|Número de publicación||US3866615 A|
|Tipo de publicación||Concesión|
|Fecha de publicación||18 Feb 1975|
|Fecha de presentación||15 Ene 1973|
|Fecha de prioridad||15 Ene 1973|
|Número de publicación||US 3866615 A, US 3866615A, US-A-3866615, US3866615 A, US3866615A|
|Inventores||Hewson John R|
|Cesionario original||Daigle Claude W|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (5), Citada por (109), Clasificaciones (14)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
United States Patent 1191 Hewson 1 Feb. 18, 1975  Inventor: John R. Hewson, Manset, Maine  Assignee: Claude W. Daigle, Ellsworth Falls,
Maine a part interest  Filed: Jan. 15, 1973  Appl. No.: 323,972
 11.8. CI. 128/419 D, 128/404  Int. Cl A6ln l/36  Field of Search... 128/404, 418, 419 C, 419 D, 128/419 E, 419 P, 421, 422, 423
 References Cited UNITED STATES PATENTS 3,518,997 7/1970 Sessions 128/419 P 3,664,347 5/1972 Havmjanz 128/419 P 3,680,544 8/1972 Shinnick et al.... 128/419 P 3,703,900 11/1972 Holznagel I 128/419 P 3,738,370 6/1973 Charms 128/419 D FOREIGN PATENTS OR APPLICATIONS v 246,004 11/1969 U.S.S.R. 128/419 P PORTABLE ELECTRONIC CARDIAC STIMULATOR 1,082,752 9/1967 Great 311111111 v1221/4191 Primary Examiner-William E. Kamm Attorney, Agent, or FirmWolf, Greenfield & Sacks  ABSTRACT A light weight portable electronic cardiac emergency stimulator which includes separate defibrillation and pacemaking electronic circuits and a selfcontained battery pack. The defibrillation and pacing circuits are selectively connectable, through a switch, to a pair of electrodes of special design which may be introduced rapidly into the patients heart by a needle through his chest wall. The electrodes are self-spreading within the heart to establish firm electrical contact with opposite sides of its inner surface. After the electrodes have been introduced to the heart, as into the left ventricle, the circuits can be selectively connected to the electrodes through a switch to controllably apply either defibrillation or pacemaking electric pulses to the heart without delay.
7 Claims, 12 Drawing Figures PORTABLE ELECTRONIC CARDIAC STIMULATOR BACKGROUND OF THE INVENTION Cardiac disorders are believed to be among the major causes of death. Usually, acute disorders appear with no warning and where the patient is remote from medical assistance. While in some less severe cardiac disorders there is sufficient time to transport the patient to a hospital for treatment, in other more severe types of cardiac disorders, such as an acute myocardial infarction, immediate aid is often required. For example, in the United States, it is estimated that approximately 1,200,000 persons suffer an acute myocardial infarction each year. Of these, 200,000 people die within minutes of the onset of their myocardial infarction, and another 50,000 die in the time interval between 15 minutes and 2 hours of the onset of their myocardial infarction. The death of a great proportion of the people in the latter group of 50,000 could largely be prevented by administering suitable medical aid quickly and without a delay. As to those persons who die of acute myocardial infarction within fifteen minutes of its onset, a great proportion could likewise be saved if proper medical attention could be employed immediately. Treatment of such acute cardiac disorders typically requires apparatus which is bulky and does not lend itself to portability. Thus, it has been necessary to transport the patient to a hopsital or other facility where such apparatus is available. The time interval ordinarily is too great and the patient dies.
In the great proportion (95 percent) of acute cardiac deaths, the patient is suffering from ventricular fibrillation. The remaining patients are in asystole, in which all heart activity has stopped. in each of these instances, there is no detectable arterial pulsation. As a result,the patient can deteriorate rapidly. For example, permanent brain damage can begin to occur approximately three minutes after pulsation stops.
Where the patient is suffering from ventricular fibrillation, it is essential first that the-fibrillation be stopped before the heart can resume more regular activity. The usual emergency procedure for treating a pulseless patient is to check his air passages and perhaps attempt mouth-to-mouth resuscitation. If that fails to restart the heart, a sharp blow is applied to the chest generally in the region of the heart. That failing, closed chest cardiac message is initiated primarily in order to maintain a semblance of blood circulation in an attempt to avoid or minimize brain damage. These techniques are rarely effective to defibrillate a fibrillating heart and do not generally restart the heart. They are employed primarily as supportive therapy until the patient can be brought to a hospital or facility where fibrillation or asystole can be more effectively treated. When the patient has reached the hospital the vigorous closed chest massage is continued until the electric defibrillation apparatus has been readied. Such apparatus generates a substantial electrical pulse which is applied to the patient by means of a pair of paddle-like electrodes which are applied to the patients chest. In general, it has been found that the most effective way to defibrillate is by applying such an electric pulse to the patient. The urgency of immediate defibrillation cannot be overstated. When the patient has no apparent pulse, closed chest massage is at best a poor substitute for a normally beating heart. Thus, even with vigorous closed chest massage the patients brain and heart: deteriorate quickly. Lactic acid builds up due to poor oxygenation of tissue which is the direct result of poor cardiac output. Thus. even when the patient reaches the hospital where he can be defibrillated electrically, the degree of deterioration which he may have suffered often is such that the defibrillation apparatus is ineffective and the patient dies. Because of the relatively nonportable bulky nature of defibrillation apparatus, many people have died within the time interval necessary to transport the patient to the hospital. i
In addition to the foregoing difficulties, even if a patient has been defibrillated, he may still remain pulseless, in asystole. Among the most effective treatments for this condition is the application of electrical pulses of a smaller magnitude to the heart at a rate approximating that of a normal heart beat. Application of such pacing pulses is of considerable assistance in restarting an asystolic heart and maintaining regular operation of that heart. However, even in a hospital environment this takes some time which may add further to the interval so critical to the patient. This is true even though the electrodes for the heart pacing arrangement are applied through a transthoracic catheter of the type shown in the Ackerman patent or through a major vein into the heart. These procedures take time in addition to the time already elapsed. Although closed chest massage is maintained throughout these intervals the pa tient deteriorates further. Moreover, it may be noted that ventricular fibrillation is recurrent and can begin again even after the heart has been. defibrillated but before the pacing electrodes have properly placed in operation. In such instance, the procedure may have to be restarted with the attendant loss in time. It is among the primary objects of my invention to provide a device and technique which minimizes greatly any interval between the time at which medical or paramedical personnel reach the patient and the time in which proper electrical stimulation of his heart is provided.
SUMMARY OF THE lNVENTlON My invention includes independent defibrillation and pacing circuits which are assembled in a compact portable housing. The housing also contains a battery power pack and a switching arrangement to enable either of the circuits to be connected to the power pack. The output from the device is connectable to an ar' rangement of electrodes which are adapted to be introduced directly into the heart by a transthoracic needle. The electrodes are arranged to make good electrical contact with the inner surface of the heart, such as within the left ventricle. After the electrodes are disposed properly within the heart, the defibrillation or pacing pulse can be applied immediately. Further aspect of the invention relates to the bipolar configuration of the electrodes. The electrodes are highly flexible and normally tend to assume a spread apart configuration. When introduced into the heart they spread apart and against opposite sides of the inner surface of the left ventricle. The portions of the electrodes which contact the wall of the ventricle are of a broad and curved configuration. The electrodes are arranged so that there is little tendency for the electrical pulse to short circuit through the blood in the heart. This ensures that the electrical pulse will be applied directly to the myocardium. Because of the direct contact of the electrodes with the heart, there is significantly less impedance to the electrical pulse than that which is presented by the usual bulky defibrillation apparatus in which the pulse is applied to the exterior of the chest. As a result, there is a substantially smaller power requirement necessary which facilitates the portability of the device so that it may be carried easily to the patient thus saving time. Additionally, the electrode configuration is highly flexible and presents substantially no resistance to contraction of the heart.
It is among the objects of my invention to provide a portable cardiac stimulator capable of immediately applying defibrillation pulses to a cardiac victim.
Another object of the invention is to provide a portable defibrillation device which can selectively be employed to apply pacing pulses to the patient.
A further object of the invention is to provide a portable apparatus which avoids the critical lag in time incurred in the usual emergency treatment of such heart disorders.
Another object of the invention is to provide a portable cardiac stimulator which is capable of immediately and selectively applying either of a defibrillation pulse or a repetitive series of pacing pulses.
Further object of the invention is to provide an improved electrode arrangement employing a pair of poles which are self-spreading into contact with the opposite sides of the patients ventricle.
Still another object of the invention is to provide an improved electrode arrangement in which each of the poles of the electrode contact the inner surface of the ventricle along a substantial area and not just point contact.
A further object of the invention is to provide an electrode configuration which presents substantially no resistance or damage to the heart in the event of contraction of the heart.
DESCRIPTION OF THE DRAWINGS The foregoing and other objects and advantages of the invention will be understood more fully from the following detailed description thereof, with reference to the accompanying drawings wherein:
FIG. 1 is a diagrammatic cross section through a patients thorax at the level of the fifth intercostal space, showing the invention with the self-spreading bipolar electrode inserted into the left ventricle of the heart;
FIG. 2 is an illustration of the electrode arrangement when in its spread configuration and having portions thereof broken away to illustrate its internal configuration;
FIG. 3A-3F are cross sections of the lead to the bipolar electrode and the bipolar electrodes themselves showing the internal arrangement of the electrode leads along successive portions of the electrode and as seen along the lines 3A--3A, 3B3B, 3C3C, 3D-3D, 3E-3E and 3F3F of FIG. 2;
FIG. 4 is a longitudinal sectional illustration of the transthoracic needle by which the bipolar electrode may be inserted into the patients left ventricle and showing the configuration of it in the manner in which the bipolar electrode is disposed within the needle in readiness to be inserted into the patient;
FIG. 5 is an enlarged illustration of the arrangement by which the electrode may be connected to the circuitry of the device;
FIG. 6 is a diagrammatic illustration of the circuitry of the invention; and
FIG. 7 is an illustration of the face of the control panel and housing for the circuitry.
DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows the invention in readiness to apply electric stimulating pulses to the patient. It includes the bipolar electrode 10 which has been inserted, in the manner described herein, through the patients chest wall 12 at the level of the fifth intercostal space, to the left of the sternum 14. When properly located, the bipolar electrode 10 is disposed within the left ventricular lumen 16 of the heart. The electrode leads are connected by a connector 18 to the output leads 20 from a compact integral and controllable pulse generator 22. As described more fully below, the pulse generator includes independent circuits adapted to generate a defibrillating pulse and pacemaking pulses which can be selectively applied to the bipolar electrodes 10.
The bipolar electrode 10 is formed from a pair of thin flexible electrically conductive wires 24 made from a metal which is biologically non-reactive such as No. 316 extra low carbon stainless steel wire. In the illustrative embodiment, the wires approximate 0.012 inches in diameter. A pair of such wires is embedded in a flexible insulative sheath which, in the preferred embodiment, has an external diameter of approximately 0.034 inches. The sheath should be made from an appropriate material which is similarly biologically non-reactive such as silastic.
The parallel insulated wires 24 and surrounding sheath 26 are bifurcated at the end of thee electrode to define a generally T-shaped configuration in which the ends of the wires 24 extend generally in opposite directions. The sheath 26 continues integrally along the separated electrode portions of the wires 24 to define electrode sheaths 28 which insulate the bifurcated electrodes 30. The insulative sheaths 28 extend fully to and about the tips of the electrodes 30 except for cutout segments 32 through which the inner electrodes 30 are exposed.
The bifurcated electrodes 30 are fabricated so that they tend to assume the spread configuration shown in FIG. 2 which is somewhat S-shaped. The outer ends of the sheathed electrodes 30 are curved with their tips tending to extend inwardly. The arrangement is such that the lateral regions of the electrodes define a substantial convex configuration. It may be noted that the outer diameter of the electrode sheaths 28 is approximately 0.017 inches. At the outwardly facing side of each of the outer arcuate segments 36, the electrode sheaths 28 are cut away at 32 to define outwardly exposed semicircular sections of the electrodes 30. The cutout segments 32 preferably are approximately 3/16 of an inch long and begin approximately 3/16 of an inch from the tip 34 of each electrode 30. The cutout segments 32 expose the electrode only laterally outwardly and over approximately of the cross sectional circumference of the electrode. The portions of the electrodes 30 which are so exposed serve as the conductive terminal ends of the electrode and are intended to bear against and establish electrical communication with the opposite inner surfaces of the ventricle wall. The electrode configuration shown in FIG. 2 is that in its completely relaxed condition. The bifurcated end of the electrode is dimensioned so as to be somewhat greater than the inner diameter of the ventricle. When the electrode arrangement is disposed within the ventricle and expands against diametrically opposite sides of the inner surface of the ventricle, the lateral arcuate segments 36 and, particularly the exposed surfaces of the electrodes will bear against the ventricle wall snugly to establish firm electrical connection. When properly disposed within the ventricle, the electrodes assume a more T-shaped configuration than that shown in FIG. 2 with the reversely curved segments 38 of the electrodes being somewhat less curved than shown in FIG. 2. This is suggested somewhat in FIG. 1. While the dimensions of the electrode wire are such to enable it to be biased with sufficient firmness against the ventricle wall, it is sufficiently light as to present substantially no resistance to contraction or flexure of the myocardium. The foregoing arrangement ensures that electrical contact will be maintained with the ventricle during contraction or other movement of the heart.
The foregoing electrode arrangement provides a number of advantages. The exposed portions of the electrodes define a relatively substantial area of electrical contact thus tending to reduce the magnitude of impedance presented. It also reduces significantly the possibility of short circuiting through the relatively conductive blood within the left ventricle. The electrodes 30 are exposed only laterally and are biased firmly against the slightly into the ventricle wall which tends to cooperate with the insulative sheathing to isolate the electrode from the blood within the ventricle. This enhances the likelihood of the electrical pulse being applied to the ventricle wall and not being short circuited through the blood. In addition, the engagement of the electrodes with diametrically opposite portions of the ventricle further reduces the possibility of short-circuiting by maximizing the distance between the exposed portions of the electrodes. Still another significant advantage of the electrode configuration is that by applying the electrodes at opposite internal surfaces of the ventricle it is more effectively ensured that a sub stantial portion, if not all of the ventricle wall will be subjected to the electrical pulse. The arrangement of the insulated tips 34 by which they extend inwardly towardeach other and away from the ventricle wall affords a further safety feature by eliminating the possiblity of accidental puncture of the ventricle wall. In this regard it may be noted that when the electrodes are properly disposed within the ventricle, the tips 34 extend inwardly toward each other even to a greater extent than that shown in FIG. 2.
FIGS. 3A-3F show the cross section of the electrode leads at various locations along their length and the manner in which the leads may be connected to the pulse generator 22. The wires 24 extend within the sheath and are connected to a pair of conductive sleeves which are spaced along the distal end of the leads and are exposed about the circumference of the sheath 26. The wires 24 are connected by appropriate means to the sleeves 40 as shown in FIGS. 38 and 3D.
The sleeved end of the sheath 26 is connected to the pulse generator 22 by a connector 18 in the manner described below.
The electrode is introduced transthoracically into the left ventricle of the heart before its trailing end is electrically connected to the pulse generator and by means of an arrangement shown in FIG. 4. This arrangement includes a plastic tube 42 having an internal diameter of approximately 0.040 inches which encloses the bipolar electrodes as shown. The electrodes are sufficiently resilient as to be able to be slipped into the tube 42 with its normally S-shaped bifurcations being constrained in the substantially straight configuration shown. The outer diameter of the tube 42 is dimensioned to fit within the hub 44 ofa l7 gage cardiac nee dle indicated generally at 46. The electrodes are introduced by inserting the cardiac needle 46 into the ventricle then removing the obturator (not shown) normally within the needle and thereafter inserting the plastic tube 42 into the hub 44 of the cardiac needle 46. The needle 46 and tube 42 are approximately each five inches long. The electrode then is advanced along the tube into and through the needle until the trailing end of the electrode sheath is flush with the end of the plastic sleeve. The length of the electrodes and sheath are related to the combined length of the cardiac needle 46 and tube 42 so that when the trailing end of the sheath is flush with the end of the tube 42 the electrode end of the sheath will have extended. approximately 1 4 inches past the inner end of the cardiac needle 46 and will have spread into its generally T-shaped configuration. The needle and tube then may be withdrawn with the electrode properly disposed within the left ventricle and with its leads extending outwardly from the patient.
The outwardly disposed lead of the electrode is connected to the output leads 20 from the pulse generator 22 by means of an appropriate connector such as that shown in FIG. 5. The illustrated connector is formed integrally with the end of the output leads 20 and has an enlarged cylindrical portion 48 formed from insulative material integral with the insulative material surrounding the output leads 20. The cylindrical portion 48 has a center bore formed therethrough approximately 0.040 inches in diameter. The bore 50 is defined in part, at spaced locations along its length, by conductive sleeves 52. Sleeves 52 are electrically connected to the conductive leads 20 and are spaced identically to the sleeves 40 disposed at the trailing end of the electrode leads. The trailing end of the electrode leads may be inserted into the bore 50 to align the sleeves 52 with the sleeves 40 and can be secured therein by a number of arrangements such as the screws 54. The set screws 54 are of non-conductive material. Transthoracic insertion of the electrode arrangement into the ventricle and subsequent connection of the trailing end of the electrode arrangement to the pulse generator can be accomplished quickly and simply and requires no moving of the patient to a hospital or the like. After the electrodes have been connected, the pulse generator may be operated immediately either to apply a defibrillating pulse or a pacing pulse to the patient.
The circuitry shown in FIG. 6 generally includes switch 60, defibrillator circuit 62., pacemaker circuit 64, and energy supply means. The source of electrical energy comprises battery banks 66 and 68 which are mutually exclusively connectable by switch 60 to mode switch 70. Each of the battery banks includes a pair of commercially available 8.4 volt mercury batteries connected in series. When the unit is to be operated the switch 60 is thrown to select either bank 66 or 68. The unused battery bank remains readily available as a spare power source.
A battery failure indicator 72 couples to the common contact of switch 60 and indicates when the battery output falls to percent of the full battery power, thus indicating the need to switch to the spare set of batteries by throwing switch 60 to its alternate position.
The mode switch 70 is a four position/double throw switch having a set of common contacts 70C and two sets of fixed contacts 70A and 708. With switch 60 connected to either of the battery banks 66, 68, switch 70 can either be in its neutral position with its movable contacts 70C open, or it can be moved to either the defib" position where the movable contacts 70C couple to the fixed contacts 70A, or the pace position where the movable contacts 70C connect to the fixed contacts 70B. When switch 70 is in the defib position energy is coupled to the defibrillator circuit 62 and an output signal is developed across output lines 74 and 76. In FIG. 6 the switch 70 is shown in the defib position. Alternatively, the switch can be moved to the pace position wherein energy is coupled to the pacemaker circuit 64 which develops its output across lines 74, 76.
When switch 70 is in the defib position power is coupled to trigger button 78 which is a typical normally open momentary contact switch. When trigger button is depressed the high voltage defibrillatory shock pulse is generated and applied to the bipolar electrode thru lines 74, 76. The defibrillation circuit 62 illustrated may be considered as being of conventional design and generally comprises a DC to DC converter 80, transistor 82, neon tube 84, capacitor 86, SCR 88, and a series of resistors appropriately interconnected. The circuit 62 is substantially identical to the pulse circuit shown in US. Pat. No. 3,614,955 and operates as follows: When button 78 is depressed a relatively high voltage signal, approximately 2,500 volts, is established at the output of DC to DC converter 80. This voltage is developed across capacitor 86. The resistor chain and the tube 84 are interconnected in such a manner that when the voltage across capacitor 86 reaches a full 2,500 volts, the tube 84 conducts. When the capacitor 86 is fully charged, the transistor 82 becomes conductive, due to the now-conducting neon tube 84. When the tube conducts there is a sufficient conduction path by way of resistors 90, 92 and 94 to cause conduction of transistor 82. Concurrently therewith, a drive current is provided to the gate of SCR 88 and the SCR also conducts, applying the voltage from the capacitor 86 across the output lines 74, 76. The output of circuit 62 has a preferable pulse width of approximately 100 milliseconds as determined by the time constant of the network. The energy output is of the order of joules at a current of approximately ma. This is significantly less than the energy requirements for previous defibrillation devices. The neon tube 84 serves the double function of being an integral part of the trigger circuit and, because it also lights up for an instant during voltage buildup in the converter 80 it also indicates that the circuit is in operation.
The device may be controlled to immediately apply lower voltage pacing pulses by operation of the switch 70 to the position in which the movable contacts 70C are connected to the fixed contacts 703. The power from one of the battery banks 66 or 68 is coupled to the circuit 64 and the cyclic output of that circuit is coupled to the output lines 74, 76. A typical output from circuit 64 is a signal 0 to milliamp, of 2.8 millisecond duration at a repetition rate of 70 pulses per minute.
The pacing circuit 64 comprises a conventional astable multivibrator including transistors 96 and 98, a pulse width regulator including transistors 100, 102, a voltage regulator including transistor 104 and a current source including transistor 106. The astable multivibrator is of conventional design and includes crosscoupling capacitors 108, and collector resistors 112, 114. A potentiometer 116 is coupled to the base of transistor 96 for varying the frequency of operation of the astable multivibrator.
The output of the multivibrator couples by way of resistor 118 to transistor 100. The collector of transistor 100 couples through resistor 120 to the power source and also by way of capacitor 122 to resistor 124 and to the base of transistor 102. When transistor 100 is not conducting capacitor 122 is discharging and transistor 102 is non-conductive. When transistor 100 conducts because of a change of state of the astable multivibrator, capacitor 122 is charged by way of resistor 124 and after a predetermined time period transistor 102 conducts. Transistor 102 conducts in one embodiment for approximately 2.8 milliseconds before transistor 100 can change its state causing transistor 102 to stop conducting. During the brief time that transistor 100 conducts Zener diode 126 is shorted out and transistor 104 becomes conductive via Zener diode 128 to transistor 106. When this occurs, transistor 106 also conducts and a constant current is fed by way of switch 70 to output leads 74, 76. The potentiometer 130 is used to control the output current which may be varied from 0 to 30 milliamps. A pulse indicator 132 may be coupled from the collector of transistor 106 to the emitter of transistor 104 for verifying that the pacemaker circuit is functioning properly. The indicator 132 may also be coupled, in an alternate embodiment, directly to the astable multivibrator.
FIG. 7 shows the control panel with mode switch 70 which may be in any of its off, defib or pace positions. When the switch 70 is in its defib position, depression of the trigger button 78 causes almost instantaneous charging and discharging of the defibrillator circuit 62 and an attendant flashing of neon bulb 84 associated therewith. This indicates that the high voltage pulse has been coupled to the output leads 74 and 76. When the switch 70 is in the pace position, indicator 132 reveals a pulse rate of 70 beats per minute, for example. The milliamperage rating from the output of the pace circuit is adjusted by dial 134 shown in FIG. 7 which is coupled to the potentiometer 130.
Thus, I have described my invention which enables controlled electrical pulses to be selectively applied to a cardiac patient both as an emergency first aid measure as well as in a hospital environment. It should be understood, however, that the foregoing description of the invention is intended merely to be illustrative thereof, and that other modifications and embodiments may be apparent to those skilled in the art without departing from the spirit.
Having thus described the invention what I desire to claim and secure by Letters Patent is:
1. A portable emergency cardiac stimulator comprismg:
defibrillation circuit means for generating a high voltage electrical pulse for defibrillating a fibrillating ventricle of a heart when applied directly to the wall of said ventricle;
pacing circuit means for generating repetitive low voltage electrical pulses at a predetermined rate;
transthoracically insertable bipolar cardiac electrode means for directly contacting substantially diametrically opposite portions the ventricle, said electrode means having leads trailing therefrom, such that when said electrode means are disposed interiorly of said ventricle the trailing ends of said leads may extend transthoracically and be disposed exteriorly of the patient;
switch means, having an input, said switch means further including a common output lead, for selectively connecting the output of either of said defibrillation circuit means or said pacing circuit means to said common output lead;
means for detachably connecting, in electrically conductive relation, the trailing leads of said electrode means to said common output lead to enable said electrode leads to be connected to said common output lead after transthoracic insertion of said electrode means into said ventricle; and
battery means connected to the input of said switch means for powering said defibrillation circuit means and said pacing circuit means.
2. A device defined in claim 1 further comprising:
said battery means including pair of identical storage batteries and second switch means for selectively connecting either of said storage batteries to the input of said first mentioned switch means.
3. A bipolar cardiac electrode comprising:
a pair of flexible, electrically conductive wires, each of said wires having a leading end and a trailing end, said leading ends of said wires extending generally transversely and away from each other when relaxed to assume a generally T-shaped configuration whereby when disposed within said cardiac lumen, the most laterally disposed regions of the leading ends of said wires may contact substantially diametrically opposite portions of the inner surface of said cardiac lumen;
said leading ends of said wires being resilient and flexible to enable said leading ends to be constrained into a substantially parallel configuration thereby to enable said leading ends to be retained within and passed through a cardiac needle and to spread and return toward said T-shaped configuration when said leading ends pass through the end of said needle into said cardiac lumen;
insulation means surrounding said wires fully along the length of said wires;
the outer extremities of the leading ends of said wires being curved inwardly toward each other, when relaxed, thereby defining curved convex configurations at the lateral extremities of said relaxed leading ends so that the lateral extremities of said wires are defined by regions between the longitudinal extremities of said leading ends thereof;
means defining a window in said insulation means surrounding each of said leading ends, each of said windows being disposed at the curved convex lateral extremity of its associated wire, each of said windows exposing its associated conductive wire outwardly and transversely;
means for exposing each of said wires at their trailing ends to enable said wires to be connected to a source of electricity.
4. A bipolar cardiac electrode as defined in claim 3 further comprising:
said windows are defined by generally laterally outwardly facing openings in said insulation and circumscribing approximately of the cross section of said wire.
5. An electrode arrangement as defined in claim 4 wherein said window is approximately 3/l6 of an inch in length.
6. A bipolar cardiac electrode as defined in claim 3 further comprising:
wherein the leading ends further comprise:
said wire being biologically nonreactive and being of a diameter of approximately 0.012 inches; and
said insulative sheath being biologically non-reactive and having an outer diameter of approximately 0.017 inches.
|Patente citada||Fecha de presentación||Fecha de publicación||Solicitante||Título|
|US3518997 *||17 Ene 1969||7 Jul 1970||Sessions Robert W||Electronic heart stimulator|
|US3664347 *||25 Jul 1969||23 May 1972||Dietrich Harmjanz||Electric heart stimulation method and electrode|
|US3680544 *||9 Sep 1970||1 Ago 1972||James P Shinnick||Transthoracic cannula-type device for cardiopulmonary resuscitation|
|US3703900 *||2 Dic 1969||28 Nov 1972||Cardiac Resuscitator Corp||Cardiac resuscitator|
|US3738370 *||18 Ene 1971||12 Jun 1973||Charms B||Method of defibrillating a malfunctioning heart by means of electrodes located within the atrium|
|Patente citante||Fecha de presentación||Fecha de publicación||Solicitante||Título|
|US4088138 *||29 Dic 1975||9 May 1978||Cardiac Resuscitator Corp.||Cardiac resuscitator and monitoring apparatus|
|US4112952 *||11 Feb 1977||12 Sep 1978||The United States Of America As Represented By The Secretary Of Health, Education And Welfare||Electrode for artificial pacemaker|
|US4236525 *||22 Nov 1978||2 Dic 1980||Intermedics, Inc.||Multiple function lead assembly|
|US4261372 *||13 Nov 1978||14 Abr 1981||Hansen Carl C||Electrode for implantation into cochlea|
|US4289138 *||9 Jun 1980||15 Sep 1981||Medical Testing Systems, Inc.||Electrode assembly for temporary pacing and heart measurements|
|US4393883 *||3 Nov 1980||19 Jul 1983||Medtronic, Inc.||Single pass A-V lead|
|US4419819 *||29 Ene 1982||13 Dic 1983||Medtronic, Inc.||Method of making biomedical lead with lobed lead anchor|
|US4522212 *||14 Nov 1983||11 Jun 1985||Mansfield Scientific, Inc.||Endocardial electrode|
|US4595012 *||13 Ene 1984||17 Jun 1986||American Hospital Supply Corporation||Lumen mounted electrodes for pacing and intra-cardiac ECG sensing|
|US4662377 *||7 Nov 1985||5 May 1987||Mieczyslaw Mirowski||Cardioverting method and apparatus utilizing catheter and patch electrodes|
|US4850359 *||4 Dic 1987||25 Jul 1989||Ad-Tech Medical Instrument Corporation||Electrical brain-contact devices|
|US4865037 *||13 Nov 1987||12 Sep 1989||Thomas J. Fogarty||Method for implanting automatic implantable defibrillator|
|US4869255 *||13 Jul 1988||26 Sep 1989||Ad-Tech Medical Instrument Corp.||Electrical connection device|
|US4919147 *||27 Oct 1987||24 Abr 1990||Josef Reinhardt||Esophagus probe|
|US4961434 *||30 Ago 1988||9 Oct 1990||Stypulkowski Paul H||Array of recessed radially oriented bipolar electrodes|
|US4991603 *||30 Oct 1989||12 Feb 1991||Siemens-Pacesetter, Inc.||Transvenously placed defibrillation leads via an inferior vena cava access site and method of use|
|US4998975 *||30 Oct 1989||12 Mar 1991||Siemens-Pacesetter, Inc.||Travenously placed defibrillation leads|
|US5010894 *||9 Ene 1989||30 Abr 1991||Edhag Knut O||Intravascular electrode lead usable for cardiac defibrillation|
|US5033477 *||8 Sep 1989||23 Jul 1991||Thomas J. Fogarty||Method and apparatus for providing intrapericardial access and inserting intrapericardial electrodes|
|US5037497 *||19 Jul 1990||6 Ago 1991||Cochlear Corporation||Method of fabricating an array of recessed radially oriented bipolar electrodes|
|US5052407 *||10 Abr 1989||1 Oct 1991||Mieczyslaw Mirowski||Cardiac defibrillation/cardioversion spiral patch electrode|
|US5071428 *||15 Feb 1991||10 Dic 1991||Ventritex, Inc.||Method and apparatus for providing intrapericardial access and inserting intrapericardial electrodes|
|US5144960 *||20 Mar 1991||8 Sep 1992||Medtronic, Inc.||Transvenous defibrillation lead and method of use|
|US5156148 *||13 May 1991||20 Oct 1992||Leonard Bloom||System for treating a malfunctioning heart|
|US5203348 *||6 Jun 1990||20 Abr 1993||Cardiac Pacemakers, Inc.||Subcutaneous defibrillation electrodes|
|US5230337 *||14 Jul 1992||27 Jul 1993||Cardiac Pacemakers, Inc.||Process for implanting subcutaneous defibrillation electrodes|
|US5275157 *||12 Abr 1991||4 Ene 1994||Physio-Control Corporation||Pulse forming circuits|
|US5282845 *||1 Oct 1990||1 Feb 1994||Ventritex, Inc.||Multiple electrode deployable lead|
|US5304219 *||5 Jun 1992||19 Abr 1994||Siemens Pacesetter, Inc.||Multipolar in-line proximal connector assembly for an implantable stimulation device|
|US5342407 *||13 Jul 1992||30 Ago 1994||Cardiac Pacemakers, Inc.||Body implantable defibrillation system|
|US5366496 *||1 Abr 1993||22 Nov 1994||Cardiac Pacemakers, Inc.||Subcutaneous shunted coil electrode|
|US5370664 *||10 Ago 1993||6 Dic 1994||Physio-Control Corporation||Pulse forming circuits|
|US5674253 *||6 Sep 1996||7 Oct 1997||Incontrol, Inc.||Cardioversion system with cardioverting energy attenuator|
|US5843132 *||7 Oct 1996||1 Dic 1998||Ilvento; Joseph P.||Self-contained, self-powered temporary intravenous pacing catheter assembly|
|US6085119 *||22 Jul 1998||4 Jul 2000||Cardiac Pacemakers, Inc.||Single pass endocardial lead for multi-site atrial pacing|
|US6141589 *||23 Ago 1999||31 Oct 2000||Duke University||Switch control for external pacing system|
|US6212434||22 Jul 1998||3 Abr 2001||Cardiac Pacemakers, Inc.||Single pass lead system|
|US6321122||22 Jul 1998||20 Nov 2001||Cardiac Pacemakers, Inc.||Single pass defibrillation/pacing lead with passively attached electrode for pacing and sensing|
|US6415168||19 Abr 2000||2 Jul 2002||Ad-Tech Medical Instrument Corporation||Electrical connector for multi-contact medical electrodes|
|US6463334||22 Jul 1999||8 Oct 2002||Cardiac Pacemakers, Inc.||Extendable and retractable lead|
|US6501990||23 Dic 1999||31 Dic 2002||Cardiac Pacemakers, Inc.||Extendable and retractable lead having a snap-fit terminal connector|
|US6505082||21 Ago 2000||7 Ene 2003||Cardiac Pacemakers, Inc.||Single pass lead system|
|US6516231||2 Jun 2000||4 Feb 2003||Daniel Flammang||Endocardial electrode lead with multiple branches|
|US6671534||17 Ene 2002||30 Dic 2003||Ad-Tech Medical Instrument Corporation||Electrical connector for multi-contact medical electrodes|
|US6876885||11 Ene 2002||5 Abr 2005||Medtronic, Inc.||Implantable bifurcated gastrointestinal lead with active fixation|
|US6889093||2 Jun 2000||3 May 2005||Biotronik Mes-und Therpiegeräte GmbH & Co. Ingenieurbüro Berlin||Electrode lead with multiple branches|
|US6915169||4 Oct 2002||5 Jul 2005||Cardiac Pacemakers, Inc.||Extendable and retractable lead having a snap-fit terminal connector|
|US6952613||11 Ene 2002||4 Oct 2005||Medtronic, Inc.||Implantable gastrointestinal lead with active fixation|
|US6983185||31 Jul 2002||3 Ene 2006||Cardiac Pacemakers, Inc.||Lead with terminal connector assembly|
|US7239915||16 Nov 2004||3 Jul 2007||Medtronic, Inc.||Hemodynamic optimization system for biventricular implants|
|US7245973||23 Dic 2003||17 Jul 2007||Cardiac Pacemakers, Inc.||His bundle mapping, pacing, and injection lead|
|US7392095||1 Jul 2005||24 Jun 2008||Cardiac Pacemakers, Inc.||Extendable and retractable lead having a snap-fit terminal connector|
|US7774934||8 Dic 2005||17 Ago 2010||Cardiac Pacemakers, Inc.||Method for making a terminal connector|
|US8078287||8 Jun 2007||13 Dic 2011||Cardiac Pacemakers, Inc.||His bundle mapping, pacing, and injection lead|
|US8165696 *||25 Feb 2005||24 Abr 2012||Boston Scientific Neuromodulation Corporation||Multiple-pronged implantable stimulator and methods of making and using such a stimulator|
|US8209035||23 Jun 2008||26 Jun 2012||Cardiac Pacemakers, Inc.||Extendable and retractable lead having a snap-fit terminal connector|
|US8285376||27 Mar 2009||9 Oct 2012||Cardiac Pacemakers, Inc.||Ventricular pacing|
|US8285398||7 Jul 2010||9 Oct 2012||Cardiac Pacemakers, Inc.||Lead with terminal connector assembly|
|US8290586||10 Oct 2008||16 Oct 2012||Cardiac Pacemakers, Inc.||Methods, devices and systems for single-chamber pacing using a dual-chamber pacing device|
|US8326423||26 Jun 2008||4 Dic 2012||Cardiac Pacemakers, Inc.||Devices and methods for steering electrical stimulation in cardiac rhythm management|
|US8346358||13 Dic 2005||1 Ene 2013||Cardiac Pacemakers, Inc.||Pacemaker which reestablishes or keeps the physiological electric conduction of the heart and a method of application|
|US8423139||26 Jun 2008||16 Abr 2013||Cardiac Pacemakers, Inc.||Methods, devices and systems for cardiac rhythm management using an electrode arrangement|
|US8428715||10 Oct 2008||23 Abr 2013||Cardiac Pacemakers, Inc.||Methods for treating the physiological electric conduction of the heart|
|US8437848||10 Oct 2008||7 May 2013||Cardiac Pacemakers, Inc.||Apparatus for treating the physiological electric conduction of the heart|
|US8538521||25 Ago 2011||17 Sep 2013||Cardiac Pacemakers, Inc.||Systems, devices and methods for monitoring efficiency of pacing|
|US8543203||17 Ago 2011||24 Sep 2013||Cardiac Pacemakers, Inc.||Endocardial pacing devices and methods useful for resynchronization and defibrillation|
|US8565880||26 Abr 2011||22 Oct 2013||Cardiac Pacemakers, Inc.||His-bundle capture verification and monitoring|
|US8688234||18 Dic 2009||1 Abr 2014||Cardiac Pacemakers, Inc.||Devices, methods, and systems including cardiac pacing|
|US8812106||2 May 2013||19 Ago 2014||Cardiac Pacemakers, Inc.||Apparatus for treating the physiological electric conduction of the heart|
|US8825159||29 Nov 2012||2 Sep 2014||Cardiac Pacemakers, Inc.||Devices and methods for steering electrical stimulation in cardiac rhythm management|
|US8838238||4 Oct 2012||16 Sep 2014||Cardiac Pacemakers, Inc.||Ventricular pacing|
|US8880169||24 Ago 2011||4 Nov 2014||Cardiac Pacemakers, Inc.||Endocardial pacing relating to conduction abnormalities|
|US8903489||12 Oct 2012||2 Dic 2014||Cardiac Pacemakers, Inc.||Methods, devices and systems for single-chamber pacing using a dual-chamber pacing device|
|US8934969||16 Sep 2013||13 Ene 2015||Cardiac Pacemakers, Inc.||Systems, devices and methods for monitoring efficiency of pacing|
|US9008768||15 Abr 2013||14 Abr 2015||Cardiac Pacemakers, Inc.||Methods, devices and systems for cardiac rhythm management using an electrode arrangement|
|US9031648||17 Sep 2013||12 May 2015||Cardiac Pacemakers, Inc.||Endocardial pacing devices and methods useful for resynchronization and defibrillation|
|US9216563||12 Ago 2014||22 Dic 2015||Boston Scientific Neuromodulation Corporation||Lead anchor with adhesive and systems and methods using the lead anchor|
|US9352147||7 Feb 2011||31 May 2016||Boston Scientific Neuromodulation Corporation||Torque lock anchor and methods and devices using the anchor|
|US9415212||24 Feb 2015||16 Ago 2016||Boston Scientific Neuromodulation Corporation||Side loading lead anchor and methods of making and using thereof|
|US9468407 *||30 May 2014||18 Oct 2016||Biosense Webster (Israel) Ltd.||Catheter with distal section having side-by-side loops|
|US9517334||12 Ago 2014||13 Dic 2016||Boston Scientific Neuromodulation Corporation||Lead anchors and systems and methods employing the lead anchors|
|US9636498||1 Ago 2016||2 May 2017||Boston Scientific Neuromodulation Corporation||Lead anchor with a wedge and systems using the lead anchor|
|US9731120 *||5 Nov 2013||15 Ago 2017||Dignity Health||Uterine electrical stimulation system and method|
|US9750422 *||23 Ene 2015||5 Sep 2017||Biosense Webster (Israel) Ltd||Catheter with transverse branches|
|US20020103522 *||11 Ene 2002||1 Ago 2002||Swoyer John M.||Implantable bifurcated gastrointestinal lead with active fixation|
|US20030069625 *||31 Jul 2002||10 Abr 2003||Ley Gregory R.||Lead with terminal connector assembly|
|US20050131469 *||16 Nov 2004||16 Jun 2005||Leonard Bloom||Hemodynamic optimization system for biventricular implants|
|US20060089698 *||8 Dic 2005||27 Abr 2006||Cardiac Pacemakers, Inc.||Lead with terminal connector assembly|
|US20060142812 *||13 Dic 2005||29 Jun 2006||Action Medical, Inc.||Pacemaker which reestablishes or keeps the physiological electric conduction of the heart and a method of application|
|US20060195143 *||25 Feb 2005||31 Ago 2006||Mcclure Kelly H||Multiple-pronged implantable stimulator and methods of making and using such a stimulator|
|US20080262587 *||23 Jun 2008||23 Oct 2008||Cardiac Pacemakers, Inc||Extendable and retractable lead having a snap-fit terminal connector|
|US20080319499 *||26 Jun 2008||25 Dic 2008||Qingsheng Zhu||Devices and Methods for Steering Electrical Stimulation in Cardiac Rhythm Management|
|US20090005846 *||26 Jun 2008||1 Ene 2009||Qingsheng Zhu||Methods, Devices and Systems for Cardiac Rhythm Management Using an Electrode Arrangement|
|US20090093859 *||10 Oct 2008||9 Abr 2009||Action Medical, Inc.||Apparatus for treating the physiological electric conduction of the heart|
|US20090093861 *||10 Oct 2008||9 Abr 2009||Action Medical, Inc.||Methods for treating the physiological electric conduction of the heart|
|US20090187226 *||27 Mar 2009||23 Jul 2009||Action Medical, Inc.||Ventricular pacing|
|US20140058473 *||5 Nov 2013||27 Feb 2014||Robert E. Garfield||Uterine Electrical Stimulation System and Method|
|US20150045865 *||5 Ago 2014||12 Feb 2015||Boston Scientific Neuromodulation Corporation||Systems and methods for making and using lead anchors for leads of electrical stimulation systems|
|US20150223715 *||23 Ene 2015||13 Ago 2015||Biosense Webster (Israel) Ltd.||Catheter with transverse branches|
|US20150342531 *||30 May 2014||3 Dic 2015||Biosense Webster (Israel) Ltd.||Catheter with distal section having side-by-side loops|
|USRE30750 *||7 May 1980||29 Sep 1981||Cardiac Resuscitator Corporation||Cardiac resuscitator and monitoring apparatus|
|USRE31990 *||18 Ago 1982||24 Sep 1985||Intermedics, Inc.||Multiple function lead assembly and method for inserting assembly into an implantable tissue stimulator|
|USRE32204 *||1 Jun 1983||15 Jul 1986||Mansfield Scientific, Inc.||Electrode assembly for temporary pacing and heart measurements|
|EP0090467A2 *||24 Mar 1983||5 Oct 1983||Walter Spaa||Cardiac stimulator|
|EP0090467A3 *||24 Mar 1983||4 Mar 1987||Walter Spaa||Cardiac stimulator|
|EP1057496A3 *||2 Jun 2000||12 Sep 2001||BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin||Electrode arrangement|
|EP1057497A3 *||2 Jun 2000||12 Sep 2001||BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin||Cardioversion arrangement|
|WO1980002231A1 *||24 Abr 1980||30 Oct 1980||J Donachy||Long-life flexible electrode lead|
|WO1992016254A1 *||21 Nov 1991||1 Oct 1992||Medtronic, Inc.||Transvenous defibrillation lead and method of use|
|Clasificación de EE.UU.||607/4, 607/34, 607/122, 607/7, 607/10|
|Clasificación internacional||A61N1/362, A61N1/39, A61N1/05|
|Clasificación cooperativa||A61N1/362, A61N1/0587, A61N1/39|
|Clasificación europea||A61N1/362, A61N1/05P, A61N1/39|