1. Field of the Invention
The invention relates to an implantable device for detecting an expansion, that is an elastic deformation of an intracorporeal vessel wall, for example, of the stomach, the oesophagus, veins, arteries etc. comprising a support structure which contains a dielectric polymer, has surface elasticity and can be applied directly or indirectly to the vessel wall, which provides at least one capacitive electrode arrangement, having an assignable electrical capacitance which can be influenced by an elastic deformation of the support structure.
2. Description of the Prior Art
Implantable devices for detecting shape changes at vessel walls are used primarily for intracorporeal blood pressure measurement of blood-carrying vessels. For this purpose, predominantly flexural elastic sensors are known which operate on the basis of capacitive or resistive strain gauges and can be attached to the vessel outer wall without adversely effecting substantially the natural deformation of the vessel wall.
An implantable blood pressure sensor of this type is described in DE 10 2005 035 022 A1 which provides a means consisting of an elastic material, which surrounds the blood-carrying vessel in annular form, whose elasticity approximately corresponds to the intrinsic elasticity of the vessel wall so that the annular means does not permanently impart the natural deformation behavior of the vessel wall caused by the blood pressure. A strain gauge with capacitively or inductively acting electrode structures is attached to the annular means to measure the deformation behavior. In the case of capacitively acting electrode structures, the electrode structures configured as capacitor electrodes are located on opposite annular regions so that the capacitor electrodes influence the blood-carrying vessel on both sides like a dielectric.
A comparable sensor unit is described in EP 1 635 158 A2 which provides at least two capacitor electrodes inserted in a strip-shaped elastic carrier element to form a closed ring to detect pulsation expansion of a blood-carrying vessel. Plate spacing is determined by the diameter of the blood-carrying intracorporeal vessel. The arrangement of two capacitor electrodes, each opposite the blood-carrying vessel is quite essential here. As a result of the pulsing expansion of the blood vessel, the capacitor plate spacing and therefore the electrical capacitance of the measuring arrangement changes at the same time. In order to determine blood pressure and detect and transmit measurement data, a planar coil, connected to the capacitor electrodes, is additionally provided to form a resonator circuit whose resonance frequency depends on the electrical capacitance of the pressure-sensitive sensor. The signal which can be read out by the resonance circuit can be detected by a receiving unit provided extracorporeally, which additionally provides a measure of the shape change of the blood vessel and ultimately is a measure for the blood pressure.
Both of the above-described implantable blood pressure measuring systems each have capacitor electrode surfaces made of thin metal which preferably is copper or gold and which have none or only a limited expansibility. In order not to adversely affect the natural deformability of the blood vessel, it is therefore important to keep the electrode surfaces as small as possible which results in the signal levels which can be evaluated for the blood pressure detection being very small.
In addition, in the above-described implantable blood pressure measurement arrangements, the capacitor electrode surfaces are disposed opposite one another relative to the blood vessel. They therefore form an electrical capacitor whose plate spacing is defined by the diameter of the blood vessel. The interposed dielectric therefore comprises the tissue material of the blood vessel and the blood flow flowing through the blood vessel. As a result, the dielectric constant must be assumed to be non-constant as a result of the pulsing flow behavior. In addition, the blood is electrically conductive which results in electrical losses occurring in the capacitive measurement, which additionally adversely affect the measured signal level which can be evaluated. Another disadvantage as a result of the capacitor electrode surfaces being located opposite to one another on the vessel to be measured is the appearance of electrical scatter fields which occur as a result of relative movements of the blood vessel to be measured relative to the surrounding tissue which can also permanently adversely affect the measurement results.
The invention is an implantable device for detecting an expansion, that is an elastic deformation of an intracorporeal vessel wall comprising a support structure which contains a dielectric polymer, has surface elasticity and can be applied directly or indirectly to the vessel wall, which provides at least one capacitive electrode arrangement having an assignable electrical capacitance which is influenced by an elastic deformation of the support structure in such a manner that on the one hand care should be taken not to influence the natural deformation behavior of the vessel wall. The signal quality and signal strength which can be evaluated is considerably improved. In particular, it is important to avoid falsely perturbing influence on the measured signals and ultimately on the measurement result, such as for example due to the occurrence of scatter fields or due to temporally varying dielectric properties of the dielectric disposed between the electrode surfaces etc.
In order to measure the natural pulsing deformation behavior of intracorporeal vessel walls composed of a very soft and highly flexible tissue material, that typically has an elastic modulus of 1 MPa and a ductility of 10% or more, without any influence that constricts and causes local surface stiffening of the elastically deforming vessel wall, a strain gauge is used with highly elastic and flexible materials, based on the capacitive measurement principle, which is not subject to any significant perturbing influences and also offers various embodiments.
The elastic deformation of the support structure is comparable to elasticity of the intracorporeal vessel wall. As a result, the support structure has no effect or only an insignificant effect on the expansion properties of the vessel wall and does not damage the viability of the vessel wall.
According to the invention, the implantable device for detecting an expansion from an elastic deformation of an intracorporeal vessel wall, comprises a support structure which contains a dielectric polymer, has surface elasticity and can be applied directly or indirectly to the vessel wall. The device provides at least one capacitive electrode arrangement with an assignable electrical capacitance which can be influenced by an elastic deformation of the support structure, in which the electrode arrangement provides at least two electrodes each composed of an electrically conductive polymer which limits at least one side of an intermediate space that influences the electrical capacitance of the electrode arrangement and is completely filled with the dielectric polymer of the support structure.
The term “vessel wall” is to be understood as an intracorporeal wall composed of biological tissue, such as for example, the vessel wall of arteries, veins, capillaries or lymph vessels and organ walls, such as the stomach wall, the oesophagus, intestinal wall or similar thereto are also applicable to the invention.
Unlike the known comparable implantable measuring devices, the device according to the invention provides an electrode arrangement preferably comprising completely an electrically conductive polymer which, as a result of its inherent surface elastic properties and its shape and size, has no effect or only an insignificant effect on the natural expansion properties of the vessel wall. In particular, the electrode arrangement is configured as capacitor electrodes with the dielectric determining the capacitance of the electrode arrangement being exclusively determined by the choice of the material of the support structure. As a result, it is already possible to calibrate the measuring device outside the body, that is “ex vivo”. Potential measurement errors caused by variable dielectric constants such as, for example, by a dynamic blood flow which flows between the capacitor electrodes can be intentionally avoided.
In order to explain the structure of an implantable device configured according to the invention and its advantageous further developments, reference is made to the following descriptions which refer to the specific exemplary embodiments shown in the figures.
The invention will be described as an example hereinafter without restricting the general inventive idea by means of exemplary embodiments with reference to the drawings. In the figures:
a-d show multisided views of an exemplary embodiment configured according to the invention;
a-d show an exemplary embodiment configured according to the invention with structured electrode arrangement;
a-d show a multisided view of an exemplary embodiment configured according to the invention with interdigital electrode arrangement;
a-d show a multisided view of an extension variant to
a-d show the basic principle of the structure of an implantable device configured according to the invention in a multisided view.
For the purpose of electrical insulation and encapsulation of the electrodes 2o and 2u are composed of an electrically conductive polymer and one insulation layer 4 is applied at least on the upper and lower side of the support structure 1, which can comprise the same surface-elastic dielectric polymer of the support structure or of a polymer material different from the support structure which however has comparable elasticity properties. Merely for reasons of better illustration, the upper insulation layer 4 has been omitted in the plan view according to
The cross-sectional view according to
One way of reading out the sensor is to connect the contact wires 3 to an implantable electrical read-out unit having an integrated energy source which, for example, may be a battery or providing the energy supply by providing an extracorporeal wireless energy supply technique. For this purpose, the electrodes 2o and 2u should be connected via the contact wires 3 to a suitable inductance which is implemented or embedded like the electrodes 2o and 2u inside the support structure 1. With the aid of an extracorporeally provided coil, electrical energy can be coupled by inductive coupling into the inductance provided intracorporeally inside the support structure 1.
The capacitance change caused by deformation can be detected with an extracorporeally provided energy supply unit which is typically an antenna unit. The inductance inside the support structure and connected to the capacitive electrodes 2o and 2u forms an oscillatory circuit, whose resonance frequency is substantially determined by the capacitance of the capacitive electrode arrangement. A change in capacitance is reflected in a change in the resonance frequency of the oscillatory circuit which in turn can be detected with the extracorporeally provided antenna unit. Such wireless detection of a measured signal is known in the art as GRID dipping.
d shows a perspective view of the implantable device configured according to the invention in which the upper insulator layer 4 is shown slightly raised to make the upper electrode 2o visible. The layer composite shown only in sections in
The blood pressure sensor illustrated in
A second embodiment illustrated in
The structure of the electrodes 2o and 2u can be achieved by laser processing. For example, the laser processing can provide an unstructured rectangular electrically conductive polymer layers which are already applied to the support structure. The laser beam is absorbed by the material of the electrically conductive polymer. The laser can penetrate largely without absorption through the dielectric support structure material. With the laser processing method, in addition to approximately arbitrary two-dimensional structures can be processed from a homogeneous application, an electrically conductive polymer layer is additionally possible to shape the boundary edges of the structured electrode layer in relation to the steepness of the flank. In this way, the electrical fields advantageously formed between the two electrodes separated by the dielectric of the support structure can advantageously be configured or optimized to avoid perturbing scatter fields.
In addition to an improved ductility, structured electrodes, formed preferably in the manner described in
In the two previously described embodiments, the electrodes 2o and 2u composed of an electrically conductive polymer are located in two different parallel planes inside the support structure 1, Subsequent embodiments are described in which both electrodes are disposed in a single plane and therefore provide an implantable device having significantly reduced thickness.
a to 3d show a multisided view of an implantable device in the same way as
The electrodes 5 and 6 are an electrically conductive polymer which is configured in the form of an interdigital structure. Each electrode comprises finger structures which mutually intermesh in a contactless manner within one plane. The space between the interdigital electrode structures, each lying opposite one another in the plane, is completely filled with the highly elastic polymer support structure material, which is preferably silicone, is the dielectric between the electrodes. When applying an electrical potential difference between both electrode structures 5 and 6, electrical field lines are formed which are perpendicular to the electrode surface between the immediately opposite electrode planes. In addition, elliptical electrical field lines are formed between the finger electrode structures running above and below the electrode planes 5 and 6 in the support structure 1. The elliptical field lines provide a substantial contribution to the measurable capacitance. A mechanical deformation of the sensor illustrated in
The interdigital electrode arrangements of
Another embodiment for an implantable device having an interdigital electrode structure arrangement is shown in
As a result of the additional interdigital electrode structure 7 provided in the second plane, a so-called differential capacitor is achieved. With the design of the differential capacitor, perturbations and in particular all common mode perturbations such as, for example, parasitic capacitances, offset errors, operating voltage and temperature influences, can be effectively suppressed. In addition, the sensitivity of the sensor is increased for deformations both in the longitudinal, x direction and in the spatial direction y oriented orthogonally to the longitudinal direction. The principle of a differential capacitor is explained by the equivalent circuit diagram to
Depending on their design structure, capacitive sensors fundamentally generate electromagnetic scatter fields which, depending on the manifestation, can extend into the spatial surroundings of the capacitor arrangement. If the electrical or dielectric properties of the surroundings change, the scatter fields active in the surroundings can ultimately have an effect on the capacitance of the sensor and influence this. If it is necessary to make capacitive measurements with only low signal levels, as is the case in the apparatus according to the invention, it is desirable to suppress any perturbing sources of error which influence the measurement results. In particular, it is necessary to minimize the falsification of the sensor signals caused by scatter fields and their environment-dependent feedback on the measurement signal. One possibility for reducing this perturbing effect is specific focusing of the electric field lines formed between the electrode structures on the area between the electrodes. It is known that electrical field lines are “guided” better in a dielectric material having a high dielectric constant than in a material having lower dielectric constant. This effect is used in a preferred exemplary embodiment of the implantable device according to the invention whereby the electrode structures with the dielectric material of the support structure inserted between the electrodes are completely surrounded by a material having a higher dielectric constant than the material in the further surroundings. In this way, the electric field is localized in a defined space around the electrode arrangement whereby the influence of possible scatter effects interacting with the surroundings is reduced. In order to influence a preferred exemplary embodiment in this respect, reference is made to
In addition, the propagation of scatter field can be reduced by a suitable adaptation of the structural quantities of the individual components of the device. If, for example, the electrode spacing between two electrodes is small compared with its surface or lateral expansion, the electrical field remains substantially focused within the capacitor structure as a result of the small electrode spacing and cannot be scattered into the surroundings.
Another possibility for reducing perturbing influences is to completely or partially externally surround the electrode structures with extra shielding electrodes. With the aid of these externally applied shielding electrodes which are placed at a defined electric potential, the scatter fields emanating from the capacitive electrodes are regularly prevented from “penetrating” into the spatial area surrounding the sensor unit. In the same way, external perturbing fields cannot “penetrate” from outside into the capacitive sensor structure.
In order to not significantly impair the intrinsic elasticity of the sensor device, shielding electrodes are only provided locally where a possible scatter field emission from the electrode structures is greatest. The shielding electrodes are preferably designed in the form of a grid structure so that the elastic deformability of the entire sensor device is substantially preserved. In the case of capacitive interdigital electrode structures, as is the case in the exemplary embodiment according to
Thus, each interdigital electrode 5 and 6 is provided with its own shielding electrode 5o, 5u, 6o and 6u which has the same basic form as the interdigital electrode 5 and 6 itself and is separated by an insulating support structure intermediate layer 1′ which is mounted above or below layer 1′. As a result, the scatter capacity between the interdigital electrodes 5 and 6 and the shielding electrodes 5o, 5u, 6o and 6u is at least largely minimized in particular when the potential of each shielding electrodes 5u, 5o, 6u and 6o is tracked to the potential of the proximate interdigital electrodes 5 and 6.
Naturally, it is also possible to configure and arrange the shielding electrodes differently from the shape and size of the capacitive electrode arrangement.
Another embodiment which is not further illustrated, is also based on an interdigital structure which, however, is distinguished by a particularly high aspect ratio of the finger structures. Here the capacitance to be measured is principally composed of the parallel electrical field formed between two opposite electrode structures. From the production technology viewpoint, such a capacitive strain gauge can be designed in such a manner that a strip of highly elastic silicone material is coated on both sides with the electrically conductive polymer. The coating can be accomplished for example by a doctor blade technique or by evaporation. The coated strip is then rolled up in meander form and potted with the highly elastic silicone material. By contacting the conductive layers and applying a potential difference, a capacitance can also be detected here. As a result of mechanical deformation, a change in the space between the conductive layers occurs in this arrangement. This spatial difference results in a change in the capacitance which is a measurable quantity.
As already mentioned, the capacitive sensor principle according to the invention allows a wireless read out of the electrically measured signal by the known “grid dipping” principle. In this case, the sensor capacity of the electrode arrangement is connected to an electrical inductance to form an electrical oscillatory circuit. The inductance is constructively configured so that an electromagnetic alternating field that is emitted from outside by a transmitter can induce an electrical alternating current in the oscillatory circuit. If the frequency of the external alternating field corresponds to the electrical resonance frequency of the oscillatory circuit, the oscillatory circuit resonates and extracts a maximum of field energy from the external alternating field. This reduction in the field energy can be detected by the transmitter of the external alternating field. If the external transmitter now transmits an alternating field having time-variable frequency, it will then detect a selective interruption of the field energy at a resonance frequency of the oscillatory circuit. This allows the resonance frequency to be determined from outside. The resonance frequency of an oscillatory circuit comprising the capacitive electrode arrangement and the inductance depends, according to known physical laws, on the constant inductance of the coil and the variable capacitance of the electrode arrangement. Thus, the capacitance can be detected in a wireless manner via the detected variable resonance frequency.
In a practical embodiment, the inductance is integrated directly in the support structure. The connection to the sensor capacitance is also made inside the support structure. In this way, all electrical lines inside the support structure can be protected. An electrical feed-through of lines towards the outside is no longer necessary. In addition, the sensor signal can be read out in a wireless manner over a specific distance.
Number | Date | Country | Kind |
---|---|---|---|
10 2010 010 348.9 | Mar 2010 | DE | national |
PCT/EP2011/000974 | Feb 2011 | EP | regional |
Reference is made to German Patent Application Serial No. 10 2010 010 348.9, filed on Mar. 5, 2010, entitled “Implantable Device for Detecting a Vessel Wall Expansion,” and also filed as PCT/EP2011/000974, filed Feb. 28, 2011, which applications are incorporated herein by reference in their entirety. This application is a Continuation-In-Part of PCT/EP2011/000974.