CMUT array comprising an acoustic window layer
11358174 · 2022-06-14
Assignee
Inventors
- Lucas Johannes Anna Maria Beckers (Eindhoven, NL)
- Franciscus Johannes Gerardus Hakkens (Eindhoven, NL)
- Peter Dirksen (Eindhoven, NL)
Cpc classification
B06B1/0292
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
An ultrasound array for acoustic wave transmission comprising at least one capacitive micro-machined ultrasound transducer (CMUT) cell (6), wherein the CMUT cell comprises a substrate (4); a first electrode (7); a cell membrane (5) having a second electrode (7′), which opposes the first electrode and the substrate with a cavity (8) there between, wherein the membrane is arranged to vibrate upon the cell activation; and an acoustic window layer (13), overlaying the cell membrane, and having an inner surface opposing the cell membrane and an outer surface. The acoustic window layer comprises a first layer comprising molecules of antioxidant and a polymeric material (47) with insulating particles (41) embedded therein, wherein the polymeric material consists of hydrogen and carbon atoms and has a density equal or below 0.95 g/cm.sup.3 and an acoustic impedance equal or above 1.45 MRayl. This acoustic window layer provides an improved acoustic performance, such as wide bandwidth and low attenuation, in application with the CMUT based array.
Claims
1. An ultrasound array for acoustic wave transmission comprising at least one capacitive micro-machined ultrasound transducer (CMUT) cell, wherein the at least one CMUT cell comprises: a substrate; a first electrode; a cell membrane having a second electrode, wherein the cell membrane opposes the first electrode and the substrate with a cavity between the cell membrane and the substrate, wherein the cell membrane is arranged to vibrate upon a cell activation; and an acoustic window disposed directly over the cell membrane without a coupling medium between the acoustic window and the cell membrane, wherein the acoustic window comprises: an inner surface opposing the cell membrane; an outer surface configured to contact a body of a patient; a first layer comprising the inner surface and molecules of antioxidant mixed with a polymeric material, said polymeric material comprising a thermoset elastomer comprising polybutadiene, wherein the polybutadiene is in an uncured state or under-cured state, wherein the first layer is in direct contact with the cell membrane.
2. The ultrasound array of claim 1, wherein the acoustic window comprises a second layer comprising the outer surface and a material different from the first layer, wherein the second layer has a larger hardness than the first layer.
3. The ultrasound array of claim 2, wherein the first layer has an acoustic impedance between about 1.4 megarayl and about 1.6 megarayl, wherein a difference in the acoustic impedance between the first layer and second layer is smaller than about 0.3 megarayl.
4. The ultrasound array of claim 2, wherein the acoustic window comprises an additional layer disposed between the first layer and the second layer, wherein the additional layer comprises polyurethane configured to glue the first layer and the second layer together.
5. The ultrasound array of claim 2, wherein the material different from the first layer comprises a thermoplastic polymer comprising polymethylpentene.
6. The ultrasound array of claim 2, wherein the material different from the first layer comprises a thermoplastic polymer comprising polyethylene.
7. The ultrasound array of claim 1, wherein the at least one CMUT cell is configured for collapsed mode operation such that the first layer is in direct contact with a first side of the cell membrane and an opposite, second side of the cell membrane is in direct contact with the substrate.
8. A catheter comprising the ultrasound array according to claim 1.
9. The ultrasound array according to claim 1, wherein the ultrasound array has a fractional bandwidth above 80% or above 100%.
10. The ultrasound array according to claim 1, wherein the thermoset elastomer has particles embedded therein.
11. The ultrasound array according to claim 10, wherein the first layer comprises 4 to 24 percent, or 15 or 20 percent, by weight of the particles based on a total weight of the first layer.
12. The ultrasound array according to claim 10, wherein the particles have an average size smaller than one tenth of an acoustic wavelength transmitted by the ultrasound array.
13. The ultrasound array according to claim 10, wherein the particles have an average size in between 10 nanometer and 10 micrometer, in between 10 nanometer and 100 nanometer, or in between 1 micrometer and 10 micrometer.
14. The ultrasound array according to claim 1, wherein the molecules of antioxidant are molecules of phenolic stabilizer.
15. The ultrasound array according to claim 14, wherein each of the molecules of phenolic stabilizer has a hydrocarbon chain coupled to a hindered phenol group.
16. The ultrasound array according to claim 14, wherein a weight ratio of the molecules of antioxidant in the first layer is at most 0.3% or 0.1%.
17. An interventional device comprising the ultrasound array according to claim 1.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) In the drawings:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
DETAILED DESCRIPTION OF EMBODIMENTS
(12)
(13) Each CMUT cell has at least a pair of electrodes 7′ and 7 separated by a cavity 8. The cavity 8 is formed in between a membrane 5 that is suspended over a cell floor 31 formed by the top surface of the substrate 4. The membrane 5 may be made of silicon nitride and is adapted to move or vibrate. It can be suspended over the cell floor 31 (or substrate) through a plurality of supporting portions 9 (in
(14) According to the principles of the present invention, the membrane 5 of the CMUT cell is acoustically coupled to an acoustic window layer 13 overlaying the cell membrane, and having an inner surface opposing the cell membrane and an outer surface located in the opposite direction of the inner surface. The outer surface may be either a patient or an object facing side, which can be the subjects of the ultrasound examination. The acoustic window layer comprises antioxidant and a first layer comprising a polymeric material 47 with particles 41 embedded therein. In accordance with the present invention the polymeric material contains hydrogen and carbon atoms and has a density equal or below 0.95 g/cm.sup.3 and an acoustic impedance equal or above 1.4 MRayl. In particular, suitable materials may be selected from thermoset rubbers (elastomers).
(15) Due to the limited content of the polymeric material to hydrogen and carbon atoms, the density of the material is relatively low compared to other polymeric materials, in particular rubbers.
(16) Elastomers are generally characterized by wide-meshed crosslinking of the “knotted” molecular chains. This type of crosslinking means that the materials have a high level of dimensional stability but are still elastically malleable. By applying load (for instance tensile load) the chains become stretched, but after removal of the load they relax again. A typical hardness of the uncured elastomers is below 50 ShoreA, measured by a durometer (A scale). In general, cured (baked) elastomers exhibit higher hardness than 50 ShoreA. In order to keep the hardness below 50 ShoreA the elastomer comprising layer can under-cured (the solvent is not entirely evaporated as described in step); in addition in order to keep the elastomer from oxidizing over time under exposure to oxygen from the atmosphere the antioxidant molecules are added to the first layer as well. Elastomers can be also thermoset, the individual molecular chains of the thermosets are characterized by three-dimensional closely meshed irreversible crosslinking Thermoset elastomers are chemically and mechanically more stable among elastomers, moreover in contrast to not meltable “pure” elastomers, thermoset elastomers may be processed similar to thermoplastics.
(17) Suitable thermoset elastomers containing hydrogen and carbon atoms and having density equal or below 0.95 g/cm.sup.3 (in particular in between 0.85 and 0.95 g/cm.sup.3) are listed in Table 1. The chemical formula represents monomers used for the polymer chains formation. For example, the initial polymer chains of the polybutadiene and bytul rubbers comprise olefins (also referred as alkenes). During the cross-linking process of the thermoset manufacturing many double carbon-carbon bonds of the polymeric chains are broken to form a network of intrechain bonds (cross-links).
(18) TABLE-US-00001 TABLE 1 Examples of the thermoset elastomers containing hydrogen and carbon atoms and having a density equal or below 0.95 g/cm.sup.3 at temperature of 25 degrees centigrade. Density Thermoset (g/cm.sup.3) at elastomer Chemical formula 25° C. Polybutadiene
Depending on the application a thermoset elastomer with different hardness can be selected. Uncured polybutadiene rubber has a hardness below 50 ShoreA, while butyl rubber, which polymeric chains consist of two monomers: isobutylene and isoprene, may show hardness values as low as 40 ShoreA. In order to reduce the hardness even lower, fatty acids can be added into a liquid mixture of the elastomer material. This will be discussed below in detail.
(19) Polymeric materials having properties in accordance with the present invention showed to have a considerably lower attenuation (acoustic energy loss measured in dB per millimeter) for an acoustic wave having its frequency in range from 1 to 20 MHz.
(20) In accordance with the principles of the present invention the reported improvement in the acoustic wave transmission (lower attenuation) through the acoustic window layer 13 comprising the polymeric material 47, such as polybutadiene, can be attributed to the different mechanism of the electro-acoustical transformation in the CMUT compared to the PZT. The PZT-based transducer typically has a parallelepiped shape, wherein at least one of its faces is adapted to vibrate in a piston-like motion during the transmission of the acoustic wave. The displacement of the vibrating (active) face is homogeneous throughout the face surface.
(21) In contrast, the CMUT's vibrating membrane has a different displacement throughout the membrane's area (surface). In a conventional operation mode the membrane's displacement is highest in the central part of the CMUT cell and lowest at the periphery of the membrane. In a collapsed mode of operation as shown in
(22) The variation in the displacement of the membrane's vibrating portions imposes different requirements on the acoustic window layer properties in order to provide an improved acoustic coupling of the operating CMUT transducer. The acoustic window layer may need to adopt its inner surface to the membrane's displacement. The relatively light molecular weight of the monomers of the polymeric material 47, preferably thermoset elastomer, combined with the material's relatively low hardness (below 60 ShoreA, preferably below 50 ShoreA) may provide an improved acoustic contact between the acoustic window layer 13 and the CMUT's membrane adapted to vibrate. In addition the low acoustic wave attenuation of this polymeric material may provide an improved transition of the wave throughout the acoustic layer 13.
(23) It has been found that in the absence of antioxidant molecules acoustic layer comprising polybutadiene increases hardness of the polymeric material caused by aging due to its oxidation. When the hardness of the acoustic layer being in contact with the CMUT array increases above 60 Shore the layers acoustic transmission properties (for the CMUT array) are substantially reduced. It is undesirable to have an acoustic material having its properties changing with time, further it is even more undesirable to end up with an acoustic window layer having unsuitable acoustic wave transmission.
(24) In accordance to the present invention antioxidant molecules are added to the polybutadiene layer. For example, molecules of phenolic stabilizer can be used. Phenolic stabilizers are primary antioxidants that act as hydrogen donors in the polymeric layer. They react with peroxy radicals to form hydroperoxides and prevent the abstraction of hydrogen from the polymer backbone.
(25) In the present embodiment, sterically hindered phenol was used with uncured polybutadiene layer. The molecule of this antioxidant (BASF trade name Irganox 1076) has a hydrocarbon chain (or tail) coupled to a hindered phenol group (head).
(26) ##STR00006##
The hydrocarbon chain of the molecule of phenolic stabilizer improves mixing of the antioxidant with the polymeric material, such as polybutadiene, while a hindered phenol group forming a head of the molecule acts as a hydrogen donor thereby buffering oxygen from outside.
(27) Another embodiment of the present invention is illustrated in
(28) In order to vary a total hardness of the acoustic window layer 13, an additional layer a polyolefin thermoplastic elastomer may be selected. For example, copolymers having monomers of ethylene and alpha olefins, such as octane or butane. Thermoplastic elastomers (TPE), sometimes referred to as thermoplastic rubbers, are a class of copolymers or a physical mix of polymers (usually a plastic and a rubber) which consist of materials with both thermoplastic and elastomeric properties.
(29) It shall be understood by a person skilled in the art that additional layers providing the acoustic window layer with improved biocompatibility or elasticity properties may be introduced into the acoustic window 13.
(30)
FBW=2.Math.(f.sub.2−f.sub.1)/(f.sub.2+f.sub.1).
A relative sensitivity of this array is about 4 MPa per 100 V of an applied a.c. signal. The relative sensitivity is determined in the following way, for each given a.c. signal applied to the CMUT electrodes 7,7′ (for instance 20V) an output pressure is measured and then normalized to the output pressure achieved at 100V.
(31)
(32) The polymeric layer, especially thermoset elastomers, which contain hydrogen and carbon atoms and have density equal or below 0.95 g/cm.sup.3 may exhibit a low acoustic energy loss (attenuation) and a suitable acoustic impedance optimization.
(33) Acoustic impedance (Z) is defined as the product of acoustic propagation velocity (v) for acoustic energy (or wave) in a medium and density (ρ) of this medium:
Z=ρ*v.
These polymeric materials may have an acoustic impedance value of above 1.4 MRayl, which is closer to a soft tissue's impedance of about 1.6 MRayl. In order to minimize an impedance mismatch between the ultrasound array and the ultrasonicated tissue it may be desirable to further increase the acoustic impedance value of the acoustic window material comprising the polymeric layer. This can be achieved by adding a filler, such as particles 41 (preferably insulating), into the polymeric layer 47. The introduction of the particles into the polymeric layer increases a total density of the first layer. It has been discovered that the additional acoustic losses caused by the embedded insulating particles are sufficiently low and do not considerably influence a quality of the acoustic wave propagation through the polymeric layer.
(34) As an example, Table 2 shows the measured changes in acoustic properties of the polybutadiene layer with the introduction of zirconium dioxide (ZrO.sub.2) insulating particles having in average diameter of about 2.5 micrometer and taking a fixed percentage of a total weight of the first layer.
(35) TABLE-US-00002 TABLE 2 Changes in the density, acoustic wave velocity, acoustic impedance and attenuation (at frequency of 7 MHz) with an increasing percentage by weight of ZrO.sub.2 particles based on the total weight of the polybutadiene layer. % Density Velocity Impedance Attenuation @7 MHz ZrO2 (g/cm.sup.3) (mm/microsec) (MRayl) (dB/mm) 0 0.906 1.570 1.423 0.55 4% 0.937 1.553 1.455 0.75 8% 0.972 1.532 1.489 0.87 16% 1.0405 1.503 1.564 1.05 20% 1.0855 1.469 1.5945 1.25
(36) As can be seen from the table with the total density increase of the first layer comprising polybutadiene, the acoustic impedance of the layer can be tuned towards higher values, e.g. closer to the tissue's acoustic impedance, while the attenuation of the layer still remains below 1.5 dB/mm, even for the layers comprising 20% of its weight taken by the insulating particles (ZrO.sub.2). When the first layer of the acoustic window layer, comprising the antioxidant molecules and the polymeric material with embedded insulating particles, has a density equal or above 0.94 g/cm.sup.3 and an acoustic impedance equal or above 1.5 MRayl a direct acoustical coupling of the acoustic window layer to the membrane of the CMUT cell is provided. Thus, no additional coupling medium between the acoustic window and the CMUT array is required. Moreover, the acoustic impedance equal or above 1.5 MRayl matches closer to the impedance of the ultrasonicated tissue.
(37) The additional advantage of the polymeric materials containing hydrogen and carbon atoms and having a density equal or below 0.95 g/cm.sup.3 and an acoustic impedance equal or above 1.45 MRayl, preferably 1.5 MRayl, is that compared to commonly used silicon based rubbers (with a typical acoustic impedance value of round 1.1-1.2 MRayl) in ultrasound, these polymeric materials, in particular polybutadiene, possess higher acoustic impedance. Therefore, in order to tune the acoustic impedance of the polymeric layer 47 to a tissue's impedance a relatively smaller amount of the filler may be used, compared to the filled silicones. Since an introduction of the insulating particles to a layer on average increases its hardness, an application of the these polymeric materials having higher acoustic impedance provides the acoustic window layer 13 with relatively smaller changed hardness after filling (remaining below 60 ShoreA, preferably below 50 ShoreA) and a considerably lower attenuation (preferably below 1.5 or 2 dB/mm) compared to filled silicones. In order to bring the acoustic impedance of the filled silicon closer to the soft tissue's impedance, i.e. from 1.1 MRayl to 1.6 MRayl, a larger amount of the filler particles is required. This introduction of the particles introduces considerable attenuation and increases the hardness of the filled silicon layer.
(38) An optimum acoustical coupling of the acoustic window layer to the membrane of the CMUT cell can be provided by a combination of uncured polymeric material having low attenuation and acoustic impedance above 1.4 MRayl, which is also resistant to oxidation over time (aging); and a relatively constant hardness of the first layer with an introduction of the embedded insulating particles.
(39) An advantage of the application of the acoustic window layer comprising the first layer in accordance with the present invention becomes even more pronounced for the transducer arrays using CMUT cells operating in the collapsed mode. The collapsed mode of operation allows operating an ultrasound array in a wide range of acoustic waves frequencies, which can be tuned by varying a dc-bias voltage applied to the CMUTs electrodes. Thus, imposing higher requirements on the acoustic window layer bandwidth, compared to a conventional (non-collapsed) CMUT operation mode. The preferred bandwidth for the ultrasound array (preferably but not limited to the CMUT ultrasound array) overlaid by the acoustic window layer 13 in accordance with the principles of the present invention is above 80%, preferably above 100% or 120%. A different from the PZTs electrical to acoustic energy conversion principle used in the CMUTs makes CMUT arrays more demanding towards the acoustic window layers being in the direct contact with the CMUTs vibrating membranes, which may become even more pronounced for the collapsed mode of the CMUT operation.
(40) To have a better control over the attenuation properties of the first layer 47 the insulating particles may have an average size smaller than one tens of an acoustic wavelength. Preferably the average size of the particles is lower than one tens of the acoustic wavelength of the shortest wave within an operation bandwidth of the ultrasound array. The bandwidth may be selected based on the ultrasound application such as high frequency (above 15 MHz) and high image resolution cardio-imaging. When the average size of the particles becomes larger than the wavelength of the propagating wave, an additional scattering in the acoustic window layer may happen. This may introduce artifacts in an ultrasound image.
(41) Particular average sizes of the particles may be: in between 10 nanometer and 10 micrometer; in between 10 nanometer and 100 nanometer; or in between 1 micrometer and 10 micrometer. These ranges of the average particles cover main application of the ultrasound imaging systems at different frequencies. For example, for acoustic wave velocity of 1500 m/s one tens of the acoustic wavelength is: 150 micrometer for frequency of 1 MHz; 15 micrometer for frequency of 10 MHz and 5 micrometer for frequency of 30 MHz.
(42) In an embodiment of the present invention it may be beneficial in using ceramic particles as the insulating particles. Ceramic particles, such as metal oxides (ZrO2, Al2O3, TiO2, Bi2O3, BaSO4, etc.) show high insulating properties, which may be advantages in providing additional insulation to the arrays electronics. Moreover, there multiple ways developed in the art for manufacturing ceramic particles of a well-defined size.
(43) A developed industrial application of the polymeric materials is described further. In
(44) This method can be advantageously applied on industrial scale owing to the simplicity of the steps and large tolerance of the ultrasound array's performance to the acoustic layer window thickness. The layer thickness can be increased by repeating the steps of dipping 34 and drying 35. Due to the possibility of the impedance optimization in step 33 and low attenuation properties of the selected polymeric materials in accordance to the principles of the present invention, a local thickness deviation in the acoustic window layer from the average value can be higher than the accepted standard in commonly used spray or spin coat manufacturing. In addition to this manufacturing method provides flexibility in different chip designs and electrical contact bonding implemented in the array.
(45) For example,
(46) The method can be also beneficially used for different chip size, especially in the area miniaturized ultrasound arrays, such as interventional devices and catheters.
(47)
(48) The ultrasound imaging system is generally denoted with reference numeral 202. The ultrasound imaging system 202 is used for scanning an area or volume of the body, e.g. of a patient 201. It is to be understood that the ultrasound system 202 may also be used for scanning other areas or volumes, e.g. body parts of animals or other living beings.
(49) For scanning the patient 201, an ultrasound probe 200 may be provided. In the embodiment shown, the ultrasound probe 200 is connected to a console device 203. The console device 203 is shown in
(50) Further, the console device 203 comprises a display 204 to display display data generated by the ultrasound imaging system 202 to the user. By this, the volume within the patient 201 that is scanned via the ultrasound probe 200 can be viewed on the console device 203 by the user of the ultrasound system 200.
(51) The ultrasound probe 200 comprises the CMUT transducer array constructed in accordance with the present invention.
(52) Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims.
(53) In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality.
(54) A single unit or device may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.
(55) A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium, supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems.