WO2007132237A1

WO2007132237A1 - Management system for hypodermic needles

Info

Publication number: WO2007132237A1
Application number: PCT/GB2007/001794
Authority: WO
Inventors: Stephen Frederick Marston; Michael Corcoran
Original assignee: Clini-Cal Design Technologies Limited
Priority date: 2006-05-16
Filing date: 2007-05-15
Publication date: 2007-11-22
Also published as: GB0609782D0

Abstract

A management system (87) for hypodermic needles that are to be used by a user in a repeating cycle (for example a daily cycle) comprises a plurality of needle containers (10) each arranged to contain a plurality of needles to be used by the user in one cycle (for example one day), and a receptacle (80) (such as a box) for removably storing the needle containers. The management system can therefore deal with a whole week's injections for a user who requires more than one injection per day. Each needle container may have a plurality of compartments each for receiving a respective needle contained in a respective needle housing, and a device that is manually operable to clamp and unclamp the needle housings in the compartments. When the needle is used, the intention is that the clamping device holds the needle housing clamped in its compartment, for example while an injection pen is attached to the needle and the needle is withdrawn from its housing, and subsequently when the used needle is reinserted into its housing for after-use storage. At the end of the week, the clamping devices of all of the needle containers can be released so that used needles and their housings can be tipped into a sharp disposal container.

Description

TITLE

Management system for hypodermic needles

DESCRIPTION

This invention relates to a management system for hypodermic needles particularly, but not exclusively, for insulin injection.

Many people suffer from diabetes mellitus and need treatment by self-injection and or the administration of tablets of insulin to help control their blood sugar level. Proper control is important. In the short-term too high blood sugar lever (hyperglycaemia) causes a general feeling of being unwell, and too low a blood sugar lever (hypoglycaemia) can cause collapse. In the longer term, improperly controlled blood sugar levels can lead to microvascular and macrovascular damage, retinopathy (eye disease), neuropathy (disease of the nervous system) and nephropathy (kidney disease). A typical regimen involves injection of long-acting insulin at regular intervals and of a dose that may be constant, varied in a predetermined manner, or varied in dependence upon measured blood sugar level. The regularity and timing of injection is important. Some sufferers require only one injection of insulin per day; others require two injections per day, for example before their breakfast and evening meal; some require two injections and one tablet per day; some require three injections per day, for example before their breakfast, lunch and tea; and others require four injections per day, for example before their breakfast, lunch, tea and bedtime. Some sufferers complement their routine injections of insulin with occasional injections of short-acting insulin, for example if they eat a meal that is particularly high in sugar or sugar-producing constituents.

With modern self-injection systems, the process of self-injection can be very simple and quick. Many people with diabetes use an injection pen, which contains a supply of insulin, and disposable single-use hypodermic needles that are supplied in individual sterile needle packs and which are unpacked and fitted to the injection pen immediately before use of the pen. Because self-injection is so simple and quick, it is a problem that sometimes (for example mid-morning) a diabetic will forget whether they took their last scheduled dose of insulin (for example before breakfast). The person is then faced with the dilemma of whether to take a dose of insulin, in which case if they did, in fact, take their last scheduled does they will increase their blood sugar level unnecessarily and possibly become hypoglycaemic, or whether to wait until their next scheduled dose, in which case if they did not, in fact, take their last scheduled dose their blood sugar level will increase.

The present invention is concerned with this problem and seeks to provide a way in which people with diabetes can readily ascertain whether they are on schedule with their insulin injections.

One known system which addresses the above-mentioned problem is described in WO 2005/049114 and relates to a container having a plurality of locations each for holding a hypodermic needle pack and a series of cover plates, each cover plate setting out a particular regime. The regime is typically daily and the container holds the needle packs required for one day, although where the regime consists of one insulin dose per day, the container could hold seven needle packs, with the cover plate setting out a weekly regime. The number of locations in the container which may potentially house the needles remains the same and the container is tailored to the needles of the customer by the use of the plates.

In accordance with a first aspect of the present invention, there is provided a management system for hypodermic needles that are to be used by a user in a repeating cycle

(for example a daily cycle), comprising a plurality of needle containers each arranged to contain a plurality of needles to be used by the user in one cycle (for example one day), and a receptacle (such as a box) for removably storing the needle containers. The management system can therefore deal with a whole week's injections for a user who requires more than one injection per day.

Preferably, there are seven such needle containers, one for each day of the week. In one example, the receptacle is arranged to store all seven needle containers. This is particularly useful for a user who spends most of their time at home, where the receptacle will usually be kept. In another example, the receptacle is arranged to store six of the seven needle containers at any one time, so that it does not need to be so bulky. This may be more appropriate for a user who spends much of their time out of their home, and who can carry the needle container for the current day with them, leaving the other six needle containers in the receptacle at home.

The management system preferably further includes a timing and/or blood glucose metering module and means for releasably attaching the timing and/or metering module to any one of the needle containers. In this case, the receptacle may be arranged also to store the timing and/or metering module. The receptacle is preferably subdivided into compartments each for storing one of the needle containers, so that the needle containers can be kept in order. Each compartment may be arranged to be able to receive one of the needle containers when attached to the timing and/or metering module. Alternatively, one of the compartments may be arranged to be able to receive one of the needle containers when attached to the timing and/or metering module, and the other compartments may be arranged each to receive merely one of the other needle containers. In this latter case, the receptacle may have a further compartment extending alongside said other compartments, for example sized and shaped to receive a syringe, injection pen, or insulin cartridge.

In some embodiments, each needle container has a plurality of compartments each for directly receiving a respective needle, so as to keep the needles organised. Each needle container may then be intended to be a single-use, disposable item.

In other embodiments, each needle container has a plurality of compartments each for receiving a respective needle contained in a respective needle housing, so as to keep the needle housings organised. In this case, means may be provided that are manually operable to clamp and unclamp the needle housings in the compartments. When the needle is used, the intention is that the clamping means holds the needle housing clamped in its compartment, for example while an injection pen is attached to the needle and the needle is withdrawn from its housing, and subsequently when the used needle is reinserted into its housing for after-use storage. At the end of the week, the clamping means of all of the needle containers can be released so that used needles and their housings can be tipped into a sharps disposal container.

This latter feature may be employed in other forms of needle management system.

Therefore, a second aspect of the present invention provides a management system for hypodermic needles, comprising a needle container having a plurality of compartments each for receiving a respective needle contained in a respective needle housing, and means that are manually operable to clamp and unclamp the needle housings in the compartments.

As with the first aspect of the invention, the system of the second aspect of the invention may further include a timing and/or blood glucose metering module and means for releasably attaching the timing and/or metering module to the needle container.

With either aspect of the invention, each compartment may have at least one surface formation for engaging with a complementary surface formation on the needle housing to prevent or limit rotation of the needle housing in the compartment. This is particularly useful in the case where an injection pen is fitted to the needle by a screw thread.

Each compartment preferably has a cover moveable between a closed position covering such a needle, or needle and needle housing, in the compartment and an open position enabling access to the needle housing and needle. After a needle has been used, it can be replaced in its compartment and the cover closed so that the needle container acts as a temporary sharps disposal container.

The or each needle container may have a pill container attached thereto. In the case where a timing and/or blood glucose metering module is provided, the pill container is releasably attached to the needle container by means complementary to the means for releasably attaching the timing and/or metering module to the needle container. The or each pill container preferably has a cover moveable between a closed position closing the pill container and an open position enabling access to the contents of the pill container.

The or each of the covers mentioned above is preferably see-through, so that it can readily be seen whether a needle has been used or a pill has been taken.

An example of the management system of the present invention provides a convenient way to store hypodermic needles in a manner which will encourage single use of such needles, and provide a safe manner to store such needles both before and after use. Further, the provision of individual transparent lids for each needle allows the user to access needles easily and assess whether medication for a particular time of day has been taken. By providing a number of housings corresponding to the number of doses of the medicament for a user in a day, and a number of needle containers corresponding to a period of a week, and by providing a timer module, the risks of a user missing their medication or taking too much will be reduced.

Specific embodiments of the present invention will now be described, purely by way of example, with reference to the accompanying drawings, in which:

Figure 1 is an isometric view from above and to the front and one end of a needle and pill container and timer assembly;

Figure 2 is similar to Figure 1, but showing the assembly with its covers open and one needle housing partly removed; Figure 3 is similar to Figure 2, but viewed from below and to the rear and said one end, and with a clamping arrangement released;

Figure 4 is a partial cross-sectioned view of the assembly, on a larger scale, with the clamping arrangement engaged;

Figure 5 is similar to Figure 4, but with the clamping arrangement released;

Figures 6 & 7 are isometric views from different viewpoints of the assembly with the timer removed;

Figure 8 is an isometric view of one form of receptacle for storing a set of assemblies of Figures 1 to 7;

Figure 9 is a schematic plan view of a needle management system employing the receptacle of Figure 8 and a set of the assemblies;

Figures 10 & 11 are similar to Figures 8 and 9, but showing a modified needle management system;

Figures 12 & 13 are again similar to Figures 8 and 9, but showing a further modified needle management system;

Figure 14 is an isometric view of a modified assembly of needle container, pill container and timer module;

Figure 15 is a cross-sectional view of the assembly of Figure 14; and

Figure 16 is an isometric view of another modified assembly;

Referring now to Figures 1 to 3, a needle and pill container 10 has two needle- containing sections 12. Each section 12 has a compartment 14 shaped and dimensioned to receive a hypodermic needle pack. Each needle pack comprises a housing 16 with a peel-off seal 18 and, located within the housing 16, a sterile hypodermic needle (not visible in the drawings). Each needle housing 16 has an outer wall provided with a plurality of external ribs 20. Each compartment 14 has three internal ribs 22 extending into the compartment 14. Each rib 22 includes a lower angled portion 24. The ribs 22 serve two functions; first, as the needle housing 16 is lowered into the compartment 14, the angled portions 24 guide the needle housing 16 into a position in which the lower part 26 of the needle housing 16 may be locked in position; and, second, the angled portion 24 of each rib 22 engages with one of the external ribs 20 of the needle housing 16 to limit rotation thereof. The hypodermic needle contained within the housing 16 is typically designed to be attached to a pen type syringe by means of corresponding threads on the needle and syringe. Limiting rotation of the needle housing 16 allows the syringe to be attached to the needle with the needle pack in situ in the container 10. To access a needle the user simply pulls off the seal 18 and attaches a syringe to the needle that is revealed.

Each compartment 14 is provided with a cover 28 pivotally mounted on a hinge 30. The free end of the cover 28 has a formation which provides a lip 32 for engagement with the underside of a wall 34 extending across the front of the compartment 14 and a tab 36. With the cover 28 in its closed configuration, the user can insert a finger under the tab 36 to open the cover 28.

Referring now also to Figures 4 and 5, the lower part of the container 10 is provided with a lever 38 attached to the container 10 by means of a hinge 40. The function of the hinged lever 38 is to actuate a clamping arrangement. The free end 42 of the lever 38 has a formation 44 which engages with a recess 46 in a wall 48 of the container 10. The hinge 40 comprises a hinge pin 50 and bores 52 located in the lever 38 and container 10, respectively. The lever 38 includes a cam 54 which engages with a retaining element 56 comprised of a piece of spring steel. The cam 54 can engage with the retaining element 56 in the region of a bend 58 in the element 56.

With the lever 38 in the open position, as illustrated in Figure 5, the cam 54 is out of engagement with the retaining member 56. As the lever 38 is moved from its open position, as illustrated in Figure 5, to its closed position, as illustrated in Figure 4, the cam 54 engages with the retaining element 56 to one side of the bend 58, rides over the bend 58 and comes to the closed position in which the apex of the cam 54 is to the upper side of the bend 58. As can be seen from Figure 4, with the lever 38 closed, the end 60 of the retaining member 56 is pressed against the lower part 26 of the needle housing 16 retaining the needle housing 16 in position in the compartment 14. Releasing the retaining member 56 simply requires the lever 38 to be opened.

The cam 54 and retaining member 56 together act to hold the lever 38 in the closed position. As can be seen from Figure 4, to open the lever 38 a force must be exerted on the lever 38, typically by the user engaging the lip 42 with a finger and exerting a downward force. This overcomes the force exerted by the retaining member 56 on the cam 54 which otherwise holds the lever 38 shut.

In addition to providing two sections 12 in which the hypodermic needle packs are held, the container 10 provides a section 62 for the storage of pills. The pill-containing section 62 is divided into upper and lower compartments 64 in which pills may be stored. The upper compartment 64 is provided with a cover 66 connected to the body of the container 10 by a hinge 68, and the cover 66 has a lip 70 for engagement by a user's finger to lift the cover 66 upwards. The lower compartment (not shown) is provided with a cover 72 connected to the body of the container 10 by a hinge 74 and the cover 72 has a lip 76 for engagement by a user's finger, when the container 10 is turned upside down, to lift the cover 72 upwards.

The covers 28,66,72 are each transparent, which provides an easy visual indication to a user as to whether particular medication has been used or not. The lever 38 may also be transparent to complement the covers 28,66,72.

A timer module 78 is mounted on one end of the container 10. The timer module 78 includes a clock with a display 80 and is programmable using buttons 82 with a series of alarms which the user can match to their dosing regime.

Referring now to Figures 6 and 7, the timer module 78 is removably mounted on the adjacent needle-containing section 12 of the container 10 by means of co-operating elements 84,86 located on the timer module 78 and needle-containing section 12, respectively. The element 84 has a recess with which element 86 mates. By sliding the timer module 78 upwards it can be removed from the container 10 and may then be attached to another container 10 as will be described in greater detail with reference to Figure 8.

Figures 8 and 9 illustrate one form of needle management system 87 for a user who requires two injections per day and also pills. The needle management system 87 comprises a box 88 with a hinged lid 90, seven of the containers 10 described above, and the timer module 78. The box is subdivided into seven bays 92, each of which can accommodate one of the containers 10 with the timer module 78 attached. Each container 10 bears a label 94 for a respective day of the week.

In use, the intention is that, once per week before their first medication of the day, the user removes the used needle packs from the needle-containing sections 12 of each of the containers 10. This is done by opening the covers 28, releasing the lever 38, and tipping the used needle packs into a sharps container. The user then fills the needle-containing sections 12 of each container 10 with fresh needle packs, by dropping the needle packs into the compartments 14, moving the lever 38 back to its closed position, and closing the covers 28 The user also replenishes the pill-containing sections 62 with pills. The user then attaches the timer module 78 to the needle container 10 marked with the current day, and places the containers 10 and timer module 78 in the bays 92 in the box 88, preferably in day order beginning with the current day.

When it is time to administer an injection or take a pill, as indicated by the timer module 78, the user takes the needle container 10 marked with the current day (and attached to the timer module 78) from the box 88 and then uses the appropriate needle pack or takes the required pill. After a needle has been used, it is replaced in its housing 16, which has remained in the needle-containing section 12, and it is readily apparent that the needle has been used because the respective seal 18 has been removed. At the beginning of each subsequent day, the used moves the timer module 78 to the next needle container 10. At the beginning of the subsequent week, the user empties the used needle packs and replenishes the system with fresh needle packs and pills, as described in the preceding paragraph.

A modified needle management system 87 is shown in Figures 9 and 10. In this case, each needle and pill container 10 has three, rather than two, needle-containing sections 12. Also, one of the bays 92A of the box 88 is of sufficient size to accommodate one of the needle and pill containers 10 with the timer module 78 attached, and the other six bays 92B are shorter and can each accommodate only a needle and pill container 10. A further bay 96C is provided alongside the shorter bays 92B and is intended to accommodate a pen-type injection device 98.

The systems shown in Figures 8 to 11 are intended for a user who spends most of their time at home. If they are planning to be away from home during the day at a time when they will need an injection or pill, the user can take their injection device 98 and the needle and pill container 10 for the appropriate day with them. If they are planning to be away for longer, they can take the whole management system with them.

A further modified needle management system 87 is shown in Figures 12 and 13, intended for a user who spends much of their time away from home and who requires four injections each day together with pills. In this case, the box 88 has six bays 92C, each of which can accommodate a respective needle and pill container 10, and the intention is that the user carries with them the seventh needle and pill container 10 for the current day with the timer module 78 attached. Also, each needle and pill container 10 has four needle-containing sections 12.

Referring now to Figures 14 and 15, a modified container assembly 100 includes a needle container 102, a pill container 104 and a timer 78. The needle container 102 has two compartments 106. Each compartment 106 is shaped and dimensioned to receive a hypodermic needle 108 and functions as both the compartment 14 and the needle housing 16 in the embodiments described above. A peel-off paper seal 18 maintains the hypodermic needle 108 in each compartment 106 in a sterile condition until the user requires access thereto, when they pull on the tab 110 to remove the seal 18 from the needle container 102.

Each compartment 106 is provided with a cover 112 pivotally attached thereto by an integrally-moulded hinge 114. The free end of each cover 112 has a formation which provides a lip 116 for engagement with the underside of wall elements 118 extending across the front of the compartments 106 and a tab 120. With the cover 112 in its closed configuration the user inserts a digit under the tab 120 to open the said cover 112.

The pill container 104 provides a compartment in which pills may be stored, the compartment being provided with a cover 122 connected to the body of the container 104 by a hinge 124. The cover 122 is provided with a lip 126 for engagement by a user's finger to lift the cover upwards. On one side of the pill container 104 is a rail element 128, which cooperates with a corresponding recess element located in the adjacent side of the needle container 102. Whilst the structure of the recess element is not shown in Figure 14, its configuration corresponds to that of element 84 illustrated in Figure 7.

The covers 112 and 122 are transparent, providing an easy visual indication to a user as to whether particular medication has been used or not. The user is given a visual indication as to whether particular injectable medication has been used or not by the presence or absence of the seals 18.

The timer 78 functions in the same manner as the timer 78 described with reference to

Figures 1 to 7. Further, the structures for attaching the timer 78 to the needle container 102 are identical to the structures used for attaching the timer 78 to the container 10 illustrated in detail and described with reference to Figures 6 and 7. As such these structures will not be described again. Referring in particular to Figure 15, the needle 108 comprises a body part 130 of plastics material, a needle element 132 passing through the body part 130 and cap 134. The body part 130 includes a stub 136 which is so shaped and dimensioned that the cap 134 is a push fit onto the stub 136. The body part 130 is itself a push fit into the compartment 106 in the needle container 102. When it is time for a user to administer a medicament, the user opens the cap 112, removes the seal 18 and attaches a delivery device to the body part 130 of the needle. The inner wall of the body part 130 is threaded, thereby providing for attachment of the delivery device to the needle 108. The user withdraws the needle 108 from the compartment 106 with the cap 134 attached to the stub 136. When the user is ready to inject the medicament they remove the cap 134. After use, the user may re-engage the body part 130 of the needle 108 with the compartment 106. The needle container 102 therefore provides a convenient sharps container. When all the needles in the container 102 have been used, the needle container 102 together with the spent needles may be placed in a sharps disposal container.

Referring now to Figure 16, like numerals are used to indicate like parts in Figure 14. The container system 100 of Figure 16 is similar to that illustrated in Figures 14 and 15, the difference being the absence of a pill container 104 and the presence of a further needle compartment 106.

It will be appreciated that many modifications and developments may be made to the embodiments of the invention described above. For example, the timer module 78 may be replaced by a module for metering blood glucose or a module mat performs both functions.

Alternatively, a blood glucose metering module may be arranged to be releasably attached to the opposite end of the needle container, or needle and pill container from the timer module 78.

It should be noted that the embodiments of the invention have been described above purely by way of example and that many other modifications and developments may be made thereto within the scope of the present invention.

Claims

1. A management system (87) for hypodermic needles that are to be used by a user in a repeating cycle, comprising a plurality of needle containers (10; 102) each arranged to contain a plurality of needles to be used by the user in one cycle, and a receptacle (80) for removably storing the needle containers.

2. A management system as claimed in claim 1, wherein there are seven such needle containers and the receptacle is arranged to store all seven needle containers.

3. A management system as claimed in claim 1, wherein there are seven such needle containers and the receptacle is arranged to store six of the seven needle containers at any one time.

4. A management system as claimed in any preceding claim, and further including a timing and/or blood glucose metering module (78) and means (84,86) for releasably attaching the timing and/or metering module to any one of the needle containers.

5. A management system as claimed in claim 4 when dependent directly or indirectly on claim 2, wherein the receptacle is arranged also to store the timing and/or metering module.

6. A management system as claimed in any preceding claim, wherein the receptacle is subdivided into compartments (92) each for storing one of the needle containers.

7. A management system as claimed in claim 6 when dependent on claim 5, wherein each compartment is arranged to be able to receive one of the needle containers when attached to the timing and/or metering module.

8. A management system as claimed in claim 6 when dependent on claim 5, wherein one of the compartments (92A) is arranged to be able to receive one of the needle containers when attached to the timing and/or metering module, and the other compartments (92B) are arranged each to receive one of the other needle containers.

9. A management system as claimed in claim 8, wherein the receptacle has a further compartment (92C) extending alongside said other compartments.

10. A management system as claimed in any preceding claim, wherein each needle container (102) has a plurality of compartments (106) each for directly receiving a respective needle.

11. A management system as claimed in any of claims 1 to 9, wherein each needle container (10) has a plurality of compartments (14) each for receiving a respective needle contained in a respective needle housing (16).

12. A management system as claimed in claim 11, further including means (38,56) that are manually operable to clamp and unclamp the needle housings in the compartments.

13. A management system for hypodermic needles, comprising a needle container (10) having a plurality of compartments (14) each for receiving a respective needle contained in a respective needle housing (16), and means (38,56) that are manually operable to clamp and unclamp the needle housings in the compartments.

14. A management system as claimed in claim 13, and further including a timing and/or blood glucose metering module (78) and means (84,86) for releasably attaching the timing and/or metering module to the needle container.

15. A management system as claimed in any of claims 11 to 14, wherein each compartment has at least one surface formation (22) for engaging with a complementary surface formation (20) on the needle housing to prevent or limit rotation of the needle housing in the compartment.

16. A management system as claimed in any of claims 10 to 15, wherein each compartment has a cover (28; 112) moveable between a closed position covering such a needle, or needle and needle housing, in the compartment and an open position enabling access to the needle.

17. A management system as claimed in any preceding claim, wherein the or each needle container has a pill container (62; 104) attached thereto.

18. A management system as claimed in claim 17 when directly or indirectly dependent on claim 4 or 14, wherein the pill container (104) is releasably attached to the needle container (102) by means (128) complementary to the means for releasably attaching the timing and/or metering module to the needle container.

19. A management system as claimed claim 17 or 18, wherein the or each pill container has a cover (66; 122) moveable between a closed position closing the pill container and an open position enabling access to the contents of the pill container.

20. A management system as claimed in claim 16 or 19, wherein the or each cover (28,66; 112, 122) is see-through.