Abstract
The invention regards a protective cap for a delivery system, said cap comprising a tip part releasably attached to a main part, wherein the tip part and the main part together form an elongated body with a closed tip end, and the main part comprises at least one means for assisting the use of the delivery system.
Claims
1. A releasable protective cap for the protection of a container part of an injection pen with an elongated, substantially tubular body for delivering a medical substance through a needle attached or to be attached to said injection pen, said releasable protective cap is configured to only partly cover said injection pen, said releasable protective cap further characterized in that: said releasable protective cap is shaped to cover all of said container part of said injection pen; said releasable protective cap comprises a tip part directly releasably attached to a main part; an outer surface including means for releasably attaching said tip part to said main part; said tip part and said main part together form an elongated, substantially tubular body with a closed tip end; said releasable protective cap comprises at least one selected from the group of a grip unit on an outside of said main part, a recess on the outside of said main part, a battery, an outward directed light source, a timer, a display, a measuring device, a blood sampling device, and a data transmitter, said releasable protective cap is arranged to be releasably attached to said injection pen by said main part which is releasable from said injection pen; thereby enabling the addition of the needle to said injection pen both when said tip part is detached from said main part while the entire main part is attached to said injection pen, and when said tip part and said main part both are detached from said injection pen, thereby enabling the delivery of the medical substance through said needle by the use of said injection pen in combination with said releasable protective cap.
2. The releasable protective cap according to claim 1 comprising the timer, wherein said timer is arranged to show a time elapsed since a last injection.
3. The releasable protective cap according to claim 1 or 2 comprising a timer, wherein said time is automatically activated when said tip part and said main part of the releasable protective cap are separated.
4. The releasable protective cap according to claim 3 comprising the timer, wherein said timer is automatically activated when said tip part and said main part are separated for a time interval greater than a specific duration.
5. The releasable protective cap according to claim 1, 2, 3 or 4 comprising the timer, further comprising a button for resetting said timer to a previous value.
6. The releasable protective cap according to claim 1 comprising the data transmitter, wherein said data transmitter transmits a time since a last injection and/or a number of injected medicine units and wherein said data transmitter can communicate wirelessly with a receiving unit.
7. The releasable protective cap according to claim 6, wherein the wireless communication happens via Bluetooth, Bluetooth low energy (BLE), near field communication (NFC) or radio frequency identification (NFC).
8. The releasable protective cap according to claim 6 or 7, wherein the receiving unit is a smartphone and/or a Blood Glucose Monitoring Device.
9. The releasable protective cap according to claim 1 comprising the outward directed light source, wherein the light source allows visualization of veins under a surface of a skin when an injection takes place.
10. The releasable protective cap according to claim 9, wherein the light source is a white, a blue, a red or near infrared light source.
11. The releasable protective cap according to claim 1 comprising the display, wherein the display is arranged to visualize a number of injected medicine units.
12. The releasable protective cap according to claim 1 comprising the measuring device, wherein the measuring device is for measuring blood sugar values.
13. The releasable protective cap according to claim 1 comprising the data transmitter, wherein the data transmitter is arranged to communicate wirelessly with a receiving unit.
14. A system comprising the injection pen and the releasable protective cap according to any of claim 1, 2, 3, 4, 5, 6, and 8-9.
15. The system according to claim 14, wherein the injection pen is an insulin pen.
Description
DESCRIPTION OF THE DRAWINGS
(1) The invention will in the following be described in greater detail with reference to the accompanying drawings. The drawings are exemplary and are not to be construed as limiting to the invention.
(2) FIGS. 1a and 1b show a schematic view of a protective cap according to the present invention.
(3) FIGS. 2a and 2b show a schematic view of alternative embodiments of a protective cap according to the present invention.
(4) FIGS. 3a and 3b show a schematic view of alternative embodiments of a protective cap according to the present invention.
(5) FIGS. 4a and FIG. 4b show a schematic view of alternative embodiments of a protective cap according to the present invention.
(6) FIGS. 5a and 5b show a schematic view of alternative embodiments of a tip part according to the present invention.
(7) FIG. 6 shows a schematic view of a protective cap with a light source according to the present invention.
(8) FIG. 7 shows a schematic view of a protective cap with a light source and a grip unit according to the present invention.
(9) FIGS. 8a and 8b show a schematic view of the use of a protective cap with a grip unit according to the present invention.
(10) FIGS. 9a, 9b and 9c show a protective cap according to the present invention for a syringe.
(11) FIG. 10a-10d illustrate the two angles ?1 and ?2.
(12) FIGS. 11a and 11b show two different grips.
(13) FIGS. 12a and 12b show alternative means for attaching a grip to a delivery system.
(14) FIGS. 13a and 13b show further alternative means for attaching a grip to a delivery system.
(15) FIGS. 14a and 14b show means for attaching an alternative grip to a delivery system.
(16) FIG. 15 shows different views of one embodiment of the invention.
(17) FIGS. 16a-16c show different views of a protective cap according to the invention.
(18) FIGS. 17a-17b show two embodiments of the invention.
(19) FIG. 18 shows an embodiment of the invention.
(20) FIG. 19a-19c show three embodiments of the invention.
(21) FIG. 20 shows an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
(22) FIG. 1a shows a protective cap 1 comprising a tip part 2 and a main part 3. To the main part 3 is attached a means 4 for assisting the use of a device in form of an insulin pen 5.
(23) The means for assisting the user is a grip unit 4 formed by a slightly curved elongated member having a first end 4a and a second end 4b. The grip unit 4 is at its first end 4a attached to the main part by a hinge 6 allowing the grip unit 4 to pivot around its mounting axis.
(24) In FIG. 1b, the means 4 for assisting the use of the device 5 has been pivoted into a position of use where it can be engaged by the first hand of the user while the user activates the delivery system using his second hand. First angle ?1 is indicated between the longitudinal direction of the delivery system and the length direction of the grip. Also, the tip part 2 has been released from the main part revealing the needle 5a of the delivery system. If a needle is not attached, the removed tip part will allow access to mount the needle on the delivery system.
(25) Thus, in FIG. 1b the main cap part is used to fasten the at least one means for assisting the use of the delivery system (here in form of grip unit 4) to the delivery system 5 in form of an insulin pen.
(26) The protective cap 1 is substantially formed as a tubular member with an open end opposing a closed end.
(27) The main cap part is substantially a tubular member with a first end 3a and a second end 3b.
(28) The protective cap, when tip part and main part are attached to each other, is arranged to be attached onto a device e.g. a delivery system as showed here to protect the end of the delivery system where the needle 5a is attached or is to be attached. When the tip part is released, and the main part is still attached to the device/delivery system the device can be used as intended and the grip unit attached to the delivery system by the main cap part can be used to stabilize the device.
(29) FIGS. 2a and 2b show different embodiments of protective caps 1 with a grip unit 4 attached to a main part. In both FIGS. 2a and 2b, the grip unit is in the form of a slim elongated bar which at its end furthest away from the point of attachment to the main cap part has a protrusion 4c extending in the direction towards the main cap part.
(30) Both FIGS. 2a and 2b show the main part 3 attached to the delivery system ready for use as well as the protective cap alone with the tip part attached to the main cap part.
(31) In FIG. 2a, the grip unit 4 is attached to the main cap part by a hinge allowing the grip unit to pivot relatively to the main cap part. The main cap part 3 has a ridge 7 which is positioned at the main cap part as an extension of the line of the grip unit 4. In FIG. 2a, the grip unit is attached to the main cap part in a manner which allows the grip unit to be flush against the main cap part when not in use.
(32) FIG. 2b shows a slightly different embodiment but where the basic elements are the same as in the previous figures. The grip unit 4 is a slim elongated bar which at its end furthest away from the point of attachment to the main cap part has a protrusion 4c extending in the direction towards the main cap part. The protrusion may improve the user's control of the grip 4. The difference between FIG. 2a and FIG. 2b is that the grip at its first end 4a is attached to the main cap part 3 by a solid attachment 8 near the second end 3b of the main cap part 3. The grip unit 4 comprises a bending hinge 6a positioned approximately ? of the longitudinal direction of the grip unit away from the attachment 8. The bending hinge 6a l allows the outer ? of the grip unit to pivot into a position of use which allows the user to engage with the grip in order to stabilize the delivery system during use. There is a narrow space 9 between the grip unit 4 and the main cap part 3 in the rest position allowing the grip unit to be used as a clip e.g. to secure the delivery device with the protective cap according to the invention in a jacket pocket (not shown).
(33) FIGS. 3a and 3b show another embodiment of the present invention in its rest position in FIG. 3a and in its position of use in FIG. 3b with the grip unit pivoted into the position of use and the tip cap part removed revealing the needle 5a of the delivery system. In this embodiment, the grip part is slightly curved forming a soft depression 10 which may improve the user's comfort and hold on the grip 4.
(34) FIGS. 4a and 4b show embodiments of the present invention wherein the grip unit 4 comprises a hinge 6 and two bending hinges 6a (FIG. 4a) and three bending hinges 6a (FIG. 4b). In these embodiments, the bending hinges 6a are used as means for changing the shape of the grip unit 4 allowing the grip unit to form a rough S-like shape.
(35) Both FIGS. 4a and 4b show the main part 3 attached to the delivery system ready for use as well as the full protective cap alone with the tip part attached to the main cap part.
(36) FIG. 5a shows a tip cap part having thread 11 for attaching the tip part to the main cap part. FIG. 5b shows a tip part with a click arrangement 11 allowing the tip part to be attached to the main cap part by a simple click lock.
(37) FIG. 6 shows a protective cap 1 according to the present invention having a tip part 2 detachable from a main cap part 3. In this embodiment, the at least one means for assisting the use of the delivery system is a light source 12 attached to the main cap part 3. Thus, by the embodiment shown in FIG. 6, the at least one means for assisting the use of the device (the light source) lights up the area of the injection site both prior to and during the injection. The light source can comprise on/off button and means for ensuring an optimal angel of the light.
(38) The light source may also advantageously be attached to e.g. a writing pen thus providing light to an area around the pen.
(39) When the main cap part is connected to the delivery system 5 and the tip cap part is released, the needle 5a is free and ready for use. In this configuration, the user can use the light source 12 to assist the use of the delivery system by improving the lighting conditions at the injection site significantly.
(40) In FIG. 6, the tip cap part is arranged with a number of elongated protrusions 13 which can improve the user's hold on the tip part when releasing and attaching it to the main cap part. The main cap part can be arranged with means of a similar function however in many embodiments, the at least one means for assisting the use of the delivery system attached to the main cap part may provide an improved hold for the user.
(41) FIG. 7 shows a delivery system with two means for assisting the use of the delivery systema grip unit 4 and a light source 12attached by the main cap part 3.
(42) FIGS. 8a and 8b show a grip unit 4 on a protective cap 1 attached to a delivery system 5 in use. The user engages the grip unit with a first hand and holds and actives the delivery system by a second hand 15.
(43) In these figures, it is seen how the shape and arrangement of the grip unit enables the user to engage with the grip and still being able to move the fingers of the first hand sufficiently to create a skin fold as often required when performing an insulin injection.
(44) FIG. 9a-9c shows a protective cap 1 having a main cap part 3 and a tip part 2 suited for use with e.g. a syringe.
(45) FIG. 9a shows a protective cap 1 having a main cap part 3 and a tip part 2 suited for use with e.g. a syringe further comprising a light source 12 as the assisting means.
(46) FIG. 9b shows a protective cap 1 having a main cap part 3 and a tip part 2 suited for use with e.g. a syringe having a grip 4 as the assisting means.
(47) FIG. 9c shows the protective cap of FIG. 10b where the tip part is released from the main part 3.
(48) FIG. 10a shows a delivery system with indication of the longitudinal direction L and a parallel second axis A2. The figure also shows first axis A1 perpendicular to L and A2 as well as an indication of the first angle ?1 between length direction of the grip and length direction L of the injection device.
(49) FIG. 10b shows the delivery system of FIG. 10a taken along the section Xb-Xb wherein the grip 4 extends in a radial manner from the delivery system i.e. where the second angle ?2 is 90?.
(50) FIG. 10c shows a delivery system similar to that of FIG. 10a wherein the grip extends in a non-radial manner from the delivery system in the present example the second angle ?2 is approximately 50?.
(51) FIG. 10d shows how the non-radial grip allows the finger to rest against the delivery system at a point P away from where the grip is attached to the delivery system opposed to the situation with the radial grip shown in FIG. 10b .
(52) FIGS. 11a and 11b, show and the following FIGS. 12 and 13 shows embodiments of grip unit and holder as known from PCT/DK2012/050321. The grips can be used in various embodiments of the present invention e.g. as grip of a protective cap.
(53) FIGS. 11a and 11b, show two alternative embodiments of a grip unit 4. FIG. 11a shows a grip unit 4 which extends perpendicular or substantially perpendicular to the delivery system 5 to which it is attached by attachment means 14. The shape of the grip unit 4 is basically a slightly curved bar. This embodiment offers a very simple solution to which comfort and/or improved grip may be provided by adjusting the curvature of the grip.
(54) The attachment means 14 can comprise a first and second lock part and may either attached the grip unit 4 releasable to the delivery system or the attachment means 14 may form a permanent attachment between grip unit 4 and delivery system 5. In either case the attachment means may form a rigid coupling fixing the grip unit 4 and delivery system with respect to each other. Alternatively the attachment means may form an at least partly flexible attachment making it possible to adjust e.g. the angle ?1 and/or ?2 between delivery system 5 and grip unit 4.
(55) FIG. 11b shows an embodiment of a grip unit which comprises a semicircular first grip part and a circular second grip part. The grip unit of FIG. 11b is attached to the delivery system 5 by attachment means 14 as described herein.
(56) The grip units of FIGS. 11a and 11b may be attached directly to the injector 5 or may releasable or permanently attached to a holder such as a main cap part or as described in the following figures.
(57) FIG. 12a shows an embodiment of the holder 9 of the instrument 1. The holder 15 comprises an upper 15a and a lower 15b crescent shaped element 16 partly encircling the delivery system 2 connected by a bar 17. The grip unit 4 is attached at or near the lower crescent shaped element 15b. The attachment of the grip unit to the holder 4 may be permanent or releasable. If the crescent shaped elements and the bar is made of e.g. thin materials the holder may add very little weight to the delivery system as well as it may be arranged to fit smoothly to the delivery system. This may make it possible to keep the holder attached to the delivery system after use if desired and detached the grip unit alone after use to store separately or together with the delivery system.
(58) FIG. 12b shows yet another embodiment of a holder according to the present invention. Here the holder simply forms a tight band 18 around a part of the delivery system 2 near the needle. The grip unit 4 may be permanently or releasable attached to the holder.
(59) As above the grip unit 4 of FIGS. 12a and 12b is attached to the holder by attachment means which are further discussed above under FIG. 10a.
(60) FIG. 13a shows an embodiment of first 20a and second 20b lock part. In this case the first lock part is a bar 21 which is arranged to engage in the second lock part in form of a bore 22 on the delivery system (or alternatively on a holder). The bore 22 is located in a part contained in the delivery system.
(61) The bar 21 and bore 22 may be shaped to match each other in different ways in order to allow fixation of the grip unit 5 at one or more angels with respect to the delivery system 5. In the present example the bore and bar have a square cross section but may have various other cross sections such as e.g. an octagon which will allow the grip and delivery system to be fixed with respect to each other in various angles.
(62) FIG. 13b shows yet another embodiment of attachment means comprising a first 20a and second 20b lock part. In this embodiment the first lock part of the grip unit 4 is a semicircular bar 23 arranged to slide into second lock part 20b of the delivery system in for of a groove 24. The semicircular bar 23 may have a collar which prevents the first lock part 20a of sliding too far into the second lock part 20b i.e. groove 24. In the present embodiment the first and second lock part are arranged to form a tight grip which is stabile but may provide the option of correcting the angle between delivery system and grip unit 4 if desired without compromising the stability of the instrument during use.
(63) FIG. 14a shows a grip 4 attached to a delivery system in form of a syringe by a holder 15 which can be slid or clicked onto the delivery system. Here the grip is an L shaped element extending from the delivery system with an angle ?1 of approximately 40 to 60?. The grip as well as the other grips described herein can be used with various delivery systems including e.g. syringes and/or injector pens.
(64) FIG. 14b shows the grip and holder from FIG. 14a disengaged from the delivery system.
(65) FIG. 15 shows three views of a protective cap 1 according to the invention, comprising a light source L, a grip 4 and a display D.
(66) FIG. 16a shows a protective cap comprising a grip 4 with a hinge 6 on one of the sides of the main part 3.
(67) FIGS. 16b and 16c show the same protective cap where the tip part is released from the main part, in two different views.
(68) FIGS. 17a and 17b show two different embodiments of the main part of a protective cap according to the invention. FIG. 17a shows a main part comprising 4 recesses (in black), an O-ring B and a clip, which may rotate around the pivot point P, as indicated by the hashed arrow. Two of the recesses are located on the clip. The main part further comprises a light L. FIG. 17b shows a main part comprising 4 recesses (in black), two O-rings A and B and a clip, which may rotate around the pivot point P, as indicated by the hashed arrow. Two of the recesses are located on the clip. The main part further comprises a light L. N: needle.
(69) FIG. 18 shows another embodiment of the main part of a protective cap according to the invention. The main part comprises a clip unit and 4 recesses (only 2 are shown, in black), where the recesses are not located on the clip. The clip unit may rotate around the pivot P, as indicated by the arrows. The embodiment shown further comprises a light L.
(70) FIG. 19a-19c show three embodiments of the invention. FIG. 19a shows an embodiment with 2 pairs of recesses (in black) and two O-rings A and B arranged symmetrically on the sides of the main part. FIG. 19b shows an embodiment with 3 pairs of recesses (in black) and two O-rings A and B arranged on the sides of the main part, but on different axes. FIG. 19c shows an embodiment with one circular recess and two partly circular recesses. N: needle.
(71) FIG. 20 shows an embodiment of a main part of the protective cap according to the invention. The main part comprises 2 pairs of recesses and two O-rings A and B arranged symmetrically on the main part, as well as a light L. N: needle.
