Adaptor for Connecting a Connector to a Drug Delivery Device

Abstract

An adaptor for connecting a drug delivery device to a connector is provided with an external thread. The adaptor includes a globally tubular body having a proximal region and a distal region, said proximal region being provided with an engagement element for mounting said adaptor on the drug delivery device. The distal region is provided on its inner wall with an internal thread intended to cooperate with said external thread so as to connect said connector to the adaptor, said internal thread defining an internal thread crest. Said internal thread crest is provided with at least one deformable radial end part configured so as to be radially deformed when said connector is screwed into the adaptor. Also disclosed is a drug delivery device including such an adaptor and a method for connecting the connector to the adaptor.

Claims

1. An adapter for connecting a drug delivery device to a connector provided with an external thread, the adaptor comprising a globally tubular body having a proximal region and a distal region, said proximal region including an engagement element for mounting said adaptor onto the drug delivery device, said distal region including an inner wall with an internal thread configured to cooperate with said external thread so as to connect said connector to the adaptor, said internal thread defining an internal thread crest wherein said internal thread crest is provided with at least one deformable radial end part configured to be radially deformed when said connector is screwed into the adaptor.

2. The adapter according to claim 1, wherein said deformable radial end part comprises at least one radial projection.

3. The adapter according to claim 2, wherein said deformable radial end part comprises a plurality of radial projections.

4. The adapter according to claim 3, wherein said deformable radial end part comprises two radial projections positioned on the internal thread crest in a diametrically opposed way with respect to a diameter defined by the internal thread crest.

5. The adapter according to claim 1, wherein said deformable radial end part comprises a continuous element extending along a length of the internal thread crest.

6. The adapter according to claim 1, wherein said deformable radial end part has a cross section selected from a group consisting of a triangle, a square, a rectangle, a hemisphere and combinations thereof.

7. The adapter according to claim 6, wherein a cross section of said deformable radial end part is a triangle.

8. The adapter according to claim 1, wherein a cross section of the internal thread crest has a trapezoidal shape.

9. The adapter according to claim 1, wherein said deformable radial end part and said internal thread crest are made of the same material.

10. The adapter according to claim 1, wherein said deformable radial end part is made of a first material and said internal thread crest is made of a second material different from said first material.

11. The adapter according to claim 10, wherein said first material has a Young's modulus smaller than a Young's modulus of said second material.

12. The adapter according to claim 1, wherein said deformable radial end part is elastically deformable.

13. An assembly comprising an adaptor according to claim 1 and a connector provided with an external thread defining an external thread root, the internal thread the adaptor configured to cooperate with said external thread to connect said connector to the adaptor, said external thread root configured to deform said deformable radial end part when said connector is screwed into said adaptor.

14. The assembly according to claim 13, wherein a diameter of the internal thread crest at a location of the deformable radial end part in a non-deformed state of said radial end part is less than a diameter at the external thread root by about 0.05 mm to about 0.80 mm.

15. A drug delivery device comprising a distal tip defining an axial passageway for the transfer of a product contained in said drug delivery device, and at least one adaptor according to claim 1 mounted on said distal tip.

16. The drug delivery device according to claim 15, wherein the distal tip is made of glass.

17. The drug delivery device according to claim 15, wherein the distal tip is conical and distally tapered.

18. A method for connecting a connector provided with an external thread onto an adaptor according to claim 1, the method comprising the step of screwing said external thread into the internal thread of the adaptor.

19. The assembly according to claim 14, wherein the diameter of the internal thread crest at the location of the deformable radial end part in the non-deformed state of said radial end part is less than the diameter at the external thread root by about 0.20 mm to about 0.60 mm.

Description

[0055] 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:

[0056] FIG. 1 is a perspective view of a first embodiment of an adaptor of the invention,

[0057] FIG. 2 is a cross sectional view of the adaptor of FIG. 1,

[0058] FIG. 3 is a top view of the adaptor of FIG. 1,

[0059] FIG. 4 is a cross sectional view showing the step of screwing a connector onto the adaptor of FIG. 1,

[0060] FIG. 5 is a partial enlarged view of FIG. 4 showing the interference between the external thread root and the deformable radial projection provided on the internal thread crest,

[0061] FIG. 6 is a partial enlarged view showing the deformed radial projection of the adaptor of FIG. 5,

[0062] FIG. 7 is a partial enlarged view showing the interference between the external thread root and the deformable radial projection provided on the internal thread crest in a second embodiment of the adaptor of the invention in which the deformable radial end part and the internal thread crest are made of two different materials,

[0063] FIG. 8 is a partial enlarged view showing the deformed radial end part of the adaptor of FIG. 7,

[0064] FIG. 9 is a perspective view of a third embodiment of an adaptor of the invention,

[0065] FIG. 10 is a cross sectional view of the adaptor of FIG. 9,

[0066] FIG. 11 is a top view of the adaptor of FIG. 9,

[0067] FIG. 12 is a cross sectional view showing the step of screwing a connector onto the adaptor of FIG. 9,

[0068] FIG. 13 is a cross sectional view of an alternative embodiment to the adaptor of FIG. 9, and

[0069] FIG. 14 is an exploded perspective view of the connection of a connector to a drug delivery device via the adaptor of FIG. 1.

[0070] With reference to FIGS. 1-3, is shown an adaptor 1 of the invention, for connecting a drug delivery device, such as the drug delivery device 100 represented on FIG. 14, to a connector, such as the connector 200 partially shown on FIG. 4.

[0071] The adaptor 1 comprises a tubular body 2 having a longitudinal axis A, a proximal region 2a and a distal region 2b. As will appear from the description below, the adaptor 1 is intended to be connected to the drug delivery device 100 by its proximal region 2a.

[0072] In particular, the proximal region 2a of the globally tubular body 2 is adapted to engage the drug delivery device 100.

[0073] In this view, the proximal region 2a of the tubular body 2 is provided with an inner annular rim 3 defining a central bore 4. The inner annular rim 3 may be radially expandable so as to fit with friction on the distal tip 101 of the drug delivery device 100. As appears from FIG. 14, the distal tip 101 is frustro-conical. The annular rim 3 is configured to engage the drug delivery device 100 and/or forms engagement means for engaging the adaptor 1 onto the distal tip 101 of the drug delivery device 100. In other embodiments not shown, the inner rim could show alternative designs as long as these designs allow the rim to be friction fitted onto the distal tip of the drug delivery device.

[0074] The adaptor 1 is intended to be connected to the connector 200 via its distal region 2b.

[0075] The distal region 2b of the tubular body 2 is provided on its inner wall with an internal thread 5 defining an internal thread crest 5a and an internal thread root 5b. As will appear from the description below, the internal thread 5 is intended to cooperate with an external thread 201 of the connector 200 to be screwed into the adaptor 1 (FIG. 4).

[0076] With reference to FIG. 4, the external thread 201 defines an external thread crest 201a and an external thread root 201b. On the example shown, the external thread 201 is a straight external thread, a ridge wrapped around a cylinder in the form of a helix, the height of the ridge and the diameter of the cylinder being both constant values.

[0077] With reference to FIGS. 1-3, the internal thread crest 5a is provided with a deformable radial end part under the form of two deformable radial projections 6. As appears from these Figures, each radial projection 6 extends radially from the internal thread crest 5a and protrudes inwardly towards the center of the central bore of the tubular body 2. As will appear from the description below, each radial projection 6 is capable of being deformed radially outwardly by the external thread root 201b when the connector 200 is screwed into the adaptor 1.

[0078] In embodiments not shown, the deformable radial end part could include or be under the form of only one radial projection, positioned anywhere along the length of the internal thread crest 5a, as long as the external thread root 201b comes in contact therewith at the time the connector is screwed into the adaptor.

[0079] In other embodiments not shown, the deformable radial end part could include or be under the form of a plurality of radial projections, positioned regularly or not along the length of the internal thread crest 5a.

[0080] In the example shown, in particular with reference to FIGS. 2 and 3, the two radial projections 6 are positioned on the internal thread crest 5a in a diametrically opposed way with respect to the diameter D1 which is defined as being the diameter of the internal thread crest 5a at the location where said internal thread crest 5a is free of any radial projection.

[0081] The capacity of the radial projections 6 to be deformed by the external thread root 201b at the time the connector 200 is screwed into the adaptor 1 may come from the design of the radial projections 6, from the nature of the material they are made of, or from a combination of these two parameters.

[0082] The design of the radial projection 6 may be defined by the shape of its cross section by a radial longitudinal plane.

[0083] In the example shown, the cross section of the internal thread crest 5a is trapezoidal, and the cross section of each radial projection 6 is triangular; in particular, as shown on FIGS. 2 and 4, the triangle of a radial projection 6 is complementary to the shape of the trapezium forming the internal thread crest 5a. Such embodiments allow using less material for the radial projections 6. In addition, the triangular form of the cross section of the radial projections 6 provides said radial projections with good capacities of deformation.

[0084] In other embodiments not shown, the deformable radial end part, in particular the radial projections 6, could have different cross sections, such as semi-circular, square, rectangular, etc . . . , as long as said cross section shapes allow the deformable radial end part to be deformed under the action of the external thread root at the time the connector is screwed into the adaptor.

[0085] With reference to FIG. 2, D2 is defined as the internal diameter at the location of the two radial projections 6 provided on the internal thread crest 5a in a non-deformed state of said radial projections 6.

[0086] With reference to FIG. 4, D3 is defined as the diameter at the external thread root 201b.

[0087] As mentioned, the external thread 201 and the internal thread 5 are intended to cooperate so as to connect the connector 200 into the adaptor 1, and in this view, D1 and D3 are dimensioned so as to allow the cooperation between the connector 200 and the adaptor 1 for a regular screwing for a conventional threaded engagement.

[0088] The presence of at least one deformable radial end part, under the form of the two radial projections 6 in the example shown, reduces the initial diameter D1 of the internal thread crest 5a to a reduced diameter D2 at a certain location of said internal thread crest 5a. Since D2 is smaller than D1, at least a part of the internal thread crest 5a does not have any more the usual dimensions for a conventional threaded engagement with the external thread 201. In addition, D2 is also smaller than D3, thereby creating an interference between the external thread root 201b and the radial projections 6. In particular, the radial projections 6 increase the contact force between the connector 200 and the adaptor 1.

[0089] On FIG. 4, is shown partially the connector 200 screwed into the adaptor 1, with the radial projection 6 virtually superimposed on the connector in order to show the interference between the external thread root 201b and the radial projection 6, referenced as ID on the FIG. 4. FIG. 5 is an enlarged view of this detail part showing the interference between the radial projection 6 and the external thread root 201b.

[0090] For example, an interference ID resulting from a value of D3-D2 ranging from 0.05 mm to 0.80 mm, preferably ranging from 0.20 mm to 0.60 mm, allows producing a good friction force between the connector 200 and the adaptor 1, and therefore an improved connection between them.

[0091] As seen above, the capacity of each radial projection 6 to be deformed may alternatively or in combination come from the nature of the material it is made of.

[0092] The material forming the radial projection 6 may be selected from a material capable of being deformed by the radial pressure exerted thereon by the external thread root 201b at the time the connector 200 is screwed into the adaptor 1.

[0093] The material forming the radial projection 6 may be the same as that of the adaptor 1 as long as the combination of the shape of the radial projection 6 and of the material forming the radial projection 6 provide the radial projection 6 with the capability of being deformed under the radial pressure exerted by the external thread root 201b of the connector 200 at the time the connector 200 is screwed into the adaptor 1.

[0094] The radial projections 6 and the internal thread crest 5a may be made of the same material.

[0095] For example, when the radial projections 6 and the internal thread crest 5a are made of the same material, said material may be selected from polycarbonate (PC), polypropylene carbonate (PPC), polysulfone (PSU) and combinations thereof.

[0096] The rest of the adaptor 1 may also be made from the same material as the material forming the radial projections 6 and the internal thread crest 5a, for example a material selected from polycarbonate (PC), polypropylene carbonate (PPC), polysulfone (PSU) and combinations thereof.

[0097] In embodiments, the cross section of the radial projection 6 is a triangle and the material forming the radial projection 6 is selected from polypropylene (PP), polyethylene (PE), thermoplastic elastomer (TPE), polycarbonate (PC), polypropylene carbonate (PPC), polysulfone (PSU) and combinations thereof. The fact that the cross section of the radial projection is a triangle allows selecting any material for said radial projection, regardless of the Young's modulus of the material, the capacity of deformation of the radial projection being given by the shape of the radial projection.

[0098] The material forming the adaptor 1 may be selected from polycarbonate (PC), polypropylene carbonate (PPC), polysulfone (PSU) and combinations thereof. For example, the material forming the adaptor 1 is polycarbonate (PC). Such materials provide the adaptor 1 with a good rigidity for receiving the connector 200.

[0099] In embodiments, the internal thread crest 5a and the radial projections 6 are made from a material different from the material forming the rest of the adaptor 1. In such a case, preferably, the material forming the internal thread crest 5a and the radial projections 6 shows a Young's modulus smaller than the Young's modulus of the material forming the rest of the adaptor 1.

[0100] In other embodiments, only the radial projections 6 may be made from a material different from the material forming the rest of the adaptor 1. For example, the material forming the radial projections 6 shows a Young's modulus smaller than the Young's modulus of the material forming the rest of the adaptor 1, including the internal thread crest 5a.

[0101] As shown on FIG. 14, the adaptor 1 of FIGS. 1-6 is intended to connect the drug delivery device 100 to the connector 200. The connection of the connector 200 to the drug delivery device 100 will now be described with reference to FIGS. 1-6 and 14.

[0102] The connector 200 of FIGS. 4 and 14 is shown partially. The external thread 201 forms the proximal end of the connector 200. The connector 200 may be any device intended to be connected to the adaptor 1, either for allowing the transfer of a product from the drug delivery device to another medical device free of needle, such as a pocket drip, a vial, an IV (Intra Venous) line, an IM (Intra Muscular) line, a catheter, a needle hub, a needleless access device, or on the contrary for safely closing the filled drug delivery device before its use and for preventing any contamination, like for example a closure cap in the storage position of the drug delivery device.

[0103] The connector 200 is usually made from a rigid material. In particular, the connector 200 is made from a material having a greater rigidity than the material forming the deformable radial end part, namely the radial projections 6 in the example shown. For example, the material forming the connector 200 has a Young's modulus greater than that of the deformable radial end part.

[0104] With reference to FIG. 14, the drug delivery device 100 and the adaptor 1 are aligned and have a common longitudinal axis A. The distal tip 101 of the drug delivery device is conical, distally tapered and it defines an axial passageway 102 for the transfer of a product (not shown) contained therein. The axial passageway 102 is open at its distal end. In embodiments not shown, the outer surface of the distal tip 101 may be provided with an annular groove, or alternatively an annular ridge.

[0105] The distal tip 101 may be made of plastic or glass material. In embodiments, the distal tip 101 is made of glass material. In another embodiment, the distal tip 101, as well as the drug delivery device 100, is made of plastic material selected from crystal clear polymer (CCP), acrylonitrile butadiene styrene (ABS), cycloolefin polymers (COP), cycloolefin copolymers (COC), polycarbonate (PC), polystyrene (PS), polypropylene (PP), polyethylene (PE) and their combinations.

[0106] In a first step, the adaptor 1 is engaged on the distal tip 101 of the drug delivery device 100 by means of its inner rim 3. In an embodiment not shown, the engagement of the adaptor and its correct positioning is possible thanks to its appropriate fitting with an annular groove located on the distal tip of the drug delivery device. In other embodiments not shown, the adaptor may be maintained onto the proximal part of the distal tip of the drug delivery device thanks to an annular ridge located on the distal tip.

[0107] With reference to FIG. 14, the adaptor 1 is then secured on the distal tip 101 of the drug delivery device 100 by friction fitting of the inner rim 3 on the distal tip 101.

[0108] The user then screws the external thread 201 into the internal thread 5 of the adaptor 1. Since D2 is less than D3, when the external thread root 201b comes in contact with the radial projections 6, it exerts on said deformable radial projections 6 a stress under the form of a radial force that causes the radial projections 6 to deform radially outwardly, as shown on FIG. 6. There is an increase of the friction between the external thread 201 and the internal thread crest 5a. This increased friction does not prevent the complete screwing of the external thread 201 in the adaptor 1. Moreover, the user does not need to increase significantly the screwing torque he exerts in order to obtain a greater friction between the external thread 201 and the internal thread 5. As a consequence, the risks that the adaptor 1 rotates with respect to the distal tip 101 at the time the connector 200 is screwed into the adaptor 1 are greatly limited.

[0109] FIGS. 5 and 6 show in detail the phenomenon of the deformation of the radial projections 6. As appears from FIG. 6, when the radial projections 6 are deformed, the diameter of the internal thread crest 5a at the location of the radial projections 6 tends towards D3.

[0110] If the radial projections 6 are made from a material elastically deformable, then the radial projections 6 may come back to their initial shape when no more pressure is exerted thereon, for example when the connector 200 is unscrewed from the adaptor 1. The adaptor 1 may then be used several times. Materials suitable for forming an elastically deformable radial projection may be selected from polypropylene (PP), polyethylene (PE), thermoplastic elastomer (TPE) and combinations thereof.

[0111] In embodiments where the radial projections 6 are made from a material plastically deformable, the radial projections 6 remain in their deformed state even when the connector is unscrewed from the adaptor. Materials suitable for forming a plastically deformable radial projection may be selected from polycarbonate (PC), polypropylene carbonate (PPC), polysulfone (PSU) and combinations thereof.

[0112] Depending on the intensity of the stress exerted on the radial projection 6, propylene may also be used to form a plastically radial projection. Indeed, polypropylene, like other materials such as polyethylene, has the property to evolve from an elastically deformable material, when the stress applied to the material is relatively low, to a plastically deformable material, when the intensity of the stress applied on the material is higher. In the adaptor of the present invention, the intensity of the stress applied on the radial projection 6 will depend on the value of the interference ID as shown on FIG. 4. The higher the interference ID, the higher the stress applied on the radial projection when the connector is screwed into the adaptor.

[0113] In both cases, the connector 200 is not damaged. In particular, the external thread root 201b is not damaged by the contact and further deformation of the radial projections 6. This is particularly advantageous as the connector 200 may therefore be reused for another connection with another drug delivery device.

[0114] The user may continue screwing the connector 200 into the adaptor 1 until the proximal end of the connector 200 reaches a point of contact on the distal tip 101. A good and reliable connection between the connector 200 and the adaptor 1 is thus obtained.

[0115] In particular, the decrease of the diameter of the internal thread crest 5a at the location of the radial projections 6 combined to the deformation of the radial projections 6 allows a better friction force between the connector 200 and the adaptor 1 of the invention. The unscrewing torque is increased, as well as the pull out force necessary to separate the connector 200 from the adaptor 1, once the connector 200 is screwed in the adaptor 1. For example, the unscrewing torque may be increased by 20%.

[0116] As an example, the unscrewing torque has been measured according to the methods described in ISO 594 and ISO 80639-7, for the two following adaptors, using the same connector: [0117] Adaptor of the invention A: adaptor 1 of FIG. 10 where the adaptor, the internal thread crest 5a and the continuous radial element 7 are all made of the same material, namely polycarbonate, [0118] Comparative adaptor B: adaptor differing from the adaptor of the invention A by the fact that it is free of the continuous radial element.

[0119] It has been determined that the unscrewing torque measured for the adaptor of the invention is 20% greater than that of the comparative adaptor.

[0120] The adaptor 1 of the invention therefore allows a more stable resulting connection, without having to exert a higher torque for screwing the connector into the adaptor and without damaging the connector 200.

[0121] With reference to FIGS. 7 and 8, is shown an alternative embodiment of the adaptor of FIGS. 1-6 in which the deformable radial end part, namely the radial projections 6, and the internal thread crest 5a are made of two different materials. The references designating the same elements as in FIGS. 1-6 have been maintained in FIGS. 7 and 8.

[0122] With reference to FIGS. 7 and 8, the first material 8 forming the radial projections 6 is for example polypropylene, while the second material 9 forming the internal thread crest 5a is for example polycarbonate. The Young's modulus of the polypropylene is 1500 Mpa, while the Young's modulus of polycarbonate is 2000 Mpa. Moreover, as seen above, polypropylene may confer to the radial projections 6 the property to be plastically deformed. Such embodiments ensure a good deformation capacity to the radial projections 6, and therefore an improved connection between the connector 200 and the adaptor 1 without having to apply too high a torque at the time the connector 200 is screwed into the adaptor 1.

[0123] Alternatively, the first material 8 could be thermoplastic elastomer (Young's modulus of 1000 Mpa) and the second material 9 could be polypropylene (Young's modulus of 1500 Mpa).

[0124] With reference to FIGS. 9-13 are shown alternative embodiments of the adaptor of FIGS. 1-6, in which the deformable radial end part is under the form of a continuous radial element 7, extending on the whole length of the internal thread crest 5a.

[0125] The references designating the same elements as in FIGS. 1-6 have been maintained in FIGS. 9-13.

[0126] In the examples shown on FIGS. 9-13, the internal thread crest 5a has a trapezoidal cross section and the continuous radial element 7 has a triangular cross section, complementary to the trapezoidal cross section of the internal thread crest 5a.

[0127] With reference to FIGS. 9-12, the internal thread crest 5a and the continuous radial element 7 are made of the same material, for example polypropylene (PP), polyethylene (PE), thermoplastic elastomer (TPE), polycarbonate (PC), polypropylene carbonate (PPC), polysulfone (PSU) and/or combinations thereof.

[0128] With reference to FIG. 13, is shown an embodiment of the adaptor of the invention differing from the embodiment of FIGS. 9-12 only by the fact that the internal thread crest 5a and the continuous radial element 7 are made of two different materials. The references designating the same elements as in FIGS. 9-12 have been maintained in FIG. 13. With reference to this FIG. 13, the first material 10 forming the continuous radial element 7 may be selected from polypropylene (PP), polyethylene (PE), thermoplastic elastomer (TPE) and combinations thereof, while the second material 11 forming the internal thread crest 5a and the rest of the adaptor 1 may be selected from polycarbonate (PC), polypropylene carbonate (PPC), polysulfone (PSU) and combinations thereof.

[0129] The screwing of the connector 200 into the adaptor 1 of FIGS. 9-12 or of FIG. 13 is operated in the same manner as described above for FIGS. 1-6 and 14. When the connector 200 is screwed into the adaptor 1, the continuous radial element 7 deforms on the whole length of the internal thread 5 of the adaptor 1. The unscrewing torque is therefore increased and the resulting connection is more secured.

[0130] In particular, with the adaptor of the invention, the unscrewing torque may be increased by 20%. The connection is therefore more reliable than with adaptors of the prior art not provided with a deformable radial projection.

[0131] The risks that the connector screwed into the adaptor of the invention be spontaneously disconnected are therefore greatly limited, even when the distal tip is made of glass and/or when the connector comprises spring-biased piece providing high counter forces against the connection, like for needleless access devices for example. The adaptor of the invention therefore allows a reproducible and safe connection of a connector on said adaptor allowing a secured and reliable passage of fluid from the drug delivery device and the connector. Further, the adaptor of the invention may be compatible with lots of available connectors of the market.

[0132] The adaptor of the invention allows the reliable connection of a connector onto the distal tip of a drug delivery device. The risks that the connector unscrews spontaneously and/or accidently from the adaptor of the invention are very limited.