Patent Application
20210177504
The present invention relates to systems, apparatuses, and methods for improving medical procedures and mapping.
Medical conditions such as cardiac arrhythmia (e.g., atrial fibrillation (AF)) are often diagnosed and treated via intra-body procedures. For example, electrical pulmonary vein isolation (PVI) from the left atrial (LA) body is performed using ablation for treating AF. PVI, and many other minimally invasive catheterizations, cause damage to targeted organ tissue to prevent electrical activity through the organ tissue.
Intra-body organs include tissue that can vary within different portion of the intra-body organ and that can also vary within different areas of chambers of the intra-body organ, such as different chambers of the heart. Accordingly, tissue proximity, as determined based on electronic signals provided by one or more electrodes may be based on the specific tissue properties at a given location of an intra-body organ, such as at different areas of a heart.
Methods, apparatus, and systems for medical procedures are disclosed herein and include receiving, at a location agnostic system and at a first time, a first plurality of electronic signals each from a respective plurality of electrodes of a catheter. A subset of electronic signals of the first plurality of electronic signals may be received at a location aware system. The location aware system may determine a location of the catheter within an intra-body organ. The location aware system may determine that the catheter is in contact with the tissue at the location, based on the subset of electronic signals and at least one tissue property at the location. A location agnostic system contact profile for the catheter may be generated based on determining, by the location aware system, that the catheter is in contact with the tissue at the location.
Methods, apparatus, and systems for medical procedures are disclosed herein and include a system for determining a contact profile, the system including a catheter that includes a plurality of electrodes configured to sense a first plurality of electronic signals. A location aware system may be configured to receive a subset of electronic signals from the first plurality of electronic signals, determine a location of the catheter within an intra-body organ, and determine that the catheter is in contact with the tissue at the location, based on the subset of electronic signals and at least one tissue property at the location. A location agnostic system may be configured to receive the first plurality of electronic signals each from the respective plurality of electrodes of the catheter and generate, at a first time, a location agnostic system contact profile for the catheter based on the determination, by the location aware system, that the catheter is in contact with the tissue at the location.
A more detailed understanding can be had from the following description, given by way of example in conjunction with the accompanying drawings wherein:
Intra-body organs, such as a heart, are often mapped, examined, and/or operated on using catheter based medical procedures. During a catheter based medical procedure, a catheter with multiple electrodes may be inserted into the intra-body organ. The multiple electrodes of the catheter may be used to, for example, map the surfaces of the intra-body organ based on proximity sensing such that a surface at a given location may be mapped if a determination is made that one or more electrodes are proximate to or in contact with the surface. The number of electrodes on the catheter may determine the resolution of the data captured by a catheter. Additionally, the number of electrodes may determine the flexibility in performing electrode-based procedures such as an ablation procedure. A higher number of electrodes may result in a higher resolution such that, for example, a larger data set may be collected based on the higher number of electrodes or a finer ablation procedure may be performed based on a higher number of electrodes.
Utilization of a higher number electrodes from one or more electrodes may depend on the ability of a system to determine if the number of electrodes are proximate to (e.g., in contact with) tissue of an intra-body organ. For example, in order to determine if electrodes of a catheter are in contact with tissue of a heart chamber, a system may need to determine if the electrodes of the catheter are in contact with the tissue of the heart chamber. A proximity determination may be made by determining that the impedance sensed at the location of a tissue is above an impedance threshold for that specific location.
The impedance threshold in a first area (e.g., a first area of the heart) may be different than the impedance threshold at a second area (e.g., a second area of the heart). The impedance thresholds may vary between different areas of an intra-body organ based on properties of the tissue corresponding to the different areas of the intra-body organ. For example, properties such as tissue thickness, tissue density, tissue type, and the like may affect the impedance thresholds to determine whether an electrode or catheter is proximate (e.g., in contact) with the tissue. Accordingly, an electrode measured impedance value X (e.g., change in impedance or percentage change in impedance) at a first location may correspond to the electrode being proximate to a tissue surface at the first location (e.g., in contact with a tissue surface) whereas the same electrode measured impedance value X at a second location may not correspond to the electrode being proximate to a tissue surface at the second location.
Accordingly, a proximity determination may be based on knowledge of the location of a catheter as well as calculation of a property (e.g., impedance) of the intra-body organ as detected by the electrodes. However, location aware systems may be limited in the number of electrode signals that such a location aware system can analyze, thereby limiting the resolution that may be made available by a catheter or group of catheters that exceed the electrode count past the limit of the location aware system. Exemplary embodiments of the present invention enable a location agnostic system to determine proximity using a location agnostic system contact profile (i.e., a tissue contact profile for determining proximity to tissue) that is based on proximity determinations by a location aware system that is providing a subset of signals from a subset of the electrodes.
The exemplary embodiments disclosed herein may enable the use of a resource intensive location aware system that may be limited to a certain number of electrode inputs (e.g., 22 inputs as disclosed in examples herein) in combination with a high resolution location agnostic system that is capable of analyzing a greater number of inputs (e.g., 120 inputs as disclosed in examples herein). Accordingly, one advantage of implementing the exemplary embodiments disclosed herein may be to use a cost effective high resolution location agnostic system to obtain a higher resolution of data in combination with an existing lower resolution but location aware system to correlate the high resolution data with location based attributes (e.g., location based tissue impedance thresholds).
According to exemplary embodiments, catheter 40 may be configured to map and/or ablate tissue areas of a cardiac chamber of heart 26. Inset 45 shows catheter 40 in an enlarged view, inside a cardiac chamber of heart 26. As shown, catheter 40 may include at least one electrode (or a plurality of electrodes 47A-N) coupled onto the body of the catheter 40. According to other exemplary embodiments, multiple elements may be connected via splines that form the shape of the catheter 40. One or more other elements (not shown) may be provided and may be any elements configured to ablate or to obtain biometric data and may be electrodes, transducers, or one or more other elements.
According to exemplary embodiments disclosed herein, the electrodes, such as electrodes 47A-N, may be configured to provide energy to tissue areas of an intra-body organ such as heart 26. The energy may be thermal energy and may cause damage to the tissue area starting from the surface of the tissue area and extending into the thickness of the tissue area.
According to exemplary embodiments disclosed herein, biometric data may include one or more of LATs, electrical activity, topology, bipolar mapping, dominant frequency, impedance, or the like. The local activation time may be a point in time of a threshold activity corresponding to a local activation, calculated based on a normalized initial starting point. Electrical activity may be any applicable electrical signals that may be measured based on one or more thresholds and may be sensed and/or augmented based on signal to noise ratios and/or other filters. A topology may correspond to the physical structure of a body part or a portion of a body part and may correspond to changes in the physical structure relative to different parts of the body part or relative to different body parts. A dominant frequency may be a frequency or a range of frequency that is prevalent at a portion of a body part and may be different in different portions of the same body part. For example, the dominant frequency of a pulmonary vein of a heart may be different than the dominant frequency of the right atrium of the same heart. Impedance may be the resistance measurement at a given area of a body part.
As shown in
As noted above, processor 41 may include a general-purpose computer, which may be programmed in software to carry out the functions described herein. The software may be downloaded to the general-purpose computer in electronic form, over a network, for example, or it may, alternatively or additionally, be provided and/or stored on non-transitory tangible media, such as magnetic, optical, or electronic memory. The example configuration shown in
According to an embodiment, a display connected to a processor (e.g., processor 41) may be located at a remote location such as a separate hospital or in separate healthcare provider networks. Additionally, the system 20 may be part of a surgical system that is configured to obtain anatomical and electrical measurements of a patient's organ, such as a heart, and performing a cardiac ablation procedure. An example of such a surgical system is the Carto® system sold by Biosense Webster.
The system 20 may also, and optionally, obtain biometric data such as anatomical measurements of the patient's heart using ultrasound, computed tomography (CT), magnetic resonance imaging (MRI) or other medical imaging techniques known in the art. The system 20 may obtain electrical measurements using catheters, electrocardiograms (EKGs) or other sensors that measure electrical properties of the heart. The biometric data including anatomical and electrical measurements may then be stored in a memory 42 of the mapping system 20, as shown in
Network 62 may be any network or system generally known in the art such as an intranet, a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a direct connection or series of connections, a cellular telephone network, or any other network or medium capable of facilitating communication between the mapping system 20 and the server 60. The network 62 may be wired, wireless or a combination thereof. Wired connections may be implemented using Ethernet, Universal Serial Bus (USB), RJ-11 or any other wired connection generally known in the art. Wireless connections may be implemented using Wi-Fi, WiMAX, and Bluetooth, infrared, cellular networks, satellite or any other wireless connection methodology generally known in the art. Additionally, several networks may work alone or in communication with each other to facilitate communication in the network 62.
In some instances, the server 62 may be implemented as a physical server. In other instances, server 62 may be implemented as a virtual server a public cloud computing provider (e.g., Amazon Web Services (AWS)®).
Control console 24 may be connected, by a cable 39, to body surface electrodes 43, which may include adhesive skin patches that are affixed to the patient 30. The processor, in conjunction with a current tracking module, may determine position coordinates of the catheter 40 inside the body part (e.g., heart 26) of a patient. The position coordinates may be based on impedances or electromagnetic fields measured between the body surface electrodes 43 and the electrode 48 or other electromagnetic components of the catheter 40. Additionally or alternatively, location pads may be located on the surface of bed 29 and may be separate from the bed 29.
Processor 41 may comprise real-time noise reduction circuitry typically configured as a field programmable gate array (FPGA), followed by an analog-to-digital (A/D) ECG (electrocardiograph) or EMG (electromyogram) signal conversion integrated circuit. The processor 41 may pass the signal from an A/D ECG or EMG circuit to another processor and/or can be programmed to perform one or more functions disclosed herein.
Control console 24 may also include an input/output (I/O) communications interface that enables the control console to transfer signals from, and/or transfer signals to electrodes 47A-N.
During a procedure, processor 41 may facilitate the presentation of a body part rendering 35 to physician 30 on a display 27, and store data representing the body part rendering 35 in a memory 42. Memory 42 may comprise any suitable volatile and/or non-volatile memory, such as random-access memory or a hard disk drive. In some exemplary embodiments, medical professional 30 may be able to manipulate a body part rendering 35 using one or more input devices such as a touch pad, a mouse, a keyboard, a gesture recognition apparatus, or the like. For example, an input device may be used to change the position of catheter 40 such that rendering 35 is updated. In alternative exemplary embodiments, display 27 may include a touchscreen that can be configured to accept inputs from medical professional 30, in addition to presenting a body part rendering 35.
As shown in the process flow chart 200 of
The plurality of electronic signals sensed by respective plurality of electrodes may be provided to/received by a location agnostic system. A location agnostic system may be any applicable system that is not aware of the location of the plurality of electrodes within the intrabody organ. The location agnostic system may include a processor (e.g., processor 40 of
At step 220 of the process 200 of
As described herein, a location agnostic system 330 may not receive or otherwise generate location information corresponding to the one or more catheters within an intra-body organ. Accordingly, the location agnostic system 330 may not be able to determine if a catheter or, more specifically, one or more electrodes are proximate to (e.g., in contact with) tissue of the intra-body organ. Notably, the location agnostic system 330 may not be able to determine if the catheter is proximate to such tissue without the location of the catheter because such proximity determinations may require location information to determine the correct impedance thresholds such that proximity can be determined based on whether received electronic signals meet the location specific impedance thresholds for tissue at the location.
At step 230 of the process 200 of
At step 240 of the process 200 of
At step 250 of the process 200 of
The location aware system 420 may be aware of the location of the catheter 405 and, based on the location of the catheter 405, may apply an impedance threshold to determine proximity (e.g., contact) with the tissue of the heart chamber 400. The location aware system 420 may determine that the subset of the electronic signals from the plurality of electrodes 405a-405n are in contact with the surface of tissue in the heart chamber 400, at a first time, based on a change in impedance values such that the change in impedance values exceeds the threshold impedance. The location aware system 420 may provide a contact indication 450 to the location agnostic system 430 upon determining contact with the intra-body organ tissue. According to an implementation, the percentage of change in impedance may be applied when determining if an impedance value exceeds the threshold impedance. Upon detection of the contact, the location agnostic system 410 may record the impedance values sensed by the plurality of electrodes 405a-405n at the first time. Notably, the impedance values determined by the location aware system 420 may differ from the impedance values determined by the location agnostic system 410 at the first time. However, based on the contact determination by the location aware system 420, the impedance values determined by the location agnostic system 410 for the plurality of electrodes 405a-405n may be stored as the location agnostic system profile 411 such that subsequent determination of impedance values that meet the location agnostic system profile are marked as contact with the tissue at the location.
At a second time, after the first time, the location agnostic system 410 may apply the location agnostic system profile to determine if the plurality of electrodes 405a-405n are in contact with the surface of tissue of the heart chamber 400. For example, the location agnostic system profile may be applied to a set of electrical signals received by the location agnostic system 410 at the second time. Electrodes that sense electronic signals that correspond to impedance values greater than those in the location agnostic system profile may be determined to be in contact with the tissue of heart organ 400. Electronic signals that correspond to impedance values greater than those in the location agnostic system profile may be considered to meet the location agnostic system profile such that they exceed impedance thresholds as provided in the location agnostic system profile.
After the determination of the location agnostic system profile, the location aware system 420 may not be needed to determine contact with the tissue surface of the heart chamber 400 at the location. According to an exemplary embodiment of the present invention, the location aware system 420 may be disconnected at the second time such that electrical signals from the one or more electrodes are only provided to the location aware system 410. Based on the process 200 of
As shown in
Notably, a location aware system (e.g., 420 of
Proximity (e.g., contact) indicated by the location agnostic system based on a location agnostic system profile may be used to map the surfaces of all or a part of an intra-body organ such as a heart chamber. Alternatively, or in addition, proximity indicated by the location agnostic system may be used to initiate ablation by an ablation electrode during a medical procedure.
Any of the functions and methods described herein can be implemented in a general-purpose computer, a processor, or a processor core. Suitable processors include, by way of example, a general purpose processor, a special purpose processor, a conventional processor, a digital signal processor (DSP), a plurality of microprocessors, one or more microprocessors in association with a DSP core, a controller, a microcontroller, Application Specific Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs) circuits, any other type of integrated circuit (IC), and/or a state machine. Such processors can be manufactured by configuring a manufacturing process using the results of processed hardware description language (HDL) instructions and other intermediary data including netlists (such instructions capable of being stored on a computer-readable media). The results of such processing can be maskworks that are then used in a semiconductor manufacturing process to manufacture a processor which implements features of the disclosure.
Any of the functions and methods described herein can be implemented in a computer program, software, or firmware incorporated in a non-transitory computer-readable storage medium for execution by a general-purpose computer or a processor. Examples of non-transitory computer-readable storage mediums include a read only memory (ROM), a random access memory (RAM), a register, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, and optical media such as CD-ROM disks, and digital versatile disks (DVDs).
It should be understood that many variations are possible based on the disclosure herein. Although features and elements are described above in particular combinations, each feature or element can be used alone without the other features and elements or in various combinations with or without other features and elements.
