METHOD FOR LOCATION OF AN IMPLANTABLE MEDICAL DEVICE

专利摘要:
device and method for navigation and catheter tip location. Devices and methods for obtaining and using endovascular electrograms in various applications and clinical settings are disclosed. in one embodiment, methods are disclosed for triggering analysis of an endovascular ecg waveform based on the detection of a peak in a skin-based ecg waveform in order to determine a location of an implantable medical device, for example , a catheter. in another embodiment, the position of a catheter or other medical device within the vasculature can be determined by analyzing the energy profile of a detected p-wave. in still other embodiments, magnetic connection devices are disclosed for establishing a connection operable through a sterile field.
公开号:BR112012019354B1
申请号:R112012019354-6
申请日:2011-02-02
公开日:2021-09-08
发明作者:Sorin Grunwald
申请人:C.R.Bard, Inc；
IPC主号:

专利说明:

CROSS REFERENCE WITH RELATED ORDERS
This application is a continuation in part of US Patent Application No. 12/854,083, filed August 10, 2010, which is a continuation in part of US Patent Application No. 12/815,331, filed June 14, 2010 , which claims the benefit of Provisional US Patent Application No. 61/213,474, filed June 12, 2009, the disclosures of which are hereby incorporated by reference in their entirety. This application also claims the benefit of Provisional U.S. Patent Application No. 61/282,397, filed February 2, 2010, the disclosure of which is incorporated herein by reference in its entirety. FUNDAMENTALS OF THE INVENTION
The heart's electrical conduction system creates specific electrical signals, electrical energy distributions and behaviors that are indicative of specific locations in the chest cavity and/or specific cardiac functions or conditions. When measured endovascularly, that is, from within blood vessels or from within the heart, certain parameters of the electrical activity of the heart can be used to identify specific locations in the cardiovascular system and/or functional conditions, whether normal or abnormal. In addition, by locally and accurately identifying the location and type of condition, therapy for these conditions can be optimized and the effect of therapy monitored in real-time.
Two types of clinical applications are typically addressed. The first is related to the guidance of endovascular devices through the cardiovascular system, while the second is related to non-invasive or minimally invasive remote monitoring of the electrical activity of the heart.
Guidance, positioning, and confirmation of placement of endovascular catheters is required in a variety of clinical applications, for example: 1. Central venous access, eg, CVC, PICC, implantable tubes; 2. Hemodialysis catheters; 3. Placement of pacemaker electrodes; 4. Hemodynamic monitoring catheters, eg Swan-Ganz and central pressure monitoring catheters; and 5. Orientation of guidewires and catheters in the left heart.
The location of the catheter tip is very important for patient safety and for the duration and success of the procedure. Today's gold standard for confirming the target location of the catheter tip is the chest X-ray. In addition, there are currently two types of real-time guidance products available on the market that attempt to overcome the limitations of chest X-ray confirmation: electromagnetic and ECG-based. In hospitals where real-time guidance is used, results have improved in terms of reducing the number of X-rays, procedure time and procedure cost. Under real-time guidance, the first time success rate typically increased from 75%-80% to 90%-95%. Furthermore, in hospitals where ECG guidance is used, for example in Italy, Belgium and Germany, chest X-ray confirmation has been eliminated for more than 90% of patients. Electromagnetic systems are mainly used in the United States, while ECG-based systems are mainly used in Europe. Among other factors that determine the difference between the markets in the United States and Europe in terms of technology adoption: a) type of health professionals authorized to perform the procedures: nurses have more flexibility in the United States, b) type of devices placed: PICCs are placed more and more frequently in the United States, c) price sensitivity: the European market appears to be more price sensitive, and d) current guidance devices are marketed by specific manufacturers to work exclusively with their catheters: market penetration of Guidance systems reflect the market penetration of the catheter manufacturer.
It was also found that there are different opinions as to where the target point's location should be: for example, lower third of the SVC or RA. Therefore, guidance technologies must allow discrimination of these locations. Chest X-ray, which is the current gold standard, does not always allow for this discrimination, which requires an accuracy typically better than 2 cm. Furthermore, as ECG-based systems make use of physiological information related to cardiac activity, their ability to guide placement is accurate with respect to anatomy. This is not the case with electromagnetic guidance systems that measure the distance between the tip of the catheter in the vasculature and an external reference typically placed on the patient's chest. Because of this aspect, ECG-based systems can be used to document the end result of catheter placement potentially replacing the chest X-ray as the gold standard.
One of the most valuable diagnostic tools available, the ECG records the electrical activity of the heart as waveforms. By interpreting these waveforms, it is possible to identify rhythm disturbances, conduction abnormalities, and electrolyte imbalances. An ECG helps in diagnosing and monitoring these conditions, such as acute coronary syndromes and pericarditis. The electrical activity of the heart produces currents that radiate through the surrounding tissue to the skin. When electrodes are attached to the skin, they sense these electrical currents and transmit them to the electrocardiograph. Because the heart's electrical currents radiate to the skin in many directions, electrodes are placed at different locations on the skin to get a full picture of the heart's electrical activity. The electrodes are then connected to an electrocardiograph device, or computer, and record information from different perspectives, which are called leads and planes. A lead provides a view of the electrical activity of the heart between two points or poles. A plan is a cross-section of the heart that provides a different view of the heart's electrical activity. Currently, the interpretation of an ECG waveform is based on identifying waveform component amplitudes, analyzing and then comparing the amplitudes with certain patterns. Modifications of these amplitude components are indicative of certain conditions, eg ST segment elevation or certain locations in the heart, eg P wave amplitude. In today's practice, ECG monitors are widely used to record shapes ECG waveform. More and more frequently applications become available for automatically identifying the amplitude components of the ECG. In certain cases, tools are available to support decision making and for automatic interpretation of ECG amplitude components in relation to underlying cardiac conditions.
Remote patient monitoring is a well-established medical field. Still, remote monitoring of cardiac conditions is not as widely accepted as it would be necessary and possible. One of the reasons is related to the relatively complicated way of acquiring signals related to cardiac activity, in particular ECG signals. Another important limiting factor of current remote monitoring technologies is the use of communications channels, for example, the telephone line, which are difficult to interface with both the patient and the physician. BRIEF SUMMARY OF THE INVENTION
Briefly, embodiments of the present invention are directed to systems, devices and methods for obtaining and using endovascular electrograms (or electrocardiograms/ECGs) in various applications and clinical settings. For example, the devices can be used to guide endovascular devices in and around the heart, eg, guide central venous access devices in the superior vena cava, right atrium and right ventricle. These central venous access devices can include central venous catheters (CVC), peripherally inserted central catheters (PICC), implantable tubes, hemodialysis catheters, tunneled catheters, and others.
In one aspect, one or several skin electrodes are used to obtain ECG signals on the skin surface simultaneously with the acquisition of endovascular (intracavitary) electrogram (ECG) signals through the use of endovascular (intracavitary) electrodes. Simultaneous and synchronized cutaneous surface and endovascular ECG signals are used in one of several ways to analyze and quantify ECG signals as a function of endovascular lead location, for example, as a function of the tip of a catheter.
In light of the above, in one modality, the ease of use of ECG-based navigation and catheter tip location is increased. In one aspect, for example, skin reference ECG waveforms are simultaneously displayed on a monitor with endovascular ECG waveforms measured at the tip of a catheter or other implantable medical device. This simultaneous acquisition and display of concomitant ECG signals allows for prompt interpretation of the endovascular ECG waveform at the catheter tip. In another aspect, a skin ECG reference signal is used to synchronize information processing algorithms applied to the endovascular ECG signal, generating results of increased reliability with respect to the P-wave changes of the endovascular ECG signal in terms of shape and energy.
In more detail, in one modality, a cutaneous ECG signal can be used as a reference and compared with an endovascular ECG signal in order to detect changes in the endovascular ECG relative to the cutaneous ECG.
In another modality, the analyzes of synchronized cutaneous and/or endovascular ECG signals can be linked to each other and/or to the periodic electrical activity of the heart. For example, a skin ECG lead can be used to detect the QRS complex R peak of a detected skin ECG waveform. Detection of the R peak in the cutaneous ECG waveform can be used to trigger analysis of the endovascular ECG signal on simultaneously corresponding segments of the endovascular ECG waveform, for example, on the segment that corresponds to the P wave. useful in the case of arrhythmia, where the cutaneous ECG waveform typically does not demonstrate a consistent P wave, whereas the endovascular ECG waveform actually includes a detectable P wave segment that changes as a function of location in the vasculature.
In another embodiment, a cutaneous ECG lead can be used to monitor the patient's cardiac activity and, at the same time, an endovascular ECG lead is employed to guide a catheter or other suitable implantable or endovascular devices through the vasculature. In another embodiment, R peaks detected in the skin ECG waveform are used to trigger correlation computation and other types of signal processing in the endovascular ECG signal to allow efficient noise reduction in the resulting endovascular ECG waveform.
In another aspect, a connector for establishing an operable connection between a catheter in the patient's sterile field and an ECG cable outside the sterile field is described, allowing a single operator use of the device for navigation and location of the catheter tip here introduced.
In another aspect, algorithms are introduced that allow the mapping of certain ECG waveforms to corresponding locations in the vasculature. In one embodiment, the algorithm analyzes directional electrical energy present at the tip of a catheter or other endovascular device capable of detecting endovascular ECG signals. In another modality, the algorithm can map the catheter tip to a certain location in the vasculature based on endovascular ECG signals to allow for catheter navigation.
In another aspect, a simplified graphical user interface is disclosed, which reveals a movable graphic indicator over a heart icon to indicate a location of a catheter tip in the vasculature as determined by the endovascular ECG signal. The graphic indicator can include different colors and shapes, for example, dots or arrows, for example. The colors and shapes of the graphic indicator may change depending on the location of the tip in the vasculature.
In another aspect, there is disclosed an ECG signal acquisition module which is operably connectable, via a suitable interface, to a cell phone or other portable electronic device. This allows control of the ECG signal acquisition module, including the analysis of the ECG signal, by a mobile phone user. In another modality, the ECG signal acquisition module can be operationally connected via an interface to other handheld or remote devices.
In another aspect, a user interface is included for use in connection with the cell phone or other portable device to allow ECG signal-based guidance of endovascular devices over the cell phone. In another embodiment, the user interface allows the use of the cell phone to support the analysis and archiving of ECG signals, catheter information, and results of a catheter placement procedure. In another modality, the user interface optimizes ECG signal acquisition for remote patient monitoring via cell phone or other handheld device.
Thus, certain modalities of the invention have been described quite broadly so that their detailed description can be better understood, and so that the present contribution to the art can be better appreciated. There are, of course, additional embodiments of the invention which will be described below and which will form the subject of the appended claims.
In this regard, before explaining at least one embodiment of the invention in detail, it should be understood that the embodiments are not limited in their application to the construction details and component arrangements shown in the following description or illustrated in the drawings. In fact, other modalities besides those described here can be conceived, practiced and carried out in various ways. Furthermore, it should be understood that the phraseology and terminology used here, as well as in the abstract, are for the purposes of description and should not be considered as limiting.
Accordingly, those skilled in the art will note that the design upon which this disclosure is based can easily be used as a basis for the design of other structures, methods, and systems to accomplish the various purposes of embodiments of the present invention. It is important, therefore, that the claims be considered to include these equivalent constructions, insofar as they do not depart from the spirit and scope of this revelation.
These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by practicing embodiments of the invention as set forth herein below. BRIEF DESCRIPTION OF THE DRAWINGS
A more particular description of the present disclosure will be made by reference to its specific embodiments which are illustrated in the accompanying drawings. It should be noted that these drawings reveal only typical embodiments of the invention and therefore should not be considered as limiting its scope. Exemplary modalities of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:
FIG. 1A is a block diagram describing an apparatus in accordance with an embodiment of the present invention.
FIG. 1B is a block diagram of an electronic module for endovascular electrocardiogram acquisition and processing in accordance with an embodiment of the present invention.
FIG. 2 depicts an adapter for an endovascular device in accordance with an embodiment of the present invention.
FIG. 3 depicts a catheter steering device in accordance with an embodiment of the present invention.
FIGS. 4A, 4B, 4C, and 4D describe electrode configurations that provide optimal endovascular electrocardiogram acquisition in accordance with various embodiments of the present invention. FIG. 4A depicts a single tap configuration, FIG. 4B depicts a modified 3-lead configuration with monitoring and guidance capabilities, FIG. 4C depicts a telemetry setup with a grounded single tap, and FIG. 4D describes a use of ECG monitors to guide endovascular devices.
FIG. 5 illustrates exemplary electrocardiogram signal amplitudes at different locations in the central venous system.
FIG. 6 illustrates exemplary power spectra of the electrocardiogram signal at different locations in the central venous system.
FIG. 7 illustrates exemplary distribution of electrical energy from the electrocardiogram signal at different locations in the central venous system.
FIG. 8 depicts a graphical user interface in accordance with an embodiment of the present invention.
FIG. 9 depicts a graphical user interface according to another embodiment of the present invention.
FIGS. 10A and 10B describe exemplary printed materials for information displayed by the graphical user interface, in accordance with an embodiment of the present invention.
FIG. 11 is a block diagram for a computer-based method for positioning an endovascular device in or near the heart using electrocardiogram signals.
FIG. 12 illustrates another decision support algorithm for a computer-based method for positioning an endovascular device in or near the heart using electrocardiogram signals, according to a modality.
FIG. 13 illustrates the heart's cardiac conduction system.
FIG. 14 illustrates the propagation of the electrical signal in the conduction system of the heart.
FIG. 15 illustrates electrical activity in the cardiovascular system due to the neuronal control system.
FIG. 16 illustrates a scheme for analyzing endovascular electrography signals, in accordance with an embodiment of the present invention.
FIG. 17 illustrates various modalities for processing the electrogram waveform.
FIG. 18A shows ECG leads arranged to form an Einthoven triangle.
FIGS. 18B-18F show multiple views of a skin ECG waveform and an endovascular ECG waveform, as represented in a graphical user interface according to a modality.
FIGS. 19A and 19B show various views of a skin ECG waveform and an endovascular ECG waveform, as represented on a graphical user interface according to a modality.
FIGS. 20A and 20F show multiple views of a skin ECG waveform and an endovascular ECG waveform, as represented in a graphical user interface according to a modality.
FIGS. 21A and 21B show various views of a skin ECG waveform and an endovascular ECG waveform, as represented in a graphical user interface according to a modality.
FIGS. 22A-22D show various sterile magnetic connectors according to certain embodiments.
FIGS. 23A and 23B show various sterile steerable connectors in accordance with certain embodiments.
FIGS. 24A-24F show multiple views of a skin ECG waveform and an endovascular ECG waveform together with a heart icon to indicate a position of an endovascular device, as represented in a graphical user interface according to a modality.
FIGS. 25A and 25B show several possible descriptions for use in guidance based on the ECG signal, as displayed on a cell phone according to a modality.
FIG. 26 shows a description of magnifying multiple ECG waveforms as displayed on a cell phone according to a modality.
FIGS. 27A and 27B show additional descriptions related to the ECG waveform as displayed on a cell phone according to a modality. DETAILED DESCRIPTION OF SELECTED MODALITIES
Reference will now be made to the figures, in which similar structures will be given similar reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are not limiting or necessarily drawn to scale.
For clarity, it should be understood that the word "proximal" refers to a direction relatively closer to a physician using the device to be described herein, while the word "distal" refers to a direction relatively farther away from the physician. For example, the end of a catheter placed inside a patient's body is considered a distal end of the catheter, while the end of the catheter that remains outside the body is a proximal end of the catheter. Furthermore, the words "which includes", "owns" and "who possesses", as used herein, including in the claims, shall have the same meaning as the word "which comprises".
Embodiments of the present invention advantageously provide an apparatus (or apparatus) of the invention, computer-based data processing algorithms and methods for obtaining and using endovascular ECGs in various applications and clinical settings. For example, the device can be used to guide endovascular devices in and around the heart, eg, guide central venous access devices in the superior vena cava, right atrium and right ventricle. These central venous access devices can include central venous catheters (CVC), peripherally inserted central catheters (PICC), implantable tubes, hemodialysis catheters, tunneled catheters, and others. Other devices that can benefit from guidance with the apparatus of the invention are temporary pacemaker electrodes placed through the central venous system. Catheters and guidewires used in left heart procedures may also benefit from the modalities described here by decreasing the amount of contrast and radiation needed to guide these devices into position. In another example, the device can be used for minimally invasive monitoring and assessment of cardiac conditions based on its electrical activity, for example, assessment of preload in a cardiac cycle or monitoring of ST segments and T waves in congestive heart failure.
In one aspect, an apparatus consisting of sterile adapters, an electronic module for signal acquisition, a computer module, software and peripheral devices and connections is described. In one modality, the electronic signal acquisition module may be dedicated for acquisition and processing of endovascular electrical signals generated by the body (endovascular ECG), and in another modality, the electronic module may be dedicated for acquisition and processing of endovascular ECGs as well as ECGs skin.
In one modality, the electronic module and the computer module can be separate modules, in another modality they can be integrated in the same module and housing and, in yet another modality, they can communicate with each other through a wireless connection, by example, Bluetooth. In one modality, the apparatus may contain an integrated printer, while in another modality the printer may be external and attached to the apparatus and the apparatus connected via a network, eg wireless, to other devices. In yet another modality, the device can be used for telemetry and for transmission of endovascular electrograms to a remote location, for example, through a telephone line, Internet and/or cordless telephone. Any combination of modalities mentioned above is also possible.
In another aspect, various configurations allow the connection of endovascular devices, for example, central venous access devices, to the electronic module for signal acquisition and processing. In one embodiment, the device consists of a connecting wire with two ends and special connectors at each end. At one end, the wire can be connected to a metal or nitinol guide wire or stylet as commonly available on the market. At the other end, the wire can be securely connected to the electronics module. In another embodiment, the device includes a coated guidewire, for example, made of nitinol or stainless steel with uncoated distal and proximal ends and cm-marked. In such an embodiment, the coated guidewire is inserted endovascularly, while the connecting wire is connected to the proximal end of the coated guidewire. In another embodiment, the device includes a catheter-syringe adapter provided with an electrical connection wire. At one end, the electrical connection wire is in contact with fluid, eg saline, flowing into the syringe-catheter adapter. At the other end, the connecting wire can be connected to the electronics module.
In another aspect, various electrode configurations allow for the optimal acquisition of endovascular ECGs. In one embodiment, a single lead is used to provide information about the location of the tip of an endovascular device within the vasculature. In another modality, the modified three-lead configuration is used to provide simultaneous 3-lead monitoring of cardiac activity while providing tip location information. In another embodiment, a modified single-lead plus ground configuration is used for telemetry and transfer of information from the catheter tip remotely.
In another aspect, algorithms are introduced to analyze ECG waveforms and to support decision making based on these waveforms. These algorithms discriminate between different locations in the vasculature and assess body functions (systemic and at specific locations in the body), in particular cardiac functionality. In various embodiments, these algorithms use time domain analysis of waveforms: morphological, eg, shape; statistics, for example, behavior.
In other embodiments, algorithms use frequency domain analysis of waveforms: morphological, eg, shape; statistics, for example, behavior. In additional modalities, the analysis of signal energy in time and frequency domains is also performed, morphological and statistical. Inaccurate, statistical and knowledge-based decision making is also contemplated by these modalities as decision support tools.
In another aspect, a user interface is provided that beneficially simplifies data interpretation and workflow. In one embodiment, the user interface includes simplified graphics that show the location in the vasculature and heart of the tip of the endovascular device in use without showing any of the ECG waveforms. In another modality, the user interface shows, in real time, the change in the location of the tip of the endovascular device in use.
In another aspect, various methods of the invention using the apparatus described herein in clinical applications are presented. In one modality, a computer-based method is provided that guides central venous catheters (CVC, PICCs, hemodialysis, implantable tubes, and others) using stylets, guide wires and saline solution to the superior vena cava, inferior vena cava , the right atrium and the right ventricle. This method is advantageously less sensitive to patients with arrhythmias than the established technique, and represents an alternative to chest X-ray confirmation of the location of the tip of central venous catheters in most clinical cases. In another embodiment, a computer-based method that guides coated guidewires into the right and left heart is provided. In another embodiment, a computer-based method is provided that guides the placement of temporary pacemaker electrodes through the central venous system. In another embodiment, a method is provided that is minimally invasive and monitors preload using depolarization and heart rates. In another modality, a method is provided that is minimally invasive and monitors arrhythmias using P wave analysis. In another modality, a method is provided that is minimally invasive and monitors heart failure using ST segment and T wave analysis.
In another aspect, one or several skin electrodes are used to obtain ECG signals on the skin surface simultaneously with the acquisition of endovascular (intracavitary) electrogram (ECG) signals through the use of endovascular (intracavitary) electrodes. Simultaneous and synchronized cutaneous surface and endovascular ECG signals are used in one of several ways to analyze and quantify ECG signals as a function of endovascular lead location, for example, as a function of the tip of a catheter.
In light of the above, in one modality, the ease of use of ECG-based navigation and catheter tip location is increased. In one aspect, for example, skin reference ECG waveforms are simultaneously displayed on a monitor with endovascular ECG waveforms measured at the tip of a catheter or other implantable medical device. This simultaneous acquisition and display of concomitant ECG signals allows for prompt interpretation of the endovascular ECG waveform at the catheter tip. In another aspect, a skin ECG reference signal is used to synchronize information processing algorithms applied to the endovascular ECG signal, generating results of increased reliability with respect to the P-wave changes of the endovascular ECG signal in terms of shape and energy.
In another modality, the analyzes of synchronized cutaneous and/or endovascular ECG signals can be linked to each other and/or to the periodic electrical activity of the heart. For example, a skin ECG lead can be used to detect the QRS complex R peak of a detected skin ECG waveform. Detection of the R peak in the cutaneous ECG waveform can be used to trigger analysis of the endovascular ECG signal on simultaneously corresponding segments of the endovascular ECG waveform, for example, on the segment that corresponds to the P wave. useful in the case of arrhythmia, where the cutaneous ECG waveform typically does not demonstrate a consistent P wave, whereas the endovascular ECG waveform actually includes a detectable P wave segment that changes as a function of location in the vasculature.
In other embodiments, sterile magnetic and steerable connectors are disclosed, as well as aspects of display and control solutions to allow a cell phone or other handheld device to control an ECG-based system that includes one or more of the above aspects.
FIG. 1A is a block diagram describing an apparatus in accordance with an embodiment of the present invention.
Apparatus 100 can be attached via an adapter (120) to a wide variety of commercially available and custom designed vascular access devices (110). Examples of these devices are: central venous catheters (CVC), peripherally inserted central catheters (PICC), implantable tubes, tunneled catheters, hemodialysis catheters, guide catheters for pacemaker electrodes, guide wires used for coronary interventions and other interventions catheters, guide catheters for coronary interventions and other vascular interventions, stylets, syringe needles, and others. If the vascular access device is a stylet, guidewire, or syringe needle, its material must be sufficiently electrically conductive, eg stainless steel or nitinol. In this case, the hook or “alligator clip” type adapter, according to a modality, must be used. If the vascular access device is a catheter, then saline solution should be used to establish a conductive pathway through one of the catheter's lumens. In that case, the syringe-catheter adapter according to a modality should be used.
The electronics module (130) receives electrical signals from the adapter and one or more other electrodes placed on the patient's skin (115). Alternatively, more than one adapter can be used at the same time to connect to more than one endovascular device to provide different electrical signals to the electronics module. The use of skin electrodes is optional in certain device configurations. The electronics module processes the electrical signals and transmits them to a computer module (140) for further processing and other functions. In one modality, the electronic module and computer module can be packaged separately and in another modality they can be integrated in the same package. In one modality the connection between the electronics module and the computer module can be wired and in another modality it can be wireless, for example using Bluetooth.
The computer module processes the signals from the electronic module that applies the algorithms (170) as described by the present embodiments. The computer module may also be connected to peripheral equipment (160), for example, a printer or label printer and storage devices, and provides connectivity, including wireless connectivity (150), to other computers or the Internet. The storage device can be used to store a database of knowledge and information regarding the application used. The connectivity interface can be used to update this database remotely with the latest knowledge and relevant information, eg new clinical cases, new findings regarding the relationship between electrograms and cardiac conditions. The computer module supports a graphical user interface (180) optimized for the purpose of the clinical application used.
FIG. 1B is a block diagram of an electronic module (2) for endovascular electrocardiogram acquisition and processing according to an embodiment of the present invention.
The patient connector interface (10) allows the connection of electrical electrodes to the patient (5). Any combination of skin electrodes and/or electrical connections to endovascular devices using the adapters discussed above can be used. In one embodiment, the amplifier (20) is a four-stage amplifier with variable gain that can amplify electrical signals coming through the patient cable, for example, typical of electrocardiographic values. The analog-to-digital converter (30) converts the signals into a digital format that can be read by the microprocessor (40). Any number and configurations of microprocessors, microcontrollers and digital signal processors can be used to implement the microprocessing function (40).
In one embodiment, a microcontroller is responsible for controlling serial communication with a computer module (90) via the serial interface (70) or via the wireless interface (80) and a digital signal processor (DSP) is responsible by implementing one or more of the algorithms of the invention described herein. Alternatively, a single processor can be used for both communication and processing.
The microprocessor (40) also receives commands from the computer module (90) and controls different elements of the electronic module, for example, the amplifier (20) correspondingly. The patient isolation block (50) electrically decouples the power (60) and the serial communication channel (70) from the patient interface (10) to ensure the patient is protected from electrical shock. In one embodiment, the isolation block (50) may consist of a transformer and/or couplers, eg optical couplers.
FIG. 2 depicts an adapter (200) for an endovascular device in accordance with an embodiment of the present invention. Vascular access devices such as catheters, syringes, syringe needles, regulator valves, infusion pumps and others connect to each other through standard connections. For example, in FIG. 2, a standard connection of this type between two devices is illustrated in device (201) by Luer-type connection (202) with inner diameter (203), and in device (250) by threaded connection (251) with inner diameter (252 ) and fluid opening diameter (253). The threaded connection (251) and the Luer-type connection (202) allow the connection of the two devices (201, 250) by threading, adhesion, coupling etc., of the connection (251) in the Luer-type connection (202).
The adapter (200) has a body (220) with two ends (226, 227), and is made, for example, of strong biocompatible plastic material with some degree of elasticity. The end (227) is shaped like a cone. In one embodiment, the end (227) has an elastic sealing portion (228) such that the end (227) can easily fit into the Luer-type connection (202) of the device (201) to seal the connection for flow. fluid. The other end (226) is in standard Luer format such as the Luer type connection (202) of the device (201). The threaded connection (251) of the device (250) can be connected to the end (226) of the adapter (200). The cone part (227) also allows a connection to a device that does not have a Luer connection. The cone piece (270) alone allows a connection between two devices with different accessible diameters. The end (227) of the adapter (200) fits within the diameter (272) of the cone part (270). The end (271) of the cone piece (270) fits a simple portion of the end of the catheter (261) of a typical device (260). For example, device (260) can be a catheter for an implantable tube.
In one embodiment, device (201) is a syringe needle, and device (250) is a syringe. Fluid, for example a conductive electrolyte, flows through the adapter (200) through a central internal bore or lumen (222) that has a certain diameter, and provides a fluid path between the devices (250, 201). A conductive metal ring (240) is attached to a portion of the substantially cylindrical surface of the lumen (222) and preferably induces very little disturbance to fluid flow. For example, the metallic ring (240) may be disposed within a recessed portion of the substantially cylindrical surface of the lumen (222). One end (230) of a lead wire (233) is electrically coupled to the metal ring (240); in one embodiment, the end (230) is welded to the metal ring (240). In another embodiment, the end (230) is trapped between the lumen surface (222) and the metal ring (240), and the end (230) and the metal ring (240) maintain good electrical contact through mechanical pressure. The wire (233) can be stripped or insulated. In a preferred embodiment, the metallic ring (240) is fixedly attached to the surface of the lumen (222), using, for example, adhesive, an interference fit, pressure adjustment, etc., while, in other embodiments, the metallic ring ( 240) can be detachably attached to the lumen surface (222), and can move freely, etc.
The wire (233) passes through a channel (231) which extends from the lumen (222) to an opening in the outer surface of the body (220). Epoxy (232) or other suitable material can be used to seal the opening of the channel (231) as well as to provide a strain relief for the wire (233). Metal ring (240) may be advantageously disposed adjacent channel (231) to provide additional sealing. In this way, the metal ring (240), wire (233), channel (231) and epoxy (232) provide a sealed electrical connection for fluid to flow through the adapter (200).
A connector (234) can provide a standard electrical connection for the electrography system; an unterminated wire can also be used. In one embodiment, the wire (233) terminates in the channel opening (231) and the connector (234) is attached directly to the body (222), while in another embodiment, the wire (233) extends through the channel opening. (231) and connector (234) is attached to the free end of wire (233).
In one embodiment, the substantially cylindrical surface of the lumen (222) is tapered along the longitudinal direction. This taper can extend along the entire length of the lumen (222), or be restricted to a certain portion of it. For example, the surface of the lumen (222) can be cone-shaped and have a larger diameter at the proximal end, or alternatively, the larger diameter can be located at the distal end.
In one example, device (201) is a syringe needle that is inserted into the lumen of a catheter for an implantable tube, and device (250) is a syringe. The syringe is filled with saline solution, which is then injected into the catheter through the adapter (200). In this way, the adapter (200) becomes filled with saline solution and, as the conductive metal ring (240) is in contact with saline solution and with the conductor wire (233), an electrical connection is established between the lumen of the catheter and the wire (233). In this way, the electrical signal at the tip of the catheter can be measured through saline solution. Other electrically conductive solutions can also be used to obtain the endovascular electrogram using the adapter (200). In another embodiment, the adapter (200) can be used with infusion pumps as well as other types of power injections. In an alternative embodiment, the adapter (200) does not include the metal ring (240), and the electrically conductive termination (230) is in direct contact with the electrolyte.
FIG. 3 illustrates a catheter steering device in accordance with an embodiment of the present invention. In this embodiment, the catheter (300) is a triple lumen catheter and the distal end of each of the lumens is spaced apart. The Catheter Steering Device can be used with any catheter that has two or more lumens spaced apart from the distal lumen. The open end of a lumen (306) of the catheter (300) is at the most distal end of the catheter, another end or opening of a lumen (305) is spaced behind the distal end, and the end or opening of the third lumen (307) it is spaced at the back compared to the second end (305). The distance between the open end (306) and the end (307) is typically one to several centimeters.
Various types of catheters have multiple lumens with spaced ends, and the targeting device of the invention can accommodate these catheters. For example, in the case of a peripherally inserted central catheter, the typical length of a catheter is 50 to 60 centimeters, and the spacing between the ends of the distal lumen (305, 306, and 307) is one to several centimeters. A two-lumen hemodialysis catheter can typically be 20 to 40 centimeters long, with a spacing of one to several centimeters between the distal ends of the two lumens. A multilumen central venous catheter (CVC) can typically be 15 to 25 cm in length with spacing between the distal ends or openings of the lumens being several millimeters to several centimeters.
At the proximal end, the catheter has a catheter concentrator (301) that divides the three lumens and connects each with a Luer-type connection (302, 303, 304). The catheter steering device of the invention includes a stylet (310) with a handle (311) at the proximal end to allow it to be pushed, pulled, and removed after use, and a steering member (320) that connects to the distal end. of the stylet (322) and which can be fed back into an opening in the distal lumen of one of the other lumens such as the lumen (307). The directing member (320) returns to the proximal end of the catheter through the lumen of the catheter and exits at the proximal end through the Luer-type fitting that corresponds to the respective lumen (304). Thus arranged, the steering device is in the installed position. In one embodiment, the member (320) has a handle (321) that can be used to pull the member through the lumen. In another embodiment, the cable (321) is detachable from the member (320).
Member (320) can be polyurethane, silicone, PTFE or other similar materials. In different embodiments, the member (320) can be any type of biocompatible fiber, for example, surgical thread. In another embodiment, the member (320) is a stainless steel wire. In one embodiment, the stylet is provided pre-inserted into one of the lumens of the catheter, typically the central lumen, with the most distal opening (306) with member 320 attached to the distal end of the stylet (322) and pre-inserted into the lumen (304) through the opening of the lumen (307). In order to guide the catheter, the user pulls member 320 out of the catheter while preventing stylet 310 from being pulled into the catheter. In this way, the tip of the catheter can be bent in a desired direction. This situation is illustrated by the curved catheter tip (350), the limb (340) that has been pulled back, and the limb (330) that is in its initial position with respect to the catheter. If the stylet (310) or the driving member (320), or both, are made of any electrically conductive material, then either or both can be used to measure electrical signals or endovascular electrograms at the distal tip of the catheter by connecting their extremities proximal to the endovascular electrography system. In one embodiment, the steering member (320) can be secured to the stylet (310) through the opening (307) of the catheter lumen.
In another embodiment, the stylet (310) and the steering member (320) are manufactured as a single component to form an extended steering member that is passed back through the opening (305) of a different lumen of the catheter. By pulling on one of the two ends of the extended steering member exiting through the Luer-type connections (304) and (302), the same effect is obtained and the tip of the catheter can be bent in a desired direction. In another embodiment, in the case of a dual-lumen catheter, the stylet (310) can be inserted into one lumen and the targeting member (320) can be inserted into the other lumen, such that the curvature effect of the tip of the catheter can be obtained by pulling the proximal ends. In a further embodiment, the steering member (320) can be inserted into the lumen (302) and through the opening (305).
FIGS. 4A, 4B, 4C, and 4D describe electrode configurations that provide optimal endovascular electrocardiogram acquisition in accordance with various embodiments of the present invention.
FIG. 4A depicts a single lead configuration with one reference electrode (410), for example, attached to the patient's skin over the right arm and with the other electrode attached through an adapter to an endovascular device (415). The reference electrode attached to the skin on the right arm is shown in this configuration for illustrative purposes only. Other reference electrode locations are possible depending on the type of ECG required. The reference electrode on the right arm together with the tip of the endovascular device used with the adapter may be similar to lead II of a standard ECG. In this case, the ECGs obtained from the superior vena cava (401) and the inferior vena cava (402) can be optimized. The reference electrode can be attached to the skin at any other location to simulate other standard ECG leads. The reference electrode can also be connected to adapters attached to other endovascular devices to obtain more local information from inside the patient's heart (400).
FIG. 4B describes a modified 3-lead configuration, with monitoring and guidance capabilities, with 4 electrodes. Three (3) electrodes correspond to the standard ECG electrodes: right arm (RA, 420), left arm (LA, 425) and left leg (LL, 430), used as reference. The fourth electrode is attached through the adapter to the endovascular device (C, 435). In this configuration, the electronic module and the algorithm perform two functions simultaneously: the three standard electrodes (RA, LL and LL) perform a heart monitoring function, while the C electrode (435) allows recording of the ECG at the device tip .
FIG. 4C depicts a telemetry configuration with a grounded single tap, including the configuration illustrated in FIG. 4A and a ground reference (450).
This setup can be used to transmit ECGs remotely via a telemetry system setup.
FIG. 4D describes the use of ECG monitors to guide endovascular devices. A standard ECG monitor that has standard inputs from RA (465), LA (460) and LL (470) is used. LA (460) is connected to the left arm and LL (470) to the patient's left leg. The RA input (465) is connected to a switch that can be used by the clinician to change the RA input (465) between the RA electrode and the catheter electrode (C) 475. of catheter placement can be obtained alternatively.
FIG. 5 illustrates exemplary electrocardiogram signal amplitudes at different locations in the central venous system.
The heart (504), right atrium (501), superior vena cava (SVC) (502), and inferior vena cava (IVC) (503) are illustrated. Location A is in the upper part of the SVC, location B is in the lower third of the SVC, location C is in the cavo-atrial junction, location D is in the right atrium, and location E is in the upper part of the inferior vena cava .
Graph 510 illustrates an ECG waveform as a function of time recorded at location A. The absolute amplitude of the waveforms is plotted on an amplitude scale (590). In the case of an endovascular ECG, the standard elements of the electrocardiogram are illustrated: the P wave (560), the R wave (570), and the T wave (580). The amplitudes and shape at location A recorded with a lead setup as in FIG. 4D are similar to an electrocardiogram recorded at the skin level with the same electrode configuration.
Graph 520 illustrates an endovascular ECG depicted at location B. The amplitude at this location is greater than that at location A, but the overall waveform shapes are similar at locations A and B.
Graph 530 illustrates an endovascular ECG depicted at location C. At location C at the cavo-atrial junction, the amplitude of the waveform is even greater than that at location B, and the P wave has changed dramatically to become larger than the R wave. This waveform is an indication of the proximity of the sinoatrial node.
Graph 540 illustrates an endovascular ECG depicted at location D. At location D in the right atrium, the amplitudes are similar to location C, but the P wave changes polarity and becomes bipolar. This is an indication that the ECG measurement takes place beyond the sinoatrial node.
Graph 550 illustrates an endovascular ECG depicted at location E. At location E in the inferior vena cava, the waveform is similar to that at location A in terms of amplitude, except that the P wave has reverse polarity. Differences in ECG waveforms at different locations are used by the algorithms introduced here to discriminate between corresponding locations and to assess heart and blood vessel functionality.
FIG. 6 illustrates exemplary power spectra of the electrocardiogram signal at different locations in the central venous system using a spectral scale (690).
The heart (604), right atrium (601), superior vena cava (SVC) (602), and inferior vena cava (IVC) (603) are illustrated. Graph 610 illustrates an endovascular ECG spectrum depicted at location A. At location A, the spectrum (610) has a single center frequency or single band (660) appearance and similar frequency distribution spectral power and energy. at the skin level.
Graph 620 illustrates an endovascular ECG spectrum depicted at location B. At location B, the frequency distribution has two major bands and greater energy and spectral power than those at location A.
Graph 630 illustrates an endovascular ECG spectrum at location C. At location C, there are multiple (3-4) principal frequencies or principal spectral components distributed over a wider range of frequencies (670). This spectral distribution is indicative of the energy distribution around the sinoatrial node. The power and spectral energy of the signal increased compared to location B.
Graph 640 illustrates an endovascular ECG spectrum depicted at location D. At location D, the spectrum is broader and wider in band, indicative of the electrical activity of the right atrium.
Graph 650 illustrates an endovascular ECG spectrum depicted at location E. The frequency spectrum at location E is similar to that at location A. Differences in spectral waveforms at different locations are used by the algorithms introduced here to discriminate between corresponding locations and to assess the functioning of the heart and blood vessels.
FIG. 7 illustrates the exemplary distribution of electrical energy from the electrocardiogram signal at different locations in the central venous system. The heart (704), right atrium (701), superior vena cava (SVC) (702), and inferior vena cava (IVC) (703) are illustrated. The graphs (710, 720, 730, 740, 750) depict the energy distribution at different locations (A, B, C, D and E, respectively), and the changes over time are used by the algorithms introduced here to discriminate between the corresponding locations and to assess the functionality of the heart and blood vessels.
Considering FIG. 16 for a moment, a scheme for analyzing endovascular electrography signals in accordance with an embodiment of the present invention is illustrated. The heart is represented by (1600), the superior vena cava by (1601), the inferior vena cava by (1602) and the right atrium by (1603). In this modality, there are three regions of interest for placement of central venous access devices: the lower third of the superior vena cava or SVC (1605), the cavo-atrial junction or CAJ (1606), and the upper part of the right atrium or RA (1607).
Graph (1620) illustrates the profile of electrical energy as a function of location in the heart, and graph (1640) illustrates the different electrographic waveforms that can be obtained at different locations in the heart. Curve (1630) illustrates the increase in electrical energy detected in each of the regions at the tip of an endovascular catheter advancing from the superior vena cava into the heart. In one modality, the energy curve is calculated in the time domain, while in another modality, the energy curve is calculated in the frequency domain using the frequency spectrum. In one modality, energy is calculated for the actual signal levels, while in another modality, the basal value or other average values are first subtracted from the signal values before energy calculations. The energy or power of the signal is calculated in time domain by summing the squared amplitude values before and/or after subtracting the base level over a given period of time, for example, one heartbeat. In the frequency domain, the energy or power of the signal is calculated by adding the squared values of the frequency components. In one modality, the curve is calculated using the entire electrogram, while in other modalities only certain segments of the electrogram are used for energy calculations, for example, only the segment that corresponds to a “P wave” of an electrocardiogram. This segment of a “P wave” is representative of the electrical activity of the sinoatrial node.
Different energy levels characterize the different locations along the catheter pathway from SVC to the heart. These regions can be differentiated in terms of their electrical energy level by using thresholds. The threshold (1631) of the energy level defines the beginning of the lower third of the superior vena cava. Energy levels (1621) define regions in the low-energy vasculature that are distant or remote from the sinoatrial node. The energy levels (1622) between the thresholds (1631) and (1632) define the region labeled as the lower third of the superior vena cava (1625 and 1605). The energy levels (1623) between the thresholds (1632) and (1633) define the region labeled as the cavo-atrial junction (1626 and 1606). The energy levels (1624) between the thresholds (1633) and (1634) define the region labeled right atrium (1627 and 1607).
Similarly, the shape and size of the electrogram on the graph (1640) relative to the base level (1650) can be correlated with a location in the heart. The thresholds (1631), (1632), (1633) and (1634) are determined specifically for the type of energy considered for the calculations, for example, the entire electrogram, the P wave and/or the S-T segment. Prior to the lower third of the SVC and corresponding to a relatively low energy level (1621), the P wave (1651) and the R wave (1652) are similar in size and shape with a standard electrocardiogram lead II recorded at level from the skin, if the standard right arm ECG lead is connected to the catheter and measuring the electrogram signal at the tip of the catheter. In the lower third of the SVC (1605 and 1645), the electrogram energy level increases, the electrogram amplitudes increase, and the P wave (1653) increases in amplitude and energy relative to the R wave (1654) to where the amplitude and energy of the P wave are between one-half and three-quarters of the amplitude and energy of the R wave. At the cavo-atrial junction (1606 and 1646), the energy level of the electrogram further increases, the electrogram amplitudes continue to increase, and the P wave (1655) increases in amplitude and energy in relation to the R wave (1656) until the amplitude and energy of the P wave are greater than or equal to the amplitude and energy of the R wave. In the right atrium (1607 and 1647), the energy level The electrogram increases further, the electrogram amplitudes increase, the P wave (1657) becomes bipolar, and its amplitude and energy relative to the R wave (1658) begins to decrease. These behaviors are quantified, analyzed and used in order to provide location information in relation to the catheter tip.
Considering FIG. 17 for a moment, various modalities of processing the electrogram waveform are illustrated. Graphs (1710) and (1720) illustrate a modality of analysis of the P wave. As the P wave corresponds to the electrical activity of the heart generated by the sinoatrial nodule, the P wave alterations are the most relevant in relation to determining the proximity of the nodule sinoatrial in an endovascular approach. Therefore, in order to assess the proximity of the sinoatrial node and the location in the vasculature, methods of signal analysis in time and frequency domains, as well as signal energy criteria, can be applied only to the P-wave segment of an electrogram. In the graph (1710), the segment designated for the P-wave analysis (1711) starts at moment (1713) and ends at moment (1714). During the time period between the onset and the end of the P wave segment, the highest amplitude detected corresponds to the peak of the P wave (1712). The start time (1713) of the P-wave segment analysis can be determined in several ways. In one modality, the heart rate is calculated and the R peak is detected as the maximum amplitude of the heart rate. The removal of each R peak from a certain percentage of the heart rate, for example, between 20% and 30%, determines the moment when the P wave analysis starts (1713). The removal of 2% to 5% of the heart rate from each R peak determines the end of the segment designated for the P wave analysis (1714). Similarly, in graph (1720), the segment designated for P-wave analysis (1721) starts at moment (1723) in the cardiac cycle and ends at moment (1724). The P wave, in this case, is bipolar with a positive maximum amplitude (1722) and a negative maximum amplitude (1725) when compared to the base level (amplitude equal to zero). For the waveform P defined between the starting point (1713 on the 1710 graph and 1723 on the 1720 graph) and the end point (1714 on the 1710 graph and 1724 on the 1720 graph), time domain and time domain algorithms are applied. frequency in accordance with embodiments of the present invention.
Graph (1730) illustrates the advantages of subtracting the base level before computing the signal energy. If signal energy is calculated in time domain as the sum of signal amplitudes squared over a heartbeat, then amplitude variations between levels (1731 and 1732) around the base level (1733) can lead to at a lower energy level than the signal with amplitude variations between levels (1734 and 1735), where the level (1734) is the basal level. The basal value (1733) is subtracted from the amplitude values (1731 to 1732) and the basal value (1734) is subtracted from the amplitude values (1734 to 1735). After subtracting the base level, the sum of squared amplitude values is calculated. Thus, this sum is proportional to the energy of signal variation around the base level and, therefore, is more suitable for characterizing changes in signal values/behavior.
The graph (1740) shows a typical electrogram waveform with a P wave (1741) and an R wave (1742) and a distorted signal with the P wave covered by high frequency noise (1744) and the R wave saturated to a maximum value (1743). In the presence of these types of artifacts (1744 and 1743), it is very difficult and sometimes impossible to recover the original signal (1741 and 1742). Therefore, according to embodiments of the present invention, an algorithm is used to detect the presence of artifacts and reduce the amount of artifacts as much as possible. If, after reducing artifacts, the signal cannot be recovered, then the signal is discarded for signal energy computation. The presence of artifacts can be detected in the time domain by a high value of the derivative and its integral, a jump in signal energy, a jump in the base level value, or different averages calculated from the signal.
In the frequency domain, artifacts can be detected as a jump in the value of the DC component (zero frequency of the spectrum), as the sudden appearance of high frequency components, and in a jump in spectral power/energy. In the frequency domain, selective filtering can be applied and all components removed, which are not “typical” for the average behavior of the signal. After selective filtering, the signal is reconstructed in the time domain using an inverse Fourier transform in order to verify the success of selective filtering.
FIG. 8 depicts a graphical user interface in accordance with an embodiment of the present invention.
The window (810) presents the real-time ECG waveform as it is acquired by the electronics module using the attached electrode configuration. Window (820) is a reference window and shows a frozen waveform used to compare with the current window. In one embodiment, the reference waveform in the window (820) can be obtained through electrodes connected to the electronics module at a reference location on the catheter and/or using a reference setting of skin electrodes. For example, such a reference waveform may be the ECG recorded using an adapter according to an embodiment of the present invention connected to an endovascular device placed at the cavo-atrial junction.
In a different modality, the reference waveform in window 820 may be a typical waveform at a certain location in the vasculature or a certain cardiac condition as it is recorded in a waveform database and as it is stored in the medium of computer system storage. If the electrode configuration allows simultaneous cardiac monitoring and recording of electrograms using an endovascular device, the window (830) shows one of the standard ECG leads for cardiac monitoring, while the window (810) shows the ECG at the tip of the endovascular devices when connected to an adapter, such as those discussed above.
The icon (870) is a representation of the heart, and locations A to E (875) illustrate different locations in the heart and vascular system that can be discriminated by endovascular ECG analysis according to the methods disclosed herein. As a location in the vasculature is identified by the algorithms, the corresponding location and the letter in the icon (875) become highlighted or otherwise visible to the user. Bars (884), (885) and (886) show the signal energy levels. The “E” bar (885) displays the amount of electrical energy computed by the ECG frequency spectrum at the current location of the tip of the endovascular device. The “R” bar (884) shows the amount of electrical energy computed by the ECG frequency spectrum at a reference location. The “M” bar (886) shows the amount of electrical energy computed by the ECG frequency spectrum using the skin electrode monitoring ECG signal. Window (840) describes monitoring information, eg heart rate. Patient information (name, procedure date, and so on) is shown in the window (850). Window (860) contains system control elements such as button and status information, eg scale, scroll speed, system parameters and system diagnostics.
FIG. 9 depicts a graphical user interface according to another embodiment of the present invention.
The icon (920) is a representation of the heart and locations A to E (930) illustrate different locations in the heart and vascular system that can be discriminated by endovascular ECG analysis. As a location in the vasculature is identified by the algorithms, the corresponding location and the letter in the icon (930) become highlighted or otherwise visible to the user. The bars (940), (950) and (960) show the energy levels of the signal. The “E” bar (940) describes the amount of electrical energy computed by the ECG frequency spectrum at the current location of the tip of the endovascular device. The “R” bar (950) shows the amount of electrical energy computed by the ECG frequency spectrum at a reference location. The “M” bar (960) shows the amount of electrical energy computed by the ECG frequency spectrum using the monitoring ECG signal coming from the skin electrodes. The “Print” button (960) allows the user to print the information that documents the case on a printer, for example, on a label printer for quick attachment to the patient's record.
FIGS. 10A and 10B describe exemplary printed materials for information displayed by the graphical user interface, in accordance with an embodiment of the present invention.
FIG. 10A illustrates printed material 1000 for the case of a catheter tip placement procedure in the lower third of the SVC. Field 1010 describes the heart icon, in which the letter “B”, which corresponds to the lower third of the superior vena cava (SVC), is highlighted (1040). Field 1030 describes the reference ECG waveform recorded at the tip of the catheter at the cavo-atrial junction in the vicinity of the sinoatrial node. Field 1020 describes the ECG waveform at the tip of the catheter at the position in which it was placed at the end of the procedure. For FIG. 10A, this location is in the lower third of the SVC and the ECG waveform corresponds to this location. The patient's name (1001) and procedure date (1002) are also printed.
FIG. 10B depicts similar printed material (1050), except that the final position at the end of the procedure is at the cavo-atrial junction at location C (1090) in the heart icon (1060). The “SA Nodule” field describes the reference ECG waveform (1080), and the “End position” field (1070) shows that the catheter was placed with the tip in the sinoatrial node: the ECG waveform at the location end is similar or even identical to that at the reference location in the sinoatrial node (SA node). It is known that the proximity of the SA Nodule indicates a location at the cavo-atrial junction. These locations are sometimes considered to be identical by some physicians.
FIG. 11 is a block diagram for a computer-based method (1100) for positioning an endovascular device in or near the heart using electrocardiogram signals.
The algorithms are applied to the input signal (1102) (ECG) acquired by the adapter to endovascular devices and, optionally, also through skin electrodes. The Error Detection Block A (1105) detects at least three types of error/exception conditions such as when a defibrillator has been applied to the patient, when a pacemaker is triggering excitation pulses, and/or when a lead/electrode is off. These errors/exceptions can be handled differently, and the user can be informed about the presence of an exception and how to handle the exception (1110).
The pre-processing block (1115) can amplify the signal, reduce noise, eliminate artifacts etc. In one modality, the scaling of the signal to the display range takes place under the user's control and is not automatic, as is the case with most ECG monitors available today. Thus, changes in ECG amplitude are easily noticed. A high-pass filter corrects the base level and reduces such artifacts as respiratory artifact. Wideband noise suppression can be achieved using a selective filter, eg a wavelet transform. Electromagnetic interference with other equipment and with the electrical network can be suppressed by a notch filter (narrow band filter) centered at 60 Hz or 50 Hz to accommodate domestic or international power supplies. High-frequency noise can be suppressed with a low-pass filter, which, in one modality, is implemented with variable length smoothing such as an open window that corresponds to one cardiac cycle, an ECG smoothing over several consecutive cardiac cycles etc. The adaptive filter block (1120) optimizes the filter coefficients by minimizing an error signal.
The time domain pattern recognition block (1130) identifies elements of the ECG waveform, their relationship(s) and their behavior(s) in time. An important aspect of the time domain pattern recognition algorithm in block 1130, as well as the frequency domain pattern recognition block 1140, is the data history. ECGs are analyzed in real-time for certain elements, and for other elements, a data buffer with an appropriate buffer length is maintained in the memory of the electronic and/or computer modules to allow analysis of historical data and the prediction based on that analysis. In one modality, the data history buffer takes several seconds, allowing the ECG signal that corresponds to several heart beats to be saved in the buffer memory. A dual buffer technique allows the waveform in one buffer to be processed while the second buffer continues to store signals. This way, no signal data is lost while the waveform in a temporary memory is processed. After the processing of data in a temporary memory has been completed, the results are sent to the decision support algorithms (1150) and the two intermediate stores switch roles. The buffer length accommodates the length of time of data processing to ensure that no data is lost. A similar double buffer technique is also applied to data submitted to the frequency domain pattern recognition block (1140).
In the case of an endovascular ECG, the elements of interest may include, without limitation, one or more of the following: 1. The P, Q, R, S, T and U waves, their peaks, amplitudes and duration; 2. The duration of the P-R, S-T and T-P segments/intervals; 3. Elevation of the S-T segment; 4. The variances of the P-P and R-R intervals; 5. The variance of S-T intervals and R-T intervals etc.; 6. The peak-to-peak values of the P wave and the QRS complex; 7. The ratio of P-wave and R-wave amplitudes and the ratio of peak-to-peak P-wave and QRS complex amplitudes; 8. The polarity of the P wave: single positive, single negative or bipolar; 9. The derivative of the P wave, QRS complex and T wave; 10. Temporal average of R-R interval and heart rate; 11. Maximum value of P wave amplitude/peak and P wave peak-to-peak amplitude over a certain period of time; 12. Maximum value of the R-wave amplitude/peak and QRS complex peak-to-peak amplitude over a certain period of time.
In the time domain, additional computations include: 13. Baseline subtraction, eg to remove respiratory artifacts and to allow analysis of changes from baseline; 14. Waveform leveling for noise reduction; 15. Computation of time domain signal energy as the sum of squares of signal amplitudes (before and after removal of the base level); 16. First derivative computations for estimating signal changes and removing high frequency artifacts; 17. Integral (sum) of the first derived values; In the frequency domain, additional computations include: 18. Removal of the DC component and quasi-DC (equivalent to base level subtraction and respiratory artifact removal); 19. Selective filtering, that is, the removal of certain frequencies associated with artifacts and noise, for example, high frequency noise, muscle artifacts, signal changes as a result of catheter and electrode manipulation, etc.; 20. Inverse Fourier transform for signal reconstruction in the time domain.
Various techniques can be used to derive the information listed above from ECG waveforms, including, without limitation, one or more of the following: 1. “Peak detection”; 2. Computation of first derivatives; 3. Processing averages over the signal in one heartbeat and over multiple heartbeats; 4. Adaptive thresholding; 5. Autocorrelation.
The fast Fourier transform in block (1125) performs a fast Fourier transform on several ECG samples stored in a temporary memory of a certain length, for example, 256, 512, 1024, 2048 or more data samples. The Fourier transform transforms the waveform from the time domain into the frequency domain.
The frequency domain pattern recognition block (1140) illustrates various aspects of pattern recognition performed on ECGs in the frequency domain, including, without limitation, one or more of the following: 1. Principal component analysis, ie, determination the most significant elements of the frequency spectrum (similarly to the determination of the morphological elements of electrograms, for example, certain waves and segments in the time domain); 2. Data compression in order to reduce the amount of computation based on major components; 3. Determining the number and morphology of the principal components, in particular determining whether the spectrum has only one, two or multiple principal frequencies (frequency bands); 4. Calculation of spectral power and signal energy from the frequency spectrum; 5. Averaging along the frequency dimension over a single spectrum in order to reduce broadband noise; 6. Processing the average over several spectra in order to filter out artifacts; 7. Determination of additional morphological elements of the spectrum, for example, the maximum frequency, the energy contained in the maximum frequency, the frequency histogram, that is, which frequencies contain how much energy, the frequency of the greatest significant peak of maximum energy, etc.; 8. Calculation of the behavior and averages over time of the principal components and other parameters determined from the spectral distribution, for example, determining the maximum value of signal energy and spectral power over a certain period of time; 9. Determine/estimate certain cardiac conditions based on spectral analysis. This determination/estimation is also performed in more detail in decision support blocks 1150 and 1250.
Several decision support algorithms use the information provided by the time domain pattern recognition and frequency domain pattern recognition algorithms. In one embodiment, block (1150) supports placement of an endovascular device in the lower third of the SVC or at the cavo-atrial junction.
In particular, block 1150 is based on the concept of first reaching the cavo-atrial junction during catheter placement. At the cavo-atrial junction or near the sinoatrial node, the P wave and other electrical parameters reach a maximum value. At the cavo-atrial junction, the P wave is unipolar. After reaching the sinoatrial node at the cavo-atrial junction, that is, the maximum value of peak P amplitude and spectral power, the catheter is pulled back several centimeters until the P wave decreases to half the amplitude reached at the cavo junction -atrial. In the location where the P wave has decreased to half the amplitude of the cavo-atrial junction, the catheter is considered to be in the lower third of the superior vena cava. Peak P-wave amplitude or peak-to-peak amplitude, as well as spectral power, is used to map the location in the vasculature to the ECG waveform.
More particularly, upon receiving an endovascular ECG signal associated with an endovascular device, the signal is processed, over several predetermined time periods, to calculate a P-wave amplitude and a spectral power for each predetermined time period. A maximum P-wave amplitude is then determined by the various P-wave amplitudes, as well as an associated maximum spectral power of the various spectral powers. The location at which these maximum values are determined is associated with a predetermined location in or near the heart, for example, the cavo-atrial junction. The location of the endovascular device is then calculated, for each predetermined time period, based on a ratio of the P wave amplitude to the maximum P wave amplitude and a ratio of the spectral power to the maximum spectral power, and the location of the device. endovascular is then displayed to the user. Additionally, P-wave polarity and R-wave amplitude can also be used to determine the location of the endovascular device.
A single criterion or a combination of these criteria can be used to support decision making. In one modality, T1, T2, and T3 can be empirically established thresholds that are different for each patient, and the algorithm can use an adaptive spiral to adjust thresholds based on current measurements. In another modality, these thresholds are predetermined.
In other modalities, the ratio of the peak P/P amplitude or the peak-to-peak amplitude of the P wave to the peak R/R amplitude or the peak-to-peak amplitude of the QRS complex can also be used to establish the location in relation to the sinoatrial node. In one modality, the P peak/amplitude must be approximately half the peak/amplitude of R and the P wave must be unipolar so that the location corresponds to the lower third of the SVC. In another modality, the peak-to-peak P wave must be half the peak-to-peak QRS amplitude and the P wave must be unipolar so that the location corresponds to the lower third of the SVC.
As discussed above, the results of the decision support algorithm block 1150 can be presented to the user, for example, by highlighting the appropriate location on the heart icon that matches the ECG type identified by the system (1160).
Decision support algorithm block 1250, described in FIG. 12 is based on comparing the spectral power of the P wave, R wave and P wave at current locations with the values of these parameters determined by skin electrocardiograms in an equivalent lead, eg lead II. Thresholds T1 to T6 are empirical values subject to adaptive adjustments for each patient. Each of the criteria or a combination of criteria shown in FIG. 12 can be used.
Other decision algorithms can also be used, in particular related to the electrical energy level calculated from the ECG spectrum. In the case of placement of endovascular devices, a criterion may be that, in the location corresponding to the lower third of the SVC, the mean electrical energy calculated from the endovascular ECG is twice as high as the average electrical energy calculated from the ECG endovascular at the skin level or from a skin ECG in a corresponding lead, eg lead II. Method for placing central venous catheters
A method of placing a central venous catheter (CVC) is presented below. 1. Estimate or measure the length of vascular access device (CVC) required for a certain patient. 2. If saline solution and adapter (200) are used, go to step 11; if not, proceed as follows. Insert a guidewire into the CVC and level-align guidewire tip and catheter tip. Measure the length of the guidewire outside the CVC. This measurement is necessary in order to be able to realign the tip of the catheter and guidewire after insertion of the guidewire into the vasculature. After measuring, for example, with a sterile measuring tape or surgical thread, remove the CVC guidewire. 3. Obtain vascular access and insert guidewire for estimated required length. 4. Insert the CVC over the wire so that the length of the guide wire measured in step 1 is outside the CVC. In this way, the CVC inserted over the wire and the ends of the guide wire are level-aligned. 5. Connect a sterile electrical adapter to the guide wire as instructed for use. 6. Connect the other end of the sterile electrical adapter to the ECG cable of the electrography system. 7. Verify that the electrography system monitor indicates the desired position of the catheter tip according to the instructions for using the electrography system: in the lower third of the SVC, at the cavo-atrial junction, or in the right atrium. Typically, the location of the catheter tip will be identifiable by the specific shape of the P wave and P wave in relation to the R wave of the electrogram and/or by energy levels and thresholds. 8. Adjust the position of the guidewire and CVC by pulling and/or pushing them together so as not to change the flush alignment until the ECG waveform on the screen indicates the desired position has been reached. Correlate the actual entered length with the estimated length. 9. After the position has been reached, disconnect the electrical adapter and remove the guide wire. 10. Fix the CVC in the location. 11. Continue here if saline and adapter (200) are used. 12. Obtain vascular access and introduce CVC over the guidewire as currently specified by existing protocols. 13. Remove the guidewire. 14. Attach the sterile adapter (200) to the CVC. 15. Attach the electrical connection (234) of the adapter (200) to the ECG cable of the electrography system. 16. Fill a syringe with saline solution and attach it to the other end of the adapter (200). Rinse the catheter lumen with saline to create a saline column conductive to the tip of the catheter. 17. Verify that the ECG waveform displayed on the electrography system monitor indicates the desired position of the catheter tip according to the instructions for use of the electrography system: in the lower third of the SVC, at the cavo-atrial junction or at the right atrium. Typically, the location of the catheter tip will be identifiable by the specific shape of the P wave and P wave in relation to the R wave of the electrogram and/or by energy levels and thresholds. 18. Adjust the CVC position by pulling and/or pushing until the ECG waveform on the screen indicates the desired position has been reached. Correlate the actual length with the estimated length. 19. After the desired position has been reached, remove the syringe and adapter (200). 20. Secure the catheter. Method for placing implantable tubes
A method for placing the catheter piece of an implantable tube is similar to the method for placing a CVC. The adapter (200) must be connected to the implantable tube catheter, and the saline syringe must be connected to the other end of the universal adapter. A different electrical adapter must be connected to a syringe needle attached to the implantable tube catheter. After reaching the desired position, the catheter must be connected to the implantable tube. Method for placing open and closed ends of peripherally inserted central catheters
Both open-ended and peripherally inserted closed-ended central catheters (PICC) can be placed as described herein, and the method of placement of PICCs is similar to that of placement of CVCs. The steering mechanism of the invention described herein can be used to bend the tip of the PICC if the catheter fails to advance in the desired direction. Method for placing hemodialysis catheters
A method for placing hemodialysis catheters is similar to the method introduced here for placing CVCs. The steering mechanism of the invention described herein can be used to bend the tip of the hemodialysis catheter if the catheter fails to advance in the desired direction. Two different guidewires with adapters (220) can be used for each of the hemodialysis catheter lumens to guide the placement of one lumen in the right atrium and the other lumen in the cavo-atrial junction using the electrography system. Each of the hemodialysis catheter lumens can be placed independently in sequence or at the same time by connecting the adapters (220) of each of the lumens to different electrodes on the ECG cable of the electrography system. Method for placing central venous access devices in patients with arrhythmias
Traditionally, patients with arrhythmias have been excluded from directing central venous access procedures using the endovascular ECG method because of the absence of visible changes in the P wave shape. The energy criteria for P wave analysis described here may be used to guide the placement of central venous access devices in patients with arrhythmias. In patients with arrhythmia, the electrical signals generated by the sinoatrial node are somewhat random, so they are not synchronized to produce a consistent P wave. However, as previous studies have shown, the electrical activity of the sinoatrial node exists and generates electrical energy of typical intensities up to the proximity of the sinoatrial node. In one embodiment, the algorithm uses the energy measured by the endovascular electrogram to map a certain location in the vasculature. As such, this algorithm can be used to guide placement in patients with arrhythmias when electrical energy alone is indicative of location but not P-wave shape. Method for monitoring tip location and certain aspects of heart electrical activity
Certain aspects of the heart's electrical activity can be monitored continuously or intermittently using the devices introduced here. An electrical adapter or adapter (200) connected to the electrography system can be used for monitoring. The electrical adapter can be connected to any stylet or other conductive member inserted into any venous access device or any arterial device. The adapter (200) can also be connected to any venous or arterial line, as long as the infusion of a conductive solution, eg saline, is possible. The adapter (200) can also be used when electrically conductive fluids are inserted into the body using an infusion pump. Monitoring the location of the tip and/or certain aspects of the electrical activity of the heart can be performed in a variety of clinical situations. 1. The adapter (200) can be attached to various central venous devices post-insertion, for example, at the bedside and/or in home care situations: PICCs, CVCs, hemodialysis catheters. By connecting the adapter to such a catheter and to an electrography system in accordance with an embodiment of the present invention and by injecting saline into the catheter, the location of the catheter tip can be confirmed and/or certain electrical activity of the heart can be monitored during the time the adapter is connected using methods similar to those introduced above in embodiments of the present invention. 2. The adapter (200) may be connected to an arterial line between the arterial line and other devices connected to the arterial line. The blood present in the arterial line and universal adapter ensures the electrical connection between the blood and the electrography system. In this way, the electrical activity of the heart can be continuously monitored. This is particularly important when monitoring preload changes that translate into changes in the electrical energy of the heart during the S-T segment of the ECG waveform. 3. Monitoring the location of the tip and the electrical activity of the heart can also be achieved by using the electrography system and connecting the adapter (200) between a central venous line and a pressure measurement system when taking venous pressure measurements central. 4. In the case of an implanted tube, a needle can be inserted into the tube chamber and the catheter can be flushed with saline using a syringe filled with saline. An electrical adapter can be attached to the needle and electrography system. The detected electrogram signal will contain information from the level of the skin where the needle is in contact with the skin and from the tip of the catheter through the column of injected saline solution. As the impedance of the pathway to the tip of the catheter is lower than that of the skin, the detected signal contains both components, that is, at the level of the skin and at the tip of the catheter. By subtracting the signal from the skin level, the signal at the tip of the catheter can be estimated and thus the position of the tip and certain electrical activity of the heart according to the algorithms described in embodiments of the present invention.
FIG. 13 illustrates the cardiac conduction system of the heart, while FIG. 14 illustrates the propagation of the electrical signal in the conduction system of the heart.
These figures illustrate the conductive mechanism of the heart, which explains why the distribution of electrical energy within the heart as a measure is indicative of specific locations within the heart. Consequently, local electrical signals, behaviors, and energy concentrations can be measured and locations within the heart and blood vessels can be more accurately determined; local cardiac conditions can also be described more accurately.
The conduction system of the heart begins with the heart's dominant pacemaker, the sinoatrial node (1310). The intrinsic rate of the SA nodule is 60 to 100 beats/minute. When an impulse leaves the SA node, it travels through the atria along the Bachmann bundle (1350) and the internodal pathways toward the atrioventricular (AV) node (1320) and ventricles. After the impulse passes through the AV nodule, it travels to the ventricles, first down to the bundle of His (1330) and then along the branches of the bundle and finally down to the fibers of Purkinje (1340). Pacemaker cells in junction tissue and Purkinje fibers in ventricles normally remain dormant as they receive impulses from the SA node. They initiate a boost only if they don't receive one from the SA node. The intrinsic rate of the AV junction is 40 to 60 beats/minute, and the intrinsic rate of the ventricles is 20 to 40 beats/minute. The different propagation speeds of electrical impulses are shown in FIG. 14. From the SA node (1410), impulses propagate through the atrial muscle (1420) and through the ventricular muscle (1460) at approximately 0.5 m/s, through the bundle branches (1440) and (1450 ) at approximately 2 m/s, through Purkinje fibers (1470) at approximately 4 m/s and through the AV node (1430) at approximately 0.05 m/s.
Electrical signals and electrical energy distribution are advantageously used to identify the proximity of the sinoatrial node and the right atrial electrical activity, even in cases of arrhythmia, that is, in the absence of a coherent P wave measured by a standardized skin electrocardiogram. Although in some cases of arrhythmia the random electrical signal generated in the right atrium is not coherent enough to propagate through the body to the skin, electrical energy is still present in the right atrium and can be detected by local endovascular measurements as a non-P wave. coherent, that is, as significant electrical activity in the P segment of the ECG waveform. Energy measurements are also less sensitive to some local abnormalities in impulse conduction: altered automaticity (arrhythmias), retrograde impulse conduction, reentry abnormalities.
Electrical signals and electrical energy distribution are also used to advantage to quantify cardiac functionality, for example, preload, which is related to cardiac muscle depolarization and extension.
Electrical signals and electrical energy distribution are also used to advantage to guide guidewires and guide catheters through the aorta in the left heart. This method is useful in simplifying access to the left atrium and coronary arteries and reducing the amount of contrast and radiation needed to guide endovascular devices to those locations. In a different application, the device of the invention can also be used to guide catheters, for example Swan-Ganz, through the right ventricle into the pulmonary artery. Other endovascular devices can be guided and used to measure endovascular electrical activity at other locations in the cardiovascular system that are identifiable by cardiograms measured with the new apparatus introduced in embodiments of the present invention.
FIG. 15 illustrates electrical activity in the cardiovascular system due to the neuronal control system. Several conduction pathways are related to the control mechanism of the heart (1530) and the activity of blood vessels (1520): receptors (1510), eg pressure receptors, transmit information related to the state of the blood vessels and the state of the heart to the nervous system through the spinal centers (1500). The hypothalamus (1540) and the higher centers (1550) are involved in processing and reacting to information received from sensors/receptors. In turn, they send impulses (1560) back to the blood vessels and heart. By measuring electrical activity related to the control system, information related to cardiac conditions that could not be obtained previously can be obtained.
FIG. 18A illustrates the Einthoven triangle of the ECG and the naming convention for the ECG leads as used herein in connection with various modalities. In order to obtain ECG signals from the patient, typically, one electrode is placed on the right arm (RA), one on the left arm (LA), and one is used as a reference on the left leg (LL). The direction in which the P wave changes the most is shown by the arrow (2200). Therefore, when using endovascular ECG for navigation and catheter tip location, the electrode corresponding to the right arm (RA) is operatively connected to the proximal end of the vascular access device (110) (FIG. 1A), for example, a catheter, in one modality. Thus, an ECG waveform detected in relation to the distal end of the catheter, for example, by means of an electrode disposed in the catheter, can be considered as detected by Lead II of the Einthoven triangle. Thus, when the catheter is advanced through the vasculature, Lead II will show the most significant P wave changes and is therefore better suited to detecting the proximity of the sinoatrial node. The sinoatrial node is located at the cavo-atrial junction and is responsible for generating the P wave (indicating right atrial electrical activity). The waveform that corresponds to Lead III in the Einthoven triangle remains relatively unchanged as the catheter navigates through the vasculature in one modality, if the AR electrode is operatively connected to the catheter. Therefore, Derivation III is used in an embodiment of the present invention as a reference derivation that serves multiple purposes, as described herein. In one embodiment, the device introduced here simultaneously displays waveforms based on the ECG signal for Lead II, also referred to herein as the endovascular ECG lead (for catheter navigation and tip positioning) and for Lead III, also referred to herein. the lead of the skin ECG (as a reference waveform).
Reference is now made again to FIG. 5, which illustrates the mapping of different endovascular ECG waveforms to corresponding locations in the vasculature and heart according to a modality. In detail, Location A corresponds to the superior portion of the superior vena cava (SVC), Location B corresponds to the inferior 1/3 of the SVC, Location C corresponds to the cavo-atrial junction, Location D corresponds to the right atrium and Location And it corresponds to the inferior atrium and/or the inferior vena cava.
FIG. 18B illustrates the endovascular ECG waveform (Lead II) (2215) obtained with a device disclosed herein, e.g., a catheter containing an ECG sensor, as measured at Location A in FIG. 5. Skin ECG waveform (2210) represents a skin ECG reference lead equivalent to Lead III. A reference P-R complex is illustrated by (2280). The typical P-R complex at Location A is illustrated by (2250). Although the P wave changes dramatically in Lead II according to the movement of the catheter and its ECG sensor within the vasculature, as seen in the PR complex (2250), for example, the P wave remains substantially constant in Lead III used as a reference (2280).
In one embodiment, the waveforms of two ECG leads (eg, Lead II and III in FIG. 18B) are described simultaneously on a monitor of a device, eg, a catheter placement system, eg, as illustrated in FIGS. 18B-18F. In another embodiment, three leads (Lead I, II and III of FIG. 18A) can be displayed at the same time as shown in FIG. 20F.
By using the method, device, and ECG electrode configuration introduced here, it is possible, in one modality, to monitor the patient's condition, for example, the patient's heart rate, using the reference skin lead (Lead III), guiding, at the same time, catheter placement using Endovascular Shunt II.
FIG. 18C illustrates the endovascular ECG waveform (2220) obtained with the device disclosed herein, as measured at Location B in FIG. 5. Skin ECG waveform (2210) represents a reference skin lead equivalent to Lead III. A reference P-R complex is illustrated by (2280). The typical P-R complex at Location B is illustrated by (2255). As before, although the P wave changes dramatically in the P-R complex (2250) in Lead II that corresponds to the tip of the catheter, the P wave remains quite constant in Lead III used as a reference (2280).
FIG. 18D illustrates the endovascular ECG waveform (2225) obtained with the device disclosed in an embodiment of the present invention at Location C in FIG. 5. The ECG waveform (2210) represents a reference skin lead equivalent to Lead III. A reference P-R complex is illustrated by (2280). The typical P-R complex at Location C is illustrated by (2260). Although the P wave changes dramatically in the P-R complex (2260) in Lead II that corresponds to the tip of the catheter, the P wave remains quite constant in Lead III used as a reference (2280).
FIG. 18E illustrates the endovascular ECG waveform (2230) obtained with the device disclosed in an embodiment of the present invention at Location D in FIG. 5. The ECG waveform (2210) represents a reference skin lead equivalent to Lead III. A reference P-R complex is illustrated by (2280). The typical P-R complex at Location D is illustrated by (2265). Although the P wave changes dramatically in the P-R complex (2265) in Lead II which corresponds to the tip of the catheter (265), the P wave remains quite constant in Lead III used as a reference (2280).
FIG. 18F illustrates the endovascular ECG waveform (2240) obtained with the device disclosed in an embodiment of the present invention at Location E in FIG. 5. The ECG waveform (2210) represents a reference skin lead equivalent to Lead III. A reference P-R complex is illustrated by (2280). The typical P-R complex at Location E is illustrated by (2270). Although the P wave changes dramatically in the P-R complex (2270) in Lead II that corresponds to the tip of the catheter, the P wave remains quite constant in Lead III used as a reference (2280).
FIG. 19A illustrates the ability of the apparatus introduced here, for example, a catheter delivery system, to show multiple display windows at the same time on its screen. One, two or more viewports can be included. Each of the display windows (3310 and 3320) can display one to three ECG waveforms (leads I, II and III) in any combination, in real-time acquisition mode, in playback mode or frozen mode. In one modality, a display window (3310) is used to show real-time ECG waveforms (catheter guidance, or endovascular lead II and skin lead reference III) and another display window (320) is used to show frozen ECG waveforms (catheter guidance lead II and reference skin lead III). In this way, the user can compare changes in the catheter orientation lead and, in particular, in the PR complex at two different locations of the catheter tip: at the location of the frozen tip in the display window (2320) and at the current location (in real-time) of the tip displayed in the window (2310).
The multi-window comparison above allows the use of the following catheter placement method, according to a modality: first advance the catheter in the atrium until the P wave reaches its maximum amplitude, as seen in window (2320) (FIG. 19B), and then pulling the catheter to a location where the P wave is half the size of its maximum amplitude. Such a location, where the amplitude of the P wave is half the size of its maximum amplitude, is indicative of the lower third of the superior vena cava (Location B in FIG. 5).
FIG. 20A illustrates how the reference skin lead can be used to analyze the P-wave segment of the catheter guidance lead (Lead II), according to a modality. The segment of the P wave, in which the P wave itself is centered, is characterized by the fact that it immediately precedes the QRS complex of the same heartbeat. The P-wave segment of a heartbeat also follows the T-wave of the previous beat. In order to detect the P wave segment, an algorithm that includes detection of the R peak of the QRS complex can be applied. The algorithm, in one modality, includes the following steps: Detect the R-peak. Compute the R-R interval.
Assume that a certain percentage of the R-R interval before the R peak is the interval at which the P wave occurs. This interval where the P wave occurs is defined as the segment of the P wave.
Detect the P peak in the P wave segment, its amplitude and polarity.
Apply processing, analysis and decision-making algorithms as illustrated in FIGS. 11 and 12.
In one embodiment, in order to apply the algorithm described above, the R peak and the R-R interval can be detected in Endovascular Lead II, ie, in the same ECG lead that is used for guidance. In another embodiment, the R-peak and R-R interval can be detected using Lead III (the reference skin lead). In particular, detection of the R peak at Lead III (2410) in FIG. 20A can be used to trigger the analysis of any segment of the ECG waveform in Lead II, including the analysis of the P-wave segment (2420) in FIG. 20A. It is also possible, if the Lead II signal quality permits, to use the R peak (2430) detected in Lead II itself to trigger processing of the Lead II waveform. In other modalities, other leads can be used to implement triggering in a lead other than that used for catheter navigation and tip positioning. For example, Lead I can optionally be used for catheter navigation and tip positioning. The modality device also allows the use of Lead I for catheter navigation and tip positioning, although Lead II is suitable in many clinical settings. Note that, in one modality, the above trigger can occur for spikes in a waveform detected by the same lead. In addition, a peak detected in Lead II can be used to trigger Lead I analysis in one modality. Thus, these and other variations are considered.
Triggering analysis on an ECG lead that is different from the ECG lead used for navigation and catheter placement as introduced here is useful in many practical situations, regardless of which ECG lead is used to trigger the analysis and which lead of ECG is used for navigation and positioning of the catheter. As will be seen in FIGS. 20B-20E and especially in FIG. 20E, triggering in a noiseless, stable lead, eg Lead III, increases the ability to process different segments from other leads, eg Endovascular Lead II used for navigation and catheter positioning in cases where the signal Lead II ECG includes a greater than desired amount of signal noise. Noisy ECG Lead II signals appear very often in practical settings because of manual manipulation of the Lead II connection by the user. Other situations can benefit from the triggering concept introduced here, as will be noted below.
FIG. 20B illustrates how the R peak detected in Reference Skin Lead III (2410) and the corresponding R-R interval trigger analysis of the PQRS segment (2430) in Navigation Lead II. As described herein, the P-wave segment and the QRS complex of ECG Lead II can be analyzed separately or in relationship to each other to predict the location of the catheter tip in the vasculature. In the case shown in FIG. 20B, the P wave has a large positive amplitude that is equal to the amplitude of R and is also bipolar (it has a first negative segment). In this case, detecting the R peak in Lead II itself is very difficult, if not impossible, through the use of algorithms. Triggering Lead II ECG waveform analysis (2430) based on detection of the R peak detected in Reference Lead III (2410), as introduced here, allows detection and processing of characteristic P-wave segment changes the location of the tip of the catheter. Such algorithmic analysis of the Lead II ECG waveform would otherwise be difficult in the case shown in FIG. 20B, because of the difficulty in clearly detecting the R peak in this lead.
FIG. 20C illustrates how triggering at the R peak of a lead, for example, the R peak of Lead III (2410), can be used to trigger analysis of the P-wave segment in Catheter Navigation Lead II (2440) in the case of a patient with arrhythmias. Typically, the P wave segment is not present in the cutaneous ECG lead in patients with arrhythmias, as seen in FIGS. 20C and 20D. However, the catheter navigation and tip positioning lead, for example, Lead II, may detect a relatively higher level of electrical activity in the P-wave segment as the catheter approaches the sinoatrial node and the cavo-atrial junction. The level of electrical activity (energy) in the P-wave segment further increases as the tip of the catheter passes the sinoatrial node and enters the right atrium. As the highest level of this increased electrical activity in the P-wave segment of Navigation Lead II cannot be predicted, for example, the amplitude of the P wave could be greater than that of the R wave in Lead II, triggering the analysis of the Such a P-wave segment at the R-peak of a skin ECG lead provides an adequate solution for P-wave detection and subsequent tip location and catheter positioning.
FIG. 20D illustrates the absence of a P wave in the case of a patient with arrhythmia in both ECG leads II and III. In FIG. 20D, lead II is connected to a skin electrode on the patient's right arm and lead III to a skin electrode on the patient's left arm. The R peak in lead III (2410) is depicted in this figure and the corresponding segment showing the absence of a discernible P wave in lead II is shown as (2450).
FIG. 20E illustrates the situation in which the catheter navigation lead, eg Lead II, is noisy or unstable and detection of the R peak and the corresponding P wave is therefore difficult. In this case, as before, the detection of the R peak (2410) in a stable reference lead, eg Skin Lead III, preserves the ability through the trigger described above to find and analyze the P wave segment (2460 ) in the noisiest shunt of catheter navigation.
FIG. 20F illustrates another embodiment, in which two leads (in this example Leads I and II - see FIG. 18A) are used to detect simultaneous, corresponding (2470) and (2475) and triangulated ECG waveforms, along with a triangulated ECG waveform. additional simultaneous ECG wave (2480) from the reference lead (Lead III), from the location of the catheter tip. In particular, a substantially accurate location of the catheter tip can be determined by looking at Leads I and II at the same time and using their correlation (or lack thereof) to reduce noise and more accurately determine P-segment, QRS-segment changes. and the relative changes between the P wave and the QRS complex.
FIGS. 21A and 21B illustrate details regarding an algorithm to use the P wave segment and/or its relationship to the QRS complex for navigation and catheter tip location in case of arrhythmia, according to a modality.
Specifically, FIG. 21A illustrates the ECG waveforms for two skin ECG leads (using skin electrodes). In FIG. 21A, Lead III, with its corresponding R peak (2510), is detected using the left arm skin electrode, and Lead II, which shows the absence of the P wave (2520), is detected using the right arm skin electrode , both being compared with the left leg skin electrode, in one modality. Previously, patients showing these typical arrhythmia ECG waveforms were not considered candidates for using the ECG-based method for navigation and catheter tip location. It was believed that since the P wave is not present at the skin level, the ECG method could not be used to determine the location of the catheter tip at the cavo-atrial junction. FIG. 21A thus illustrates a situation where the R peak of the reference skin lead (2510) can be used to compute the characteristics and energy of the P segment (P wave) in the navigation lead at locations where the P wave is not. gift.
In more detail, FIG. 21B illustrates ECG waveforms as obtained with the apparatus described in connection with FIGS. 20A-20E and shows that, with the device and method described here, even patients with arrhythmia can be treated using ECG-based navigation and catheter tip location. Depending on the processing algorithms described in FIGS. 11 and 12, the ECG signal obtained from the catheter tip in Lead II is more accurate and less noisy when compared to the established technique. Thus, changes in the P wave segment (2530) become visible when the tip of the catheter is close to the sinoatrial node. They correspond, as justified by physiology, to a random electrical activity of the right atrium. This random electrical activity and its changes can be detected with the device introduced here, as illustrated by the P wave segment (2530). This random electrical activity typically cancels out after reaching the skin and Lead III and thus is difficult or impossible to detect by established technique ECG methods.
Sometimes the random electrical activity of the right atrium above is also very weak and a device like the one introduced here is needed to detect it, even at the tip of the catheter. By observation and/or analysis of P-wave segment changes in the catheter navigation lead, the location of the catheter tip can be mapped, for example, to locations in the superior vena cava (weak, low or no P-wave energy) , to locations in the cavo-atrial junction and to locations in the right atrium. FIG. 21B illustrates how the R peak in the reference lead (eg Skin Lead III) can trigger analysis of the corresponding P wave (P-segment) in the navigation lead (eg Endovascular Lead II) at locations where a wave segment P (2530) is present.
In addition to those algorithms described in FIGS. 11 and 12, it is observed that other decision algorithms can be used, such as those related to the level of electrical energy as calculated from the electrogram spectrum, when placing a catheter or other endovascular devices. For example, a criterion specifies that, at the location corresponding to the lower third of the SVC, the average electrical energy calculated from the endovascular electrogram is twice as high as the average electrical energy calculated from the endovascular electrogram at the skin level, by example, from a skin electrocardiogram in a corresponding lead, eg Lead III.
In addition to the algorithms disclosed above in connection with FIGS. 11 and 12, the concepts of directional energy and decision-making based on it are introduced here. As seen, for example, in FIGS. 18B in (2250) and 18C in (2255), the P wave is unipolar, that is, it has a single polarity, the polarity being positive. In comparison, FIGS. 18D in (2260) and 18E in (2265) illustrate a bipolar P wave, that is, a P wave that has both a negative component and a positive component. FIG. 18F illustrates a P-wave segment at (2270) with a unipolar P-wave segment, but of reverse polarity, compared to that of the P-wave segment shown in FIGS. 18B and 18C.
The polarity change in the P-wave segment above is caused by the location of the tip of the catheter in relation to the sinoatrial node and the locations of the skin electrodes according to the Einthoven triangle (FIG. 18A). In the cases illustrated here, as the catheter navigates from the superior vena cava through the cavo-atrial junction, through the right atrium, and into the inferior vena cava, the polarity of the P-wave segment changes similarly.
According to an embodiment and in light of the above, the location of the catheter tip can be determined by the following: a positive energy value and a negative energy value are determined for a P wave detected by the apparatus described herein, for example, a catheter delivery system. The positive P wave energy value is determined according to the energy computation algorithms described here, but only for positive P wave values (ie, values above the baseline ECG level). Correspondingly, the negative energy value of the P wave is determined according to the energy computation algorithms described here, but only for negative values of the P wave (ie, values below the baseline ECG level). These energy values (positive and negative) determined in accordance with the present modality are also referred to herein as "directional energy" values, as they are related to the direction and location of the catheter tip at which point the P wave is being detected by means of an appropriate sensor in operable connection with a corresponding ECG lead, eg the Endovascular Lead II discussed above.
The directional energy of the P wave described above can be used to guide the navigation of a catheter and to locate a catheter tip, according to a modality. Particularly, in one embodiment, a standardized Einthoven electrode configuration, with the right arm electrode detecting endovascular ECG signals at the tip of the catheter (as described above in connection with FIGS. 20A-20E), is considered. Note that other electrode configurations are also possible. If the P wave energy is substantially entirely positive, the tip of the catheter is considered to be located above the sinoatrial node, for example, in the superior vena cava. If the P wave includes positive energy and a relatively small amount of negative energy, but the positive energy is less than the R wave energy, as noted at (2260) in FIG. 18D, the tip of the catheter may be located at the cavo-atrial junction. If the P-wave segment includes a large amount of negative energy relative to its positive energy, then the positive energy is comparable to that of the R-wave energy, as noted in (2265) in FIG. 18E, the tip of the catheter may be in the right atrium. If the P wave includes substantially entirely negative energy, as noted at (2270) in FIG. 18F, the tip of the catheter is approaching the inferior vena cava or is in the inferior vena cava. Thus, the directional energy introduced here is used by the present method described herein for navigation and location of the catheter tip.
FIGS. 22A-22D and 23A-23B illustrate various details with respect to a connector according to exemplary embodiments, which allow use of the apparatus and method described herein by a single operator in the sterile field.
In particular, FIG. 22A shows a connecting object (2915) that includes magnetic attraction properties and a surface that includes electrically conductive properties. The connecting object (2915) electrically connects to the two connectors (2910) and (2920). The connector (2910) is connected to one end of a sterile device/adaptor (2905). The other end of the sterile device (2905) may be connected to a sterile guidewire or stylet or a sterile saline adapter as described further above. The connector (2920) may be attached to or itself an end of an ECG cable to the apparatus illustrated in FIG. 1A.
The connection object surface (2915) can be implemented in various ways. In one embodiment, a magnet is built into a housing with an electrically conductive surface. The magnet attracts the electrical connectors (2910) and (2920) to the metal surface and secures them to the surface, thereby establishing electrical contact between the connector (2910) and the electrically conductive surface of the connecting object (2915) and another contact electrical connection between the electrically conductive surface of the connecting object (2915) and the other electrical contact (2920).
Connector object 2915 illustrates one type of connector that can be used with the methods described herein by a single operator in the sterile field. Consequently, in one modality, the object (2915) is placed prior to the commencement of a catheter placement procedure in the non-sterile field in such a way that it can be reached by the single sterile operator during the procedure. The operator then not yet sterile connects one end of the non-sterile connector (2920) to an ECG cable and “loosen” the end of the connector shown in FIG. 22A on the surface of the connecting object 2915. Because of the magnet incorporated in the object (2915), the connector (2920) is attracted to the electrically conductive surface of the connecting object and adheres to its surface. The end of the ECG cable to which the connector (2920) is attached or included can be the ECG lead itself, thus simplifying the workflow.
During the procedure, the only operator is sterile. The operator opens the sterile package in which the connector (adapter) (2910, 2905) is packaged, holds the end of the sterile connector (2915) with sterile-gloved hands, and releases the sterile connector onto the electrically conductive surface of the connecting object (2915). Similar to the connector (2920), the connector (2910) is magnetically attracted to the connecting object (915) by the embedded magnet, which secures the connector (2910) to the electrically conductive surface of the connecting object. Using this method, an electrical connection can be established between a sterile electrical connector (2910) and a non-sterile connector (2920) without compromising the sterile field. Again, this method can be used by a single operator and allows the single sterile operator to use the device described here.
FIG. 22B illustrates another embodiment of the connector, where the connecting object (2930) is directly connected to a wire or is an integral part of an ECG cable (2935). This embodiment simplifies the method described above in connection with FIG. 22A, as the sterile connector (2925) connected to the sterile adapter (2905) must be released onto the electrically conductive surface (2930) of the connecting object (2930) during the sterile procedure.
FIG. 22C illustrates another embodiment of the connecting object, in which a connector (2940) of the sterile adapter (2905) is similar to the adapter (2905) and the connector (2910) described above in connection with FIG. 22A. During a catheter placement procedure, the sterile operator loosens the sterile connector (2940) onto a connecting object, or coupling piece (2945). The coupling piece (2945) includes a dome that receives the connector (2940). A magnet is built into the dome, which draws the connector (2940) into the dome to secure it there. At the same time, the dome ensures electrical connectivity. The coupling piece (2945) can be an integral part of an ECG cable (2950) (for example, one end of an ECG lead), one end of a wire for connecting to an ECG cable, or some other configuration proper. The method for using coupling piece 2945 is similar to that described in connection with FIG. 22B, with one difference being that the dome (2945) has the ability to draw suction on the connector (2940) for a relatively tight male/female connection. As is the case with the embodiments described in connection with FIGS. 22A, 22B and 22D, the shapes and materials used for the connecting objects can vary as long as they ensure proper electrical contact for the interconnected components.
FIG. 22D illustrates a connection object configuration similar to that described in connection with FIG. 22C, except that a dome (2960), which contains a magnet to operably connect with a connector (2955), includes, on an opposite end, a connector (2965) to which an ECG cable clip can be attached. Thus, during a placement procedure, a non-sterile operator can attach the connector (2965) to a commercially available ECG cable by using the clip provided with the ECG cable. Subsequently, during the sterile procedure, the sterile operator releases the sterile connector (2955) into the dome (2960), similar to the method described in connection with FIG. 22C.
FIG. 23A illustrates details of a sterile steerable adapter (3010) according to one embodiment, which includes a stiffened piece of sterile connector (3020) of rigid plastic, for example. Instead of loosening the sterile connector piece (3020) into a coupling piece (3030) as in FIGS. 22C and 22D, the sterile operator can use the rigid connector piece (3020) of the sterile adapter (3010) to direct it, for example, push, rotate, etc., into the coupling piece. In one embodiment, the coupling piece (3030) includes an embedded magnet to attract the connector part 3020. In another embodiment, the coupling piece (3030) does not include a magnet, but is of an appropriate size and shape for the part. of the connector (3020) fits into it so as to establish proper electrical contact between them.
FIG. 23B illustrates a steerable connector piece (3040) according to an embodiment, which can be pushed and operatively connected with a simple coupling piece (3050) without the need for a magnet. In addition to what has been shown and described, other shapes are possible for the connector (3040) and its coupling piece (3050), eg rails or screws.
It should be noted that any suitable combination of the connector modalities discussed above can be used. For example, the steerable connector of FIG. 23B may include a coupling piece like that shown in FIG. 22D.
FIGS. 24A-24F illustrate various details of catheter navigation according to a modality. As shown, each of these figures includes two display windows: a first window that shows ECG waveforms, and a second window that shows a representation, or icon, of a heart and an additional location icon that indicates the point of measurement of the ECG signal to which the ECG waveforms in the first window correspond. Mapping between ECG waveforms and the location icon is performed in one modality using the algorithms and methods described above. The two viewports can be used independently or together. In one embodiment, the two display windows are shown simultaneously on the graphical user interface (FIG. 1A) to allow the operator to correlate the observed ECG waveform(s) with the location of the catheter tip . In another modality, only the heart and location icon window is shown in order to simplify the user interface.
The location icon can include any one or more of several possible configurations, including an arrow to show progress in a certain direction, a dot, cross, star, etc., to show an identifiable location. Each of these icons can include different colors to emphasize location relevance. In another modality, different sounds can be associated with each of the identifiable locations of the tip. Sounds and icons that identify tip locations can be used together or independently to help the user navigate the catheter and locate the tip within the patient's vasculature.
In one embodiment, a simplified user interface is employed, in which only the heart icon and the corresponding location icon(s) are displayed. In this case, the ECG waveforms and computation behind the location mapping are not visible to the user. Thus, the device described here can be used for navigation and tip location without requiring the user to interpret the ECG waveforms. The simplified user interface with just the heart and catheter tip location icons can be used as shown in the embodiment illustrated in FIG. 25B, for example.
In more detail, FIG. 24A illustrates ECG waveforms that correspond to catheter tip locations outside the chest cavity in the upper body: a Reference ECG Skin Lead III (3110) and an Endovascular Catheter Navigation II ECG Lead (3115) . In the icon display window, a heart icon (3125) is displayed and a location icon (3120) shows that the catheter is moving toward the chest cavity. In another embodiment, the arrow-shaped location icon (3120) may be replaced with a cross, dot, or any other suitable icon that shows location above and outside the superior vena cava.
The arrow-shaped location icon (3120) is displayed by the device according to a modality only if the algorithms detect changes in the Navigation ECG Lead II that support the fact that the catheter tip is moving towards the heart , for example, a steady increase in electrical energy and a P wave with positive directional energy, indicating that the tip is approaching the sinoatrial node. If the algorithms do not detect a steady increase in electrical energy of the endovascular ECG signal as the catheter advances through the vasculature, only a dot, star, cross, or other suitable location icon is displayed at a location above and outside the vena cava. higher. Sounds associated with each of these locations and situations can be played in addition to or instead of the graphic icons.
FIG. 24B illustrates the ECG waveforms that correspond to the reference lead (3110) and the navigation lead of the catheter (3115) at a location that corresponds to the superior portion of the superior vena cava. The icon display window shows the heart icon (3125) and a dot-shaped location icon (3130) that indicates the upper portion of the superior vena cava in the heart icon. This location is determined by the instrument, as further described above, based on the ECG waveforms (3110) and (3115). As in FIG. 24A, any suitable icon shape and color can be used, and/or a sound or melody can be played when the catheter tip reaches the location indicated by the detected ECG waveforms.
FIG. 24C illustrates the ECG waveforms that correspond to the reference lead (3110) and the navigation lead of the catheter (3115) at a location that corresponds to the lower third of the superior vena cava. The icon display window shows the heart icon (3125) and a dot-shaped location icon (3140) that indicates the lower third of the superior vena cava in the heart icon. This location is computed by the instrument, as further described above, based on the ECG waveforms (3110) and (3115). As in FIG. 24A, any suitable icon shape and color can be used and/or a tone or melody can be played when the catheter tip reaches the location, as indicated by the detected ECG waveforms.
FIG. 24D illustrates the ECG waveforms that correspond to the reference lead (3110) and the navigation lead of the catheter (3115) at a location that corresponds to the cavo-atrial junction. The icon display window shows the heart icon (3125) and a dot-shaped location icon (3150) that indicates the cavo-atrial junction on the heart icon. This location is computed by the instrument, as further described above, based on the ECG waveforms (3110) and (3115). As in FIG. 24A, any suitable icon shape and color can be used and/or a tone or melody can be played when the catheter tip reaches that location, as indicated by the detected ECG waveforms.
FIG. 24E illustrates the ECG waveforms that correspond to the reference lead (3110) and the navigation lead of the catheter (3115) at a location that corresponds to the right atrium. The icon display window shows the heart icon (3125) and a dot-shaped location icon (3160) that indicates the right atrium on the heart icon. This location is computed by the instrument, as further described above, based on the ECG waveforms (3110) and (3115). As in FIG. 24A, any suitable icon shape and color can be used and/or a tone or melody can be played when the catheter tip reaches that location, as indicated by the detected ECG waveforms.
FIG. 24F illustrates ECG waveforms that correspond to catheter tip locations outside the chest cavity in the lower body: the Reference ECG Skin Lead III (3110) and the Endovascular Catheter Navigation ECG Lead II (3115) . In the icon display window, the heart icon is displayed (3125) and an arrow-shaped location icon (3170) which shows that the catheter is moving away from the chest cavity, for example towards the vena cava bottom. In another embodiment, the arrow-shaped location icon (3170) may be replaced with a cross, a dot, or any other suitable icon that shows the location below the right atrium.
The arrow-shaped location icon (3170) is displayed by the device in one mode only if the algorithms detect changes in the Navigation ECG Lead II that support the fact that the catheter tip is moving away from the heart, by example, a steady decrease in electrical energy and a P wave with negative directional energy, indicating that the tip is moving away from the sinoatrial node. If the algorithms do not detect a steady decrease in electrical energy of the endovascular ECG signal as the catheter advances through the vasculature, but detect a negative P wave, only a dot, star, cross, or any other location icon is displayed in a location below and outside the right atrium. The sounds associated with each of these locations and situations can be played in addition to or instead of the graphic icons.
FIG. 25A illustrates a display window on a graphical user interface of a cell phone (3210), tablet PC, or any other suitable handheld or portable device. In particular, the mobile phone user interface is shown displaying waveforms (3220) of two ECG leads: the reference lead and the catheter navigation lead. The cell phone or other suitable device is held, in one modality, in a horizontal position to allow a longer time (more cardiac cycles) for the ECG waveform to be displayed. If the display device is in real-time display mode, the monitor automatically switches to show ECG waveforms each time the device is rotated horizontally. In another modality, only one ECG lead is displayed at a time. In yet another mode, three or more leads can be displayed simultaneously. As described in one embodiment of the present invention, in another embodiment, the display device screen can be split in real time to describe a display window (current location) and a frozen window (reference location) to allow for easier evaluation of ECG waveform changes. The two-way interaction between the apparatus shown in FIG. 1A and cellular telephone (3210) to enable functionality shown and described in connection with FIGS. 25A-27B can be achieved in one embodiment via the wireless connectivity component 150 shown in FIG. 1A. It should be noted that the cell phone (3210) is equipped with corresponding wireless connectivity so as to allow communication between them, as noted by those skilled in the art.
FIG. 25B illustrates a simplified user interface (3230) displayed on the screen of a cell phone (3210) or other suitable handheld/portable device based on the navigation interface depicted in FIGS. 24A-24F. When in real-time display mode and if the display device is positioned vertically, the device automatically displays the simplified user interface shown in FIG. 25B. When in real-time display mode, the device automatically switches back and forth between displaying ECG waveforms when the device is held horizontally, illustrated in FIG. 25A, and display of the navigation user interface, illustrated in FIG. 25B when the device is held vertically.
FIG. 26 illustrates, in one embodiment, the zoom and scroll functions on the touch-sensitive screen of a cell phone (3310), tablet PC, or similar device. User can use two fingers (3320) to zoom in and out of ECG waveforms for better viewing. Scrolling through recording the ECG waveform can also be achieved using fingers and the touch screen.
FIG. 27A illustrates the ability, in one embodiment, to use a mobile phone (3410), tablet PC, or other suitable handheld/portable device to communicate ECG waveforms and/or with the simplified user interface and patient data with another computer or device. The communication interface is illustrated by (3420). This transfer can be performed by cell phone (3410) via a wireless network, cell phone or other suitable network.
FIG. 27B illustrates the graphical user interface of a mobile phone (3410), tablet PC, or other suitable handheld/portable device that allows the display of patient data (3430), ECG waveforms (3440) or a heart icon simplified, depending on the device orientation, and the navigation, control and arrangement in an interface (3450) of one or more patient records, including deletion, copy to memory etc.
It should be noted that the apparatus, algorithms and methods described here can be practiced in connection with different environments and with the use of different components and systems. An example of an ECG monitoring system with which the modalities of the present invention can be practiced can be found in US Patent Application Publication No. 2010/0036227, filed September 10, 2009, and entitled "Apparatus and Display Methods Relating to Intravascular Placement of a Catheter”. Another example of an ECG monitoring system can be found in U.S. Patent Application Publication No. 2009/0259124, filed April 21, 2009, and entitled "Method of Locating the Tip of a Central Venous Catheter." Each of the aforementioned applications is incorporated herein by reference in their entirety.
Non-limiting examples of ECG sensing stylets that can be used in connection with embodiments of the present invention can be found in US Patent Application Publication No. 2010/0222664, filed August 21, 2009, and entitled “Catheter Assembly Including ECG Sensor and Magnetic Assemblies", and in US Patent Application No. 2011/0015533, filed September 29, 2010, and entitled "Stylets for use with Apparatus for Intravascular Placement of a Catheter", each of which is incorporated herein by reference in its entirety.
Embodiments of the invention may be exemplified in other specific forms without departing from the spirit of the present disclosure. The modalities described are to be considered in all respects as illustrative only, not restrictive. The scope of the modalities is therefore indicated by the appended claims and not by the description given above. All changes that fall within the meaning and breadth of equivalence of the claims must be encompassed within their scope.

权利要求:
Claims (12)
[0001]
1. Method for locating an implantable medical device within a patient's body (300), the method characterized by comprising: - detecting a first peak in a first ECG waveform acquired by means of a first electrode placed on the skin (410); - trigger analysis of a second ECG waveform when the first peak is detected, the second ECG waveform being acquired by means of a second electrode (240, 230, 310, 320, 475) disposed in a portion of the implantable medical device; - detection of a second peak in the second ECG waveform; and - determining a position of a portion of the implantable medical device based on a characteristic of the second peak, wherein detection of an R wave peak as the first peak in the first ECG waveform is performed when a wave peak P is absent in the first ECG waveform due to arrhythmia, but at least a portion of a P waveform is present in the second ECG waveform.
[0002]
A method for locating according to claim 1, further comprising: - repeatedly detecting the second peak, wherein determining a position further comprises determining the position of the portion of the implantable medical device based on a change in the characteristic as the second peak is repeatedly detected.
[0003]
A method for locating according to claim 1, characterized in that the implantable device includes a catheter (300), and wherein the portion of the implantable device includes a distal tip of the catheter.
[0004]
Method for localization, according to claim 1, further characterized by comprising: - simultaneous display of the first and second ECG waveforms on a first portion of a monitor.
[0005]
Method for locating, according to claim 1, further comprising: - simultaneous display of a current view of the first and second ECG waveforms on a first portion of a monitor; and - displaying an anterior view of the first and second ECG waveforms on a second portion of the monitor.
[0006]
Method for locating, according to claim 5, further comprising: - displaying a locating icon representing a position within the body of the portion of the implantable medical device on a portion of the monitor; and - updating the display of the location icon in accordance with repeated determination of the position of the portion of the implantable medical device.
[0007]
7. Method for locating, according to claim 6, characterized in that the display of the location icon further comprises: - display of the location icon on top of a representative image of a patient's heart.
[0008]
Method for locating, according to claim 1, further comprising: - displaying at least one of the first and second ECG waveforms on a monitor of a cell phone or handheld device by means of wireless transfer.
[0009]
9. Method for localization, according to claim 1, characterized in that the triggering of the analysis of the second ECG waveform is performed automatically by a processor of a catheter localization device.
[0010]
Method for locating, according to claim 1, characterized in that it comprises: - calculating at least one of a positive amplitude amount of the P wave and a negative amplitude amount of the P wave; and - determining a position of a portion of the implantable medical device based on the calculated amount of at least one of the positive amplitude and the negative amplitude of the P wave.
[0011]
11. Method for locating, according to claim 10, characterized in that the calculation of at least one of the positive amplitude amount of the P wave portion and the negative amplitude amount of the P wave portion further comprises: - detection of a frequency of at least one of the positive amplitude amount of the P-wave portion and the negative amplitude amount of the P-wave portion.
[0012]
Method for localization according to claim 3, characterized in that it comprises: - displaying a current view of the cutaneous ECG waveform and the endovascular ECG waveform in a first window; and - display an anterior view of the cutaneous ECG waveform and the endovascular ECG waveform in a second window.

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同族专利:

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公开号 | 公开日

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ES2811107T3|2021-03-10|

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EP2531098A1|2012-12-12|

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US10912488B2|2021-02-09|

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EP2531098A4|2015-09-09|

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WO2011097312A1|2011-08-11|

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BR112012019354A2|2012-08-02|

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CN102821679B|2016-04-27|

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US9125578B2|2015-09-08|

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US10231643B2|2019-03-19|

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EP2531098B1|2020-07-15|

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CN102821679A|2012-12-12|

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US20150374261A1|2015-12-31|

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US20110196248A1|2011-08-11|

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US20180070856A1|2018-03-15|

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JP2013518676A|2013-05-23|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-07-21| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-09-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 02/02/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |

优先权:

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申请号 | 申请日 | 专利标题

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US28239710P| true| 2010-02-02|2010-02-02|

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US61/282,397|2010-02-02|

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US12/815,331|US9339206B2|2009-06-12|2010-06-14|Adaptor for endovascular electrocardiography|

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US12/815,331|2010-06-14|

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US12/854,083|US9445734B2|2009-06-12|2010-08-10|Devices and methods for endovascular electrography|

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US12/854,083|2010-08-10|

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PCT/US2011/023497|WO2011097312A1|2010-02-02|2011-02-02|Apparatus and method for catheter navigation and tip location|

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