巴西专利BR112013002431B1 SYSTEM FOR RECONFIRMING THE POSITION OF A CATHETER INSIDE A PATIENT

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专利摘要:
METHOD FOR RECONFIRMING THE POSITION OF A DEVICE METHOD INTERNAL IN THE BODY OF A PATIENT SYSTEM FOR RECONFIRMING THE POSITION OF A CATHETER INSIDE THE VASCULATURE OF A PATIENT The reconfirmation of the position of an intravascularly placed catheter with assistance is revealed of the patient's ECG signals, thus assisting in determining the subsequent displacement of the catheter within the patient's vasculature. In one embodiment, a method for reconfirming the position of a medical device within a patient's body comprises first placing the medical device within a patient's body comprising first placing the medical device within a patient's body using ECG signs of the patient. A first ECG signal profile referring to an initial position of the internal medical device is stored after initial placement of the medical device. A second ECG signal profile relating to the position of the internal medical device at a time subsequent to initial placement of the internal medical device is then obtained. The first ECG signal profile is compared with the second ECG signal profile to determine if displacement of the internal medical device has occurred.
公开号:BR112013002431B1
申请号:R112013002431-3
申请日:2011-08-19
公开日:2021-06-29
发明作者:Kelly B. Powers；Jim C. Beasley
申请人:C.R. Bard, Inc；
IPC主号:

专利说明:

CROSS REFERENCE WITH RELATED ORDERS
[001] This application claims the benefit of US Provisional Patent Application No. 61/375,442, filed August 20, 2010, and entitled "System for Reconfirmation of ECG-Assisted Catheter Placement," which is incorporated into the present by reference in its entirety. BRIEF SUMMARY
[002] Briefly summarized, the embodiments of the present invention are directed to reconfirming a position of a catheter or other internal device that has been placed with the assistance of patient ECG signals. The system and methods described in this application allow the clinician to confirm that the distal tip of the indwelling catheter remains positioned in the same location as when the catheter was initially placed. If the tip is found to have moved to another position, steps can be taken to return it to its proper position.
[003] In another embodiment, a method for reconfirming the position of a medical device internal to a patient's body comprises first placing the medical device within a patient's body using the patient's ECG (Electrocardiogram) signals. A first ECG signal profile referring to an initial position of the internal medical device is stored after initial placement of the medical device is complete. A second ECG signal profile referring to a position of the internal medical device at a time subsequent to the initial placement of the medical device is then obtained. The first ECG signal profile is compared with the second ECG signal profile to determine if displacement of the internal medical device occurred after initial placement of the medical device. If displacement has occurred, the physician may take the necessary steps to reposition the catheter as needed.
[004] These and other features of the embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by practicing the embodiments of the embodiment as hereinafter indicated. BRIEF DESCRIPTION OF THE DRAWINGS
[005] A more particular description of the present disclosure will be presented with reference to its specific characteristics which are illustrated in the accompanying drawings. It is appreciated that these drawings show only typical embodiments of the invention and are thus not to be considered as limiting the scope. Exemplary embodiments of the invention will be described and explained in greater specificity and detail through the use of the accompanying drawings, in which: FIG. 1 is a block diagram showing various elements of a system for intravascular placement of a catheter, in accordance with an exemplary embodiment of the present invention; FIG. 2 is a simplified view of a patient and a catheter being inserted therein with the assistance of the system of FIG. 1; FIG. 3 is a partial cross-sectional view of a conductive path configuration within the catheter of FIG. 2 according to an embodiment; FIG. 4 is a perspective view of a card reader/encoder system for use in accordance with an embodiment; FIG. 5 is a top view of a catheter bifurcation including an RFID chip in accordance with an embodiment; FIG. 6 is a simplified top view of an RFID reader/encoder; and FIG. 7 is a display view of the system of FIG. 2 showing a plurality of ECG waveforms during use of the system in confirming a position of a catheter, in accordance with an embodiment. DETAILED DESCRIPTION OF SELECTED MODALITIES
[006] Reference will now be made to figures in which similar structures will be provided with similar indications of reference. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, being neither limiting nor necessarily drawn to scale.
[007] For clarity, it should be understood that the word "proximal" refers to a direction relatively closer to the clinician using the device to be described in the present application, while the word "distal" refers to a direction relatively farther from the clinician. clinical. 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. Also, the words "including," "has," and "having," as used in the present application, including the claims, will have the same meaning as the word "comprising".
[008] Embodiments of the present invention are generally directed to reconfirming a position of a catheter or other internal device that has been placed with the assistance of ECG signals from the patient. As explained in the present application, the system and methods described in the present application particularly enable the physician to confirm that the distal tip of the indwelling catheter remains positioned in the same location where the catheter was initially placed. If the tip is found to have migrated to another position, steps can be taken to return it to its proper position.
[009] Reference is first made to FIGS. 1 and 2, where an example of the placement of a catheter and monitoring system is shown, usually indicated at 10. System 10 allows the visualization of a subcutaneous vessel of a patient 70 by means of ultrasound images, followed by insertion, advancement and final placement of a catheter 72 into the patient's vasculature by monitoring ECG signals emitted by an SA node of the patient's heart. A simplified block diagram of hardware and other components of system 10 is shown in FIG. 1, while FIG. 2 shows the system and catheter 72 with respect to patient 70. As shown, system 10 in one embodiment generally includes a console 20 which houses a display 30, an ultrasound probe 40, and a sensor unit 50 for placement in the chest of the patient 70.
[0010] In greater detail and as mentioned above, FIG. 2 shows the general relationship of system 10 components of a patient 70 during a procedure for placing catheter 72 into the patient's vasculature at an insertion site in the skin 73. FIG. 2 shows that catheter 72 generally includes a proximal portion 74 that remains outside the patient and a distal portion 76 that remains within the patient's vasculature after placement is complete. System 10 is employed to finally position a distal tip 76A of catheter 72 in a desired position within the patient's vasculature. In one embodiment, the desired position of the distal tip 76A of the tip catheter is close to the patient's heart, as in the lower first third (1/3) portion of the Superior Vena Cava ("SVC"). Of course, system 10 can be used to place the distal tip of the catheter in other locations. The proximal portion of catheter 74 further includes a bifurcation 74A that provides fluid communication between one or more lumens of catheter 72 and one or more extension ends 74B that extend proximally from the core. Each 74B extension end includes a 74C luer connector for attachment to suitable medical devices.
[0011] Console 20 houses various components necessary for operating system 10. A processor 22, which includes 15 non-volatile memory such as EEPROM, for example, is included in console 20 for controlling system function during system operation. 10, thus acting as a control processor. A digital controller/analog interface 24 is also included in console 20, being in communication with both processor 22 and other system components to direct the interface between ultrasound probe 40, sensor 50, and other system components.
[0012] Console 20 additionally includes ports 52 for connection to sensor 50 and optional components 54 including a printer, storage media, keyboard, etc. Ports 52 in one embodiment are USB ports, although other port types or a combination of port types may be used for this and other interface connections described in the present application. A power link 56 is included on console 20 to allow operative connection to an external power supply 58. An internal battery 60 may also be employed, either with or exclusive to an external power supply. Power management circuit 59 is included with the console's digital controller/analog interface 24 to regulate power usage and distribution.
[0013] The display 30 of the system 10 in this modality application is integrated with the console 20, being used to display information to the clinician during the catheter placement procedure and, as will be seen, during the reconfirmation of the position of the distal tip of the catheter. according to the modalities to be described below. Optionally, the display can be detached from the console. In one embodiment, a console button interface 32 and the buttons included in probe 40 can be used to control the functionality of system 10 during the catheter placement procedure. Thus, a single display 30 of the console system 20 can be used to guide the ultrasound in accessing the patient's vasculature, in ECG confirmation of the placement of the distal tip of the catheter in relation to the patient's heart node, as well as subsequent confirmation the position of the distal tip of the catheter, as seen below. In one embodiment, the display 30 is an LCD device.
[0014] As mentioned above, the ultrasound probe 40 is employed in connection with the ("US")-based ultrasound visualization of a subcutaneous vessel, such as a vein, in preparation for insertion of the catheter 72 into the vasculature. This view provides real-time ultrasound guidance for catheter introduction into the patient's vasculature (via insertion site 73) and helps to reduce complications normally associated with such introduction, including inadvertent arterial perforation, hematoma, pneumothorax, etc.
[0015] The manual probe 40 includes a head housing, a piezoelectric set for the production of ultrasonic pulses and for receiving their echoes after reflection by the patient's body when the head is placed against the patient's skin, close to the location of prospective insertion 73. Probe 40 may additionally include a plurality of control buttons to control system 10, thus eliminating the need for the clinician to reach the sterile field, which is established at the insertion site in the patient prior to catheter placement, to control the functionality of the system.
[0016] Thus, in one modality the physician employs the ultrasonic modality of the system 10 to determine a suitable insertion site and establish vascular access, such as with a needle or introducer, and then with the catheter. The clinician can then seamlessly switch, by tapping the buttons on probe 40, to an ECG-based catheter tip orientation modality (described below), without having to reach the sterile field. Thus, system 10 assists the clinician in guiding the distal tip of catheter 72 through the vasculature toward an intended destination.
[0017] FIG. 1 shows that probe 40 additionally includes a button and memory controller 42 to guide operation of the button and probe. The button and memory controller 42 can have a non-volatile memory, such as an EEPROM, in one mode. The button and memory controller 42 are in operative communication with a probe interface 44 of the console 20, which includes a piezo input/output component 44A for interfacing with the piezoelectric assembly of the probe and a button and input/output component. output from memory 44B to interface with the button and memory controller 42.
[0018] As mentioned, the system 10 includes a functionality in which the determination of the distal tip of the proximity of the catheter 76A with respect to a sinoatrial ("SA") or other electrical pulse-emitting node of the patient's heart 70 can be determined , thus providing a better quality for accurate placement of the distal tip of the catheter in a desired location close to the node. Also referred to in the present application as "ECG" or "ECG-based tip confirmation," this modality of the system 10 allows the detection of ECG signals from the SA node to place the distal tip of the catheter at a desired location within the patient's vasculature. . Note that the US and ECG modalities are seamlessly combined in the present system 10, and can be used together or individually to aid in catheter placement. In addition, other modalities such as magnetic element-based catheter location may also be included in system 10. In one modality, it is understood that the ECG modality as described in this application may be included in a standalone system without the inclusion of the US or other modalities. Thus, the environments in which the embodiments of the present disclosure are described are understood to be merely exemplary environments and are not considered to be unique in the present embodiment application. Also note that other ECG-based guidance/monitoring systems may be employed in connection with the distal tip reconfirmation modalities described below.
[0019] FIGS. 1 and 2 show a stylet 130 removably predisposed within the lumen of catheter 72 being inserted into patient 70 through insertion site 73. Stylet 130 includes a sensing component, i.e., an electrode near its distal end for sensing signals. ECG produced by the SA node. Stylet 130 includes a retainer 134 extending from its proximal end that operatively connects to sensor 50. In summary, stylet retainer 134 provides a conductive path that allows ECG signals detected by the ECG electrode included in a portion. distal end of stylet 130 are transported to sensor 50 during advancement of the catheter.
[0020] Ground and reference 138 ECG skin electrodes are attached to the patient's skin surface 70 and are operationally attached to the sensor 50 to allow the system to filter out high-level electrical activity unrelated to electrical activity of the SA node of the heart, thus enabling ECG-based tip confirmation functionality. Along with the reference and ground signals received from ECG skin electrodes 138 placed on the patient's skin, the ECG signals sensed by the stylet electrode are received by sensor 50 positioned on the patient's chest or other indicated component of the system 10. The sensor 50 and/or the console processor 22 can process the ECG signal data to produce an electrocardiogram waveform on the display 30. In the case where the sensor 50 processes the ECG signal data, a processor is included therein to perform the desired functionality. If console 20 processes the ECG signal data, processor 22, controller 24, or another processor can be used on the console to process the data.
[0021] Thus, when the catheter 72 is advanced through the patient's vasculature, the display 30 shows an ECG ECG waveform produced as a result of the electrical activity of the patient's heart as detected by the stylet electrode 130. In more detail, the ECG electrical activity from the SA node, including a portion of the P-wave of the waveform, is detected by the stylet electrode 130 and sent to sensor 50 and console 20. The electrical ECG activity is then processed for display on display 30. A physician who placing the catheter can then observe the ECG data, including the P-wave display, to determine the optimal placement of the distal tip 76A of the catheter 72, as close to the SA node in a modality.
[0022] Note that the ECG waveform its P-wave change changes when the stylet electrode 130 moves relative to the SA node of the patient's heart. For example, the P wave of the ECG waveform usually increases in amplitude as the electrode approaches the SA node and usually decreases when the electrode retracts from the SA node. As mentioned, in one embodiment the console 20 includes electronic components, such as the processor 22, necessary to receive and process the ECG signals detected by the stylus electrode. In another configuration, sensor 50 may include the electronics necessary to process the ECG signals. Further details regarding the catheter delivery system described in this application and its uses can be found in U.S. Patent Application Publication No. 2010/0036227, filed September 10, 2009, and entitled "Display Equipment and Methods Regarding Intravascular Catheter Placement," which is incorporated herein by reference in its entirety. It is, of course, appreciated that the ECG-based catheter delivery system described above is only one example of an ECG monitor that can be used in practice of the modalities described in the present application; in fact, other ECG-based placement and monitoring systems can also be employed.
[0023] Note that the stylet electrode 130 in the present embodiment application includes a distal portion of the conductive stylet wire, so that ECG signals are detected and transmitted by the stylet wire to the hold 134 and the sensor 50. However, note Note that an electrode used to detect intravascular ECG signals can be configured in several ways. Thus, "electrode" as used in the present application can generally refer to any structure that can be used to detect ECG signals from the patient's heart. As will be seen, an electrode in other embodiments may include a portion of a column of conductive solution disposed in a lumen of the catheter, among other possible electrode configurations.
[0024] As described further below, monitoring the detected ECG signal emitted by the SA node when the stylet electrode(s) are advanced into the vasculature allows the physician to place the catheter to determine when the distal tip of the catheter 72 is positioned as desired within the vasculature. Again, an example of a desirable position for the distal tip of the catheter includes placing it in the lower third of the superior vena cava ("SVC"). After placement of catheter 72 is complete, stylet 130 is removed from the lumen of catheter 72 and the catheter is prepared for initial use. The ECG waveform detected when the distal tip 76A of catheter 72 is initially placed in its desired position within the patient's vasculature is also indicated in the present application as the first ECG signal profile.
It is generally desirable to reconfirm the position of the distal tip of the 76A catheter later after initial placement of the catheter so that inadvertent malposition or displacement of the distal tip does not occur. In turn, this ensures that medications or other solutions delivered to the patient through the catheter are inserted into the desired region of the vasculature. System 10 or another suitable ECG monitoring system can be employed to reconfirm proper post-placement of the position of the distal tip of the catheter.
[0026] In one embodiment, this reconfirmation of placement of the distal tip of the catheter can be done by measuring the ECG waveform - also referred to in this application as second ECG signal profile - detected at or near the distal tip of the placed catheter through of a properly placed electrode, and then comparing the second ECG profile to the first ECG profile taken when catheter 72 was initially placed using system 10.
[0027] To measure the ECG signals at the distal tip of the indwelling catheter and thus obtain the second ECG profile, an appropriate conductive path must be present in the 72 catheter to allow the ECG signals with respect to the distal tip of the catheter to be detected and transmitted to System 10 or another suitable ECG monitor. In one embodiment, a lead wire temporarily placed in the catheter is used as a conductive medium, with its distal end serving as an electrode for detecting ECG signals. The lead wire can be inserted into one of the luer connectors 74C and its respective extension end 74B, and then distally through a lumen of the catheter 72. Knowing the length of the placed catheter 72, the wire is advanced until its distal end is proximal or coterminal with the 76A distal tip of the catheter.
[0028] A proximal end of the lead wire extending beyond the proximal end of the catheter 72 and to the extension end 74B through which the wire extends is operatively connected to the system 10 similarly to the stylet 130 and of hold 134 of FIG. This setting allows the ECG signals emitted by the SA node, i.e., the second ECG profile, to be detected at or near the distal end of the lead wire and transmitted by the lead wire to system 10, thus informing the clinician whether the ECG profile of the Distal tip 76A of catheter 72 is in the current position.
[0029] As mentioned, the lead wire configured as discussed immediately above is similar to the stylet 130 shown in FIG. 2. In fact, in one embodiment the stylet 130 used for initial placement of the catheter can be used again after initial placement to confirm the location of the distal tip of the catheter by inserting it into the lumen of catheter 72 and operatively connecting it to system 10 by detent 134 as shown in FIG. 2, so that the second ECG profile of the distal tip of the catheter at its current location is allowed to be obtained. In addition, another suitable stylet or guidewire may be employed to provide the aforementioned conductive path from the distal tip of the catheter to the system.
[0030] FIG. 3 shows details of another configuration for providing a conductive electrode path at or near the distal end of the indwelling catheter 76A and system 10 for reconfirming the position of the tip. In particular, the conductive path includes a conductive solution 200 placed at the respective extension end 74B and catheter lumen 72 so as to extend to its distal tip 76A. The conductive solution 200 includes a conductive saline solution, or any other biocompatible, electrically conductive solution or other solution. Thus configured, the conductive solution 200 serves as an electrode and a part of a conductive path for detecting ECG signals at the distal tip 76A of the catheter 72. A cap 202 is connected to the luer connector 74C of the respective fluid-filled extension end 74B. .
[0031] In addition to the conductive solution 200, the conductive path of the embodiment of FIG. 3 further includes a lead wire 208 which passes through the cap 202 and extends distally from the respective extension end 74B so that its distal end 208B is immersed in the conductive solution. A proximal portion of lead wire 208 terminating at a proximal end 208A extends through cap 202. An alligator clip 210 or other suitable electrical connector is attached to the proximal portion of lead wire 208. Clip 210 is operatively connected to a retainer 234, connecting sensor 50 of system 10, similarly to detent connection 134 in FIG. 2, thereby operatively connecting the conductive solution column 200 placed in catheter 72 to the system and allowing ECG signals detected by the conductive solution to be transmitted to the system. Thus, the second ECG signal profile representative of the position of the distal tip 76A of catheter 72 within the vasculature can be obtained. In addition to that described in connection with FIGS. 2 and 3, note that other conductive path configurations may be employed in other embodiments. Thus, these conductive path solutions must be considered as non-limiting.
[0032] To compare the first ECG signal profile obtained at the time of initial placement of the distal tip of the catheter to the subsequent second ECG profile measured at the time of reconfirmation of the position of the distal tip, a storage component of the first ECG signal profile is required at the time of initial placement. In one embodiment, this is done by mounting system 10 or other ECG monitoring system with a card reader/encoder 250, an example of which is shown in FIG. 4 as mounted on console 20. Thus, when catheter 72 is initially placed using system 10, a patient data card 254 can be encoded by system 10 by inserting the card into reader/encoder 250, which encodes and stores on a tape magnetic data card 256 various data pertaining to initial placement of the catheter, including the first ECG signal profile at the time of initial placement. Card 254 is then given to the patient or otherwise stored.
[0033] Thereafter, when reconfirmation of the position of the distal tip 76A of the previously placed catheter 72 (FIG. 1) is desired, the catheter is operatively connected to the system 10 in one of the configurations described above in connection with FIGS. 2, 3, or otherwise suitable so as to provide a conductive path from the distal tip 76A of the catheter to the system. Card 254, encoded at the time of initial catheter coding, is then inserted into reader/encoder 250 of system 10 so as to be read. This provides system 10 with the first ECG signal profile of the position of the distal tip of the catheter at the time of initial placement. The first ECG signal profile, including, for example, an ECG waveform as detected by an electrode at or near the distal end 76A of catheter 72 at the time of initial placement, can be shown on display 30 of console system 20 (FIG. 1), or otherwise taken to the doctor.
[0034] A new ECG signal measurement is then taken using an electrode placed at or near the distal tip 76A of the catheter 72 and the appropriate conductive path connecting the electrode to the system 10, to produce a second ECG signal profile regarding the position current from the distal tip of the catheter into the vasculature. The second ECVG signal profile can, like the first ECG signal profile, also be shown on display 30 of the console system 20. The two ECG signal profiles can be superimposed as ECG waveforms one on top of the other and compared by some appropriately (e.g., measuring the absolute voltage values of the P-wave) in order to determine whether the distal tip 76A of the catheter 72 has been undesirably displaced. If this happens, appropriate procedures can be taken by the physician to properly reposition the distal tip of the 76A catheter. If not displaced, catheter 72 can be used as intended. Note that the specific order of the process described above may vary in other modalities. For example, obtaining the second ECG signal profile can occur before entering the first ECG signal profile into the system in a modality.
[0035] FIG. 5 shows another possible storage component to allow storage and access to initial placement of the first ECG signal profile and other data, wherein an RFID chip 270 is integrated into a portion of the catheter 72 itself, so that the bifurcation 74A (see also FIG. 2). An RFID encoder/reader 274 including an antenna 280 and associated circuitry 282, as shown in FIG. 6, may be included in system 10 or other suitable ECG monitor to allow the first ECG signal profile relating to the position of the distal tip of catheter 76A at the time of initial placement to be encoded and stored in the RFID catheter chip 270. In one modality , the RFID 270 chip is a field programming chip, including both read-only memory for the unique identification of the chip itself, as well as non-volatile memory that is programmable by the RFID 274 encoder/reader to store the first ECG signal profile in the time of initial placement.
[0036] In addition to the first ECG signal profile, other data may be stored on the RFID chip 270 (or on the card 254 of FIG. 4 or other suitable storage component), including the patient's name, date and location of the initial placement, the final length of the catheter after adjustment, recording of previous energy injections, creatinine counts or other blood counts, etc. In one modality, the length of the portion of the PICC that remains outside the insertion site after placement is complete is stored. In another configuration, web portal information may be stored to direct the user to a web site where useful information or other assistance is provided. Note that the RFID 270 chip can be either active or passive. Note further that other storage components are possible for storing the first and/or second ECG signal profiles, including a memory location within the system 10 itself and remote storage where the ECG signal monitor can access the profiles in a seamless manner. wire, such as via WiFi or other suitable wireless protocol.
[0037] FIG. 7 shows a possible example of a screen display 300 for showing display 30 of system 10 during reconfirmation of the position of the distal tip of the catheter in accordance with an embodiment. As shown, screen display 300 shows ECG waveforms 310, including a waveform 310A that corresponds to the first ECG signal profile at the time of initial placement of the catheter and a waveform 310B corresponding to the second ECG signal profile in the time of reconfirmation of the placement of the distal tip described above. The two waveforms 310A and 310B can be calibrated by the system 10 and superimposed one on top of the other in one mode so that a comparison is made between them. In one embodiment, for example, a P wave 312A of initial waveform 310A may be compared to a P wave 312B of current waveform 310B in order to determine whether displacement of the distal tip of catheter 76A relative to node SA has occurred. .
[0038] The right side of the screen display 300 also shows other data 314 regarding the patient, catheter type, catheter length, etc. Of course, the ECG signal and other data shown here can have one or many shapes and forms. In fact, the data content can vary according to desire or need, as appreciated by the person skilled in the art. In one modality, for example, both the peak magnitude of the P wave during initial placement of the catheter, as well as the magnitude of the P wave after removal of the catheter for final placement of the distal tip during initial placement, are stored for comparison back with similar magnitudes taken at the time of reconfirmation of the tip.
Thus, according to an embodiment, a method for reconfirming a position of a catheter or other medical device internal to a patient's body is disclosed. The method includes placing the medical device inside a patient's body using the patient's ECG signals, and then storing a first ECG signal profile that refers to an initial position of the internal medical device after initial placement of the medical device. be complete. As mentioned, the first ECG signal profile can be stored on a patient card, an RFID chip, a system memory, writing or printing the ECG signal data, or other suitable storage component. The method further includes obtaining a second ECG signal profile relating to a position of the internal medical device at the time after initial placement of the medical device, and comparing the first ECG signal profile with the second ECG signal profile to determine whether displacement of the internal medical device occurred after initial placement of the medical device. Note that the comparison of profiles can be done directly by a physician who observes the waveforms shown on the display of console 30, or automatically through suitable executable algorithms by processor 22 of console 20.
[0040] The embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described modalities must be considered in all occurrences as illustrative only and not restrictive. Therefore, the scope of the modalities is indicated in the appended claims rather than in the description above. All changes that fall within the meaning and scope of equivalence of the claims shall be encompassed within this scope.

权利要求:
Claims (13)
[0001]
1. System (10) for reconfirming the position of a catheter (72) within a patient (70), the catheter being placed in the vicinity of an ECG signal producing node of the patient's heart, the system CHARACTERIZED by comprising: at least one electrode for obtaining a first ECG signal profile, the first ECG signal profile referring to an initial position of a distal tip (76A) of the catheter within the patient being completed at a final target destination, the at least an electrode also for obtaining a second ECG signal profile relating to a subsequent position of the distal tip of the catheter within the patient; a storage component (254; 270) for storing at least the first ECG signal profile; and an ECG signal monitor (20) which receives the first ECG signal profile from the storage component and also receives the second ECG signal profile, the ECG signal monitor sending data relating to the first and second ECG signal profiles in a manner allowing the determination of whether the subsequent position of the distal tip of the catheter differs from the initial position at the final target destination allowing a comparison between a waveform (310A) corresponding to the first ECG signal profile and a corresponding waveform (310B) to the second ECG signal profile, where the system is configured to calibrate the two waveforms (310A, 310B) and to overlay the two waveforms on top of each other.
[0002]
2. System (10) for reconfirmation, according to claim 1, CHARACTERIZED by the fact that the at least one electrode for obtaining the first ECG signal profile is included in the catheter inside a patient's body, and in that the at least one electrode is operatively connected to the ECG signal monitor by a conductive path.
[0003]
3. System (10) for reconfirmation according to claim 1 or 2, CHARACTERIZED in that the at least one electrode includes a stylet (130) disposed within a lumen of the catheter, and wherein the conductive path includes a retainer operatively connected to at least one electrode.
[0004]
4. System (10) for reconfirmation, according to any one of claims 1 to 3, CHARACTERIZED by the fact that the at least one electrode and the conductive path include a conductive solution disposed within a lumen of the catheter.
[0005]
5. System (10) for reconfirmation, according to claim 4, CHARACTERIZED by the fact that a lead wire is partially placed in the conductive solution, the lead wire extending from the catheter and operatively connecting to the ECG signal monitor .
[0006]
6. System (10) for reconfirmation, according to any one of claims 1 to 5, CHARACTERIZED by the fact that the storage component includes an RFID chip (270) included in the catheter, and in which the ECG signal monitor includes an RFID encoder/reader (274) for encoding and reading the first ECG signal profile of the RFID chip.
[0007]
7. System (10) for reconfirmation, according to claim 6, CHARACTERIZED by the fact that the RFID chip is a field programming chip.
[0008]
8. System (10) for reconfirmation, according to any one of claims 1 to 7, CHARACTERIZED by the fact that the storage component is remotely disposed in relation to the catheter.
[0009]
9. System (10) for reconfirmation, according to claim 8, CHARACTERIZED by the fact that the storage component includes a card (254) that includes a programmable magnetic strip (256), and in which the ECG signal monitor includes an encoder/card reader (250).
[0010]
10. System (10) for reconfirmation according to any one of claims 1 to 9, CHARACTERIZED by the fact that the ECG signal monitor wirelessly receives the first ECG signal profile from a remote location.
[0011]
11. System (10) for reconfirmation according to any one of claims 1 to 10, CHARACTERIZED by the fact that at least one of the first and second ECG signal profiles includes data referring to at least a length of the part of the catheter that is external to the patient's body after placement and a web portal where further information can be obtained.
[0012]
12. System (10) for reconfirmation, according to any one of claims 1 to 11, CHARACTERIZED by the fact that the ECG signal monitor includes at least one electrode placed internally in the patient and at least two electrodes (138) for placement on the patient's skin.
[0013]
13. System (10) for reconfirmation, according to any one of claims 1 to 12, CHARACTERIZED by the fact that a first electrode is used to obtain the first ECG signal profile and a second electrode is used to obtain of the second ECG signal profile.

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WO2012024577A3|2013-09-06|

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