Components for testing the functionality of measuring objects

Abstract

An assembly for testing the functionality of a medical implant or at least a part of a medical implant, i.e., a DUT, is described. The assembly is a component for testing the functionality of a medical implant or at least a part of a medical implant, and the assembly comprises: a test signal generator; a test module connected to the test signal generator and having a first receiving structure having at least one contact electrode, into which an adapter, rigidly connected to the DUT in a removable manner, can be inserted, forming at least one electrical contact; and a control and analysis unit connected directly or indirectly to the test signal generator and the test module wirelessly or wired.

Description

[Technical field]

[0001] The present invention relates to a component for testing the functionality of a measurement object, known as a DUT, in the form of a medical implant or at least a part of a medical implant. [Background technology]

[0002] Implantable medical devices for electrical stimulation of local body regions, i.e. implantable pulse generators (IPGs) (e.g. for cardiac defibrillation, pacemaker and resynchronization applications, as well as for neurostimulation measurements such as spinal cord stimulation, brain stimulation or vagus nerve stimulation), generally comprise a fluid-tight housing. The housing comprises components for electrical pulse generation, including at least one source of electrical energy in the form of a battery or an induction coil, and further comprising an electrical circuit structure connected thereto. Furthermore, adjacent to the housing in most cases is a so-called head section, which has an electrical contact assembly for connection to the energy source and the electrical circuit structure, into which a fluid-tight plug assembly can be inserted, which terminates in the head section, for the local application of the electrical stimulation signal within the body. The head section contacts the electrical input and output wires. Furthermore, if applicable, a fluid-tight plug assembly can be inserted to provide the local pick-up electrical signal within the body to the electrical circuit structure within the housing.

[0003] As the range of functions of medical implants increases, so does the number of electrical and / or electronic components incorporated within the implant, which, due to minimal space requirements, are densely packed and wired together in complex ways on at least one printed circuit board. The electrical energy required to operate a medical implant is provided by a battery integrated within the implant or by inductive energy transfer.

[0004] Validation and control procedures are essential both for the deployment and manufacture of implants as well as for quality control and assurance in the manufacture of multiple medical implants. In order to eliminate carryover of defects occurring during the manufacturing process, metrological inspections are carried out on function-determining components during the entire manufacturing process, respectively at different stages of the finished medical implant process. Of particular importance in this context is the reproducibility and procedure compliance of the individual functional tests.

[0005] US 2018 / 9931629 A1 discloses a test assembly for testing the functionality of a semiconductor assembly, in which the semiconductor assembly to be tested is placed in a test socket to which a test signal is applied wirelessly.

[0006] US 2002 / 0079912 A1 discloses a test assembly for an electrical printed circuit board, which can be placed in a test socket for testing purposes and to which electrical test signals can be applied.

[0007] DE202006000739U1 discloses a device for testing electronic components, more particularly components having integrated circuits, having a contact base to which the component to be tested can be contacted. Summary of the Invention

[0008] The object of the present invention is to provide a component for testing the functionality of a measurement object, preferably in the form of a medical implant or at least a part of a medical implant, such that functionality tests on finished products (preferably medical implants or parts thereof) manufactured both in small batches and on an industrial scale can be carried out safely, reliably and reproducibly, in compliance with procedures and in compliance with warranty requirements.

[0009] The object on which the present invention is based is set forth in claim 1. Features which advantageously further develop the inventive concept are the subject matter of the dependent claims and are also described in the following description, in particular with reference to the illustrated examples of embodiments.

[0010] The component according to the invention is preferably in the form of a medical implant, or at least part of a medical implant, for testing the functionality of a measurement object, hereinafter referred to as DUT (Device Under Test), and comprises a test signal generator, a test module, an adapter module which can be inserted into the test module, and a control and analysis unit.

[0011] A test signal generator, preferably connected to the test module via an interface, generates a test signal for checking the DUT, which is sent directly to the DUT via the test module. In principle, known test signal generators with fixed or freely selectable predefined electrical test signals are suitable. Depending on the type of DUT to be tested and the intended use, the test signal generator can, for example, replicate an ECG signal or generate an electrical signal form that corresponds, for example, to a neuron electrical signal. Preferably, a test signal generator for generating any determinable time course and a periodically reoccurring electrical voltage is suitable. This voltage can also be individually predeterminable. Preferred test signal generators are, for example, analog or digital function generators.

[0012] In the simplest embodiment, the test module, which is preferably connected to the test signal generator via a connection cable, comprises a first receiving structure having at least one, preferably a plurality of contact electrodes, into which an adapter can be inserted which is firmly connected to the DUT in a releasable manner and forms at least one electrical contact.

[0013] The test module comprises a housing, which is provided with a first receiving structure, preferably in the form of a recess in the housing, into which an adapter module, firmly connected in a removable manner to a DUT, is inserted forming an interlocking connection. The interlocking connection formed by inserting the adapter module into the first receiving structure ensures a one-to-one fit of the adapter module in the first receiving structure (i.e. of the DUT to the first receiving structure of the test module). At the same time, an electrical connection is formed between the adapter module and at least one contact electrode applied in the region of the recess of the receiving structure.

[0014] In addition to the interlock connection, the adapter module is optionally secured to the test module by an additional frictional connection, for example through the provision of a spring-loaded clamp or latch connection between the adapter module and the test module. Of course, alternative retention means may be provided directly or indirectly on the test module, which can releasably secure the adapter module to the test module.

[0015] By providing a first receiving structure in the test module, the following is guaranteed: several identically or differently designed DUTs, each inserted into an adapter module that is individually adapted to the DUT and can be used in a uniformly designed receiving structure, can be tested under exactly the same test conditions, i.e. maintaining in each case a defined spatial position and electrical contact. In this way, reproducible and reliable check procedures can be carried out on the DUTs.

[0016] Thus, one and the same test module can be used to test multiple differently assembled DUTs, each of which is used in an adapter module that is individually matched to each DUT and can be inserted into the first receiving structure of the text box.

[0017] To check a DUT connected to an adapter module inserted in the first receiving structure, the test signals generated by the test signal generator are transmitted to the DUT via the test module and the adapter module. For this purpose, depending on the number and arrangement of electrical contacts (hereinafter referred to as counter electrodes) applied to the DUT, corresponding contact electrodes are provided on the adapter module side, via which the test signals, and optionally also the measurement signals, can be transmitted between the test module and the DUT.

[0018] A control and analysis unit, connected directly or indirectly to the test signal generator as well as to the test module, is used for testing and analyzing the recorded measurement signals. The connection may be wired or wireless and in the first example serves to transmit control and measurement signals between the individual components. The control and analysis unit is typically configured in the form of a computer or PC, having all the components and peripherals such as memory, monitor, etc. required to analyze and record the measurement signals.

[0019] In a further embodiment, the test module comprises a second receiving structure, which is arranged in a spatially fixed manner relative to the first receiving structure and into which an additional electrical component, such as, for example, an inductive coil or a signal antenna assembly, can be inserted, which interacts non-contact with the DUT for the purpose of electrical energy and / or signal transmission.

[0020] In the case of a DUT comprising an induction coil device and / or an antenna assembly, the functional capacity of the contactless energy and / or signal transmission between the DUT and the external coil and antenna unit can be checked with the aid of electrical additional components inserted into the second receiving structure, which for this purpose is preferably designed in the form of a drawer-like recess in the test module and further arranged directly below the first receiving structure, thereby ensuring a defined relative position between the DUT arranged in the first receiving structure and the electrical additional components arranged in the second receiving structure.

[0021] In addition to or as an alternative to connecting the control and analysis unit to the test module, preferred embodiments envisage a wired connection between the electrical components and the control and analysis unit along which electrical energy can flow for supplying energy to the DUT and along which measurement signals can be transmitted that are picked up on the DUT and forwarded to the control and analysis unit.

[0022] In order to ensure that the electrical additional component is mounted in a spatially fixed manner in the second receiving structure, the inner contour of the preferably drawer-like second receiving structure and the housing surrounding the electrical additional component are arranged opposite each other, which allows for reliable insertion and fixing of the electrical additional component in the second receiving structure and makes it possible to form an interlocking connection, optionally assisted by an additional frictional connection.

[0023] For testing medical implants during manufacturing, the DUT typically takes on different configurations: a) The first stage of checking involves testing the printed circuit boards with mounted electronic and electrical components to ensure functionality of all electrical / electronic components and to rule out possible low temperature soldering points.

[0024] b) In a subsequent manufacturing process, the electrical conductors are electrically connected to contacts provided on a printed circuit board and fixed relative to one another with so-called grommet plates for the purpose of a spatially defined fixation relative to one another.

[0025] c) in a further processing step the electrical conductor structure is brought into contact with an electrical contact assembly and d) in the final completion stage of the medical implant in the so-called head part, this is part of the electrical contact structure, the purpose of which is to contact a cable connection leading away from the medical implant, via which an electrical stimulation signal can be applied to an electrode assembly placed inside the body separate from the medical implant.

[0026] At each of the above mentioned manufacturing stages, it is checked that different DUTs are present and the first receiving structures in the test module must be adapted on an individual DUT basis, thus generating reproducible test situations in each case.

[0027] The test module according to the invention is designed to have a uniform first receiving structure, into which adapter modules can be inserted, each designed to fit the first receiving structure, each having a third receiving structure individually adapted to the DUT to be tested. Alternatively, the remaining parts of the assembly, relating to the test generator, the test module, the electrical additional components and the control and analysis unit, are not changed. The only measures to be taken to test differently designed DUTs concern the modular exchange of different adapter modules, each having an individual DUT-adjusted third receiving structure.

[0028] In each case, for the purpose of electrical contact of the DUT in the first receiving structure of the test module and / or in the third receiving structure of the adapter module, the respective receiving structure has at least one contact surface on which is arranged at least one contact electrode which can be brought into frictional and interlocking contact with the DUT by means of a counter electrode applied to the DUT side.

[0029] Depending on the number, spatial application and orientation of the counter electrodes provided on the DUT side, the contact electrodes provided on the at least one contact surface should be designed in a suitable manner, in each case contoured oppositely. In a preferred embodiment, the at least one contact electrode and the counter electrode are configured like a plug-socket contact structure. Alternatively or in combination, the contact electrodes and / or the counter electrodes can be designed in the form of spring-loaded, flexibly supported contact pins. Other alternative forms and structures of the contact electrodes and counter electrodes are also conceivable.

[0030] To test a finished medical implant in the form of an implantable pulse generator (IPG), which typically comprises a supply part in which the electric / electronic components are accommodated and a head part having at least one electric socket structure and attachable thereto, the implant is inserted into a first receiving structure adapted in terms of shape and size in a third receiving structure in a test module or in an adapter module. The insertion procedure brings the medical implant into contact with the appropriate contact electrodes provided on the test module or adapter module on electrically accessible contact areas, i.e. along the contact electrodes provided in the plug-socket structure. Due to a precisely pre-determined spatial allocation between the implant and the electrical additional components integrated in the test module, the implant is supplied with electrical energy in a contactless manner. Via electrical contacts generated in the socket structure between the implant and the test module or adapter module, test signals generated by a test signal generator are applied to the medical implant. Measurement signals necessary for testing the functionality and for recording the proper functioning are read out contactless via further electrical components arranged in the second receiving structure and supplied to an analysis and control unit.

[0031] In addition to the use of the assembly according to the invention for checking functionality, the test assembly according to the invention is suitable for updating medical implants as part of a software update. This is especially so since the signal transmission between the electrical add-on component and the medical implant is also carried out in the direction of the medical implant. For this, the analysis and control unit must supply the current operating data record in the form of an electrical data signal to the electrical add-on component, which transmits the data signal in a contactless manner. This is carried out by inductive coupling to the medical implant, and the information is received in an appropriately provided DUT-specific storage and calculation unit and processed accordingly.

[0032] The assembly according to the invention allows for reliable and reproducible testing of medical implants. Based on a modular building block principle, by providing differently designed adapters and / or test modules, each adapted for a different DUT configuration, the entire manufacturing history of the medical implant can be monitored and recorded. In this way, quality assurance is significantly improved during the manufacturing of the medical implant.

[0033] The assembly for checking functionality according to the invention in particular also makes it possible to perform the checks of the DUT automatically, since all the components and operational steps required to perform the functional checks are carried out by a suitably implemented robot. [Brief description of the drawings]

[0034] By way of example, without limiting the general inventive concept, the invention will now be described by way of example of an embodiment with reference to the drawings in which: [Figure 1] An outline of the assembly checking functionality is given below. [Diagram 2] 2 illustrates different embodiments of a DUT. [Diagram 3] 1 shows a receiving structure with spring-loaded contact pins. [Figure 4] 1 shows an adapter module. [Diagram 5] 1 shows a receiving structure having socket contacts. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Figure 1 shows an overall view of an assembly for checking the functionality of a measurement object. The DUT (Device Under Test) comprises a test signal generator 1, a test module 2 and a control and analysis unit 3 for energy and signal exchange, which are connected to the test module 2 by electrical additional components 4. The core element is the test module 2, which comprises a first receiving structure 5, into which the DUT to be checked can be rigidly inserted, directly or indirectly, and electrically contacted in a removable manner.

[0036] The assembly according to the invention is intended to check functionality and guarantee quality during and after the manufacture of a medical implant. In Fig. 2 a typical DUT is shown, which represents a medical implant in different manufactured forms. Fig. 2a shows a first manufacturing stage for assembling a medical implant in the form of an electric circuit board 6 on which electric / electronic components 7 are arranged. Fig. 2b shows a subsequent second expansion stage, with a grommet plate 8 through which electrical conductors 9 are fed and fixed, each connected at one end to a contact 10 on the circuit board 6. Fig. 2c shows a housing 11, which preferably surrounds the circuit board 6 together with the grommet plate 8 in a fluid-tight manner. Preferably, the housing 11 is in the form of a hardened epoxy resin mass or a metal housing, for example a titanium housing. Fig. 2d shows a finished medical implant 12 with a head part 13, which in the example of the embodiment comprises two sockets 14 along which contact electrodes connected to the electrical conductors 9 are arranged. Plugs, which terminate fluid-tightly in the head part 13 and are connected to electrodes arranged inside the body, are inserted into the sockets 14.

[0037] In order to check the functionality of the individual expansion stages of the medical implant 12 according to the different designs of DUT shown in Figures 2a-d, the test module 2 shown in Figure 1 has a first receiving structure 5 which assumes a recess 16 in the test module 2 having at least one contact surface 15 and a contact electrode 17 arranged thereon.

[0038] For example, to measure the circuit board shown in FIG. 2 a as a DUT, a test signal, for example in the form of an ECG signal, is generated by the test signal generator 1 and transmitted to the DUT, which is indirectly placed in the first receiving structure 5 by the adapter module, via a cable connection 18 extending between the test signal generator 1 and the test module 2.

[0039] For this purpose, the receiving structures 5 provided in the test modules 2 are designed for the insertion of adapter modules 23, which match the first receiving structures 5 with a counter-contour, see FIG. 4. All adapter modules 23 have a uniform mating contour 24 for insertion and electrical contact in the first receiving structures 5 of the test modules 2. Depending on the DUT to be tested, each adapter 23 has a third receiving structure 25 with a different finish. DUTs of different shapes and sizes can always be inserted in the respective third receiving structures 25 in an interlocking manner or, if necessary, in a friction fit manner. The DUT comes into contact with contact electrodes 25 appropriately provided on the adapter modules 23.

[0040] For electrical contact of an adapter module spatially fixed in the first receiving structure 5, at least some of the contact electrodes 17 provided in the recesses 16 are in electrical contact with counter electrodes 20 present on the adapter module. Figure 3 shows a possible implementation of the contact electrodes 17 arranged on the test module 2 in the form of spring-loaded contact pins 19 which are in contact with counter electrodes 20 applied to the underside of the adapter module 23.

[0041] Depending on the electrical component configuration of the DUT, the test signal generator 1 supplies electrical energy via a cable connection 18 to the DUT to be checked.

[0042] The test module 2 also comprises a second receiving structure 21 (see FIG. 1) in the form of a drawer-like recess, through which an electrical additional component 4, preferably in the form of an induction coil and / or an antenna arrangement, can transmit electrical energy and measurement signals contactlessly.

[0043] Optionally, the control and analysis unit 3 is connected directly to the test module 2 (see cable connection 22') or directly to the electrical add-on component 4 (see cable connection 22). Via the respective cable connection 22, 22', the measurement signals picked up by the contact electrodes 17 can be transmitted to the control and analysis unit 3. Likewise, the DUT can be supplied with electrical energy via the cable connections 22, 22'.

[0044] For the purpose of electrical contacting of the DUT in the adapter module 23, there are for example spring-loaded contact pins 19 as shown in Fig. 3 and / or contact electrodes in the form of socket connections, respectively, as shown in Fig. 5. Fig. 5 shows the adapter module 23 with socket contacts 25 into which plug contacts 27 of the DUT can be inserted. The third receiving structure 25 of the adapter module 23 allows for mechanical insertion of the DUT relative to the adapter module 23 along a force direction F.

[0045] In principle, there are no limitations to the form of embodiment for manufacturing both the first and the third receiving structure 5,25. [Explanation of symbols]

[0046] 1: Test signal generator 2: Test module 3: Control and analysis unit 4: Electrical add-ons 5: First receiving structure 6: Electric circuit board 7: Electrical / electronic components 8: Grommet plate 9: Electrical conductor 10: Contact 11: Housing 12: Medical implants 13: Head section 14: Socket 15: Contact surface 16: Recess 17: Contact electrode 18: Cable connection 19: Contact pin 20: Counter electrode 21: Second receiving structure 22,22': Cable connection 23: Adapter module 24: Joint contour 25: 3rd Receiving Structure 26: Socket 27:Plug contact pin

Claims

1. A component for testing the functionality of a measurement object called a Device Under Test (DUT), i.e. a medical implant or at least a part of a medical implant, a) a test signal generator; b) a test module connected to the test signal generator and comprising a first receiving structure having at least one contact electrode, into which an adapter module can be inserted, the adapter module being firmly connected to the DUT in a removable manner and forming at least one electrical contact; c) a control and analysis unit connected directly or indirectly, wirelessly or by wires, to said test signal generator and to said test module; Equipped with the test module includes a second receiving structure; The second receiving structure is arranged in a spatially fixed manner with respect to the first receiving structure, and can receive an inductive coil or a signal antenna assembly, which is an additional electrical component that interacts with the DUT in a non-contact manner for electrical energy and / or signal transmission. parts.

2. The component of claim 1 , wherein the electrical add-on component comprises an inductive coil and / or a signal antenna.

3. 3. The component according to claim 1 or 2, wherein the control and analysis unit is in wireless or wired connection with the electrical additional components.

4. the first receiving structure includes at least one contact surface; the contact surface is contactable against the adapter module, and has at least one contact electrode disposed thereon, and when the adapter module is inserted into the first receiving structure, the contact surface is in interlocking and frictional contact with a counter electrode provided by the adapter module; 4. A component according to any one of claims 1 to 3.

5. the adapter module includes a third receiving structure; the third receiving structure has at least one contact electrode into which the DUT can be inserted and which forms at least one electrical contact; 5. A component according to any one of claims 1 to 4.

6. the third receiving structure comprises at least one contact surface capable of contacting the DUT and having at least one contact electrode disposed thereon; the contact electrode contacts a counter electrode provided by the DUT in a friction and interlock manner when the DUT is inserted into the third receiving structure; 6. The component of claim 5.

7. 7. The component according to claim 4, wherein the at least one contact electrode and the counter electrode are configured in the form of a plug-and-socket structure.

8. 7. The component according to claim 4, wherein the at least one contact electrode and / or counter electrode is configured in the form of a spring-loaded, deflectably supported contact pin.

9. The DUT includes: Electrical circuit boards for medical active implants, an electrical circuit board having electrical input / output leads; a medical active implant having at least one electrical contact assembly; At least one of the electrical components 9. A component according to any one of claims 1 to 8.

10. 10. The component of claim 9, wherein the medical active implant is an implantable pulse generator (IPG).

11. 11. The component of claim 1, wherein the test signal generator generates an ECG signal.

12. the third receiving structure in the adapter module is individually aligned with the DUT; at least two adapter modules having differently designed third receiving structures are each uniformly designed to be inserted into the first receiving structure of the test module; 7. A part according to claim 5 or 6.

13. Component according to any one of claims 1 to 12 for diagnosing and / or updating a medical implant as part of a software update.

Images