embodiments, when the seal member of the fluid container is pressed against the peg, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion removably locks the fluid container.

[0014] In one or more embodiments, when the seal member of the fluid container is pressed against the peg, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion permanently locks the fluid container.

[0015] In one or more embodiments, the vial adapter further comprises a removable seal disposed over the protrusion.

[0016] In one or more embodiments, the connecting member of the elongated body comprises a male thread and the syringe connecting member comprises a female thread. In one or more embodiments, the connecting member of the elongated body and the syringe connecting member comprise a luer fitting. In one or more embodiments, the connecting member of the elongated body comprises a flange and the syringe connecting member comprises a twist-locking receptacle.

[0017] A second aspect of the present disclosure relates to a fluid extraction kit comprising a vial adapter, a fluid container, and a syringe configured to draw fluid from the fluid container together with the fluid container. The fluid container has a neck and a seal member that abuts the neck. The syringe comprises a plunger rod and a barrel, the barrel defining a proximal end and a distal end of an opening in which the plunger rod is disposed, the distal end defining a distal wall, the distal wall having an integrally formed needle hub in which a collar and a needle cannula are disposed within the lumen of the needle hub, the needle cannula and the needle hub being in fluid communication with the barrel, the collar having a corresponding connecting member.

[0018] The vial adapter comprises a wall having a plurality of protrusions extending distally from the wall, at least one of the plurality of protrusions having a protruding inner flange configured to lock onto the neck of the fluid container. The vial adapter also comprises a peg having a tip protruding distally from the wall defining the length, the peg having at least one inlet extending at least partially along the length of the peg. The vial adapter further comprises a lumen extending from at least one inlet through the wall, the lumen defining an opening within the wall, the lumen being in fluid communication with at least one inlet, the lumen being an elongated body extending proximally from the wall defining a longitudinal cavity, the cavity defining an inner wall and a proximal opening, the elongated body having a connecting member disposed longitudinally along the outer wall of the elongated body, the connecting member being configured to removably secure the vial adapter to the syringe connecting member.

[0019] In one or more embodiments, the cavity further defines an inner tapered surface that forms an interference fit with a needle hub on the syringe.

[0020] In one or more embodiments, the lumen and the cavity define an inner channel through which a needle cannula of the syringe passes, the needle cannula is press-fitted non-removably into the hub of the syringe, and the cannula does not extend beyond at least one inlet of the stake.

[0021] In one or more embodiments, when the fluid container is fully depressed against the wall, at least one inlet of the stake does not extend beyond the seal member, and when the seal member is fully depressed against the wall, the stake pierces the seal member and provides fluid communication from the fluid container through at least one inlet and the lumen.

[0022] In one or more embodiments, when the seal member of the fluid container is pressed against the stake, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion removably locks the fluid container.

[0023] In one or more embodiments, when the seal member of the fluid container is pressed against the stake, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion permanently locks the fluid container.

[0024] This summary is provided to introduce, in simplified form, a selection of concepts that are further described in the detailed description below. This summary is not intended to identify all important features or essential features of the claimed subject matter, nor is it intended to be used alone as an aid in determining the scope of the claimed subject matter.

[0025] Additional features and advantages of the present disclosure will be described in the following description, some of which will be apparent from the description or can also be learned by practicing the present disclosure. The features and advantages of the present disclosure can be realized and obtained by the means and combinations specifically pointed out in the claims. These features and other features of the present disclosure will become fully apparent from the following description and the appended claims, or can also be learned by practicing the disclosure described herein.

Brief Description of the Drawings

[0026]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Best Mode for Carrying Out the Invention

[0027] Before describing some exemplary embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps shown in the following description. The present disclosure can be other embodiments and can be implemented or executed in various ways.

[0028] For the purposes of the following description, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall relate to the present disclosure as oriented in the drawings. However, it will be understood that the present disclosure may assume alternative variations unless explicitly specified to the contrary. It is also to be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present disclosure. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered limiting.

[0029] References to “needles” include needles configured to fill and / or inject a syringe with liquid. In the present disclosure, the portion of the needle closest to the healthcare provider operating the needle is referred to as “proximal,” and the portion of the needle farthest from the healthcare provider and towards the patient (for injection) or vial containing the liquid (for filling) follows the convention of being referred to as “distal.”

[0030] As used herein, a “filling needle” refers to a needle configured to fill a syringe, but in some embodiments, is not configured to inject a patient. For example, in some embodiments, the filling needle is a blunt needle configured or adapted to penetrate the rubber stopper of a fluid container, but not configured or adapted to penetrate the skin of a patient.

[0031] In this specification, the term "syringe" refers to a simple pump-like device consisting of a plunger rod that fits snugly into a barrel or tube. By pulling the plunger rod into and advancing it within the barrel, the syringe can inhale and exhale liquids or gases through the opening at the open end of the barrel.

[0032] As used herein, "fluid container" refers to a vial having a seal member configured to hermetically seal the contents of the fluid container, preferably a liquid. In some embodiments, the fluid container comprises a substantially cylindrical container body having a neck disposed opposite the closed end. The neck generally defines an opening covered by a sealed seal member, commonly referred to as an elastomeric or rubber "stopper" or "septum". The seal member in one or more embodiments is hot or cold and is fused directly to the neck. In other embodiments, an end cap compresses the seal member onto the neck and the end cap is airtight fixed to the neck. The end caps of some embodiments are fixed by an adhesive, screw connection, or lock connection to the neck. The fluid container according to one or more embodiments includes glass, ceramic, metal, polymer or plastic. When non-foldable wall materials (such as glass, ceramic, metal and rigid plastics) are used, a ventilation function is often essential for the fluid container, essential for the seal member, or a feature of the filling needle. When foldable wall materials (such as soft polymers) are used, the wall collapses due to the pressure difference between the inside of the container and the outside air when the contents are extracted, creating a vacuum inside the container, so extraction can be performed without a ventilation function. Alternatively, the practitioner can prepare the container by first injecting air into the container with a filling needle and then withdrawing the contents of the fluid container to stabilize the pressure. In some embodiments where preparation is required, the syringe is provided with a pre-filled sterilized gas that is transferred to the fluid container before the fluid is withdrawn. If the contents are substantially withdrawn and the filling needle can no longer capture the remainder, the fluid container is inverted or placed in an upward position and the filling needle is slightly withdrawn to capture the remainder accumulated in the neck.

[0033] Exemplary configurations for couplers, connectors, ports, and adapters include commercially available luer locks, luer slip ports, lock ports, screw connections, interlock connections, or other common medical device connectors generally known in the art.

[0034] The present disclosure relates to a vial adapter configured to draw medical fluid from a fluid container having a septum without the need to replace the needle after filling the administration needle configured to be injected into a patient. The vial adapter of one or more embodiments enables a practitioner to use a small gauge needle while drawing medical fluid from the fluid container, while minimizing needle tip damage and buckling to the small gauge needle. By way of example and not limitation, the vial adapter can utilize a single subcutaneous injection needle on the order of 27 gauge to draw, administer, or inject medical fluid without damaging the needle or compromising the need to use a second needle such as a fill needle.

[0035] As shown in FIGS. 1A and 1B, the present disclosure relates to a vial adapter 110 and an exemplary fluid extraction kit 102 configured to directly draw fluid 104 from a fluid container 10 having a self-sealing seal member 12 with a syringe 30. In one or more embodiments, the syringe 30 is first connected to the vial adapter 110. Then, the fluid container 10 is pressed against the vial adapter 110, and the vial adapter 110 removably locks the fluid container 10 to the vial adapter. While removably locked, the practitioner may draw fluid 104 by moving the plunger rod 32 in the proximal direction.

[0036] As shown in FIGS. 2A and 2B, the vial adapter 110 includes a substantially elongated body 150 having a distal wall 112. In the illustrated embodiment, the distal wall 112 has a substantially circular shape. The peg 130 projects distally from the distal wall 112 of the vial adapter 110. The peg 130 is disposed at the center of the distal wall 112 to allow direct penetration of the seal member 12 (not shown). To assist in the penetration of the seal member 12, the peg 130 has a sharp tip, which is shown as having an inclined tip 132. The peg 130 further includes at least one elongated inlet 134 extending from the inclined tip 132 at least partially along the length of the peg 130. The at least one elongated inlet 134 is in fluid communication with the lumen 136 of the vial adapter 110. The lumen 136 extends from the at least one inlet 134 through the distal wall 112. The elongated inlet 134 may be of any shape such as rectangular, square, circular, or oval that communicates with the lumen 136. The at least one elongated inlet 134 extends longitudinally along about 50% of the length of the peg 130, either at the inclined tip 132 or a few millimeters from the inclined tip 132, such that when the fluid container 10 is pressed against the vial adapter 110, at least a portion of the opening of the at least one elongated inlet 134 is in fluid communication with the fluid 104 of the fluid container 10.

[0037] The vial adapter 110 further includes a plurality of protrusions 114 disposed around the distal wall 112. The plurality of protrusions 114 extend distally from the distal wall 112, and at least one of the plurality of protrusions has a protruding inner flange 116. In some embodiments, each of the plurality of protrusions has a protruding inner flange 116 that defines a plurality of inner flanges 116 for removably securing the fluid container 10 to the vial adapter 110.

[0038] In some embodiments, the distal wall 112 further includes a distally-directed circular protrusion 118 and a circular groove 120, and the circular groove 120 is disposed within the circular protrusion 118. The circular protrusion 118 and the circular groove 120 are concentrically arranged on the distal wall 112. In one or more embodiments, when the fluid container 10 is fully depressed against the distal wall 112, the fluid container 10 abuts against the circular protrusion 118. When the fluid 104 is withdrawn, leakage can accumulate within the circular groove 120, preventing further outflow to the outside of the vial adapter 110. In one or more embodiments, at least one elongate inlet 134 does not extend to the height of the circular protrusion 118, preventing the at least one elongate inlet 134 from being exposed to the external environment when the seal member 12 is fully depressed against the distal wall 112.

[0039] The elongate body 150 further defines a longitudinal cavity 152 that is in fluid communication with the lumen 136. The cavity 152 is further defined by an inner sidewall 154, an outer sidewall 156, and a proximal opening 159. The inner sidewall 154 further includes a proximal portion 157 and a distal inner ramp 164. The connection element 162 is longitudinally disposed along the proximal portion of the outer sidewall 156. In certain embodiments, the connection element 162 includes a plurality of female threads 163 having a helical shape. The connection element 162 removably secures the vial adapter 110 to a corresponding connection element 52 of the syringe 30. In some embodiments, the device includes at least one male thread having a helical shape. Further, in additional embodiments, the connection element 162 includes a flange for twist-locking into a corresponding receptacle.

[0040] As shown in FIG. 3, the syringe 30 includes a barrel 34 and a plunger rod 32. The barrel 34 defines an opening proximal end 36, a distal end 38, and a distal wall 40. The side wall 42 extends from the distal end 38 to the opening proximal end 36 and includes an inner surface that defines a chamber 46 for holding or gripping fluid, and in some embodiments, includes a liquid medicament and / or other liquid. The collar 54 of the syringe 30 is disposed on the distal end 38 of the barrel 34, extends from the distal wall 40 of the barrel 34, and forms a compartment 62 that surrounds the conical needle hub 64, and the needle hub 64 is integrally formed with the distal wall 40. In one or more embodiments, the needle cannula 72 is press-fitted non-removably into the hub of the syringe. The collar 54 includes an inner surface that defines the compartment 62 and an opening distal end. The inner wall of the collar 54 has a corresponding connecting element 52. The collar 54 surrounds the needle hub 64, and the needle hub 64 projects beyond the collar 54. The inner surface of the syringe barrel 34 may have a smooth surface without protrusions or depressions. In use, the plunger rod 32 is inserted into the opening proximal end 36 of the syringe barrel 34.

[0041] The lumen of the syringe 30 that extends the length of the hollow needle cannula 72 defines an opening passage through which the needle cannula 72 is in fluid communication with the chamber of the syringe barrel of the syringe 30. In one or more embodiments, the needle cannula 72 engages the hub 64 by friction. The needle cannula 72 is disposed on the hub 64. In one or more embodiments, the needle cannula 72 has an angled needle tip 74. The needle cannula 72 according to embodiments of the present disclosure is formed from a conventional material such as steel, i.e., stainless steel. Those skilled in the art will recognize that materials such as medical plastics, composite materials, ceramics, etc. can be substituted.

[0042] FIG. 4 shows a syringe 30 that engages threadedly with a vial adapter 110. A connection element 162 of the vial adapter 110 is screwed into a corresponding connection element 52 of the syringe 30. A proximal portion 157 of an inner sidewall 154 of the elongated body 150 may be conical or tapered to form an interference fit with a needle hub 64 of the syringe 30. In certain embodiments, the interference fit between the hub 64 and the proximal portion 157 of the inner sidewall 154 forms a fluid-tight seal. In some embodiments, the interference fit may be sufficient to secure the vial adapter 110 to the syringe 30 without utilizing the connection elements (162, 52). In further embodiments, the connection elements (162, 52) may be a luer slip connection.

[0043] In use, when the vial adapter 110 is screwed onto a collar 54 of the syringe 30, a needle cannula 72 is inserted and received within a lumen 136 of the elongated body 150. The needle cannula 72 extends at least partially through a peg 130. Insertion of the needle cannula 72 is assisted by an internal bevel 164. The lumen 136 of the elongated body 150 and the cavity 152 define an inner channel or fluid channel through which the contents of a fluid container 10 (not shown) can flow into and / or out of the fluid container 10 and at least one elongated inlet 134. The needle cannula 72 is in fluid communication with the lumen 136 of the elongated body 150. Thus, when the peg 130 penetrates a seal member 12 of the fluid container 10, fluid 104 may flow from the fluid container 10 through at least one elongated inlet 134 into the lumen 136 of the elongated body 150, through the needle cannula 72, and into a chamber 46 of the syringe 30. With the vial adapter 110 screwed onto the collar 54 of the syringe 30, the peg 130 protects the needle cannula 72 and functions as a filling needle, and the needle cannula 72 functions as an administration needle for delivering a medical fluid to a patient.

[0044] As shown in FIG. 5, a fluid container 10 of a particular embodiment includes an end cap 18 that wraps around and compresses a seal member 12 against a spout 15. The spout 15 is disposed on a neck 14 of the fluid container 10. The end cap 18 includes a generally cylindrical end cap body having an inner side wall, an outer cap side wall 22, a proximal cap end 24, and a substantially open distal cap end 26. The open distal cap end 26 defines an internal cavity that extends to a bottom wall (not shown), and the bottom wall is disposed at the proximal cap end 24. The bottom wall of the end cap 18 has a concentric opening (not shown) extending therethrough. The seal member in the illustrated embodiment includes a generally cylindrical distal portion 28 and a generally cylindrical proximal portion 29. The distal portion 28 has a diameter smaller than the diameter of the proximal portion 29. The transition from the distal portion 28 to the proximal portion 29 defines a ridge 27. Other embodiments of the seal member include a generally cylindrical body having a substantially trapezoidal, triangular, or tapered cross-section. The material of the seal member 12 in some embodiments is generally an elastomeric polymer or rubber, creating a barrier that allows for repeated penetration by a conventional needle and transfer of fluid through the barrier without leakage. In one or more embodiments, the seal member 12 is in the shape of a septum.

[0045] Referring to FIG. 6, during use, the fluid container 10 is pressed against the vial adapter 110, and the vial adapter 110 removably secures the fluid container 10 to the vial adapter 110 by a plurality of protrusions 114 of the vial adapter 110. When the fluid container 10 is pressed against the distal wall 112, the protruding inner flange 116 of the plurality of protrusions 114 interferes with the end cap 18 of the fluid container 10. The interference between the protruding inner flange 116 and the end cap 18 elastically deforms the plurality of protrusions 114, allowing the fluid container 10 to be fully depressed and abut against the distal wall 112. In the fully depressed position, the protrusions 114 completely surround the end cap 18 and at least partially surround the neck 14 of the fluid container 10. The ridge 27 is adjacent to the spout 15 of the fluid container 10. The spout 15 is connected to the end cap 18 by interference press fit. In one or more embodiments, the spout 15 is connected to the end cap 18 using a screw connection, a locking mechanism, or a medical adhesive, or a combination thereof. When fully assembled, the opening of the end cap 18 is large enough to allow a conventional needle, a filling needle, or in this embodiment, the stake 130 to penetrate the seal member 12. In some embodiments, the fluid container 10 has a sealed seal member directly adhered to the spout 15 without the need for an end cap.

[0046] As shown in FIGS. 6 and 7, the cross-section of the plurality of protruding inner flanges 116 has a substantially rhombic cross-section that defines a front surface 114a, a rear surface 114b, a proximal surface 114c, and a distal surface 114d. The distal surface 114d may be a concave or rounded surface to facilitate the insertion of the end cap 18. The front surface 114a removably abuts against the neck 14 of the fluid container 10, and the length of the front surface 114a is less than the length of the neck 14. The proximal surface 114c and the front surface 114a form a spout defined by the downward position of the surfaces (114a, 114c) that capture an end cap 18 (not shown). Finally, the distal surface 114d is angled to enable centering of the seal member 12 when the fluid container 10 is pressed against the vial adapter 110. In an alternative embodiment, the fluid container 10 may have a sealed seal member directly adhered to the spout 15 without the need for an end cap, and the hook may capture a spout (not shown) of the fluid container 10.

[0047] Since the dimensions of commercially available fluid containers vary infinitely, a number of sizes of vial adapters with different wall diameters or protrusion lengths may be provided. In one or more embodiments, the diameter of the distal wall 112 is the same as or slightly larger than the diameter of the end cap 18 such that after the plurality of protrusions 114 elastically deform and return to their natural position, the protruding inner flange 116 can fit into the recess formed by the neck 14. Similarly, in some embodiments, the height of the plurality of protrusions 114 is at least the height of the end cap 18 to enable the protruding inner flange 116 to slide securely into the recess formed by the neck 14.

[0048] As shown in FIG. 8, the removable seal 90 is disposed distally to the plurality of protrusions 114 of the vial adapter 110. The removable seal 90 defines a sealed region in which the peg 130 is disposed. According to one or more embodiments, the removable seal 90 comprises a pull tab. The removable seal 90 reduces or prevents contamination of the peg 130 during shipment and storage of the safety needle device. The removable seal 90 is generally maintained in a closed position until immediately prior to the injection and / or aspiration procedure, at which time the removable seal 90 is removed from the housing. The removable seal minimizes potential particulate hazardous ingress and provides a substantially impermeable housing for the peg 130 prior to use of the vial adapter 110. The removable seal provides a sufficient seal over a range of temperature, pressure, and humidity. In certain embodiments, the syringe 30 and the vial adapter 110 are pre-packaged together as a kit 102 in a sealed or sterilized package such as a blister pack.

[0049] One aspect of the present disclosure provides a method by which a practicing physician can withdraw and then administer the contents of fluid container 10 using a vial adapter. The practicing physician may remove the assembled kit 102 from a package such as a medical tray or a thermoformed package, and then remove the removable seal 90. Next, the practicing physician may push fluid container 10 into vial adapter 110 by applying a longitudinal force to vial adapter 110. End cap 18 and neck 14 of fluid container 10 interfere with a plurality of protrusions 114, elastically deforming the plurality of protrusions 114, while peg 130 simultaneously penetrates seal member 12 and then applies a continuous longitudinal force to vial adapter 110 to penetrate seal member 12. With further depression, the plurality of protrusions 114 return to their normal position, and the projecting inner flange 116 releasably locks the neck 14 of the seal member. Further, seal member 12 is fully abutted against circular protrusion 118, and peg 130, by fully penetrating seal member 12, enables fluid communication between fluid 104 within fluid container 10 and lumen 136 via the plurality of protrusions 114.

[0050] Alternatively, the vial adapter 110 may be individually packaged and the practitioner may first secure the vial adapter 110 to the syringe 30 before withdrawing fluid 104 from the fluid container 10. In this alternative method, the connection element 162 of the vial adapter 110 is first removably secured to the corresponding connection element 52 of the syringe 30. By engaging the two connection elements (162, 52), the needle cannula 72 self - centers within the lumen 136 of the vial adapter 110. Self - centering is further assisted by a threading motion that establishes the removably fixed connection and by an internal ramp 164 within the cavity 152 of the elongate body 150. When fully secured, the needle tip 74 does not extend beyond at least one inlet 134 of the peg 130. Moving the plunger rod 32 proximally away from the barrel 34 creates a negative pressure within the barrel 34. The negative pressure causes the fluid 104 to flow into the needle cannula 72 through at least one inlet 134 and into the barrel 34, enabling fluid extraction as the negative pressure approaches zero.

[0051] In an alternative embodiment, at least one inlet 134 extends beyond the seal member 12 of the fluid container 10 when the fluid container 10 is fully depressed against the distal wall 112, and at least one inlet 134 exposes an air ventilation channel (not shown) for normalizing the internal pressure of the vial, whereby air may flow into the fluid container 10, where the negative pressure is created by pulling the plunger rod 32 proximally away from the barrel 34.

[0052] After the desired amount of fluid 104 has been drawn into barrel 34, the two connection elements (162, 52) are disengaged by turning the vial adapter 110 in the opposite direction. The practitioner may operate the fluid container 10, which remains fixed to the vial adapter 110, without fixing the vial adapter 110. By operating the fluid container 10, the needle cannula 72 is further away from the practitioner's hand due to the added length of the vial adapter 110, reducing the risk of injury. Next, the needle cannula 72 may be freely inserted into the patient's skin for administration. After administration, the vial adapter 110 may be fixed again to the used syringe 30, allowing for the disposal of the vial adapter 110, syringe 30, and fluid container 10 in accordance with acceptable hazardous waste procedures.

[0053] As shown in FIG. 8, a plurality of gripping elements 160 are longitudinally disposed along the distal portion of the outer sidewall 156. In one or more embodiments, the plurality of gripping elements 158 are longitudinally disposed ribs, which assist in removing the vial adapter 110 from the syringe 30 and provide structural support to the elongated body 150.

[0054] In yet another embodiment, the fluid container 10 is primed by first injecting air into the fluid container 10 to create a positive pressure within the fluid container 10, and then pulling the plunger rod 32 in the proximal direction away from the barrel 34 to draw out the fluid 104 and stabilizing the pressure of the fluid container 10 near zero.

[0055] References to "one embodiment", "a particular embodiment", "various embodiments", "one or more embodiments", or "an embodiment" throughout this specification mean that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. That is, appearances of phrases such as "in one or more embodiments", "in a particular embodiment", "in various embodiments", "in one embodiment", or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0056] Although the present disclosure has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the invention without departing from the spirit and scope. Accordingly, the present disclosure is intended to cover modifications and variations that are within the scope of the appended claims and their equivalents.

Claims

1. A vial adapter configured to draw fluid from a fluid container equipped with a syringe, A wall having a circular protrusion and a circular groove facing distally, the circular groove being disposed in the circular protrusion, having a plurality of protrusions extending distally from the wall, and at least one of the plurality of protrusions having a protruding inner flange configured to lock to the neck of the fluid container; A peg protruding distally from the wall and defining a length, having at least one inlet extending longitudinally along 50% of the length of the peg, either a tapered tip or at least one inlet extending a few millimeters from the tapered tip, and the at least one elongated inlet not extending up to the height of the circular protrusion; A lumen extending through the wall from the at least one inlet, the lumen defining an opening in the wall, the lumen being in fluid communication with the at least one inlet, the lumen accommodating the needle cannula of the syringe, and the needle cannula being in fluid communication with the at least one inlet; An elongated body extending proximally from the wall defining a longitudinal cavity, the cavity defining an inner wall and a proximal opening, and including a connecting member configured to connect to a syringe connecting member. A vial adapter comprising:

2. The vial adapter according to claim 1, wherein the cavity further defines an inner tapered surface, and the inner tapered surface forms an interference fit with a needle hub on the syringe.

3. The vial adapter according to claim 1, wherein the lumen and the cavity define an inner channel through which the needle cannula of the syringe passes, and the needle cannula is press-fitted non-removably into the needle hub of the syringe.

4. The vial adapter according to claim 3, wherein the needle cannula does not extend beyond the at least one inlet of the peg.

5. When the fluid container is fully pushed down against the wall, the at least one inlet of the stake does not extend beyond the seal member of the fluid container, and when the seal member is fully pushed down against the wall, the stake pierces the seal member and causes fluid communication from the fluid container through the at least one inlet and the lumen. The vial adapter according to claim 1. **Claim 6** The vial adapter according to claim 1, wherein when the fluid container is fully pushed down against the wall, the at least one inlet of the stake extends beyond the seal member of the container. **Claim 7** The vial adapter according to claim 1, wherein a cross-section of the plurality of protruding inner flanges has a substantially rhombic cross-section. **Claim 8** The vial adapter according to claim 1, wherein when the seal member of the fluid container is pressed against the stake, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion removably locks the fluid container. **Claim 9** The vial adapter according to claim 1, wherein when the seal member of the fluid container is pressed against the stake, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion permanently locks the fluid container. **Claim 10** The vial adapter according to claim 1, further comprising a removable seal disposed on the protrusion. **Claim 11** The vial adapter according to claim 1, wherein the connecting member of the elongated body comprises a male thread and the syringe connecting member comprises a female thread. **Claim 12** The vial adapter according to claim 11, wherein the connecting member of the elongated body and the syringe connecting member comprise a luer fitting. **Claim 13** The vial adapter according to claim 1, wherein the connecting member of the elongated body includes a flange, and the syringe connecting member includes a twist-lock receptacle.

14. A fluid extraction kit comprising a vial adapter, a fluid container, and a syringe configured to draw fluid from the fluid container together with the vial adapter, The fluid container has a neck and a seal member that abuts against the neck. The syringe includes a plunger rod and a barrel. The barrel defines a proximal end and a distal end of an opening in which the plunger rod is disposed. The distal end defines a distal wall. The distal wall has a collar and an integrally formed needle hub. A needle cannula is disposed within the lumen of the needle hub. The needle cannula and the needle hub are in fluid communication with the barrel. The collar has a corresponding connecting member. The vial adapter A wall having a circular protrusion and a circular groove facing distally, the circular groove being disposed in the circular protrusion, the wall having a plurality of protrusions extending distally from the wall, at least one of the plurality of protrusions having a protruding inner flange configured to lock to the neck of the fluid container. A stake having a tip protruding distally from the wall defining the length, the stake having at least one inlet extending longitudinally along 50% of the length of the stake, either a slanted tip or at least one inlet extending longitudinally for several millimeters from the slanted tip, the at least one elongated inlet not extending to the height of the circular protrusion. A lumen extending through the wall from the at least one inlet, defining an opening in the wall and in fluid communication with the at least one inlet. An elongated body extending proximally from the wall defining a longitudinal cavity, the cavity defining an inner wall and a proximal opening, the elongated body having a connecting member disposed longitudinally along the outer wall of the elongated body, the connecting member configured to removably secure the vial adapter to a syringe connecting member. A fluid extraction kit comprising **Claim 15** The fluid extraction kit according to claim 14, wherein the cavity further defines an inner tapered surface, and the inner tapered surface forms an interference fit with a needle hub on the syringe. **Claim 16** The fluid extraction kit according to claim 14, wherein the lumen and the cavity define an inner channel through which the needle cannula of the syringe passes, the needle cannula is not press-fitted removably into the needle hub of the syringe, and the cannula does not extend beyond the at least one inlet of the stake. **Claim 17** The fluid extraction kit according to claim 14, wherein when the fluid container is fully pushed down against the wall, the at least one inlet of the stake does not extend beyond the seal member, and when the seal member is fully pushed down against the wall, the stake pierces the seal member to provide fluid communication from the fluid container through the at least one inlet and the lumen. **Claim 18** The fluid extraction kit according to claim 14, wherein when the seal member of the fluid container is pressed against the stake, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion removably locks the fluid container. **Claim 19** The fluid extraction kit according to claim 14, wherein when the seal member of the fluid container is pressed against the stake, the protrusion elastically deforms, and when the fluid container is fully pressed against the wall, the protrusion permanently locks the fluid container. **Claim 20** The fluid extraction kit according to claim 14, wherein the connecting member of the elongated body comprises a male thread and the syringe connecting member comprises a female thread.

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