WO2018034660A1

WO2018034660A1 - Universal medication injection adapter assembly for use with a needleless pharmaceutical syringe

Info

Publication number: WO2018034660A1
Application number: PCT/US2016/047389
Authority: WO
Inventors: Shlomi BEN-SASSON
Original assignee: SID TECHNOLOGIES LLC; SID Tech LLC
Current assignee: SID TECHNOLOGIES LLC; SID Tech LLC
Priority date: 2016-08-17
Filing date: 2016-08-17
Publication date: 2018-02-22
Anticipated expiration: 2019-02-17

Abstract

A universal medication injection adaptor assembly for use with a needleless pharmaceutical syringe having a distal end terminating in a male Luer connector. A cannula hub having a hub melting temperature has a distal end disposed in a cavity of a cylindrical coupling and a proximal end configured as a female Luer connector for mating with the syringe' s male Luer connector. A mount in the cavity supports the cannula-hub distal end. Ultrasonic energy directors in the internal cavity has an energy-director melting temperature greater than the hub melting temperature. A safety shield extending from the coupling distal end at least partially surrounds a needle cannula having a proximal end extending from the hub distal-end and distal end terminating in an exposed needle tip. The ultrasonic energy directors are embedded in the cannula-hub distal end for fixedly attaching the cannula-hub distal end in the coupling.

Description

TITLE OF THE INVENTION

[00011 Universal Medication Injection Adapter Assembly For Use With A Needleless Pharmaceutical Syringe BACKGROUND OF THE INVENTION

[0002J The present invention is generally directed to a medication injection adaptor assembly for use with a needleless pharmaceutical syringe and, more particularly, to a universal female intradermal adapter having disposed therein a needle hub with a needle cannula projecting therefrom.

[0003] Intradermal injections are used for delivering a variety of diagnostic and treatment compositions into a patient. Intradermal injections are typically injections of a relatively small amount of medicament into the dermis, the dermal layer or even into a lower portion of the epidermis of a patient's skin. Administering an intradermal injection can be difficult and generally requires an experienced nurse or medical professional.

[0004] With presently used syringes having a hub with a projecting needle cannula, potentially dangerous needle stick injuries are commonplace and most often occur between the time the medication is injected into the patient and the time the syringe is disposed in a sharps container. To avoid needle sticks, a preferred intradermal injection technique typically requires a healthcare professional to attach an adapter with a needle safety shield to the hub of the syringe prior to administration of the medication. The procedure for attaching the adapter exposes the healthcare professional to the additional risk of a needle stick prior to the injection of the medication. Further, incorrect assembly of the intradermal injection device may lead to misalignment of the needle cannula in the adapter resulting in incorrect placement of the tip of a needle cannula at the injection site, which, in turn, may lead to a failed injection.

[0005] Commonly owned WIPO International Publication No. WO 2008/131440 entitled "Methods and Devices for Intradermal Injection" discloses an intradermal adapter configured for longitudinal insertion of a syringe having a hub with a needle cannula projecting therefrom. The syringe is placed into the adapter in a radial direction through an opening formed to not interfere with the syringe cannula during insertion such that the longitudinal axes of the syringe cannula and the adapter are co-axial. Thereafter, the syringe is pushed distally in a longitudinal direction until the distal end of the syringe barrel contacts a latch attached to the adapter body and the forward tip of the needle cannula is enclosed in a conical section of the adapter having a needle opening. In use, an axial force applied to the syringe barrel causes the latch to deflect extending the tip of the needle cannula through the needle opening.

[0006] Commonly owned WIPO International Publication No. WO 201 1/01 1697 entitled "Intradermal Injection Device^" discloses an intradermal adapter configured for side insertion of a syringe having a needle cannula projecting therefrom. The adapter includes a side opening that extends along an entire length of the adapter, generally parallel to the longitudinal axis. The side opening permits insertion of the syringe into the adapter such that the cannula is disposed in a cannula channel extending through a central portion of the adapter generally parallel to the longitudinal axis of the adapter. Upon insertion, the exposed tip of the cannula is spaced distally relative to the cannula channel edge of the adapter, and is generally fixed in this position in the assembled configuration.

|0007J The foregoing adapters have several short comings. They are designed for use with syringes having specific dimensionality and a pre-attached needle cannula. Accordingly, a specific adapter can not by used with a variety of syringe configurations. Further, whether the adapter provides for longitudinal insertion or side insertion, the insertion procedure may be dexterously difficult and lead to inaccurate placement of the needle cannula relative to the longitudinal axis of the adapter.

10008] WO 201 1/01 1697 Figs. 1 1 and 12 disclose the general concept of longitudinally inserting a hub with a cannula projecting therefrom in an adapter, mounting the cannula thereto and attaching the proximal end portion of the body of the adapter to a needleless syringe using a conventional Luer connector. The manner in which the hub is attached to the adapter body is not disclosed. Further, the adapter body does not include a side opening for receipt of the syringe.

(0009] Most popular, conventional, commercially available needle hubs with a female Luer connector are made from a polypropylene material; in contrast, the typical intradermal adapter is made from a polycarbonate material. It is known that polypropylene material does not bond with polycarbonate material such that it is problematic to mount a commercially available needle hub in an intradermal adapter.

[0010] Therefore, it would be desirable to have a universal medication injection adaptor assembly attachable to a needleless syringe by a standardized Luer connector and having fixedly disposed therein a needle hub with a needle cannula projecting therefrom; thereby allowing a healthcare professional to provide a relatively simple and safe intradermal injection device, that is relatively easy to use. BRIEF SUMMARY OF THE INVENTION

[0011] Briefly stated, one embodiment of the present invention is directed to a universal medication injection adaptor assembly for use with a needleless pharmaceutical syringe having a syringe barrel with a syringe-barrel distal end terminating in a male Luer connector. The universal injection adaptor assembly comprises a generally cylindrical coupling having a coupling distal end and a coupling proximal end. A coupling cavity is provided in the coupling. The coupling cavity extends between the coupling distal end and the coupling proximal end. A cannula hub has a cannula-hub distal end and a cannula-hub proximal end. The cannula-hub distal end is disposed in the coupling cavity. The cannula-hub proximal end is configured as an exposed female Luer connector compatible with the male Luer connector of the syringe-barrel distal end. A mount is in the coupling cavity. The mount is configured to support the cannula- hub distal end thereon. An ultrasonic energy director is in the coupling cavity. A needie- cannula safety shield extends from the distal end of the coupling. A needle cannula has a needle-cannuia proximal end and a needie-cannula distal end. The needle-cannuia proximal end extends from the cannula-hub distal end. The needie-cannula safety shield at least partially surrounds the needle cannula. The needle-cannuia distal end terminates in an exposed needle tip. The cannula hub has a hub melting temperature and the ultrasonic energy director has an energy-director melting temperature. The hub melting temperature is less than the energy- director melting temperature. The ultrasonic energy director is embedded in the cannula-hub distal end fixedly attaching the cannula-hub distal end to the coupling.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0012] The foregoing summary , as well as the following detailed description of a preferred embodiment of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, the drawings show an embodiment which is presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

[0013] In the drawings:

[0014) Fig. 1 is a left-side, elevation view, partially in cross section, of an intradermal syringe assembly including a first preferred embodiment of a needleless-syringe adapter in accordance with the present invention; [0015] Fig. 2 is a left-side, bottom-perspective view of an enlargement of the distal portion of the needleless-syringe adapter of Fig. 1 showing in transparency the distal portion of the syringe barrel to which the needleless-syringe adapter is attached;

[0016] Fig. 3 is an exploded left-side, bottom-perspective view of the needleless-syringe adapter of Fig. 2;

[0017] Fig. 4 is a left-side, perspective elevation view of the needleless-syringe adapter of Fig. 1 showing the distal portion of the syringe barrel in cross section;

[0018] Fig. 5 is a left-side, cross-sectional elevation view of the needleless-syringe adapter of Fig. 1 ;

[0019] Fig. 6 is a right-side, perspective elevation view of the cover of the needleless- syringe adapter of Fig. 1 ;

[0020] Fig. 7 is a front cross-sectional view of the cover of the needleless-syringe adapter of Fig. 6;

[0021] Fig. 8 is an enlarged front cross-sectional view of the needleless-syringe adapter of Fig. 1 along line 8-8 in Figure 5, showing the position of the cover relative to the base of the adapter prior to initiation of sonic welding;

[0022] Fig. 9 is an enlarged front cross-sectional view of the needleless-syringe adapter of Fig. 1 along line 9-9 in Figure 5, showing the position of the cover relative to the base of the adapter upon completion of sonic welding; and

[0023] Fig. 10 is a flow diagram of a preferred embodiment of a method for manufacturing a needleless-syringe adapter in accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0024] Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0025] As used in the description of the invention and the appended claims, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The words "and/or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. The words

"comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[0026j The words "right," "left." "lower" and "upper" designate directions in the drawings to which reference is made. The words "inwardly," "outwardly," refer to directions toward and away from, respectively, the geometric center of an assembly (e.g. , the geometric center of the needleless-syringe adapter) or other related parts thereof. The terminology includes the words noted above, derivatives thereof and words of similar import.

[0027] Although the words first, second, etc. , are used herein to describe various elements, these elements should not be limited by these words. These words are only used to distinguish one element from another. For example, a first surface could be termed a second surface, and, similarly, a second surface could be termed a first surface, without departing from the scope of the present invention.

[0028) Referring to the drawings in detail, where like numerals indicate like elements throughout, there is shown in Figs. 1 -9 a first preferred embodiment of a universal medication injection adaptor assembly, generally designated 10, and hereinafter referred to as the

'^"needleless-syringe adapter"^* in accordance with the present invention. While reference is made herein specifically to a pre-filled needleless syringe, it is understood that the present invention is not so limited. For example, the needleless-syringe adapter 10 described in detail below may also be used with nearly any type of needleless syringe, such as those to be filled by a patient or user, for example. The needleless-syringe adapter 1 0 is preferably designed for intradermal injection. However, the needleless-syringe adapter 10 is not limited to use only for intradermal injections.

[0029] The needleless-syringe adaptor 10 is for use with a needleless pharmaceutical syringe 1 having a syringe barrel 2 with a syringe-barrel distal end 3 terminating in a male Luer connector 4.

[0030] The needleless-syringe adaptor 10 has a generally hollow cylindrical coupling 12 having a coupling distal end 14 and a coupling proximal end 16. A coupling cavity 1 8 extends between the coupling distal end 14 and the coupling proximal end 16. The coupling 12 has a coupling melting temperature. Preferably, the coupling 12 is made from polycarbonate material and the coupling melting temperature is the temperature at which polycarbonate melts, namely. 155°C.

[0031 ] A cannula hub 20 has a cannula-hub distal end 22 disposed in the coupling cavity 18 and a cannula-hub proximal end 24 configured as an exposed female Luer connector 26 compatible with the male Luer connector 4 of the syringe-barrel distal end 3. In some embodiments, the cannula hub 20 has at least one radially outwardly projecting hub bar 28 having a generally rectangular cross-section and extending a length of the distal end-portion 30 of the cannula hub 20. Preferably, the cannula hub 20 has a plurality of diametrically opposed hub bars 28 projecting from the cannula hub 20.

[0032] The cannula hub 20 has a cannula-hub melting temperature. Preferably, the cannula hub 20 is made from a polypropylene material and the cannula-hub melting temperature is the temperature at which polypropylene melts, namely, at 130 °C.

[0033] The coupling 12 has a first coupling portion 32 partially surrounding the cannula-hub distal end 22. A first coupling-portion lateral opening 34 extends longitudinally in the first coupling portion 32. The first coupling-portion lateral opening 34 provides transverse access to the coupling cavity 18. A second coupling portion 36 is configured to cover the first coupling- portion lateral opening 34. The coupling 12 circumscribes the coupling cavity 1 8 when the first coupling-portion lateral opening 34 is covered by the second coupling portion 36.

[0034] In some embodiments, the coupling 12 has a radially inwardly extending bulkhead 38 with a bulkhead lateral opening 40 extending generally parallel to a longitudinal axis "A^" of the needleless-syringe adapter 10. The bulkhead 38 serves as a stop preventing longitudinal movement of the cannula hub 20 beyond the cannula-hub distal end 22. In some embodiments, the cannula-hub distal end 22 abuts the bulkhead 38. In other embodiment, the cannula-hub distal end 22 may extend into the bulkhead lateral-opening 40.

[0035] A mount 42 in the coupling cavity 18 is configured to support the cannula-hub distal end 22. Preferably, the mount 42 extends radially inwardly from the first coupling portion 32 and directly supports the hub bars 28 on a rib-like surface extending longitudinally.

[0036] A needle cannula 44 has a needle-cannula proximal end 46 extending from the cannula-hub distal end 22 and a needle-cannula distal end 48 terminating in an exposed needle tip 50.

[0037] A needle-cannula safety shield 52 extends from the coupling distal end 14 at least partially surrounding the needle cannula 44. In some embodiments, the needle-cannula safety- shield 52 further comprises a safety-shield distal section 54 configured to orient the needleless- syringe adapter 10 at an angular position relative to the skin of the patient during intradermal administration of the medication. Preferably, the safety-shield distal section 54 has a first safety-shield surface 56 and a second safety-shield surface 58 different than the first safety- shield surface 56. The first safety-shield surface 56 lies entirely in a first plane generally parallel to the longitudinal axis of the needleless-syringe adapter 10 and is configured to contact a first skin-area (not shown) of a patient. The second safety-shield surface 58 is spaced from the needle-cannula 44, lies entirely in a second plane at a predetermined angle Θ relative to the first plane and is also configured to contact a second skin area (not shown) of the patient.

[0038] The coupling cavity 18 has two opposite ultrasonic energy directors 60 each having an energy-director melting temperature that is greater than the melting temperature of the cannula hub 204. The ultrasonic energy director 60 extends radially inwardly from the second coupling portion 36. Preferably, the radially inwardly most extending portion of the ultrasonic energy director 60 terminates in an ultrasonic energy concentrator 62. The coupling cavity 18 preferably also has a leading ultrasonic energy concentrator 62 and a trailing ultrasonic energy concentrator 62 disposed between the two opposite ultrasonic energy directors 60 along the cylindrical coupling 12. The ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 are intended to be embedded in the distal end-portion 30 of the cannula hub 20 fixedly attaching the cannula-hub distal end 22 to the coupling 12. {see, Fig. 9).

[0039] Referring to Fig. 10, a preferred method, generally designated 100, for

manufacturing the needleless-syringe adapter assembly 10 and hereafter referred to as the "method 100" in accordance with the present invention comprises at least the steps described below.

[0040] In an insertion step 105, the cannula-hub distal end 22 is inserted through the first coupling-portion lateral opening 34 into the coupling cavity 18 such that the first coupling portion 32 partially surrounds the cannula-hub distal end 22, the needle-cannula safety shield 52 at least partially surrounds the needle cannula 44, and the needle-cannula distal end 48 terminates in an exposed needle tip 50.

[0041] In a supporting step 1 10, the cannula-hub distal end 22 is supported on the mount 42 extending radially inwardly from the first coupling portion 32.

[0042] In a closing step 1 15, the first coupling-portion lateral opening 34 is closed with the second coupling portion 36 such that the ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 are in direct contact with the cannula-hub distal end 22 (Fig. 8).

[0043] In the embedding step 120, a person skilled in the art of ultrasonically welding polymeric materials will understand that ultrasonic energy is applied to the coupling 12 in an amount which is sufficient to soften the polypropylene cannula hub 20 but not the polycarbonate ultrasonic energy directors 60 and the polycarbonate ultrasonic energy concentrators 62 such that the pressure applied to the ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 embed the ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 in the cannula-hub distal end 22.

[0044] In the bonding step 125, the second coupling portion 36 is bonded to the first coupling portion 32 using ultrasonic welding (Fig. 9).

[0045] The foregoing detailed description of the invention has been disclosed with reference to a specific embodiment. However, the disclosure is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Those skilled in the art will appreciate that changes could be made to the embodiment described above without departing from the broad inventive concept thereof. Therefore, the disclosure is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

[0046] All references, patent applications, and patents mentioned above are incorporated herein by reference in their entirety and are not to be construed as an admission that any of the cited documents constitutes prior art, or as an admission against interest in any manner.

Claims

CLAIMS We claim:

1 . A universal medication injection adaptor assembly for use with a needleless pharmaceutical syringe having a syringe barrel with a syringe-barrel distal end terminating in a male Luer connector, the universal injection adaptor assembly comprising:

a cylindrical coupling having a coupling distal end and a coupling proximal end;

a coupling cavity provided in the coupling, the coupling cavity extending between the coupling distal end and the coupling proximal end;

a cannula hub having a cannula-hub distal end and a cannula-hub proximal end, the cannula-hub distal end disposed in the coupling cavity, the cannula-hub proximal end configured as an exposed female Luer connector compatible with the male Luer connector of the syringe-barrel distal end;

a mount in the coupling cavity, the mount configured to support the cannula-hub distal end thereon;

an ultrasonic energy director in the coupling cavity, the ultrasonic energy director having an energy-director melting temperature greater than the hub melting temperature,

a needle-cannula safety shield extending from the coupling distal end;

a needle cannula having a needle-cannula proximal end and a needle-cannula distal end, the needle-cannula proximal end extending from the hub distal end, the needle-cannula safety shield at least partially surrounding the needle cannula, the needle-cannula distal end

terminating in an exposed needle tip,

wherein the cannula hub has a hub melting temperature and the ultrasonic energy director has an energy-director melting temperature, the hub melting temperature being less than the energy-director melting temperature, and

wherein the ultrasonic energy director is embedded in the cannula-hub distal end fixedly attaching the cannula-hub distal end to the coupling.

2. The universal medication injection adaptor assembly according to claim 1 , wherein the coupling comprises:

a first coupling portion partially surrounding the cannula-hub distal end;

a first coupling-portion lateral opening extending longitudinally in the first coupling portion, the first coupling-portion lateral opening providing transverse access to the coupling cavity: and

a second coupling portion configured to cover the first coupling-portion lateral opening, wherein the coupling circumscribes the coupling cavity when the first coupling-portion lateral opening is covered by the second coupling portion.

3. The universal medication injection adaptor assembly according to claim 2, wherein the mount extends radially inwardly from the first coupling portion.

4. The universal medication injection adaptor assembly according to claim 1 , wherein the coupling has a radially inwardly extending bulkhead with a bulkhead lateral- opening extending generally parallel to a longitudinal axis of the adapter, the hub distal end abutting the bulkhead.

5. The universal medication injection adaptor assembly according to claim 1 , wherein the cannula hub is made from polypropylene and the cylindrical coupling is made from polycarbonate.

6. The universal medication injection adaptor assembly according to claim 1 , wherein the cannula hub has at least one radially outwardly projecting hub bar extending a length of a distal end-portion of the hub, the hub bar supported by the mount.

7. The universal medication injection adaptor assembly according to claim 3, wherein the coupling has a radially inwardly extending bulkhead with a bulkhead lateral- opening extending generally parallel to a longitudinal axis of the adapter, the cannula hub has at least one radially outwardly projecting hub bar extending a length of the distal end-portion of the hub, the distal end of the hub bar abutting the bulkhead and supported by the mount, and the needle cannula passes through the bulkhead lateral-opening.

8. The universal medication injection adaptor assembly according to claim 3, wherein:

the cannula hub has a radially outwardly projecting hub bar extending a length of the distal end-portion of the hub, the hub bar supported by the mount, and

the ultrasonic energy director extends radially inwardly from the second coupling portion and is embedded in the hub bar.

9. The universal medication injection adaptor assembly according to claim 1 , wherein the needle-cannula safety shield further comprises a safety-shield distal section configured to orient the adapter at an angular position relative to the skin of the patient during intradermal administration of the medication.

10. The universal medication injection adaptor assembly according to claim 1 , wherein the radially inwardly most extending portion of the ultrasonic energy director terminates in an ultrasonic energy concentrator.

1 1. The universal medication injection adaptor assembly according to claim 9.

wherein the distal end of the needle-cannula safety shield has a first adapter-surface and a second adapter-surface, the first adapter-surface configured to contact a first skin-area of a patient, the first adapter-surface lying entirely in a first plane generally parallel to the longitudinal axis of the adapter; and the second adapter-surface configured to contact a second skin area of the patient, the second adapter-surface different than the first adapter-surface, spaced from the cannula and lying entirely in a second plane at a predetermined angle relative to the first plane.

12. A method for manufacturing the universal medication injection adaptor assembly according to claim 2 comprises the steps of:

inserting the cannula-hub distal end in the coupling internal cavity such that the first coupling portion partially surrounds the cannula-hub distal end, the needle-cannula safety shield at least partially surrounding the needle cannula, and the needle-cannula distal end terminates in an exposed needle tip;

supporting the cannula-hub distal end on the mount, the mount extending radially inwardly from the first coupling portion;

closing the first coupling-portion lateral opening with the second coupling portion such that the ultrasonic energy director is in direct contact with the cannula-hub distal end;

embedding the ultrasonic energy director in the cannula-hub distal end using ultrasonic welding; and

bonding the second coupling portion to the first coupling portion using ultrasonic welding.

13. The method for manufacturing the universal medication injection adaptor assembly according to claim 12, wherein in the embedding step an amount of ultrasonic energy applied to the coupling is sufficient to soften the polypropylene cannula hub but not the polycarbonate ultrasonic energy directors and the polycarbonate ultrasonic energy concentrators such that pressure applied to the ultrasonic energy directors and the ultrasonic energy concentrators during ultrasonic welding embed the ultrasonic energy directors and the ultrasonic energy concentrators in the cannula-hub distal end.