Assembly for functional testing of a measurement object

Abstract

A component for functionally testing a measurement object, a so-called DUT, in the form of a medical implant or at least a part of a medical implant is described. The component comprises a test signal generator, a test module connected to the test signal generator and having a first receiving structure with at least one contact electrode, an adapter module releasably fixedly connected to the DUT, which can be placed into the first receiving structure with formation of at least one electrical contact, and a control and evaluation unit indirectly or directly wirelessly or wiredly connected to the test signal generator and the test module.

Description

Technical Field

[0001] The present invention relates to a component for functional testing of a measurement object, i.e., a so-called DUT, which is in the form of a medical implant or at least a portion thereof. Background Technology

[0002] Implantable medical devices for localized electrical stimulation of internal regions, such as defibrillators, pacemakers, and resynchronization devices for cardiac treatment, and transiently implantable pulse generators (IPGs) for neurostimulation therapy, such as spinal cord stimulation, brain stimulation, or vagus nerve stimulation (to name just a few), typically have a fluid-tightly sealed housing containing components for generating electrical pulses, i.e., at least one power source in the form of a battery or induction coil, and a circuit structure connected to said power source. Furthermore, a so-called head portion is mostly connected to the housing, containing electrical contact components electrically connected to the power source or circuit structure. A plug assembly, fluid-tightly sealed to the head portion, can be inserted into these electrical contact components. This plug assembly connects to input and output wire contacts for locally applying electrical stimulation signals within the body and, if necessary, transmitting locally tapped electrical signals to the circuit structure present on the housing side.

[0003] As medical implants become increasingly functional, the number of electrical or electronic components housed within them also increases. These components are arranged compactly and intricately interconnected on at least one circuit board to minimize space requirements. The electrical energy required to operate the medical implant is supplied either through a battery integrated into the implant or via inductive power transfer.

[0004] Inspection and control processes are essential not only for improving and manufacturing implants but also for quality control and quality assurance in the mass production of medical implants. To eliminate delays caused by malfunctions during production, functionally defined components are inspected using measurement techniques throughout the entire production process, at different stages of implant construction. The repeatability and recordability of each functional test are therefore of particular importance.

[0005] Publication US2018 / 9931629 A1 discloses a test assembly for functional testing of a semiconductor component assembly, wherein the semiconductor component assembly to be tested is arranged in a test socket, the test socket being wirelessly subjected to a test signal.

[0006] Publication US2002 / 0079912A1 discloses an inspection assembly for a circuit board, which can be inserted into an inspection socket for inspection purposes and can be subjected to an electrical inspection signal.

[0007] Publication DE 20 2006 000 739 U1 discloses an apparatus for testing electronic components, particularly components having integrated circuits and contact sockets, wherein the component to be tested is capable of contacting the contact sockets. Summary of the Invention

[0008] The object of the present invention is to provide a component for functional testing of a measurement object, preferably in the form of a medical implant or at least a portion thereof, so that the manufactured product, preferably a medical implant or a portion thereof, can be functionally tested safely, reliably, and with reliable repeatability, the medical implant being manufactured not only in small batches but also on an industrial scale, and the functional testing is further recorded to meet warranty requirements.

[0009] The objective upon which this invention is based is given in the technical solution of this invention. Features that further improve the inventive concept in an advantageous manner can be learned from the technical solution of this invention and, in particular, from the further description of the embodiments illustrated in the drawings.

[0010] The components for functional testing of the measured object according to the solution basically consist 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. The measured object is preferably in the form of a medical implant or at least a portion of a medical implant and is further referred to as a DUT (Device Under Test).

[0011] Preferably, a test signal generator connected to the test module via an electrical interface generates the test signals required for testing the DUT, which are indirectly transmitted to the DUT through the test module. Known test signal generators with pre-defined electrical test signals that can be fixedly or freely selected are generally suitable. Depending on the type of DUT and its intended use, the test signal generator can simulate, for example, EKG signals or generate electrical signal forms corresponding to, for example, neural electrical signals. Preferably, the test signal generator is suitable for generating voltages with arbitrarily pre-defined time variation curves and time cycle cycles, which can also be individually pre-defined. Preferred test signal generators are, for example, analog or digital functional generators.

[0012] In the simplest implementation, the test module, preferably connected to the test signal generator via a connecting cable, has a first receiving structure with at least one, preferably multiple, contact electrodes, and an adapter module that can be loosely fixedly connected to the DUT can be placed into the first receiving structure while forming at least one electrical contact.

[0013] The test module has a housing, and a first receiving structure is preferably disposed within the housing as a recess. An adapter module, which can be releasably fixed to the DUT, can be inserted into the first receiving structure in a form-fit configuration. This form-fit connection ensures accurate placement of the adapter module within the first receiving structure, and consequently, accurate placement of the DUT relative to the first receiving structure of the test module. Simultaneously, an electrical connection is formed between at least one contact electrode disposed in the region of the recess in the first receiving structure and the adapter module.

[0014] To complement the shape fit, the adapter module can optionally be fixed to the test module by an additional force-fit connection, for example, by setting a clamping connection or locking connection between the adapter module and the test module with applied spring force. Alternative retaining measures can also be provided directly or indirectly on the test module, which can spatially fix the adapter module relative to the test module in a releasable but immovable manner.

[0015] By placing the first receiving structure inside the test module, multiple DUTs, each with identical or different structures, can be tested under precisely identical testing conditions—that is, while adhering to defined spatial positions and electrical contacts. Each DUT is placed into an individually matched adapter module, which can be fitted into a uniformly constructed receiving structure. In this manner, repeatable and reliable testing of the DUTs can be achieved.

[0016] Thus, the same test module is provided for inspecting multiple different pre-processed DUTs, each of which is placed into an adapter module that matches the corresponding DUT, and the adapter module can be placed into the first receiving structure of the test box.

[0017] To inspect the DUT connected to the adapter module, the adapter module is incorporated into a first receiving structure. Test signals generated from the test generator side are transmitted to the DUT via the test module and the adapter module. For this purpose, corresponding contact electrodes are provided on the test module and on the adapter module side, depending on the number and arrangement of electrical contacts, also referred to as counter electrodes, placed on the DUT. Test signals, and optionally test signals, can also be transmitted between the test module and the DUT via these contact electrodes.

[0018] A control and evaluation unit is used to examine and evaluate the detected test signals. This unit is connected, indirectly or directly, to the test signal generator and also to the test module. The connection can be wired or wireless and is primarily used for transmitting control and test signals between the various components. The control and evaluation unit is typically designed in the form of a computer or PC, having all the components or peripherals necessary for evaluating and recording the test signals, such as memory, monitors, etc.

[0019] In another embodiment, the test module has a second receiving structure spatially fixed relative to the first receiving structure, and electrically attached components, such as induction coils and / or signal antenna assemblies, that interact non-contactly with the DUT for power and / or signal transmission can be coupled to the second receiving structure.

[0020] In the case of a DUT with an induction coil and / or antenna assembly, the ability to transmit energy and / or signals without contact between the DUT and external coil and antenna elements can be verified by means of an electrical attachment inserted into a second receiving structure. For this purpose, the second receiving structure is preferably constructed in the form of a drawer-type recess inside the test module, directly below the first receiving structure, thereby ensuring a defined relative position between the DUT disposed inside the first receiving structure and the electrical attachment placed inside the second receiving structure.

[0021] To supplement or replace the connection between the control and evaluation unit and the test module, a preferred embodiment provides a wired connection between the electrical attachment and the control and evaluation unit. Along this wired connection, not only can electrical energy be transmitted for the power supply of the DUT, but also for the transmission of test signals tapped at the DUT and further transmitted to the control and evaluation unit.

[0022] To ensure that the electrical attachment is spatially fixed inside the second receiving structure, the internal contour of the second receiving structure, which is preferably constructed in a drawer-like manner, is correspondingly contour-fitted to the housing surrounding the electrical attachment, so that the electrical attachment can be reliably inserted into and fixed in the second receiving structure when a form-fit connection is formed, which can optionally be supplemented by an additional force-fit connection.

[0023] During the testing of medical implants during manufacturing, DUTs typically exhibit the following different structural forms:

[0024] a) In the first inspection phase, inspect the circuit boards equipped with electronic and electrical components to ensure the functionality of all electrical / electronic components and eliminate possible cold solder joints.

[0025] b) In the subsequent manufacturing process, the wires are electrically connected to the contacts set on the circuit board and are fixed to each other relative to each other by so-called perforated plates in order to spatially define their relative positions.

[0026] c) In a continuing process step, the electrical lead structure is brought into contact with an electrical contact assembly, d) which is part of the electrical contact structure inside the so-called head portion during the final manufacturing stage of the medical implant, to connect a cable leading from the medical implant, through which an electrode assembly placed in the body independently of the medical implant can be subjected to an electrical stimulation signal.

[0027] In all the aforementioned manufacturing stages, there are different DUTs. In order to test the different DUTs, the first receiving structure inside the test module is individually matched with the DUT to achieve repeatable test results.

[0028] The test module of the solution is constructed with a unified first receiving structure. Adaptor modules, each constructed to match this first receiving structure, can be placed into it. Each adapter module has a third receiving structure, which is individually matched with the DUT to be tested. Furthermore, the remaining components involving the test generator, test module, electrical attachments, and control and evaluation unit remain unchanged. To individually test differently constructed DUTs, a single measure can be taken, which involves simply replacing the different adapter modules, each with a third receiving structure individually assembled with the DUT.

[0029] In order to connect the DUT electrical contacts inside the first receiving structure of the test module or inside the third receiving structure of the corresponding adapter module, the corresponding receiving structure has at least one contact surface, and at least one contact electrode is arranged on the at least one contact surface, which is capable of contacting the counter electrode disposed on the side of the DUT in a force-fitting and form-fitting manner with the DUT.

[0030] Depending on the number, spatial arrangement, and orientation of the counter electrodes disposed on the side of the DUT, the contact electrodes disposed on at least one contact surface are constructed in a suitable manner and with corresponding profiles. In a preferred embodiment, at least one contact electrode and counter electrode are constructed in the form of a plug-and-socket contact structure. Alternatively or in combination, the contact electrode and / or counter electrode can be constructed in the form of contact pins that are respectively spring-loaded and offsetly supported. Other alternative contact electrode or counter electrode forms and structures can also be fully considered.

[0031] To verify a final-manufactured medical implant in the form of an implantable pulse generator (IPG), the implant is placed into a first receiving structure within a test module or a third receiving structure within an adapter module, tailored to the shape and size of the IPG. The pulse generator typically includes a power supply section and a head section connected thereto, the power supply section having electrical / electronic components contained therein, and the head section having at least one electrical plug-and-receptacle structure. The placement process brings the medical implant into contact with an electrically contactable area, that is, along electrical contact electrodes disposed within the plug-and-receptacle structure, with suitable contact electrodes disposed on the test module or adapter module. Electrical power is supplied to the implant contactlessly through a precisely pre-defined spatial configuration between the implant and the electrical attachments also integrated within the test module. Test signals generated on the test signal generator side are applied to the medical implant through the electrical contact established in the plug-and-receptacle structure between the implant and the test module or adapter module. Test signals required for verifying and recording functional effectiveness are contactlessly read and transmitted to the evaluation and control unit via electrical attachments disposed within a second receiving structure.

[0032] In addition to using components constructed according to the solution for functional testing applications, the testing components according to the solution are also suitable for updating medical implants within a software update framework, because signal transmission between the electrical attachment and the medical implant can also be directed towards the medical implant. For this purpose, an evaluation and control unit transmits current operating data in the form of electrical data signals to the electrical attachment, which then transmits the data signals to the medical implant contactlessly via inductive coupling. Information within the medical implant can be received and processed accordingly in the DUT's own appropriately configured memory and computing unit.

[0033] The solution's components enable reliable and repeatable testing of medical implants. Based on a modular, building-block component principle, the entire manufacturing process of medical implants can be monitored and recorded by setting up adapters and / or test modules of different designs, each matched to a different structural form of the DUT. This significantly improves quality assurance in the production of medical implants.

[0034] The components used for functional testing according to the solution also enable automated DUT testing, because all parts and required operational steps for functional testing can be performed by a suitably assembled robot. Attached Figure Description

[0035] The invention will now be described by way of example with reference to the accompanying drawings, without limiting the general inventive concept. In the drawings:

[0036] Figure 1 An overview view of the components used for functional testing is shown.

[0037] Figure 2 illustrates different implementations for the DUT.

[0038] Figure 3 This diagram shows a receiving structure with a contact pin subjected to a spring force.

[0039] Figure 4 Showing the adapter module, and

[0040] Figure 5 A receiving structure with plug and socket contacts is shown. Detailed Implementation

[0041] Figure 1 This diagram shows an overall view of the components used for functional testing of a device under test (DUT), which includes a test signal generator 1, a test module 2, and a control and evaluation unit 3. The control and evaluation unit is connected to the test module 2 via an electrical attachment 4 for energy and signal exchange. The core component is the test module 2, which has a first receiving structure 5 into which the DUT under test can be loosely and securely embedded, and electrically contacted, either indirectly or directly.

[0042] The components of the solution are used for functional testing and quality assurance of the medical implant during and after its manufacture. Figure 2 shows a typical related DUT, illustrating a medical implant in different manufacturing forms. Figure 2a The first manufacturing stage for constructing a medical implant in the form of a circuit board 6 is shown, the circuit board having electrical / electronic components 7 arranged thereon. Figure 2b The diagram illustrates a subsequent second manufacturing stage with a perforated plate 8, through which electrical wires 9 are guided and secured, the wires being connected to contacts 10 on a circuit board 6 on one side. Figure 2c The housing 11 is shown, which preferably fluid-tightly surrounds the circuit board 6 and the perforated plate 8. Preferably, the housing 11 is constructed in the form of a rigid epoxy resin material or as a metal housing, such as a titanium housing. Figure 2d A fabricated medical implant 12 is shown, which additionally has a head portion 13. In the illustrated embodiment, the head portion has two sockets 14 along which contact electrodes are arranged, the contact electrodes being connected to electrical leads 9. A plug, fluid-tightly sealed to the head portion 13 and connected to electrodes placed in the body, is inserted into the sockets 14.

[0043] In order to determine the basis Figure 2aFunctional testing was performed on the medical implants 12 with different DUT configurations shown in Figure d at various manufacturing stages. Figure 1 The test module 2 shown has a first receiving structure 5, which is disposed in a recess 16 inside the test module 2. The recess has at least one contact surface 15 and a contact electrode 17 disposed on the at least one contact surface.

[0044] In order to, for example, as a DUT, in Figure 2a The circuit board 6 shown is used for measurement. For example, a test signal in the form of an EKG signal is generated from the test generator 1 and transmitted via cable connection 18 to the DUT arranged indirectly in the first receiving structure 5 through an adapter module, the cable connection extending between the test signal generator 1 and the test module 2.

[0045] The receiving structure 5 in the test module 2 is constructed in such a way that the adapter modules 23, which mate with the contour of the first receiving structure 5, can be inserted respectively. See [reference needed]. Figure 4 Each adapter module 23 has a uniform connection profile 24 for being inserted into and electrically contacted within the first receiving structure 5 of the test module 2. Correspondingly, each adapter module 23 has a different assembled third receiving structure 25. DUTs of different shapes and sizes can be permanently, form-fitted, and, if necessary, additionally, force-fitted into the corresponding third receiving structure 25. The DUT contacts contact electrodes 25 suitably disposed on the adapter module 23.

[0046] In order to make electrical contact with the adapter module that is spatially fixed inside the first receiving structure 5, at least a portion of the contact electrode 17 disposed inside the recess 16 makes electrical contact with the counter electrode 20 present on the adapter module. Figure 3 A possible implementation of a contact electrode 17 arranged on a test module 2 in the form of a contact pin 19 subjected to a spring force is shown, the contact electrode being in contact with a counter electrode 20 disposed on the underside of an adapter module 23.

[0047] According to the electrical component layout of the DUT, the power supply to the DUT under test is also achieved through the cable connection 18 from the side of the test signal generator 1.

[0048] Furthermore, the test module 2 has a second receiving structure 21 in the form of a recessed portion constructed in a drawer-like manner, see [link / reference]. Figure 1 Preferably, an electrical attachment 4 in the form of an induction coil and / or antenna assembly is placed in the recess, through which electrical energy and test signals can be transmitted without contact.

[0049] Optionally, the control and evaluation unit 3 can be directly connected to the test module 2 (see cable connection 22') or to the electrical attachment 4 (see cable connection 22). Test signals detected at the contact electrode 17 can be transmitted to the control and evaluation unit 3 via the corresponding cable connections 22, 22'. Power can also be supplied to the DUT via cable connections 22, 22'.

[0050] In order to electrically connect the DUT inside the adapter module 23, for example in Figure 3 The contact pin 19 and / or contact electrode shown are subjected to spring force as Figure 5 As shown, they function as plug-and-socket connections. Figure 5 An adapter module 23 with socket contacts 26 is shown, into which the plug contacts 27 of the DUT can be inserted. A third receiving structure 25 of the adapter module 23 enables the DUT to be forcefully inserted into the adapter module 23 along the force direction F.

[0051] In principle, the implementation forms used to construct the first receiving structure and the third receiving structure 5, 25 are not restricted.

[0052] List of reference numerals

[0053] 1. Test signal generator

[0054] 2. Test Module

[0055] 3 Control and Evaluation Unit

[0056] 4 Electrical attachments

[0057] 5 First receiving structure

[0058] 6 Circuit Boards

[0059] 7 Electrical / Electronic Components

[0060] 8 Perforated Plate

[0061] 9. Electrical wires

[0062] 10 contacts

[0063] 11. Outer shell

[0064] 12 Medical Implants

[0065] 13 head parts

[0066] 14 sockets

[0067] 15 Contact surfaces

[0068] 16 Recessed portion

[0069] 17 Contact Electrode

[0070] 18. Cable Connection

[0071] 19 Contact pins

[0072] 20 pairs of electrodes

[0073] 21 Second receiving structure

[0074] 22, 22' cable connection

[0075] 23 Adaptation Module

[0076] 24 Connecting contours

[0077] 25 Third receiving structure

[0078] 26 sockets

[0079] 27. Plug contact pin.

Claims

1. A component for functional testing of a plurality of differently constructed measurement objects, i.e., so-called DUTs, each of the measurement objects being in the form of a medical implant or at least a portion thereof, the component having: a) Test signal generator, b) A test module connected to the test signal generator and having a first receiving structure with at least one contact electrode, wherein an adapter module releasably fixed to the DUT can be inserted into the first receiving structure while forming at least one electrical contact, and c) A control and evaluation unit, which is indirectly or directly connected to the test signal generator and the test module. in, The test module has a second receiving structure that is spatially fixed relative to the first receiving structure and constructed in the form of a drawer-type recess. Electrically attached components that interact with the DUT without contact can be coupled into the second receiving structure. The adapter module has a third receiving structure that is individually matched with the DUT and has at least one contact electrode. The DUT can be placed into the third receiving structure while forming at least one electrical contact. The third receiving structure within each adapter module is individually matched with the DUT, and at least two adapter modules with different third receiving structures are configured to be uniformly inserted into the first receiving structure of the test module. The first receiving structure has at least one contact electrode for directly and releasably embedding the DUT and for making electrical contact with the DUT.

2. The component according to claim 1, characterized in that, The electrical attachments include induction coils and / or signal antennas.

3. The component according to claim 1 or 2, characterized in that, The control and evaluation unit is wirelessly or wiredly connected to the electrical attachment.

4. The component according to claim 1, characterized in that, The first receiving structure has at least one contact surface that can contact the adapter module, and at least one contact electrode is disposed on the at least one contact surface. When the adapter module is inserted into the first receiving structure, the at least one contact electrode makes force-fit and form-fit contact with the counter electrode disposed on the side of the adapter module.

5. The component according to claim 1, characterized in that, The third receiving structure has at least one contact surface that can contact the DUT, and at least one contact electrode is disposed on the at least one contact surface. The at least one contact electrode contacts the counter electrode disposed on the side of the DUT in a force-fit and form-fit manner when the DUT is placed in the third receiving structure.

6. The component according to claim 4 or 5, characterized in that, The at least one contact electrode and the counter electrode are constructed in the form of a plug and socket contact structure.

7. The component according to claim 4 or 5, characterized in that, The at least one contact electrode and / or counter electrode is constructed in the form of a contact pin that can be supported offset by a spring force.

8. The component according to any one of claims 1 to 2 and 4 to 5, Its features are, The DUT is one of the following electrical components: - Circuit board for active medical implants - A circuit board with input and output wires - A medical active implant having at least one electrical contact component.

9. The component according to claim 8, characterized in that, The medical active implant is an implantable pulse generator (IPG).

10. The component according to any one of claims 1 to 2 and 4 to 5 and 9, characterized in that, The test signal generator produces an EKG signal.

11. An application of the components according to any one of claims 1 to 10 for diagnosing and / or updating medical implants within a software update framework.

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