Needle cap for medical injector

Abstract

The invention relates to a needle cap for a medical injector, which is convenient to penetrate through a plug of a small medicine bottle and directly suck medicine into the injector through an injection needle of the injector. The proximal end of the needle cap is coupled to the needle hub of the syringe, wherein the outer diameter of the syringe needle is captured within and in sealing engagement with the inner diameter of the needle seal. The open tip tapered distal end of the needle cap is inserted through the stopper of the drug vial. Retraction of the syringe plunger draws medication through the open tip of the needle cap, directly through the syringe needle, into the syringe chamber. After completion of aspiration of the medication into the syringe, the needle cap is removed and the syringe is ready to administer the medication to the patient.

Description

Technical Field

[0001] The present disclosure generally relates to a needle cap configured to cover a medical syringe. More particularly, embodiments of the needle cap of the present disclosure facilitate direct aspiration of a drug from a vial into the injection needle of a medical syringe when the needle cap is coupled to the needle hub of the syringe. Background Art

[0002] Liquid medications and other pharmaceuticals are typically stored in glass ampoules or vials and sealed with elastomeric stoppers, including stoppers with or without slit septa (by way of non-limiting example). To aspirate the drug contained within the vial into a syringe for subsequent administration to a patient, a cylindrically contoured blunt fill needle is typically attached to the Luer connector of the syringe in order to pierce the stopper / septa, after which the syringe plunger is retracted to aspirate the drug into the syringe chamber. After filling the syringe with the desired amount of drug, the blunt fill needle is separated from the syringe and replaced with a hypodermic needle for injection into the patient. Attaching and replacing the two separate types of needles to the syringe is both cumbersome and time consuming. Each separate attachment introduces potential drug administration errors and / or contamination. When the blunt fill needle is separated from the syringe, any remaining drug aspirated into the lumen of the fill needle that is not contained within the syringe chamber is wasted. The generally cylindrically contoured blunt fill needle does not allow complete aspiration of all of the drug contained within the vial because the flat needle tip cannot maintain contact with the residual drug contained within the bottom corners of the vial. Summary of the Invention

[0003] Embodiments of the present disclosure relate to a needle cap configured to cover a medical syringe, the needle cap facilitating aspiration of a drug into the syringe through the stopper of a drug vial. When the needle cap is coupled to the needle hub of the syringe, the drug is aspirated directly through the injection needle of the syringe from the vial. The proximal end of the needle cap is coupled to the needle hub of the syringe, wherein the outer diameter of the syringe needle is captured within and sealingly engages the inner diameter of a needle seal. The open tip tapered distal end of the needle cap is inserted through the stopper of the drug vial. Retraction of the syringe plunger aspirates the drug through the open tip of the needle cap, directly through the syringe needle, into the syringe chamber. After completing aspiration of the drug into the syringe, the needle cap is removed and the syringe is ready for administration of the drug to the patient.

[0004] One aspect of the present disclosure relates to a needle cap for a medical syringe. The needle cap includes a tubular body having an inner wall surface that defines a cap lumen. The inner wall surface defines a first cavity portion of an end-open female Luer taper profile on a proximal end of the tubular body configured to selectively couple to a needle hub of a syringe. The inner wall surface defines an open cap tip at a distal end of the tubular body. A needle seal within the cap lumen divides the cap lumen into a second proximal portion and a third distal portion isolated from each other. The needle seal defines a through-hole that communicates with both the isolated second proximal portion and the third distal portion of the cap lumen. The through-hole is in unobstructed direct fluid communication with the open cap tip, and the through-hole defines an inner diameter configured to matingly seal with an outer diameter of the needle when the syringe needle is captured therein. The tubular body has a tapered frustoconical outer surface profile at its distal end that terminates at the open cap tip.

[0005] Another aspect of the present disclosure relates to a syringe having a needle cap. The syringe includes a syringe barrel having a proximal end, a distal end, and a syringe cavity within the syringe barrel, as well as a plunger and a plunger stopper coupled within the proximal end of the syringe barrel. A male Luer connector is oriented on the proximal end of the syringe barrel and is in fluid communication with the syringe cavity. A Luer needle hub is coupled to the male Luer connector and is in fluid communication with the syringe cavity. The syringe includes a hollow syringe needle having a distal open needle tip and a proximal end coupled to the Luer needle hub and in fluid communication with the syringe cavity. The syringe includes a needle cap having a tubular body having an inner wall surface that defines a cap lumen that captures the distal open needle tip. The inner wall surface of the needle cap defines a first cavity portion of an end-open female Luer taper profile on a proximal end of the tubular body coupled to the needle hub. The inner wall surface of the cap also defines an open cap tip at a distal end of the tubular body. A needle seal within the cap lumen divides the cap lumen into a second proximal portion and a third distal portion isolated from each other. The needle seal defines a through-hole that communicates with both the isolated second proximal portion and the third distal portion, and the through-hole has an inner diameter configured to matingly seal with an outer diameter of the syringe needle captured therein. The distal open needle tip is oriented within the third distal portion of the cap lumen and is in unobstructed direct fluid communication with the open cap tip. The tubular body has a tapered frustoconical outer surface profile at its distal end that terminates at the open cap tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, wherein:

[0007] Figure 1 is an isometric view of a medical syringe of the present disclosure having a coupled needle cap and needle shield;

[0008] Figure 2 is Figure 1 an axial cross-sectional view of a medical syringe having a coupled needle cap and needle shield;

[0009] Figure 3 A is Figure 2 an axial cross-sectional view of a needle cap with an inserted syringe needle and needle hub;

[0010] Figure 3 B is an axial cross-sectional view of an alternative embodiment of a medical syringe having a coupled needle cap and needle shield and an inserted syringe needle and needle hub;

[0011] Figure 4 is Figure 1 an exploded view of a medical syringe, needle cap, and needle shield; and

[0012] Figure 5 is Figure 1 a view of the needle cap and syringe piercing the stopper of a vial to aspirate medication.

[0013] For ease of understanding, the same reference numerals are used, where possible, to designate the same elements common to the figures. The figures are not drawn to scale. DETAILED DESCRIPTION

[0014] A needle cap for a medical syringe facilitates piercing the stopper of a vial to aspirate medication into the syringe. When the needle cap is coupled to the needle hub of the syringe, medication is aspirated directly through the injection needle of the syringe from the vial. The proximal end of the needle cap is coupled to the needle hub of the syringe, where the outer diameter of the syringe needle is captured within and sealingly engages the inner diameter of a needle seal. The open-tip tapered distal end of the needle cap is inserted through the stopper of the vial. Retraction of the syringe plunger aspirates medication through the open tip of the needle cap, directly through the syringe needle, into the syringe chamber. The needle seal blocks fluid communication with the proximal portion of the needle cap chamber between the seal and the proximal end of the needle cap, such that excess medication not aspirated into the syringe chamber is not wasted. The tapered distal tip of the needle cap facilitates complete aspiration of medication from the vial. After aspirating the medication into the syringe, the needle cap is removed and the syringe is ready to administer the medication to a patient.

[0015] Before describing several 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 set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in many ways.

[0016] In the present disclosure, a convention is followed where the distal end of a device is the end closest to the patient and the proximal end of the device is the end farthest from the patient and closest to the practitioner.

[0017] The following definitions are provided for terms used in this disclosure. As used herein, the use of "a", "an", and "the" includes both singular and plural.

[0018] As used herein, the term "Luer connector" refers to a connection collar, which is a standard method for attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. In some embodiments, the Luer connector includes a Luer slip connector, which includes male and female interlocking tubes (male Luer slip connector and female Luer slip connector), which are slightly tapered so as to better hold together even by a simple press / twist fit. The Luer connector may optionally include an additional threaded outer edge to make it more secure. The male end of the Luer connector is generally associated with a flush syringe and can be interlocked and connected to the female end located on a vascular access device (VAD). The Luer connector also has a distal end passage for releasably attaching the Luer connector to the hub of the VAD and a proximal end passage for releasably attaching the Luer connector to the syringe barrel.

[0019] As used herein, ISO 80369-7:2016 defines the specifications of a standard Luer connector, including a 6% taper between the distal end and the proximal end. The male standard Luer connector increases from the open distal end to the proximal end. The female standard Luer connector decreases from the open proximal end to the distal end. According to ISO 80369-7:2016, the outer cross-sectional diameter measured at 0.75 mm from the distal end of the tip of the male standard Luer connector is between 3.970 mm and 4.072 mm. The length of the male standard Luer taper is between 7.500 mm and 10.500 mm. The outer cross-sectional diameter measured at 7.500 mm from the distal end of the tip is between 4.376 mm and 4.476 mm. As used herein, the phrases "male standard Luer connector" and "female standard Luer connector" shall refer to connectors having the dimensions described in ISO 80369-7 (which is hereby incorporated by reference in its entirety into this document).

[0020] As will be readily appreciated by those skilled in the relevant art, although descriptive terms such as "tip", "hub", "thread", "protrusion / plug", "boss", "bevel", "wall", "top", "side", "bottom", etc. are used throughout this specification to facilitate understanding, they are not intended to limit any of the components that can be used in combination or alone to implement the various aspects of the embodiments of this disclosure.

[0021] The matters illustrated in this specification are provided to assist in a comprehensive understanding of the exemplary embodiments of the present disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. Additionally, descriptions of well-known functions and structures are omitted for clarity and brevity.

[0022] In an exemplary implementation of an embodiment of the present disclosure, Figures 1 to 3 syringe 10 is depicted. Syringe 10 includes a syringe barrel 12 having a proximal end 14 and a distal end 16. A plunger 18 and an attached plunger stopper 20 are inserted into the proximal end 14 of syringe barrel 12. A syringe chamber 21 is defined between the distal end 16 of syringe barrel 12 and the distal end of plunger stopper 20. A male Luer connector 22 on the distal end 16 of syringe barrel 12 is in fluid communication with syringe chamber 21. A needle hub 24 is coupled to male Luer connector 22, which is also in fluid communication with syringe chamber 21. A hollow syringe needle 26 has a proximal end coupled to needle hub 24 and a sharp distal open needle tip 28 for subcutaneous puncture of a patient. The distal open needle tip 28 is in fluid communication with syringe chamber 21 via a lumen defined within syringe needle 26.

[0023] Referring Figure 2 and Figure 3 , needle cap 30 has a hollow tubular body 31 having a proximal end 32 incorporating a radially outwardly projecting gripping flange 33. A first inner wall surface 34 of hollow tubular body 31 defines an end-open female Luer tapered profile, a first chamber portion 35. The first inner wall surface 34 is coupled to the outer surface of needle hub 24 in a mutually sliding fit, friction engagement. In other embodiments, the first inner wall surface defines a female threaded Luer connector including an internal female thread of the threaded Luer connector configured for engagement with a corresponding male thread of a threaded Luer hub including a male threaded Luer connector. The inner wall of hollow tubular body 31 defines a necked-down portion 36 distal to first inner wall surface 34. The distal end of necked-down portion 36 within hollow tubular body 31 has a reduced diameter inner wall surface 38 which in turn defines a proximal second portion 39 of the needle chamber and an inwardly projecting radial lip 40. The inner wall of hollow tubular body 31 distal to radially projecting lip 40 further defines a seal chamber inner wall 42 and a seal retention shoulder 44.

[0024] The annular needle seal 46 is oriented within the inner wall 42 of the seal cavity between an inwardly projecting radial lip 40 and a seal retention shoulder 44. The needle seal 46 has an outer diameter surface 48 that sealingly engages the inner wall 42 of the seal cavity. The annular needle seal defines a through hole 50 between its proximal axial end 52 and its distal axial end 54. The through hole 50 receives and captures the syringe needle 26 therein and has an inner diameter surface that sealingly engages the outer surface of the syringe needle. The open needle tip 28 projects outwardly from the distal axial end 54 of the needle seal 46 and is in fluid communication with the open distal cap tip 56 of the needle cap 30. The open distal cap tip 56 of the needle cap 30 is in direct, unobstructed fluid communication with the syringe chamber 21 through the syringe hub 24 via a fluid flow path that passes from the open needle tip 28 of the syringe needle 26 through the lumen of the syringe needle 26. The needle seal 46 divides the inner cavity of the needle cap 30 into a proximal second portion 39 and a distal third portion 60. The proximal second portion 39 is defined between the proximal axial end 52 of the needle seal 46 and the first cavity portion 35. The distal third portion 60 is defined between the distal axial end 54 of the needle seal 46 and the open distal cap tip 56 of the needle cap. In Figures 1 to 4 the syringe embodiment, the needle seal 46 is a discrete component that includes an elastomeric material. In other embodiments, the needle seal is integrally formed within the needle cap.

[0025] The drug aspirated through the open distal cap tip 56 enters only the distal third portion 60 of the needle cap 30 and flows directly through the open needle tip 28 and ultimately into the syringe barrel 12 of the syringe 10 in an unobstructed manner. The needle seal 46, which sealingly engages the inner wall 42 of the seal cavity and the outer diameter of the syringe needle 26, blocks fluid leakage into the proximal second portion 39 and the first cavity portion 35 of the needle cap 30 so that the aspirated drug is not trapped and wasted within the needle cap. In some embodiments, the volume of the so-called "dead space" within the third distal portion 60 of the needle cap 30 is minimized to minimize waste of the aspirated drug.

[0026] Referring to Figure 3 A through Figure 3 B and Figure 4 , the outer outer surface profile of the needle cap 30 forms a tapered distal end 62 that terminates at the open distal cap tip 56. In other embodiments, the tapered distal end includes other tapered polygonal profiles that terminate at the open distal cap tip. Figure 3B shows an alternative embodiment in which the annular needle seal 46 is eliminated and the needle seal is integrally formed within the needle cap 30. In this alternative embodiment, the connection between the needle hub and the needle cap is airtight, thereby eliminating the additional annular needle seal 46 element between the needle cap 30 and the syringe needle 26. The distal open needle tip 28 is positioned proximal to the distal cap tip 56 to avoid accidental needlestick injuries and, at the same time, to minimize drug waste during aspiration from a medical container (e.g., vial). Any such drug waste is expected to be lower than when using a separate blunt fill needle to aspirate the drug. As Figure 3 shown in B, the distal seal end 52 contacts the syringe needle 26 adjacent the open distal needle tip, and the integral annular needle seal 47 is not provided by Figure 3 the discrete components shown in A, but is provided between the distal seal end 52 and the proximal seal end 54, thereby eliminating Figure 3 the proximal second portion 39 and the distal seal portion 60 in the embodiment shown in A. In Figure 3 the embodiment of B, the needle seal is integrally formed with the cap, and when the needle is captured therein, the cap forms a mating seal engagement with the outer diameter of the syringe needle. In other embodiments, a tight annular seal with a sliding fit and frictional engagement at the interface 37 formed between the first inner wall surface 34 and the outer surface of the needle hub 24 may supplement or replace Figure 3 the annular needle seal 47 in B and Figure 3 the additional annular needle seal 46 element in A. Thus, the tight annular seal at the interface 37 will eliminate the need for the annular needle seal 47 or the additional annular needle seal 46 element in some embodiments. If a tight seal is formed at the interface 37, air will not be drawn in from this interface and liquid will not leak at the needle cap-needle hub interface.

[0027] Figure 1 、 Figure 2 and Figure 4 show a selectively removable needle shield 64 coupled to and covering the distal end of the needle cap 30. The needle shield 64 has a proximal open end 66 and a blunt closed tip 68 at its distal end. The needle shield 64 seals the open distal cap tip 56 to prevent foreign matter from entering the needle cap 30 and the syringe 10; its blunt tip 68 also prevents accidental piercing of the sterile syringe package, which could occur if the tapered distal end 62 of the syringe is not covered by the needle shield.

[0028] As Figure 5As shown, the conical distal end 62 of the tip of the needle cap 30 facilitates direct aspiration of the drug from the drug vial 70 while the syringe needle remains in place within the needle cap. The conical distal end 62 of the needle cap 30 pierces the septum 72 of the drug vial 70 and reaches the bottom 74 of the vial to aspirate the drug 76 or other medical fluid such as water for injection or saline flush solution directly into the syringe 10. The conical distal end 62 of the needle cap 30 allows its open cap tip 56 to extract all of the drug from the bottom 74 of the vial. The smooth conical distal end 62 of the needle cap 30 reduces the potential ingress of particulate matter from the breached vial septum 72, which could contaminate the drug 76 if a sharp syringe needle tip were used directly to aspirate the drug from the vial 70. Advantageously, when the needle cap 30 covers the syringe needle, it also protects the syringe needle from bending or from contact injury due to the needle tip glinting. After aspirating the desired amount of drug into the syringe chamber, the healthcare practitioner removes the needle cap 30 to expose the injection needle for subsequent injection into the patient. Since the needle and needle hub remain attached to the syringe during drug aspiration into the syringe, the handling of the exposed, sharp injection needle is minimized.

[0029] In contrast, in the absence of the benefit of using the needle cap 30 of the present disclosure, a healthcare practitioner performing a patient drug administration protocol would otherwise need to attach a blunt filling needle to the bare syringe Luer connector - either by first removing its associated injection needle or by using a syringe without an injection needle. After attaching the blunt filling needle, the healthcare practitioner aspirates the drug from the vial into the syringe chamber and then replaces the blunt filling needle with an injection needle in order to administer the drug to the patient. Using a separate, known blunt filling needle instead of the needle cap 30 of the present disclosure requires additional syringe preparation steps, thereby increasing the likelihood of administration errors and potential sterility compromise.

[0030] The syringe and syringe needle cap embodiments disclosed herein are constructed of medical grade materials known to those of skill in the art. In some embodiments, the described barrel, plunger, and shaft are made of polypropylene and polycarbonate polymers, but are not limited thereto. In some embodiments, the seal is made of an elastomer - such as, by non-limiting example, crosslinked rubber, thermoplastic elastomer, or fiber-filled polytetrafluoroethylene (PTFE) polymer. In some embodiments, the stopper is made of polyisoprene polymer or other known elastomers such as butyl rubber, thermoplastic elastomer, or thermoplastic vulcanizate.

[0031] References throughout this specification to "one embodiment", "certain embodiments", "various embodiments", "one or more embodiments", or "an embodiment" 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. Thus, phrases such as "in one or more embodiments", "in certain embodiments", "in various embodiments", "in one embodiment", or "in an embodiment" that appear 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.

[0032] Although the present disclosure provides descriptions 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 present disclosure without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A needle cap for a medical syringe, the needle cap comprising: A tubular body having an inner wall surface that defines a cap lumen therein, the inner wall surface further defining a first cavity portion of an end-open female Luer tapered profile at a proximal end of the tubular body, the proximal end being configured to selectively couple to a needle hub of a syringe, and the inner wall surface defining an open cap tip at a distal end of the tubular body; A needle seal within the cap lumen that divides the cap lumen into a second proximal portion and a third distal portion isolated from each other, the needle seal defining a through-hole that communicates with both the second proximal portion and the third distal portion of the cap lumen, the through-hole being in unobstructed direct fluid communication with the open cap tip, and the through-hole having an inner diameter that is configured to mate in a sealing engagement with an outer diameter of the syringe needle when the syringe needle is captured within the through-hole; And The tubular body has a tapered frustoconical outer surface profile at a distal end of the tubular body, the tapered frustoconical outer surface profile terminating at the open cap tip.

2. The needle cap according to claim 1, wherein, The inner wall surface of the tubular body defines a radially inwardly directed lip that abuts a proximal axial end of the needle seal and a retention shoulder that abuts a distal axial end of the needle seal.

3. The needle cap according to claim 2, wherein, The needle cap further includes a separate elastomeric needle seal.

4. The needle cap according to claim 1, wherein, The needle seal is integrally formed with the needle cap and forms a mating sealing engagement with the outer diameter of the syringe needle when the syringe needle is captured within the needle seal.

5. The needle cap according to claim 2, wherein, The tubular body defines a diameter-reduced necking portion located intermediate the first cavity portion of the female Luer tapered profile of the tubular body and the tapered frustoconical distal end, and the needle seal is oriented distal to the necking portion.

6. The needle cap according to claim 1, wherein, The tubular body defines a diameter-reduced necking portion located intermediate the first cavity portion of the female Luer tapered profile of the tubular body and the tapered frustoconical distal end, and the needle seal is oriented distal to the necking portion.

7. The needle cap according to claim 1, wherein, The proximal end of the tubular body defines an outwardly projecting gripping flange.

8. The needle cap according to claim 1, wherein The inner wall surface defining the first cavity portion of the cap lumen further includes a female Luer slip connector.

9. The needle cap according to claim 1, wherein, The inner wall surface defining the first cavity portion of the cap lumen further includes a female threaded Luer connector.

10. The needle cap according to claim 1, wherein, The needle cap further includes an elastomeric needle seal.

11. The needle cap according to claim 1, wherein, The needle cap further includes a needle shield that is coupled to the distal end of the tubular body and seals the open cap tip.

12. A syringe, the syringe comprising: A syringe barrel having a proximal end, a distal end, and a syringe cavity within the syringe barrel; A plunger and a coupled plunger plug within the proximal end of the syringe barrel; A male Luer connector at the proximal end of the syringe barrel that is in fluid communication with the syringe cavity; A Luer needle hub that is coupled to the male Luer connector and is in fluid communication with the syringe cavity; A hollow syringe needle having a distal open needle tip and a proximal end coupled to the Luer needle hub and in fluid communication with the syringe chamber; A needle cap having a tubular body with an inner wall surface that defines a cap inner cavity within the tubular body, the cap inner cavity capturing the distal open needle tip, the inner wall surface further defining an end-open female Luer tapered profile first cavity portion at the proximal end of the tubular body coupled to the needle hub, and the inner wall surface defining an open cap tip at the distal end of the tubular body; A needle seal within the cap inner cavity that divides the cap inner cavity into a second proximal portion and a third distal portion isolated from each other, the needle seal defining a through-hole in communication with both the second proximal portion and the third distal portion, the through-hole having an inner diameter configured to matingly seal with the outer diameter of the syringe needle captured within the through-hole; The distal open needle tip is oriented within the third distal portion of the cap inner cavity and is in unobstructed direct fluid communication with the open cap tip; and The tubular body has a tapered frustoconical outer surface profile at its distal end that terminates at the open cap tip.

13. The syringe according to claim 12, wherein, The inner wall surface of the tubular body defines a radially inwardly projecting lip that abuts the proximal axial end of the needle seal and a retention shoulder that abuts the distal axial end of the needle seal.

14. The syringe according to claim 13, wherein, The syringe further includes an elastomeric needle seal.

15. The syringe according to claim 13, wherein, The tubular body defines a diameter-reduced necking portion intermediate the female Luer tapered profile cavity portion of the tubular body and the tapered frustoconical distal end, and the needle seal is oriented distal to the necking portion.

16. The syringe according to claim 12, wherein, The tubular body defines a diameter-reduced necking portion intermediate the female Luer tapered profile cavity portion of the tubular body and the tapered frustoconical distal end, and the needle seal is oriented distal to the necking portion.

17. The syringe according to claim 12, wherein The proximal end of the tubular body defines an outwardly projecting gripping flange.

18. The syringe according to claim 12, wherein, The inner wall surface defining the first cavity portion of the cap inner cavity further includes a female Luer slip connector that mates with a corresponding male Luer slip connector of the needle hub.

19. The syringe according to claim 12, wherein, The inner wall surface defining the first cavity portion of the cap inner cavity further includes a female threaded Luer connector that mates with a corresponding male threaded Luer connector of the needle hub.

20. The syringe according to claim 12, wherein, The syringe further includes a needle shield coupled to the distal end of the tubular body and sealing the open cap tip.

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