CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present patent application claims the benefits of priority of commonly assigned Canadian Patent Application No. 2,895,103, entitled "Coloured Pen Needles, Kit And Method For Using The Same" and filed at the Canadian Patent Office on June 25, 2015, the content of which is incorporated herewith by reference.

FIELD OF THE INVENTION

[0002] The present invention belongs to the filed of medical devices and methods for treatment injection of a medication, in particular, but not limited to auto- or self-treatment of diabetes using insulin injection.

BACKGROUND OF THE INVENTION

[0003] Insulin injections are traditionally given with either an insulin syringe, usually having an integrated needle permanently or semi-permanently incorporated, or an insulin pen whereby a disposable pen needle is attached to facilitate drug container access and allow fluid egress from the container through the needle into the patient. One of the methods used to inject self- administered medication is using combination of a pen injector and a sterile single use pen needle, such as those disclosed in U.S. patents no. 7,645,264 B2 (Marsh) or 8,882,706 B2 (Cronemberg), or in Canadian patent application no. 2 858 665 Al (Herr).

[0004] The pen needle should be changed after each use to prevent the risk of infection, lipodystrophy, lipohypertrophy and other complications. A recent study published in Canadian Journal of Diabetes shows the seriousness of the problem, in Berard L. et al., "Injection technique practices in population of Canadians with Diabetes: Results from a recent patient/diabetes educator survey", Canadian Journal of Diabetes, (2015), Vol. 39, Issue 2, 146- 151. The table below shows the number of times a patient use a single-use needle versus the percentage of patients. [0005] As shown in the table above, 4.4% of the patient re-used their pen-needle more than ten times; one third of pen needles users used their pen needle 2 to 5 times. There is thus a need for improvement in education of rotation of injection sites.

[0006] In addition to changing the pen needle, the patient should rotate the injection site regularly to avoid lipohypertrophy. In Berard L. et al. mentioned above, it is shown that the vast majority of participants (80.4%) injected medication into the abdomen; 36.6% had no explicit injection routine, whereas 31.4% injected into the same site at the same time each day. Overall, 24.6% of patients observed lipohypertrophy at injection sites, while only 13.3% of diabetes educators observed the same complication. Not rotating the injection site leads indeed to skin complications like scar tissue and lipohypertrophy which will lead to decreased insulin absorption by the body.

[0007] An international survey on insulin injection technique (DeConinck C et al, « Results and analysis of the 2008-2009 insulin injection technique questionnaire survey », Journal of Diabetes 2010; 2: 168-179) revealed that: · 47% of the participants had experienced lipohypertrophy and this was associated with repeated injections into a site smaller than a postage stamp;

• 28% of the participants could not remember ever having their injection sites checked by a HCP;

• Higher AIC levels have been reported with patients injecting into lipohypertrophic sites.

[0008] Absorption - uptake at the injection site is a critical part of the efficacy of medications delivered into the subcutaneous tissue. The nature of diabetes as a long term, self-managed disease, paired with recommendations of increased frequency of injections means health professionals need to be aware of some of the issues related to how injection site health can affect glucose control.

[0009] Absorption issues can contribute to variable glucose levels (hypoglycemia or hyperglycemia); leakage and therefore loss of injected dose from under the skin; gradual increase in insulin daily amounts (+20% over a year) along with the presence of scar tissue, atrophy or hypertrophy, indicating that absorption may be the issue; and fewer healthy injection sites available for use.

[0010] All of current pen needles used by a single patient have the same appearance. Users or patients do not remember or whether they have changed the needle or not or they are not motivated to do so. Users or patients can forget to change the injection site or they are not motivated to rotate the injection site or they do not know they should rotate the injection site.

[0011] US patent no. US 7,857,138 B2 (Temple) teaches a system for organizing and storing pre-determined dosages of medication by matching indicia on both the storage apparatus and the apparatus containing the medication. The invention by Temple is particularly directed to a method for administrating the good dosage but do not resolve the problem of changing needles and injection sites.

[0012] US patent applications no. US 2013/0144256 Al (Wessel et al.) and US 2014/0188074 Al (Jacques R. et al.) teach usage of a medical marking apparatus and tattoo activation device containing a medical ink barrel. This method will increase the complication of injection and administration of medication because it ads extra mechanical parts to the injection device and extra steps to each injection. This method might not be well accepted by the patient, because it creates random ink marks on the skin which can be unpleasant for the patient. A similar injection site marking method is disclosed in US patent no. US 8,574,194 B2 (Taylor), but has the same drawbacks mentioned above.

[0013] There is thus a need for new tools and methods to help patients to integrate regular change of the needle and rotation of injection site to their daily disease management routine.

SUMMARY OF THE INVENTION

[0014] The shortcomings of the prior art are generally mitigated by the present invention, which is first directed to a kit to be used for medical treatment. The kit comprises a plurality of pen needles adapted for giving an injection of a medication to a patient in need thereof; and a compartment adapted to contain and provide said plurality of pen needles; each pen needle comprising a distinctive mark in order to be distinguished from at least one other pen needle having a different distinctive mark, whereby in use, the patient selects the desired pen needle in function of a given mark of the distinctive mark, the patient selects the desired pen needle in function of a mark of the distinctive mark.

[0015] According to one preferred embodiment, the distinctive mark may be a distinctive colour. The present invention is thus also directed to a kit to be used for medical treatment. The kit comprises a plurality of pen needles adapted for giving an injection of a medication to a patient in need thereof; and a compartment adapted to contain and provide said plurality of pen needles; each pen needle comprising a distinctive coloured mark in order to be distinguished from at least one other pen needle having a different distinctive colour mark, whereby in use, the patient selects the desired pen needle in function of a given colour of the distinctive coloured mark, the patient selects the desired pen needle in function of a colour of the distinctive mark.

[0016] The invention is also directed to a tattoo assembly to be used in a medical treatment by injection of a medication to a patient in need thereof. The tattoo assembly comprises a plurality of guiding non-permanent tattoos, each tattoo being adapted to be affixed on a body injection site selected by the patient prior the injection and has a mark, a colour and/or a shape to assist the patient in remembering the selected body injection site prior to inject the medical treatment.

[0017] The invention is also directed to the use of the kit and/or tattoo assembly defined herein for assisting a patient in a treatment by injection. It has to be understood that the treatment is preferably an auto-treatment which does not imply the assistance of a medical professional such as a doctor or a nurse. More preferably, the kit and assembly tattoo in accordance with the present invention are adapted for the treatment of diabetes, such as by insulin injection.

[0018] The invention is also directed to a method for assisting a patient in the auto- administration of a medication by injection, the method comprising at least the following steps:

a. assigning one distinctive mark, such as a colour, to each injection time of a day; b. providing a pen needle having a distinctive mark, such as a colour mark, corresponding to the distinctive mark assigned to a given injection time of the day, for administering the medication; and

c. repeating step b) in accordance with a number of injection times of the day; and d. repeating steps b) to c) the following day.

[0019] The invention is also directed to a method for assisting a patient in the auto- administration of a medication by injection, the method comprising at least the following steps:

a. assigning one distinctive mark, such as a colour, to each injection time of a day and to each body injection site;

b. providing a pen needle having a distinctive mark corresponding to the distinctive mark assigned to a given injection time of the day and to a given body injection site, for administering the medication; and

c. repeating step b) in accordance with a number of the injection times of the day; and

d. repeating steps b) to c) the following day. [0020] The invention is further directed to a method for assisting a patient in the auto- administration of a medication by injection, the method comprising at least the following steps:

a. assigning at least one body injection site to a given injection time;

b. assigning a distinctive mark, colour and/or shape to each body injection site; c. providing a non-permanent guiding tattoo having a distinctive mark, colour and/or shape matching the distinctive mark, colour and/or shape assigned in step b) to each body injection site assigned in steps a);

d. affixing each guiding tattoo to each assigned body injection site;

e. selecting a pen needle having a distinctive mark matching the distinctive mark, colour and/or shape of the guiding tattoo for injecting the medication in the assigned body injection site at the injection time;

f. repeating step e) at each injection time; and

g. repeating step d) when at least one of the non-permanent guiding tattoos has disappeared from the assigned body injection site.

[0021] The invention is further directed to a method for assisting a patient in the auto- administration of a medication by injection, the method comprising at least the following steps:

a. assigning at least one distinctive mark, colour and/or shape to a given injection time of the day;

b. selecting a first body injection site;

c. defining one location on the first body injection site for each distinctive mark, colour and/or shape assigned in step a);

d. providing a non-permanent guiding tattoo having a distinctive mark, colour and/or shape matching the distinctive mark, colour and/or shape assigned in step a); e. affixing each guiding tattoo to each location of the first body injection site defined in step c);

f. at a given injection time, selecting a pen needle having a distinctive mark matching the distinctive mark, colour and/or shape assigned in step a) for injecting the medication in the defined location of the selected first body injection site where the matching marked tattoo is affixed;

g. repeating step f) at each injection time for one or two days; and h. repeating steps b) to g) for a subsequent body injection site for the following days.

[0022] The invention is yet further directed to a method for assisting a patient in the administration of a medication by injection, the method comprising at least the following steps:

a. assigning one distinctive mark to each injection week;

b. providing a pen needle having the distinctive mark corresponding to the distinctive mark assigned to a given week, for administering the medication; and c. repeating step b) in accordance with a number of the injection times per week; and

d. repeating steps b) to c) the following weeks.

[0023] According to preferred embodiments, the distinctive marks mentioned above for the methods of administration of a medication may be distinctive colours applied to the pens or tattoos. The distinctive marks may also be selected from the group consisting of different colours, geometric forms, symbols, letters, numbers and a combination thereof.

[0024] By distinctive colors or marks to the pen needles provide to the user or patient different, and assigning each color or mark to time of injection patient will remember to change the needle. By assigning each color or mark to different injection sites, patient will remember to change the injection site each time they use a new color or mark.

[0025] The invention is particularly adapted for auto- or self treatment of children, teenagers, or senior person in that the use of coloured pen needles, in association or not with corresponding tattoos to be affixed on the body injection site, empower children and teenagers by involving them in decision-making about their diseases management, such as diabetes. By giving the child the responsibility of choosing the colour of pen needle he or she wants to use, it is possible to encourage positive self-care behaviour without posing any risk to diabetes management. The present invention encourages people, such as those living with diabetes, to implement the «best practices)) and get the most out of their insulin treatment. By using the new marked pen needles, the healthcare professional can create a protocol of care that works best for the patient to manage the injections.

[0026] Other and further aspects and advantages of the present invention will be obvious upon an understanding of the illustrative embodiments about to be described or will be indicated in the appended claims, and various advantages not referred to herein will occur to one skilled in the art upon employment of the invention in practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above and other aspects, features and advantages of the invention will become more readily apparent from the following description, reference being made to the accompanying drawings in which:

[0028] Figure 1 is an illustration of a kit according to a preferred embodiment of the invention.

[0029] Figure 2 is an illustration of a pen needle according to a preferred embodiment of the invention.

[0030] Figure 3 is an illustration of pen needles of a kit according to a preferred embodiment of the invention.

[0031] Figure 4 is an illustration of different body injection sites of a patient according to a preferred embodiment of the invention.

[0032] Figure 5 is an illustration of pen needles and tattoo assembly of a kit according to a preferred embodiment of the invention.

[0033] Figure 6 is an illustration of four different kits according to a preferred embodiment of the invention.

[0034] Figure 7 is an illustration of pen needles of a kit and tattoo assembly according to another preferred embodiment of the invention where the distinctive marks are symbols.

[0035] Figure 8 is an illustration of pen needles of a kit according to another preferred embodiment of the invention where the distinctive marks are Roman capital letters.

[0036] Figure 9 is an illustration of pen needles of a kit and tattoo assembly according to another preferred embodiment of the invention where the distinctive marks are numbers.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0037] Novel kit, tattoo assembly and methods will be described hereinafter. Although the invention is described in terms of specific illustrative embodiments, it is to be understood that the embodiments described herein are by way of example only and that the scope of the invention is not intended to be limited thereby. Furthermore, even if the following description of preferred embodiments relates in particular to distinctive colours as distinctive marks, the invention cannot be limited to these preferred embodiments. Any kind of distinctive marks, combined or not with a distinctive colour, can be used without departing from the scope of the present invention. Description of a kit in accordance with one embodiment of the invention

[0038] According to one embodiment of the invention, the kit may comprise a plurality of pen needles adapted for giving an injection of a medication to a patient in need thereof; and optionally a compartment adapted to contain and provide the plurality of pen needles. Each pen needle comprises a coloured mark in order to be distinguished from at least one other pen needle having a different colour mark, whereby in use, the patient selects the desired pen needle in function of a colour of the coloured mark.

[0039] According to a preferred embodiment, the colour mark of the pen needles of the kit present one colour different from at least another colour mark of pen needles of at least another kit.

[0040] According to a preferred embodiment, the container comprises pen needles may have from 2 to 31 different distinctive marks. The number of different marks or colors may depend on the nature of the medication and treatment implying different injection times, such as daily (e.g. 2 to four injections times), weekly (up to 7 injections times), monthly (up to 31 injection times). More preferably, the kit is adapted for a daily treatment, such as insulin injection, wherein the container may comprises pen needles having two to four different coloured marks.

[0041] According to a preferred embodiment, the kit may further comprises a plurality of guiding non-permanent tattoos adapted to be affixed on a selected body injection site of the patient, each tattoo having a colour corresponding to the coloured mark of the pen needles. Preferably, the tattoos may further have different shapes in function of the selected body injection site.

[0042] When the distinctive mark is not a coloured mark but a distinctive shaped mark, such as a geometric form printed on the pen needle (square, triangle, circle, star, or the like), the corresponding tattoo can either be a tattoo matching the same geometric shape as the geometric shape of the distinctive mark (squared tattoo, triangle shape tattoo, round tattoo, star shaped tattoo or the like), or the corresponding tattoo has the corresponding distinctive shaped mark printed on the upper surface of the tattoo. The distinctive mark can also be a letter, a number, a pictogram or any mark or symbols allowing distinguishing one pen needle to another.

[0043] According to one preferred embodiment, each pen needle of the kit may comprise:

a hub adapted to receive a medication pen body having a medication compartment therein; a needle cannula affixed to the hub having a distal end extending from a the hub and adapted to inject the medication in the patient and a proximal end adapted to access the medication compartment in the pen body;

an inner cap arranged on the hub for encircling the distal en of the needle cannula; and

an outer cap removably connected to the hub for covering the inner cap and the hub in an initial state prior to use.

[0044] According to one preferred embodiment, when the distinctive mark is a coloured mark, the outer cap of the kit may comprise the coloured mark. Preferably, the outer cap is entirely coloured forming as such the coloured mark. Alternatively, when the distinctive mark is a geometric form, the form can be printed on the outer cap of the pen needle. Alternatively, coloured marks can be combined with geometric forms. This embodiment can be particularly adapted for colour blind people that could have difficulties in differentiate some colours.

[0045] According to a preferred embodiment, the hub and/or the inner cap of the needle pen comprise the distinctive mark, the outer cap being then transparent allowing seeing the distinctive mark, such as a coloured mark and/or geometric shaped mark.

[0046] According to a preferred embodiment, the pen needle may further comprise a cover removably connected to the hub for protecting the proximal end of the needle canulla in the initial state prior to use. [0047] According to a preferred embodiment, the kit may further comprise a medication pen, said medication pen comprising the medication pen body having a medication compartment therein.

[0048] According to a preferred embodiment, the kit may further comprise instructions for use of said kit. [0049] According to a preferred embodiment, the medication comprises insulin for treating diabetes. It is to be understood that other diseases in need of giving daily injections to a patient can be treated using the present invention. The invention is also particularly adapted, but not limited to, the treatment of a child or a teenager.

[0050] The invention is also directed to the use of the kit as defined herein, for the treatment of a patient, such as a child or a teenager, suffering of diabetes. [0051] The invention is also directed to a tattoo assembly to be used in a medical treatment by injection of a medication to a patient in need thereof. The tattoo assembly comprises a plurality of guiding non-permanent tattoos, each tattoo being adapted to be affixed on a body injection site of the patient and have a distinctive mark and/or colour and/or shape to assist the patient in selecting a given body injection site.

[0052] According to a preferred embodiment, the plurality of tattoos may present from two to four different distinctive marks and/or colours and/or different shapes. More preferably, the plurality of tattoos presents four different distinctive marks and/or colours and/or different shapes. [0053] According to a preferred embodiment, the plurality of tattoos are provided on a support, such as paper sheet or the like, the support being adapted to transfer the tattoo from the support to the body injection site of the patient.

Example of a pen needle in accordance with a preferred embodiment of the invention

[0054] Reference numbers of Figures 1 to 6 are the following:

PI : Front view of a patient;

P2: Back view of the patient;

1-10: Ten different injection body sites of the patient;

K and Kl to K4: Kit(s)

100 Pen needle;

120 Hub;

140 Needle canulla;

160 Inner cap;

180 Outer cap;

181 184: Outer caps with four different colours; 200: Tattoo assembly;

210: Tattoo support;

281-284: Tattoos with four different colours;

300: Container;

310: Opening of the container;

381-384: Four different symbols as distinctive marks;

481-484: Four different Letters as distinctive marks; and

581-584: Four different Numbers as distinctive marks.

[0055] In accordance with a preferred embodiment of the invention, the kit (K) as illustrated on Figure 1, may comprise pen needles (100) adapted for giving an injection of a medication to a patient in need thereof; and a compartment (300) adapted to contain and provide the plurality of pen needles (100). In the example of Figure 1, the container may contain up to 100 pen needles.

[0056] The container may be of any kind known in the art such as a box, a bag, etc. As illustrated on Figures 1 or 6, the container (300) is preferably a box made of carton, hard paper, plastic or the like, and comprises an aperture (310) to provide the pen needles (100) therefrom. As illustrated on Figure 6, each of the boxes (Kl to K4) of the kit can have a color matching at least one of the color of the pen needles (Kl is green, K2 id yellow, K3 is blue and K4 is purple). The kit can have one box containing pen needles of different colors or distinctive marks.

[0057] As illustrated on Figure 2, each pen needle (100) of the kit may comprises a hub (120) adapted to receive a medication pen body (not illustrated) having a medication compartment therein. Any kind of medication pen compatible with the pen needle can be used. A needle cannula (140) is affixed to the hub having a distal end extending from the hub and adapted to inject the medication in the patient and a proximal end (not illustrated) adapted to access the medication compartment in the pen body. Example of needle cannula used for injecting insulin to children has a diameter of 0.23 mm (32G model).

[0058] An inner cap (160) is arranged on the hub for encircling and protecting the distal end of the needle cannula (140).

[0059] An outer cap (180) is removably connected to the hub (120) for covering the inner cap (160) and the hub (120) in an initial state prior to use. [0060] The pen needle disclosed herein and in the Figures is one of the like. It is to be understood that other kinds of pen needles known in the art can be used without departing from the present invention. In general, the pieces of the pen needles are made of a plastic material, and the needle is made of a metallic material.

[0061] The pen needle may further comprise a cover (not illustrated) removably connected to the hub for protecting the proximal end of the needle canulla in the initial state prior to use. The cover is generally a paper foiled than can be peeled off the base of the hub prior to connect the hub to the pen. The cover guarantees the needle canulla to remain sterile prior to use.

[0062] As illustrated on Figure 1 or 3, each pen needle (100) comprises a coloured distinctive mark in order to be distinguished from at least one other pen needle having a different colour mark (each different coloured cap is identified on Figures 1 and 3 with reference numbers 181, 182, 183 or 184). One container can contained different coloured pen needles as illustrated on Figure 1, or each container can contain pen needles having the same colour marks as illustrated on Figure 6.

[0063] As illustrated in Figures 1 and 3, the container comprises pen needles having four different coloured marks, where the outer cap may be entirely coloured forming as such the coloured mark (181 - 184). In the example illustrated on Figures, the colors are purple (181), green (182), blue (183) or yellow (184). Other colours can be used as long as the pen needles are easily distinguishable one to another. [0064] As illustrated in Figure 7, the container comprises pen needles having four different distinctive marks being symbols such as a heart (381), a star (382), a diamond (383) or a circle (384). As illustrated in Figure 8, the container comprises pen needles having four different distinctive marks being capital letters such as a A (481), a B (482), a C (483) or a D (484). As illustrated in Figure 9, the container comprises pen needles having four different distinctive marks being numbers; such as a 1 (581), a 2 (582), a 3 (583) or a 4 (584). Other distinctive marks can be used as long as the pen needles are easily distinguishable one to another. Also the marks are located on the top of the cap of each pen needles, they can be located in any other part of the pen needles as long as they are easily visible by the user.

[0065] According to a preferred embodiment illustrated on Figure 5, the kit may further comprises a plurality of guiding non-permanent tattoos (281 - 282) adapted to be affixed on a selected body injection site of the patient. Each tattoo has a given colour corresponding to the colour of the pen needles (181 - 184). Preferably, the tattoos may further have different shapes in function of the selected body injection site.

[0066] According to preferred embodiments illustrated on Figures 7 and 9, the kit may further comprises a plurality of guiding non-permanent tattoos (200) adapted to be affixed on a selected body injection site of the patient. Each tattoo has a given distinctive mark corresponding to the marks of the pen needles (181 - 184). On Figure 7, each of the tattoos may have a shape corresponding to the shape of the symbols used as distinctive mark of the pen needles.

[0067] According to a preferred embodiment, the kit may further comprise a medication pen (not illustrated), said medication pen comprising the medication pen body having a medication compartment therein.

[0068] According to a preferred embodiment, the kit may further comprise instructions for use of the kit. As illustrated on Figure 1 or 6, the instructions can be directly printed on the container (300). Of course, the instructions can be presented separately.

[0069] According to a preferred embodiment, the medication comprises insulin for treating diabetes. It is to be understood that other diseases in need of giving daily injections to a patient can be treated using the present invention. The invention is also particularly adapted, but not limited to, the treatment of a child or a teenager.

[0070] The invention is also directed to a tattoo assembly (200) such as the one illustrated on Figures 5, 7 or 9. The tattoo assembly can be part of the kit or sold separately. It is used in a medical treatment by injection of a medication to a patient in need thereof. The tattoo assembly comprises a plurality of guiding non-permanent tattoos, each tattoo being adapted to be affixed on a body injection site of the patient and have a distinctive mark, a colour and/or a shape to assist the patient in selecting a given body injection site. It is to be understood that the tattoo preferably presents at least one area where there is no ink thought which the patient will inject the medication.

[0071] According to a preferred embodiment, the plurality of tattoos may present from two to four different colours and/or different shapes. More preferably, the plurality of tattoos presents four different colours and/or different shapes. The invention is not limited to the shape and/or colour of the tattoo. [0072] The non-permanent tattoos are provided on a support, such as paper sheet or the like, the support being adapted to transfer the tattoo from the support to the body injection site of the patient. The tattoo generally gets erased after several days.

[0073] The present invention is also directed to methods of use of the kit, in particular in the treatment of diabetes with children in needs. But the invention can also be used by adults and elderly persons that are in needs of such treatment.

Methods of use;

[0074] In the examples disclosed herein, the medication is insulin for treatment of diabetes. Of course, other treatments needing daily, weekly or monthly injections can ne provided using the kit and methods according to the present invention. Preferably, the methods described herein are not performed by a doctor or a nurse, or any medical assistant, but by the patient himself / herself. The present methods are therefore defined as being preferably auto- or self- administration or treatment performed by the patient him/herself.

[0075] Users or patients may not remember before a new injection whether or not they have changed the needle, or they are not motivated to do so. Users or patients can also forget to change the injection site or they are not motivated to rotate the injection site or they do not know they should rotate the injection site.

[0076] Locations of most common body injection sites for insulin are illustrated in Figure 4. For instance in the abdomen (Sites 1 to 4), the legs (sites 5 or 6), the arms (Sites 7 and 8) or the buttock (sites 9 or 10). Each body injection can be also subdivided into a plurality of injection locations, as long as the locations are separated one to the other by an adequate distance, for example by an inch or two.

[0077] Regarding the rotation of injection site, two types of rotation can be defined:

Changing the injection site, for example injecting once in right arm and the next time in left arm, etc.

- Within the same injection site but for different injection locations, for example by injecting the first time in right arm and next time again in right arm but in a different location with one inch distance from the first location of the injection. Methods of use with assigned injection times; Example 1: Weekly rotation:

[0078] The method consists in assigning a distinctive mark such as a colour mark to an injection each week, following Table 1 shows one option on how assigning the color of the pen needle to the inj ecti on times :

Table 1:

[0079] The method of use of the kit of the invention may comprise at least the following steps: a. assigning one colour to each injection week;

providing a pen needle having a colour mark corresponding to the colour assigned to a given week, for administering the medication; and

repeating step b) in accordance with a number of the injection times per week; and repeating steps b) to c) the following week.

Example 2:

[0080] In the example 2, the distinctive mark is a coloured mark. The method consists in assigning a colour to an injection time in the day. following Table 2 shows tree options on how assigning the color of the pen needle to the injection times: Table 2:

[0081] The method of use of the kit of the invention may comprise at least the following steps: a. assigning one colour to each injection time of a day;

b. providing a pen needle having a colour mark corresponding to the colour assigned to a given injection time of the day, for administering the medication; and

c. repeating step 2) in accordance with a number of the injection times of the day; and d. repeating steps 2) to 3) the following day.

[0082] As an example, the number of injection times of the day is 4 as in option 3 of Table 1 above. The method may comprise the following steps:

1) assigning one colour to each of the four injection times of a day; 2) providing a pen needle having a first colour mark corresponding to a first injection time of the day, for administering the medication;

3) providing a pen needle having a second colour mark corresponding to a second injection time of the day, for administering the medication;

4) providing a pen needle having a third colour mark corresponding to a third injection time of the day, for administering the medication;

5) providing a pen needle having a fourth colour mark corresponding to a fourth injection time of the day, for administering the medication;

6) repeating steps 2) to 5) a following day. Methods of use with assigned injection times and sites;

Example 3;

[0083] The following Table 3 shows different options on how assigning the color of the pen needle to the injection time and the injection sites. Reference is made to Figure 4 and injections sites 1 to 10.

Table 3:

[0084] The method of use of the kit of the invention may comprise at least the following steps: a. assigning one colour to each injection time of a day and to each body injection site; b. providing a pen needle having a colour mark corresponding to the colour assigned to a given injection time of the day and to a given body injection site, for administering the medication; and

c. repeating step 2) in accordance with a number of the injection times of the day; and d. repeating steps 2) to 3) the following day.

[0085] As an example, the number of injection times and body injection sites of the day is 4 as in options 4 to 6 of Table 3 above. The method may comprise the following steps:

a. assigning one colour to each of the body injection sites and injection times of a day; b. providing a first pen needle having a first colour assigned to a first injection of the day and first body injection site, for administering the medication; c. providing a second pen needle having a second colour assigned to a second injection of the day and second body injection site, for administering the medication; d. providing a third pen needle having a third colour assigned to a third injection of the day and third body injection site, for administering the medication; e. providing a fourth pen needle having a fourth colour assigned to a fourth injection of the day and fourth body injection site, for administering the medication; and f. repeating steps 2) to 5) the days after.

Methods with the combined use of coloured pen needles and guiding tattoos;

[0086] With the combination of tattoo and colour pen needles, the invention is particularly adapted to help the patient with different methods according to the patient preference. Some patients prefer to use one site for 1 or 2 days and rotate within the same site then move to another site while others prefer to change the injection site after each injection.

[0087] In order to assist the user or patient, the kit may further comprise a guiding tattoo assembly as defined herein.

Example 4;

[0088] The following Table 4 shows different options on how assigning the color of the pen needle combined with the colour of shape of the guiding tattoos to the injection time and the injection sites. Reference is made to Figure 4 and injections sites 1 to 10.

Table 4:

[0089] According to another preferred embodiment, the method may comprise the following steps:

a. assigning a body injection site to each injection time;

b. assigning a colour and/or a shape to each body injection site;

c. providing a guiding tattoo from the guiding tattoo assembly having a colour mark and/or a shape matching the colour and/or shape assigned to a given body injection site;

d. affixing the guiding tattoo to the given body injection site;

e. selecting a pen needle having a colour mark matching the colour of the guiding tattoo for injecting a medication in the assigned body injection at the given injection time;

f. repeating steps 3) to 5) at least once in function of a number of times the medication has to be injected.

[0090] As an example, the number of injection times and body injection sites of the day is 4 as in options 7 or 8 of Table 4 above. The method may comprise the following steps:

a. assigning a first body injection site to a first injection time;

b. assigning a first colour and/or a shape to the first body injection site; c. providing a first guiding tattoo from the guiding tattoo assembly having a colour mark and/or a shape matching the first colour and/or shape assigned to the first body injection site;

d. affixing the first guiding tattoo to the first body injection site;

e. selecting a first pen needle having a colour mark matching the first colour of the guiding tattoo for injecting a medication in the first body injection at the first injection time;

f. repeating steps 3) to 5) at the second, third and fourth injection times when the medication has to be injected; and

g. repeating steps 3) to 6) the day after.

[0091] Although the examples refer to the "day after" in step 7), it is to be understood that the method can be used on a daily, weekly or monthly base. Example 5;

[0092] The following Table 5 shows examples on how assigning the color of the pen needle combined with the colour of shape of the guiding tattoos to the injection time and different locations of one injection site. Reference is made to Figure 4 and injections sites 1 to 10. Table 5:

[0093] According to another preferred embodiment, the method for assisting a patient in the administration of a medication by injection may comprise at least the following steps:

a. assigning at least one colour and/or a shape to a given injection time of the day; b. selecting a first body injection site;

c. defining one location on the first body injection site for each color assigned in step a);

d. providing a non-permanent guiding tattoo having a colour mark and/or a shape matching the colour and/or shape assigned in step a);

e. affixing each guiding tattoo to each location of the first body injection site defined in step c); f. at a given injection time, selecting a pen needle having a colour mark matching the colour assigned in step a) for injecting the medication in the defined location of the selected first body injection site where the matching coloured tattoo is affixed;

g. repeating step f) at each injection time for one or two days; and

h. repeating steps b) to g) for a subsequent body injection site for the following days.

[0094] For the example of Table 5, the number of injection times of the day is four, the method may thus comprise the steps of:

a. assigning one colour and/or a shape to each of the four injection times of the day; b. selecting a first body injection site;

c. for each colour assigned in step a), defining one location on the first body injection site selected in step b);

d. providing a non-permanent guiding tattoo having a colour mark and/or a shape matching the colour and/or shape assigned in step a);

e. affixing each guiding tattoo to the four locations of the first body injection site defined in step c);

f. at the first injection time, selecting a pen needle having a colour mark matching the colour assigned in step a) for injecting the medication in the defined location of the selected first body injection site where the matching coloured tattoo is affixed;

g. repeating step f) at the second, third and fourth injection times for one or two days; and

h. repeating steps b) to g) for a subsequent body injection site for the following days.

[0095] In the example 4 detailed above, 4 different tattoos can be provided with 4 different colors matching those of the pen needles to the patient. The patient will assign one color to each injection time and each injection site. Then the patient will affix each color of tattoo to the corresponding injection site. For example yellow tattoo to right arm, green tattoo to left arm, pink tattoo to right side of belly and blue tattoo to left side of belly. And each time will pick the needle matching the time of the day and inject in the site which corresponds to the color.

[0096] In the other method of example 5, the patient will only assign one color to each injection time. Then the patient will affix the 4 colours of tattoo (or one tattoo sheet including 4 colors) to one injection site that prefers to start with. Every time the patient picks a pen needle, the medication is injected in the corresponding area on the same injection site, but in a different location which is defined by the colors on the tattoo. After using all the locations of the tattoo on one site, the patient will move on to the next site and repeat the same procedure.

[0097] Administering daily medication to children can be challenging. The use of the present invention allows starting the conversation about diabetes in a neutral way without putting guilt or pressure on the patient. The dialogue can be started by asking which colour of needle was used for the previous injection or asking which colour they prefer to use for the current injection. The use of the present invention also allows empowering children by involving them in decisionmaking about their diabetes management. By giving the child the responsibility of choosing the colour of pen needle he/she wants to use, it is possible to encourage positive self-care behaviour without posing any risk to diabetes management.

Personalised injection plan (Survey results);

[0098] A questionnaire was distributed among 19 diabetes educators who were member of DES (Diabetes Education Section) of CDA (Canadian Diabetes Association) Chapter of Montreal. 16 questionnaires were completed. The table below presents the results of teh survey :

methods are more efficient than 100% 0% 0% condensed amount of text

If there is a tool or concept that can ease

the management of "site rotation", 100% 0% 0% without imposing higher cost on patient, I

am willing to try it

[0099] Different studies done in different countries show that lipohypertrophy is a serious issue among people with diabetes. Also they show that people with diabetes do not rotate their injection site efficiently. The results of the above mentioned survey ran by Montmed is also aligned with these clinical studies.

[00100] There is strong need for practical and patient friendly methods to implement the site rotation. According to the above mentioned survey, 94% of diabetes educators consider a tool or solution as valuable if it just helps a bit to improve the current situation of site rotation. 100% of them prefer visual methods versus text to solve the current existing problem. More importantly, 100% diabetes educators will be willing to implement a new tool or concept that can ease the management of site rotation. These data proves the need for an innovation in this area and the importance of the present invention.

[00101] While illustrative and presently preferred embodiments of the invention have been described in detail hereinabove, it is to be understood that the inventive concepts may be otherwise variously embodied and employed and that the appended claims are intended to be construed to include such variations except insofar as limited by the prior art.