Abstract
A sealed package containing a medical device, such as a syringe, that has a predefined centre of mass. The package may include a cavity containing the device and a removable backing that seals the device inside the cavity. A fulcrum within the cavity is defined as a point of contact between the device and a wall of the cavity, the fulcrum being positioned such that the predefined centre of mass of the device is forward of the fulcrum so that the device tends to pivot forward about the fulcrum into a stable position. A front pocket is formed in the cavity which extends forward of and below the fulcrum to receive a front end of the device when the device is free to pivot into a stable position.
Claims
1. A sealed package containing a medical device that has a predefined centre of mass, the package comprising: a cavity containing the device; a removable backing that seals the device inside the cavity; a fulcrum within the cavity, defined as a point of contact between the device and a wall of the cavity, the fulcrum being positioned such that the predefined centre of mass of the device is forward of the fulcrum so that the device tends to pivot forward about the fulcrum into a stable position; and a front pocket formed in the cavity which extends forward of and below the fulcrum to receive a front end of the device when the device is free to pivot into a stable position.
2. (canceled)
3. (canceled)
4. A sealed package according to claim 1, wherein the device is contained in an unstable position with the removable backing forming a surface of the sealed package that is in contact with a rear end of the device.
5. A sealed package according to claim 4, wherein the cavity is arranged such that, when the backing is removed, the device is free to pivot forward so that the rear end of the device projects out of the cavity beyond said surface.
6. A sealed package according to claim 5, wherein the front pocket extends below the fulcrum to such a depth that the rear end of the device projects out of the cavity beyond said surface when the forward end is received in the front pocket.
7. (canceled)
8. A sealed package according to claim 1, wherein the front pocket comprises a catch arranged to hold the front end once the device has pivoted forward into a stable position.
9. A sealed package according to claim 8, wherein a wall of the cavity in the front pocket includes a recess to provide the catch.
10. (canceled)
11. A sealed package according to claim 1, wherein the front end comprises a removable cover and wherein the cavity comprises means for gripping the removable cover.
12. (canceled)
13. (canceled)
14. A sealed package according to claim 1, wherein the cavity comprises a central portion having a central depth and the front pocket is defined by a forward portion of the cavity having a depth that is greater.
15. A sealed package according to claim 14, wherein the fulcrum is formed by a corner in a wall of the cavity between the front pocket and the central portion.
16. A sealed package according to claim 14, wherein the device is supported in an unstable position by a wall of the cavity in the central portion.
17. A sealed package according to claim 14, wherein the cavity further comprises a rear pocket, the central portion being positioned between the front pocket and the rear pocket, and the rear pocket having a depth that is greater than the central depth of the central portion but not as great as the depth of the front pocket.
18. (canceled)
19. A sealed package according to claim 14, wherein the central portion comprises a central pocket having a depth that is less than the depth of the front pocket.
20. A sealed package according to claim 19, further comprising an additional component for use with the medical device that is contained in the central pocket.
21. A sealed package according to claim 14, wherein the central portion comprises side walls that support the device and a lower wall that is spaced away from the device.
22.-25. (canceled)
26. A sealed package according to claim 1, wherein the cavity has an outer profile below the device which is shaped such that, when the package rests on a horizontal surface, the predefined centre of mass of the device is forward of the fulcrum.
27. (canceled)
28. (canceled)
29. A sealed package according to claim 1, comprising a plurality of said cavities.
30.-39. (canceled)
40. A sealed package according to claim 1, further comprising a removable support arranged outside the package to deform the cavity so as to substantially prevent the device from pivoting forward into a stable position inside the package.
41.-43. (canceled)
44. A method of sealing a package containing a medical device that has a predefined centre of mass, the package comprising: a cavity containing the medical device; a fulcrum within the cavity, defined as a point of contact between the device and a wall of the cavity, the fulcrum being positioned such that the predefined centre of mass of the device is forward of the fulcrum so that the device tends to pivot forward about the fulcrum into a stable position; and a front pocket formed in the cavity which extends forward of and below the fulcrum to receive a front end of the device when the device is free to pivot into a stable position, the method comprising: deforming one or more walls of the cavity such that the medical device contained in the cavity is supported on the fulcrum in an unstable position inside the package; and applying a removable backing to seal the cavity.
45. (canceled)
46. A method according to claim 44, wherein deforming one or more walls of the cavity comprises arranging a support outside the package.
47. (canceled)
48. A method according to claim 44, further comprising releasing the one or more walls of the cavity after applying the removable backing.
49. (canceled)
Description
[0056] Some preferred embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:
[0057] FIG. 1 shows an embodiment of a packaging containing a syringe;
[0058] FIG. 2 shows an embodiment of the packaging where the backing has been partially removed;
[0059] FIG. 3 shows a perspective view of the packaging;
[0060] FIG. 4 shows a side profile of the packaging;
[0061] FIG. 5 shows a view from the underside of the packaging;
[0062] FIG. 6 shows an end-on view of the packaging;
[0063] FIG. 7 shows a side view of the packaging, highlighting the front pocket;
[0064] FIG. 8 shows a side profile of the packaging, highlighting a slice through relating to the anti-vibration feature;
[0065] FIG. 9 shows a cross-sectional view through line A-A in FIG. 8;
[0066] FIG. 10 shows a perspective view of the packaging containing a syringe;
[0067] FIG. 11 shows a side view of the packaging, drawing attention to the internal structure which prevents the syringe from sliding within the packaging;
[0068] FIGS. 12a-c show the backing being removed from the package and the syringe pivoting;
[0069] FIGS. 13a-c show a user removing the syringe from the package by physically pulling the syringe;
[0070] FIGS. 14a-c show a user removing the syringe by tipping the package over such that it falls out onto a surface;
[0071] FIGS. 15a-b show another embodiment of a packaging cavity for a needlean isometric view in
[0072] FIG. 15a of the empty cavity and a top view in FIG. 15b of the cavity containing a needle hub;
[0073] FIGS. 16a-i show a user opening such a package, attaching a syringe to the needle, optionally fastening the needle, and then returning the needle after use;
[0074] FIG. 17 shows another embodiment of a package containing a needle;
[0075] FIG. 18 shows another embodiment of a package containing a needle;
[0076] FIG. 19 shows another embodiment of a packaging cavity for a needle;
[0077] FIGS. 20a-f show a user attaching a syringe to the needle, withdrawing the needle from its cover, and then returning the needle after use;
[0078] FIG. 21 shows another embodiment of a package;
[0079] FIG. 22 shows a U-shaped clip that can be used as a support for a package;
[0080] FIG. 23 shows a perspective view of the U-shaped clip of FIG. 22 applied to the package of FIGS. 1-14;
[0081] FIG. 24 shows the U-shaped clip being applied;
[0082] FIG. 25 shows the package being pressed down into the U-shaped clip;
[0083] FIG. 26 shows a side cross-sectional view of the U-shaped clip applied to the package; and
[0084] FIG. 27 shows a front cross-sectional view of the U-shaped clip applied to the package.
[0085] FIG. 1 shows an embodiment of a package 2 containing a typical hypodermic syringe 4. The package 2 is comprised of a cavity 6 and a backing 8. A front pocket 10 is located at one end of the cavity 6 and a central flat portion 12 extends from the front pocket 10 towards a rear pocket 14 at the opposite end of the cavity 6. The cavity 6 is moulded from a relatively hard, clear thermoplastic material, for example PET (polyethylene terephthalate) or a PET copolymer such as PETG. The cavity 6 holds it shape because it is not made from a plastics film, like traditional syringe packages, but sheet material such as 0.4 mm thick PET. This ensures that the cavity 6 does not easily deform when handled by a user. The backing 8 consists of a nonwoven sheet material such as Tyvek (available from DuPont). A 0.15 mm thick sheet of Tyvek has been found tough enough to avoid the syringe 4 piercing through the backing 8 e.g. during transit.
[0086] Also shown in FIG. 1 is a protrusion 16 moulded on the top surface of the cavity 6. The backing 8 is sealed to the top surface of the cavity 6 around a peripheral portion 28 such that when it is removed there is an opening to allow the syringe 4 to be removed. The backing 8 is not sealed past the point of the protrusion 16. The protrusion 16 therefore acts to hold an end portion 30 of the backing 8 away from the cavity 6 so that it forms a tab which can easily be grabbed by a user. This is particularly advantageous when the package 2 is used in medical situations where a user may be wearing sterile gloves, which can reduce manual dexterity and make opening the packaging 2 difficult.
[0087] The syringe 4 contained in the package 2 comprises a plunger 18, a barrel 20 with scale markings 22, a fluid transfer tip 24 and a lever member 26 which is mounted around the fluid transfer tip 24. It can be seen that the front pocket 10 has a depth which is greater than that of the central portion 12. It can be seen that the syringe 4 pivots about a fulcrum 32 formed where the surface of the barrel 20 comes into contact with a corner in the cavity wall where the central portion 12 drops down into the front pocket 10 of the cavity 6. In the embodiment shown, as the lever member 26 is positioned around the fluid transfer tip 24, due to the mass this adds in the region proximal to the fluid transfer tip 24 it is evident that the centre of mass is forward of the fulcrum 32.
[0088] As seen in FIG. 2, the backing 8 can be partially removed from the cavity 6 such that the syringe 4 is free to pivot within the cavity 6. The syringe 4 pivots such that the plunger 18 protrudes from the cavity 6 and the fluid transfer tip 24 moves towards the bottom of the cavity 6 into the front pocket 10. This helps to reduce the risk of contamination of the fluid transfer tip 24, firstly because the plunger 18 is readily accessible meaning that the user is more likely to grab the syringe 4 by the plunger 18, and secondly because the fluid transfer tip 24 moves towards the base of the cavity 6 making it a less attractive portion to remove the syringe 4 by.
[0089] FIG. 3 shows a different perspective of the packaging 2. It can be seen that the central portion 12 where the syringe barrel 20 rests is narrower than the front pocket 10 of the cavity 6. The outer surface of this narrower central portion 12 provides a surface for the user to grab the cavity 6 when removing the backing 8 and the syringe 2. This can be seen in more detail in later Figures, specifically: FIGS. 12, 13 and 14. This narrower central portion 12 also fits around the barrel 20 on the syringe 4 to restrict its movement within the packaging 2.
[0090] FIG. 4 shows a side view of the package 2. In this Figure it can be seen that the front pocket 10 extends substantially deeper that the flat section 12 to enable the syringe 4 to pivot within the cavity 6. The extra volume defined by the front pocket 10 provides the space for the fluid transfer tip 24 to pivot forward into.
[0091] FIG. 5 shows a view from the underside of the package 2, specifically from the base of the cavity 6. It can be seen that the peripheral portion 28 of the cavity 6 extends around the whole outer perimeter of the cavity 6. This is to ensure that when the backing 8 is sealed to the cavity 6 that the syringe 4 is completely sealed within the package 2. Also visible in this Figure are the protrusions 16. There is a protrusion 16 located at both corners at one end of the package 2, in this embodiment the opposite end to the fluid transfer tip 24. The purpose of the two protrusions 16 is to make it easier for the user, whether they are left or right handed, to remove the backing 8.
[0092] FIG. 6 shows an end-on view of the package 2 and it can be seen that the end portion of the front pocket end 10 narrows to a thinner portion 34. The purpose of this is to follow the shape of the syringe 4, particularly the fluid transfer tip 24, in order to restrict general movement of the syringe 4 within the package 2.
[0093] The front pocket 10 within the cavity 6 is illustrated by the dashed region on FIG. 7. The front pocket 10 provides a space for the fluid transfer tip 24 and lever member 26 of the syringe to pivot into once the backing 8 has been removed. The depth of the front pocket 10 is such that a portion of the plunger 18 protrudes out of the cavity 6 which is appropriate for a user to grab. In the embodiment shown, the shape of the front pocket 10 is shaped to accommodate features of the syringe, for example the lever member 26. It is also possible to see in this Figure that, when the backing 8 is still sealed to the cavity 6, the plunger 18 of the syringe 4 rests against the backing 8 and this prevents it from tipping. Therefore, as soon as the backing 8 is removed, the syringe 4 is free to pivot. The backing 8 is made from a sufficiently strong material that this pressure does not weaken the backing 8 to the point where the plunger 18 may break through it. This is particularly relevant as during transportation the device may move within the packaging 2, which may result in the plunger 18 repeatedly pressing against the backing 8, potentially weakening the material.
[0094] Another issue associated with the packaging of medical devices, such as the syringe 4 contained in a blister-type packaging 2, is that both high and low frequency vibrations which arise during storage and transportation can cause markings 22 on the device to wear away. FIG. 8 shows how the embodiment of the syringe packaging 2 helps to reduce these effects. On the central portion 12 of the cavity 6, where the syringe barrel 20 comes into contact with a wall of the cavity 6, there is provided a recess such that the cavity 6 only comes into contact with opposed side portions of the barrel 20, rather than a lower portion where the scale 22 is typically marked. Accordingly the supporting surface walls of the cavity 6 are located away from the printed markings 22 on the syringe 4.
[0095] FIG. 9 shows a cross-sectional view through the line A-A of FIG. 8. It can be seen that the syringe barrel 20 is supported on the side portions 36 of its circumference by the cavity side walls 38. The lower portion 40 of the cavity 6 is shaped such that there is a space 42 between the lower portion 40 of the cavity 6 and the lower portion 44 of the barrel 20, such that the lower portion 44 of the barrel 20 does not come into contact with the cavity and therefore the amount of wearing of the markings 22 is reduced.
[0096] As seen in FIG. 10 the width of the cavity 6, more specifically the front pocket 10, is similar to that of the syringe 4. In the embodiment shown, where the syringe 4 also comprises a lever member 24, the syringe 4 is prevented from rotating axially within the cavity 6 as the lever member 24 would quickly come into contact with the side walls of the cavity 6 and be prevented from further rotating. This ensures that the syringe 4 remains in this orientation such that it does not come into contact with the walls of the cavity 6. The finger grip portion 46 proximal to the plunger 18 also assists in preventing the syringe from rotating. The syringe is supported on the sides of the syringe rather than being supported from the bottom. FIG. 10 also shows a syringe 4 inside the package 2 and it can be seen that the syringe barrel 20 has a finger grip portion 46. This finger grip portion 46 positioned in the rear pocket 14 can also act to prevent the syringe 4 from rotating, this ensures that the markings on the barrel 20 remain in the position shown in FIG. 9.
[0097] FIG. 11 shows the finger grip portion 46 of the syringe 4 abutting against an inside wall 48 of the rear pocket 14. As the finger grip portion 46 abuts against this wall 48 it prevents the syringe 4 from sliding forward in the package 2 and thus prevents the fluid transfer tip 24 from coming into contact with the end wall 50 of the cavity 6. It keeps a space 52 shown by the lines in the Figure. The wall 48 helps to ensure that the fluid transfer tip does not come into contact with the cavity wall 50 even as the syringe 4 pivots within the cavity.
[0098] FIG. 12 illustrates the various stages of opening the packaging 2. As shown in FIG. 12a, a user is able to hold the packaging 2 by the cavity 6 in one hand 54 and peel the backing off using a second hand 56. The user peels the backing 8 by pulling on a tab at the end proximal to the plunger 18 of the syringe 4 within the packaging 2. FIG. 12b illustrates how peeling the backing 8 away from the cavity 6 allows the syringe 4 to pivot within the cavity 6 such that the plunger 18 of the syringe 4 presents itself out of the cavity 6. It can also be seen in this Figure how the fluid transfer tip 24 moves down into the front pocket 10 of the cavity. FIG. 12c illustrates how, when the backing 8 is peeled away by a sufficient amount, the tip 24 moves fully into the front pocket 10 and the plunger 18 of the syringe 4 protrudes sufficiently such that it can easily be grabbed by a user.
[0099] FIG. 13 illustrates the various stages of the removal of the syringe 4 from the packaging 2 by pulling the syringe 4 out by hand. FIG. 13a illustrates how a user grabs the plunger end of the syringe 4 which is protruding out of the cavity 6 and then proceeds to pull with both a horizontal and vertical component. It can be seen in this Figure that the backing 8 is peeled completely away from the cavity 6, however this may not be necessary and it may be possible for the syringe 4 to be removed without completely removing the backing 8. FIG. 13b shows how, when the syringe 4 is pulled out of the packaging 3, the lever member 26 slides along an inside wall 48 of the cavity 6. The angle of this wall 48 is such that it facilitates sliding of the lever member 26 out of the packaging 2. FIG. 13c shows the syringe 4 removed completely from the packaging 2 without the user coming into contact with the fluid transfer tip 24 of the syringe 4.
[0100] FIG. 14 illustrates the various stages of the removal of the syringe 4 from the packaging 2 in an aseptic situation. As shown in FIG. 14a, a user is able to firstly remove the backing 8 from the cavity 6 by peeling it from the tab located proximal to the plunger end of the syringe 4. This minimises the chances of the user coming into contact with the fluid transfer tip 24 of the syringe 4 thus avoiding contamination. Once the backing 8 is removed the user is then able to hold the cavity 6 in one hand 54 as seen in FIG. 14b. The user is then able to tilt the packaging 2 such that the syringe 4 begins to tip out of the cavity 6. The package is fully tilted as seen in FIG. 14c and the syringe 4 then falls out of the cavity 6, this can be onto a disinfected Main General Aseptic Field 58 such as a portable tray or a procedure trolley for surgical use, or a Main Critical Aseptic Field such as a sterilised drape.
[0101] In the embodiments shown the cavity 6 is formed from a single piece of plastic with an internal structure which provides the fulcrum 32. However it will be appreciated that this may be achieved by alternative means, for example a less structured blister package could be used and an insert could be placed into the cavity of the blister package to provide the fulcrum.
[0102] Although it has been identified that it is advantageous for the plunger end of the device to protrude from the cavity when the backing is removed, it will be appreciated that in certain situations it may be advantageous for the fluid transfer tip to protrude from the cavity. In such situations the pivot point could be arranged so that this would tend to happen. It will also be appreciated that the syringe or other medical device may, additionally, be able to adopt one or more positions in the package where it does not tend to pivot. For example, the device may be able to slide within the cavity of the package. In such a scenario a user would be able to first peel away the backing to open the cavity and then tilt the package slightly such that the centre of mass of the device moves forward of the fulcrum, thus causing the device to pivot and present one end.
[0103] Although in the embodiments shown the syringe 4 is removed from the package 2 whilst the package 2 is still being held in a user's hand, it is also envisaged that the backing 8 could be removed and the package 2 could be subsequently placed on a surface at which point the syringe 4 may be removed.
[0104] In the embodiments shown the backing 8 is sealed around a peripheral portion 28 of the top surface of the cavity 6 and when it is peeled away it is left in contact with one end of the cavity 6. However it will be appreciated that the backing may be completely removed from the device or may be attached or sealed by other suitable means. For example it may be designed such that only part of the backing is able to be peeled away to ensure that the fluid transfer tip remains in at least a partially sealed portion such that the user is only able to grab the plunger end of the syringe.
[0105] In the embodiments shown the syringe 4 comprises a lever member 26 which substantially affects the position of the centre of mass. It will be appreciated that the packaging can be used with other medical devices which do not comprise a lever member, in such cases the fulcrum is appropriately positioned such that the centre of mass can fall within the front pocket of the package thus allowing the medical device to pivot.
[0106] FIGS. 15 to 20 relate to alternative embodiments of a package containing a needle instead of a syringe, in particular a needle comprising a needle hub and a removable cover. There is seen in FIGS. 15a and 15b a moulded plastic cavity 106 that can be closed by a removable backing (not shown) to form a sealed package. In a similar way to the embodiments described previously, the cavity 106 comprises a front pocket 110, a central portion 112 and a rear pocket 114. A fulcrum 132 is formed at a corner between the front pocket 110 and the central portion 112. In addition, the front pocket 110 is provided with a recess 111 at its forward end that can catch and retain a needle cover in use. This will be understood with reference to FIGS. 16a-16i.
[0107] FIG. 16a shows an unopened package 102 comprising such a cavity 106 sealed by a removable backing 108. A needle hub 160 and needle cover 170 is contained inside the cavity 106. FIG. 16b shows the backing 108 being removed, the needle hub 160 tilting forwards into the front pocket 110, and a user connecting a syringe 180 to the needle hub 160, for example pushing a tapered fluid transfer tip into the needle hub to form a friction fit e.g. Luer slip-type connection. FIG. 16c shows a user pushing the syringe 180 and needle hub 160 forwards in the cavity 106 so that the needle cover 170 locks into the recess 111 at the front of the cavity 106. This is assisted by the angled shape of the front pocket 110.
[0108] FIG. 16d shows an optional variant where the needle cover 170 has a square cross-section at its tip. The square shape of the recess 111 holds the needle cover 170 like a wrench and prevents it from rotating. Once the syringe 180 has been pushed forward to lock the needle cover 170 in the recess 111, a user can rotate the syringe 180 while the needle hub 160 is held stationary. This may allow a locking collar 182 to twist into engagement with the needle hub 160, for example providing a Luer lock-type connection in addition to a friction fit. Such connections are described in more detail in the Applicant's prior publications WO 2014/020090 and WO 2015/014914.
[0109] FIG. 16e shows a user withdrawing the syringe 180 with the needle hub 160 attached, leaving the needle cover 170 inside the package 102. FIG. 16f shows an optional variant where the needle cover 170 has a square cross-section at its tip and the syringe 180 is rotated while pulling to release the needle hub 160 from the cover 170.
[0110] After the syringe 180 has been used for a medical procedure, the needle hub 160 can be safely recapped with the needle cover 170 that is retained in the original package 102, as shown in FIGS. 16g-16i. FIG. 16h shows how the syringe 180 may include a lever member 126 that is operated to disconnect the needle hub 160 once it is safely resheathed. The syringe 180 can then be withdrawn, with the needle hub 160 safely stored in the package 102, ready for disposal.
[0111] FIGS. 17a-d show an alternative embodiment of the package 102, with an additional gripping part 190 inserted into the cavity to add additional gripping for the needle cover 170. This small piece of plastic or metal locks the needle cover 170 when the needle hub 160 is pushed forwards in the cavity, for example when connecting a syringe 180. The gripping part 190 may be seated in the recess 111 or take its place. FIGS. 18a-d show another alternative embodiment of the package 102, with an additional gripping part 195 that can lock the needle cover 170 when the needle hub 160 is pushed forwards in the cavity, for example when connecting a syringe 180. An angled edge of the gripping part 195 allows for the needle cover 170 to enter through an aperture before it is locked permanently from removal.
[0112] There is seen in FIG. 19 a moulded plastic cavity 206 that can be closed by a removable backing (not shown) to form a sealed package. In a similar way to the embodiments described previously, the cavity 206 comprises a front pocket 210, a central portion 212 and a rear pocket 214. A fulcrum 232 is formed at a corner between the front pocket 210 and the central portion 212. In this embodiment, the front pocket 210 is provided with a recess 211 at its rear end that can catch and retain a needle cover in use. This will be understood with reference to FIGS. 20a-20f.
[0113] FIG. 20a shows such a cavity 206 as part of an opened package 202 where the backing 208 has been removed. A syringe 280 connected to a needle hub 260 is pushed down into the recess 211 so that the needle cover 270 is caught. FIG. 20b shows the needle cover 270 held in the cavity 206 by friction. It is seen from FIG. 20c that the syringe 280 and needle hub 260 can be withdrawn, leaving the needle cover 270 with the package 202. After the syringe 280 has been used for a medical procedure, the needle hub 260 can be safely recapped with the needle cover 270 that is retained in the original package 202, as shown in FIGS. 20d-20f. FIG. 20d shows the needle being placed back in the needle cover 270. FIG. 20e shows a user pressing a lever member 226 on the syringe 280 to release the needle hub 260. FIG. 20f shows the syringe 280 now detached from the needle hub 260, the needle left safely stored in the needle cover 270.
[0114] In FIGS. 19 and 20 the cavity 206 comprises a front pocket 210 that is angled forwards and down from a fulcrum 232 so that a device contained in the cavity 206 tends to tip forwards and present itself for ease of removal once the backing 208 is removed. However, it is envisaged that such a package 202 may not always include this feature and the cavity 206 may simply provide a recess 211 to assist a user in removing a cover from the devicewhether the device is a needle hub or other medical device.
[0115] Another embodiment of a package 302 is seen in FIG. 21. The package 302 comprises a cavity 306 that can contain a medical device (not shown) and be sealed by a removable backing 308. The materials of the cavity 306 and backing 308 may be the same as previously described with respect to FIG. 1. The package 302 is similar to the one described in relation to FIGS. 1-14 in terms of its general form and function. However the package 302 differs in that the cavity 306 comprises a front pocket 310, a rear pocket 314 and a central portion extending therebetween which is not flat but defines an additional central pocket 312. It can be seen that the central pocket 312 and rear pocket 314 both define an outer surface extending in the same plane, so that the package 302 can be supported stably on a horizontal surface with the front pocket 310 tilted to promote ease of removal of the device contained in the package 302.
[0116] The central pocket 312 may be used to contain another component separately from the medical device, for example a cap for the device. As soon as the package is opened, a device contained in the cavity 306 will pivot forward into the front pocket 310, as previously described, so as to present its rear end to a user. If the device is not to be used straightaway for a medical procedure, then a user can grasp the device at its rear end to remove it from the cavity 306 and then push the front end of the device down into engagement with the cap (or other component) contained in the central pocket 312. The central pocket 312 may be shaped to grip the cap, for example so that the device can be twisted where the cap requires a screw connection. The front end of the device, which may for example comprise the fluid transfer tip of a syringe, does not come into contact with the user or the external environment and can be kept sterile while covered by the cap. The package 302 therefore provides a complete solution ensuring that the aseptic technique is not compromised.
[0117] While different variants of a package and cavity have been described separately above, it will be understood that a single package could combine one or more such cavities, for example with a shared backing. For instance, a package could include one cavity for a needle hub and another cavity for a syringe, or one cavity for a catheter and another for a catheter connector.
[0118] When sealing a package that contains a medical device such as a syringe, a potential problem is that the device may tend to pivot within the package such that its rear end e.g. the plunger of a syringe protrudes from the cavity. The protruding plunger can interfere when applying the backing which seals the package. This can be overcome by including a step within the sealing process which supports the device in an unstable e.g. horizontal position such that it does not pivot forward with its rear end protruding from the cavity. This can be achieved in many ways, but in the following Figures and discussion a U-shaped clip is described which supports, e.g. lifts and holds, a syringe in a horizontal position in a package.
[0119] FIG. 22 shows a U-shaped clip 60 which can be used in conjunction with any of the packages 2, 102, 202, 302 shown in previous Figures. The U-shaped clip 60 is formed of a relatively rigid material with a flat base 62 and side walls comprised of a lower vertical portion 64 and a top flared portion 66.
[0120] FIG. 23 shows the U-shaped clip 60 applied to the package 2. The U-shaped clip 60 can be pressed onto the outside of the cavity 6 proximal to the front pocket 10. This Figure shows how the U-shaped clip 60 can be pushed into place until the base 62 of the U-shaped clip 60 is flush with the bottom surface 68 of the front pocket 10. The width of the lower portion of the U-shaped clip 60 defined by the lower vertical portions 64 is narrower than the front pocket 10. This causes the walls of the cavity 6 in the front pocket 10 to deform when the U-shaped clip 60 is pushed into place. This forces the syringe 4 within the cavity 6 to pivot into a horizontal position and be supported in this position allowing the backing 8 to be applied without interference.
[0121] FIG. 24 shows a side view of the package 2 before being placed onto the U-shaped clip 60. It can be seen that the syringe 4 is naturally in a pivoted position within the package 2 such that lever member 26 and fluid transfer tip 24 are pivoted forward into the front pocket 10. In the pivoted position the plunger 18, at the rear end of the syringe 4, protrudes from the cavity 6. The protruding plunger 18 can cause difficulties when attaching the backing 8 to the cavity 6 during manufacture of the package 2. With the plunger 18 protruding from the cavity 6 it would be necessary to push the plunger 18 down as the backing 8 (seen in FIG. 23) is attached and sealed. This may cause the backing 8 to be loose. This is particularly undesirable as the syringe 4 would be free to move around within the package 2. By pressing the package 2 into the U-shaped clip 60 this ensures that the syringe 4 is horizontal within the cavity 6 thus the backing 8 can be applied without any obstructions. Also shown in this Figure is an optional further attachment 70. The attachment 70 acts to support the rear pocket 14 of the cavity 6. The attachment 70 may be integrally moulded as part of the clip 60 and attached by an elongate member 72. The attachment 70 acts to keep the cavity 6 horizontal which may further assist during manufacture when applying the backing 8.
[0122] FIG. 25 shows a cross-sectional view through the line A-A in FIG. 24. When the U-shaped clip 60 is not attached to the cavity 6 it can be seen that the syringe 4 is pivoted forward within the cavity 6 such that the lever member 26 sits in the bottom of the front pocket 10. The flared portions 66 of the U-shaped clip 60 assist in guiding the cavity 6 into the U-shaped clip 60 in the direction shown by an arrow.
[0123] FIG. 26 shows the U-shaped clip 60 attached to the cavity 6. The vertical portions 64 of the clip 60 act to squeeze together the walls of the front pocket 10 and deform the cavity 6 so that the syringe 4 cannot pivot forward into a stable position. It can be seen in this Figure that the syringe 4 is supported in a horizontal position within the cavity 6 such that the plunger 18 is contained within the rear pocket 14. In this position the backing 8 can easily be attached to the cavity 6.
[0124] FIG. 27 shows a cross sectional view through the line B-B in FIG. 26. The side walls of the cavity 6, specifically to the walls of the front pocket 10, have been deformed by the U-shaped clip 60. As the U-shaped clip 60 is pushed into place, the force applied by its vertical portions 64 deforms the side walls of the front pocket 10 and subsequently forces the lever member 26 which is attached to the syringe 4 upwards to be supported in a horizontal position.
[0125] The flared shape of the U-shaped clip 60 is particularly advantageous as the motion of the cavity 6 being pressed onto the U-shaped clip 60 assists in pushing the syringe 4 upwards. If for instance the side walls of the cavity 6 were just pressed inwards, this may not necessarily cause the syringe 4 to pivot upward and instead it may just hold it in place in a stable position.
[0126] Although it is shown that the syringe 4 is contained within the cavity 6 and then the U-shaped clip 60 is attached it may be possible for the cavity 6 to be deformed by applying the clip 60 before the syringe 4 is placed into the cavity 6. This would mean that the syringe 4 is inserted into the cavity 6 and is instantly supported in a horizontal position.
[0127] Although the U-shaped clip 60 is shown to be positioned on the front pocket 10, it is envisaged that it could be positioned anywhere on the cavity 6 such that it causes deformation resulting in the syringe 4 being supported in an unstable horizontal position within the cavity 6.
[0128] It will be appreciated that the U-shaped clip 60 may form part of a machine in the manufacturing process and depending on the type of machine there may also be an array of such U-shaped clips 60.
[0129] Although the U-shaped clip 60 is discussed with reference to a manufacturing and sealing process for the package 2, it is envisaged that it could be utilised for other purposes. For example the U-shaped clip 60 could remain attached to the front pocket 10 of the cavity 6 until the user wishes to release the syringe 4. In such an example the user may peel away the backing 8 and the U-shaped clip 60 may hold the syringe in place until the user wishes to remove the syringe 4. When the user wishes to remove the syringe 4 he may then simply remove the U-shaped clip 60 so that the syringe 4 is free to pivot forward into a more stable position.
