Vial Access Needle Device

Abstract

A vial access needle device is described. The device includes a base with a base plate and a base wall extending proximally from the base plate. The base wall is configured to receive a portion of the base of a vial. The device also includes a cap having a proximal closed end and configured to be removably attached to the base, the proximal closed end having a proximal side and a distal side. A cap wall extends distally from the proximal closed end and is configured to receive a reduced diameter portion and a portion of the vial. The cap is removably attached to the base plate and configured to form an airtight seal with the base.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to Provisional Patent Application No. 63 / 452,587, filed March 16, 2023, which is incorporated herein by reference in its entirety.

[0002] The present technology relates to vial access needle ("VAN") devices, and in particular to VAN devices for use in sterile environments such as operating rooms. [Background technology]

[0003] Liquid medications are typically provided to health care professionals and hospitals in vials. To access the medication contained in the vial, a doctor or clinician would typically use a syringe to extract the medication from the vial. To prevent leakage and limit exposure of the fluid to air, the top of the vial is often configured to contain a small opening suitable for receiving the needle of a syringe. Thus, to extract the medication into the syringe, the user must first align the needle with a corresponding opening in the top of the vial and then insert the needle. This process can present risks to the user. For example, if the needle is not properly aligned with the vial, the resulting contact may cause the needle to break or accidentally puncture the user.

[0004] To mitigate these risks, clinicians may use VAN devices. Such devices allow clinicians to safely access medications in medication vials without the risk of accidental needlesticks. VAN devices typically include a cap with a needle extending from the top of the cap. The top of the vial fits into the cap, and the needle enters the vial through an opening in the top of the vial. VAN devices also typically include a luer connector, allowing a user to connect a syringe to the VAN device and thereby extract the medication through the needle.

[0005] The foregoing examples of the related art and their associated limitations are intended to be illustrative and not exhaustive. Other limitations of the related art will become apparent to those skilled in the art upon a perusal of the specification and an examination of the drawings. Summary of the Invention [Means for solving the problem]

[0006] The following aspects and embodiments thereof described and illustrated below are intended to be exemplary and illustrative, not limiting in scope.

[0007] In one aspect, provided is a device comprising a base including a base plate and a base wall. The base wall extends proximally from the base plate and is configured to receive a portion of the base of a vial or container. The device also includes a cap having a proximal closed end and configured to be removably attached to the base, the proximal closed end having a proximal side and a distal side. The cap includes a cap wall extending distally from the proximal closed end, the cap wall configured to receive a reduced diameter portion or other portion of the vial or container. In embodiments, the cap is configured to be removably attached to the base plate. In embodiments, the cap wall forms an airtight seal with the base when attached to the base.

[0008] In one embodiment, the device further comprises a gripper fixedly attached to the base. In some embodiments, the gripper extends proximally from the base plate. In other embodiments, the gripper surrounds the base wall.

[0009] In one embodiment, the distal side of the proximal closed end is configured to receive a needle, hi some embodiments, the proximal side of the proximal closed end is configured to receive a syringe.

[0010] In one embodiment, the cap is configured to be removably attached to the base plate by inserting the cap wall between the gripping portion and the base wall.

[0011] In some embodiments, the device is a medical device.

[0012] In another aspect, a medical device is provided. The medical device includes a base including a base plate and a base wall extending proximally from the base plate, the base wall configured to receive a portion of the base of a separate external vial or container. The device further includes a gripper fixedly attached to the base and, optionally, extending proximally from the base plate and surrounding the base wall. The device further includes a cap having a proximal closed end and configured to be removably attached to the base, the proximal closed end having a proximal side and a distal side. The cap includes a cap wall extending distally from the proximal closed end, the cap wall configured to receive a necked-down portion or other portion of the vial or container. The distal side of the proximal closed end is configured to receive a needle (external to the device and provided by a user of the device). The proximal side of the proximal closed end is configured to receive a syringe (external to the device and provided by a user of the device). The cap is configured to be removably attached to the base plate by inserting the cap wall between the grip and the base wall. In some embodiments, the cap wall forms an airtight seal with the base when attached to the base.

[0013] In another aspect, a method for withdrawing a composition from a vial or container is provided, the method comprising providing a device as described herein and directing insertion of a vial or container comprising the composition into the device.

[0014] In some embodiments, the composition in the vial or container is a flowable composition. In some embodiments, the composition in the vial or container is a semi-solid or viscous composition or a non-viscous composition.

[0015] In some embodiments, the method further comprises withdrawing the composition from the container while the container is inserted into the device. In some embodiments, withdrawing comprises withdrawing using a needle. In some embodiments, withdrawing comprises withdrawing using a needle attached to the barrel of a syringe.

[0016] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by review of the following descriptions.

[0017] Additional embodiments of the device and its method of use will be apparent from the following description, drawings, and claims. As can be understood from the foregoing and following description, every feature described herein, and every combination of two or more of such features, is included within the scope of the present disclosure, provided that the features included in such combinations are not mutually inconsistent. In addition, any feature or combination of features may be specifically excluded from any embodiment of the present disclosure. Additional aspects and advantages of the present disclosure are set forth in the following description and claims, and will become apparent, particularly when considered in conjunction with the accompanying examples and drawings. [Brief explanation of the drawings]

[0018] [Figure 1] FIG. 1 is a semi-transparent perspective view of an exemplary VAN device.

[0019] [Figure 2] FIG. 2 is a cutaway perspective view of an exemplary VAN device.

[0020] [Figure 3]FIG. 3 is a perspective view of the base of an exemplary VAN device.

[0021] [Figure 4] FIG. 4 is a cutaway side view of an exemplary VAN device assembled with a vial. DETAILED DESCRIPTION OF THE INVENTION

[0022] Detailed Description I. Definition Various aspects will now be described more fully hereinafter. However, such aspects may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art.

[0023] When a range of values ​​is provided, each intervening value between the upper and lower limits of that range, and any other stated or intervening value within that stated range, is intended to be encompassed within the present disclosure. For example, if a range of 1 μm to 8 μm is stated, then 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, and 7 μm, as well as ranges of values ​​greater than or equal to 1 μm and ranges of values ​​less than or equal to 8 μm, are also intended to be expressly disclosed.

[0024] The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to a "polymer" includes a single polymer as well as two or more than two of the same or different polymers, reference to an "excipient" includes a single excipient as well as two or more than two of the same or different excipients, etc.

[0025] The term "about," particularly when referring to a given numerical quantity, is intended to encompass deviations of plus or minus 5 percent.

[0026] The compositions of the present disclosure can comprise, consist essentially of, or consist of the disclosed components.

[0027] All percentages, proportions, and ratios are based on the total weight of the composition and all measurements are made at about 25° C. unless otherwise specified.

[0028] The phrase "pharmaceutically acceptable" is employed herein to refer to compounds, salts, compositions, dosage forms, etc. that are, within the scope of sound medical judgment, suitable for use in contact with the tissues of humans and / or other mammals, without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit / risk ratio. In some aspects, "pharmaceutically acceptable" means approved by a federal or state government regulatory agency or listed in the United States Pharmacopeia or other generally recognized pharmacopoeias for use in mammals (e.g., animals), and more particularly, humans.

[0029] The term "treating" is used herein with reference to methods of treating, for example, cancer, and generally includes administration of a compound or composition to reduce the frequency of or delay the onset of symptoms of a medical condition (e.g., cancer) in a subject relative to a subject not receiving the compound or composition. This can include reversing, reducing, or halting symptoms, clinical signs, and underlying pathology in a manner that improves or stabilizes the subject's condition (e.g., regression of tumor growth).

[0030] Less than the complete range of the disclosure may be claimed for any reason, reserving the right to exclude or exclude, with the reservation, any individual member of any such group, including any subrange or combination of subranges within that group that may be claimed according to range or in any similar manner. Furthermore, less than the complete range of the disclosure may be claimed for any reason, reserving the right to exclude or exclude, with the reservation, any individual substituent, analog, compound, ligand, structure, or any member of the group or claimed group.

[0031] Throughout this disclosure, various patents, patent applications, and publications are referenced. The disclosures of these patents, patent applications, and publications in their entireties are incorporated by reference into this disclosure to more fully describe the state of the art known to those skilled in the art as of the date of this disclosure. In the event of any inconsistency between the cited patents, patent applications, and publications and this disclosure, the present disclosure will control.

[0032] For convenience, certain terms employed in the specification, examples, and claims are collected here. Unless defined otherwise, all technical and scientific terms used in this disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0033] II. Devices Existing VAN devices are configured to fit over the top of a vial, leaving the body and bottom of the vial exposed. Because vials typically cannot be sterilized before use and are not kept in a sterile environment, existing VAN devices are not suitable for use in sterile environments, such as operating rooms. In this environment, surfaces may be divided into sterile and non-sterile areas. The vial is placed on a non-sterile surface, and a sterile cap is applied over the top of the vial. A sterile syringe is then attached to the Luer connector, and the drug is extracted. To prevent contamination of the sterile environment (sterile area), the process of extracting the drug must be rigorously planned to ensure that non-sterile components or personnel do not come into contact with sterile components or personnel. This process therefore increases the risk of site contamination.

[0034] As a result, there is a need in the art for a VAN device that can be used in a sterile environment without the need for non-sterile components or personnel to be present in the environment and without the need to protocolize the process for drawing the drug out of the vial.

[0035] The present technology addresses these and other shortcomings by providing a VAN device that completely surrounds the vial and provides a sterile shield. The clinician can attach the VAN device to the vial outside of the sterile environment, thus eliminating the need for any non-sterile surfaces or personnel to be present in the vicinity of the site.

[0036] An exemplary VAN device embodying the present technology includes a base plate including a base wall and a gripping portion. The VAN device further includes a cap with a closed end and configured to be removably attached to the base. The interior of the VAN device cap includes a needle configured to enter a vial. The exterior of the VAN device cap includes a connector, such as a Luer connector, configured to receive a syringe. During use, a vial is placed on the base within the base wall. The cap is then affixed to the top of the vial and lowered onto the base plate, and the cap wall is attached to the base plate between the base wall and the gripping portion. Optionally, this connection forms an airtight seal between the base and cap, allowing the exterior of the VAN device to remain sterile at all times. The VAN device completely surrounds the vial, so no part of the vial can come into contact with the outside.

[0037] 1-2 , an exemplary VAN device as described herein is shown to include a base 1 at the distal end of the VAN device. Base 1 comprises a base plate 10 and a base wall 11 extending proximally from base plate 10. The base further comprises, in some embodiments, an optional gripping portion 12. In some embodiments, the gripping portion extends proximally from base plate 10 and surrounds a portion of base wall 11. The exemplary VAN device further includes a cap 2. Cap 2 comprises a proximal closed end 20 and a cap wall 21 extending distally from proximal closed end 20. Cap wall 21 is shaped to receive a necked-down portion and a portion of a vial (not shown). The proximal side of proximal closed end 20 is configured to receive a needle 22. The distal side of proximal closed end 20 includes a luer 23 that mates with a luer on a syringe (not shown), although other connectors may be used. Cap 2 is configured to be removably attached to base plate 10 by inserting cap wall 21 between gripping portion 12 (if present) and base wall 11. Cap wall 21, optional gripping portion 12, and base wall 11 are sized and configured so that cap wall 21 can be inserted between optional gripping portion 12 and base wall 11, or between cap wall 21 and base wall 11 when gripping portion 12 is not present. In certain embodiments, cap wall 21, optional gripping portion 12, and base wall 11 are sized and configured so that cap wall 21 can form an airtight seal between cap 2 and base plate 10, thereby preventing non-sterile vials from contacting the sterile field.

[0038] As shown in Figure 2, base plate 10, in some embodiments, does not contain any holes or openings. As shown in Figure 3, base wall 11 and, if present, gripping portion 12, are fixedly attached to and extend distally from base plate 10. Thus, base 1 comprises a unitary component that may be generated by welding separate components together or by forming base 1 in a single casting. This ensures that, after assembly, the base of the vial cannot contact the outside of the VAN device.

[0039] To assemble the VAN device, as shown in FIG. 4 , vial 3 is placed on base 1. In some implementations, vial 3 is inserted into a cavity formed by base wall 11, for example, such that vial 3 is secured by base wall 11. Cap 2 is then placed over the vial and secured to base 1 by securing cap wall 21 between base wall 11 and optional gripping portion 12. In certain embodiments, cap 2 is placed over the vial and secured to base 1 by securing cap wall 21 between base wall 11 and forming an airtight seal between cap 2 and base 1. In embodiments, needle 22 then punctures the top of vial 3 once cap 2 is placed over the vial. Once cap 2 is fully secured to base 1, needle 22 may extend through the top of vial 3, thereby allowing a composition, such as a pharmaceutical drug, to be withdrawn out through luer 23 into a syringe (not shown). After assembly, vial 3 is fully enclosed by base 1 and cap 2. This process may be accomplished in a non-sterile environment and does not require the presence of non-sterile components within the sterile environment. As described above, this allows the exterior of the VAN device to remain sterile and prevents any part of the non-sterile vial from coming into contact with the sterile field.

[0040] III. Method of Use In another aspect, a method for administering a composition is provided. In some embodiments, the composition is a flowable composition. In some embodiments, the composition is a flowable sterile composition, such as a pharmaceutical composition to be administered in vivo. In some embodiments, the composition is a semi-solid composition. In some embodiments, the composition is a semi-solid sterile composition. As used herein, "semi-solid" refers to the mechanical-physical state of a material that is flowable under moderate stress. Semi-solid materials may generally have a viscosity of about 1,000 to 3,000,000 mPa-s at 37°C, or a viscosity of about 1,000 to 50,000 mPa-s at 37°C. Thus, in embodiments, the composition is a viscous composition that may have a viscosity equal to or greater than about 100 cP (100 mPa-s) at 25°C, for example. In embodiments, the composition is a viscous composition, which may have a viscosity of, for example, greater than or equal to about 100 cP (100 mPa-s) at 25° C. and less than or equal to about 3,000,000 mPa-s at 37° C., less than or equal to 50,000 mPa-s at 37° C., less than or equal to 20,000 mPa-s at 37° C., or less than or equal to 10,000 mPa-s at 37° C. In certain embodiments, the composition is a non-viscous composition, such as an aqueous-based or organic solvent-based composition. In embodiments, the non-viscous composition may have a viscosity of less than or equal to about 100 cP (100 mPa-s) at 25° C.

[0041] In one embodiment, the VAN is for use with a vial, which contains a semi-solid therapeutic composition comprising an active agent and a pharmaceutically acceptable excipient, the semi-solid composition intended for delivery via a needle. In an embodiment, the needle is attached to a syringe. The semi-solid (or flowable) composition is removed from the vial via the needle and / or syringe for administration to a subject in need. An "active agent" or "active ingredient" refers to any compound or mixture of compounds that produces a beneficial or useful result. Generally, an "active agent" or "drug" refers to any organic or inorganic compound or substance that has biological activity and is adapted or used for therapeutic purposes. An active agent is distinguishable from such pharmaceutically acceptable excipients or ingredients, such as vehicles, carriers, diluents, lubricants, binders, and other compounding agents that support, encapsulate, or otherwise protect the ingredients. Examples of active agents are pharmaceutical, agricultural, or cosmetic agents. Suitable pharmaceutical agents include locally or systemically acting pharmaceutically active agents, which may be administered to a subject by topical or intralesional application (including, for example, application to abraded skin, lacerations, puncture wounds, etc., as well as into surgical wounds or incisions) or by injection, such as subcutaneous, intradermal, intramuscular, intraocular, or intraarticular injection.

[0042] In some embodiments, the semi-solid therapeutic composition comprises a polymer as a pharmaceutically acceptable excipient. In some embodiments, the polymer is a biodegradable and / or biodegradable polymer. In some embodiments, the biodegradable and / or biodegradable polymer is a synthetic polymer. Exemplary polymers include polylactic acid, poly(lactic-co-glycolic) acid, and polycaprolactone, each of which is an exemplary biodegradable polymer. Another example is a polyorthoester, including the non-thermoplastic polyorthoesters described in U.S. Pat. Nos. 6,613,355 and 9,694,079 (incorporated herein by reference). While any polyorthoester can be used, preferred polyorthoesters are composed of alternating residues resulting from the reaction of a diketene acetal and a diol, with each adjacent pair of diketene acetal-derived residues separated by the residue of the reacted diol. The polyorthoesters may comprise α-hydroxy acid-containing subunits, i.e., subunits derived from α-hydroxy acids or their cyclic diesters, such as subunits comprising glycolide, lactic acid, or combinations thereof, i.e., subunits comprising poly(lactic acid-co-glycolide), including all ratios of lactic acid to glycolide, such as 75:25, 65:35, 50:50, etc. Such subunits are also referred to as latent acid subunits, and these latent acid subunits also fall within the more general "diol" classification as used herein due to their terminal hydroxyl groups. Polyorthoesters can be prepared, for example, as described in U.S. Pat. Nos. 4,549,010 and 5,968,543, incorporated herein by reference.

[0043] In some embodiments, the polymer is a non-biodegradable and / or non-biodegradable polymer such as silicone rubber, polyethylene, acrylic, polyurethane, polypropylene, and polymethyl methacrylate, etc. In other embodiments, the polymer can be a biologically compatible synthetic or natural biodegradable polymer such as polyglycolide, polylactic acid, polyhydroxybutyric acid, polyethylene glycol, cellulose, chitosan, and hyaluronic acid.

[0044] In another embodiment, the pharmaceutically acceptable excipient forms an oil phase, resulting in a flowable composition that is an emulsion, such as an oil-in-water emulsion. For example, the oil phase can comprise one or more of an emulsifier, an oil, and a surfactant. The aqueous phase of the oil-in-water emulsion can comprise one or more of an osmolality adjuster and a pH adjuster. The active agent can be lipophilic or hydrophilic and will therefore partition into the oil or aqueous phase of the emulsion. Exemplary oil-in-water emulsions are described, for example, in U.S. Pat. No. 9,808,465 (incorporated herein by reference). In some embodiments, the oil of the oil-in-water emulsion is selected from the group consisting of structurally modified or hydrolyzed coconut oil, olive oil, soybean oil, safflower oil, triglycerides, octyl and decyl glycerates, ethyl oleyl, glyceryl linoleate, ethyl linoleate, glyceryl oleate, cholesteryl oleyl / linoleyl, or mixtures thereof. In certain embodiments, the emulsifier is selected from the group consisting of egg phospholipids, soybean phospholipids, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol, phosphatidylinositol, phosphatidic acid, mixed-chain phospholipids, lysophospholipids, hydrogenated phospholipids, partially hydrogenated phospholipids, and mixtures thereof. Other suitable emulsifiers include propylene glycol mono- and di-fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene fatty acid esters, polyoxyethylene-polyoxypropylene copolymers and block copolymers, salts of fatty alcohol sulfates, sorbitan fatty acid esters, esters of polyethylene-glycol glycerol ethers, oil- and wax-based emulsifiers, glycerol monostearate, and sorbitan glycerol fatty acid esters.

[0045] As mentioned, the flowable composition is provided to a user in a vial or container, and the composition in the vial or container is sterilized and ready for in vivo administration. The exterior of the vial is not sterilized. A method for withdrawing a flowable composition from its vial or container is provided. The method includes providing a device as described herein and instructing insertion of a vial or container containing the flowable composition into the device. In some embodiments, the method further includes withdrawing the flowable composition from the container while the container is inserted into the device. In some embodiments, withdrawing includes withdrawing using a needle. In some embodiments, withdrawing includes withdrawing using a needle attached to the barrel of a syringe. Also, as can be understood from the disclosure herein, the flowable composition may be a semi-solid or viscous composition or a non-viscous composition.

[0046] The foregoing is for purposes of illustration of the present device and its uses. It will be readily apparent to those skilled in the art that the present device may be modified or substituted in various ways without departing from the spirit and scope of the present invention. The invention is therefore defined by the scope of the claims which follow, and it is intended that such claims be interpreted as broadly as is reasonable.

Claims

1. A device, a base comprising a base plate; a base wall extending proximally from the base plate, the base wall configured to receive a portion of the base; a cap configured to be removably attached to the base, the cap having a proximal closed end, the proximal closed end having a proximal side and a distal side; Equipped with the cap includes a cap wall extending distally from the proximal closed end, the cap wall configured to receive a reduced diameter portion and a portion of the vial; the cap is configured to be removably attached to the base plate; device.

2. The device of claim 1 , further comprising a grip portion fixedly attached to the base portion.

3. The device of claim 2 , wherein the gripping portion extends proximally from the base plate.

4. The device of claim 2 , wherein the gripping portion surrounds the base wall.

5. The device of claim 2 , wherein the cap is configured to be removably attached to the base plate by inserting the cap wall between the gripping portion and the base wall.

6. The device of any one of claims 1 to 5, wherein the cap wall forms an airtight seal with the base when attached to the base.

7. The device of any one of claims 1-6, wherein the distal side of the proximal closed end is configured to receive a needle.

8. The device of any one of claims 1-7, wherein the proximal side of the proximal closed end is configured to receive a syringe.

9. A medical device comprising: a base comprising a base plate; a base wall extending proximally from the base plate, the base wall configured to receive a portion of the base; a gripper fixedly attached to the base, the gripper extending proximally from the base plate and surrounding the base wall; a cap having a proximal closed end configured to be removably attached to the base, the proximal closed end having a proximal side and a distal side; Equipped with the cap includes a cap wall extending distally from the proximal closed end, the cap wall configured to receive a reduced diameter portion and a portion of the vial; a distal side of the proximal closed end configured to receive a needle; a proximal side of the proximal closed end configured to receive a syringe; the cap is configured to be removably attached to the base plate by inserting the cap wall between the gripping portion and the base wall. Medical devices.

10. The medical device of claim 9 , wherein the cap wall forms an airtight seal with the base when attached to the base.

11. A method for withdrawing a composition from its container, comprising inserting a container comprising said composition into a device according to any one of claims 1-10.

12. 12. The method of claim 11, wherein the composition is withdrawn from the container while the container is inserted into the device.

13. The method of claim 12, wherein the composition is withdrawn using a needle.

14. The method of claim 13 , wherein the needle is attached to the barrel of a syringe.

15. The method of any one of claims 11 to 14, wherein the composition is a flowable composition.

16. The method of claim 15, wherein the flowable composition is a semi-solid or non-viscous composition.

17. 17. The method of claim 16, wherein the semi-solid composition has a viscosity of greater than about 100 cP at 25°C and less than about 50,000 cP at 37°C, or greater than about 100 cP at 25°C and less than about 30,000 cP at 37°C.

18. 17. The method of claim 16, wherein the semi-solid composition has a viscosity of about 1,000 to 50,000 cP at 37°C.

19. 17. The method of claim 16, wherein the non-viscous composition has a viscosity of less than or equal to 100 cP at 25°C.

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