WO2007075732A2 - Stimulateur temporaire intracardiaque ou extracardiaque multifonctionnel, pouvant fonctionner sans guidage fluoroscopique - Google Patents

Stimulateur temporaire intracardiaque ou extracardiaque multifonctionnel, pouvant fonctionner sans guidage fluoroscopique Download PDF

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WO2007075732A2
WO2007075732A2 PCT/US2006/048507 US2006048507W WO2007075732A2 WO 2007075732 A2 WO2007075732 A2 WO 2007075732A2 US 2006048507 W US2006048507 W US 2006048507W WO 2007075732 A2 WO2007075732 A2 WO 2007075732A2
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pacing
cardiac
pacemaker
ecg
intra
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WO2007075732A3 (fr
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Shou-Nian Fan
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Shou-Nian Fan
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3702—Physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3625—External stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Definitions

  • This invention is in the field of temporary pacemaker.
  • This invention propels the temporary pacemaker to a higher level by eliminating the need of X-ray machine or other equipment's guidance in inserting leads to heart ventricle or atrium.
  • This novel device combines single-chamber and dual-chamber capacities. Additionally, this novel and useful device has additional benefit of cost-effectiveness (less expensive than current models), better safety, more reliability and more user friendliness.
  • Pacemakers are prescribed for people of all ages whose hearts beat too slowly. Pacemakers detect the slow heart rate and send electrical impulses to the heart to stimulate the heart muscle to beat faster. Well over 2 million pacemakers have been implanted worldwide since 1960.
  • transvenous leads leads that could be inserted through a vein leading to the heart, replaced earlier leads that were attached to the outer surface of the heart. Pacemaker and lead implants could now be done without opening the chest cavity or using general anesthesia.
  • pacemaker settings could be programmed using radio-frequency signals. This eliminated the need for surgery when/if any pacemaker programming adjustments were necessary.
  • Dual-chamber Pacing The first programmable pacemaker that could sense and pace the upper (atrium) and lower (ventricle) chambers of the heart was introduced in the late 1970s. Using two leads, dual-chamber pacemakers maintain synchronized timing between the upper and lower chambers of the heart to ensure efficient blood flow.
  • Rate Responsive Pacing - Pacemakers with a "rate responsive" feature became available in the mid-1980s.
  • a tiny crystal sensor inside the pacemaker detects body movement and its signals adjust the pacemaker rate up or down according to the wearer's activity.
  • pacemakers operate like micro-computers, are smaller than earlier devices (1/2 the size), and can last much longer. With the recent introduction of "mode switching,” devices can recognize an abnormally fast heart rate in the upper chamber of the heart and react by automatically changing the therapy the pacemaker delivers. This feature allows the pacemaker to deliver the most appropriate pacing therapy.
  • pacemakers can mimic the heart's natural rhythm even more closely by adjusting the rhythm according to a person's activity level.
  • Pacemakers can now collect information and store it until the next clinic visit. Some pacemakers also make follow-up easier by storing patient data directly into the memory of the pacemaker (such as name, diagnosis, doctor).
  • transcutaneous external cardiac pacing has been present for over 200 years.
  • transcutaneous pacing was not made practical until Zoll's work in the early 1950s.
  • Technological improvements during the late 1980s made TEPs more comfortable and less cumbersome than early models.
  • external pacing was found useful as a temporizing measure in patients with symptomatic bradycardia and a pulse but of little benefit in pulseless situations. They also may be of some benefit for overdrive pacing in treatment of certain tachycardias.
  • AHA ACLS American Heart Association Advanced Cardiac Life Support
  • Galvani reported that electrical current applied across the heart of a dead frog resulted in myocardial contraction.
  • Duchenne (1872) successfully resuscitated a child who had drowned, by attaching one electrode to a leg while rhythmically tapping the precordium with another electrode.
  • Gould (1929) also reported successful resuscitation of a cardiac arrest patient using a self-designed transthoracic pacemaker. Hyman was the first to coin the term "artificial cardiac pacemaker.” In 1932, he published the design of an external pulse generator for use in animals.
  • ZoIl patented and introduced a transcutaneous external pacemaker with a longer pulse duration (40 msec) and a larger electrode surface area (80 cm 2 ). This reduced the current requirement for capture and increased comfort for the patient. Additionally, this model could be applied much more rapidly than earlier TEPs, paving the way for renewed interest in TEPs.
  • the current AHA ACLS guidelines included the use of TEPs for symptomatic bradycardias.
  • Electrodes/pads and monitor leads are placed on the patient. About 2-3 cm of space should be left if separate defibrillation pads are required, and the second pad should be placed posteriorly, just below the left scapula.
  • the desired heart rate is chosen and the current is set to zero milliamperes (mA).
  • the TEP is then turned on and the current is increased as tolerated until capture is achieved.
  • Pulse duration is the time of impulse stimulation.
  • Early TEPs used short (1-2 msec) duration impulses. Such impulses resembled the action potential and preferentially stimulated skeletal muscle. In contrast, cardiac muscle action potentials are much longer, requiring 20-40 msec to reach maximum.
  • ZoIl found that increasing the duration from 1 to 4 msec resulted in a 3 -fold reduction in threshold (the current requirement for stimulation). Increasing the current from 4 to 40 msec further halves the threshold. Longer durations produced no further advantage.
  • Current TEPs deliver 40 (ZoIl) or 20 (all others) msec pulses.
  • External pacing in dogs requires 30-100 times greater than internal transvenous pacing.
  • Human studies have shown that the average current necessary for external pacing is about 65-100 mA in unstable bradycardias and about 50-70 mA in hemodynamically stable patients and volunteers. At this current, more than 90% of patients tolerated pacing for 15 or more minutes.
  • Animal studies have found that stimulation up to 10-20% over the threshold stimulates only the ventricles. Higher amounts are needed to stimulate the atria.
  • Electrodes Pain is a function of the current delivered per unit of area. Pain sensation is minimized by electrodes with a surface area of at least 5 cm . The amount of pain for a current of a given strength reaches a plateau once the electrode surface area exceeds 10 cm 2 . Most commercially available electrodes are 80-100 cm 2 . TEPs generally perform best with their own pads, but different combinations may be helpful. No study has evaluated the effects of body habitus or gender on tolerance of TEPs.
  • the TEP delivers an electrical stimulus at preset intervals, independent of intrinsic cardiac activity. In theory, this could induce arrhythmias if stimulation occurs during the vulnerable period of the cardiac cycle.
  • Early models only had fixed-rate capabilities. Most current models have fixed rate and synchronous pacing. Synchronous pacing is a demand mode in which the pacer fires only when no complex is sensed for a predetermined amount of time. Pacing generally should be started in the synchronous mode.
  • Varghese reported that external pacing simultaneously stimulated all 4 heart chambers in dogs. Madsen, however, echocardiographically demonstrated in humans that atrial stimulation was retrograde without opening the mitral valve.
  • Skeletal muscle contraction can be uncomfortable and is often the limiting factor in TEP use. Placing electrodes over areas of least skeletal muscle can minimize discomfort. Placement is generally best in the midline chest and just below the left scapula. The physician also should use the lowest effective current. Sedation should be considered if these measures are inadequate. Ultrasound has also been reported to assist in determining the lowest rate of capture.
  • Hemodynamically unstable bradycardias have 50-100% survival-to-discharge rates reported in prehospital and hospital settings. Two neonates with AV block who survived with the assistance of immediate external pacing have been reported.
  • Tachyarrhythmias Single and multiple beat pacing stimulation have been described as a useful treatment of tachycardias. The objective is to place a ventricular extrasystole during the vulnerable period of the cardiac cycle. More than 150 cases of successful overdrive pacing for tachycardias using TEPs have been noted. Overall termination rates for ventricular tachycardia reportedly have been between 57 and 95%; however, acceleration occurred in 4-26% of the reported attempts. Fisher reported termination in 57% and acceleration in 0.5% using single beat capture compared with 94% termination and 3.6% acceleration in 3.6% using multiple beat rapid burst attempts.
  • Transesophageal pacing is a process in which an esophageal pacing lead is inserted via the nostrils into the esophagis, as in the insertion of a nasogastric tube.
  • the proximity of the esophagus to the atria makes it an ideal location for the recording of electrical activity from the atrium and for Transesophageal pacing.
  • the optimal Transesophageal pacing site is determined by using the unipolar esophago-atrial electrogram. Pacing is performed with a programmed stimulator capable of delivering currents of up to 12-18 mM with a pulse -width of 8-10 msec. The entire procedure generally lasts less than 10 minutes.
  • Atrial flutter and many types of supraventricular tachyarrhythmias are examples of tachyarrhythmias which occur as a result of reentry.
  • Transesophageal pacing can be used to terminate such tachyarrhythmias by interrupting the reentrant pathways.
  • the inventor developed electrocardiophysiological signal and stimulating pulse-switching device, which can be connected to a multi-lead and multi-channel physiological recorder.
  • the inventor built a limiting amplitude device for electrocardiophysiological and ECG signal recoding during intra-/extra-cardiac stimulation (ref. 11, 13). This device greatly improved ECG recording quality and met the clinical demands on high quality ECG for diagnosis purpose.
  • the inventor made a portable cardiac programmed stimulator with a pull down menu on LCD screen. This new device totally differed from the conventional cardiac programmed stimulator. It was a portable, multifunctional and easy to use programmed stimulator for both clinicians and electro-cardiophysiologists. This device was issued a Chinese National Patent (ZLOOl 13102.7).
  • MCS desktop model multi-functional cardiac programmed stimulator which can be used for both intra- and extra cardiac (transesophageal) stimulation and obtained the Chinese National Patent (ZLOOl 13102.8).
  • ZLOOl 13102.8 Chinese National Patent
  • 2001-2002 we independently developed a palm-size ECG monitoring device, and fixed frequency cardiac pacing device with LCD monitoring system. Both devices have been applied in clinics successfully.
  • Medtronic Inc. USA produces the most advanced temporary cardiac pacemaker (pulse generator) and occupies the largest market share in the world.
  • the two most current models Medtronic Inc. manufactured are 1). Single-Chamber Model 5348 External (Temporary) Pulse Generator with VOO/VOO and VWAAl pacing functional modes, and 2). Dual-Chamber Model 5388 External (Temporary) Pulse Generator with AOO/VOO, AAI/ VVI, DOO, DVI, DDI and DDD pacing functional modes.
  • This LCD display has a great value in clinical practice.
  • the LCD screen has functions of ECG freezing, scan speed and gain adjustment, and heart rate display.
  • this LCD screen also serves as an interface to set pacing mode and parameters via a person to computer dialog box on the screen. For instance, setting, adjusting, and confirming important parameters (such as; pacing mode, pacing site, pacing frequency, pulse width, PA-PV intervals) can be accomplished on the LCD display.
  • clinicians can perform cardiac catheter lead insertion at the bedside under the guidance of intra-chamber ECG. This procedure can be carried out even without X-ray machine or fluoroscopy.
  • This novel clinical utility may extend the application of temporary cardiac pacemaker in clinics, and raise the market potential of this pacing technique and its related equipment.
  • the integrated LCD screen can be used for choosing pacing function and setting pacing parameters. After choosing pacing function and setting parameters, the LCD screen can be used to monitor real time ECG and guide the insertion of pacing leads in position. Further, the LCD display can be used to monitor pacing ECG. If our device is not used for temporary cardiac pacing, it can be used as a portable, mobile independent ECG monitor system.
  • Our device provides an option, a non-invasive pacing technique for clinicians. Since we are the pioneers to apply this technique in China, we have applied the transesophageal cardiac pacing in many clinical fields, such as cardiology, interventional cardiology, cardiovascular surgery, OBGYN, operating room, emergency room, and emergency rescue for total about 400 cases. The results show that the transesophageal cardiac pacing is a reliable, safe and has less side-effect procedure to terminate selected cardiac arrhythmia.
  • our device is capable of recording both intra-chamber ECG (within the heart), and body surface ECG.
  • Signal source selection can be completed on the LCD display manually. This function provides option to monitor the heart and increases the chance to obtain high quality ECG recording.
  • This unique switching system was consisted of computer software-controlled three level ON/OFF circuits that were located at different positions of ECG amplifiers. At different temporal phase, this switch system produced different ON/OFF state to prevent amplifier damage due to large tissue after potential generated by wide pulses during transesophageal cardiac pacing. This switch system guaranteed the normal working condition and the functional integration of the amplifiers during transesophageal temporary cardiac pacing.
  • the ECG signal source can be chosen via a function bar under pacing parameters on LCD screen. This unique function assures TTL (negative) signal stability during signal sensing, especially, this function offers more advantage during transesophageal temporary cardiac pacing. While there is a poor esophageal signal sensing, the operator can switch to intra-cardiac ECG sensing to get better ECG signal recording.
  • Our device provides the hardware support for multipurpose use of pacing technology in clinics.
  • the LCD screen we integrated the LCD screen with our device, we can monitor the intra-chamber ECG at a real time basis, that allows physicians to insert the catheter leads into the heart chambers at the bedside without an X-ray machine.
  • LCD screen can be set to receive the electrical cardiac signals from the body surface to monitor the pacing condition.
  • the conventional cardiac pacemakers both the temporary and permanent receive signals and send stimulating pulses within the heart chamber.
  • the electrical signals generated from the myocardia have large amplitude values and small impedance (only ⁇ 80-500 ⁇ ).
  • the stimulating pulses sending to the myocarda have low altitude values (0.5-2 V) and small width of the pulses (0.5-1 ms). Therefore, the design for amplifying ECG signals and managing the signal/pulse switching system are easy.
  • Our invention added a transesophageal pacing function (extra-cardiac pacing) that shares the same channel of ECG amplifier with intra-cardiac pacing.
  • the stimulating pulses for the transesophageal pacing have high pulse amplitude values (18-50 V), and wide width of pulses (9-12 ms), further, the after potential produced by the heart following the stimulation is larger and last longer. These factors increase degree of difficulty to design the amplifier.
  • Our design is able to avoid the obstruction of electrical trafficking within the amplifier and safe guard the ECG signal sensing and recording during transesophageal cardiac pacing.
  • FIGURE l PACE 2006 Hardware Structure
  • FIGURE 2 CPUl Data Acquisition and Display Flow Chart
  • FIGURE 3 CPU1&2 Communications Flow Chart
  • FIGURE 4 Models: PACE2006 and PACE140 Portable Temporary Pacemakers
  • the present invention extended the application of available technology of temporary cardiac pacing.
  • Our invention provides novel designs in structure and creates a unique multifunctional temporary cardiac pacing device described in details as the follows:
  • Our invention differs from the currently available temporary cardiac pacemaker or pulse generators.
  • structure design we innovatively integrated a LCD screen into our portable pacing device that displays a single channel ECG signal.
  • circuit design we applied a dual channel preamplifier system to better handle the electrical signal trafficking.
  • single chamber temporary cardiac pacing one channel is able to receive intra-cardiac chamber ECG signal, and another channel received surface ECG signal simultaneously.
  • dual chamber temporary cardiac pacing (less used in clinics), the dual channel preamplifier system can be used for dual chamber ECG signal sensing and displaying.
  • our device provides two forms of sensing mechanisms (can be selected manually); sensing via intra-cardiac chamber lead, or via body surface leads (under WI mode). This unique function assures the reliability of sense signal input, such dual sensing mechanism has not been reported previously in the temporary cardiac pacing device.
  • our device can be used as a small, mobile and portable ECG monitoring device while the temporary cardiac pacing function is not in use.
  • ECG signal input There are two methods for ECG signal input; A. ECG leads (1-1.5 m in length) connected with the patient's body surface for long term monitoring; B. On the back of our device, there is three lead buttons, in emergency, physicians can just put the device on the left chest (near the apex area of the heart) to view ECG information on the LCD screen without extra-ECG leads.
  • paroxysmal supraventricular tachycardia is a common emergent condition. It is an emergent condition in clinics due to PSVT impact on circulation.
  • the physician can rapidly inserted a catheter with pacing lead near the tip end into the esophagus, through the catheter lead, clinicians can monitor the esophageal ECG and send stimulating pulses for treatment via this esophageal catheter.
  • ECG shows P wave >R wave (A wave >V wave)
  • the larger the P:R ratio; the better indicative the lead by the left atrium level, and the lower pacing threshold for the stimulating pulses the operator can use AOO mode to generate an overdrive suppression rate, generally, only, needs 2-5 sec to terminate PSVT episode.
  • transesophageal cardiac pacing The whole process from initiating PSVT to terminate by transesophageal cardiac pacing and reverted to normal sinus rhythm can be displayed on the built in LCD screen.
  • This temporary extra-cardiac pacing function (transesophageal) has great clinical application potentials due to it is easy to use, safe, reliable, and quick to obtain treatment effects.
  • Our portable device can be a useful tool for many clinical settings.
  • transesophageal cardiac pacing technique Another application of transesophageal cardiac pacing technique is to protect patients from life-threatening arrhythmia during surgical procedure.
  • an esophageal pacing lead can be inserted in bradycardia patients who have sinus-atrium transduction block (S-AB), but no atrium- ventricle transduction block (A-VB) prior anesthesia.
  • Esophageal ECG can be monitored on the LCD screen.
  • the operator can use AOO or AAI pacing modes to prevent the risk of bradycardia.
  • Our device also can be used as an independent and portable ECG monitoring system, it is important equipments for ambulance, rescue helicopter, emergency room and doctor's office for emergence pacing needs.
  • the pacing voltage threshold is about 10-20 times higher in the esophagus than intra-cardiac.
  • the pulse width for transesophageal cardiac pacing is about 10 times wider than that intra-cardiac. Since the distance of pacing lead in the esophagus to the heart is longer, transesophageal cardiac pacing causes a larger distributed electrical capacitance, larger after potential and longer stimulating duration than intra-cardiac pacing. All these factors greatly affect the normal working condition of the preamplifiers.
  • the more important problems are the input port of the preamplifier directly facing 1) bioelectrical signal sensing from the heart and 2) stimulating pulses delivering to the heart. While the stimulating pulses are delivered to the heart, the heart electrical signals from the stimulating pulses are also directly imported into the input port of preamplifiers. It is a problem that causes pre-amplifiers malfunction and cannot be tolerated.
  • Intra-cardiac/OFF/Extra-cardiac switch on the face board to change the gain of preamplifier; 40 times for intra-cardiac chamber, and 120 times for extra-cardiac (transesophageal).
  • the preamplifier port is responsible for ECG signal sensing and stimulating pulse delivery, in addition, this port also is connected to bioelectric load from patient (ref. Diagram 1 for detail). Therefore, the input port of preamplifier receives bioelectric signals from patient and signals of stimulating pulses via the pacing leads simultaneously.
  • the grid electrode is at a high electrical level and the drain and source electrode are at a low impedance state ( ⁇ 18 ⁇ ). This allows bioelectrical signal passing.
  • the second level switch is placed behind the emitter follower; a high fidelity analogue switch chip made by Maxim Co. USA carries out the switch function.
  • the analogue switch chip not only forms high resistant state at the pre- and post-amplifying, but also short-circuits the input port of amplifier located behind the switch to the ground.
  • the third level switch is placed at the most end of exporting port of ECG amplifier, before formation of TTL electrical level of the signal sensing circuit, and there is a coupling capacitance between the third level switching systems (ref. Diagram 1 for detail).
  • the switch circuits simultaneously grounds the two electrodes of coupling capacitance instantaneously via the drain and source electrodes of two field effect transistors.
  • the ON/OFF condition for stimulating pulses and bioelectrical signals are controlled by a negative TTL electrical level that has a pulse width wider than the pacing pulse width.
  • the corresponding control electrical circuits and microprocessor#2 (CPU 2) provide the negative TTL electrical level that is exported from CTRLl and CTRL2 port of the CPU2.
  • Each control signal exporting is 10 ms prior the synchronized stimulating pulse exporting.
  • the control signals exported from CTRLl and CTRL2 ports have 40 ms and 60 ms delay respectively. Results from our laboratory testing and clinical trials proved that our switch controlling procedures prevent the destructive effect of stimulating pulse delivery on the functional integration of preamplifiers, and avoid the sensing error caused by over-sized stimulating pulses and after potential generated by human body following receiving the stimulating pulse delivery.
  • Fan S.N. et al Transesophageal low-energy cardioconversion in an animal model of life-threatening tachycardia arrhythmias. Circulation. 80:1354-1359, 1989. 9. Fan S.N. et al. Terminating atrial fibrillation with transesophageal Low energy cardioconvesion in an animal model. Tienjing Medicine. June, 1990.
  • Grubb BP Samoil D
  • Temesy-Armos P The use of external, noninvasive pacing for the termination of supraventricular tachycardia in the emergency department setting. Ann Emerg Med 1993 Apr; 22(4): 714-7.
  • the pacing modes for intra-cardiac pacing AOO/VOO, AAWVI, VAT, DVI.
  • the pacing modes for extra-cardiac pacing (transesophageal): AOO/VOO, AAI/VVI, VAT, DVI.
  • LCD ECG display functions display intra-cardiac ECG including atrial ECG and ventricular ECG, display intra-esophageal ECG (esophageal ECG), display body surface ECG.
  • Sense signal source selection function including intra-cardiac chamber signals, transesophageal signals, and body surface signals.
  • ECG signal source display selection function intra-cardiac chamber ECG, transesophageal ECG, and body surface ECG.
  • the testing instrument is Fluck 123 digital oscilloscope and Fluck 17 universal meter (Fluck Co. USA).
  • the main pacing parameters are the following: (1). AOO/VOO mode:
  • Pulse width Intra-cardiac: 0.5, 1.0, 1.5, 2.0 ms, default value 1.0 ms, error ⁇ 5%; Extra-cardiac: 10-40 ms continuing adjustable, error ⁇ 5%; (2).
  • AAI/VVI mode Intra-cardiac: 0.5, 1.0, 1.5, 2.0 ms, default value 1.0 ms, error ⁇ 5%; Extra-cardiac: 10-40 ms continuing adjustable, error ⁇ 5%; (2).
  • AAI/VVI mode AAI/VVI mode
  • Extra-cardiac 0-50 V continuing adjustable, error ⁇ 5%; Pulse width: Intra-cardiac: 0.5, 1.0, 1.5, 2.0 ms, default value 1.0 ms, error ⁇ 5%;
  • Extra-cardiac 10-40 ms continuing adjustable, error ⁇ 5%; There is 200 ms artificial refractory period after each pulse delivery.
  • Extra-cardiac 0-50 V continuing adjustable, error ⁇ 5%; Pulse width: Intra-cardiac: 0.5, 1.0, 1.5, 2.0 ms, default value 1.0 ms, error ⁇ 5%;
  • Extra-cardiac 10-40 ms continuing adjustable, error ⁇ 5%; There is 200 ms artificial refractory period after each pulse delivery.
  • Extra-cardiac 0-50 V continuing adjustable, error ⁇ 5%;
  • A-V interval 0 ms ⁇ PA-V ⁇ 400 iris, default value 160 ms, error ⁇ 5%
  • Pulse width Intra-cardiac: 0.5, 1.0, 1.5, 2.0 ms, default value 1.0 ms, error ⁇ 5%;
  • Extra-cardiac 10-40 ms continuing adjustable, error ⁇ 5%; There is 200 ms artificial refractory period after Pl delivery.
  • the prototype device has been applied to 111 clinical cases. Under the different temporary cardiac pacing functions, we applied intra-cardiac pacing mode VVI for 12 patients, AOO for 11 patients, VAT for 2 patients, DVI for one patient. In addition, extra- cardiac pacing (transesophageal) was used in the operating rooms terminating 72 PSVT patients under AOO mode with overdrive suppression, and AAI mode for 13 patients. All the catheter lead insertions were accomplished under the guidance of ECG on the LCD screen display.
  • PACE 140 multi-functional temporary pacemaker (abbr. PACE 140) developed by the inventor provided several pacing modes such as AOO/VOO, AAI 5 VVI, VAT and DVI. It Different from traditional temporary cardiac pacemakers, PACE 140 had an accessional LCD for displaying intracardiac electrograph or surface ECG. Additionally, manual operation, intra-cardiac or extra-cadiac sense could be chosen arbitrarily. PACE 140 can be used as a portable monitor for cardiac arrhythmia.
  • Percutaneous transvenous introducer techniques were used to enter the left or right subclavian veins.
  • the electrode was passed from subclavian vein into the proper intracardiac sites and connected to PACE 140 under the guidance of intracardiac electrograph shown in LCD without fluoroscopy.
  • the pattern of intrinsic atrial excitation was recognized when the electrode tip reached the right atrial cavity. Further advancement of the electrode resulted in a ventricular intra-cavity electrograph pattern.
  • the electrode's position or orientation should be better.
  • the optimal position of the electrodes in right atrium showed that the amplitude of A wave was much wider than that of V wave. A wave was noticeable while V wave was not.
  • the optimal position of the electrode was that the amplitude of V wave should be distinctly wider than that of A wave, the amplitude of V wave was noticeable while A wave indistinct.
  • the target sites of pacing electrode-tip were as the follows: (a) Single-chamber pacing: The sites were the top or in the outflow tract of the right ventricle (2 cases) and of the right auricle (2 cases), (b) Dual-chamber pacing. The sites were the top or the outflow tract of the right ventricle and the right auricle (2 cases). However, in two cases, one electrode-tip located in the top or the efferent tract of the right ventricle, the other floated
  • VVI mode were used for 2 patients ( Figure 1), AAI for 6 (Figure 2), VAT for 2 (Figure 3), DVI for 2 ( Figure4). If both the pacing and sense function were good, then fix the sheath and the electrode-end would be fixed.
  • Parameters of the pacemaker 50 ⁇ 60 ( 57 ⁇ 7.5 ) ppm pacing frequency.
  • VVI pacing 20 ⁇ 100(82 ⁇ 15) rate of A/V for the atrial sense. 65-100 (91 ⁇ 14) rate of V/A for the ventricular sense.
  • VVI pacing we used the sense method of surface ECG R wave that lasted for 3 hours, and the VVI pacing functions worked well.
  • AAI pacing functions were also performed successfully after taken trans-esophageal signal sense.
  • Fluoroscopy is unquestionably the best method for assisting the operator to direct the pacing catheter through the venous system to cadiac cavities.
  • pacing catheter placement also can be achieved by monitoring the electrograph derived from the pacing catheter's distal electrode. The electrograph is monitored as the pacing catheter is advanced. The pattern of intrinsic atrial excitation is recognized when the catheter tip reaches the right atrial cavity. Further advancement of the catheter results in a ventricular intracavity electrograph pattern.
  • PACE 140 with multi-mode pacemaker and LCD is suitable not only for the catheter-tip approaching the target sites without fluoroscopy, but also for the different situation in which the patients have different needs of pacing modes.
  • PACE 140 has the optional sense technique, by which the intracardiac electrograms or surface/esophageal electrical signals can be sensed selectively. If electrode displaced during temporary VVI pacing, the pacing would be immediately recovered by R wave sense. In the situation of AAI pacing, a bipolar electrode is put into esophagus and connected to surface ECG. The biggest amplitude of A wave can be acquired by esophageal electrogram. Therefore, the problem of electrode displace should be solved by extra-cardic or esophageal A wave sense.

Abstract

L'invention concerne un stimulateur cardiaque d'un nouveau type, présentant des modes de stimulation multifonctionnels, pouvant être utilisé pour une stimulation temporaire intracardiaque ou extracardiaque de cavité unique/double. Un écran à cristaux liquides est intégré dans ce dispositif portable pour obtenir une surveillance d'électrocardiogramme (ECG) en temps réel. Ce dispositif affiche un ECG intracavitaire permettant de guider le médecin pour introduire un cathéter dans le coeur, sans qu'il soit nécessaire d'avoir recours à une machine à rayons X/fluoroscopie, ou à un autre équipement de guidage. Le dispositif de l'invention peut également être utilisé en tant que système indépendant de surveillance d'ECG de surface, à long terme. Le dispositif de l'invention est conçu pour être économique, sûr, fiable et facile à utiliser. Il est doté d'une conception de circuit à contours précis, d'un système de commutation unique à trois niveaux destiné à gérer une stimulation électrophysiologique, d'une interface de dialogue personne/machine, et d'un système d'enregistrement de signaux cardiaques. Cet appareil multifonctionnel destiné à établir un diagnostic et un traitement clinique répond au besoin clinique de stimulation cardiaque temporaire, et présente également d'autres fonctionnalités.
PCT/US2006/048507 2005-12-22 2006-12-20 Stimulateur temporaire intracardiaque ou extracardiaque multifonctionnel, pouvant fonctionner sans guidage fluoroscopique WO2007075732A2 (fr)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10130824B2 (en) 2016-04-28 2018-11-20 Medtronic, Inc. Asystole detection and response in an implantable cardioverter defibrillator
WO2022040670A1 (fr) * 2020-08-17 2022-02-24 Expanse Medical, Inc. Système de stimulation transveineuse
EP3988162A1 (fr) * 2020-10-23 2022-04-27 Osypka Medical GmbH Technique de commande du fonctionnement d'un stimulateur cardiaque réglable par l'utilisateur ou d'un modèle logiciel associé en mode d'entraînement

Citations (1)

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Publication number Priority date Publication date Assignee Title
US6246898B1 (en) * 1995-03-28 2001-06-12 Sonometrics Corporation Method for carrying out a medical procedure using a three-dimensional tracking and imaging system

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6246898B1 (en) * 1995-03-28 2001-06-12 Sonometrics Corporation Method for carrying out a medical procedure using a three-dimensional tracking and imaging system

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10130824B2 (en) 2016-04-28 2018-11-20 Medtronic, Inc. Asystole detection and response in an implantable cardioverter defibrillator
US10940325B2 (en) 2016-04-28 2021-03-09 Medtronic, Inc. Asystole detection and response in an implantable cardioverter defibrillator
WO2022040670A1 (fr) * 2020-08-17 2022-02-24 Expanse Medical, Inc. Système de stimulation transveineuse
EP3988162A1 (fr) * 2020-10-23 2022-04-27 Osypka Medical GmbH Technique de commande du fonctionnement d'un stimulateur cardiaque réglable par l'utilisateur ou d'un modèle logiciel associé en mode d'entraînement
EP4162975A1 (fr) * 2020-10-23 2023-04-12 Osypka Medical GmbH Stimulateur cardiaque externe réglable par l'utilisateur

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