ORDER FOR FUNCTIONAL TESTING OF A MEASURING OBJECT

Description

Technical area

[0001] The invention relates to an arrangement for functional testing of a measurement object, a so-called DUT, in the form of a medical implant or at least a part of the medical implant. State of the art

[0002] Implantable medical devices for the purpose of electrical stimulation of local intracorporeal areas, or implantable pulse generators (IPGs) for short, for example for cardiac defibrillation, pacemaker and resynchronization applications, or for neurostimulation therapy measures such as spinal cord stimulation, brain stimulation or vagus nerve stimulation, to name just a few, generally have a fluid-tight housing containing components for electrical pulse generation, such as at least an electrical energy source in the form of a battery or an induction coil, and an electrical circuit structure connected to this. In addition, a so-called head section is usually connected to the housing, in which athe electrical circuit structure contains an electrical contact arrangement which is electrically connected and into which a plug arrangement which is fluid-tightly connected to the head part can be inserted, which plug arrangement is contacted with electrical supply and discharge lines for the purpose of the intracorporeal local application of the electrical stimulation signals and, if necessary, the supply of intracorporeally locally tapped electrical signals to the electrical circuit structure present on the housing side.

[0003] As the functional scope of the medical implant increases, so does the number of electrical and electronic components installed within the implant. These components are densely packed and complexly interconnected on at least one printed circuit board to minimize space requirements. The electrical energy required to operate the medical implant is provided either by a battery integrated within the implant or by inductive energy transfer.

[0004] Testing and inspection procedures are essential both for the development and manufacture of implants and for quality control and assurance in the high-volume production of medical implants. To prevent the propagation of errors that occur during the production process, metrological tests are carried out on functional components throughout the entire manufacturing process, each at different stages of development of a medical implant. Of particular relevance in this context are the reproducibility and recordability of the individual functional tests. The publication US 2018 / 9931629 A1 discloses a test setup for functional testing of a semiconductor device arrangement. The semiconductor device arrangement to be tested is arranged in a test socket that is wirelessly supplied with test signals.

[0005] The document US2002 / 0079912 A1 discloses a test arrangement for electrical circuit boards which can be inserted into a test socket for testing purposes and can be supplied with electrical test signals.

[0006] The document DE 20 2006 000 739 U1 discloses a device for testing electronic components, in particular components with integrated circuits, with a contact base into which a component to be tested can be brought into contact.

[0007] The documents CN 109 143 028 A, CN 107 064 776 A, US 2007 / 005118 A1, CN 109 975 640 A and WO 2015 / 069522 A1 disclose arrangements for functional testing of a medical implant. Description of the invention

[0008] The invention is based on the object of specifying an arrangement for functional testing of a measurement object, preferably in the form of a medical implant or at least a part of a medical implant, such that functional tests on finished products, preferably medical implants, or parts thereof, which are manufactured both in small batch sizes and on an industrial scale, can be carried out safely, reliably and with robust reproducibility, which can also be recorded in order to satisfy warranty claims.

[0009] The object underlying the invention is defined in claim 1. Features that advantageously further develop the inventive concept can be found in the subject matter of the dependent claims and the further description, in particular with reference to illustrated embodiments.

[0010] The arrangement according to the solution for functional testing of a measurement object, which is in the form of a medical implant or at least a part of a medical implant and is referred to below as DUT (Device Under Test), essentially consists of a test signal generator, a test module, an adapter module that can be inserted into the test module and a control and evaluation unit.

[0011] The test signal generator, preferably connected to the test module via an electrical interface, generates the test signals required to test the DUT, which are then transmitted indirectly to the DUT via the test module. Generally, known test signal generators with fixed or freely selectable electrical test signals are suitable. Depending on the type and intended use of the DUT to be tested, the test signal generator can, for example, simulate ECG signals or generate electrical signal forms that correspond, for example, to neural electrical signals. A test signal generator is preferably suitable for generating electrical voltages with an arbitrarily predeterminable time profile and periodic recurrence, which can also be individually predeterminable. Preferred test signal generators include analog or digital function generators.

[0012] In a simplest embodiment, the test module, which is preferably connected to the test signal generator via a connecting cable, has a first receiving structure with at least one, preferably a plurality of contact electrodes, into which an adapter module, which is detachably and firmly connected to the DUT, can be inserted to form at least one electrical contact.

[0013] The test module has a housing in which a first receiving structure, preferably in the form of a recess within the housing, is provided, into which the adapter module, which is detachably and firmly connected to the DUT, can be inserted, forming a positive connection. The positive connection formed by inserting the adapter module into the first receiving structure ensures a unique fit of the adapter module within the first receiving structure and thus also of the DUT relative to the first receiving structure of the test module. At the same time, an electrical connection is formed between at least one contact electrode arranged in the region of the recess of the first receiving structure and the adapter module.

[0014] In addition to the form fit, the adapter module can optionally be secured to the test module by an additional force-lock connection, for example, by providing a spring-loaded clamp or snap-in connection between the adapter module and the test module. Of course, alternative mounting measures can also be provided directly or indirectly on the test module, allowing the adapter module to be removably and firmly fixed in place relative to the test module.

[0015] By providing the first mounting structure within the test module, it is ensured that a large number of DUTs, each of identical or differently designed, can be tested under exactly the same test conditions, i.e., while maintaining a defined spatial position and electrical contact. This allows for reproducible, reliable test results for the DUT.

[0016] Thus, one and the same test module is available for testing a large number of differently assembled DUTs, each of which is inserted into an adapter module individually adapted to the respective DUT, which in turn can be inserted into the first receiving structure of the test box.

[0017] To test a DUT connected to an adapter module inserted into the first receiving structure, the test signals generated by the test generator are transmitted to the DUT via the test module and adapter module. Depending on the number and arrangement of the electrical contact points attached to the DUT, referred to as counter electrodes, corresponding contact electrodes are provided on the test module and the adapter module side. These electrodes can be used to transmit the test signals and, optionally, measurement signals between the test module and the DUT.

[0018] A control and evaluation unit, which is directly or indirectly connected to the test signal generator and the test module, is used to test and evaluate the acquired measurement signals. The connection can be wired or wireless and primarily serves to transmit control and measurement signals between the individual components. The control and evaluation unit is typically implemented in the form of a computer or PC, which contains all the components and peripherals required for evaluating and logging the measurement signals, such as memory, a monitor, etc.

[0019] The test module has a second receiving structure that is arranged spatially fixed to the first receiving structure, into which an additional electrical component that interacts with the DUT without contact for the purpose of electrical energy and / or signal transmission, for example an induction coil and / or signal antenna arrangement, can be inserted.

[0020] In the case of a DUT that has an induction coil device and / or antenna device, the functionality of the contactless energy and / or signal transmission between the DUT and an external coil and antenna unit can be tested using the additional electrical component incorporated in the second receiving structure. For this purpose, the second receiving structure is designed in the form of a drawer-like recess within the test module, which is located directly below the first receiving structure to ensure a defined relative position between the DUT arranged centrally within the first receiving structure and the additional electrical component placed within the second receiving structure.

[0021] In addition or as an alternative to the connection of the control and evaluation unit to the test module, a preferred embodiment provides a wired connection between the additional electrical component and the control and evaluation unit, along which both electrical energy for supplying the DUT with power and the transmission of the measurement signals tapped at the DUT and forwarding to the control and evaluation unit can take place.

[0022] In order to ensure that the additional electrical component is implemented in a spatially fixed manner within the second receiving structure, the inner contour of the second receiving structure, which is preferably designed in the manner of a drawer compartment, and a housing comprising the additional electrical component are each designed with counter-contours to one another, so that a reliable insertion and fixing of the additional electrical component into the second or in the second receiving structure is possible, forming a positive connection, which can optionally be supplemented by an additional non-positive connection.

[0023] During the manufacturing-accompanying testing of a medical implant, the DUT typically takes the following different forms: a) In the first stage of testing, a printed circuit board equipped with electronic and electrical components is tested to ensure the functionality of all electrical / electronic components and to rule out possible cold solder joints. b) In a subsequent manufacturing process, electrical wires are electrically connected to contact points provided on the printed circuit board and secured relative to each other with a so-called leadthrough plate for the purpose of spatially defined fixation.c) In a further process step, the electrical conductor structures are contacted with an electrical contact arrangement which d) in a final stage of the medical implant, is part of an electrical contact structure within a so-called head part, for the purpose of contacting a cable connection leading away from the medical implant, via which an electrode arrangement located intracorporeally, separately from the medical implant, can be subjected to electrical stimulation signals.

[0024] In all of the manufacturing stages described above, different DUTs are present, for the testing of which the first receiving structure within the test module would have to be adapted to each DUT individually in order to create a reproducible test situation.

[0025] The test module according to the solution is designed with a uniform first mounting structure, into which adapter modules adapted to the first mounting structure can be inserted. Each adapter module has a third mounting structure that is individually adapted to a DUT to be tested. The remaining arrangement regarding the test generator, the test module, the additional electrical components, and the control and evaluation unit remain otherwise unchanged. The only measure that must be taken for testing differently designed DUTs concerns the modular exchange of different adapter modules, each of which has a third mounting structure that is individually configured for each DUT.

[0026] For the purpose of electrically contacting the DUT within the first receiving structure of the test module or within the third receiving structure of each adapter module, the respective receiving structures have at least one contact surface on which at least one contact electrode is arranged, which can be brought into contact with the DUT in a force-fitting and form-fitting manner with a counter electrode attached to the DUT.

[0027] Depending on the number, spatial placement, and orientation of the counterelectrodes provided on the DUT side, the contact electrodes to be provided on the at least one contact surface must be designed in a suitable shape, each with a countercontour. In a preferred embodiment, the at least one contact electrode and counterelectrode are designed in the manner of a plug-socket contact structure. Alternatively, or in combination, the contact electrodes and / or counterelectrodes can be designed in the form of spring-loaded, deflectably mounted contact pins. Other alternative contact electrode or counterelectrode shapes and structures are also conceivable.

[0028] For testing a finished medical implant such as an implantable pulse generator (IPG), which typically comprises a supply unit containing the electrical / electronic components and an adjoining head section with at least one electrical connector socket structure, the implant is inserted into a first receiving structure within the test module or a third receiving structure within an adapter module, adapted in terms of shape and size. During the insertion process, the medical implant is contacted at electrically accessible contact areas, i.e., along the electrical contact electrodes provided within the connector socket structure, with suitable contact electrodes provided on the test module or adapter module.Due to the precisely defined spatial arrangement between the implant and the additional electrical component, which is also integrated within the test module, the implant is supplied with electrical energy without contact. The test signals generated by the test signal generator are applied to the medical implant via the electrical contacts established in the plug socket structure between the implant and the test module or adapter module. The measurement signals required for functional testing and logging of functional capability are read out without contact via the additional electrical component located within the second receiving structure and transmitted to the evaluation and control unit.

[0029] In addition to using the system designed according to the solution for functional testing, the test system designed according to the solution is also suitable for updating the medical implant as part of a software update, especially since signal transmission between the additional electrical component and the medical implant can also take place in the direction of the medical implant. For this purpose, a current operating data set in the form of electrical data signals must be supplied to the additional electrical component with the aid of the evaluation and control unit. The additional electrical component transmits the data signals contactlessly via inductive coupling to the medical implant. The information can be received and processed accordingly in a suitably provided DUT-specific storage and processing unit.

[0030] The solution's design enables robust and reproducible testing of medical implants. Thanks to the modular design principle, the entire manufacturing history of a medical implant can be monitored and recorded by providing differently designed adapter and / or test modules, each adapted to different DUT designs. This significantly improves quality assurance in the production of medical implants.

[0031] The solution-based arrangement for functional testing also enables automated testing of DUTs, especially since all components and necessary manipulation steps for performing the functional test can be carried out with a suitably configured robot. Brief description of the invention

[0032] The invention is described below, without limiting the general inventive concept, using exemplary embodiments with reference to the drawings. They show: Fig. 1Overview of an arrangement for functional testing Fig. 2Different designs for a DUT, Fig. 3Receiving structure with spring-loaded contact pins Fig. 4Adapter module and Fig. 5Receiving structure with plug-socket contacts. Ways of implementing the invention, industrial applicability

[0033] Fig. 1 shows an overall view of an arrangement for functional testing of a measurement object, DUT ( D Service Under Test) comprising a test signal generator 1, a test module 2, and a control and evaluation unit 3, which is connected to the test module 2 via an additional electrical component 4 for the purpose of energy and signal exchange. The core element is the test module 2, which has a first receiving structure 5 into which a DUT to be tested can be permanently inserted, directly or indirectly detachably, and electrically contacted.

[0034] The solution-based arrangement serves to test the functionality and quality assurance of a medical implant during and after its manufacture. Fig. 2 Typical DUTs are illustrated, showing a medical implant in different manufacturing forms. Fig. 2a shows a first manufacturing stage for the construction of a medical implant in the form of an electrical circuit board 6 with electrical / electronic components 7 arranged thereon. Fig. 2bshows a subsequent second expansion stage, with a feedthrough plate 8 through which electrical conductors 9 are guided and fixed, each of which is connected on one side to contact points 10 on the circuit board 6. Fig. 2c shows a housing 11, which preferably surrounds the circuit board 6 and the feedthrough plate 8 in a fluid-tight manner. The housing 11 is preferably designed in the form of a solidified epoxy resin mass or as a metal housing, e.g., a titanium housing. Fig. 2d shows a finished medical implant 12, which additionally has a head part 13, which in the illustrated embodiment has two connector sockets 14, along which contact electrodes are arranged, which are connected to the electrical conductors 9. Plugs connected to intracorporeally located electrodes and fluid-tightly sealed to the head part 13 are inserted into the connector sockets 14.

[0035] For functional testing of the individual stages of a medical implant 12 according to the Fig. 2a to d illustrated differently designed DUT shows the Fig. 1 illustrated test module 2 has a first receiving structure 5 which provides a recess 16 within the test module 2 with at least one contact surface 15 and contact electrodes 17 arranged thereon.

[0036] To carry out the measurement, for example the one in Fig. 2a illustrated circuit board 6 as a DUT, test signals, for example in the form of ECG signals, are generated by the test generator 1 and transmitted via a cable connection 18, which runs between the test signal generator 1 and the test module 2, to the DUT arranged in the first receiving structure 5 indirectly via an adapter module.

[0037] The receiving structure 5 provided in the test module 2 is designed in such a way that adapter modules 23 adapted to the first receiving structure 5 can be used, see Figure 4 Each adapter module 23 has a uniform joining contour 24 for insertion and electrical contact within the first receiving structure 5 of the test module 2. Depending on the DUT to be tested, each adapter module 23 has differently configured third receiving structures 25. The DUTs, which vary in shape and size, can be inserted into the third receiving structure 25, always with a positive fit and, if necessary, also with a force fit. The DUTs are contacted using contact electrodes 25 suitably provided on the adapter module 23.

[0038] For electrical contacting of the adapter module spatially fixed within the first receiving structure 5, at least some of the contact electrodes 17 provided within the recess 16 come into electrical contact with counter electrodes 20 present on the adapter module. Fig. 3 shows a possible realization of the contact electrodes 17 arranged on the test module 2 in the form of spring-loaded contact pins 19, which come into contact with counter electrodes 20 attached to the underside of the adapter module 23.

[0039] Depending on the electrical component configuration of the DUT, the test signal generator 1 also supplies electrical power to the DUT to be tested via the cable connection 18.

[0040] The test module 2 also has a second receiving structure 21 in the form of a drawer-like recess, see Figure 1, into which the additional electrical component 4, preferably in the form of an induction coil and / or antenna arrangement, via which electrical energy and measurement signals can be transmitted without contact.

[0041] The control and evaluation unit 3 can be connected either directly to the test module 2 (see cable connection 22'), or to the additional electrical component 4 (see cable connection 22). The measurement signals acquired by the contact electrodes 17 can be transmitted to the control and evaluation unit 3 via the respective cable connection 22, 22'. Likewise, the DUT can be supplied with electrical energy via the cable connection 22, 22'.

[0042] For electrical contacting of the DUT within an adapter module 23, for example, the Fig. 3 illustrated spring-loaded contact pins 19 and / or contact electrodes each in the form of a plug-socket connection, as shown in Fig. 5 is illustrated. Fig. 5 shows an adapter module 23 having socket contacts 26 into which plug contacts 27 of a DUT can be inserted. The third receiving structure 25 of the adapter module 23 enables a force-loaded insertion of the DUT into the adapter module 23 along the force direction F.

[0043] In principle, there are no limits to the forms of training for the first and third admission structures 5, 25. List of reference symbols

[0044] 1Test signal generator 2Test module 3Control and evaluation unit 4Additional electrical component 5First receiving structure 6Electrical circuit board 7Electrical / electronic component 8Feedthrough plate 9Electrical conductors 10Contact points 11Housing 12Medical implant 13Head part 14Socket connector 15Contact surface 16Recess 17Contact electrodes 18Cable connection 19Contact pin 20Counter electrode 21Second receiving structure 22, 22'Cable connection 23Adapter module 24Joining contour 25Third receiving structure 26Socket connector 27Contact pin

Claims

1. Assembly for checking the function of a plurality of differently assembled measuring objects, known as DUTs, each in the form of a medical implant (12), or at least of a part (6, 11) of the medical implant, with a) a test signal generator (1), b) a test module (2) which is connected to the test signal generator (1) and comprises a first receiving structure (5) with at least one contact electrode (17) into which an adapter module (23) detachably firmly connected to a DUT, can be inserted forming at least one electrical contact, as well as c) a control and evaluation unit (3), which is indirectly or directly connected to the test signal generator (1) and the test module (2) in a wireless or wired manner, characterised in that the test module (2) has a second receiving structure (21) that is arranged fixed in space with regard to the first receiving structure (5) and is designed in the form of a drawer compartment-like recess, into which an electrical additional component (4) interacting in a contactless manner with the DUT for the purpose of electrical energy and / or signal transmission, can be fitted, in that the adapter module (23) comprises a third receiving structure (25) individually adapted to the DUT with at least one contact electrode (26), into which the DUR can be inserted forming at least one electrical contact (27), in that at least two adapter modules (23) with differently designed third receiving structures (25) are provided which are each standardly designed for insertion into the first receiving structure (5) of the test module (2), and in that the first receiving structure (5) with the at least one contact electrode (17) is designed for the direct detachably fixed insertion and electrical contacting of a DUT.

2. Assembly according to claim 1, characterised in that the electrical additional component (4) comprises an induction coil and / or a signal antenna.

3. Assembly according to claim 1 or 2, characterised in that the control and evaluation unit (3) is connected to the electrical additional component (4) in a wireless or wired manner.

4. Assembly according to any one of claims 1 to 3 characterised in that the first receiving structure (5) comprises at least one contact surface (15) that can be brought into contact with the adapter module (23) and on which the at least one contact electrode (17) is arranged, which in the state of an adapter module (23) inserted in the first receiving structure (5), is positively and non-positively in contact with a counter electrode (20) applied on the part of the adapter module.

5. Assembly according to any one of claims 1 to 4 characterised in that the third receiving structure (25) comprises at least contact surface that can be brought in to contact with the DUT and on which the at least contact electrode (26) is arranged, which in the state of a DUT inserted into the third receiving structure is positively and non-positively in contact with a counter-electrode (27) applied on the part of the DUT.

6. Assembly according to claim 4 or 5 characterised in that the at least one contact electrode (26) and counter-electrode (27) is designed in the form of a plug-socket contact structure.

7. Assembly according to any one of claims 4 to 6, characterised in that the at least one contact electrode and / or counter-electrode is designed in the form of a spring-loaded contact pin (19) mounted in a deflectable manner.

8. Assembly according to any one of claims 1 to 7, characterised in that the DUT is one of the following electrical components: - electrical printed circuit board (6) of a medically active implant (12) - electrical printed circuit board (6) with suppling and dissipating electric lines - medically active implant with at least one electrical contact arrangement9. Assembly according to claim 8 characterised in that the medically active implant (12) is an implantable pulse generator (IPG).

10. Assembly according to any one of claims 1 to 9 characterised in that the test generator (1) generates ECG signals.

11. Use of the assembly according to any one of claims 1 to 10 for the diagnosis and / or updating of a medical implant as part of a software update.