Abstract
The embodiments include an apparatus used in combination with a computer for sensing biopotentials and electrode contact impedance. The apparatus includes a catheter in which there is a plurality of sensing electrodes, a corresponding plurality of local amplifiers, each coupled to one of the plurality of sensing electrodes, a data, control and power circuit coupled to the plurality of local amplifiers, and a photonic device bi-directionally communicating an electrical signal with the data, control and power circuit. An optical fiber optically communicated with the photonic device. The photonic device bi-directionally communicates an optical signal with the optical fiber. An optical interface device provides optical power to the optical fiber and thence to the photonic device and receives optical signals through the optical fiber from the photonic device. The optical interface device bi-directionally communicates electrical data, control, and power signal to the computer.
Claims
1. An apparatus for robotically performing electrophysiological and/or renal macros in combination with a remote mapping station comprising: a flexible catheter having a distal portion and a plurality of sensing electrodes included in the distal portion for sensing native biometric signals; one or more multiplexers included in the distal portion of the catheter and coupled to the plurality of sensing electrodes to multiplex the biometric signals; an amplifier circuit included in the distal portion of the catheter and coupled to the one or more multiplexers to amplify the biometric signals in the distal portion of the catheter; a microcontroller included in the distal portion of the catheter coupled to the amplifier circuit to digitize the biometric signals and to format the digitized amplified biometric signals according to a communications protocol; a flexible sheath coupled at a distal end to the distal portion of the catheter and including a digital communications cable and control wires; a remote handle coupled to a proximal end of the sheath, to the digital communications cable and to the control wires, the remote handle including a kinematic mechanism coupled to the control wires to selectively deflect a distal end of the catheter including the plurality of sensing electrodes, and the remote handle including circuitry for digitizing and/or formatting the digitized amplified multiplexed biometric signals for bidirectional transmission to the remote mapping station; and a robot engaging the remote handle for selectively deflecting the distal tip of the catheter, rotating the catheter and/or translating the catheter in response to computer commands to learn and/or execute electrophysiological and/or renal macros.
2. The apparatus of claim 1 where the distal portion of the catheter is comprised of at least a distal subportion and a separate proximal portion, the distal and proximal subportions being coupled by a flexible wiring cable, which allows relative rotation of the two subportions.
3. The apparatus of claim 2 where the distal subportion includes the plurality of sensing electrodes and the proximal subportion includes the multiplexers, amplifier circuit and microcontroller.
4. The apparatus of claim 1 where the amplifier circuit comprises an amplifier chain.
5. The apparatus of claim 4 where the amplifier chain comprises an instrumentation amplifier, an active filter coupled to the instrumentation amplifier and level shift amplifier coupled to the active filter.
6. The apparatus of claim 1 where the remote handle further comprises an impedance measuring circuit.
7. The apparatus of claim 1 where circuitry for digitizing and/or formatting the digitized amplified multiplexed biometric signals comprises a handle microcontroller.
8. The apparatus of claim 1 where circuitry for digitizing and/or formatting the digitized amplified multiplexed biometric signals comprises a power isolator and a signal isolator coupled to the circuitry carried on a printed circuit board which includes a copper free zone including the power isolator and the signal isolator isolating the circuitry from the mapping station.
9. The apparatus of claim 1 where the sensing electrodes, multiplexers, amplifier circuit and microcontroller are disposed on one or more flexible printed circuit boards included inside of the sheath having a predetermined French size.
10. The apparatus of claim 1 where the computer commands transmitted to the robot are stored and/or generated in the mapping station.
11. A method of robotically and dynamically controlling the movement of a catheter in a body organ cavity of a patient as directed by a surgeon comprising: disposing an optical catheter into the body organ cavity under manual control by the surgeon at one or more anatomical sites in the body organ cavity as chosen by the surgeon; recording the positions of the one or more anatomical sites in the body organ cavity as identified by the surgeon; measuring one or more biometric signals at a corresponding one or more positions in the body organ cavity using the catheter as identified by the surgeon; robotically moving the optical catheter in the body organ cavity on a path selected by the surgeon to the one or more anatomical sites and/or positions in the body organ cavity; generating a map of the biometric signals from positions on the path; and displaying the map.
12. The method of claim 11 where recording the positions of the one or more anatomical sites in the body organ cavity comprises recording the positions of the one or more anatomical sites in the body organ cavity as corrected for dynamic movement of the body organ within the patient, of cardiac movement, of respiratory movement, and of patient movement.
13. The method of claim 12 where recording the positions of the one or more anatomical sites in the body organ cavity comprises identifying selected ones of the anatomical sites and/or positions as sites or positions respectively requiring medical mediation.
14. The method of claim 13 where identifying selected ones of the anatomical sites and/or positions as sites requiring medical mediation comprises identifying a path in the body organ cavity along which medical mediation is required.
15. The method of claim 13 further comprising robotically performing a medical mediation procedure at selected ones of the anatomical sites and/or positions as sites or positions respectively.
16. The method of claim 11 where measuring one or more biometric signals at a corresponding one or more positions in the body organ cavity using the catheter as identified by the surgeon comprises measuring local cardiac or local renal signals from positions with the body organ cavity contacted by the catheter.
17. The method of claim 11 where measuring local cardiac or local renal signals from positions with the body organ cavity contacted by the catheter comprises measuring cardiac or local renal signals substantially free of any far-field signals.
18. The method of claim 11 where the optical catheter is an electrophysiology catheter and further comprising robotically and automatically performing a cardiac mediation procedure in a heart at selected ones of the anatomical sites and/or positions as sites or positions respectively as automatically guided by the generated map of the biometric//signals of the heart.
19. The method of claim 15 further comprising using artificial intelligence to analyze the generated map of biometric signals and to generate from the map a program of controlled robotic movement and operation of the catheter to automatically perform the medical mediation procedure at selected ones of the anatomical sites and/or positions as sites or positions respectively.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0073] FIG. 1 is a perspective view of the catheter tip, sheath and manually operated handle includes three views of the smart catheter electronic components and its scaffold, starting with an external side view at the top, an internal side view in the middle and an internal top view of the circuit-carrying components at the bottom. FIG. 1.1, included in an inset in FIG. 1A, is perspective view of the printed circuit board layout of the catheter tip. FIG. 1.2, included in an inset in FIG. 1A, is an enlarged perspective view of the distal end of the catheter sheath. FIG. 1.3, included in an inset in FIG. 1A, is an enlarged side transparent or internal view of the manual handle connected to the proximal end of the catheter. FIG. 1.4 is a side cross-sectional view of handle, and FIG. 1.5 is an exploded perspective view of handle. FIG. 1.6 is side transparent view of catheter tip and the opposing pair of pull wires along with a safety wire fixed to tip to insure its retention on the catheter.
[0074] FIG. 2 is a circuit block diagram of the Huygens catheter assembly depicting the distal tip subassembly containing all functional elements for the detection, amplification, digitization, multiplexing, and communication of the native signal using multiple split electrodes.
[0075] FIG. 3 is a circuit block diagram of the circuits in the catheter handle which includes the functional elements that detect contact pressure of the electrode with tissue, enabling the discerning genuine contact with the tissue from other kinds of contact conditions.
[0076] FIG. 4 is a schematic diagram of two views of geometry of the distal end of the catheter with the tip electrode, the split electrodes, and their configuration with a set of vias corresponding to the individual electrodes. A side internal view is provided above and an internal top view below. A circuit block diagram of corresponding circuitry of FIG. 2 is shown above the two internal views identifies in the figure the elements in the electrode array and in the associated circuitry as the circuitry carried by the printed circuit views shown in enlarged scale.
[0077] FIG. 5 shows two internal top plan layouts of the Huygens catheter distal electrode flex circuit, the interconnecting cable and the interface to the electronic circuit assembly, the upper plan layout is a pictorial illustration of the distal electrode flex circuit and interface and the lower plan layout is a diagrammatic depiction of the distal electrode flex circuit connected by the interconnecting cable to the interface. A block diagram of the corresponding circuitry in FIG. 2 is shown above the two internal top plan views and identifies the interconnecting cable.
[0078] FIG. 6 is a diagram of the isolation and trilateralization circuit and is identified in the circuit block diagram of FIG. 2 above the diagram.
[0079] FIG. 7.1 is a block diagram of the multiplexing circuit located proximal to the flexible printed circuit board (FPC) and FIG. 7.2 shows its physical placement on the FPC is a perspective view. In FIG. 7.3 the multiplexing circuit is identified in the circuit block diagram of FIG. 2 to the left side of the diagram.
[0080] FIG. 8.1 is a schematic circuit diagram depicting the amplification elements of the Huygens catheter with its physical location on the FPC shown in FIG. 8.2 in perspective view depiction. FIG. 8.3 identifies on the circuit diagram of FIG. 2 the corresponding portion of the circuitry.
[0081] FIG. 9.1 is a schematic circuit diagram of the A/D processing circuit for the DC voltage potential with its physical location on the FPC shown in FIG. 9.2 in perspective view. FIG. 9.3 identifies on the circuit diagram of FIG. 2 the corresponding portions of the circuitry.
[0082] FIG. 10.1 is a schematic circuit diagram of the data transmission elements with their physical location on the FPC shown in FIG. 10.2. FIG. 10.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry.
[0083] FIG. 11.1 is a block circuit diagram of the cardiac signal flow elements with their physical layout on the FPC shown in FIG. 11.2 with the wiring labels. FIG. 11.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry.
[0084] FIG. 12.1 is a circuit block diagram of communication elements used between the electrodes and the electronic circuit with their physical layout on the FPC shown in FIG. 12.2. FIG. 12.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry.
[0085] FIG. 13.1 is a schematic circuit diagram of the impedance measuring circuit with its physical layout on the FPC shown in FIG. 13.2. FIG. 13.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry.
[0086] FIGS. 14.1 and 14.2 are schematic circuit diagrams of the universal asynchronous receiver-transmitter (UART) for the communication protocol and the signal integration of the cardiac signal output with its physical layout on the FPC shown in FIG. 14.3. FIG. 14.4 identifies on the circuit diagram of FIG. 2 the corresponding circuitry.
[0087] FIG. 15.1 is a schematic diagram of the power circuitry and isolation technique of the Huygens catheter with its physical layout on the FPC shown in FIG. 15.2. FIG. 15.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry.
[0088] FIG. 16 is a perspective view of the robotic navigation device without catheter loaded as shown on the left side and with catheter inserted as shown on the right side of the figure.
[0089] FIG. 17 is a perspective side view of the robotic navigation device shown some of its mechanical components.
[0090] FIG. 18 is an exploded perspective view of the robotic navigation device better displaying some of its mechanical components.
[0091] FIG. 19 is a top perspective view of the robotic navigation device.
[0092] FIG. 20 is a side plan view of the robotic navigation device with the catheter loaded in it.
[0093] FIG. 21 is a top plan view of the robotic navigation device with the catheter loaded in it.
[0094] The disclosure and its various embodiments can now be better understood by turning to the following detailed description of the preferred embodiments which are presented as illustrated examples of the embodiments defined in the claims. It is expressly understood that the embodiments as defined by the claims may be broader than the illustrated embodiments described below.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0095] FIG. 1 is a perspective representation of a catheter 100 employed in the Huygens Catheter as described below, with its three main subassemblies: 1) the distal end of the catheter FPC 120, 2) the overlay sheath 5, and 3) the catheter handle 200 having a kinematic mechanism therein as partially seen in FIG. 1.3 for differentially tensioning the pulley wires to deflect the catheter tip 120. The kinematic mechanism is described in more detail in incorporated application Ser. Nos. 16/424,202 and 17/468,460, and is shown in greater detail in FIGS. 1.4-1.6. FIG. 1.4 is a side cross-sectional view of handle 200 and FIG. 1.5 is an exploded perspective view of handle 200. Knob 202 has internal threading and threadably engages a piston 203 by means of opposing pairs of tabs 205 riding in the threading of knob 202 in order to move piston 203 longitudinally within handle 200 as knob 202 is rotated. Pull wire 7 has one end fixed within handle 200 and is coupled by a stop or other means to the proximal end of piston 203, led around pulley wheel 211, then led distally out of handle 200 to and fixed to catheter tip 120. The opposing pull wire 7 is also fixed to catheter tip 120 and is led proximally back to handle 200 where it is led through end 209 of piston 203 and fixed to handle 200. Both ends of pull wires 7 fixed to handle 200 are spring loaded to allow resilient tension to be maintained on pull wires 7. Differential tension or extension applied by piston 203 by means of knob 202 causes catheter tip 120 to be deflected or allows it to straighten. FIG. 1.6 is side transparent view of catheter tip 120 and the opposing pair of pull wires 7 along with a safety wire 213 fixed to tip 120 to insure its retention on the catheter.
[0096] The size of the sheath 5 is typically 6 or 7 French for use in the cardiovascular system and all circuitry and chips must be dimensioned to fit within the inner diameter of a catheter of that size, while still maintaining the required flexibility. Hence, the sizing and placement of rigid integrated circuit chips and their associate wiring must be carefully thought out and the following figures shown an embodiment in which such placements or layouts can be realized. The catheter assembly includes a handle 200, a distal end flex circuit 120 carrying the sensing electrodes 111-119, a protective overlay sheath 5, enclosing the entire assembly, including a sleeve ring 6 to which a safety wire 135, shown in FIG. 1A, and a pair of pulley wires 7 are affixed. Pulley wires 7 are disposed in PTFE liners to insure lubrication and sheath 5 is coated with an inner PTFE layer and reinforced with a flexible braid. Handle 200 includes a rotatable knob 202, which selectively tensions each of the pair of opposing pulley wires 7 to deflect catheter tip 120. The proximal flex section 150 of the assembly in FIG. 1.1 includes the electronic processing unit is electrically connected via a wire bundle 140 to FPC 120. The structural as well as functional elements of the novel catheter and its intended use are detailed below.
[0097] FIG. 1A includes three views of the smart catheter electronic components and its scaffold, starting with an external side view at the top, an internal side view in the middle and an internal top view of the circuit-carrying components at the bottom. These views of the catheter 100 depict the placement of the major electronic elements included in the Huygens catheter assembly. The catheter 100 provides the sensing elements, such as the set of electrodes 111-119 mounted on a distal tip 110 and attached to a flex printed circuit board (PCB) 120 to provide the necessary metrics customary in an electrophysiological study, for example the metrics provided by an electrode assembly having a spacing of 2 mm between a tip electrode 111 and a first pair of electrodes 112-113, another spacing of 2 mm between the first pair 112-113 and a second pair of electrodes 114-115, a spacing of 5 mm between the second and a third pair of electrodes 116-117 and a spacing of 2 mm between the third and a fourth and last electrode pair 118-119. These metrics are preserved to provide a standard for an electroanatomical waveform.
[0098] A safety wire 135 connects the distal tip electrode 111 to the sleeve 6. The proximal end flex circuit 150 carries the electronic assembly which enables the DC potential signal to be sensed by the electrodes 111-119, and thereafter digitized, amplified, filtered, multiplexed and transmitted via a communication protocol to the electronics in handle 200. The details of this signal flow are described in the subsequent figures. A programming flap 182 is provided for programming the digital circuits in proximal FPC 150 and is removed or cut off once the circuits have been programmed.
[0099] FIG. 2 is a circuit block diagram of the Huygens catheter assembly depicting the distal tip subassembly containing all functional elements for the detection, amplification, digitization, multiplexing, and communication of the native signal using multiple split electrodes. The block diagram of the catheter assembly depicts the distal tip 110 with its signal acquisition electrode inputs 111-119, connected via wire bundle 140 to the proximal end flex circuit 150 to capture the sensing potential from the endocardial surface of the heart, to multiplex (multiplexers 172, 174) and amplify the signals via a set of amplification stages, digitize the amplified signals and to transmit the multiplexed, digitized, amplified native heart signal from the endocardial surfaces via a communication protocol to an external conventional mapping station (not shown).
[0100] The circuit diagram of FIG. 2 depicts the major functional elements that form the Huygens catheter, items such as the signal processing circuits comprised of a 2-1 MUX 172, an 8-1 MUX 174, an instrumentation amplifier 176, a bandpass filter 177, a level shift amplifier gain 175, a microcontroller unit (MCU) 179, programmable gain circuit 182 controlling instrumentation amplifier 179, a charge pump 183, a 3.3V low dropout regulator (LDO) 184, an RS-485 input/output circuit (I/O) 180, and universal asynchronous receiver/transmitter (UART) 185. Electrodes 111-113 are selectively used to sense contact impedance using control signals Impedance IN and OUT, and cardiac signals as described below. The sensed signals are multiplexed into an amplifier chain 176, 177 175, digitized by MCU 179 and formatted into an UART 185 protocol and line driver 180. The multiplexed digital output/input of the circuitry of FIG. 21 is presented at line driver 180 as the transmission signals TX+. TX and input signals RX+, RX.
[0101] FIG. 3 is a circuit block diagram of the Huygens catheter assembly depicting the distal tip subassembly containing all functional elements for the detection, amplification, digitization, multiplexing, and communication of the native signal using multiple split electrodes. The circuit diagram depicts the handle electronic circuit containing a microcontroller 270 which maintains the communication with and control of the flex circuit 150 in FIG. 2 as well as the Impedance measuring circuit (IMC) 255 and communication protocol. The handle 200 serves multiple requirements, namely it includes an impedance circuit 255 which enables the catheter sensing element to determine whether the catheter electrodes 110 are in contact with the endocardial surfaces of the heart, or if the electrodes 110 are nested in the heart chamber and blood pool. The handle electronics of FIG. 3 includes a MCU 270 sets the priorities for communication of the signal from and to the distal and proximal electronics. The handle circuitry includes the RS-485 line driver 260, MCU 270, 3.3V LDO 272, charge pump 274, power isolator 276, signal isolator 278, UART decoder 280 and UART encoder 281. Bidirectional data and control signals, RX+, RX, TX+, TX are input and output from line driver 260 into and from the internal ADC and DMA of MCU 270. The impedance measuring circuit 255 is also coupling bidirectional impedance signals Impedance IN and Impedance OUT into and out of MCU 270. Data is serialized in MCU 270, formatted by UART 281 and communicated through an isolator 278 to a UART transceiver 279. Catheter power management is also provided by the circuitry in handle 200 though LDO 272, charge pump 274, and power isolator 276.
[0102] FIG. 4 is a schematic diagram of two views of geometry of the distal end of the catheter with the tip electrode, the split electrodes, and their configuration with a set of vias corresponding to the individual electrodes. A side internal view is provided above as an internal top view below. A circuit block diagram of corresponding circuitry shown in FIG. 2 above the two internal views identifies the elements 110 in the electrode array and in the associated circuitry. In addition a temperature sensor 132 (also shown in FIG. 2) compensates for variations of temperature to control a baseline of the signal is provided. Each electrode 110 has a dedicated connection to its corresponding via except for the first ring electrode (E2). Top and bottom half-ring electrodes 114, 115 (E3-E4) on the first ring are shorted together and identified as the E2 signal, since half-ring electrodes 114, 115 (E3-E4) need to function as a bipolar pair with the nosecone electrode (E1).
[0103] FIG. 4 further depicts the elements that form the distal end of the catheter distal tip 110 which includes the nose electrode 111, electrode split-rings 112-119 mounted on flex PCB 120, connected via distal FPC pads 121-130 to the proximal end circuit 150. One of the preferred embodiments of this geometric layout includes the use of split electrodes on each of the axial layouts of the quadrupolar catheter configuration, whereby the distal most electrode pair 112-113 is able to pick up the DC potential signal from the endocardial surface as either electrode 111 or its counterpart pair 112-113 are touching the endocardial surface thereby providing a signal via the impedance measuring circuit 255 located at the handle electronic board 250, which sends an AC test current through the tip electrode 111 in combination with electrode pair 112-113 to sense impedance to determine whether the catheter electrodes 110 are in contact with the endocardial surface or situated within the blood pool in the heart chamber. Such determination is further described in detail by FIG. 13, where the usefulness and clinical value of this circuit is further described.
[0104] FIG. 5 shows two internal top plan layouts of the Huygens catheter distal electrode flex circuit, the interconnecting cable 140 and the interface to the electronic circuit assembly. The upper plan layout in FIG. 5 is a pictorial illustration of the distal electrode flex circuit and interface and the lower plan layout in FIG. 5 is a diagrammatic depiction of the distal electrode flex circuit connected by the interconnecting cable 140 to the interface. A block diagram of the corresponding circuitry of FIG. 2 shown is shown above the two internal top plan views and identifies the interconnecting cable 140. FIG. 5 illustrates certain manufacturing and physical attributes of the Huygens catheter. The layout further shows the distal flex circuit 120 FPC tabs (MPAD1-MPAD10) which are connected to a set of vias located at the end of the distal FPC 120 by employing a 40 AWG Daburn wire bundle 140. The number system describes the sequence of the electrodes and their location. Proximal FPC (MPAD1-MPAD10) through 40 AWG Daburn wires are bundled in a strand. For assembly convenience, the corresponding vias have same numbering.
[0105] Distal FPC 120 containing the electrodes with distal FPC tabs 121-130, wire bundle 140, proximal end 150, proximal FPC tabs 161-170 are shown for clarity, and their separation with the bundle of interconnecting wire 140 enables free rotation of the distal catheter tip 120 along the Y- and Z-axis for rotation and along the X-axis for translation without any limitation associated with the stiffness of the catheter shaft because of electronic circuit FPC 155 or the distal FPC 120. Both FPC 155 and FPC 120 are linked mechanically by wire bundle 140 to enable a high degree of movement along any axis.
[0106] FIG. 6 is a diagram of the isolation and trilateralization circuit shown and is identified in the circuit block diagram above the diagram. The isolation and trilateralization circuit is where conventional RF trilateralization signals to map the position of the catheter 100 are picked up from electrodes 111-119 and independently carried with a set of wires through the shaft of the catheter 100 and are transmitted to an external system, such as a conventional CARTO/EnSite NavX, where trilateralization is computed and displayed using position and orientation vector data collected from external RF patches mounted on the body of the patient according to conventional electrophysiology practice, and augmented with additional information such as impedance, DC potential, timing and temperature, and varieties of other electrical parameters as disclosed below. FIG. 6 depicts the proximal FPC 155, which receives the signals from the electrodes 111-119 provided to proximal FPC tabs 161-170 each through a Schottky protection diode 171.
[0107] FIG. 7.1 is a block diagram of the multiplexing circuit located proximal to the flexible printed circuit board (FPC) and FIG. 7.2 shows its physical placement on the FPC is a perspective view. In FIG. 7.3 the multiplexing circuit is identified in the circuit block diagram of FIG. 2. The inputs from nosecone electrode 111 in FIG. 4 and first ring electrodes (E1 & E2) 112-113 are coupled to a pair of 2-to-1 MUXs 172. These sets of electrodes have a dual-function and their use is determined by the MCU 270 located in the handle 200 which switches the use of the electrodes 112-113 for either impedance measurement (contact or non-contact of the electrodes to endocardial surface), or for DC potential measurement of the endocardial surface. The IMP SEL pins of the 2-to-1 MUX 172 control which function these electrodes serve. The outputs of the two MUXs 172 along with the rest of 6 input signals (E3-E8) connected to 8-to-1 MUX 174 are multiplexed to a single analog signal. Each input via from proximal FPC 161-170 (MPAD1-MPAD8) has an ESD protection diode 173 (D3-D10). Electrodes E1, E2, E3, E5, and E7 have split traces that connect to the mapping station such as a conventional EnSite NavX/CARTO (not shown) for the purpose of tri-lateralization of locating signals as described in FIG. 6. FIG. 7 further depicts the distal tip 110, proximal end 150, proximal FPC tabs 161-170, Schottky diode 171, 2-1 MUX signal converter 172, protection diode 173, and 8-1 MUX 174.
[0108] FIG. 8.1 is a schematic circuit diagram depicting the amplification elements of the Huygens catheter with its physical location on the FPC shown in FIG. 8.2 in perspective view depiction. FIG. 8.3 identifies on the circuit diagram of FIG. 2 the corresponding portion of the circuitry. The amplification is provided where the multiplexed analog signals enter instrumentation amplifier 176 (MAX41400), and are referenced to the patient's right leg, where a standard bipolar recording is provided utilizing a right limb lead to enable the measurement of the potential difference between the catheter and its limb reference point. The amplifier 176 has a programmable gain set to 200x. After the initial amplification, the signal is input to a second order Butterworth lowpass filter 177 configured in a Sallen-Key topology. The filter 177 is designed to have-3 dB cutoff frequency at 1 KHz in order to filter out the trilateralization signals. The second stage of the operational signal amplifier 175 shifts the entire signal so that its voltage range is entirely in positive domain. FIG. 8.1 depicts the distal tip 110, proximal end 150, 8-to-1 MUX 174, Instrumentation amp 176, Butterworth bandpass filter 177, and signal amp 175.
[0109] FIG. 9.1 is a schematic circuit diagram of the A/D processing circuit for the DC voltage potential with its physical location on the FPC shown in FIG. 9.2 in perspective view. FIG. 9.3 identifies on the circuit diagram of FIG. 2 the corresponding portions of the circuitry. FIG. 9.1 illustrates the A/D processing of the DC voltage potential, where the amplified signal is input into (STM32G031Y8Y6TR) microcontroller MCU 179 where its internal ADC (not shown) converts the processed cardiac signal into digital format. The microcontroller (MCU) 179 also collects the temperature data from MPAD9. Thereafter, the MCU 179 compiles these converted digital signals and outputs in a UART format with a BAUD rate of 4 Mbps. The microcontroller MCU 179 is programmed through J1 tab 182, which is removed once the component has been programmed.
[0110] FIG. 10.1 is a schematic circuit diagram of the data transmission elements with their physical location on the FPC shown in FIG. 10.2. FIG. 10.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry. FIG. 10.1 depicts the data transmission scheme, where the UART signal is processed through an RS-485 transmitter 186 and receiver 187 before sent to the handle PCB (HAN300001) 251. RS-485 transmitter 186 allows the data transmission to be done in a differential paired mode, providing immunity over EMI in a long strand of wires.
[0111] FIG. 11.1 is a block circuit diagram of the cardiac signal flow elements with their physical layout on the FPC shown in FIG. 11.2 with the wiring labels. FIG. 11.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry. FIG. 11.1 depicts the cardiac signal flow, whereby the 40-AWG Daburn wires 205 from the tip are connected to the distal portion of handle PCB 251 (HAN300001). As shown in the assembly drawing, the via labeling for wiring connection corresponds to the tip FPCs for ease of wire assembly. From the handle 200 to the external devices, bigger diameter wires are used, resulting in bigger vias (1 mm hole diameter).
[0112] FIG. 12.1 is a circuit block diagram of communication elements used between the electrodes and the electronic circuit with their physical layout on the FPC shown in FIG. 12.2. FIG. 12.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry. FIG. 12.1 illustrates the communication format between the electrodes and the electronic circuit 261, which outputs the RS-485 differential pair signals connected to vias MPAD16 to MPAD18. These signals are input into full-duplex RS-485 driver 260, where the signals are converted back to a UART format. The converted UART signals are input to the microcontroller 270 and processed.
[0113] FIG. 13.1 is a schematic circuit diagram of the impedance measuring circuit with its physical layout on the FPC shown in FIG. 13.2. FIG. 13.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry. FIG. 13.1 illustrates the impedance measuring circuit, comprising an impedance converter AD5933 254 and two operational amplifiers 256, 257. Impedance converter AD5933 254 sends a small current to MPAD19 which is communicated to the 2-to-1 MUX 172 at the proximal FPC 155. When the read signal is asserted, the impedance-reading current travels through the nosecone electrode 111 and returns to the first ring electrodes 112-113. The current returns to the handle 200 via MPAD20, and back to impedance converter AD5933 254. The calculated impedance is sent to the microcontroller (MCU) 270 via an inter-integrated circuit (I2C) communication protocol.
[0114] FIGS. 14.1 and 14.2 are schematic circuit diagrams of the universal asynchronous receiver-transmitter (UART) for the communication protocol and the signal integration of the cardiac signal output with its physical layout on the FPC shown in FIG. 14.3. FIG. 14.4 identifies on the circuit diagram of FIG. 2 the corresponding circuitry. FIGS. 14.1 and 14.2 illustrate the UART communication protocol and the signal integration of the cardiac signal output, where the microcontroller MCU 270 combines the digital input from the tip FPC 120 and the impedance data. The MCU 270 combines all the data and outputs the combined data via a UART protocol. To comply with medical device regulations, all signals and power must be isolated. Therefore, the UART signals are optically isolated before connecting to an external programmable logic controller (PLC). The circuit of FIG. 14.2 depicts the serial communication channel 1 265, serial communication channel 2 266, handle MCU 270, power isolator 276, and signal isolator 278.
[0115] FIG. 15.1 is a schematic diagram of the power circuitry and isolation technique of the Huygens catheter with its physical layout on the FPC shown in FIG. 15.2. FIG. 15.3 identifies on the circuit diagram of FIG. 2 the corresponding circuitry. FIG. 15.1 shows that the power circuitry and isolation circuitry of the Huygens catheter receives +5V power from PLC's USB connector 285. The voltage and ground from external PLC (not shown) is isolated before it powers the catheter 100. The 3.3V low dropout voltage regulator (LDO) 272 supplies local electronic components while the isolated +5V and the 5V that is generated from the charge pump 274 is connected to the tip FPCs. FIG. 15.3 depicts the catheter handle electronics 250, serial communication channel 1 265, serial communication channel 2 266, handle MCU 270, handle LDO 272, handle charge pump 274, power isolator 276, and power input 285.
Proteus Robot
[0116] FIG. 16 is a perspective view of the robotic navigation device 400 without catheter 100 loaded as shown on the left side and with catheter 100 inserted as shown on the right side of the figure. FIG. 17 is a perspective side view of the robotic navigation device shown some of its mechanical components, showing the top carriage assembly 410, baseplate 420, proximal pillow block 430, distal pillow block 440, deflection-rotary drive (DRD) 450, rotary drive 452, linear translation drive (LTD) 460, angle mounting system (AMS) 470. Handle 200 is disposed in device 400. DRD 450 engages knob 202 to bidirectionally rotate it using a computer controlled electric motor and toothed belt combination to selectively deflect the catheter tip 120. DRD drive 452 uses a computer controlled electric motor and toothed belt combination to selectively rotate the body of handle 200 thereby rotating the catheter as a unit. Linear translation drive 460 uses a computer controlled linear electric motor to selectively translate the upper portion of device 400, namely pillow blocks 440 and 430 to translate handle 200 carried therein and catheter 100. The angular inclination of lower platforms 420 and 470 are varied using a scissor hinge connecting platforms 420 and 470. FIG. 18 is an exploded perspective view of the robotic navigation device better displaying some of its mechanical components, showing again the top carriage assembly 410, baseplate 420, proximal pillow block 430, distal pillow block 440, deflection-rotary drive (DRD) 450, linear translation drive (LTD) 460, angle mounting system (AMS) 470. FIG. 19 is a top perspective view of the robotic navigation device 400. FIG. 20 is a side plan view of the robotic navigation device with the catheter loaded in it. FIG. 21 is a top plan view of the robotic navigation device with the catheter loaded in it.
[0117] Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiments have been set forth only for the purposes of example and should not be taken as limiting the scope of the invention.
[0118] Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following claims. For example, not withstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly under stood that the invention includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other but may be used alone or combined in other combinations. The excision of any disclosed element of the invention is explicitly contemplated as within the scope of the invention.
[0119] The words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.
[0120] The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a sub combination or variation of a sub-combination. Accordingly, the scope of the invention is limited only by the claims and equivalents thereto.
