MRI compatible 3-D intracardiac echography catheter and system
11039811 · 2021-06-22
Assignee
- Georgia Tech Research Corporation (Atlanta, GA)
- The United States Of America, As Represented By The Secretary, Department Of Health And Human Services (Bethesda, MD)
Inventors
- Fahrettin Levent Degertekin (Atlanta, GA, US)
- Coskun Tekes (Alpharetta, GA, US)
- Robert Jay Lederman (Chevy Chase, MD, US)
- Ozgur Kocaturk (Bethesda, MD, US)
- M. Wasequr Rashid (Atlanta, GA, US)
- Maysam Ghovanloo (Atlanta, GA, US)
Cpc classification
A61B8/12
HUMAN NECESSITIES
G01S15/8925
PHYSICS
A61B8/546
HUMAN NECESSITIES
B06B1/0292
PERFORMING OPERATIONS; TRANSPORTING
A61B1/05
HUMAN NECESSITIES
G01S7/5208
PHYSICS
International classification
A61B8/00
HUMAN NECESSITIES
A61B1/05
HUMAN NECESSITIES
A61B8/12
HUMAN NECESSITIES
Abstract
An intracardiac imaging system has an MRI compatible intracardiac echography catheter having transmitters, receivers, a multiplexer, and a beamformer. The catheter can include an atraumatic tip disposed on the distal end of the catheter, a pair of inductively coupled coils proximal the atraumatic tip, at least one CMUT-on-CMOS volumetric imaging chip disposed between the pair of coils, and a cable lumen disposed within the volume sized to house a small number of electrical connections due to significant multiplexing in the CMUT-on-CMOS chip. The catheter can be made of MRI compatible materials and can include active cooling channels.
Claims
1. An ultrasound imaging catheter comprising: a plurality of transmitters configured to transmit an imaging pulse; a plurality of receivers configured to receive the imaging pulse, at least a portion of the plurality of receivers configured to generate a receiver signal; a multiplexer configured to receive a number of the receiver signals simultaneously and configured to generate a number of output signals, based on the received receiver signals, the number of output signals being fewer than the number of received receiver signals; and a beamformer configured to communicate with at least a portion of the plurality of transmitters, wherein the ultrasound imaging catheter is compatible with magnetic resonance imaging (“MRI”).
2. The catheter of claim 1, wherein the ratio of the number of receiver signals simultaneously received by the multiplexing component to the number of output signals is between 15-to-1 and 50-to-1.
3. The catheter of claim 1, wherein the catheter is visible with MRI.
4. The catheter of claim 3, wherein the ultrasound imaging catheter is visible with X-ray imaging.
5. The catheter of claim 1, further comprising at least one inductively or conductively coupled marker for catheter tracking with MRI.
6. The catheter of claim 1 further comprising a housing containing the plurality of transmitters, the plurality of receivers, the multiplexer, and the beamformer, wherein the housing is compatible with MRI.
7. The catheter of claim 6, further comprising output signal cables disposed within the housing, wherein the output signal cables are compatible with MRI.
8. The catheter of claim 1, wherein the multiplexing component produces the output signals using time division multiplexing (“TDM”).
9. The catheter of claim 1, wherein the multiplexing component reduces the number of output signals, based on the receiver signals, by a ratio of at least 16-to-1.
10. The catheter of claim 1, further comprising a first capacitive micromachined ultrasonic transducer on complementary metal-oxide-semiconductor (“CMUT-on-CMOS”) chip in which the plurality of transmitters, the plurality of receivers, the multiplexer, and the beamformer are integrated.
11. The catheter of claim 10, wherein the plurality of transmitters comprises capacitive micromachined ultrasonic transducer (“CMUT”) transmitters; and wherein the plurality of receivers comprises CMUT receivers.
12. The catheter of claim 11, wherein the CMUT receivers are positioned proximate to the CMUT transmitters; wherein each CMUT receiver is configured to generate a receiver signal; wherein the multiplexer is configured to receive at least half of the generated receiver signals simultaneously and is configured to reduce a number of output signals, based on the received receiver signals, by a ratio of between 15-to-1 and 50-to-1; and wherein the beamformer is configured to communicate simultaneously with the CMUT transmitters.
13. The catheter of claim 1, wherein a first capacitive micromachined ultrasonic transducer on complementary metal-oxide-semiconductor (“CMUT-on-CMOS”) chip comprises at least a portion of the plurality of transmitters and from none to all of the plurality of receivers; wherein a second CMUT-on-CMOS chip comprises a remainder of the plurality of transmitters and a remainder of the plurality of receivers; wherein the first CMUT-on-CMOS chip and the second CMUT-on-CMOS chip are oriented in a stacked configuration.
14. An intracardiac ultrasound echography catheter having an internal volume, a proximal end and a distal end, the catheter comprising: an atraumatic tip disposed approximate the distal end of the catheter; an inductively or conductively coupled marker for catheter tracking under magnetic resonance imaging (“MRI”); a plurality of transmitters disposed proximal of the tip, the plurality of transmitters configured to transmit an imaging pulse; a plurality of receivers configured to receive the imaging pulse, and at least a portion of the plurality of receivers configured to generate a receiver signal; a multiplexer configured to receive at least a portion of the generated receiver signals simultaneously and produce a number of output signals, based on the received receiver signals, by a ratio of between 15-to-1 and 50-to-1; a beamformer configured to communicate with at least a portion of the plurality of transmitters; and a cable lumen disposed within the internal volume configured to receive output signal cables.
15. The catheter of claim 14, wherein the catheter is approximately 6 French to approximately 10 French.
16. The catheter of claim 14, wherein the catheter further comprises a cooling lumen configured to cool the catheter.
17. The catheter of claim 14, wherein the catheter further comprises: a first inductively coupled coil proximal to the atraumatic tip; and a second inductively coupled coil distal to the atraumatic tip, wherein the first and second coils are visible with MRI.
18. The catheter of claim 14, wherein the catheter further comprises: a body comprising at least one MRI compatible material; and a direction wire comprising at least one MRI compatible material disposed in a directional wire lumen, wherein the catheter is configured to be used during at least one of interlaced and simultaneous MRI and ultrasound operation.
19. The catheter of claim 14, wherein the multiplexer produces the number of output signals using time division multiplexing (“TDM”).
20. The catheter of claim 14, wherein the catheter is visible with X-ray imaging.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) This invention is described with particularity in the appended claims. The above and further aspects of this invention may be better understood by referring to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
(2) The drawing figures depict one or more implementations in accord with the present teachings, by way of example only, not by way of limitation. In the figures, like reference numerals refer to the same or similar elements.
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DETAILED DESCRIPTION OF THE INVENTION
(23) To facilitate an understanding of the principles and features of the various embodiments of the invention, various illustrative embodiments are explained below. Although exemplary embodiments of the invention are explained in detail, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the invention is limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or carried out in various ways. Also, in describing the exemplary embodiments, specific terminology will be resorted to for the sake of clarity.
(24) It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. For example, reference to a component is intended also to include composition of a plurality of components. References to a composition containing “a” constituent is intended to include other constituents in addition to the one named.
(25) Also, in describing the exemplary embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.
(26) Ranges may be expressed herein as from “about” or “approximately” or “substantially” one particular value and/or to “about” or “approximately” or “substantially” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and/or to the other particular value.
(27) Similarly, as used herein, “substantially free” of something, or “substantially pure”, and like characterizations, can include both being “at least substantially free” of something, or “at least substantially pure”, and being “completely free” of something, or “completely pure”.
(28) By “comprising” or “containing” or “including” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.
(29) It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Similarly, it is also to be understood that the mention of one or more components in a composition does not preclude the presence of additional components than those expressly identified.
(30) The materials described as making up the various elements of the invention are intended to be illustrative and not restrictive. Many suitable materials that would perform the same or a similar function as the materials described herein are intended to be embraced within the scope of the invention. Such other materials not described herein can include, but are not limited to, for example, materials that are developed after the time of the development of the invention.
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(32) The 3D MRICE catheter 100 is similar in mechanical properties and steerability to current 2D ICE, and thus less likely to fail clinically. One example, as illustrated in
(33) As an example, the imaging can be done over a 90°×90° field of view (“FOV”) at 5 cm and narrowing to 45°×45° at 15 cm. This is one example of a desired spatial range of most ASD, ventricular septal defect (“VSD”), left atrial appendage (“LAA”) occlusion, and mitral procedures. Within this framework, 3D MRICE catheter 100 can provide: (1) Collection of full volumetric ultrasound image data over 5-15 cm penetration depth with less than 10 transmit firings; (2) high information rate over few transmission lines; (3) catheter and operational design to avoid MRI interference, and (4) thermal management of RF catheter heating.
(34) To provide these benefits, the key features of the invention are:
(35) 1. CMUT-on-CMOS technology implementing large aperture 2D receive arrays with more than 100 elements and about 100 μm×100 μm element size for large FOV and integrated low noise electronics to obtain high SNR.
(36) 2. On-chip electronics that allow for massively parallel RF data transfer (in an example, greater than 200 MHz bandwidth per line) to capture volumetric image data in few transmit firings.
(37) 3. On-chip electronics and backend processing strategies for volumetric imaging with minimal motion artifacts, from simply defocused/focused, temporally coded defocused/focused to spatially coded multiplane phased array transmit beamforming implementation. This feature, along with massively parallel RF data transfer, can allow up to 50× reduction in cable count as compared to conventional cabling.
(38) 4. A 3D ICE catheter with as few as 14 transmission lines to minimize RF heating under MRI, and concurrent or (if necessary) coordinated MRI RF excitation to minimize MRI interference.
(39) 5. A closed-loop actively cooled MRI safe ICE catheter design using materials and techniques to minimize MRI artifacts and RF heating.
(40) 6. Inductively or conductively coupled marker coils for catheter tracking under MRI with minimized RF heating.
(41) Sample array designs for 3D MRICE development are summarized in
(42) Another example ICE2 206 design improves the lateral resolution beyond current 2D ICE arrays by Tx beamforming in both directions and operating at 10 MHz center frequency. It can also achieve ˜2 mm slice thickness in elevation at 5 cm. Another example ICE3 208 design can add phased array capability with spatial and temporal coding. In this example, an image over a 2D plane can be obtained during each Tx firing. Up to 90 plane images, which can be displayed in multiplanar format, can be collected to form the 3D volume. In this case the volumetric image is formed plane by plane where image for each plane is collected using one or two transmit firings. Improved resolution in ICE2 206 and ICE3 208 can be realized using improved SNR from design improvements, coding, and increasing the imaging frequency. In this example, these approaches enable full volumetric imaging with minimum motion artifacts. Although Doppler flow is not considered, flow measurement over 2D planes can be implemented as part of the real time imaging system using correlation techniques over frames obtained during consecutive firings.
(43) In other examples of the invention, the on-chip electronics with massive RF multiplexing for fast full volume imaging overcomes one of the challenges for on-chip electronics. The examples of the invention can overcome the difficulty of the parallel readout of 192 Rx channels over 8 RF transmission lines during each firing. Overcoming this existing limitation can reduce the total number of transmission lines. This can be achieved by FDM or TDM using interleaved samples from different Rx channels on the same line. This same technique can be used to reduce the number of cables for 1D ICE arrays for other purposes including making them suitable for use under MRI.
(44) A multiplexing component 301 is illustrated by example using a FDM solution can be analog Quadrature Amplitude Modulation (“QAM”), which is a form of FDM. An example of a FDM solution using QAM 300 is illustrated in the overall electronics schematic of
(45) The average power can be much lower since even in the ICE2 206 design, the chip can be active for only 18 ms of a 50 ms duty cycle at 20 frames/second. Even when the average power consumption of the Tx side is added, the overall figure can be significantly lower than 3-4 W consumed in 2D ICE catheters, again due to lower duty cycle. An on-chip temperature 320 sensor can be implemented for continuous monitoring of MRI induced heating, and the chip can have a shut off feature when the temperature exceeds 43° C.
(46) On the transmit side, a beamforming component 350 can be used and is illustrated in an example having each CMUT transmitter element 352 connected with a high voltage on chip pulser 354. To change the FOV depth from 5 cm to 15 cm, the pulse repetition rate can be changed. In one example, this can be done by using an on-chip counter 354. A temporal and spatial coded excitation sequence can be used in the ICE chips 300, the code can be stored on-chip using a flash memory array, floating gate arrays or can be generated using digital logic circuits and a clock signal. For programming the on-chip flash memory, a few extra cables can be required which can be cut off once the chip is programmed before mounting on the catheter 100.
(47) In an example of ICE1 204, DC voltages can be applied directly, or DC voltages can be generated on chip from an AC input signal to improve electrical safety and to further reduce the transmission line count to 14. This represents 15×, 25× and 50× reduction in transmission line number as compared to traditional implementations of the ICE1, ICE2, and ICE3 arrays 204, 206, 208, respectively, considering that ICE3 308 array has 704 elements.
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(49) In an example, the proximal shaft 402 can be reinforced with non-metallic fibers (e.g., Vectran® or Kevlar®) instead of Nitinol or MP35N alloy braiding wires. The non-metallic fibers can preserve catheter pushability and torquability. The catheter 300 can have a cylindrical enclosure 108 to house the side looking CMUT-on-CMOS chip 102, 204, 206, 208, and a round atraumatic distal tip 110. A semi-rigid polymer or MRI compatible metals can be used in the enclosure body depending on the final design.
(50) In a manufacturing example, the enclosure 108 can be designed using 3D CAD software (e.g., Wildfire 4.0, Pro-Engineer). A metal model from the CADs can be manufactured from thin wall nitinol tube using 4-axis laser metal processing equipment (e.g., ProLas, Lasag Laser Industries) and the polymer model can be formed using a rapid prototyping system (Uprint, Strasys Inc., MN).
(51) Non-planar inductively coupled marker coils or loop coils 106 (that can provide separate receive channels connected to a scanner via coaxial transmission lines) can be embedded into both ends of the enclosure groove 108, in order to impart unambiguous real-time MRI visibility and trackability to the catheter 100. While the SNR of inductively coupled coils can be orientation dependent, this example allows further miniaturization by eliminating coaxial transmission lines, which occupy valuable space within the catheter shaft and which also would contribute to RF induced heating.
(52) The example of the multi-lumen thermoplastic catheter shaft 402 shown in
(53) A distal tip deflector mechanism 414 (see
(54) The system can handle any RF induced heating of the transmission lines when under MRI. Although the CMUT-on-CMOS silicon chip 102 is not expected to heat under MRI, the cooling can also remove the heat conducted to the chip through the solder connections. The two separate lumens 412 can converge at the distal end and can connect to a rotary circulation pump. The liquid circulation speed can be adjusted based on the real time temperature measurement through embedded thermistor probe located on the CMUT-on-CMOS chip 102, 204, 206, 208 in the 3D MRICE catheter 300. The temperature data can be transmitted on one of the RF output cables when no imaging data is being collected and before the power is turned off for the next frame. The 3D MRICE system can provide that data to the display located in the MR control room and also to the cooling system controller that adjusts the rotary circulation pump speed within predetermined range. Both the controller and the rotary circulation pump can be located in the MRI control room. The temperature data can be projected to the MRI room for the operator's review. The 3D MRICE catheter handle 416 can provide dedicated buttons to control deflection amount and direction for each plane with single-handed operation. The proximal end of the handle also has dedicated ports to be connected to the imaging equipment and the cooling pump.
(55) The imaging system can include a graphics processing unit (“GPU”) based real-time 3D MRICE volumetric imaging and graphical user interface (“GUI”) for flexibility in implementing different beamforming schemes and image processing, as illustrated in
(56) The other relevant system and processing requirements of the ICE arrays 204, 206, 208 are given in
(57) For real time volume rendering and multi-plane image reconstruction, an Open Source framework for medical image reconstruction, the Gadgetron, which has recently been developed at the NHLBI and at Aarhus University, Denmark, can be utilized. Several previous projects have already demonstrated that it is indeed possible to obtain the desired volumetric rendering rates on the GPU, and that high performance open source software tools are available, as well as several tutorials from leading graphics conferences. The GUI for this application can resemble commercial 3D TEE and can depict multiplanar 2D images and surface-rendered 3D volumes. It also can allow 3D point-marker placement for complex geometry assessment.
(58) In a further example of the multiplexing component, the reduction of cables of ICE can also be achieved by implementing on-chip high frequency TDM.
(59) In an example of ICE1 204, DC voltages can be applied directly, or DC voltages can be generated on chip from an AC input signal to improve electrical safety and to further reduce the transmission line count to 14. This represents 15×, 25× and 50× reduction in transmission line number as compared to traditional implementations of the ICE1, ICE2, and ICE3 arrays 204, 206, 208, respectively, considering that ICE3 308 array has 704 elements.
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(62) For demodulation, the received signal is mixed with orthogonal sine and cosine signals at the modulation frequency and then low pass filtered to get back the message signals as:
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(66) Specifics regarding some of the components of the OFDM multiplexing component 800 are illustrated in
(67) The STD 806 can convert the single ended signal of the TIA 804 to a fully differential signal. Fully differential signal processing reduces the effect of external noises, clock injection and even order harmonic and increases dynamic range.
(68) The passive mixer 810 can be designed to modulate the outputs of multiple (in this example 8) different LPFs 808 with orthogonal carrier frequency of 40 MHz, 80 MHz, 120 MHz and 160 MHz.
(69) The buffer 814 can be a current feedback source degenerated push-pull type. A simulated bandwidth of the buffer 814 can be ˜350 MHz for a load of 35 pf∥1MΩ. Further, a clock generator 816 can be provided. In an example, two clocks of 240 MHz and 320 MHz are supplied externally. Using divide by 3, and a walk-in-ring oscillator circuit, the 40 MHz orthogonal carrier signals are generated from 240 MHz signals. Using divide by 2, and a walk-in-ring oscillator circuit, the 80 MHz orthogonal carrier signals can be generated from 320 MHz. 120 MHz and 160 MHz orthogonal carriers can be generated by feeding 240 MHz and 320 MHz clocks directly to walk-in-ring oscillator respectively.
(70) A simulation of the OFDM multiplexing component 800 was performed in a CADENCE environment using Specter circuit simulation tool. Post layout simulation was performed of the individual blocks and the entire system.
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(72) Although not detrimental, cross talk between the channels, lower than −20 dB, is also observed which may be due to the non-ideal single to differential, differential to single conversion or mixing. To verify the functionality of the entire designed chip 7 MHz 80% BW Gaussian pulses with different phase were applied to all 8 channels and modulated.
(73) While the present disclosure has been described in connection with a plurality of exemplary aspects, as illustrated in the various figures and discussed above, it is understood that other similar aspects can be used, or modifications and additions can be made to the described aspects for performing the same function of the present disclosure without deviating therefrom. For example, in various aspects of the disclosure, methods and compositions were described according to aspects of the presently disclosed subject matter. However, other equivalent methods or composition to these described aspects are also contemplated by the teachings herein. Therefore, the present disclosure should not be limited to any single aspect, but rather construed in breadth and scope in accordance with the appended claims.