Instructions for use with implantable medical devices
An integrated multilingual patient implant card in the instruction manual addresses the MDR requirements by reducing costs and weight, enhancing handling, and ensuring language coverage with symbol-based instructions and a backup card.
Patent Information
- Application Number
- JP2025518044
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-10-04
- Filing Date
- 2023-09-28
- Publication Date
- 2025-10-15
AI Technical Summary
The EU's Medical Device Regulation (MDR) requires patient implant cards (PICs) in multiple languages, leading to high costs, increased weight, and difficult handling due to the large number of individual cards.
An integrated multilingual patient implant card is incorporated into the instruction manual, using symbol-based instructions and perforations for easy detachment, with a backup card provided, reducing the need for multiple physical cards and allowing for cost-effective and efficient handling.
This design significantly reduces production and transportation costs, improves handling, and ensures all languages are covered without additional paper, while providing a backup card for damaged cards.
Smart Images
Figure 2025534308000001_ABST
Abstract
Description
[Technical Field]
[0001] 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).
[0002] The EU's so-called Medical Device Regulation (MDR) requires such PIC in each national language of the EU for all VI implant products.
[0003] Therefore, the current design of such a PIC consists of 24 individual PICs, each written in one of those languages and pinned to an instruction manual (also written as IFU for Instructions for Use).
[0004] The large number of individual PICs makes the cost and weight of a 24-language PIC relatively high. Furthermore, the large number of PICs makes them difficult to handle.
[0005] Based on the above, the problem to be solved by the present invention is to provide an improved instruction manual and corresponding method for processing patient implant cards with regard to the above difficulties.
[0006] 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.
[0007] According to claim 1, an instruction manual for an implantable medical device is disclosed, comprising at least one front page having a front and a back side, the front page comprising an integral patient implant card detachably connected to an adjacent portion of the front page.
[0008] In particular, this design offers the possibility of using an efficient multilingual patient implant card (PIC) integrated into the front page of the instruction manual (IFU). It also facilitates separation from the instruction manual, which is currently impossible due to the large number of individual patient implant cards for each language. In particular, the patient implant card according to the present invention covers all national languages using symbol-based instructions / explanations that can be understood regardless of language. Having only a single patient implant card (or a relatively small number of such cards) allows for significantly improved handling of such card(s). Furthermore, production costs are significantly reduced. Furthermore, advantageously, the weight of the instruction manual is reduced, and in particular, less paper is required to produce the instruction manual.
[0009] According to a preferred embodiment of the invention, the abutment portion surrounds the patient implant card, which allows for a secure connection of the patient implant card to the instruction manual and also reduces the risk of damaging the patient implant card.
[0010] In a preferred embodiment of the invention, the patient implant card is connected to an adjacent portion via an elongated perforation that extends along, and in particular around, the patient implant card.
[0011] Preferably, in one embodiment of the invention, the elongated perforation preferably comprises two opposing ends on one side of the patient implant card. According to yet another preferred embodiment of the invention, at least one front page comprises an elongated slit extending between said opposing ends. This allows the patient implant card to be more easily manually separated from the adjacent portion of the front page, for example by inserting a finger of a person handling the instructions into said slit, and the slit allows the patient implant card to be conveniently pulled to separate from the surrounding adjacent portion by tearing the front page along the elongated perforation line that separates the patient implant card from the adjacent portion of the front page of the instructions.
[0012] According to an alternative preferred embodiment, the patient implant card is detachably connected to an adjacent portion of the front page by adhesive, wherein in particular said adjacent portion forms the backing of the patient implant card.
[0013] According to a further preferred embodiment of the present invention, the patient implant card comprises a marked area for affixing a sticker to the patient implant card, preferably the sticker containing an identifier identifying the implantable medical device (particularly the model and manufacturer) implanted in the person to whom the patient implant card has been assigned, in particular said sticker being removable from the packaging of the implantable medical device.
[0014] Apart from the identifier, the patient implant card is configured to include one, some or all of the following information: patient name, hospital name, doctor name, implant date, and implantable medical device (e.g., stent) location.
[0015] According to one embodiment of the present invention, the patient implant card includes a dedicated area for receiving the patient's name.
[0016] Furthermore, in accordance with one embodiment of the present invention, the patient implant card includes a dedicated field for receiving the name of the hospital.
[0017] Additionally, in accordance with one embodiment of the present invention, the patient implant card includes a dedicated area for receiving the physician's name.
[0018] Additionally, in accordance with one embodiment of the present invention, the patient implant card includes a dedicated field for receiving the date of implantation.
[0019] Furthermore, in accordance with one embodiment of the present invention, the patient implant card includes a dedicated area for receiving the location of an implantable medical device (eg, a stent).
[0020] According to yet another embodiment of the present invention, the patient implant card comprises fold markings indicating fold lines for folding the two integrally connected portions of the patient implant card together. Thus, once the patient implant card is separated from the front page of the instruction manual, the patient implant card can be conveniently folded, particularly to reduce its size, so that, in particular, the patient can store the patient implant card in a wallet in the folded state. In particular, the patient implant card can have the dimensions of a regular credit card.
[0021] Furthermore, in accordance with an embodiment of the present invention, the patient implant card comprises two opposing recesses disposed opposite each other, and said fold markings extend between said recesses.
[0022] Preferably, in one embodiment of the present invention, the instruction manual comprises a final page having a front and a back, the final page comprising a redundant or backup integrated patient implant card detachably connected to an adjacent portion of the final page. Current IFU / PIC solutions do not provide for a backup PIC. In the event of a damaged PIC, whether due to a manufacturing defect or improper handling by the operator, the physician essentially has three options: (i) secure the damaged PIC with adhesive (tape) or any other securing means, (ii) 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: in option (i), the damaged, temporarily secured PIC remains susceptible to further damage. In option (ii), the operator must reorder a new IFU / PIC from the device manufacturer or distributor, and in option (iii), the patient is discharged with a PIC that is not in the patient's native or preferred language.
[0023] Furthermore, according to a preferred embodiment of the present invention, the instruction manual comprises a plurality of intermediate pages arranged between at least one first page and a last page, in particular the intermediate pages containing technical information about the implantable medical device, in particular in different languages.
[0024] Furthermore, in accordance with a preferred embodiment of the present invention, the intermediate pages each include a basis weight that is lower than the basis weight of at least one of the first and / or last pages. In particular, the intermediate pages can include a significantly lower basis weight by not including a patient implant card, thereby further reducing the weight and size of the instruction manual.
[0025] Furthermore, in accordance with a preferred embodiment of the present invention, at least one leading page is formed from a flexible sheet of material. According to a further embodiment, the last page is formed from a flexible sheet of material. According to yet another embodiment, the intermediate pages are each formed from a flexible sheet of material.
[0026] Preferably, in one embodiment, at least one first page and / or last page and / or patient implant card has a weight of 25-350 g / m 2 in the range of 80 to 240 g / m 2 range, more preferably 120 to 200 g / m 2 and most preferably in the range of 160 g / m 2 basis weight (also known as basis weight or areal density).
[0027] Furthermore, in accordance with a preferred embodiment of the present invention, at least one of the first and / or last pages, and / or intermediate pages, and / or patient implant cards comprise or are formed from one of the following materials: paper, such as cellulose-based paper, parchment, grass paper, or recycled paper, polymer film or foil, metal film or foil, or any other suitable printable material.
[0028] According to a further aspect of the present disclosure, there is provided a method for processing a patient implant card, the method comprising: providing instructions for use with an implantable medical device according to the present invention; Separating the patient implant card from the instructions; adhering a sticker removed from packaging of the implantable medical device, the sticker including an identifier that identifies the implantable medical device implanted in the patient; Handing over the patient implant card to the patient; A method is disclosed that includes:
[0029] In particular, further information, such as that described above, can be provided on the patient implant card before it is handed over to the patient. In particular, the method according to the invention can be further specified by the features that are described in conjunction with the instructions for use according to the invention.
[0030] In the following, embodiments of the invention as well as further features and advantages of the invention are described with reference to the figures. [Brief explanation of the drawings]
[0031] [Figure 1] FIG. 1 shows the front page of one embodiment of an instruction manual according to the present invention with an integrated patient implant card. [Figure 2] FIG. 2 is a diagram showing the back side of the first page shown in FIG. [Figure 3] FIG. 10 shows the front of the last page of one embodiment of an instruction manual having an integrated redundant or backup patient implant card. [Figure 4] FIG. 4 is a diagram showing the back side of the last page shown in FIG. 3. DETAILED DESCRIPTION OF THE INVENTION
[0032] Typically, with implantable medical devices, a situation arises where a product is sold in 25 different languages on the CE market. Currently, the cover of the instructions for use incorporates a separate PIC, i.e., 12 additional pages of cardboard, for each language. Only one of these is used by the patient at a time. If a 25th language is required by the MDR, four more pages of cardboard will be added.
[0033] In contrast, FIGS. 1-4 illustrate an embodiment of an instruction manual 1 according to the present invention that provides at least one integrated patient implant card (PIC) 20, which, as shown in FIG. 1, may be incorporated into the first page 10 of the instruction manual 1. A further redundant or backup PIC 40 may be incorporated into the last page 30 of the instruction manual 1. Note that intermediate pages that may be provided between the first page 10 and the last page 30 are not shown in the figures for simplicity. In particular, the redundant or backup PIC 40 incorporated into the last page serves as a backup. The first page 10 and the last page 30 each have a front surface 10a, 30a and a back surface 10b, 30b, with the back surfaces 10b, 30b of the respective pages 10, 30 facing away from the front surfaces 10a, 30a.
[0034] The present invention can save approximately 12 to 16 pages that would normally be required. Preferably, only the front (i.e., first page 10) and back (i.e., last page 30) of the instruction manual 1 are made of cardboard.
[0035] The patient implant card 20 is provided with elongated perforations 21 extending along the outer edge of the PIC 20, allowing for easy removal of the PIC 20 from the adjacent portion 10c of the first page 10 of the instruction manual 1. The perforations provide tear or retention points along the length of the PIC on either side of the folds 23, 43. The tear or retention points are provided along the width of the PIC on the left and right sides of the folds 23, 43. At the marking points, the elongated perforations 21 are replaced by slits (e.g., cuts) 22, which allow for easier tearing. Thus, the slits / cuts 22 extend between the opposing ends 21a, 21b of the perforations 21.
[0036] Similarly, adjacent portion 30c surrounds backup patient implant card 40 on final page 30 (see Figures 3 and 4), and again, redundant or backup patient implant card 40 is connected to adjacent portion 30c via elongated perforation 41 including two opposing ends 41a, 41b with slit (e.g., cut) 42 extending therebetween (see above).
[0037] 2, the patient implant card 20 preferably includes a marked area 20c for affixing a sticker 2 to the patient implant card 20, the sticker 2 including an identifier that identifies the implantable medical device implanted in the person. The same applies to a backup PIC 40, if present, which may also include a marked area 40c for such a sticker 2. The backup / redundant PIC 40 can be used in the event that the PIC 20 is damaged or mishandled.
[0038] In particular, each PIC 20, 40 may include a fold mark 23, 43 indicating a fold line along which the two integrally connected portions 201, 202 or portions 401, 402 of the respective patient implant card 20, 40 are folded together. Furthermore, each patient implant card 20, 40 may include two opposing recesses 24, 25 or recesses 44, 45 disposed opposite each other, with each fold mark 23, 43 extending between the recesses 24, 25 or recesses 44, 45. Due to these recesses, each PIC 20, 40 has rounded corners on both sides of the fold line when folded. Preferably, other corners of the PIC 20, 40 opposite the fold line 23, 43 are also rounded. The rounded corners facilitate the perforation process.
[0039] The instruction manual 1 may include a number of intermediate pages between the first page 10 (shown in FIGS. 1 and 2) and the last page 30 (shown in FIGS. 3 and 4) that may contain technical information about the implantable medical device, particularly in different languages. The intermediate pages may each have a thickness that is less than the thickness of the first page 10 and / or the last page 30 for weight and space reasons.
[0040] Preferably, the PICs 20, 40 use standard symbols. The symbols and instructions for handling each PIC 20, 40 are preferably explained in the instruction manual 1 in a multilingual format, i.e., without using a specific language, by using symbols that can correspond to pictograms and that can be understood by each medical facility regardless of language. Thus, additional new languages can be covered without increasing the amount of paper for the PICs 20, 40 or the instruction manual 1. The symbols / instructions for handling each PIC 20, 40 can be provided, for example, on the second side 10b of the first page 10 of the instruction manual above the PIC 20 (e.g., on the adjacent portion 10c), as shown in FIG. 2.
[0041] In particular, the Patient Implant Card (PIC) 20 must be carefully removed from the first page 10 (or last page 30) of the Instructions for Use 1. The sticker 2 from the inside or outside label of the implantable medical device is then removed and placed in the corresponding blank / marked area 20c on the PIC 20. The same PIC 20 can be used for multiple implants if devices of the same family are implanted and if there is space on the PIC 20.
[0042] After placing the sticker 2 on the PIC 20, the following information is typically written in the corresponding marked areas: patient (e.g., name), hospital and physician, implantation date, and location (implantation site) of the medical device (e.g., stent).
[0043] Finally, the PIC20 is handed over to the patient.
[0044] Other mechanisms may also be used to detach or remove the PIC20 and / or PIC40 from the instruction manual 1, such as solutions using adhesive labels or other adhesive techniques.
[0045] The present invention has the advantage that it eliminates the need for each customer to select their language from 24 different PICs. Furthermore, based on the specific design of the PIC according to the present invention, significant cost savings in production and transportation are achieved due to reduced weight. Finally, due to the lower weight per product, more products can be shipped per shipment.
Claims
1. At least one leading page (10) having a front surface (10a) and a back surface (10b), At least one front page (10), the front page (10) comprising an integral patient implant card (20) detachably connected to an adjacent portion (10c) of the front page (10). An instruction manual (1) for an implantable medical device comprising:
2. 2. The instruction manual of claim 1, wherein the abutment portion (10c) surrounds the patient implant card (20).
3. 3. Instructions for use according to claim 1 or 2, wherein the patient implant card (20) is connected to the adjacent part (10c) via an elongated perforation (21).
4. 4. The instruction manual of claim 3, wherein the elongated perforation (21) comprises two opposite ends (21a, 21b).
5. 5. The instruction manual of claim 4, wherein the at least one front page (10) comprises an elongated slit (22) extending between the opposing edges (21a, 21b).
6. 10. The instruction manual of claim 1, wherein the patient implant card (20) is detachably connected to the adjacent portion (10c) of the front page by an adhesive.
7. 7. The instruction manual of any one of claims 1 to 6, wherein the patient implant card (20) comprises a marked area (20c) for applying a sticker (2) to the patient implant card (20).
8. 8. The instruction manual of claim 1, wherein the patient implant card (20) comprises fold marks (23) indicating fold lines for folding the two integrally connected parts (201, 202) of the patient implant card (20) together.
9. 9. The instruction manual of claim 8, wherein the patient implant card (20) comprises two opposing recesses (24, 25) arranged opposite each other, and the fold mark (23) extends between the recesses (24, 25).
10. 10. The instruction manual (1) of any one of claims 1 to 9, wherein the instruction manual (1) comprises a final page (30) having a front surface (30a) and a back surface (30b), the final page (30) comprising a redundant or backup integrated patient implant card (40) detachably connected to an adjacent portion (30c) of the final page (30).
11. 11. The instruction manual (1) according to claim 10, wherein the instruction manual (1) comprises a plurality of intermediate pages arranged between the at least one first page (10) and the last page (30).
12. 12. The instruction manual of claim 11, wherein the intermediate pages each comprise a basis weight that is lower than the basis weight of the at least one first page (10) and / or the last page (30).
13. The at least one first page (10) and / or the last page (30) and / or the patient implant card (20) have a weight of 25 to 350 g / m ２ 13. The instruction manual of claim 1, comprising a basis weight in the range of
14. 1. A method for processing a patient implant card (20), said method comprising: Providing an instruction manual (1) for an implantable medical device according to any one of claims 1 to 13; Separating the patient implant card (20) from the instruction manual (1); adhering a sticker (2) removed from the packaging of the implantable medical device, the sticker (2) including an identifier that identifies the implantable medical device implanted in the patient; handing over the patient implant card (20) to the patient; A method comprising:
15. Use of the instruction manual (1) according to any one of claims 1 to 13 for an implantable medical device.