DE102014212323A1 - An ultrasound apparatus and method for inspecting a viewed substrate - Google Patents

Abstract

The present invention relates to an ultrasonic device (10) for examining a coated substrate (4). It comprises a receiving device (5) which is adapted to receive a coated substrate (4) and an ultrasound imaging device (1, 2) which is capable of receiving an ultrasound image of a coated substrate (5) accommodated in the receiving device (5). 4). The ultrasonic device (10) is capable of moving the coated substrate (4) received in the receiving device (5) and the ultrasound imaging device (1, 2) relative to one another. The invention also relates to a corresponding method.

Description

The present invention relates to an ultrasonic device for inspecting a coated substrate and a method for inspecting a coated substrate.

Substrates, in particular implants intended for implantation, in particular in human bodies, are often coated with a layer of, for example, polymer material. Such a layer can in particular increase the biocompatibility of an implant and / or serve as a drug carrier. If an implant with a damaged layer is implanted in the body, such as a stent, however, parts of the coating may come off and lead to vessel blockages. In this case, damage that is not visible to the naked eye, such as microcracks, can lead to undesired detachment of layer material. Accordingly, there are high demands on the layer integrity for implants to be implanted.

An object of the present invention is to allow an investigation of coated substrates in order to detect any damage, especially microcracks, early on. The investigation should be as simple as possible and at least semi-automatic feasible.

These objects are achieved with the ultrasonic device and the method according to the independent claims.

Advantageous embodiments and development will become apparent from the dependent claims.

In the context of this description, an ultrasound device may generally be a device which is designed to examine ultrasound-coated substrates. A substrate may in particular be an implant and / or comprise a carrier body and / or substrate body, which may be provided with a coating. An implant can be provided for implantation in a body, in particular a human body. It is conceivable that the implant has an implant body, which may comprise a metallic material, such as titanium and / or steel and / or iron and / or magnesium and / or nickel and / or copper and / or a suitable alloy, the implant body alternatively or additionally comprise and / or consist of a suitable polymer, such as polylactides, and / or other suitable material such as ceramic and / or glass and / or fiber material such as carbon fiber and / or glass fiber and / or composite material. It is conceivable that the implant is designed as a stent. The implant or substrate may have a coating, in particular a polymer coating. Other conceivable coatings may consist of ceramics, glasses or glassware. The coating can be provided to surround and / or cover the implant body or carrier body. For example, the coating may be used as a carrier of active ingredient and / or to enhance biocompatibility and / or protection of underlying material and / or control degradation of underlying or contained biodegradable material, such as metallic substrate or implant material such as magnesium and / or drug may be provided. A coating and / or the material of the coating may be biodegradable and / or resistant to degradation in the body. One or more interfaces may be formed between the carrier body or implant body and the coating. A substrate or implant, in particular a stent, can have one or more openings, in particular lateral openings, through which ultrasonic waves are able to penetrate. For example, an implant such as a stent may be net-like and / or have stitches and / or struts. It is conceivable that a coated substrate or implant, in particular a stent, has a flow-through space and associated openings, which may be defined by the implant body. The ultrasound device can be provided to examine at least one boundary layer between the carrier body or implant body and the coating. In particular, one or more examinations may be provided after the coating but before implantation. An ultrasound imaging device may generally be designed to generate an ultrasound signal and / or to direct it to the implant or substrate to be examined. It is conceivable that an ultrasound imaging device has one or more sound transducer devices, for example one or more ultrasound transmitter devices and / or one or more ultrasound receiver devices and / or one or more transceivers. A sound transducer device may generally be designed to convert electrical signals into ultrasound and / or vice versa. A transmitting device may comprise one or more sound transducer devices designed as transmitters. A receiving device may comprise one or more transducer devices designed as receivers. A transmitting / receiving device may comprise one or more sound transducer devices designed as transmitter and receiver. A sound transducer device may be arranged individually, in a group and / or in a phased array. An ultrasound receiver can be designed in particular as a hydrophone. A sound converter device, In particular a transmitting device and / or a transmitter, may include a focusing and / or cooperate with such a focusing of ultrasound to produce a desired sound field, such as a substantially parallel sound field and / or at a certain distance and / or on the surface and / or interface of the implant or substrate focused or focusable sound field. The focusing device can be adjustable, in particular in accordance with a control device and / or as a function of the ultrasound frequency. It is conceivable that the ultrasonic imaging device comprises at least one transmitter / receiver device and / or a transmitter and an associated receiver for ultrasonic reflection measurement and a transmission receiver for transmission measurements of ultrasonic waves. Such a transmission receiver can be arranged such that the implant is arranged during the examination between the transmission receiver and a transmission transmitter. Such a transmission transmitter may be part of a device for the reflection measurement. Generally, in a transmission measurement, an ultrasound signal may be sent from a transmitter through the coated implant to a receiver. In a reflection measurement, a signal reflected from the coated implant can be detected by a suitable receiver. In general, an ultrasound imaging device can be designed to generate an image of a substrate or implant by means of ultrasound. In this case, reflected sound waves, sound waves in transmission, transverse sound waves and / or surface waves can be detected and / or used, in particular detected by serving for receiving sound transducer. The ultrasound imaging device can be designed as an ultrasound microscopy device. In general, the ultrasound device can have one or more control devices, in particular one or more electronic control devices such as a processor and / or microcontroller and / or computer and / or other suitable electronic circuits, and / or be connected or connectable to the data transmission and / or control system. The one or more control devices can be designed to control the ultrasound device. Several control devices or components of control devices can be interconnected or connectable for data transmission, for example via suitable interfaces and / or cable and / or radio links. In general, a control device may be designed to generate an image from signals from one or more sound transducers, which may in each case be in particular designed as receivers or transceivers, and / or to receive such signals. The irradiation of the substrate or implant or a region of the substrate or implant with ultrasound from a transmitter, optionally detecting a response approximately in reflection and / or transmission, can be regarded as scanning the coated substrate or implant or the corresponding region.

According to the invention, an ultrasound device is provided for examining a coated substrate, in particular an implant. The ultrasound device comprises a receiving device, which is designed to receive a coated substrate or implant, and an ultrasound imaging device, which is capable of providing an ultrasound image of a coated substrate or implant received in the receiving device. The ultrasonic device is designed to move the coated substrate or implant received in the receiving device and the ultrasound imaging device relative to each other. Thus, a comprehensive examination of the coated substrate or implant, in particular the coating can take place. In particular, small defect structures and / or microcracks of the coating can be detected at least semi-automatically and / or automatically. In this case, different areas of the coated substrate or implant can be detected by the image and / or different angles of incidence of ultrasound can be used. In particular, the ultrasound device can be designed to move the substrate or implant and the ultrasound imaging device relative to one another in such a way that the ultrasound imaging device is able to create an image of the surface and / or the three-dimensional structure of the substrate or implant. The ultrasound device can be designed as a tomography device. An image can be provided for example by a signal and / or a digital reproduction. It is conceivable for an image to comprise a plurality of partial images, for example different sectional views and / or views of different regions of the coated substrate or implant. An ultrasound image may comprise one or more two-dimensional representations of one or more surfaces, in particular an interface between implant body and coating and / or a surface of the coated substrate or implant, and / or one or more reproductions of the three-dimensional structure of the coated substrate or implant. The receiving device may have a receiving space, which may be defined by a wall, and / or a holder for holding the coated substrate or implant. The wall and / or wall parts of the receiving space can be movable. It is conceivable that sound transducer of the ultrasonic imaging device at the Wall mounted or attachable. In particular, one or more sound transducers may be attached or attachable to a movable wall part and / or movably mounted or attachable to the wall. The ultrasonic device may include one or more drive means such as motors, drive spindles and / or guides or the like to facilitate and / or guide relative movement between the ultrasound imaging device and the substrate or implant. It is conceivable that a control device for controlling at least one such drive device and / or for controlling the relative movement of the coated substrate or implant and the ultrasound imaging device is formed and / or connected or connectable. A control device may be designed and / or connected or connectable for controlling the ultrasound imaging device and / or for creating and / or receiving and / or storing and / or processing and / or evaluating the image. Generally, the ultrasound device may include and / or receive a transmission medium capable of transmitting ultrasound between a transducer and the implant. A transfer medium may in particular comprise or be a liquid such as water and / or glycol and / or glycerol and / or a water-surfactant mixture or oils. Such a medium may be arranged or arrangeable such that it fills a space between one or more acoustic transducers and the coated implant and / or substrate and / or surrounds the implant. The medium can be accommodated in the receiving device and / or a container-forming part of the receiving device. A holder for the coated substrate or implant may include a pivot bearing and / or translation device in order to rotate the coated substrate or implant and / or to be able to move in a translation. By way of example, a holder may have at least one holding device which can be inserted into an opening of the coated substrate or implant, for example an input or output opening of a stent, and / or gripping device such as a pin and / or a spindle or the like. In particular, two opposing holding and / or gripping devices can be provided, which can be designed to receive and / or clamp and / or hold a coated substrate or implant, in particular a stent, between them. A holding and / or gripping device can be designed such that it influences an ultrasound signal as little as possible and / or in a defined manner. In this case, in particular, a part of the holding and / or gripping device penetrating the coated substrate or implant in contact with the coated substrate or implant can be transparent for ultrasound, for example by a suitable choice of material and / or by a suitable shape. For example, a holding device may comprise two or more struts and / or fingers, which are insertable into an opening of the coated substrate or implant and / or which are able to hold the coated substrate or implant, between which one or more free spaces are formed, which are ultrasonic signals allow yourself to propagate freely. Such free spaces can be accessible for transmission medium and / or filled with transmission medium or be fillable. A control device can be configured to the type and / or shape and / or position of such holding device in evaluating the edge regions of the coated substrate or implant, in particular of areas in the vicinity and / or on the holding and / or gripping devices take into account and / or take into account in controlling the movement of the coated substrate or implant and / or the ultrasound imaging device. Thus, peripheral areas of the coated substrates or implants can also be sufficiently examined. The ultrasound imaging device may be designed to generate and / or to deliver ultrasound in a frequency range and / or at a mapping frequency of approximately 50 kHz to 500 MHz, in particular 80 MHz to 400 MHz, and / or above 50 MHz and / or 80 MHz and / or 100 MHz capture and / or use. In general, the ultrasound imaging device can be embodied such that it is capable of detecting and / or detecting defect structures, in particular defect structures that are invisible to the naked eye, of the coating, and in particular microstructures such as microcracks. The invention also generally relates to use of an ultrasonic device described herein for examining coated substrates or implants or at least one coated substrate or implant.

The ultrasound device can be designed to move the coated substrate or implant received in the receiving device relative to the ultrasound imaging device. In particular, the receiving device and / or a subassembly of the receiving device can be movable like a holder for the coated substrate or implant. For example, it is conceivable that a holder and / or the holder with the coated substrate or implant is movable within a receiving space. In this case, the coated substrate or implant can be moved or movable in a transmission medium. In a variant, the ultrasound device can be designed such that coated substrate or implant in a translation along a longitudinal axis, in particular along a longitudinal axis of the coated substrate or implant, to move and / or to rotate about a rotation axis. The axis of rotation may in particular be a longitudinal axis of the coated substrate or implant and / or the translation axis or a parallel axis of the translation axis. The ultrasound device may be configured to move the coated substrate or implant such that substantially all of the coated substrate or implant and / or the entire top and / or exterior surface of the coated substrate or implant and / or the entire coated substrate or implant can be scanned or scanned and / or imaged or imaged by the ultrasonic imaging device.

In a development, the ultrasound imaging device is designed to create a multiplicity of images of the coated substrate or implant received in the receiving device. The images may be created or created during a relative movement of the coated substrate or implant to the ultrasound imaging device.

It can be provided that the ultrasound imaging device is designed to image the coating of the coated substrate or implant received in the receiving device. In this case, in particular, at least one interface between coating and carrier body or implant body can be imaged and / or imaged.

In general, the ultrasound imaging device can be designed to image the coated substrate or implant received in the receiving device in transmission and / or reflection. In particular, the ultrasound imaging device can be designed to image the coated substrate or implant essentially simultaneously in transmission and reflection.

The ultrasound imaging device may have a plurality of imaging frequencies and / or frequency ranges. The frequencies may be in a frequency range mentioned above and / or be selected such that they are able to resolve certain types of defects of the coating. For example, droplet formation produces larger structures than microcracking and thus can be resolved at a lower frequency. The ultrasound imaging device can be one or more tunable via one or more specific frequency ranges sound transducers and / or transducers with convertible frequency and / or with multiple frequencies for generating and / or detecting different imaging frequencies and / or one or more transducers of different frequency for generating and / or detecting different imaging frequencies. It is conceivable that the ultrasound device is designed to perform a plurality of examination runs, each with different frequencies, and / or to perform at least one pass in which the coated substrate or implant is scanned and / or imaged with a plurality of frequencies. It can be provided that at each frequency, the coated substrate or implant as possible (and / or substantially) is completely scanned and / or imaged.

A control device may be provided, which is capable of comparing an image, produced by the ultrasound imaging device, of the coated substrate or implant with a reference or error reference. Thus, errors can already be detected by the controller and / or the investigation can be supported by the controller. The reference may be a reference signal and / or a reference image. It is conceivable that the control device includes and / or is connectable to a reference database which stores one or more references and / or makes the control device accessible for comparison. In particular, the control device can be designed to compare the image with more than one reference and / or references in a reference library or reference database. A reference can represent in each case a typical defect image of an implant or a defect-free and / or within a defined tolerance range error-free coated substrate or implant. The control device can be provided to perform several comparisons with different references, for example to check the coated substrate or implant for several types of errors. The controller may be configured to determine based on the comparison whether the coated substrate or implant is defective and / or to provide a signal representing the comparison result, such as an error signal and / or alarm signal. It is conceivable that, based on an error signal, a coated substrate or implant is labeled as defective and / or rejected and / or provided for a manual inspection. References can be generated by experiment and / or deliberately manipulated and / or manually controlled coated substrates or implants and / or simulation. Alternatively or additionally, it can be provided that the control device is designed to detect and / or store deviant images and / or deviating coated substrates or implants as references from a reference considered as error-free and optionally from existing defects, and / or for to mark a manual check and / or provide a corresponding signal.

In a further development, the distance between the ultrasound imaging device and the coated substrate or implant can be adjustable, in particular the distance between one or more sound transducers and the coated substrate or implant and / or the receiving device and / or a holder for the coated substrate or implant and / or a location of the coated substrate or implant to be scanned or scanned. The distance may in particular be defined transversely to a longitudinal axis and / or axis of rotation and / or longitudinal movement axis of the coated substrate or implant and / or be relevant for the propagation of sound. For example, the ultrasound device can be designed to be able to approach and remove the ultrasound imaging device and the coated substrate or implant, for example by means of a suitable drive device, which can be controlled by a control device. It can be provided that the coated substrate or implant and / or the holder is moved relative to at least one transducer of the ultrasonic imaging device to change the distance. The ultrasonic device can be designed to change the distance as a function of the imaging frequency. In particular, it can be provided that the distance is reduced with a higher imaging frequency. For example, it may be provided that for an imaging frequency range above 100 MHz or above 150 MHz or above 200 MHz or above 300 MHz and / or for a frequency at which transverse waves and / or surface waves are to be detected on the coating and / or the coated substrate or implant , The distance is set such that such waves, in particular transverse waves, are able to spread to the transducer and / or receiver, in particular in reflection, and / or not weggedämpft. A suitable distance may be at most 5 wavelengths or at most 4 wavelengths or highest 3 wavelengths or at most 2 or 1 wavelength. In general, the ultrasound imaging device can be configured to measure the actual distance between the coated substrate or implant, in particular a point of the coated substrate or implant currently being scanned and / or imaged and the ultrasound imaging device and / or a wall of the ultrasound device and / or a or to determine a plurality of sound transducers, for example by means of a transit time measurement. Alternatively or additionally, one or more distance measuring device and / or Abstandseinstelleinrichtungen be provided, such as a mechanical device such as a micrometer screw and / or an optical and / or electromagnetic device such as a laser and / or a magnetic device.

The invention also relates to a method for examining a coated substrate or implant with an ultrasound device, in particular an ultrasound device described herein. An ultrasound imaging device and a coated substrate or implant to be imaged are moved relative to each other. In particular, the features or operations described herein may be implemented or performed.

In particular, an image generated by the ultrasound imaging device can be compared with at least one reference.

Generally, a substrate or implant after coating and / or after application to a carrier, such as a balloon catheter and / or stent and / or prior to delivery or insertion into a body may be subjected to the examination described herein.

In the following, an ultrasound device for examining coated implants will be explained by way of example with reference to the enclosed figures.

Show it:

1 schematically a variant of an ultrasonic device;

2 schematically another variant of a US;

3 schematically a section of a coated implant.

1 schematically shows an ultrasonic device 10 , The ultrasound device 10 has a receiving device, which in this example has a receiving space with a wall in which a transmission medium 3 as water is absorbed. The receiving device further has a holder 5 which, in this example, comprises two opposing spindles, between which a coated implant 4 is included. The implant 4 is from the transmission medium 3 surround. The ultrasound device 10 further comprises a sound transducer assembly, which in this case a transmitter / receiver 1 includes. The transmitter / receiver 1 comprises a focusing device which focuses the radiated sound field at infinity, ie generates a parallel sound field. The transmitter / receiver 1 is designed on the one hand to generate a sound field for ultrasound examination, and on the other hand to detect sound waves reflected by an irradiated object and to transmit corresponding signals to a control device (not shown). Further, as a hydrophone 2 trained transducer provided on a the transmitter / receiver 1 opposite side of a wall is arranged and as a transmission receiver for the transmitter / receiver 1 originating signals serves. Transmitter-receiver 1 and hydrophone 2 are arranged to transmit or receive ultrasonic signals into the transmission medium 3 plunge. The holder 5 is formed such that it is in the direction of the dashed longitudinal axis of the implant 4 within the receiving space is movable or movable and the implant 4 is rotatable about this longitudinal axis. Furthermore, it can be provided that the distance between the transmitter / receiver 1 and / or hydrophone 2 and the implant can be changed, such as by the holder 5 is movable in a direction transverse to the longitudinal axis and / or the transmitter / receiver 1 associated wall and / or the hydrophone 2 associated wall are designed to be movable. Thus, in particular, one or more receivers may be close to the implant 4 brought to receive surface waves and transverse waves from the implant. In this example, the implant is 4 cylindrically shaped and the spindles of the holder 5 penetrate into opposite openings of the implant 4 one.

2 schematically shows a variant of an ultrasonic device 10 with an implant 4 , which is designed as a stent. The implant has meshes with cross struts that define deformation sites. In such places, the risk of microcracks is particularly pronounced.

3 schematically shows a mesh of an implant 4 detail. A wire frame 6 has struts 7 with slight deformations. The ultrasound device 10 is particularly suitable in the field of struts 7 and to detect defects of the coating that occur in the deformations and to increasingly automate the investigation.

For the implementation of the invention, the features listed may be relevant individually or in any combination.

LIST OF REFERENCE NUMBERS

1

 Transmitter-receiver

2

 hydrophone

3

 transmission medium

4

 coated implant

5

 bracket

6

 wire frame

7

 strut

10

ultrasound device

Claims (10)

Ultrasonic device ( 10 ) for examining a coated substrate ( 4 ), comprising: - a receiving device ( 5 ), which is adapted to a coated substrate ( 4 ); An ultrasonic imaging device ( 1 . 2 ), which is capable of an ultrasound image of a in the receiving device ( 5 ) coated substrate ( 4 ) to provide; wherein the ultrasonic device ( 10 ) it is possible that in the receiving device ( 5 ) coated substrate ( 4 ) and the ultrasonic imaging device ( 1 . 2 ) relative to each other. Ultrasonic device according to claim 1, wherein the ultrasonic device ( 10 ) is adapted to the in the receiving device ( 5 ) coated substrate ( 4 ) relative to the ultrasound imaging device ( 1 . 2 ) to move. Ultrasonic device according to one of the preceding claims, wherein the ultrasound imaging device ( 1 . 2 ) is adapted to a plurality of images of the in the receiving device ( 5 ) coated substrate ( 4 ) to create. Ultrasonic device according to one of the preceding claims, wherein the ultrasound imaging device ( 1 . 2 ) is adapted to the coating of the in the receiving device ( 5 ) coated substrate ( 4 ). Ultrasonic device according to one of the preceding claims, wherein the ultrasound imaging device ( 1 . 2 ) is adapted to the in the receiving device ( 5 ) coated substrate ( 4 ) in transmission and / or reflection. Ultrasonic device according to one of the preceding claims, wherein the ultrasound imaging device ( 1 . 2 ) has multiple imaging frequencies. Ultrasound device according to one of the preceding claims, wherein a control device is provided, which is able, a generated by the ultrasonic imaging device image of the coated substrate ( 4 ) with a reference. Ultrasonic device according to one of the preceding claims, wherein the distance between the ultrasonic imaging device ( 1 . 2 ) and the coated substrate ( 4 ) is adjustable. Method for examining coated substrates with an ultrasonic device ( 10 ), in particular an ultrasonic device ( 10 ) according to one of the preceding claims, in which an ultrasound imaging device ( 1 . 2 ) and a coated substrate to be imaged ( 4 ) are moved relative to each other. A method of inspecting coated substrates as claimed in claim 9, wherein a method described by the ultrasonic imaging apparatus (US Pat. 1 . 2 ) is compared with at least one reference.

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