Adaptor for a drug delivery device and method for mounting said adaptor thereon
10258540 ยท 2019-04-16
Assignee
Inventors
Cpc classification
A61M2039/1077
HUMAN NECESSITIES
A61J1/18
HUMAN NECESSITIES
A61M5/344
HUMAN NECESSITIES
A61J1/2096
HUMAN NECESSITIES
International classification
A61J1/20
HUMAN NECESSITIES
A61J1/18
HUMAN NECESSITIES
Abstract
An adaptor intended to be mounted on a distal tip of a drug delivery device is provided. The distal tip defines an axial passageway for transfer of a product contained in the drug delivery device. The adaptor has a longitudinal axis A aligned on the axial passageway. The adaptor includes: a connection member for connecting the adaptor to a connector; an inner ring releasably engageable on the distal tip; and a compression component separate from the inner ring and configured to be unreleasably snap-fitted onto the inner ring engaged on the distal tip by proximal movement of the compression component with respect to the inner ring. The compression component is configured to exert a centripetal pressure on the inner ring so as to prevent axial movement of the inner ring with respect to the distal tip.
Claims
1. An adaptor intended to be mounted on a distal tip of a drug delivery device, said distal tip defining an axial passageway for transfer of a product contained in said drug delivery device, said adaptor having a longitudinal axis A aligned on said axial passageway, the adaptor comprising: a connection member for connecting said adaptor to a connector; an inner ring releasably engageable on said distal tip, the inner ring comprising a circular wall configured to be outwardly radially expanded under a pressure exerted radially outwardly on an inner face of said circular wall, and configured to be inwardly radially compressed under a pressure exerted radially inwardly on an outer face of said circular wall; and a compression component separate from said inner ring and configured to be unreleasably snap-fitted onto said inner ring engaged on said distal tip by proximal movement of said compression component with respect to said inner ring, said compression component being configured to exert a centripetal pressure on said inner ring so as to prevent axial movement of said inner ring with respect to said distal tip, said compression component comprising an outer ring configured to receive at least partly said inner ring, said outer ring comprising an inner radial rim configured to exert a centripetal pressure on said outer face of said circular wall when said compression component is snap-fitted onto said inner ring, said circular wall comprising a longitudinal cut along a portion of a circumference thereof, and said longitudinal cut extending from a proximal end to a distal end of said circular wall.
2. The adaptor according to claim 1, wherein said portion of the circumference of said circular wall is wide enough for defining an empty space between two longitudinal edges of said longitudinal cut, when no pressure is exerted on said circular wall.
3. The adaptor according to claim 2, wherein said portion of the circumference of the circular wall is at least 2 mm wide.
4. The adaptor according to claim 1, wherein said circular wall comprises a distal annular outer rim configured to cooperate with said inner radial rim for unreleasably snap-fitting said compression component onto said inner ring.
5. The adaptor according to claim 1, wherein said connection member is located on the compression component.
6. The adaptor according to claim 1, wherein said connection member comprises a thread provided on an inner wall of said outer ring.
7. A drug delivery device comprising: a distal tip defining an axial passageway for transfer of a product contained in said drug delivery device; and at least one adaptor configured to be mounted on said distal tip and having a longitudinal axis A aligned on said axial passageway, the adaptor comprising: a connection member comprising a thread for connecting said adaptor to a connector; an inner ring releasably engageable on said distal tip, the inner ring comprising a circular wall configured to be outwardly radially expanded under a pressure exerted radially outwardly on an inner face of said circular wall, and configured to be inwardly radially compressed under a pressure exerted radially inwardly on an outer face of said circular wall; and a compression component separate from said inner ring and configured to be unreleasably snap-fitted onto said inner ring engaged on said distal tip by proximal movement of said compression component with respect to said inner ring, said compression component being configured to exert a centripetal pressure on said inner ring so as to prevent axial movement of said inner ring with respect to said distal tip, said compression component comprising an outer ring configured to receive at least partly said inner ring, said outer ring comprising an inner radial rim configured to exert a centripetal pressure on said outer face of said circular wall when said compression component is snap-fitted onto said inner ring, said circular wall comprising a longitudinal cut along a portion of a circumference thereof, and said longitudinal cut extending from a proximal end to a distal end of said circular wall.
8. An assembly comprising: an adaptor configured to be mounted on a distal tip of a drug delivery device, said distal tip defining an axial passageway for transfer of a product contained in said drug delivery device, said adaptor having a longitudinal axis A aligned on said axial passageway, the adaptor comprising: a connection member for connecting said adaptor to a connector; an inner ring releasably engageable on said distal tip, the inner ring comprising a circular wall configured to be outwardly radially expanded under a pressure exerted radially outwardly on an inner face of said circular wall, and configured to be inwardly radially compressed under a pressure exerted radially inwardly on an outer face of said circular wall; and a compression component separate from said inner ring and configured to be unreleasably snap-fitted onto said inner ring engaged on said distal tip by proximal movement of said compression component with respect to said inner ring, said compression component being configured to exert a centripetal pressure on said inner ring so as to prevent axial movement of said inner ring with respect to said distal tip, said compression component comprising an outer ring configured to receive at least partly said inner ring, said outer ring comprising an inner radial rim configured to exert a centripetal pressure on said outer face of said circular wall when said compression component is snap-fitted onto said inner ring, said circular wall comprising a longitudinal cut along a portion of a circumference thereof, and said longitudinal cut extending from a proximal end to a distal end of said circular wall; and a connector connected to said connection member of said adaptor.
9. The assembly according to claim 8, wherein said adaptor further comprises a tamper evidence component for removing the connector from the adaptor.
10. The drug delivery device according to claim 7, wherein the distal tip is made of glass.
11. The drug delivery device according to claim 7, wherein the distal tip is conical and distally tapered.
12. The drug delivery device according to claim 7, wherein the distal tip comprises an annular groove configured to receive said inner ring when said inner ring is engaged on said distal tip.
13. A method for mounting an adaptor on a distal tip of a drug delivery device, wherein said distal tip defines an axial passageway for transfer of a product contained in said drug delivery device, said adaptor being configured to be mounted on the distal tip and having a longitudinal axis A aligned on said axial passageway, the adaptor comprising: a connection member for connecting said adaptor to a connector; an inner ring releasably engageable on said distal tip, the inner ring comprising a circular wall configured to be outwardly radially expanded under a pressure exerted radially outwardly on an inner face of said circular wall, and configured to be inwardly radially compressed under a pressure exerted radially inwardly on an outer face of said circular wall; and a compression component separate from said inner ring and configured to be unreleasably snap-fitted onto said inner ring engaged on said distal tip by proximal movement of said compression component with respect to said inner ring, said compression component being configured to exert a centripetal pressure on said inner ring so as to prevent axial movement of said inner ring with respect to said distal tip, said compression component comprising an outer ring configured to receive at least partly said inner ring, said outer ring comprising an inner radial rim configured to exert a centripetal pressure on said outer face of said circular wall when said compression component is snap-fitted onto said inner ring, said circular wall comprising a longitudinal cut along a portion of a circumference thereof, and said longitudinal cut extending from a proximal end to a distal end of said circular wall, the method comprising: slidingly engaging the inner ring onto the distal tip; and snap-fitting the compression component onto the inner ring by proximal movement of said compression component with respect to said inner ring.
14. The method according to claim 13, wherein the inner ring is slidingly engaged on the distal tip until the inner ring is received into an annular groove.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The invention and the advantages arising therefrom will clearly emerge from the detailed description that is given below with reference to the appended drawings in which:
(2)
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DESCRIPTION OF THE INVENTION
(9) In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the distal direction is to be understood as meaning the direction of injection, with respect to the drug delivery device the adaptor of the invention is intended to be mounted on, and the proximal direction is to be understood as meaning the opposite direction to said direction of injection.
(10) With reference to
(11) The connector intended to be connected to the drug delivery device 1 thanks to the adaptor 10 of the invention may be any device capable of being connected to the adaptor 10, either for allowing the transfer of a product from the drug delivery device 1 to another medical device, such as a needle hub, a pocket drip, a vial, an IV (Intra Venous) line, an IM (Intra Muscular) line, or on the contrary for safely closing the filled drug delivery device 1 before its use and for preventing any contamination, like for example a closure cap 40 in the storage position of the drug delivery device (as will be shown on
(12) With reference to
(13) On the example shown, the circular wall 21 further comprises a plurality of circumferentially distributed proximal tabs 21a, separated from each other by a plurality of spaces 21b, and linked together by the annular outer rim 22. On the example shown, the circular wall 21 comprises five such proximal tabs 21a. In examples not shown, the circular wall 21 may comprise less or more of these proximal tabs 21a, such as two, three, four, six or more. The inner face 21c of these proximal tabs 21a is intended to surround the outer surface of the distal tip 2 when the inner ring 20 is engaged thereon (see
(14) On
(15) With reference to
(16) As shown on
(17) In an embodiment not shown, the connecting means can be a groove provided on the outer face of the circular wall of the inner ring, in which a connector may be clipped. In other embodiments, the connection member or thread 34 may comprise other connection mechanisms for connecting a connector to the drug delivery device 1 via the adaptor 10. In one embodiment, the connector is connectable to the connection member or thread 34 of the adaptor 10 with the first component or inner ring 20 in the second position.
(18) The inner ring 20 and the outer ring 30 may be made of a material selected from acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polypropylene (PP), polyethylene (PE), polyamide (PA), thermoplastic elastomer (TPE) and their combinations.
(19) Anyway, as it will appear from the description below, as the outer ring 30, and in particular its inner radial rim 32, is intended to compress inwardly radially the proximal tabs 21a of the circular wall 21 of the inner ring 20 when the adaptor 10 is mounted on the distal tip 2 (see
(20) For example, in embodiments, the outer ring 30, and in particular the inner radial rim 32, is made of polyamide and the proximal tabs 21a are made of polyethylene.
(21) In other embodiments, the outer ring 30, and in particular the inner radial rim 32, may be made of polybutylene terephthalate and the proximal tabs 21a may be made of thermoplastic elastomer.
(22) As it will appear in the description later, the adaptor 10 is intended to be engaged on the distal tip of a drug delivery device in a two-step process (see
(23) With reference to
(24) The drug delivery device 1 and the adaptor 10 are aligned and have a common longitudinal axis A. The outer surface of the distal tip 2 is conical and distally tapered. The distal tip 2 defines an axial passageway 3 for the transfer of a product (not shown) contained or intended to be contained in the drug delivery device 1. The axial passageway 3 is open at its distal end 3a. In the example shown, the distal tip 2 is further provided with a proximal annular groove 4. The proximal annular groove 4 is defined between a distal step 4a and a proximal shoulder 4b formed by the distal part of the barrel 5 of the drug delivery device 1. For example, the outer diameter of the distal tip 2 at the location of the proximal annular groove 4 is smaller than the outer diameter of the distal tip 2 at its most distal part.
(25) In embodiments not shown, the outer surface of the distal tip 2 may be free of any annular groove, or alternatively may be provided with an annular ridge.
(26) The distal tip 2 may be made of plastic or glass material. In embodiments, the distal tip 2 is made of glass material. In another embodiment, the distal tip 2, as well as the drug delivery device, is made of plastic material selected from crystal clear polymer (CCP), acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polystyrene (PS), polypropylene (PP), polyethylene (PE), polyamide (PA) and their combinations.
(27) On
(28)
(29) As already mentioned above, the cap 40 is not part of the adaptor 10 of the invention and is intended to be replaced with a connector (not shown) provided with a thread capable of cooperating with the thread 34 of the outer ring 30, in view of transferring product from the drug delivery device 1 to another medical device.
(30) On
(31) In a first step, the user engages the inner ring 20 onto the distal tip 2. This step is easy to perform thanks to the distally tapered shape of the outer surface of the distal tip 2 and also thanks to the capability of the circular wall 21 of the inner ring 20 to expand outwardly radially. In particular, the presence of the longitudinal cut 23 of the circular wall 21 facilitates the mounting of the inner ring 20 onto the distal tip 2. On the example shown, the inner ring 20 is engaged on the distal tip 2 beyond distal step 4a of proximal annular groove 4. With reference to
(32) In embodiments where the distal tip 2 is free of any annular groove, the inner ring 20 may be engaged on said distal tip 2 until the proximal end of the inner ring comes close to the shoulder formed by the distal part of the barrel 5 of the drug delivery device 1.
(33) When the inner ring 20 is engaged on the distal tip 2 and the outer ring 30 is not yet snap-fitted thereon, the proximal tabs 21a of the circular wall 21 may exert a slight radial inward force on the distal tip 2, regardless form the fact that said distal tip 2 is provided with an annular groove or not. Alternatively, these proximal tabs 21a may exert no inward radial force onto the distal tip 2. At this stage, the inner ring 20 is engaged on the distal tip 2 in a releasable way, and the potential radial inward force exerted by the circular wall 21 on the distal tip 2 does not limit the axial movement of the inner ring 20 with respect to the distal tip 2. The inner ring 20 may still be translated with respect to the distal tip 2.
(34) In the example shown, where the distal tip 2 is provided with an annular groove 4 forming a distal abutment 4a for the inner ring 20, the proximal tabs 21a of the circular wall 21 do not exert any radial inward force on the outer face of the annular groove 4 if the outer diameter of the proximal annular groove 4 is less than the inner diameter of the circular wall 21 in a rest position.
(35) Then, the user approaches the outer ring 30 to the distal end of the distal tip 2, engages it thereon and towards the inner ring 20 already in place on the distal tip 2. When the user moves the outer ring 30 in the proximal direction, the inner radial rim 32 comes in contact with the distally tapered outer face 22a of the annular outer rim 22 of the inner ring 20. Thanks to the distally tapered outer face 22a of the annular outer rim 22 and to the inherent flexibility of the material forming the outer ring 30, the inner radial rim 32 overcomes the annular outer rim 22 and gets engaged on the outer face 21d of the circular wall 21. The outer ring 30 is therefore snap-fitted into the inner ring 20.
(36) In embodiments where the distal tip 2 is provided with an annular groove 4 and where the outer diameter of the proximal annular groove 4 is less than the inner diameter of the circular wall 21 in a rest position, the inner radial rim 32 may even cause the annular outer rim 22 to deflect radially inwardly thanks to the capability of the circular wall 21 to be compressed under a pressure exerted on its outer face 21d radially inwardly.
(37) With reference to
(38) In addition, as shown on
(39) Additionally, in an embodiment not shown, some locking means or locking component may be formed on the outer surface of the distal tip, such locking means being preferably aligned on the longitudinal axis of the drug delivery device. These locking means may have the form of ribs capable of locking the adaptor firmly in rotation thanks to a mechanical abutment with the proximal tabs 21a. These ribs may fit closely within the space existing between two adjacent proximal tabs in order to prevent any rotational movement of the adaptor with respect to the distal tip. Preferably at least two locking means would be required, but the number of the locking means and their distribution on the surface of the distal tip may depend on the number of free spaces existing between two adjacent proximal tabs 21a.
(40) As a consequence, the adaptor 10 is now firmly attached to the distal tip 2, and it may not be disconnected from said distal tip, even if a user tries to pull it out in a direction or the other. The presence of the proximal annular groove 4 on the distal tip 2 increases the fastening resistance of the adaptor 10 onto the distal tip 2 if a user tries to pull it in the distal direction.
(41) As shown in
(42) In embodiments, the adaptor 10 may be provided with the cap 40 already screwed in the outer ring 30, before any mounting step of the adaptor 10 onto the distal tip of the drug delivery device. The adaptor 10 may then be provided with a tamper evidence component or tamper evidence means of the removal of the cap 40. For example, a tearable label 50 as shown on
(43) For using the drug delivery device 1, the user only needs to remove first the tearable label 50 if present, and then the cap 40 by unscrewing it from the outer ring 30. This step is easy to complete thanks to the secured fixation of the adaptor 10 onto the distal tip 2. In particular, the user knows that the removal of the cap 40 can be done safely and may not cause the adaptor 10 to be separated from the distal tip 2. Once the cap 40 is removed, the user may then screw on thread 34a corresponding outer thread provided on a connector (not shown) in order to proceed to the transfer of the product contained in the drug delivery device to another medical device via the connector.
(44) Again, because of the optimized fixation of the adaptor 10 on the distal tip 2, the connection of the connector to the adaptor 10, and therefore to the distal tip 2 is facilitated.
(45) The adaptor of the invention allows the reliable connection of a connector on the distal tip of a drug delivery device. The risks that the adaptor of the invention be displaced and eventually misplaced on the distal tip of the drug delivery device and that the connector be wrongly connected are greatly limited.