The present invention relates to an instruction manual for an implantable medical device. Furthermore, the present invention relates to a method for processing a patient implant card (PIC).

The so-called Medical Device Regulation (MDR) of the EU requires such a PIC for every VI implant product in the respective national language of the EU.

Therefore, the current design of such a PIC consists of 24 individual PICs, each written in one of the languages and pinned to the instruction manual (also denoted IFU for instructions for use).

The large number of individual PICs results in relatively high costs and weight for the 24- language PIC. Furthermore, due to the large number of PICs, their handling is difficult, too.

Based on the above, the problem to be solved by the current invention is to provide an instruction manual and a corresponding method for processing a patient implant card that are improved regarding the above stated difficulties.

This problem is solved by an instruction manual for an implantable medical device comprising the features of claim 1. Furthermore, the problem underlying the present invention is solved by a method having the features of claim 14. Preferred embodiments of these aspects of the present invention are claimed in the corresponding dependent claims and are described below.

According to claim 1, an instruction manual for an implantable medical device is disclosed, comprising at least a first page having a front side and a back side, wherein the first page comprises an integrated patient implant card releasably connected to an adjacent portion of the first page.

Particularly, this design offers the possibility to use an efficient multilingual patient implant card (PIC) that is integrated in the first page of the instruction manual (IFU). And can be easily separated from the instruction manual which is currently not possible due to the high number of individual patient implant cards for each language. Particularly the patient implant card according to the present invention covers all national languages using instructions/explanations based on symbols that can be understood independent of language. Having only a single patient implant card (or a relatively small number of such cards) allows to improve the handling of such card(s) considerably. Furthermore, production costs are significantly reduced. Furthermore, advantageously the weight of the instruction manual is reduced and less paper is needed for production of the instruction manual, in particular.

According to a preferred embodiment of the present invention, the adjacent portion surrounds the patient implant card. This allows one to securely connect the patient implant card to the instruction manual which also allows reducing the risk of damaging the patient implant card.

In the preferred embodiment of the present invention, the patient implant card is connected to the adjacent portion via an elongated perforation that extends along and particularly around the patient implant card.

Preferably, in an embodiment of the invention, said elongated perforation comprises two opposing ends, preferably on one side of the patient implant card. According to yet another preferred embodiment of the invention, the at least one first page comprises an elongated slit extending between said opposing ends. This allows an easier manual separation of the patient implant card from the adjacent portion of the first page due to the fact that e.g. a finger of a person handling the instruction manual can be inserted into said slit, which allows pulling on the patient implant card in a convenient fashion so as to separate the patient implant card from the surrounding adjacent portion by tearing the first page along said elongated perforation line which releases the patient implant card from the adjacent portion of the first page of the instruction manual.

According to a preferred alternative embodiment, the patient implant card is releasably connected to the adjacent portion of the first page by an adhesive. Here, particularly said adjacent portion forms a backing of the patient implant card.

According to a further preferred embodiment of the present invention, the patient implant card comprises a marked area for applying a sticker to the patient implant card, wherein preferably the sticker comprises an identifier identifying the implantable medical device implanted into the person (particularly model and manufacturer) to which the patient implant card is assigned. Particularly, said sticker is removable from a packaging of the implantable medical device.

Apart from said identifier, the patient implant card is configured to contain one, several or all of the following information: the name of the patient, the of the hospital, the name of the doctor, the date of the implantation, the location of the implantable medical device (e.g. stent).

According to an embodiment of the invention, the patient implant card comprises a dedicated area for receiving the name of the patient.

Furthermore, according to an embodiment of the invention, the patient implant card comprises a dedicated area for receiving the name of the hospital

Furthermore, according to an embodiment of the invention, the patient implant card comprises a dedicated area for receiving the name of the doctor.

Further, according to an embodiment of the invention, the patient implant card comprises a dedicated area for receiving the date of the implantation. Further, according to an embodiment of the invention, the patient implant card comprises a dedicated area for receiving the location of the implantable medical device (e.g. stent).

According to yet another embodiment of the present invention, the patient implant card comprises a fold line marker indicating a fold line for folding two integrally connected parts of the patient implant card onto one another. Thus, once the patient implant card has been separated from the first page of the instruction manual, the patient implant card can be conveniently folded, particularly so as to reduce its size, which particularly allows the patient to store the patient implant card in a wallet in a folded state. Particularly, the patient implant card can comprise the dimensions of a usual credit card.

Furthermore, according to an embodiment of the present invention, the patient implant card comprises two opposing recesses arranged opposite one another, said fold line marker extending between said recesses.

Preferably, in an embodiment of the present invention, the instruction manual comprises a last page having a front side and a back side, wherein the last page comprises a redundant or back-up integrated patient implant card releasably connected to an adjacent portion of the last page. Current IFU/PIC solutions do not provide a back-up PIC. In case of a damaged PIC, either through a manufacturing defect or improper handling by the operator, the physician essentially has three options: (i) fix the damaged PIC with an adhesive (tape) or any other fixation means, (iii) remove an intact IFU/PIC from another (unopened) device in the required language or (iii) use an intact IFU/PIC in a language other than the patient’s native or preferred language. All three alternatives have disadvantages: For option (i) the damaged, temporarily fixed PIC remains prone to further damage. In case of option (ii) the operator needs to reorder a new IFU/PIC with the device manufacturer or distributor and in case (iii) the patient is discharged from the hospital with a PIC not written in the native or preferred language of the patient.

Further, according to preferred embodiment of the present invention, the instruction manual comprises a plurality of intermediary pages arranged between the at least one first page and the last page, wherein particularly said intermediary pages contain technical information about the implantable medical device, particularly in different languages.

Further, according to a preferred embodiment of the present invention, the intermediary pages each comprise a grammage being lower than a grammage of the at least one first page and/or of the last page. Particularly, due to the fact that the intermediary pages do not comprise patient implant cards, they can comprise significantly lower grammages, thus further reducing weight and size of the instruction manual.

Furthermore, according to a preferred embodiment of the present invention, the at least one first page is formed out of a flexible material sheet. According to a further embodiment, the last page is formed out of a flexible material sheet. According to yet another embodiment, the intermediary pages are each formed out of a flexible material sheet.

Preferably, in an embodiment, the at least one first page and/or the last page and/or the patient implant card comprises a grammage (also known as basic weight or area density) in the range from 25 to 350 g/m ² , preferably in the range from 80 to 240 g/m ² , more preferably in the range from 120 to 200 g/m ² , most preferably the grammage amounts to 160 g/m ² .

Furthermore, according to a preferred embodiment of the present invention, the at least one first page and/or the last page, and/or the intermediary pages, and/or the patient implant card comprise(s) or is/are formed out of one of the following materials: paper, for example cellulose-based paper, parchment paper, grass paper or recycled paper, polymeric films or foils, metallic films or foils, or any other suitable printable material.

According to a further aspect of the present invention, a method for processing a patient implant card is disclosed, the method comprising the steps of:

Providing an instruction manual for an implantable medical device according to the present invention,

Separating the patient implant card from the instruction manual, Adhering a sticker removed from a packaging of the implantable medical device, the sticker comprising an identifier identifying the implantable medical device implanted into the patient, and handing over the patient implant card to the patient.

Particularly, before handing over the patient implant card to the patient, further information, e.g. as described above, can be provided on the patient implant card. Particularly, the method according to the present invention can be further specified by the features described in conjunction with the instruction manual according to the present invention.

In the following, embodiments of the present invention as well as further features and advantages of the present invention are described with reference to the Figures, wherein

Fig. 1 shows a front side of a first page of an embodiment of an instruction manual according to the present invention, having an integrated patient implant card;

Fig. 2 shows a back side of the first page shown in Fig. 1;

Fig. 3 shows a front side of a last page of an embodiment of the instruction manual with an integrated redundant or back-up patient implant card; and

Fig. 4 shows a back side of the last page shown in Fig. 3.

Typically, regarding implantable medical device, the situation arises where the product is to be marketed in the CE market with 25 different languages. Currently, a separate PIC is integrated in the cover of the Instruction for Use for each language, i.e. 12 additional pages with thick paper. Only one of these is used for the patient at a time. With the 25th language required by MDR, another 4 pages of thick paper would then be added.

In contrast thereto, Figs. 1 to 4 show embodiments of an instruction manual 1 according to the present invention, which provides at least one integrated patient implant card (PIC) 20, wherein as indicated in Fig. 1, the PIC 20 can be integrated in the first page 10 of the instruction manual 1. A further redundant or back-up PIC 40 can be integrated into a last page 30 of the instruction manual 1. Note that intermediary pages that can be provided between the first and the last page 10, 30 are not shown in the Figures for reasons of simplicity. Particularly, the redundant or back-up PIC 40 integrated in the last page serves as a back-up. The first and the past page 10, 30 each comprise a front side 10a, 30a and a back side 10b, 30b, the back side 10b, 30b of the respective page 10, 30 facing away from the front side 10a, 30a.

Due to the present invention, about 12 to 16 pages that are normally necessary can be saved. Preferably, only the front (i.e. first page 10) and back (i.e. last page 30) of the instruction manual 1 are made of thick paper.

The patient implant card 20 is provided with an elongated perforation 21 extending along an outer edge of the PIC 20 which allows easy removal of the PIC 20 from an adjacent portion 10c of the first page 10 of the instruction manual 1. The perforation comprises break or hold points along the lengths of the PIC on either side of the fold line 23, 43. Break or hold points are provided along the width of the PIC on the left and on the right side of the fold line 23, 43. At a marking point, the elongated perforation 21 is replaced by a slit (e.g. cut) 22, which makes it easier to break out. Thus, the slit/cut 22 extends between opposing ends 21a, 21b of the perforation 21.

In the same fashion, an adjacent portion 30c surrounds the back-up patient implant card 40 of the last page 30 (cf. Figs. 3 and 4), wherein also here the redundant or back-up patient implant card 40 is connected to the adjacent portion 30c via an elongated perforation 41 comprising two opposing ends 41a, 41b between which a slit (e.g. cut) 42 extends (see above).

Furthermore, as shown in Fig. 2, the patient implant card 20 preferably comprises a marked area 20c for applying a sticker 2 to the patient implant card 20, the sticker 2 comprising an identifier identifying the implantable medical device implanted into the person. If present, the same can apply to the back-up PIC 40, which may also comprise a marked area 40c for such a sticker 2. The back-up/redundant PIC 40 can be used in case the PIC 20 is damaged or has been processed erroneously.

Furthermore, particularly, the respective PIC 20, 40 can comprise a fold line marker 23, 43 indicating a fold line for folding two integrally connected parts 201, 202 or 401, 402 of the respective patient implant card 20, 40 onto one another. Furthermore, the respective patient implant card 20, 40 can comprise two opposing recesses 24, 25 or 44, 45 arranged opposite one another, wherein the respective fold line marker 23, 43 extends between said recesses 24, 25 or 44, 45. Due to these recesses, the respective PIC 20, 40 comprises rounded corners in the folded state on both sides of the fold line. Also the other corners of the PICs 20, 40 opposite the fold line 23, 43 are preferably rounded. The rounded comers facilitate the perforation process.

In between the first page 10 (shown in Figs. 1 and 2) and the last page 30 (shown in Figs. 3 and 4) the instruction manual 1 can comprise a plurality of intermediary pages that may contain technical information about the implantable medical device, particularly in different languages. The intermediary pages can each comprise a thickness being smaller than a thickness of the first page 10 and/or of the last page 30 to safe weight and space.

Preferably, the PICs 20, 40 use standard symbols. The symbols and instructions for handling the respective PIC 20, 40 are preferably explained in multilingual fashion in the instruction manual 1, i.e. without the use of a specific language, by using said symbols that can correspond to pictograms and are understandable irrespective of the language by the respective health care facility. Thus, additional new languages can be covered without increasing the amount of paper of the PIC 20, 40 or manual 1. The symbols/instructions for handling the respective PIC 20, 40 can be provided e.g. on the second side 10b of the first page 10 of the instruction manual (e.g. on said adjacent portion 10c) above the PIC 20, as indicated in Fig. 2.

Particularly, the patient implant card (PIC) 20 shall be gently removed from the first page 10 (or last page 30) of the instruction manual 1. Then, the sticker 2 of the inner or outer label of the implantable medical device is peeled off and placed onto the corresponding empty field/marked area 20c on the PIC 20. In case devices from the same family are implanted, and if there is space on the PIC 20, the same PIC 20 can be used for more than one implant.

After having provided the sticker 2 on the PIC 20, usually the following information is filled in on corresponding marked areas: Patient (e.g. name and surname); Hospital and Doctor;

Date of implantation; Location (implantation site) of the medical device (e.g. stent).

Eventually, the PIC 20 is handed over to the patient. For detaching or removing the PIC 20 and/or 40 from the instruction manual 1, other mechanisms can also be used, e.g. as with adhesive labels or solutions using other adhesion technologies.

The present invention comprises the advantages according to which the respective customer does not have to choose his language from 24 different PICs. Furthermore, significant cost savings in production and transport due to the weight reduction are achieved based on the specific design of the PIC according to the present invention. Finally, due to a lower weight per product, more products per transport trip can be shipped.