WO2002058549A1 - Endoluminal expandable implant with integrated sensor system - Google Patents

Endoluminal expandable implant with integrated sensor system Download PDF

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Publication number
WO2002058549A1
WO2002058549A1 PCT/DE2002/000234 DE0200234W WO02058549A1 WO 2002058549 A1 WO2002058549 A1 WO 2002058549A1 DE 0200234 W DE0200234 W DE 0200234W WO 02058549 A1 WO02058549 A1 WO 02058549A1
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Prior art keywords
φ
ß
film
tj
implant
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PCT/DE2002/000234
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German (de)
French (fr)
Inventor
Hagen Thielecke
Andrea Robitzki
Alexandra REININGER-MACK
Thomas Stieglitz
Oliver Scholz
Karl Konstantin Haase
Tim SÜSELBECK
Original Assignee
Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
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Priority to DE2001103503 priority Critical patent/DE10103503A1/en
Priority to DE10103503.9 priority
Application filed by Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. filed Critical Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V.
Publication of WO2002058549A1 publication Critical patent/WO2002058549A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876Blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031Implanted circuitry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007Evaluating blood vessel condition, e.g. elasticity, compliance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radiowaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6862Stents

Abstract

The invention relates to an endoluminal expandable implant with integrated sensor system, especially a stent. The stent base (1) is at least substantially enclosed on its inner or outer diameter by a flexible and extensible film (2). In said film (2), a plurality of electrodes (4), a thinned semiconductor chip (6) with integrated electronics and conductor tracks (5) for linking the integrated electronics (6) with the electrodes (4) are arranged in the form of an array. The integrated electronics (6) is adapted to control the electrodes for registering impedance spectra in order to obtain spatially resolved impedance spectra across the surface of the film (2). Conductor tracks (5) that establish an electrical link at an angle to the longitudinal axis of the implant body (1) on the film (2) are produced from a flexible material and/or have a meandering structure. The inventive implant can be conventionally implanted and expanded and supplies proliferation parameters for the purpose of a reliable risk stratification.

Description

Endoluminal expandable implant with integrated sensors

Technical Field

The present invention relates to an endo-luminal expandable implant, in particular a stent of a cylindrical radially expandable implant body which is enclosed on its inner or outer periphery of a flexible film at least for the most part, in the sensor elements and a thinned semiconductor chip with integrated

Electronics and conductor tracks are arranged for connection of the integrated electronics with the sensor elements. The implant can be designed in particular as a stent, the integrated sensor provides data for risk stratification, for therapeutic monitoring and optionally for controlling a controlled drug release in the body.

PRIOR ART For the treatment of stenosis in patients with coronary heart disease, percutaneous transluminal coronary Ballonangloplastie (PTCA) is applied. In this technique, an expandable balloon is introduced into the vessel and inflated there for a certain period of time, so that it expands the vessel at this point. A major limitation of PTCA is in the occurrence of restenosis in a period of 3-6 months of the intervention. The occurrence of recurrent stenosis is primarily due to the following factors. Very early after balloon dilation present in the vessel wall elastic chamfers perform a return movement that reduces the vessel lumen initially reached. Through the mechanism of balloon dilatation it comes to severe damage to the endot elialen cell layer, causing an unmasking of subendothelial localized vessel wall structures. Platelet adhesion, platelet aggregation, platelet activation and thrombus formation are further consequences of this vessel wall injury. Activated platelets perform a release of growth factors to activation of proliferation of active cell systems, but can on the other hand also by promoting thrombus formation at an early complication of PTCA, thrombotic vessel closure result.

The conditional by the expansion of the balloon compression and dissection of the stenotic plaque leads to a proliferation of smooth muscle cells in the media. This smooth muscle cells migrate from the media into the intima and cause several weeks after initial balloon dilatation another, so-called late lumen loss.

In order to reduce the undesirable recoil of the vessel wall motion vascular prostheses (stents) are implanted either to prior balloon dilatation of the vessel or directly via a balloon dilatation catheter. The stent is composed of a cylindrical-shaped, radially-expandable implant body, which supports the expanded vessel lumen after implantation, and optionally subsequent radial expansion. The reduction in the incidence of restenosis after stent implantation is mainly explained by an additional lumen gain. After stenting, there is a renewed endo- thelialisation the dilated and stented vessel segment that is completed, depending on the stent length after about four weeks. Parallel to this endothelial lining of the vessel lumen of the implanted stent induces a proliferation stimulus to the vessel wall and into this area of ​​a lumen reduction, which in some of the patients treated at a focal or diffuse, the entire stent length may concerning lead in-stent stenosis. Due to non-invasive parameters, it is not possible to to make a secure risk stratification that allows an individual predictability for the development of restenosis after stenting.

only stents with integrated sensors are currently known from the prior art which are designed for the measurement of flow parameters. The measured values ​​detected via the sensor are wirelessly transmitted to a receiver outside of the vessel in which the stent is implanted, or outside the body.

Thus 6,053,873 shows the US such a stent with integrated electronics and sensors for flow measurement. Around the stent an elastic coil is placed which serves as an antenna for data transmission and for energy consumption for operation of the electronics. The document shows an embodiment of a stent, wherein detecting the impedance of the current flowing through the stent lumen blood and used to determine the flow rate. a plurality of axially spaced apart electrode pairs of respectively opposite electrodes are arranged together with the electronics in a thin flexible film for this impedance measurement, which is attached to the stent. However, the stent of US 6,053,873 does not go in for safe risk stratification, since this knowledge of proliferation parameters is necessary. These can not be reliably determined from the measured flow parameters.

The US 5,967,986 also describes a stent with integrated electronics as well as sensors for measuring various physical and biological parameters, in particular for flow measurement. In one embodiment extend over the length of the stent anähernd helically two electrodes at a constant distance, can be detected on the tissue growth within the stent. The sensors or electrodes and the associated electronics are disposed on a thin flexible film which encloses the stent on its inner surface for the most part.

Even with the stent of this publication no reliable proliferation parameters can be obtained after implantation, the safe for a

Risk stratification suffice. Furthermore, in this as well as in the stent of the aforementioned publication the problem is that expansion of the stent after implantation may result in damage to the integrated sensors.

Starting from this prior art, the invention has the object of providing an expandable endoluminal graft having an integrated sensor, in particular a stent, indicate that enables secure risk stratification after implantation.

Summary of the Invention

The object is achieved with the implant according to claim. 1 Advantageous embodiments of the implant are the subject of the dependent claims.

This expandable endoluminal implant, hereinafter referred to according to the preferred embodiment, as a stent, is composed in known manner of a cylindrical radially expandable implant body. The construction of such implant body is known to the expert. The implant body is enclosed on its inner or outer periphery of a thin and flexible first film at least for the most part. In the film sensor elements are arranged, a thinned semiconductor chip with integrated electronics and conductor tracks connecting the integrated electronics with the sensor elements. The film is suitably attached to the implant body. In the present implant, the first film with the integrated sensor elements, and the semiconductor chip is stretchable configured so that it can at any time following a radial expansion of the implant. The sensor elements are formed by a plurality of array-like over the film surface are arranged distributed first electrodes. The integrated electronics is to

Driving the first electrodes for the reception of impedance spectra between the or each formed of the first individual electrodes on the surface of the first film - to obtain spatially resolved impedance spectra - and thus the inner or outer circumference of the implant. Furthermore, where appropriate, traces that make an electrical connection transversely to the longitudinal axis or axial direction of the implant body on the first film formed from a stretchable material and / or meander. The electrodes and the at least one semiconductor chip arranged so that no electrical connections across the longitudinal axis of the implant body on the first sheet are required, so the latter measure is of course not necessary.

In this implant, which is preferably configured as a stent, thus a plurality of electrodes, preferably at least 6 electrodes arranged on the first film so as to surround the tissue or plaque material which overcame the inside or outside of the stent have electrical contact. The electrodes are electrically connected to the electronics of the semiconductor chip, which drives the electrodes for detecting the spatially resolved impedance spectra. Additionally, the electronics is preferably used for evaluation and / or transmission of the recorded

formed measurement data to an external receiver. To determine the spatial distribution of tissue and plaque parameter in or around the stent, the impedance spectra are respectively arranged at different locations of the stent there between

Electrodes recorded. From the impedance spectra of an electrode pair, the parameters of the tissue or plaque material can be determined, which is located between the ω co 4-> g TJ Φ φ ß ß Ö co N) ω Φ Φ Φ o -H 4-> φ rd 4-) 3 4J ß ß -a 1 J φ s 4-1 rH o rd oil T ß ß φ -rl. i3 1 rH φ

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provide. The stent can be implanted in a conventional manner and expand within the vessel without jeopardizing the electronic components as well as the measurement properties as a result.

In a preferred embodiment of the present implant a second thin film is provided, which abuts optionally via a thin intermediate layer on the first slide. The second film is the same as the first film and designed elastically extensible. The second film carries a capacitor array as well as conductor tracks for connecting the capacitors of the capacitor array with one another and connects the capacitor array via an electrical contact to the first slide for supplying power to the electronics of the semiconductor chip. The conductor tracks on the second film, the transverse electrical connection insbeosndere perpendicular to the longitudinal axis of the implant body to produce, are formed of a stretchable material cash and / or meandering run-shaped. This second film to the capacitor array, an energy store is provided which stores the optionally wirelessly transmitted from an external power source or internal power obtained by converting energy and provides, if required the electronics of the semiconductor chip. The second film is for this purpose as the first electrically insulating sheet and carrying a plurality of micro-capacitors, which are connected together by the conductor tracks. The implant with the two sheets differs in its dimensions due to the small thickness of the films only insignificantly by a conventional implant without integrated sensor. By such a capacitor array, the capacitors are distributed over the full inner or outer surface of the stent, a high storage capacity is made possible without reducing the lumen of the stent significantly. On the other hand, this energy storage enables reliable operation of the integrated electronics. Through the extensible design of the second film and the extensibility of the conductor tracks because of the particular material or meandering course, the stent can expand in the usual manner after implantation.

Arranged in the second film electrical components, that is, the capacitor array and the conductor tracks may be for the same purpose also integrated directly into the first sheet and relative to the other components of the first film corresponding electrically insulated. In such an embodiment, no separate second film, but only a sheet-like structure of the first film is required.

In a further advantageous embodiment, the substrate film (first film) of the electrode arrays made of a piezoelectric material. On both sides of this film are second electrodes, for example, arranged as a correspondingly structured electrode layer. These electrodes are separated by an insulating layer from the first electrode thereon, the sensor elements. Through this embodiment, a continuous power supply, and thus continuous monitoring can be realized independent of external energy sources. By pressure changes inside the stent, beispiels-, by the pulse, the piezoelectric film is stretched so that a change in voltage between the second electrodes of the two sides of the film results. The converted energy is stored for an AC / DC conversion in the capacitor array or directly serves the energy supply of semiconductor electronics. The power management in this case is also due to the integrated in the semiconductor chip electronics. The second electrodes to the longitudinal axis of the implant body, that is, in the direction of elongation extending perpendicularly are again configured either expandable and / or in that direction meandering.

Preferably the first electrodes are arranged on the first foil that they are equidistant to the intended expansion of the stent. This enables a simplified evaluation of the measured data on the spatial distribution of tissue parameters. The person skilled in the relationships to derive these parameters from the spectral impedance measurements are known. Therefore, this result that biological tissues exhibit characteristic electrical and dielectric properties, which can be determined by impedance spectroscopy.

Preferably, a semiconductor chip is coated with an approximately rectangular shape to the first film, or integrated into it, having a greater longitudinal than transverse dimension. The semiconductor chip is oriented in such a way on the slide, that its longitudinal axis is approximately parallel to the longitudinal axis of the implant body. In this way, a stress of the semiconductor chip by the stretching of the film is minimized transversely to the axial direction. Optionally, the elasticity of this film in the region of the semiconductor chip may be further reduced.

In a further advantageous embodiment, all electrodes each lie on parallel to the longitudinal axis of the implant body straight lines on the slide, wherein a separate semiconductor chip with integrated electronics for controlling the electrodes provided on the respective line for each of the lines. In this case no electrical connection between the electrical components on the film in the stretch direction, ie transverse to the longitudinal axis of the implant required. All interconnects run parallel to the longitudinal axis of the implant, so that the electrical components are not stressed by an elongation of the film due to the expansion of the implant.

The electronics are preferably designed for the evaluation and / or transmission of measurement data to an external unit. For this, a transmitter and receiver coil is helical or double wound helically around the implant body and connected to the electronics. The electronics may also have outputs to control an optionally arranged on the implant body microsystem drug delivery. Such a micro system for drug release is disclosed in the parallel German patent application 100 63 612.8, whose design features are preferably also realized in the present implant. The electronics in this case includes a program which controls the drug release depending on the measured parameters. The microsystem of 100 63 612.8, which is arranged reservoir via a preferably integrated in the implant drug, consisting of a thin carrier substrate, which is made of a material impermeable to the active material and having one or more through openings for the active ingredient. In the area of ​​the through holes a plurality of electrodes are arranged, which are driven by a built-in electronics, the carrier substrate or directly from the electronics in the present first film. The through-openings are formed as micro-column and / or micro-channels, each arranged on both sides electrodes and covers on one side of the carrier substrate by a layer of an electro-porous material.

According to a further embodiment of the forward lying implant a second stent body is coaxially arranged around the first stent body, wherein the first and optionally second film between the two stent bodies are. The inner stent body is expanded here so that it is pressed against the outer stent body, so that the entire system is under mechanical tension.

In order to allow the penetration of tissue into the stent, the first and optionally second film are preferably carried out perforated. Further, these films may be provided with a layer that is under tensile stress, so that the films at any time bear against the surface of the implant body due to the tensile stress. It goes without saying that the direction of the tensile stress must be appropriately selected for this purpose, depending on whether the film on the inner or on the outer periphery of the stent body is applied. Of course, widened sensor elements can be disposed on the first sheet and connected to the electronics to detect optionally further biological or physical parameters.

Brief Description of Drawings

This implant will be explained below with reference to embodiments in conjunction with the drawings without limiting the general inventive idea. show:

Fig. 1 shows schematically a view of a

Stents with integrated sensor system for detecting the spatial distribution of tissue and plaque parameters according to a

Embodiment of the present invention;

Fig. 2 is a schematic representation of a flexible, stretchable film with an electrode array and an integrated

Circuit (not to scale);

Figure 3 is a schematic illustration of a flexible and stretchable film with a stretchable capacitor array. Fig. 4 is a block diagram of the integrated

Circuit according to an embodiment of the present invention; Fig. 5 is a schematic representation of a

Stent in accordance with another embodiment of the present invention;

6a shows an example of a piezoelectric film for energy conversion in plan view.

Figure 6b is a schematic sectional view of a sensor structure having a piezoelectric film according to the figure 6a as a substrate material. Fig. 7 shows an example of an arrangement of

Electrodes, interconnects and IC's on a stretchable foil; and

Fig. 8 shows an example for a stent having an applied sensor system that is under its own tension, before and after a radial stent expansion.

Ways of carrying out the invention Figure 1 schematically shows a representation of a possible embodiment of a stent with integrated sensors for the continuous detection of the spatial distribution of tissue and plaque parameters after implantation of the stent. The stent comprises a radially expandable cylindrical stent body 1, on its outer surface in this example, a stretchable, flexible thin film 2 is applied, the array one electrode carries an integrated circuit and interconnects. On this first sheet 2, a second flexible and extensible film 3 is applied which carries a micro-capacitor array of conductor tracks to the corresponding interconnection of the individual capacitors. In the figure, the individual electrodes 4 of the electrode array of the film 2 are very easy to see that come into contact with the stent in hineinwachsendem tissue. The stent itself is constructed in conventional manner and consists for example of a wire mesh. The two films 2 and 3 surround the stent body 1 in this example, almost completely. The attachment to the stent body and the connection between the films can be made via art-known adhesive.

In a radial expansion of the stent shown in Figure 1, the two films stretch applied in the same way as the stent, without the electrical components, which are integrated in or on the films to damage.

For preparing a flexible, elastic electrode arrays, that is, the first sheet 2 with the electrode array of the electrodes 4, are deposited on an elastomeric sheet 2 metal layers for the electrodes 4 and conductor lines 5 and patterned. An ultra-thin flexible silicon chip 6 is formed in semiconductor technology and connected by a well-known technique for connecting flexible chips on flexible substrates with the elastomer sheet. 2 The chip 6 is designed as a narrow rectangle and is preferably applied to the electrode substrate 2, the edges of the narrow sides of the rectangle lie in the direction in which the electrode substrate 2 is stretched upon expansion of the stent body. 1

Techniques for bonding a thinned semiconductor chip with a foil, for example, from Aschbrenner et al. , Concepts for Ultra Thin Packaging Technologies, Proceedings. 4 th International Conference on Adhesive Joining and Coating Technology in Electronics Manufacturing, 2000, pages 16-19, are known.

Figure 2 shows an example of an applied on a slide 2 of electrode array with associated conductor tracks 5 and the semiconductor chip 6. The film 2 is an at least in one direction (indicated by the arrows) extensible elastic and electrically non-conductive elastomer sheet in a schematic representation. On the film, the exposed electrodes 4 of the electrode array can be seen, which are connected via conductor tracks 5 to the semiconductor chip 6, which takes over the driving of the electrodes. In order to minimize the forces on the electrical connections between the electrode array and the semiconductor chip 6 during and after stent expansion, the extensibility of the film 2 in the region in which the chip 6 is located can be reduced. This can vary depending on

Elastomeric material for example be achieved by local heat treatment or light (for example laser).

The electrodes 4 are arranged so that they are equidistant after stent expansion. Further, the conductor tracks 5, in areas in which they extend in the direction of elongation of the film 2, meandering run. This meander-shaped course of the conductor tracks 5 allows the stretching of the film 2 in the specified direction, without the conductor lines 5 thereby be damaged or interrupted. Thus, the meander-shaped course allowing elastic electrical connection of the electrodes 4 with the semiconductor chip in the figure are further connections 7 for a drug delivery system as well as connections 8 for the power supply of the semiconductor chip 6 to recognize 6. The semiconductor chip 6 has an electronic circuit or an integrated circuit (IC) that drives the electrodes 4 of the electrode array for the Impedance measurement. It is controlled here so that a spatially resolved measurement of the impedance in dependence is obtained by the wavelength.

Of course, the number of electrodes in this and the other examples can also further increase to z. to achieve as a specific spatial resolution or to cover a larger area.

An example of a block diagram of the integrated circuit is shown in FIG. 4 The electrodes 4, located on a line (hereinafter referred to as l..m longitudinal axis) parallel to the longitudinal axis of the stent body are each have a

Multiplexer connected. The multiplexers connect any two adjacent electrodes 4 with a longitudinal axis impedance analyzers, to determine the impedance spectra for the electrode pairs. The impedance spectra are written via a control circuit either in a memory which is located on the chip 6 or telemetrically transmitted to a receiver unit outside the vessel. By analyzing circuit events can be determined, which control signals are applied to a system for the controlled release of active ingredient from the impedance spectra. The switching circuit, the energy is inductively fed from an external power source and / or energy converters, which are located on the stent. The energy is stored in a capacitor array. For the operation of the circuit the capacitor array energy is taken. The power management takes on a power management module that is integrated into the semiconductor chip. 6

3 shows an example of a sheet 3 having an array of metallized film capacitors 9. The film 3 in turn consists of an elastomer substrate on which the film capacitors 9 are produced by a combined deposition and patterning of metal and polymer layers. are capacitors concepts for the separation of materials for the production of monolithic film, for example, in Rząd et al. .

Advanced Materials for High Energy Density Capacitors, IEEE 35 h International Power Sources Symposium, 1992..

The individual film capacitors 9 are in this example, via conductor tracks 10 of an elastic, electrically conductive material, preferably a polymeric material, connected or interconnected. The terminals 11 of the capacitor array are connected to the terminals of the energy storage on the film 2 with the electrode array. Thereafter, the sheets 2, 3 for electrode and capacitor array are placed together around the stent body. 1 A thin wire is wound double-helix shape the stent with the sensor system, whereby a transmitter and receiver coil is formed. The ends of the coil are connected to the corresponding inputs on the semiconductor chip. 6 g TJ m ß ß ß o ri TJ Φ rH ^ F Φ φ Φ ^ ß approx. SH

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Figure imgf000021_0001

Compression of this sheet 13 to the stent a voltage is generated across the electrodes 14 via the piezoelectric effect, by which the semiconductor chip 6 operated and / or the capacitor array can be charged. This integrated piezoelectric energy converter, the sensor can be operated over a long period regardless of external energy sources.

In a further embodiment for the control and data acquisition is for each of the electrodes 4 that are parallel to the longitudinal axis of the stent body 1 on a line or axis, a separate integrated circuit (6a - 6d) used. By this arrangement to dispense stretchable conductor tracks or the number thereof can be reduced within the electrode structure. The IC 's (6a - 6d) for each axis, for example, connected to a common transmitting and receiving coil and communicate with an external unit. Figure 7 this shows a

Embodiment in which no separate foils are provided for the electrode array and the capacitor array. The electrodes of the electrode array are arranged rather on the same sheet 2 as the condensation sator array. Of course, the conductor tracks are insulated by a corresponding intermediate layer 10 of the capacitor array with respect to the electrodes 4 and 5 strip conductors of the electrode array. The elongation of the film during expansion of the stent in this example is perpendicular to the course of the 5th in the figure conductor tracks shown Figure 8 shows schematically an example of a stent, wherein the sensor system 18 consisting of the film 2 with the electrode array, and optionally sator array of another film with the condensate, is provided with a layer that is under tensile stress. This layer is deposited in the manufacture of the electrode array on the slide. 2 By this tension, the film itself takes on a sleeve shape. The cuff is expanded or zusa-mmengedrückt and placed around a stent body 1 and inserted into a stent body. 1 In the example of Figure 8a is a pushed over the stent body 1 can be seen cuff 18 (sensor system). The sensor system is stuck on the stent body due to its own tension. When mounting the cuff on the inner periphery of the stent body, the applied layer must cause a voltage to the outside of course. Upon radial expansion of the stent, the sleeve expands as can be seen in figure part b of FIG. 8 Due to the residual stress, however, the cuff is still safe to the stent body. The electrodes are arranged in this sensor system so that they have the desired position in the expanded state.

Of course, other detectors for tissue or plaque may be disposed on the characterization or sheets adjacent electrodes. Also, the arrangement of additional sensors for other biological or physical parameters is possible. In this case, the electronics of the semiconductor chip has to be adjusted accordingly to the measurement tasks.

Although in the foregoing exemplary embodiments, each individual aspects of the possible configurations of the electrode array as well as the condensate sator arrays and the underlying substrate films are shown, the skilled person will be understood that these individual embodiments can be combined arbitrarily. Thus, for example, be arranged on a common film composed of a piezoelectric material may be in addition to corresponding electrodes to decrease the voltage to both the capacitor array and the electrode array. Also, the piezoelectric film, a film for the electrode array as well as a foil for the capacitor array can be used separately. The arrangement of the electrodes of the electrode array is not limited to any particular pattern or spacing. rather, these depend on the desired spatial resolution. Furthermore, the connection of the individual electrode for receiving the impedance spectra in different way can be carried out, as is known in the art. Thus, both two-pole, three-pole and quadrupole for such a task are.

LIST OF REFERENCE NUMBERS

Stent body first stretchable film second stretchable film first electrode first conductor tracks semiconductor chip connections for a drug delivery system connections for a system for supplying energy to film capacitor second conductor tracks pad second stent body piezoelectric foil second electrode pad back pad front passivation layer sensor system

Claims

claims
1. An endoluminal expandable implant, in particular stent, of a cylindrical radially expandable implant body (1) which at its inner or outer periphery of a thin and flexible first sheet (2) is surrounded, at least for the most part, in the sensor elements (4) and a thinned semiconductor chip (6) with integrated electronics and conductor tracks (5) for connecting the integrated electronics with the sensor elements (4) are arranged, characterized in that the first film (2) is configured extensible, the sensor elements of a plurality of via is the surface of the film are arranged distributed first electrodes (4) are formed and the integrated electronics for driving the first electrodes (4) for the reception of spatially resolved impedance spectra formed, optionally printed conductors (5) transverse to the longitudinal axis of an electrical connection implant body (1) on the first film (2) prepared from a dehnb consist arene material and / or meander.
2. The implant according to claim 1, characterized in that a second sheet (3) which is elastic and stretchable configured, optionally via an intermediate layer on the first film (2), wherein the second film (3) is a capacitor array and conductor tracks ( 10) bears with one another to connect the capacitors (9) of the capacitor array and an electrical contact to the first film (2)
Capacitor array connects to the power supply to the electronics of the semiconductor chip (6), wherein the conductor tracks (10) on the second film (3) transverse to the longitudinal axis of the implant body, an electrical connection (1), made of a stretchable material and / or meander run.
3. The implant according to claim 1, characterized in that the first film (2), a capacitor array and conductor tracks (10) contributes to the connection of the capacitors (9) of the capacitor array to each other, said capacitor array is connected to the power supply to the electronics of the semiconductor chip (6) and establish an electrical connection vertically to the longitudinal axis of the implant body (1), the conductor tracks (10) are made of a stretchable material and / or meander.
4. The implant according to one of claims 1 to 3, characterized in that the first film (2) consists of a piezo-electric material (13) arranged on either side second electrode (14) by an insulating layer (17) against the first electrodes (4) are isolated, wherein electric voltages applied by stretching or compression of the first film (2) due to the piezoelectric effect between the second electrode (14), via electrical connections for charging the capacitor array and / or
Power supply of the semiconductor chip (6) can be used and second electrodes (14), which extend transversely to the longitudinal axis of the implant body (1) on the first film (2), consist of a stretchable material and / or meander.
5. Implant according to one of claims 1 to 4, characterized in that the first electrode (4) in such a manner on the first film (2) are arranged such that they are equidistant to the intended expansion of the implant body (1).
6. Implant according to one of claims 1 to 5, characterized in that the semiconductor chip (6) has an approximately rectangular plan shape with greater longitudinal and transverse axis, the longitudinal axis of the semiconductor chip (6) approximately parallel to the
extends the longitudinal axis of the implant body (1).
7. The implant according to one of claims 1 to 6, characterized in that the stretchability of the first sheet (2)
Region of the semiconductor chip (6) is reduced.
8. The implant according to one of claims 1 to 7, characterized in that the first electrodes (4) on a plurality of parallel to each other and to the longitudinal axis of the implant body (1) extending lines are arranged, wherein for each of the lines, a separate semiconductor chip with integrated electronics for activation of the electrode (4) is provided on the respective line and the conductor tracks (5) (4) and the semiconductor chips only run parallel to the lines between the electrodes.
9. The implant according to one of claims 1 to 8, characterized in that the electronics is designed for the evaluation and / or transmission of measurement data to an external unit.
10. The implant according to claim 9, characterized in that the electronics comprises at least one impedance analyzer, a multiplexer, a memory, a transmitting and receiving unit and a power management module.
11. The implant according to claim 10, characterized in that the electronics has a respective multiplexer for each of a fixed number of electrodes (4) of the plurality of electrodes of the first film (2).
is 12. The implant according to one of claims 1 to 11, characterized in that a transmitter and receiver coil double-helical or helically around the implant body (1) is wound and connected to the electronics.
13. The implant according to one of claims 1 to 12, characterized in that the electronic outputs arranged for controlling the implant body (1) unit includes drug delivery.
14. The implant according to one of claims 1 to 13, characterized in that a further cylinder-shaped and radially expandable implant body (12) coaxially above the first implant body (1) is arranged, wherein the first (2) and optionally second film (3) between the first (1) and the other implant body (12) lie, and the first
is the implant body (1) is mechanically tensioned by expansion against the other implant body (12).
15. The implant according to one of claims 1 to 14, characterized in that the first (2) and / or the second film (3) are perforated.
16. Implant according to one of claims 1 to 15, characterized in that the first film (2) is provided with a layer that is under tensile stress, so that the film (2) at any time due to the tensile stress at the surface of the implant body
(1) applies.
17. Implant according to one of claims 1 to 16, characterized in that further sensor elements on the first sheet
are arranged (2) and connected to the electronics of the semiconductor chip (6).
PCT/DE2002/000234 2001-01-26 2002-01-24 Endoluminal expandable implant with integrated sensor system WO2002058549A1 (en)

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US8396548B2 (en) 2008-11-14 2013-03-12 Vessix Vascular, Inc. Selective drug delivery in a lumen
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US10124195B2 (en) 2002-04-08 2018-11-13 Medtronic Ardian Luxembourg S.A.R.L. Methods for thermally-induced renal neuromodulation
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