NEEDLE SHIELD REMOVER AND A MEDICAMENT DELIVERY DEVICE COMPRISING THE NEEDLE SHIELD REMOVER

Abstract

A needle shield remover for a medicament delivery device is presented that has a metal tubular body, a proximal part, a distal part, and a substantially circular cross-section, where the tubular body is arranged with a slot extending from a distal end of the body, at least half the length of the body, towards a proximal end, such that at least the distal part of the body may flex radially outwards to exert a radially inwardly directed clamping force on a needle shield accommodated by the body.

Claims

1. A cap assembly for a medicament delivery device, the cap assembly comprising: a cap removably attached to a proximal end of the medicament delivery device, the cap comprising a cap housing and a lid; and a needle shield remover comprising a metal tubular body having a longitudinal axis and an attachment structure located at a proximal end of the tubular body, where the attachment structure comprises a radially outwardly directed flange that is securely held inside of the cap.

2. The cap assembly of claim 1, wherein the flange is sandwiched between an inner surface of the lid and a bearing surface located inside of the cap housing.

3. The cap assembly of claim 1, wherein the flange connects directly to an inner surface of the lid when the lid is attached to a proximal part of the cap housing.

4. The cap assembly of claim 1, wherein the flange comprises a plurality of tongues.

5. The cap assembly of claim 1, wherein the flange comprises at least two tongues and a cut-out adjacent and separating the at least two tongues.

6. The cap assembly of claim 1, wherein the flange comprises tongues that are formed by cut-outs in a terminal end of the proximal end of the tubular body.

7. The cap assembly of claim 1 further comprising a plurality of gripping members located in a distal part of the tubular body that protrude radially inwards relative to the longitudinal axis, where the gripping members are configured to engage a needle shield such that axial movement of the tubular body directly results in simultaneous axial movement of the needle shield.

8. The cap assembly of claim 7, wherein the tubular body further comprises a distal part having a substantially circular cross-section, where a portion of the distal part flexes radially outwards relative to the longitudinal axis when a needle shield is positioned within the tubular body, where the outward radial flexing of the portion of the distal part causes a simultaneous radial inward clamping force exerted by a portion of the proximal end on the needle shield.

9. The cap assembly of claim 1 further comprising an engaging structure located in a proximal part of the tubular body configured to prevent outward radial flexing of the proximal part when the portion of the distal part flexes radially inward.

10. The cap assembly of claim 1, wherein a distal part of the tubular body comprises an inner diameter, that in a relaxed state, is smaller than an outer diameter of a needle shield that is to be accommodated by the tubular body.

11. The cap assembly of claim 1, wherein the tubular body is formed from a single rolled metal sheet.

12. The cap assembly of claim 1, wherein the tubular body further comprises substantially parallel opposing edges of a single rolled metal sheet.

13. The cap assembly according to claim 12, wherein opposing edges of a proximal part of the tubular body are arranged with mutually engaging structures to prevent radial flexing of the proximal part of the tubular body when a distal part of the tubular body flexes radially to accommodate insertion of a needle shield.

14. The cap assembly according to claim 1, wherein the flange comprises a plurality of tongues that are formed by punching cut-outs along an edge of a single metal sheet and then folding the tongues before shaping the metal sheet into the tubular body such the tongues are generally perpendicular to the longitudinal axis.

15. A medicament delivery device comprising: a housing comprising a needle mounted to a medicament container, where the needle is covered by a needle shield; and a cap assembly removably attached to a proximal end of the medicament delivery device, where the cap assembly comprises: a cap having a cap housing and a lid; and a needle shield remover comprising a metal tubular body having a longitudinal axis and an attachment structure located at a proximal end of the tubular body, where the attachment structure comprises a radially outwardly directed flange that is securely held inside of the cap.

16. The medicament delivery device of claim 15, wherein the tubular body further comprises a plurality of gripping members located in a distal part of the tubular body that protrude radially inwards relative to the longitudinal axis, where the gripping members are configured to engage the needle shield such that axial movement of the tubular body directly results in simultaneous axial movement of the needle shield, wherein outward radial flexing of a portion of a distal part of the tubular body causes a simultaneous radial inward clamping force exerted by a portion of the proximal end of the tubular body on the needle shield, and wherein the flange is sandwiched between an inner surface of the lid and an inner surface located in a proximal part of the cap.

17. The medicament delivery device of claim 15, wherein the flanged is positioned within the cap such that the cap housing and the lid can rotate relative to the tubular body but axial proximal movement of the cap housing relative to the needle shield will cause axial movement of the tubular body such that the gripping members engage the needle shield.

18. The medicament delivery device of claim 16, wherein the gripping members comprise rigid punched sheet metal structures each having a proximally directed edge.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0039] FIG. 1 is a cross-sectional view of a prior art cap, needle shield remover, and syringe;

[0040] FIG. 2 is a perspective view of a needle shield remover according to a possible embodiment of the present disclosure;

[0041] FIG. 3 is a perspective view of a needle shield remover according to another embodiment of the present disclosure;

[0042] FIG. 4 is a perspective view of a needle shield remover according to yet another embodiment of the present disclosure;

[0043] FIG. 5 is a perspective view of a needle shield remover according to still another embodiment of the present disclosure;

[0044] FIG. 6 is a perspective view of a needle shield remover according to yet another possible embodiment of the present disclosure;

[0045] FIG. 7A is a perspective view of a cap containing a needle shield remover according to an embodiment of the present disclosure;

[0046] FIG. 7B is an exploded perspective view of a cap and a needle shield remover according to a third embodiment of the present disclosure;

[0047] FIG. 8 is a conceptual schematic view of a possible manufacturing set-up for making the needle shield removers of the present disclosure; and

[0048] FIG. 9 is a perspective view of a needle shield remover according to yet another possible embodiment of the present disclosure.

DETAILED DESCRIPTION

[0049] FIG. 1 shows a cross-sectional view of a known cap and needle shield remover. A needle 95 is fixedly mounted in a proximal end of a container 94, such as a glass syringe. The syringe is accommodated in a housing 99 of a medicament delivery device. A generally tubular cap 90 is assembled with a tubular needle shield remover 91 via a connection, where a mutual circumferential groove-protrusion 97 of the needle shield remover, mating with a corresponding protrusion-groove 98 located in a cup 96 of the cap 90. The cap-needle shield remover assembly is removably attached to the housing 99. A flexible needle shield 93b, embedding the needle 95, is attached to, and accommodated in, a rigid needle shield 93a. The needle shield remover 91 comprises flexible gripping members 92, in the form of radially inwardly protruding tongues, which engage the needle shield 93a and 93b by protruding into holes, or depressions, in a tubular wall of the rigid needle shield 93a. When the medicament delivery device is to be used, a user pulls the cap 90 proximally away from the housing 99. The gripping members 92 will thereby pull the rigid needle shield 93a and the flexible needle shield 93b off the needle 95, exposing the needle 95.

[0050] As previously described, prior art needle shield removers are relatively expensive components of a medicament delivery device, because they are often manufactured from seamless stainless steel tubes, which are cut in desired lengths and provided with gripping members 92 and attachments structures, such as the groove-protrusions 97, 98. They also rely on the flexible gripping members 92 being able to engage the needle shield, either at a depression at the circumferential side surface of the needle shield, or at the distal end, i.e. a rear-facing end surface of the needle shield. Due to tolerances and an uncertain position of the container 94 in relation to the housing 99, such an engagement cannot always be assured.

[0051] An object of the present disclosure is therefore to provide a less costly and more reliable needle shield remover. Basically, the solution pertains to a needle shield remover 30 which comprises a metal tubular body 100, 200, having a proximal part A, a distal part B, and a substantially circular cross-section, the tubular body 100, 200 being arranged with a slot extending from a distal end of the body, at least half the length of the body 100, 200, towards a proximal end, such that at least the distal part B of the body may flex radially outwards to exert a radially inwardly directed clamping force on a needle shield accommodated by the body 100, 200. See FIGS. 2-6.

[0052] The clamping force may be produced by ensuring that an inner diameter of at least the distal part B of the body, in a relaxed state, is smaller than an outer diameter of the needle shield that is to be accommodated by the body. Thus, when the container with its needle and needle shield are mounted in a housing of the medicament delivery device, similarly to the prior art device shown in FIG. 1, the needle shield remover 30, which is assembled with a cap 40 (FIGS. 7A and 7B), may be pushed onto the needle shield such that the distal part B of the body 100, 200 is radially expanded relative to a longitudinal axis 500. As the metal body seeks to relax towards the relaxed, non-expanded state, the radially inwardly directed clamping force is exerted on the needle shield.

[0053] The clamping force may be exploited for the employment of an improved kind of rigid gripping members 32, as compared to the flexible prior art gripping members 92. The rigid gripping members 32 protrude radially inwards from a tubular wall of the distal part B of the body 100, 200. The gripping members 32 are formed as radially inwardly directed punched structures, having proximally directed edges to enhance friction between the body 100, 200 and a needle shield accommodated in the body 100, 200, when the body is proximally urged, such as when the cap 40 is removed from the housing of the medicament delivery device by the user.

[0054] The rigid gripping members 32 are relatively strong and mechanically resistant in relation to the conventional, flexible, gripping members 92. The radially inwardly directed clamping force of the body urges the rigid gripping members 32 into contact with a needle shield accommodated in the body 100, 200. By comparison, the conventional, flexible, gripping members 92 would be pressed flat against the needle shield due to the radial clamping force of the body 100, 200 of the needle shield remover 30. Consequently, flexible gripping members 92 would not be able to engage an outer surface of the needle shield.

[0055] The inwardly directed structures, having proximally directed edges, comprise holes punched out of the metal body. The rim, or edge, of each hole has a relatively sharp lip which provides a frictional engagement with the outer surface of the needle shield accommodated in the body 100, 200. Accordingly, an increased clamping force of the body of the needle shield remover also increases the frictional engagement since the gripping members 32 are rigid and do not deform under the clamping force of the body 100, 200.

[0056] The slot 10, 20 expands, or widens, as the needle shield is accommodated in the needle shield remover 30 from the distal end of the needle shield remover 30. Usually, the needle shield does not extend the whole length of the needle shield remover 30. The main flexing movement and clamping force of the needle shield remover will therefore be exerted by the distal part B. Furthermore, the proximal part is configured to be attached to the cap 40, as will be explained below. To ensure a good attachment to the cap it may be preferable to stabilise the proximal part A, to reduce the radial flexing thereof.

[0057] In one embodiment, the body 100 is formed of a rolled metal sheet. See FIGS. 2-5. The rolled metal sheet may be formed into a tubular body in a number of simple processing steps (FIG. 8). The metal sheet tubular body 100 is therefore a less costly alternative to the seamless stainless tube 91 of prior art devices. The diameter of the body 100 is furthermore easy to set during manufacture of the body 100 to configure the appropriate clamping force.

[0058] The slot 10 of the rolled metal sheet tubular body is formed of a gap between substantially parallel opposing edges of the rolled metal sheet. The slot 10 extends the whole length of the body 100. Basically, the whole body may be allowed to flex radially as the needle shield is accommodated therein, without significantly affecting the attachment of the cap 40 at the proximal part A of the body 100. Such a configuration is shown in FIG. 2.

[0059] However, if the radial flexing of the proximal part A of the body 100 is perceived as a problem, various measures may be taken to reduce the flexing in the proximal part A, as mentioned above. FIG. 3 shows the needle shield remover 30 wherein a transversal cut-out 34 intersects the slot 10 between the proximal part A and the distal part B to reduce radial flexing of the proximal part A of the body when the distal part B of the body 100 flexes radially due to accommodation of a needle shield therein. The transversal cut-out thereby relieves the proximal part A of the radial forces at work in the distal part B when accommodating the needle shield in the needle shield remover 30, which stabilises the attachment of the needle shield remover with the cap 40. The transversal cut-out may be described as two transversal cut-out arms which extend from the slot 10. Each cut-out arm preferably extends at least a quarter of the circumference of the body 100 from the slot 10.

[0060] An alternative solution is shown in FIGS. 4 and 5, wherein the opposing edges of the proximal part A of the body 100 are arranged with mutually engaging structures 36a, 36b such as to prevent radial flexing of the proximal part of the body when the distal part of the body flexes radially due to accommodation of a needle shield therein. The mutually engaging structure 36a (FIG. 4) is shown as a positive connection, such as a jigsaw connection 36a. Other forms of connections are also conceivable, such as latches, snap fits, etc. The purpose is to lock the opposing edges of the proximal part A to each other to reduce the radial flexing.

[0061] Another alternative solution to achieve the stable proximal part A, but still provide the clamping forces around the needle shield is to form the slot 20 as a partial cut-out from a distal end of a wall of a metal tube such that the proximal part A of the body 200 is radially rigid and the distal part B of the body 200 is radially flexible. See FIG. 6. Obviously, the advantage of the low-cost, rolled metal sheet is lost, but the clamping forces achieved by the slot still allow the use of the rigid gripping members 32.

[0062] In FIGS. 2-7, the needle shield remover 30 is shown with the body 100, 200 arranged with an attachment structure 38, 39 for connecting the needle shield remover to a cap 40 of a medicament delivery device. The attachment structure may be radially extending tongues 38 formed by cut-outs of the proximal end of the tubular body 100, 200 or a radially outwardly directed flange 39 (FIG. 6).

[0063] An alternative attachments structure may be the conventional groove-protrusion structure known from prior art. An elongated protrusion along the circumferential surface of the body 100, 200 is configured to mate with an elongated groove of a corresponding attachments structure of the cap 40 in a snap-fit connection (not shown). Of course, the protrusion of the body may be exchanged for a groove as exemplified in FIG. 9, and the groove of the cap may be exchanged for a corresponding protrusion. However, the radially extending tongues 38, or flange 39, described above, are more robust to any radial flexing of the proximal part A of the needle shield remover 30.

[0064] An alternative attachments structure may be the conventional groove-protrusion structure known from prior art. An elongated protrusion along the circumferential surface of the body 100, 200 is configured to mate with an elongated groove of a corresponding attachments structure of the cap 40 in a snap-fit connection (not shown). Of course, the protrusion of the body may be exchanged for a groove, and the groove of the cap may be exchanged for a corresponding protrusion. However, the radially extending tongues 38, or flange 39, described above, are more robust to any radial flexing of the proximal part A of the needle shield remover 30.

[0065] FIG. 8 shows a conceptual view of some manufacturing steps of the needle shield remover 30 having a rolled metal sheet body 100. Metal sheets are supplied (i) and cut into preferred widths and lengths. Gripping members and attachment structures are punched in the metal sheets (ii). The attachments structures are folded (iii). The sheets are formed into half-pipes (iv), followed by shaping of the half-pipes into tubular forms (v), which concludes the fabrication of the needle shield remover (vi).