Minimally invasive medical instrument

The present invention relates to a minimally invasive medical device having a proximal end and a distal end, the medical device having a sensor device located at the distal end of the medical device. The sensor device comprises a sensor configured to generate sensor data in the form of an electrical sensor signal, particularly an ultrasonic transducer or a camera medical imaging sensor. The present invention further relates to a method of manufacturing such a minimally invasive medical device. The present invention further relates to such a sensor device and a method of manufacturing such a sensor device.

There is a tendency to incorporate electronic functions in the form of intelligent sensors at the tips of minimally invasive medical devices. These sensors can help the physician guide the medical device through the body, or allow for a more accurate diagnosis. For example, the use of sensors such as optical cameras or ultrasonic transducers at the tip of an endoscope is well known. However, such electronic functions are also contemplated in smaller medical devices such as catheters or (catheter) guide wires.

For example, the reference "Flex-to-Rigid (F2R): A Novel Ultra-Flexible Technology for Smart Invasive Medical Instruments", Benjamin Mimoun, Vincent Henneken, Ronald Dekker, published in "Stretchable Electronics and Conformal Biointerfaces (Mater. Res. Soc.) Symp. Proc. Volume 1271E, Warrendale, PA, 2010), paper 1271-JJ05-09 "(see also ectm.ewi.tudelft.nl/linkto/ectm_publications.php) is a particularly smart or minimally invasive medical device. Discloses techniques for manufacturing partially flexible small sensors interconnected by ultra-flexible interconnects used in, which are incorporated herein by reference. To do.

<p num="0004"> When such sensors or sensor devices of small size are envisioned, data compression hardware cannot generally be included in the distal tip of a medical device. Therefore, a relatively high data rate of sensor data is generated, for example, from an ultrasonic transducer or camera. High data rates generally require electrical wires with well-defined characteristic impedances, such as coaxial cables. However, even the smallest coaxial cable has a diameter of several hundred μm. For example, only one coaxial cable may be incorporated into a minimally invasive medical device (eg, the guidewire has a diameter of 300 μm), which limits the data rate. Thus, high data rates have so far required the use of electrical wires that extend from the distal end to the proximal end of the medical device, which requires a lot of space. However, the use of such wires, which require a lot of space, makes the medical device larger, which is not desirable, especially in minimally invasive medical devices. Therefore, there must be a trade-off between the data rate and the size of the medical device.</p><p num="0005"> An object of the present invention is to provide an improved minimally invasive medical device, particularly a small medical device, and to transmit sensor data at a high data rate from the distal end to the proximal end of the minimally invasive medical device. It is to provide a minimally invasive medical device that enables, and a method of manufacturing it.</p>

<p num="0006"> In the first aspect of the present invention, it is a minimally invasive medical device having a proximal end and a distal end, having a sensor device located at the distal end of the medical device, the sensor device being an electrical sensor. A medical device is presented that has a sensor configured to generate sensor data in the form of a signal. The sensor device further includes a data conversion device configured to convert the electric sensor signal into an optical signal and having an electric input unit for inputting the electric sensor signal and an optical output unit for transmitting the optical signal. The sensor device further comprises an optical fiber configured to transmit an optical signal from the distal end to the proximal end, the optical fiber being coupled to the output of the data converter to receive the optical signal. The optical fiber extends from the distal end to the proximal end of the instrument.</p><p num="0007"> In another aspect of the invention, a method of making minimally invasive medical instruments having proximal and distal ends, comprising the step of making a sensor device, the step being in the form of an electrical sensor signal. A step of providing a sensor configured to generate sensor data, an electrical input unit configured to convert an electrical sensor signal into an optical signal, an electrical input unit for inputting the electrical sensor signal, and an optical fiber for transmitting the optical signal. A step of providing a data converter having an output, a step of providing an optical fiber configured to transmit an optical signal from the distal end to the proximal end, and a step of providing the data converter to receive the optical signal. Includes a step of coupling the optical fiber to the output section. The method further comprises placing the sensor device at the distal end of the medical device such that the optical fiber extends from the distal end to the proximal end of the instrument.</p><p num="0008"> In another aspect of the invention, such a sensor device is presented. In another aspect of the invention, a method of manufacturing such a sensor device is presented.</p><p num="0009"> The basic idea of the present invention is to use an optical fiber to transmit high data rate sensor data from the distal end to the proximal end of a medical device. It provides a fast optical data link from the distal end or tip of the medical device. If a small size minimally invasive medical device is planned, the data compression hardware cannot be included in the distal end and therefore a relatively high data rate is generated at the distal end of the device. It is transmitted through an optical data link to the proximal end. A data converter is used to convert the electrical sensor signal generated by the sensor into an optical signal that can be transmitted by an optical fiber. In particular, the optical fiber has a first end and a second end, the first end is coupled to the optical output of the data converter and the second end is proximal to the device. It is placed at the end and connects to, for example, a signal processor. In this way, a minimally invasive device is provided that allows the transmission of sensor data at high data rates while still providing small medical devices. Moreover, by using optical fiber instead of electrical wire, the signal is electrically isolated. This makes the medical device even more MRI compatible and / or reduces noise (eg through a ground loop or RFI (Radio Frequency Interference)).</p><p num="0010"> In one example, the sensor can be a medical imaging sensor. Medical imaging sensors can generate sensor data that represent images (eg, the patient's body or parts thereof). Medical imaging sensors can generate large amounts of sensor data and therefore high data rates, which requires high data rate transmissions. In one example, the sensor can be an ultrasonic transducer configured to transmit and / or receive ultrasonic waves, particularly a capacitive micromachined ultrasonic transducer (CMUT). In another example, the sensor can be a camera. These are sensors that are particularly useful for medical imaging. However, in general, it will be appreciated that any other type of sensor, especially those that produce high data rates, can be used.</p><p num="0011"> A preferred embodiment of the present invention is set forth in the dependent claims. It is understood that the method of manufacturing the minimally invasive medical device according to the claim has the same and / or the same preferred embodiment as the medical device according to the claim and the dependent claim. It should be. Furthermore, it should be understood that the sensor device, or method of manufacturing the sensor device, has the same and / or the same preferred embodiment as the medical device or method of manufacturing the medical device according to claim.</p><p num="0012"> In one embodiment, the sensor device further comprises a substrate having a first surface and a second surface, and the data conversion device is placed on the first surface. In this way, a good support for the data conversion device is provided. In the corresponding method, the manufacture of the sensor device further comprises the step of providing a substrate having a first surface and a second surface, and the step of arranging the data conversion device on the surface of the first substrate.</p><p num="0013"> In another embodiment or modification, the optical fiber is arranged in a hole in the substrate that extends from the surface of the second substrate to the surface of the first substrate. In this way, a simple way of coupling an optical fiber to a data converter is provided. In particular, the holes can be arranged perpendicular to the surface substrate. In this way, the optical fiber is arranged perpendicular to the surface substrate. In particular, the holes can be arranged such that the first end of the optical fiber is coupled to the output of the data converter. For example, the data converter can be arranged to transmit an optical signal towards the surface of the first substrate, especially in the region where the first end of the optical fiber is located. In a corresponding method, the manufacture of the sensor device further includes a step of providing a hole in the substrate extending from the surface of the second substrate to the surface of the first substrate, for example by etching, and a step of arranging the optical fiber in the hole. And, including. In another embodiment or modification, the substrate has a base layer and at least one insulating layer on the base layer, the insulating layer forming at least the first substrate surface. In this way, by using the insulating layer, an electrical connection or an electrical connection can be made on the surface of the first substrate even when the base layer is conductive or semi-conductive. In particular, the substrate base layer can be made of silicon and / or the insulating layer can be made of silicon oxide. The use of silicon is easy to manufacture and / or inexpensive. In a corresponding method, the step of providing a substrate comprises a step of providing a base layer and a step of providing at least one insulating layer on the base layer, the insulating layer forming at least the first substrate surface. To do. For example, the insulating layer can be provided by an oxidation treatment.</p><p num="0014"> In modifications or modifications of these embodiments, the holes terminate at the insulating layer that forms the surface of the first substrate. In particular, the hole can be a blind hole. In this way, the insulating layer insulates the output of the data converter from the optical fiber, but is still thin enough for the optical signal to pass through. Therefore, the insulating layer can be particularly optically transparent. Further, an easy manufacturing method for arranging the optical fiber in the hole of the substrate can be provided in this way. In the corresponding method, the step of making holes ends or ends at the insulating layer forming the first substrate surface. For example, the holes are etched from the surface of the second substrate, pass through the base layer of the substrate, and end at the insulating layer.</p><p num="0015"> In other embodiments or modifications, the optical fiber is fixedly connected to the substrate. In this way, the (s) optical fibers can be permanently attached to the substrate and thus the sensor device. Therefore, the optical fiber can be permanently coupled to the output of the data converter. This provides better optical coupling. For example, a device can be provided that is smaller than the removable connection or air gap between the optical fiber and the optical output. In particular, an optically transparent adhesive can be used to fix the optical fiber to the substrate. For example, the remaining space in the hole between the substrate and the optical fiber can be filled with an optically clear adhesive. In a corresponding method, coupling an optical fiber to an optical output includes fixing the optical fiber to a substrate, particularly using an optically transparent adhesive.</p><p num="0016"> In other embodiments or modifications, the sensor device further comprises an electrical wire extending from the distal end to the proximal end of the instrument. In this way, the device can be powered (eg, electrical wires can be used to power the sensor device) and / or provide additional functionality. Can be done. For example, electrical wires can be used for low speed data transmission (eg transmission of control signals). In a corresponding method, manufacturing a sensor device further comprises providing an electrical wire that extends from the distal end to the proximal end of the instrument.</p><p num="0017"> In other embodiments or modifications, the electrical wires are arranged through through holes in the substrate that extend from the surface of the first substrate to the surface of the second substrate. In this way, simultaneous connections of electrical wires and optical fibers to substrates (eg, silicon chips) can be provided. It is particularly easy to manufacture. In a corresponding method, manufacturing a sensor device comprises providing the substrate with through holes extending from the surface of the first substrate to the surface of the second substrate, and arranging electrical wires through the through holes. .. For example, through holes can be etched through the substrate.</p><p num="0018"> In another embodiment or modification, the electrical wire is fixedly connected to the substrate. In this way, the electrical wire can be permanently attached to the substrate and thus to the sensor device. For example, a solder connection can be used to connect the electrical wire to the substrate in a fixed manner. In particular, both optical fibers and electrical wires can be fixedly connected to the substrate. In the corresponding method, manufacturing the sensor device further comprises connecting the electrical wire to the substrate in a fixed manner.</p><p num="0019"> In another embodiment or modification, the sensor is located on a second substrate located above or below the substrate on which the data converter is located in the length direction of the medical device. In this way, the sensor and the data conversion device are arranged on different or separate substrates. In this way, small medical devices can be provided. In the corresponding method, manufacturing the sensor device further includes a step of providing a second substrate on which the sensor is located and above or below the substrate on which the data converter is located in the length direction of the medical device. Includes a step of positioning the second substrate.</p><p num="0020"> In another embodiment or modification, the sensor device has a pre-processed electronic circuit configured to preprocess the electrical sensor signal, the pre-processed electronic circuit having an input unit that receives the electrical sensor signal and preprocessing. It has an output unit for transmitting the generated electric sensor signal to the data conversion device. In this way, the pretreatment can be performed at the distal end or tip of the medical device. For example, preprocessing can adapt electrical signals for conversion by a data converter and / or transmission over optical fiber. However, preprocessing electronics are generally unable to provide high data compression. Preprocessing electronic circuits generally do not require much space. Thus, the pretreatment electronic circuit can be easily incorporated into the sensor device at the distal end of the medical device. In this way, the raw sensor data or signal from the sensor does not need to be transmitted to the proximal end and the sensor data can be preprocessed. For example, preprocessing electronic circuits can be configured to amplify and / or multiplex electrical sensor signals (eg, so that electrical sensor signals can be transmitted through optical fibers). In particular, pretreatment electronic circuits can be, or are part of, electronic circuits used to control sensors, such as application specific integrated circuits (ASICs). sell. In the corresponding method, manufacturing the sensor device further comprises providing such a pretreatment electronic circuit.</p><p num="0021"> In another embodiment or modification, the pretreatment electronic circuit is located on a third substrate located above or below the substrate on which the data converter is located in the length direction of the medical device. In this way, the pretreatment electronic circuit and the data conversion device are arranged on different or separate substrates. In this way, a small medical device is provided. In the corresponding method, manufacturing the sensor device is a step that provides a third substrate on which the pretreatment electronics are located, and in the length direction of the medical device, above or above the substrate on which the data converter is located. Includes a step to position the third substrate below.</p><p num="0022"> In another embodiment or variant, the instrument is a guide wire with an elongated guide wire core. Guide wires are a particularly useful minimally invasive medical device.</p><p num="0023"> In a modification of this embodiment, the optical fiber forms a guide wire core. In this way, medical devices are cheaper and / or the size of medical devices can be further reduced. Optical fibers are used not only to transmit sensor data to the proximal end, but also as a mechanical core or support for guidewires.</p><p num="0024"> In another embodiment or variant, the data converter is a vertical cavity surface emitting laser (VCSEL), light emitting diode (LED) or dynamic mirror device (DMD). In this way, inexpensive and / or small devices can be provided. VCSELs are particularly useful for transmitting optical signals to the surface of the first substrate.</p><p num="0025"> In other embodiments or variations, the data converter is also configured to convert an optical signal into an electrical signal. In this way, the data converter can convert the signal in both directions. In this case, the optical fiber provides a high speed optical data link both to and from the distal end. This allows bidirectional communication. For example, the data converter can be a VCSEL with a photodiode (eg, under or around the VCSEL). For example, electrical signals can be used to drive and / or control sensors.</p><p num="0026"> These and other viewpoints of the present invention are apparent from the embodiments described below and are described below with reference to them.</p>

<figref num="1">Schematic of a minimally invasive medical device according to an embodiment.</figref><figref num="2">A schematic cross-sectional view of a part of a sensor device for a medical device according to an embodiment.</figref><figref num="3">Schematic cross-sectional view of a portion of a sensor device for a medical device according to another embodiment.</figref><figref num="4a">The figure which shows the method of manufacturing the sensor device of FIG.</figref><figref num="4b">The figure which shows the method of manufacturing the sensor device of FIG.</figref><figref num="4c">The figure which shows the method of manufacturing the sensor device of FIG.</figref><figref num="4d">The figure which shows the method of manufacturing the sensor device of FIG.</figref><figref num="5">Schematic cross-sectional view of a medical device according to one embodiment.</figref><figref num="5a">FIG. 5 is a perspective view of the distal end of the medical device of FIG.</figref><figref num="5b">FIG. 5 is a schematic cross-sectional view of the sensor device of FIG. 5 at the end of its production.</figref><figref num="6">Schematic cross-sectional view of a medical device according to another embodiment.</figref><figref num="7">Schematic cross-sectional view of a portion of a medical device according to another embodiment.</figref>

FIG. 1 shows a schematic view of the minimally invasive medical device 100 according to one embodiment. The minimally invasive medical device 100 (also referred to as the minimally invasive medical device) has a proximal end 100b and a distal end 100a (also referred to as a distal tip). In medical invasive interventions, the distal end 100a is placed at the anatomical site of the patient's body where the intervention is performed. The minimally invasive medical device 100 includes a sensor device 10 located at the distal end 100a of the medical device. The sensor device 10 includes a sensor 20 configured to generate sensor data in the form of an electrical sensor signal. The sensor 20 has a sensor output unit 21 that transmits an electric sensor signal. The sensor device further comprises a data converter 40 configured to convert the electrical sensor signal into an optical signal. The data conversion device 40 has an electrical input unit 41 that receives an electrical sensor signal from the sensor 20, particularly from the sensor output unit 21. The sensor output unit 21 is connected to the electrical input unit 41 of the data conversion device 40 through the electrical connection 25. The data conversion device 40 further includes an optical output unit 42 that transmits an optical signal. The sensor device 10 further comprises an optical fiber 50, particularly an optical fiber, configured to transmit an optical signal from the distal end 100a to the proximal end 100b. For example, the length of the optical fiber 50 is long enough to reach the distal end 100a to the proximal end 100b. The optical fiber 100 has a first end 50a and a second end 50b. The optical fiber 50 is coupled to the optical output unit 42 of the data conversion device 40 in order to receive an optical signal. More specifically, the first end 50a of the optical fiber 50 is coupled to the output 42 of the data converter 40. The optical fiber 50 extends from the distal end 100a to the proximal end 100b of the medical device 100. The second end 50b of the optical fiber 50 is located at the proximal end 100b of the medical device 100. Thus, the optical fiber is used to transmit the high data rate sensor data of the sensor 20 from the distal end 100a to the proximal end 100b of the medical device 100. This is the distal end of medical device 100 1 It provides a high speed optical data link from 00a and / or to the distal end 100a. Although only one optical fiber 50 is shown in the drawings, any number or multiple optical fibers can be used.

In the embodiment shown in FIG. 1, the second end 50b of the optical fiber 50 is on a signal processor 120 configured to read and / or process sensor data or electrical sensor signals, eg, for medical imaging. Be connected. For example, the signal processor 120 can be configured to convert an optical signal (received from an optical fiber 50) back into an electrical signal. In addition, the signal processor 120 can be configured to process electrical signals in the digital domain (eg, if required by the application).

A corresponding method of manufacturing such a minimally invasive medical device 100 first comprises the step of manufacturing such a sensor device 10. The steps of manufacturing the sensor device 10 include providing the sensor 20, providing the data conversion device 40, providing the optical fiber 50, and coupling the optical fiber 50 to the output section 42 of the data conversion device 40. The method of manufacturing the medical device 100 further comprises placing the sensor device 10 at the distal end of the medical device 100. The optical fiber 50 extends from the distal end 100a of the instrument 100 to the proximal end 100b.

In this description, the sensor 20 shown in the figure is an ultrasonic transducer configured to transmit and / or receive ultrasonic waves, particularly a capacitive micromachined ultrasonic transducer (CMUT). This is a particularly useful sensor for minimally invasive devices, especially for medical imaging. Ultrasonic transducers generate large amounts of sensor data (hence high data rates), which requires high data rate transmissions. In particular, the ultrasonic transducer 20 includes a plurality of ultrasonic transducer cells 22, particularly CMUT cells, which are arranged next to each other. However, it will be understood that the sensor can be any other type of medical imaging sensor that produces sensor data that represents an image (eg, the patient's body or part thereof). For example, the sensor is a camera (eg, a CCD chip or a CMOS image sensor chip). Medical imaging sensors produce large amounts of sensor data and therefore high data rates, which require high data rate transmission. However, it will be appreciated that generally any other type of sensor, especially one that produces high data rates, can be used. In general, the sensor can be a sensor that produces a low data rate, such as a pressure sensor. However, the high speed optical data links described herein are useful for sensors that produce particularly high data rates, such as ultrasonic transducers or cameras.

FIG. 2 shows a schematic cross-sectional view of a portion of the medical device 100 according to one embodiment, particularly the sensor device 10 of the medical device described with respect to FIG. The sensor device 10 includes a sensor (not shown in FIG. 2), a data conversion device 40, and an optical fiber 50, as described in particular with respect to FIG. The sensor device 10 further includes a substrate 30 (eg, a silicon chip) having a first surface 30a and a second surface 30b. The data conversion device 40 is arranged or mounted on the first substrate surface 30a. In this embodiment shown in FIG. 2, the optical fiber 50 is arranged in the hole 34 of the substrate 30. The holes 34 extend from the second substrate surface 30b to the first substrate surface 30a. The holes 34 are arranged perpendicular to the substrate surfaces 30a and 30b. Therefore, the optical fiber 50 arranged in the hole 34 is also arranged perpendicular to the substrate surfaces 30a and 30b. The hole 34 is arranged so that the first end 50a of the optical fiber 50 is coupled to the output 42 of the data converter 40. In other words, the data conversion device 40 is arranged so as to transmit an optical signal toward the surface 30a of the first substrate in the region where the first end 50a of the optical fiber 50 is located. The first end 50a or hole 34 is centered on the optical output 42 so that the center of the optical fiber 50 receives all of the optical signal or light transmitted from the optical output. .. The second end 50b of the optical fiber is located at the proximal end 100b of the medical device. To show this, the optical fiber is shown in the cut plane in FIG.

In this embodiment shown in FIG. 2, the substrate has a base layer 31 (eg made of silicon) and a first insulating layer 32 (eg an oxide such as silicon oxide) on the base layer 31. The first insulating layer 32 forms the first substrate surface 30a. The insulating layer 32 is electrically insulated. By using the first insulating layer 32, even if the base layer 31 is conductive or semi-conductive, the electrical connection portion 46 that provides the electrical connection to the data conversion device 40 can be the first substrate 30a. Can be placed on top. For example, the base layer 30 can be made of silicon. In this case, the insulating layer can be made of silicon oxide, which can be formed by oxidizing silicon. Optionally, the substrate 30 can have a second insulating layer 33 on the base layer 31, which forms a second substrate surface 30b as shown in FIG.

In this embodiment shown in FIG. 2, the holes 34 terminate at the first insulating layer 32 forming the first substrate surface 30a. Therefore, the hole 34 is a blind hole. The first insulating layer 32 is optically transparent. For example, silicon oxide is optically transparent. The first insulating layer 32 insulates the optical output section 42 of the data converter 40 from the optical fiber 50, but is thin enough for the optical signal to pass through the insulating layer 32. The optical fiber 50 is fixedly connected to the substrate 30. In other words, the optical fiber 50 is permanently attached to the substrate 30. In this way, the optical fiber 50 is permanently coupled to the output unit 42 of the data conversion device 40. In particular, an optically transparent adhesive 52 is used to fix the optical fiber 50 to the substrate 30. As can be seen from FIG. 2, the remaining space of the holes 34, in particular the space between the substrate 30 (or its insulating layer 32) and the optical fiber 50, is filled with an optically transparent adhesive 52. This improves the optical coupling. Further, as can be seen from FIG. 2, an optically transparent underfill material 48 is provided between the data conversion device 40 and the first substrate surface 30a, particularly between the optical output unit 42 and the first of the data conversion device 40. It is arranged between the substrate surface 30a (or the first end 50a of the optical fiber 50). This further improves the optical coupling.

In this description, the data converter 40 shown in the figure is a vertical cavity surface emitting laser (VCSEL). The VCSEL40 has an electrical input unit for inputting an electrical sensor signal. In FIG. 2, in particular, the electrical connection 46 for providing an electrical connection from the sensor 20 to the data converter 40 is VCSELed by a solder bump 47. Connected to 40 or its input. VCSEL40 includes an active region 44 that produces laser light. In particular, the active region 44 is a laser cavity (or quantum well) located between the first mirror (or Bragg reflector), the second mirror (or Bragg reflector), and the first and second mirrors. ) And. The VCSEL40 further includes an optical output unit 42. The optical output unit 42 faces the first substrate surface 30a. The light output unit 42 receives the generated laser light and transmits or emits it as an optical signal. VCSEL40 is particularly useful for transmitting optical signals towards the first substrate surface 30a. However, in general, it is understood that any other type of data conversion device configured to convert the electrical sensor signal into an optical signal can be used. For example, the data converter can be a light emitting diode (LED) or a dynamic mirror device (DMD).

The data converter 40 can also be configured to convert an optical signal (transmitted through an optical fiber 50) into an electrical signal (eg, for driving and / or controlling a sensor). In this way, the data converter 40 can convert the signal in both directions. Thus, fiber optic 50 provides high speed optical data links both from the distal end 100a and to the distal end 100a. This allows bidirectional communication. As mentioned above, when the data converter is a VCSEL, for example, the photodiode is placed under or around the VCSEL or its active region.

FIG. 3 shows a schematic cross-sectional view of a part of the sensor device 10 of the medical device 100 according to another embodiment. Since the embodiment of FIG. 3 is based on the embodiment of FIG. 2, the same description given for the embodiment of FIG. 2 also applies to the embodiment of FIG. In the embodiment shown in FIG. 3, the sensor device 10 additionally has an electrical wire 60 extending from the distal end 100a to the proximal end 100b of the medical device 100. The electrical wire 60 includes a first end 60a and a second end 60b. The first end 60a is located at the sensor device 10 and therefore at the distal end 100a of the medical device. The second end 60b is located at the proximal end 100b of the medical device. To show this, the electrical wire is shown in the cut plane in FIG. In the embodiment of FIG. 3, two electrical wires 60 arranged next to each other are shown. However, any other (appropriate) number of electrical wires can be used. For example, the electrical wire 60 can be used to power the sensor device or for low speed data transmission (eg, control signals).

The electric wire 60 is arranged through a through hole 63 of the substrate 30, and the through hole 63 extends from the first substrate surface 30a to the second substrate surface 30b and vice versa. By providing holes 34 for the optical fiber 50 and through holes 63 for the electrical wire 60, simultaneous connection of the optical fiber 50 and the electrical wire 60 to the substrate 30 is readily provided, for example, in one processing step. be able to. The electrical wire 60 includes a conductive core 61 and an insulator 62 that surrounds the core 61. The insulator 62 electrically insulates the conductive core 61. As can be seen from FIG. 3, the electric wire 60 or the core 61 is fixedly connected to the substrate 30. In other words, the electrical wire 60 is permanently attached to the substrate 30. At the first end 60b, the electrical wire 60 has an insulation-free portion. For example, as can be seen in FIG. 3, the solder joint 64 can be used to fix the electrical wire 60 or core 61 of the first end 60a to the substrate 30. As can be seen from FIG. 3, the core 61 of the electrical wire 60 at its first end 60a is connected to the electrical connection 65 on the first substrate surface 30a by the solder junction 64. In short, in the embodiment of FIG. 3, the optical fiber 50 and the electric wire 60 are fixedly connected to the substrate. The optical fiber 50 is fixedly connected by an optically transparent adhesive 52, and the electrical wire 60 is fixedly connected by a solder joint or connection.

The method of manufacturing the sensor device 10 will be described in more detail with respect to FIGS. 4a-4d. Each of FIGS. 4a-4d shows different steps in the method of manufacturing the sensor device 10 of FIG. The manufacture of the sensor device 10 begins with providing a substrate 30 (eg, a silicon chip) having a first surface 31 and a second surface 30b. For example, as shown in FIG. 4a, a base layer 31 (eg made of silicon) can be provided, such as an insulating layer 32 made of an oxide such as silicon oxide, which is a base (eg by thermal oxidation). It can be provided on layer 31. The insulating layer 32 forms the first substrate surface 30a. The sensor 20 can be provided on the first substrate surface 30a, more specifically on the insulating layer 32 (not shown in FIG. 4a). Then, with reference to FIG. 4b, holes 34 are provided in the substrate 30 (eg, by etching), and the holes 34 extend from the second substrate surface 30b to the first substrate surface 30a. As can be seen from FIG. 4b, the step of providing the holes 34 ends with the insulating layer 32. In this case, the holes 34 are etched from the second substrate surface 30b through the substrate base layer 31 and end at the insulating layer 32. As shown in FIG. 4b, a through hole 63 is further provided in the substrate 30, and the through hole 63 extends from the second substrate surface 30b to the first substrate surface 30a. In this case, the through hole 63 is etched from the second substrate surface 30b through the substrate 30. In particular, the step of providing the hole 34 (for example, etching) and the step of providing the through hole 63 (for example, etching) are carried out in one processing step. Optionally, support layer 49 (eg made of polyimide) can be used when providing holes 34 and through holes 63 (eg etching), as shown in FIG. 4b.

Next, with reference to FIG. 4c, a data converter 40 is provided. The data conversion device 40 is arranged on the first substrate surface 30a. In this case, an electrical connection is provided to the electrical connection portion 46 arranged on the first substrate surface 30a. As can be seen from Figure 4d, fiber optic 50 is provided. The optical fiber 50 (or its first end 50a) is coupled to the optical output section 42 of the data converter 40. This is done by arranging the optical fiber 50 in the hole 34. Next, an optically transparent adhesive 52 is filled in the remaining space of the holes 34 in order to fix the optical fiber 50 to the substrate 30. Finally, an electrical wire 60 (see Figure 3) is provided. The electrical wire 60 is arranged through the through hole 63. A solder joint 64 can be used to fix the electrical wire 60 to the substrate 30. It will be appreciated that the steps described above can also be performed in any other suitable order.

FIG. 5 shows a schematic cross-sectional view of the medical device 100 according to one embodiment, and FIG. 5a shows a perspective view of the distal end 100a of the medical device 100 of FIG. A portion of the sensor device 10 described with reference to FIG. 3 is used in this embodiment. Therefore, the description in the previous embodiment applies to the embodiment of FIG. In the embodiment shown in FIG. 5, the sensor device 10 further comprises a pre-processing electronic circuit 70 configured to pre-process the electrical sensor signal. Therefore, the pretreatment is performed at the distal end 100a of the medical device 100. For example, the preprocessing electronic circuit 70 can be configured to amplify and / or multiplex the electrical sensor signal. In this way, the raw sensor data or signal from the sensor 20 does not need to be transmitted to the proximal end 100b and the sensor data can be preprocessed (eg adjusted). The pre-processed electronic circuit can be, in particular, an electronic circuit used to control the sensor 20, or such an electronic circuit, or can be incorporated or part thereof. For example, the pretreatment electronic circuit can be an application specific integrated circuit (ASIC). The preprocessing electronic circuit 70 includes an input unit 71 for receiving an electric sensor signal from the sensor 20. In particular, the preprocessing electronics include a plurality of input ports for receiving electrical sensor signals from the sensor. An electrical connection 25a is provided between the sensor 20 or the sensor output 21 and the electronic circuit 70 or its input 71. The pre-processed electronic circuit 70 further includes an output unit 72 for transmitting the pre-processed electric sensor signal to the data conversion device 40. An electrical connection 25b is provided between the electronic circuit 70 or its output 72 and the data converter 40 or its input 41. In the embodiment of FIG. 5 (see FIG. 5a), the electrical connections 25a, 25b are flexible electrical connections. It will be appreciated that the pretreatment electronic circuit 70 can also be used in connection with any of the embodiments described with reference to FIGS. 1 to 4.

Further, in the embodiment of FIG. 5, the sensor 20 (in this case, the ultrasonic transducer cell 22) is defined in the length direction L of the medical device 100 (in this case, from the proximal end 100b to the distal end 100a). The data converter 40 is arranged on the second substrate 80, which is positioned above the first substrate 30 on which the data converter 40 is arranged. Therefore, the sensor 20 and the data converter 40 are arranged on two separate substrates 30, 80. Further, the preprocessing electronic circuit 70 is arranged on a third substrate 90 located above the first substrate 30 on which the data conversion device 40 is arranged in the length direction L. Therefore, again, the preprocessing electronic circuit 70 and the data converter 40 are arranged on two separate substrates 30, 90. In other words, each of the data conversion device 40, the sensor 20, and the preprocessing electronic circuit 70 is arranged on a separate substrate. In the embodiment of FIG. 5, the third substrate 90 is located below the second substrate 80 and between the first substrate 30 and the second substrate 80. The second substrate 80 with the sensor 20 is placed in the most distal portion of the instrument 100 for optimal sensing or sensor data generation.

Further, in the embodiment of FIG. 5, the medical device 100 is a guide wire having an elongated guide wire core 110 (eg, made of stainless steel). As can be seen from FIG. 5a, each of the first substrate 30, the second substrate 80 and the third substrate 90 is a disk surrounding the guide wire core 110. The guide wire can further include a stretchable sheath that surrounds the guide wire (eg, surrounds the substrates 30, 80, 90). However, in general, it will be appreciated that any other suitable minimally invasive medical device can be used.

FIG. 5b shows a schematic cross-sectional view of the sensor device 10 of FIG. 5 at the end of its production. Corresponding manufacturing methods include a step of providing a first substrate 30 on which the data converter 40 is located, a step of providing a second substrate 80 on which the sensor 20 is located, and a preprocessing electronic circuit 70. A step of providing a third substrate 90, and the like. In the embodiment of FIG. 5b, the first substrate 30, the second substrate 80 and the third substrate 90 are formed from a single continuous substrate. Substrates 30, 80, 90 are separated from each other by etching separate holes 85, 95 within one contiguous substrate. In this way, the sensor device 10 having the substrates 30, 80, 90 can be easily manufactured.

After the sensor device 10 is manufactured as shown in FIG. 5b, the second substrate 80 and the third substrate 90 are above the first substrate 30 in the longitudinal direction L (FIG. 5 or 5a). (See) respectively. Flexible electrical connections 25a, 25b provide electrical connections between sensors 20, electronic circuits 70, and data converters 40 on different substrates 30, 80, 90, respectively.

FIG. 6 shows a schematic cross-sectional view of the medical device 100 according to another embodiment. The embodiment of FIG. 6 differs from the embodiment of FIG. 5 in that the optical fiber 50 forms the guide wire core 110. The guide wire core 110 of FIG. 5 is replaced by an optical fiber 50. Thus, the optical fiber 50 is used not only to transmit the sensor data of the sensor 20 (not shown in FIG. 6) to the proximal end, but also as the mechanical core 110 or support of the guidewire. For example, in the embodiment of FIG. 6, the sensor 20 can be bent and placed around one or more substrates, especially around the perimeter of the guide wire.

Further, the embodiment of FIG. 6 is the embodiment of FIG. 5 in that the third substrate 90 having the electronic circuit 70 is positioned below the first substrate 30 having the data conversion device 40 in the length direction L. Different from the form. A first substrate 30 having an optical fiber 50 is placed in the most distal portion of the medical device 100 to provide mechanical support to the most distal portion of the medical device 100.

Further, the embodiment of FIG. 6 differs from the embodiment of FIG. 5 in that the electrical wire 60 is arranged on the additional substrate 92. Therefore, the data converter 40 and the electrical wire 60 are arranged on two separate substrates. The additional substrate 92 is positioned below the first substrate 30 and below the third substrate 90 in the longitudinal direction L. However, it will be appreciated that the electrical wire 60 can also be arranged in any other suitable manner. For example, FIG. 7 shows a schematic cross-sectional view of a portion of a medical device according to another embodiment. In this embodiment of FIG. 7, the electrical wire 60 is arranged on the same substrate 30 as the data converter 40.

Although the guidewire is described here, it will be understood that the minimally invasive medical device can be any type of minimally invasive medical device. For example, the minimally invasive medical device can be a catheter, guidewire, laparoscopic device or endoscope. Minimal invasive medical devices are, for example, diameters of 10000 μm or less, especially 8000 μm or smaller, especially 3000 μm or smaller, especially 1000 μm or smaller, especially 500 μm or smaller, especially. It can have a diameter of 300 μm or less. As a specific example, a laparoscopic instrument can have a diameter of, for example, 8 mm to 3 mm, a catheter can have a diameter of 3 mm to 1 mm, and / or a guide wire can have a diameter of less than 0.5 mm. Can have. For example, the minimally invasive medical device can be a smart medical device. Smart medical devices include sensors and sensor electronics (eg, ASICs) at their distal ends.

The present invention is illustrated and described in detail in the drawings and the above description, but such illustrations and descriptions should be considered as explanatory or exemplary rather than restrictive. The present invention is not limited to the disclosed embodiments. Other modifications to the disclosed embodiments can be understood and achieved by one of ordinary skill in the art in carrying out the invention described in the claims, from the drawings, disclosure and examination of the appended claims.

In the claims, the word "comprising" does not exclude other components or steps, and the indefinite article "a" or "an" does not exclude pluralities. A single component or other unit can perform the function of some of the items listed in the claims. The mere fact that certain means are listed in different dependent claims does not indicate that a combination of these means cannot be used in an advantageous manner.

The reference numerals in the claims should not be construed as limiting the scope of the present invention.