ES2425838T3 - Optional use of a conductive cable for a unit subcutaneous implantable cardioverter defibrillator - Google Patents

Abstract

An implantable cardioverter-defibrillator, the implantable cardioverter-defibrillator comprising: a housing having a first end and a second end; a first electrode disposed at the first end of the housing; a second electrode disposed at the second end of the housing; an electrical circuit located within the housing, and configured to provide cardioversion-defibrillation energy; and a lead wire electrode electrically coupled to the electrical circuitry within the housing, whereby the implantable cardioverter-defibrillator is configured for placement subcutaneously on the rib cage of a patient; the electrical circuit is coupled to the first and second electrodes and to the lead wire electrode; characterized: in that the housing is dimensioned such that the first and second electrodes in the housing are spaced apart to provide a defibrillation vector between them; and in that the lead wire electrode with the first and second electrodes in the housing form second and third defibrillation vectors, and the electrical circuit is programmed to select from among the second and third defibrillation vectors a defibrillation vector for use.

Description

DESCRIPTION Optional use of a conductive cable for a unit subcutaneous implantable cardioverter defibrillator. Background of the invention

Defibrillation / cardioversion is a technique used to combat arrhythmic states of the heart that include some tachycardias in the atria and / or ventricles. Typically, electrodes are used to stimulate the heart with electrical impulses or shocks of a magnitude substantially greater than the impulses used in cardiac pacing with pacemakers. Because current density is a key factor in defibrillation and cardiac pacing with pacemakers, implantable devices can improve as much as possible with the normal waveform in which current and voltage decrease over time. of pulse release. Therefore, a waveform that maintains a constant current throughout the duration of delivery to the myocardium can improve defibrillation as well as cardiac pacing with pacemakers.

Defibrillation / cardioversion systems include implantable electrodes in the body that are connected to a tightly sealed container that houses the electronic elements, a battery supply and capacitors. The complete system is called implantable defibrillator / cardioverter (ICD). The electrodes used in the ICDs may have the form of patches applied directly to the epicardial tissue, or more commonly, they are in the distal areas of small isolated cylindrical catheters that are normally introduced into the subclavian vein system, traverse the superior vena cava and , one or more endocardial areas of the heart. Such electrode systems are called intravascular or transvenous electrodes. US Patent Nos. 4,603,705, 4,693,253, 4,944,300, 5,105,810 describe intravascular or transvenous electrodes, used alone or in combination with an epicardial patch or with subcutaneous electrodes. Deformable epicardial defibrillators are described in US Pat. Nos.

4,567,900 and 5,618,287. A configuration of a detector epicardial electrode is described in US Patent No. 5,476,503.

In addition to epicardial and transvenous electrodes, subcutaneous electrode systems have also been developed. For example, US Patent Nos. 5,342,407 and 5,603,732 teach the use of a pulse monitor / generator surgically implanted in the abdomen and subcutaneous electrodes implanted in the thorax. This system is much more complicated to use than current ICD systems that use transvenous conductor cable systems together with an active sheath electrode and, therefore, have no practical use. In fact, it has never been used due to the surgical difficulty of applying such a device (3 incisions), the impractical abdominal location of the generator and the poor electrical aspects of detection and defibrillation of such a system.

Recent work to improve the efficiency of ICDs has led manufacturers to produce ICDs small enough to be implanted in the chest area. In addition, advances in circuit design have allowed the housing of the ICD to form a subcutaneous electrode. Some examples of ICDs in which the ICD housing serves as an optional additional electrode are described in US Patent Nos. 5,133,353, 5,261,400, 5,620,477 and 5,658,321.

ICDs are now an established therapy for the treatment of heart rhythm disorders that can cause death, mainly ventricular fibrillation (V-fib). ICDs are very effective in the treatment of V-fib, but they are therapies that still require major surgery.

US Patent No. 5,713,926 describes a pulse generator housing for enclosing and containing the defibrillation circuits of the pulse generator. Said housing is entirely formed by an electrically conductive metal that defines an outer conductive surface of the electricity that is connected to the pulse generating circuits to release defibrillation energy to the heart. The pulse generator housing is implanted in the pectoral area near the heart with the conductive surface directed towards the heart. The areas of the conductive outer surface may be electrically isolated and dedicated to the detection and cardiac stimulation by separate shocks. The outer surface may be coated with platinum. Other electrodes of rolled segments may extend from the housing and may be electrically connected to the outer conductive surface to increase the effective area of the conductive surface. A detector is arranged to determine if the housing is inside or outside a patient's body to disconnect the conductive surface of the pulse generator from the pulse generator circuits when the unit is outside the body of a patient.

When ICD therapy becomes more prophylactic in nature and is used progressively in fewer sick people, especially children at risk of cardiac arrest, the need for an ICD therapy to use intravenous catheters and transvenous conductive wires is an impediment to very long-term management. term when most people begin to develop complications related to the malfunction of the cable system, sometimes within 5-10 years, often sooner. In addition, chronic transvenous conductive cable systems, their reimplantation and withdrawal, can damage the cardiovascular venous system and the tricuspid valve, as well as causing perforations with risk of death in the great vessels and in the heart. Therefore, the use of transvenous conductor cable systems, despite its many advantages, is not free from limitations in the treatment of chronic patients who have a life expectancy of more than 5 years. The problem of the complications of the conductor cables is even greater in children in which the growth of the body can substantially alter the function of the transvenous conductor cable and cause additional cardiovascular problems and reviews. On the other hand, transvenous ICD systems also increase the cost and require specialized intervention spaces and equipment, as well as a special ability for insertion. These systems are normally implanted by cardiac electrophysiologists who have had extensive additional training.

In addition to the background related to ICD therapy, the present invention requires a brief understanding of a related therapy, that of automatic external defibrillator (AED). The AED uses skin patch electrodes, rather than implantable conductor cable systems, to perform defibrillation under the direction of a bystander who treats a patient suffering from V-fib with a portable device that contains the necessary electronics and the power supply that allows defibrillation. AEDs can be almost as effective as an ICD for defibrillation if applied without delay to the victim of ventricular fibrillation, that is, within 2 to 3 minutes from the beginning of ventricular fibrillation.

AED therapy has great appeal as a tool to reduce the risk of death in public spaces such as a plane flight. However, an AED must be used by another person, not the one who suffers the potential fatal rhythm. It is more a public health tool than a patient-specific tool such as an ICD. Because more than 75% of cardiac arrests occur at home, and more than half occur in the bedroom, patients at risk of cardiac arrest are often alone or sleeping and cannot be helped in time with an AED . On the other hand, its success depends to a reasonable extent on an acceptable level of skill and calm of the accidental user.

Therefore, what is needed, especially for children and for long-term prophylactic use in people at risk of cardiac arrest, is a combination of the two forms of therapy that would provide rapid and almost certain defibrillation, such as an ICD, but without the long-term adverse consequences of a transvenous conductor cable system, while simultaneously using most of the simplest and lowest-cost technology of an AED. What is also needed is a cardioverter / defibrillator that has a simple design and can be comfortably implanted in a patient for many years.

Compendium of the invention

This object is achieved by means of an implantable cardioverter / defibrillator in accordance with the technical teachings of the accompanying claims.

Brief description of the drawings

For a better understanding of the invention, reference is now made to the drawings in which equal numbers represent similar objects in the figures, where:

Figure 1 is a schematic view of a Subcutaneous ICD (S-ICD);

Figure 2 is a schematic view of a subcutaneous electrode;

Figure 3 is a schematic view of a subcutaneous electrode;

Figure 4 is a schematic view of the S-ICD and the conductor cable of Figure 1 implanted subcutaneously in the thorax of a patient;

Figure 5 is a schematic view of the S-ICD and the conductor cable of Figure 2 implanted subcutaneously at an alternative location within a patient's chest;

Figure 6 is a schematic view of the S-ICD and the conductor cable of Figure 3 implanted subcutaneously in the thorax of a patient;

Figure 7 is a schematic view of the method of making a subcutaneous path from the preferred incision and the implantation point of the housing to a termination point for placing a subcutaneous electrode of the present invention;

Figure 8 is a schematic view of an introducer assembly for carrying out the conductive cable insertion method;

Figure 9 is a schematic view of an alternative S-ICD illustrating an implanted conductor cable subcutaneously and serpiginously in a patient's chest for use especially in children;

Figure 10 is a schematic view of an alternative S-ICD; Figure 11 is a schematic view of the S-ICD of Figure 10 implanted subcutaneously in the thorax of a patient;

Figure 12 is a schematic view in which the S-ICD receptacle has a shape that is especially

useful for contiguous subcutaneous placement parallel to a patient's rib; Y Figure 13 is a schematic view in which the S-ICD receptacle has a shape that is especially useful for contiguous subcutaneous placement parallel to a patient's rib;

Figure 14 is a schematic view of a Unitary Subcutaneous ICD (US-ICD); Figure 15 is a schematic view of the US-ICD implanted subcutaneously in a patient's chest; Figure 16 is a schematic view of the method of realization of a subcutaneous path from the incision

preferred for the implantation of the US-ICD; Figure 17 is a schematic view of an introducer for performing the US-ICD implantation method; Y Figure 18 is a schematic view of an exploded view with a male plug part containing

operating circuits and means for generating cardioversion / defibrillation shock waves; Figure 19 is a perspective view from above of an alternative S-ICD receptacle representing the

upper side of the receptacle housing and an electrode of the conductive cable coupled to the S- receptacle ICD; Figure 20 is a perspective view from below of an exploded view of the S-ICD receptacle of the

Figure 19 showing an electrode in the shape of a thumbnail located on the lower surface of the

receptacle housing; Figure 21 is a front elevational view of the S-ICD receptacle of Figure 19 depicting the curved receptacle housing;

Figure 22 is a partial schematic view of the S-ICD receptacle implanted subcutaneously in the thorax

of the receiving patient; Figure 23A is a top plan view of an alternative S-ICD receptacle having an end duck-shaped towards the receptacle housing at the proximal end;

Figure 23B is a top plan view of an alternative S-ICD receptacle having an end

duck-shaped with an alternative proximal head configuration; Figure 24A is a top plan view of an alternative S-ICD receptacle having a receptacle housing rectangular;

Figure 24B is a top plan view of an alternative S-ICD receptacle having a

square receptacle housing with a triangular shaped electrode; Figure 24C is a top plan view of an alternative S-ICD receptacle having a square-shaped receptacle housing with a square-shaped electrode;

Figure 25A is a top plan view of an alternative S-ICD receptacle having a

medical spatula-shaped receptacle housing; Figure 25B is a top plan view of an alternative S-ICD receptacle having a modified housing of the medical spatula shaped receptacle;

Figure 26A is a top plan view of an alternative S-ICD receptacle having a

multi-segment receptacle housing; Figure 26B is a front elevational view of the S-ICD receptacle of Figure 26A depicting the curved proximal segment and the flat distal segment of the multi-segment receptacle housing;

Figure 26C is a front elevational view of the S-ICD receptacle of Figure 26A depicting the curved proximal segment and the curved distal segment of the multi-segment receptacle housing; Y

Figure 27 is a perspective view from below of the receptacle of the US-ICD according to the invention, having an electrode of the conductor wire attached.

Detailed description of the invention

Turning now to Figure 1, the S-ICD is illustrated. The S-ICD consists of an electrically active receptacle 11 and a subcutaneous electrode 13 attached to the receptacle. The receptacle has an electrically active surface 15 that is electrically isolated from the connector block 17 of the electrode and the housing 16 of the receptacle by means of an insulating area 14. The receptacle can be similar to the numerous commercially available electrically active receptacles in which the receptacle will contain a supply via battery, a capacitor and operating circuits. Alternatively, the receptacle can be thin and elongated to fit the intercostal space. The circuits will be able to monitor the heart rhythms in case of tachycardia and defibrillation, and if it has been detected, it will start charging the condenser and then release cardioversion / defibrillation energy through the active surface of the housing and towards the subcutaneous electrode. Examples of such circuits are described in US Patent Nos. 4,693,253 and 5,105,810. Receptacle circuits can provide cardioversion / defibrillation energy of different types and waveforms. In one embodiment a biphasic waveform of 100 [mu] F of approximately 10-20 ms total duration and with an initial phase containing approximately 2/3 of the energy is used, although any type of such waveform can be used. as single phase, biphasic, multiphasic or alternative waveforms known in the art.

In addition to providing cardioversion / defibrillation energy, the circuits can also provide transthoracic cardiac pacing energy with pacemakers. Optional circuits will be able to monitor the heart for rhythms of bradycardia and / or tachycardia. Once a rhythm of bradycardia or tachycardia has been detected, the circuits can then release an appropriate cardiac pacing stimulation energy at appropriate intervals through the active surface and subcutaneous electrode. Cardiac pacemaker stimulation stimuli can be biphasic in one embodiment and similar in pulse amplitude to those used for conventional transthoracic cardiac pacing stimulation.

These same circuits can also be used to release low amplitude shocks on T waves for induction of ventricular fibrillation to test the performance of S-ICD in the treatment of V-fib as described in US Patent No. 5,129,392. The circuits may also be provided with a rapid induction of ventricular fibrillation or ventricular tachycardia using rapid cardiac stimulation with ventricular pacemakers. Another optional way to induce ventricular fibrillation would be to provide a continuous low voltage, that is, approximately 3 volts, in the heart throughout the cardiac cycle.

Another optional aspect is that the operating circuits can detect the presence of atrial fibrillation described in Olson, W. et al. "Onset and stability for ventricular tachyarrhytmia detection in an implantable cardioverter and defibrillator", Computers in cardiology (1986) pp. 167-170. Detection can be provided by means of R-R cycle length instability detection algorithms. Once atrial fibrillation is detected, the operating circuits then provide a QRS synchronized atrial defibrillation / cardioversion that uses the same shock energy and waveform characteristics used for atrial defibrillation / cardioversion.

The detection circuits will use the electronic signals generated from the heart and will mainly detect the QRS waves. In one embodiment the circuits will be programmed to detect only tachycardia or ventricular fibrillation. The detection circuits use in their most direct form a speed detection algorithm that starts the capacitor charge once the ventricular rate exceeds a predetermined level for a fixed period of time: for example, if the ventricular velocity exceeds 240 bpm on average for more than 4 seconds. Once the capacitor is charged, a rhythm confirmation check would ensure that the rate persists for at least another second before discharge. Similarly, termination algorithms can be established to ensure that a rate of less than 240 bpm persists for at least 4 seconds before the capacitor charge is brought to an internal resistance. The detection, confirmation and termination algorithms described above and in the art can be modulated to increase sensitivity and specificity by examining the QRS beat-to-beat uniformity, the QRS signal frequency content, the stability data of the RR interval, and signal amplitude characteristics, all or part of which can be used to increase or decrease the sensitivity and specificity of the S-ICD arrhythmia detection function.

In addition to the use of detection circuits for the detection of V-Fib or V-Tach by examining QRS waves, the detection circuits can check the presence or absence of breathing. The respiration rate can be detected by monitoring the impedance through the thorax using currents below the threshold released through the active sheath and the electrode of the high-voltage subcutaneous conductive cables and monitoring the frequency in the undulation of the form of wave resulting from undulations of transthoracic impedance during the respiratory cycle. If there is no undulation, then the patient does not breathe, and this shortness of breath can be used to confirm the QRS symptoms of cardiac arrest. The same technique can be used to provide information on the respiratory rate or estimated cardiac output described in US Patent Nos. 6,095,987, 5,423,326, 4,450,527.

The receptacle may be made of a titanium alloy or other currently preferred electrically active receptacle designs. However, it has been contemplated that a malleable receptacle that can be adapted to the curvature of the patient's chest is preferred. In this way the patient can have a comfortable receptacle that adapts to the shape of the patient's rib cage. Examples of adapted receptacles are provided in US Patent No. 5,645,586. Therefore, the receptacle can be made of numerous materials such as plastics, metals and medical grade alloys. In the preferred embodiment, the receptacle has a volume of less than 60 cc with a weight of less than 100 g for long-term wear resistance, especially in children. The container and the lead wire of the S-ICD can also be fractal or wrinkled surfaces in order to increase the surface area to improve defibrillation capacity. Due to the main role of prevention of therapy and the probable need to reach energies greater than 40 joules, one characteristic of one embodiment is that the charging time for therapy has been left on purpose relatively long to allow the condenser to charge inside of device size limitations. Examples of small ICD housings are described in US Patent Nos. 5,597,956 and 5,405,363.

Different subcutaneous electrodes are illustrated in Figures 1-3. Turning back to Figure 1, the conductive cable 21 of the subcutaneous electrode is preferably composed of a silicone or polyurethane insulation. The electrode is connected to the receptacle at its proximal end through a connection port 19 that is located in an electrically isolated area 17 of the receptacle. The illustrated electrode is an electrode composed of three different electrodes attached to the conductor cable. In the illustrated embodiment, an optional anchor segment 52 is attached at the most distal end of the subcutaneous electrode to anchor the electrode in the soft tissue so that the electrode does not leave its site after implantation.

The most distal electrode of the composite subcutaneous electrode is a coiled electrode 27 that is used to release high-voltage cardioversion / defibrillation energy to the heart. The coiled cardioversion / defibrillation electrode is approximately 5-10 cm long. Near the wound electrode are two detector electrodes, a first detector electrode 25 is located proximally to the wound electrode, and a second detector electrode 23 is located proximally to the first detector electrode. The detector electrodes are separated enough to have a good QRS detection. This separation can range from 1 to 10 cm, a separation of 4 cm being currently preferable. The electrodes may or may not be circumferential with the preferred embodiment. Having non-circumferential electrodes and placed outward towards the surface of the skin is a means to minimize the muscle mechanism and improve the quality of the QRS signal. The sensing electrodes are electrically isolated from the cardioversion / defibrillation electrode by means of the insulating zones 29. Similarly, the types of cardioversion / defibrillation electrodes are currently commercially available in a transvenous configuration. For example, US Patent No. 5,534,022 describes an electrode consisting of a rolled cardioversion / defibrillation electrode and sensing electrodes. Modifications to this provision are considered. One such modification is illustrated in Figure 2, in which the two sensing electrodes 25 and 23 are non-circumferential sensing electrodes and one is located at the distal end, the other is located proximal to it with the wound electrode located between the Two detector electrodes. In this embodiment, about 6 to about 12 cm are separated depending on the length of the coil electrode used. Figure 3 illustrates a further embodiment in which the two sensing electrodes are located at the distal end of the composite electrode with the wound electrode located next to it. For example, there are other possibilities that have only one detector electrode, either proximal or distal to the wound cardioversion / defibrillation electrode, with the winding that serves as the detection electrode and a cardioversion / defibrillation electrode.

It has also been considered that the detection of QRS waves (and transthoracic impedance) can be carried out by means of detecting electrodes in the receptacle housing or in combination with the coiled cardioversion / defibrillation electrode and / or the conductive cable detector electrode (s) subcutaneous. In this way, the detection could be carried out by means of a rolled electrode located in the subcutaneous electrode and of the active surface in the receptacle housing. Another possibility would be to have only one detector electrode located in the subcutaneous electrode, and the detection would be performed by that electrode and the electrode wound in the subcutaneous electrode or by the active surface of the receptacle. The use of sensing electrodes in the receptacle would eliminate the need for sensing electrodes in the subcutaneous electrode. It has also been considered that the subcutaneous electrode is provided with at least one sensing electrode, the receptacle with at least one sensing electrode and, if several sensing electrodes are used, in the subcutaneous electrode and / or in the receptacle, for identifying the Better combination of QRS wave detection when the S-ICD is implanted and this combination can be selected, which activates the best detection arrangement of all existing detection possibilities. Returning again to Figure 2, two sensing electrodes 26 and 28 are located on the electrically active surface 15 with electrical insulating rings 30 located between the sensing electrodes and the active surface. These receptacle sensing electrodes could be disconnected and electrically isolated during, and for a short period of time after, the release of the defibrillation / cardioversion shock. The detection electrodes of the receptacle can also be located on the electrically inactive surface of the receptacle. In the embodiment of Figure 2 there are effectively four sensing electrodes, two in the subcutaneous conductor cable and two in the receptacle. In the preferred embodiment, the ability to change the electrodes used for detection is a programmable feature of the S-ICD to adapt to changes in the physiology and size (in the case of children) of the patient over time. Programming can be done by using physical switches in the receptacle, or as currently preferred, by using a programming stylus

or through a wireless connection to program the circuits inside the receptacle.

The receptacle can be used as a cathode or an anode of the cardioversion / defibrillation system of the S-ICD. If the receptacle is the cathode, then the subcutaneous wound electrode is the anode. Likewise, if the receptacle is the anode, then the subcutaneous electrode would be the cathode.

The active receptacle housing provides intermediate power and voltage to those available with ICDs and most AEDs. The typical maximum voltage required for ICDs that use the most biphasic waves is approximately 750 volts with an associated maximum energy of approximately 40 joules. The typical maximum voltage required for AEDs is approximately 2,000-5,000 volts with an associated maximum energy of approximately 200-360 joules depending on the model and waveform used. The S-ICD and the US-ICD of the present invention use maximum voltages in the range of about 50 to about 3,500 volts and associated with energies of about 5 to about 350 joules. The capacitance of the devices may be in the range of about 25 to about 200 microfarads.

In another embodiment, the S-ICD and US-ICD devices provide power with a pulse width of about one millisecond to about 40 milliseconds. The devices can provide a cardiac stimulation current with pacemakers from about one milliampere to about 250 milliamps.

The detection circuits contained within the receptacle are very sensitive and specific for the presence or absence of ventricular arrhythmias with mortal risk. The characteristics of the sn programmable detection algorithm and the algorithm are focused on the detection of high-speed V-FIB and V-TACH (> 240 bpm). Although S-ICD can rarely be used for a real case of fatal risk, simplicity of design and implementation allow it to be used in large populations of low-risk patients at low cost by non-cardiologist electrophysiologists. Therefore, the S-ICD focuses mainly on the detection and therapy of the most malignant rhythm disorders. As part of the applicability of the screening algorithm to children, the upper rate range is programmable upwards for use in children, known for having rapid supraventicular tachycardia and faster ventricular fibrillation. The energy levels are also programmable downwards in order to allow the treatment of neonates and children.

Turning now to Figure 4, the optimal subcutaneous situation of the S-ICD is illustrated. As would be evident to a person skilled in the art, the real situation of the S-ICD is in a subcutaneous space that has developed during the implantation process. The heart is not exposed during this process and the heart is schematically illustrated in the figures only to aid in the understanding where the receptacle and the wound electrode are located three-dimensionally in the left middle clavicular line approximately at the level of the inframammary fold at approximately the 5th. rib. The conductive cable 21 of the subcutaneous electrode passes through a subcutaneous path around the thorax ending with its end of the distal electrode in the posterior axillary line ideally just lateral to the left scapula. In this way, the receptacle and the subcutaneous cardioversion / defibrillation electrode provide a reasonably good path for the release of current to most of the ventricular myocardium.

Figure 5 illustrates a different placement. The receptacle of the S-ICD with the active housing is located in the approximately posterior left axillary line of the tip of the lower part of the scapula. This placement is especially useful in children. The conductive cable 21 of the subcutaneous electrode passes through a subcutaneous path around the thorax ending with its distal end of the electrode in the anterior precordial area, ideally in the inframammary fold. Figure 6 illustrates the embodiment of Figure 1 implanted subcutaneously in the thorax with the proximal sensing electrodes 23 and 25 located in approximately the left axillary line with the cardioversion / defibrillation electrode just lateral to the tip of the lower part of the scapula.

Figure 7 schematically illustrates the method for implantation of the S-ICD. An incision 31 is made in the left anterior axillary line approximately at the level of the cardiac apex. This placement of the incision is different from that chosen for the placement of the S-ICD, and is specifically selected to allow the placement of the receptacle to be more in the middle in the left inframammary fold and the placement of the conductive cables more later by means of the introducer assembly (described below) around the lateral left posterior axillary line of the left scapula. That is, the incision can be anywhere in the chest that the doctor who implants it considers reasonable, although in the preferred embodiment, the S-ICD will be applied in this area. A subcutaneous path 33 is then created in the middle of the inframammary fold for the receptacle and posterior to the lateral left posterior axillary line of the left scapula for the lead wire.

The S-ICD 11 receptacle is then subcutaneously placed at the site of the incision or in the middle in the subcutaneous area in the left inframammary fold. The subcutaneous electrode 13 is placed with a specially designed curved introducer assembly 40 (see Figure 8). The introducer assembly comprises a curved trocar 42 and a removable rigid curved sheath 44. Said removable sheath is curved to facilitate its placement around the patient's rib cage in the subcutaneous space created by the trocar. The sheath must be rigid enough to facilitate the placement of the electrodes without the sheath sinking or bending. Preferably the sheath is made of a biocompatible plastic material and is perforated along its axial length to facilitate splitting it into two sections. The trocar has a proximal handle 41 and a curved shaft

43. The distal end 45 of the trocar is narrowed to allow dissection of a subcutaneous path 33 in the patient. Preferably, the trocar is provided with a cannula having a central light 46 and terminates in an opening 48 at the distal end. Local anesthesia, such as lidocaine, can be administered, if necessary, through the lumen or through a curved and elongated needle designed to anesthetize the path to be used for trocar insertion, if not General anesthesia is used. The removable curved sheath 44 has a pull tab 49 to break the sheath into two halves along its axial axis 47. The sheath is placed on a guide wire inserted through the trocar after the subcutaneous path has been created. This subcutaneous path is then developed until it ends subcutaneously in a place that, if a vertical line were drawn from the place of the receptacle until the end of the path, the line would intersect a substantial part of the patient's left ventricular mass. Then the guide wire is removed leaving the sheath removable. The subcutaneous conductor cable system is then inserted through the sheath until it is in the proper place. Once the subcutaneous conductor cable system is in the proper place, the sheath is divided into halves by the pull tab 49 and removed. If more than one subcutaneous electrode is being used, a new removable curved sheath can be used for each subcutaneous electrode.

The S-ICD will have prophylactic use in adults in which the conductive cable systems of the chronic transvenous / epicardial ICD mean excessive risk or have had problems, such as aseptic or fractured conductor cable. It has also been considered that greater use of the S-ICD system will be for prophylactic use in children who are at risk of fatal arrhythmias, in which chronic transvenous conductor cable systems represent significant treatment problems. Additionally, with the use of normal transvenous ICDs in children, problems develop during patient growth because the conductive cable system does not adapt to growth. Figure 9 illustrates the placement of the S-ICD subcutaneous conductor cable system, which overcomes the problem that growth presents to the conductor cable system. The distal end of the subcutaneous electrode is located in the same place described above which provides a good place for the coiled cardioversion / defibrillation electrode 27 and the sensing electrodes 23 and 25. However, the insulated conductor cable 21 is no longer placed in A known configuration. Instead, the conductive cable is serpiginously placed with an introducer trocar and a sheath specially designed to have numerous waves or curves. As the child grows, the waves or curves become straight, which lengthens the conductor cable system while maintaining the proper electrode position. Although it is expected that the fibrous scar, especially around the defibrillation curl, helps anchor it in position to maintain its posterior position during growth, a conductive cable system with a distal tip or anchoring system 52 with electrode screw can also be incorporated into the distal tip to facilitate the stability of the conductor cable (see Figure 1). Other anchoring systems such as hooks, sutures, or the like can also be used.

Figures 10 and 11 illustrate another embodiment. In this embodiment there are two subcutaneous electrodes 13 and 13 ′ of polarity opposite to that of the receptacle. The additional subcutaneous electrode 13 'is essentially identical to the previously described electrode. In this embodiment the cardioversion / defibrillation energy is released between the active surface of the receptacle and the two wound electrodes 27 and 27 ’. Additionally, means are provided in the receptacle for selecting the optimum detection arrangement among the four detection electrodes 23, 23 ′, 25 and 25 ’. The two electrodes are subcutaneously placed on the same side of the heart. As illustrated in Figure 6, one subcutaneous electrode 13 is located inferiorly and the other electrode 13 'is located superiorly. It has also been considered with this dual subcutaneous electrode system that the receptacle and a subcutaneous electrode have the same polarity, and the other subcutaneous electrode has an opposite polarity.

Turning now to Figures 12 and 13, they illustrate additional embodiments in which the receptacle 11 of the S-ICD has a shape that is particularly useful for placing it subcutaneously contiguous and parallel to a patient's rib. The receptacle is long, thin and curved to fit the shape of the patient's rib. In the embodiment illustrated in Figure 12, the receptacle has a diameter between about 0.5 cm and about 2 cm, with 1 cm currently being preferred. Alternatively, instead of having a straight circular section, the receptacle could have a rectangular or square straight section as illustrated in Figure 13. The length of the receptacle may vary depending on the size of the patient's chest. In one embodiment, the receptacle has a length of about 5 cm to about 40 cm. The receptacle is curved to adapt to the curvature of the ribs of the thorax. The radius of curvature varies depending on the size of the patient, with smaller radii for smaller patients and larger radii for older patients. The radius of curvature can be between about 5 cm and about 35 cm depending on the size of the patient. Additionally, the radius of curvature does not need to be uniform throughout the receptacle, so that it can have a shape closer to that of the ribs. The receptacle may have an active surface 15 that is located on the inside (concave) part of the curvature and an inactive surface 16 that is located on the outside (convex) part of the curvature. The conductive cables of these embodiments, which are not illustrated except for the junction port 19 and the proximal end of the conductive cable 21, can be any of the previously described conductive cables, the conductive cable illustrated in Figure 1 being currently preferred.

The circuits of this receptacle are similar to the circuits described above. Additionally, the receptacle may optionally have at least one detector electrode located on the active surface or the inactive surface, and the circuits within the receptacle can be programmable as described above to facilitate the selection of the best detection electrodes. It is currently preferred that the receptacle has two sensing electrodes 26 and 28 located on the inactive surface of the illustrated receptacles, wherein the electrodes are approximately 1 to 10 cm apart, with a separation of approximately 3 cm currently preferred. However, the detection electrodes may be located on the active surface as described above.

It is envisioned that the embodiment of Figure 12 will be implanted subcutaneously contiguous and parallel to the 5th left anterior rib either between the 4th and 5th ribs or between the 5th and 6th ribs. Other places can also be used.

Another component of the S-ICD is a skin test electrode system designed to stimulate the high voltage subcutaneous shock electrode system as well as the QRS heart rate detection system. This test electrode system is composed of a skin patch electrode with a surface area and an impedance similar to that of the S-ICD receptacle together with a cutaneous strip electrode comprising a defibrillation strip as well as two button electrodes for QRS detection. Several cutaneous strip electrodes are available to facilitate the testing of several bipolar separations to optimize signal detection comparable to the implantable system.

Figures 14 to 18 represent particular embodiments of the US-ICD. The various cardiac pacemaker detection, shock and stimulation circuits, described above in detail with respect to the S-ICD embodiments, may be further incorporated into the following embodiments of the US-ICD. In addition, the particular aspects of any individual S-ICD embodiment discussed above can be incorporated in whole or in part in the embodiments depicted in the following figures.

Turning now to Figure 14, it illustrates the US-ICD. The US-ICD consists of a 1211 curved housing with first and second ends. The first end 1413 is thicker than the second end 1215. This thicker area houses a supply via battery, a capacitor and operating circuits of the US-ICD. The circuits can monitor the heart rhythms in case of tachycardia and fibrillation and, if detected, start the condenser charge and then release the cardioversion / defibrillation energy through two cardioversion / defibrillation electrodes 1417 and 1219 located on the outer surface of the two ends of the housing. The circuits can provide cardioversion / defibrillation energy with different types of waveforms. In one embodiment a biphasic waveform of 100 [mu] F of approximately 10-20 ms total duration and with an initial phase containing approximately 2/3 of the energy is used, although any type of such waveform can be used. as monophasic, biphasic, multiphasic or alternative waveforms, as is known in the art.

The housing may be made of a titanium alloy or other currently preferred ICD designs. It has been considered that the housing is also made of plastic materials that electronically isolate the electrodes from each other. However, a malleable receptacle that can be adapted to the curvature of the patient's chest has been considered to be preferred. In this way the patient can have a comfortable receptacle that adapts to the unique shape of the patient's rib cage. Examples of adaptable ICD housings are provided in US Patent No. 5,645,586. In the preferred embodiment the housing is curved in the shape of a 5th rib of a person. Because there are many different sizes of people the accommodation will come with different sizes that increase progressively to allow a good match between the size of the ribcage and the size of the US-ICD. The length of the US-ICD is between about 15 and about 50 cm. Because the main preventive role of therapy and the need to achieve energies greater than 40 joules, a characteristic of the preferred embodiment is that the charging time for therapy is deliberately long to allow the condenser to charge within the limitations of device size

The thick end of the housing is currently necessary to facilitate the placement of the supply by battery, operating circuits, and capacitors. It has been considered that the thick end will be between 0.5 cm and approximately 2 cm in width, with a width of approximately 1 cm being currently preferred. As the microtechnology progresses the thickness of the housing will be less.

The two cardioversion / defibrillation electrodes in the housing are used to release high-voltage cardioversion / defibrillation energy through the heart. In the preferred embodiment the cardioversion / defibrillation electrodes are wound electrodes, although other cardioversion / defibrillation electrodes such as those with electrically insulated active surfaces or platinum alloy electrodes can also be used. The cardioversion / defibrillation electrodes are approximately 5-10 cm long. Located in the housing between the two cardioversion / defibrillation electrodes are two detection electrodes 1425 and 1427. The detection electrodes are sufficiently separated to have a good QRS detection. This separation can range from 1 to 10 cm, with 4 cm currently being preferred. The electrodes may or may not be circumferential with the preferred embodiment. The electrodes may or may not be circumferential with the preferred embodiment. The electrodes may or may not be circumferential with the preferred embodiment. Being non-circumferential electrodes and placed outward, towards the surface of the skin, is a means to minimize the muscle mechanism and improve the quality of the QRS signal. The sensing electrodes are electrically isolated from the cardioversion / defibrillation electrode by means of the insulating areas 1423. Analog types of cardioversion / defibrillation electrodes are now commercially available in a transvenous configuration. For example, US Patent No. 5,534,022 describes an electrode consisting of a cardioversion / defibrillation electrode and detection electrodes. Modifications to this provision are being considered. One modification is to have the detection electrodes at both ends of the housing and have the cardioversion / defibrillation electrodes located between the detection electrodes. Another modification is to have three or more separate detection electrodes throughout the housing and facilitate the selection of the two best detector electrodes. If three or more sensing electrodes are used, then the ability to change which electrodes are to be used for detection is a programmable feature of the US-ICD to adapt to changes in the physiology and size of the patient over time. Programming could be done through the use of physical switches in the receptacle, or as currently preferred, through the use of a programming stylus or via a wireless connection to program the circuits inside the receptacle.

Turning now to Figure 15, it illustrates the optimal subcutaneous placement of the US-ICD. As is evident to a person skilled in the art, the real situation of the US-ICD is a subcutaneous space that develops during the implantation process. The heart is not exposed during this process and the heart is schematically illustrated in the figures only as an aid to its understanding, where the device and its various electrodes are three-dimensionally located in the patient's chest. The US-ICD is located between the left middle clavicular line approximately at the level of the inframammary fold in approximately the 5th rib and the posterior axillary line, ideally just lateral to the left scapula. In this way the US-ICD provides a reasonably good path for the release of current to most of the ventricular myocardium.

Figure 16 schematically illustrates the method for the implantation of the US-ICD. A 1631 incision is made in the left anterior axillary line approximately at the level of the cardiac apex. Subsequently, a subcutaneous path is created that extends later to allow the placement of the US-ICD. The incision can be anywhere in the chest considered reasonable by the doctor who implants it, although in the preferred embodiment, the US-ICD of the present invention will be applied in this area. The subcutaneous path is created in the center of the inframammary fold and subsequently extends to the left posterior axillary line. The road is developed with a specially designed curved introducer 1742 (see Figure 17). The trocar has a proximal handle 1641 and a curved shaft 1643. The distal end 1745 of the trocar is narrowed to facilitate dissection of a subcutaneous path in the patient. Preferably, the trocar is provided with a cannula having a central light 1746 and ending in an opening 1748 at the distal end. Local anesthesia, such as lidocaine, can be released, if necessary, through the lumen or through a curved and elongated needle designed to anesthetize the path to be used for trocar insertion, in case it is not use general anesthesia. Once the subcutaneous path has developed, the US-ICD implanted in the subcutaneous space, the incision in the skin is closed using normal techniques.

As described above, the US-ICD varies in length and curvature. US-ICDs are provided in sizes that progressively increase for subcutaneous implantation in patients of different sizes. Turning now to Figure 18, a different exploded view is shown schematically illustrated that provides US-ICDs of different size that are easier to manufacture. US-ICDs of different sizes will all have a 1413 thick end with the same size and shape. The thick end is hollow inside to facilitate the insertion of an operative central member 1853. The central member comprises a housing 1857 containing the supply by battery, the capacitor and the operating circuits of the US-ICD. The proximal end of the central member has a plurality of electronic male plug connectors. The male plug connectors 1862 and 1863 are electronically connected to the detection electrodes by means of pressure adjustment connectors (not shown) within the thick end, which are normal in the art. The male plug connectors 1865 and 1867 are also electronically connected to the electrodes of the cardioverter / defibrillator by means of pressure adjustment connectors inside the thick end. The distal end of the central element comprises an end cap 1855, and a ribbed joint 1859 that creates a water tight joint when the central element is inserted into the opening 1851 of the thick end of the US-ICD.

The S-ICD and the US-ICD, in alternative embodiments, have the ability to detect and treat atrial rhythmic disorders, which include atrial fibrillation. The S-ICD and the US-ICD have two or more electrodes that provide a distant field view of the cardiac electrical activity that includes the ability to record the P wave of the electrocardiogram as well as the QRS. One can detect the onset and termination of atrial fibrillation by referring to the P wave recorded during the sinusoidal rhythm and monitoring its change in speed, morphology, amplitude and frequency content. For example, a well-defined P wave that disappeared abruptly and was replaced by a low amplitude signal, of variable morphology would be a very clear indication of the absence of sinusoidal rhythm and the beginning of atrial fibrillation. In an alternative embodiment of a detection algorithm, the ventricular detection rate could be monitored for stability of the R-R coupling interval. In examining the sequence of R-R intervals, atrial fibrillation can be recognized by providing an irregularly irregular coupling interval on a beat-by-beat basis. A graph of R-R intervals during AF seems "like a cloud" in appearance when several hundreds or thousands of R-R intervals are drawn over time when compared to sinusoidal rhythm or other supraventricular arrhythmias. In addition, a distinctive feature compared to other rhythms that are irregularly irregular is that the QRS morphology is similar on a beat-to-beat basis despite the irregularity in the R-R coupling interval. This is a distinctive feature of atrial fibrillation compared to ventricular fibrillation when QRS morphology varies on a beat-to-beat basis. In yet another embodiment, atrial fibrillation can be detected by seeking to compare the timing and amplitude relationship of the detected P wave of the electrocardiogram with the detected QRS (R wave) of the electrocardiogram. The normal sinusoidal rhythm has a fixed relationship that can be placed in a template matching algorithm that can be used as a reference point if the relationship changes.

In other aspects of the atrial fibrillation detection process one can include alternative electrodes that can be carried to support the S-ICD or US-ICD systems either by placing them in the detection algorithm circuits by means of a programming maneuver or by manually adding such electrode systems additional to the S-ICD or US-ICD at the time of implantation or at the time of subsequent evaluation. Electrodes can also be used for the detection of atrial fibrillation that may or may not be used for the detection of ventricular arrhythmias, which may or may not be used for the detection of ventricular arrhythmias given the different anatomical locations of the atria and ventricles. with respect to the accommodation of the S-ICD or the US-ICD and the places of surgical implantation.

Once atrial fibrillation is detected, arrhythmia can be treated by releasing a synchronized shock that uses energy levels up to a maximum performance of therapy with the device to terminate atrial fibrillation or for other supraventricular arrhythmias. The S-ICD or US-ICD electrode system can be used to treat atrial and ventricular arrhythmias not only with shock therapy but also with cardiac pacemaker stimulation therapy. In a subsequent embodiment of the treatment of atrial fibrillation or other atrial arrhythmias, it may be possible to use different electrode systems than are used to examine ventricular arrhythmias. Another embodiment would be to facilitate different types of therapies (amplitude, waveform, capacitance, etc.) of atrial arrhythmias compared to ventricular arrhythmias.

The central member of the US-ICD of different shape and size will be the same size and shape. Thus, during implantation procedures, US-ICDs of many sizes may be available for implantation, each without a central member. Once the implantation procedure is performed, then the correct size US-ICD can be selected and the central member can be inserted into the US-ICD and then programmed as described above. Another advantage of this configuration is that when the battery inside the central member needs to be replaced, it can be done without removing the entire US-ICD.

Figures 19-27 generally refer to alternative embodiments of the S-ICD / US-ICD receptacle. Although the following designs, the various material structures, dimensions and curvatures of the receptacle, which are discussed in detail below, can be incorporated into the embodiments of S-ICD or US-ICD receptacles, hereafter will only be discussed with respect to S-ICDs.

The receptacles illustrated in these figures have a configuration that can 1) help the initial implantation of the receptacle; 2) limit the movement of the receptacle once properly placed; 3) create a set of energy focused coherently towards the heart of the recipient with less expense in other areas of the thorax; 4) facilitate a good reception of the signal from the heart by an S-ICD system; or 5) provide significant long-term comfort and duration to a broad spectrum of patients with different sizes and shapes of the chest. More particularly, Figures 19-27 detail different structures, dimensions and curvatures of the material that are incorporated into the numerous S-ICD receptacle designs detailed in Figures 19-27.

Referring now to particular embodiments, Figure 19 depicts a receptacle 190 of the S-ICD. The receptacle housing 190 of the S-ICD comprises a hermetically sealed housing 192 enclosing the electronics of the receptacle 190 of the S-ICD. As with the previously described S-ICD devices, the electronics of the present embodiment include, at a minimum, a battery supply, a capacitor and operating circuits. Figure 19 also represents an electrode 191 of the conductor cable coupled to the housing of the receptacle through a conductor cable 193. A dorsal fin 197 can be arranged on the electrode 191 of the conductor cable 191 to facilitate placement of the electrode of the conductor cable.

The devices of the S-ICD provide an energy (electric field strength (V / cm), a current density (A / cm2), a voltage gradient (V / cm) or other measured unit of energy) of the heart of a patient. S-ICD devices will generally use voltages in the range of 700 V to 3,150 V, which require energies of approximately 40 J to 210 J. These energy needs will vary, however, depending on the form of treatment, the proximity of the receptacle of the patient's heart, of the electrode relationships of the S-ICD receptacle to the lead wire electrode, of the nature of the underlying disease of the patient's heart, of the specific cardiac disorder being treated, and of the ability to overcome the diversion of the electrical expenditure of the S-ICD to other thoracic tissues.

Ideally, the energy emitted from the S-ICD device will be directed to the patient's anterior mediastinum, through most of the heart, and out towards the electrode of the coupled conductive cable located in posterolateral and / or lateral thoracic locations. It is also convenient that the receptacle 190 of the S-ICD be able to release this directed energy, as a general rule, at an effective field strength of about 3-5 V / cm to about 90% of a patient's ventricular myocardium by A biphasic waveform. This effective field strength released would be adequate for defibrillation of the patient's heart.

Higher energy needs require additional or alternatively additional batteries and capacitors. The last of these two options is often the most convenient in order to reduce the total depth of the resulting receptacle 190 of the S-ICD. However, by increasing the number of batteries and capacitors, the length and possibly the depth of the receptacle 190 of the S-ICD will be increased. Therefore, numerous S-ICD devices of varying depth, widths and lengths are manufactured to accommodate the particular energy needs of a variety of recipient patients. For example, an overweight male adult may require a larger and more bulky S-ICD receptacle 190 than that of a small child. In particular, the young child is generally less, has a relatively low resistance to current flow and contains a body mass that deflects the current than that of an overweight male adult. As a consequence, the energy required to apply effective therapy to the heart of the young child can be considerably less than for the overweight male adult, and therefore the young child can use a smaller and more compact S-ICD receptacle 190. In addition, one may find that individuals, despite an equivalent body size, may have different therapy requirements due to differences in their underlying heart disease. This may allow some patients to receive a smaller receptacle compared to those of other patients of equal body size but with a different type of heart disease.

The space requirements of a resulting receptacle 190 also depend on the type of operating circuits used inside the device. The receptacle 190 of the S-ICD can be programmed to monitor the heart rhythms in case of tachycardia and fibrillation, and if detected, the charge of the condenser or condensers will be initiated to release the appropriate cardioversion / defibrillation energy. Examples of such circuits are described in US Patent Nos. 4,693,253 and 5,105,810. The receptacle 190 of the S-ICD may additionally be provided with operating circuits for transthoracic cardiac pacing with pacemakers. These optional circuits monitor the heart in case of rhythms of bradycardia and / or tachycardia. In the event that a rhythm of bradycardia or tachycardia is detected, the operating circuits release the stimulation energy with appropriate pacemakers at appropriate intervals to treat the disorder.

In other embodiments, the operating circuits may be: 1) programmed to release low amplitude shocks on the T wave for induction of ventricular fibrillation to examine the functioning of the S-ICD receptacle; 2) programmed for rapid ventricular pacing with pacemakers to induce or terminate tachyarrhythmia; 3) programmed to detect the presence of atrial fibrillation; and / or 4) programmed to detect ventricular fibrillation or ventricular tachycardia by examining QRS waves; all of which are described above in detail. Additional operating circuits, which are known in the art of detection, cardiac stimulation by shock and cardiac stimulation with pacemakers, are hereby further incorporated.

The main function of the receptacle housing 192 is to provide a protective barrier between the electrical components within their limits and the surrounding environment. Therefore, the receptacle housing 192 must be of sufficient hardness to protect its contents. Materials that have this hardness can be numerous suitable biocompatible materials such as plastics, ceramics, metals and medical grade alloys. Although materials having such hardnesses are generally rigid, in particular embodiments it is convenient to use materials that are flexible or deformable. More specifically, it is convenient that the housing 192 of the receptacle be able to partially flex in its general shape without fracturing.

Deformable receptacle housings 192 often provide greater comfort when implanted in recipient patients. The receptacles 190 of the S-ICD formed with such materials allow a limited, but important, flexion of the housing 192 of the receptacle with certain thoracic movements. Examples of allowable push-ups are those that are applied to the housing 192 of the receptacle by the surrounding muscle tissue. The use of a deformable receptacle housing is particularly beneficial in embodiments of a receptacle housing that extends over a significant part of a patient's chest. The deformable material in this embodiment may comprise a part of the receptacle housing, or alternatively, may comprise the receptacle housing in its entirety. The selection of the correct material (or a combination of it), therefore, is useful for the elimination of the sensation of the device by the patient and an improvement of the long-term wear resistance of the implanted device.

The materials selected for housing 192 of the receptacle should also be able to be sterilized. Commercial sterilization processes often involve exposure to high temperatures and pressures

or to chemical treatments. Therefore, it is important that the materials used in the formation of the receptacle housing are capable of withstanding such exposures without degrading or in any case compromising their total integrity.

Polymeric materials suitable for housing 192 of the receptacle include polyurethanes, polyamides, polyetheretherketones (PEEK), polyether block amides (PEBA), polytetrafluoroethylene (PTFE), silicones, and mixtures thereof. Ceramic materials suitable for housing 192 of the receptacle include ceramic products with zirconium and ceramic products based on aluminum. Suitable metal materials for housing 192 of the receptacle of the present invention include stainless steel and titanium. Alloys suitable for housing 192 of the receptacle include steel alloys and titanium alloys such as nickel titanium. In certain embodiments, classes of materials can be combined to form housing 192 of the receptacle. For example, a non-conductive polymeric coating, such as parylene, can be selectively applied to a surface of the housing 192 of a titanium alloy receptacle in order to allow only a specific surface area such as that of the lower surface of the distal end in duckbill to receive signals and / or apply a therapy.

In general, it is convenient to keep the size of the housing 192 of the S-ICD receptacle below a total volume of approximately 50 cubic centimeters. In alternative embodiments it is convenient to keep the size of the housing 192 of the S-ICD receptacle below a total volume of approximately 100 cubic centimeters. In another alternative embodiment it is convenient to keep the size of the housing 192 of the S-ICD receptacle below a total volume of approximately 120 cubic centimeters.

On the other hand, it is also convenient to keep the total weight of the S-ICD receptacle 190, as a whole (which includes the receptacle housing, operating circuits, capacitors and batteries) below approximately 50 grams. In alternative embodiments it is convenient to keep the total weight of the S-ICD receptacle 190 below approximately 100 grams. In other alternative embodiments it is convenient to keep the total weight of the S-ICD receptacle 190 below approximately 150 grams.

The maintenance of weight and size within the parameters identified above is essential for patient comfort depending on the shape of the device. The implantation of a receptacle 190 of the S-ICD is a long-term solution for cardiac dysfunctions, and as such, the ideal solution would be to remain in the patient until the batteries of the device need to be replaced or that an alternative therapy eventually requires their withdrawal. Consequently, a considerable amount of engineering work is dedicated to minimizing the discomfort associated with the installed device.

Weight and size considerations are especially important for younger recipient patients. Children with ICDs are more likely to be aware of any additional weight or volume associated with heavier and / or larger devices. The present invention overcomes these problems by designing an S-ICD receptacle 190 that takes into account the problems of these smaller recipient patients. For example, lighter materials can be used to minimize the discomfort associated with heavier materials. In addition, the receptacle 190 of the S-ICD (length, width and depth) in its entirety, or only a part thereof, can be modified in order to adapt to the different sizes of the receiving patients. For example, the shape of the housing 192 of the S-ICD receptacle can also be achieved in a variety of anatomical configurations to better ensure comfort and operation in young children or in younger adults, throughout the life of their receptacles 190 of the S-ICD. In order to adapt to certain patients, a physician may subsequently place the receptacle 190 with the lead wire electrode previously placed in the patient's body, contrary to the usual placement of the receptacle 190. This placement of the receptacle 190 is particularly useful when It is implanted in very young children. Such placement of receptacle 190 generally optimizes the comfort of small receivers. In addition, the shape of the receptacle 190 can be specifically modified to fit a female thorax, where the breast tissue can alter the demands of comfort and functioning.

Referring now to specific parts of the receptacle 192 of the receptacle, Figure 19 depicts a receptacle 192 of the receptacle having an upper surface 194, a lower surface 196, and surrounding sides 198 connecting these two surfaces. The housing 192 of the S-ICD receptacle shown in Figure 19 further includes a distal end 200 and a proximal end 202. In particular embodiments of the receptacle housing, the receptacle housing 192 may lack a proximal end and a distal end .

The upper surface 194 of the housing 192 of the receptacle is generally smooth and without accessories or openings. The smooth upper surface 194 allows the receptacle 190 of the S-ICD to advance effortlessly through the subcutaneous tissues during an implantation procedure. The smoothing of the upper surface reduces the friction coefficient of the receptacle 190 of the S-ICD. Such measures reduce abrasion and also reduce inflammation associated with insertion and advancement of the device. The advantages of a reduction in surface friction also continue after implantation through a significant reduction in inflammation and pain, giving a general feeling of wear resistance and comfort.

In alternative embodiments, the upper surface 194 of the receptacle housing 192 may include one or more openings, detectors, electrodes, accessories, or a combination thereof. The openings in the upper surface 194 of the receptacle housing 192 are generally in the form of a connection port 203, or of several connection ports, for coupling auxiliary devices to the receptacle itself. More specifically, the connection ports 203 couple the operating circuits housed within the receptacle to these auxiliary devices, as well as to an electrode 191 of the conductor cable. The connection ports 203 may be placed anywhere along the receptacle 192 of the receptacle, although in certain embodiments the connection ports 203 are located at the distal end 200 or at the proximal end 202 of the receptacle 192 of the receptacle. The connection ports 203 may additionally be located along the sides 198 of the receptacle housing and on the lower surface 196.

In yet another embodiment, the connection ports 203 are located at the distal end 200 and at the proximal end 202 of the housing 192 of the receptacle. Placing the connection ports 203 at the distal end 200 and at the proximal end 202 can improve the care provided by the receptacle 190 of the S-ICD. In particular, this arrangement of the receptacle allows the operating circuits in the receptacle 190 of the S-ICD to use various electrodes and detectors to regulate and better treat the particular state experienced by the receiving patient. Examples of suitable auxiliary devices for application are a conductor cable 193, such as a conductor cable for detection, cardiac stimulation by shock and cardiac stimulation with pacemakers. Additionally, other auxiliary devices suitable for application to receptacle 190 of the S-ICD are incorporated, which are known in the art, (for example, heart failure monitoring detectors).

The upper surface 194 of the receptacle housing 192 may additionally include certain accessories. The accessories are especially useful for anchoring the housing 192 of the receptacle in a fixed relative position, or alternatively, in advancing the housing 192 of the receptacle within the receiving patient. An example of an accessory that can be incorporated into the upper surface 194 of the receptacle housing 192 is an extendable flap. A flap-like accessory can extend from the receptacle 192 of the receptacle in order to better direct the receptacle 190 of the S-ICD during the implantation procedure. With this capability, the extended fin acts as a rudder that prevents the advance of the S-ICD receptacle 190 deviating from its desired path. The extended flap can additionally help prevent the receptacle 190 of the S-ICD from moving from its original position after implantation, especially in the direction perpendicular to the longitudinal one of the fin. The extensible fins can extend over the entire length of the housing 192 of the receptacle, or alternatively, in a part of the length. Additionally, the extensible fins may be disposed on the lower surface 196 of the housing 192 of the receptacle in order to provide similar functions.

The accessories can also help doctors move the receptacle 190 of the S-ICD to a desired location within the patient. The mobility enhancement accessories allow the physician to push, pull or otherwise direct the receptacle 190 of the S-ICD in a particular way throughout the patient's body. During the procedure, a doctor usually applies a medical instrument to the mobility enhancement accessory. This application step can occur either before or after the S-ICD receptacle 190 has been inserted into the patient. An example of a medical instrument capable of being applied to the mobility improvement accessory is a hemostat. Other similar medical instruments, known to those skilled in the art, can also be used in this application step. The physician then advances the hemostat in a desired direction to properly place the S-ICD receptacle 190 within the patient's body.

The surrounding sides 198 of the housing 192 of the receptacle are generally smooth and substantially rounded between the upper surface 194 and the lower surface 196 of the housing 192 of the receptacle. The smoothing of the lateral surfaces 198 helps the insertion of the receptacle 190 of the S-ICD during the implantation procedure. More specifically, smoother side surfaces 198 allow the S-ICD receptacle 190, as a whole, to easily slide through the surrounding body tissue while minimizing abrasion. In addition, rounded and smooth transition surfaces allow surrounding tissues to adapt better to the presence of the device, which makes the device more comfortable for the patient during chronic implantation.

On the contrary, acute edge formations may have the tendency to cut, or at a minimum, to irritate the surrounding tissue during the implantation process. Subsequent tissue irritation may occur long after the implantation process. Small fluctuations in the placement of a receptacle with sharp edges can lead to an inflammatory reaction in the surrounding tissue. Minor fluctuations are often the result of simple day-to-day movements. The movement of the arms, the flexion of the waist and the rotation of the torso are all daily activities that can cause the surrounding tissue to scrape against the installed receptacle. However, smoothing these edges would greatly reduce tissue abrasion, and consequently, reduce the pain and discomfort associated with the receptacle 190 of the implanted S-ICD.

Referring now to Figure 20, the bottom surface 196 of the receptacle 190 of the S-ICD of Figure 19 is shown. In particular, an electrode 204 having an electric conductive surface is represented within the limits, and sealed tightly inside, of housing 192 of the S-ICD receptacle. Although an electrode 204 has been specifically illustrated, any detector capable of receiving physiological information and / or emitting energy can also be located in the housing 192 of the receptacle. For example, a detector may be located in the housing 192 of the receptacle that can monitor the level of blood glucose, respiration, blood oxygen content, blood pressure and / or cardiac output of the patient. Specifically with reference to Figure 20, the exposed electrode 204 is electrically coupled to the operating circuits enclosed within the housing 192 of the receptacle. Therefore, electrode 204 performs many of the functions defined by the programming of the operating circuits. More specifically, electrode 204 is the vehicle that actually receives the signals that are being monitored, and / or emits the energy required for cardiac stimulation with pacemakers, by shock or otherwise stimulating the heart. Although only a single electrode 204 is shown for illustrative purposes, certain embodiments of the S-ICD receptacle 190 may be fabricated with several electrodes. For these embodiments, the various electrodes often have a specific task, where each electrode 204 performs a single function. In alternative embodiments, a single electrode 204 can perform the functions of monitoring and cardiac stimulation by shock.

Electrodes 204 are generally located at ends 200 and 202 of housing 192 of the receptacle. In the receptacle 190 of the S-ICD shown in Figure 20, the electrode 204 is located at the distal end 200 of the housing 192 of the receptacle. Although the electrode 204 is located very close to the distal end 200, the side 198 of the housing 192 of the receptacle closest to the distal end 200 generally should not expose any part of the electrical conductive surface of the electrode 204. Additionally, although the electrode is generally flat In certain embodiments, the electrode may have a curved shape.

The size of the electrical conductive surface of an electrode 204 in a given embodiment is approximately 500 square millimeters. In alternative embodiments it is convenient to maintain the size of the electrical conductive surface with an area between approximately 100 square millimeters and approximately 2,000 square millimeters. As with the size of the receptacle 192 of the receptacle, the size of the electrical conductive surface may vary to accommodate a particular receiving patient. In addition, the shape and size of an electrode 204 may vary to accommodate electrode 204 in housing 192 of the receptacle. The shape and size of an electrode can also be varied to fit the specified diagnosis and therapeutic functions performed by the receptacle 190. For example, the size and shape of the electrode 204 can be modified to minimize energy losses to the tissues. surrounding body, or to minimize the deviation of the current that goes to the heart.

A factor for minimizing the current deviation is the maintenance of an equal current density distribution across the conductive surface of the electrode 204. A control factor in the current distribution of the electrode 204 is the general shape of the electrode. 204. Certain forms of electrode 204 attract current to certain areas of the conductive surface of electrode 204 (eg, acute angles). As a consequence, these electrodes 204 create an uneven distribution of current density. For example, electrodes 204 having sharp corners may have higher current densities in the areas defined by the sharp corner. This uneven distribution of current density results in limited "hot spots." The formation of hot spots can be convenient and intentional, such as when trying to increase the density of current adjacent to the sternum. On the other hand, hot spots may not be convenient when these places with a high current density can scorch or burn the surrounding tissue when electrode 204 emits electrical energy. Also, electrodes 204 having numerous hot spots on the conductive surface of said electrode 204 thus generate areas of low current density, or "cold spots". This unequal distribution can make electrode 204, as a whole, very inefficient.

In contrast, embodiments of electrode 204 can be substantially rounded. In particular, areas of electrode 204 that traditionally have sharp corners, these are rounded to prevent the formation of hot spots at the ends. However, the most distal segment of the electrode 200 is slightly angled in order to concentrate current at the tip to a small extent, and therefore, direct the current further through the mediastinum and into the patient's heart.

Another control factor in the distribution of the current density in an electrode 204 is the general size of said electrode 204. The relatively small conductive surfaces of the electrodes 204 discussed above minimize the possibility of forming hot or cold spots. On the contrary, larger electrodes have surfaces that may be more conducive to generating more areas with an uneven current distribution.

As discussed above, electrodes 204 may vary in shape and size to accommodate a variety of housing designs 192 of the receptacle. For illustrative reasons, Figure 20 and Figures 23A-25A show various forms of electrodes arranged in various housings 192 of the receptacle. However, the receptacle housings 192 shown in these figures are not limited to the shape of the electrode specifically illustrated.

The electrode 204 shown in Figure 20 has a "thumbnail" shape. The margin 206 of the distal end of the electrode 204 with this shape generally follows the contour of the rounded distal end 200 of the housing 192 of the receptacle. As the electrode 204 moves proximally in the longitudinal direction of the housing 192 of the receptacle, the conductive surface ends. In the thumbnail embodiment the conductive surface of the electrode is generally contained within the rounded portions of the distal end 200 of the housing 192 of the receptacle. In alternative embodiments, the conductive surface of the electrode may extend proximally further into the housing 192 of the receptacle. In another embodiment of the thumbnail, the margins of the electrode conductive surface do not follow the exact rounded contour of the housing 192 of the receptacle.

In figure 23A an electrode 236 in the form of a "blade" is shown. The distal end of the blade-shaped electrode also generally follows the contour of the rounded distal end 234 of the housing 220 of the receptacle. As the shovel-shaped electrode 236 moves proximally along the length of the receptacle 220 of the receptacle, the conductive surface ends at a rounded proximal end. Similar to the thumbnail embodiment described above, the conducting surface of the blade-shaped electrode is generally contained within the distal end 234 of the housing 220 of the receptacle. In alternative embodiments, the conductive surface of the blade-shaped electrode may extend proximally further into the housing 220 of the receptacle. In yet another embodiment of the blade-shaped electrode 234 the margins of the conducting surface of the blade-shaped electrode do not follow the exact rounded contour of the receptacle 220 of the receptacle, but substantially form a blade-shaped configuration.

A circular shaped electrode 238 is illustrated in Figure 23B.

A rectangular electrode 246 is shown in Figure 24A. The rectangular electrodes 246 also incorporate electrodes that have substantially a rectangular shape. In particular, in Figure 24A the corners of the rectangular electrode 246 are rounded. On the other hand, a margin of the rectangular electrode conductive surface generally follows the rounded shape of the distal end 246 of the housing 241 of the receptacle.

A triangular shaped electrode 254 is shown in Figure 24B. The triangular shaped electrodes 254 also incorporate electrodes that are substantially triangular in shape. In particular in Figure 24B, the corners of the triangular shaped electrode 254 are rounded.

A square shaped electrode 257 is shown in Figure 24C. The square-shaped electrodes 257 also incorporate electrodes that have a substantially square shape. In particular, in Figure 24C the corners of the square electrode 254 are rounded.

An ellipsoidal electrode 268 is shown in Figure 25A. The distal end of the ellipsoidal electrode 268 generally follows the contour of the rounded distal end 264 of the housing 260 of the receptacle. As the ellipsoidal electrode 268 moves proximally along the length of the housing 260 of the receptacle, the conductive surface lengthens and then reduces its length to form a rounded proximal end. Similarly to the thumbnail and blade-shaped embodiments described above, the ellipsoidal electrode conductive surface is generally contained within the distal end 264 of the housing 260 of the receptacle. In alternative embodiments, the ellipsoidal electrode conductive surface may extend proximally further into the housing 260 of the receptacle. In yet another embodiment, electrode 264 ellipsoidal in shape, the margins of the conductive surface of the electrode ellipsoidally do not follow the exact rounded contour of the housing 260 of the receptacle, although they substantially form an ellipsoidal shaped configuration.

The energy emissions from any of the electrodes 204 described above generally follow a path of least resistance. Therefore, the planned path of the issue may not necessarily be the path that the broadcast eventually follows. This is especially a problem with the emissions made within the human anatomy where the conductivities of the tissues are highly variable. Obstructions or low conductivity tissues such as bones, fat, and lungs with air can divert energy to the heart. Alternatively, the surrounding non-cardiac muscle tissue or striated muscle, which is generally a high conductivity tissue, can divert energy emissions from the heart. This is a specific problem of the pectoral, intercostal, and broad dorsal musculature, as well as other thoracic, non-cardiac musculature existing between the S-ICD treatment electrodes. Since the S-ICD receptacle 190 does not make direct contact with the cardiac muscle itself, such low and high conductivity tissues will impede and / or divert a percentage of the emissions from electrode 204, which causes the heart to receive only one part of the total energy emitted.

The present invention minimizes the effect of the tissues that hinder and / or obstruct by means of the design of an electrode 204 and a housing 192 of the receptacle capable of focusing the set of emitted energy of the electrode. Focusing the electrode energy assembly on a very concentrated beam allows the resulting beam to be hindered or diverted only by any surrounding body tissue. Therefore, this focused set releases more of the energy originally emitted directly inside the mediastinum, and therefore, into the planned heart muscle, than would otherwise occur if the entire receptacle, or a majority of the receptacle, electrically active, as is the case with normal ICD transvenous systems. The present invention provides a design of electrode 204 and housing 192 of the receptacle that creates a set of energy focused coherently towards the chambers of the heart of the receiver.

Generally, it is convenient to have the longest flat conductive surface of the electrode positioned perpendicularly to the ribs that extend into the patient's rib cage. Aligning electrode 204 in this manner prevents the longest conductive plane from extending directly over any given rib. If the longer conductive surface were extended along the length of a rib, a greater percentage of emitted energy would be distributed through the rib material, and as a result, it could not reach the heart muscle. When aligned perpendicular to the ribs only a part of the conductive surface is directly on any given rib. This alignment allows only a small percentage of the energy emitted to be obstructed by the material that hinders the ribs. Therefore, especially the embodiments of the receptacle 190 that extend parallel to the patient's rib cage, the width 205 of the electrode conductive surface is approximately greater than or equal to the length 207 of the electrode conductive surface. This sizing of electrode 204 is best illustrated with reference to Figure 20. The conductive surface of the thumbnail-shaped electrode in Figure 20 is represented as low and wide. In contrast, embodiments of the S-ICD receptacle 190, which extend perpendicular to the receiver's rib cage, may have the length 207 of the conductive surface greater than the width of the conductive surface 205. The proper alignment of the receptacle 190 of the S-ICD, and therefore the proper alignment of electrode 204, are determined by the type of receptacle 190 of the S-ICD chosen for the receiving patient. Figures 23A-26C illustrate numerous embodiments of housing 192 of the S-ICD receptacle for properly placing an electrode 204 in the heart of a receiver. However, the embodiments represented are for illustrative purposes only.

Another solution to the problem of thoracic tissues that interfere with the release of energy is the design of a housing 192 of the receptacle that can be strategically placed very close to the patient's heart. One embodiment has a curved housing 192 of the receptacle, which allows the receptacle 190 of the S-ICD to be advanced just above the rib cage of the recipient patient. On the other hand, in another embodiment the curvature of the receptacle 190 of the S-ICD directly mimics the natural curvature of the rib cage.

Referring now to Figure 21, the receptacle 190 of the S-ICD of Figure 19 is shown sideways. Figure 21 shows the upper surface 194 of the S-ICD receptacle, the lower surface 196 and lateral 198 of the housing 192 of the receptacle. In the embodiment shown, the upper surface 194 and the lower surface 196 of the housing 192 of the receptacle are curved. In fact, along most of the proximal end 202 of the housing 192 of the receptacle the curvature is generally similar, and indeed can be identical, between the upper surface 194 and the lower surface 196. In alternative embodiments the upper surface 194 can be generally flat while the lower surface 196 is curved. In yet another embodiment the upper surface 194 may be curved and the lower surface 196 is generally flat.

With reference again to the embodiment shown in Figure 21, the curvatures between the upper surface 194 and the lower surface 196 are shown separating towards the distal end 200 of the housing 192 of the receptacle. At the distal end 200 of the S-ICD receptacle, the curvature of the upper surface 194 of the receptacle housing narrows downward towards the lower surface 196 of the receptacle. This narrowing causes the distal end 200 of the receptacle housing 192 to be narrower (of a smaller depth) than the proximal end 202 of the receptacle. In certain embodiments this depth narrowing may be gradual along the length of the receptacle 192 of the receptacle, or alternatively, the narrowing may be limited to a given area.

Narrowing the depth of the housing 192 of the receptacle can improve the overall operation of the receptacle 190 of the S-ICD. In particular, a narrowed distal end 200 may aid in the insertion and advancement of the S-ICD receptacle 190 into the body of the recipient patient. A narrowed distal end 200 allows the receptacle 190 of the S-ICD to pass through narrow subcutaneous spaces. In particular, a doctor generally attempts to create a passage into the patient's body that has appropriate dimensions for the receptacle, especially with respect to the placement of the distal end of the receptacle with the end containing the electrode very close to the sternum. The narrowing of the distal end eliminates unnecessary trauma to the patient in the narrow spaces adjacent to the sternum. However, for larger receptacles this narrow subcutaneous space is difficult to traverse. Therefore, these larger receptacles can cause the doctor to perform a wide incisive and direct dissection of the patient's tissues in order to place the larger receptacle in the desired location. However, regardless of the extent of the dissection, non-narrowed distal segments can be extremely uncomfortable if they are pushed into a parasternal position to meet the needs of focusing energy through the mediastinum, and therefore, to the patient's heart.

In contrast, embodiments that have narrow receptacles 192 can easily cross such passages. In addition, the narrowing of the distal end 200 of the S-ICD receptacle further makes the receptacle housing 192 aerodynamic, and thus facilitates the implantation procedure. The narrowing of the distal end 200 of the S-ICD receptacle is particularly important when placing the distal end of the receptacle housing as close as possible to the left edge of the patient's sternum. This placement of the housing 192 of the receptacle optimizes the release of energy to the mediastinum, and therefore to the patient's heart.

The depth of the receptacle 192 of the receptacle is shown as very narrow in terms of the length 207 of the receptacle housing. The depth of the receptacle housing is less than about 15 millimeters. In alternative embodiments the depth of the receptacle housing depth is from about 5 millimeters to about 10 millimeters. At the narrowed distal end 200, the receptacle housing may have a depth of approximately 1-4 millimeters.

In certain embodiments it is convenient to place the receptacle 190 of the S-ICD very close to the heart of the recipient patient without making direct contact with the heart. A preferred place for this placement of the receptacle 190 of the S-ICD is precisely on the patient's rib cage. More particularly, in certain embodiments it is preferable to place the S-ICD receptacle 190 just to the left of, and adjacent to, the sternum with a segment at the distal end 200 containing the electrode 204 closest to the sternum. Figure 22 depicts the placement of the receptacle 190 of the S-ICD with the lead wire electrode that passes through the subcutaneous tissues laterally to the armpit and then subsequently to "capture" the current when emitted from the parasternal electrode 204 and previously to the electrode. 191 of the conductor cable when it receives the current that comes out of the tissues of the posterior mediastinum and paraspinal.

During the implantation procedure a single incision 210 is made in the left anterior axillary line approximately at the level of the cardiac apex, or about the fifth to the sixth intercostal space. The situation of this single incision 210 allows the physician to place the receptacle 190 of the S-ICD and the auxiliary devices of the receptacle (for example, the conduction cables of the cardiac stimulation with pacemakers, the conductive cables of the cardiac stimulation by shock, etc. ) from this single incision 210. Once this incision 210 is made, the doctor can insert surgical instruments or a specially designed tool (not shown) through the incision 210 in order to form a passage for the receptacle 190 to navigate the S-ICD. Although a tool may be used in certain embodiments, a tool is not required, as normal surgical instruments are sufficient along with the general shape of the S-ICD receptacle 190 to facilitate correct placement of the device in the left anterior thorax as far as possible. next possible to the sternum.

In certain embodiments, a physician advances the receptacle 190 of the S-ICD and the electrode 91 of the conductive cable into the patient to form a depolarization vector with respect to the heart 218 of the patient. The depolarization vector is a vector that has an origin, a first end point and a second end point.

In one embodiment the origin of the depolarization vector originates approximately within the chambers of the patient's heart 218. Likewise, the first endpoint of the vector comprises the placement of the electrode 204 of the S-ICD receptacle with respect to the heart 218 of the patient. Finally, the second end point of the vector comprises the placement of the electrode 191 of the conductor cable with respect to the heart 218 of the patient. In alternative embodiments, the second endpoint of the vector comprises a second electrode of the receptacle.

The electrode of the conductive cable can be placed in various positions within the body because the length of the conductive cable 193 can be varied. For example, the devices of the S-ICD can have conductive cables with lengths between 5 centimeters and 55 centimeters. Therefore, the receptacle 190 of the S-ICD and the electrode 191 of the conductor cable can create numerous depolarization vectors.

In certain embodiments there is a degree of separation of 180 degrees or less between the electrode 204 of the S-ICD receptacle and the electrode 191 of the conductor cable. In alternative embodiments the degree of separation between electrode 204 of the S-ICD receptacle and electrode 191 of the conductor cable is between approximately 30 degrees and approximately 180 degrees.

In order to obtain the desired degree of separation for the depolarization vector, generally a device (the receptacle 190 of the S-ICD or the electrode 191 of the conductor cable) has to be advanced previously while the other device is subsequently advanced from the initial incision 210. Consequently, when the receptacle 190 of the S-ICD is advanced subcutaneously and previously from the incision 210, the electrode 191 of the conductor cable has to be advanced subcutaneously and subsequently from the incision

210. With this particular embodiment, a physician can advance the receptacle 190 of the S-ICD in the middle towards the patient's left inframammary fold to a place close to the patient's sternum 212.

Alternatively, the physician may advance, and subsequently place the S-ICD receptacle 190 into the anterior part of the patient's ribcage 216. This anterior placement may also include the patient's left parasternal zone, an anterior placement within the patient's third and twelfth ribs area 214, or generally in any anterior subcutaneous position of the thoracic cage 216 of the patient's heart 218. In order to complement the placement of the receptacle 190 of the S-ICD and obtain the correct depolarization vector, the electrode 191 of the lead wire electrode can then be advanced towards the paraspinal or paraspular zone of the patient's ribcage 216.

In another embodiment, the spatial positioning of the receptacle 190 of the S-ICD and the electrode 191 of the conductor cable, described above in detail, is reversed.

With reference again to Figure 21, the curvature of certain embodiments of the receptacle 190 of the S-ICD can be designed to mimic the natural curvature of the patient's rib cage 216. These embodiments 190 of the S-ICD receptacle limit displacement and increase comfort to the patient having an S-ICD receptacle 190 implanted. The anatomical shape of a rib cage 216 of a receiving patient varies. The present invention includes numerous curvatures of the housing 192 of the S-ICD receptacle to support these variable shapes. In particular, the present invention includes S-ICD receptacles 190 sized and formed to accommodate children, as well as others to properly fit fully developed adults.

The curvature of the housing 192 of the receptacle generally has an arc shape. The degree of curvature of any particular embodiment is measured through a theta vector (8). The curvature vector 8 is a vector having an origin 199, a first end point and a second end point.

In one embodiment the origin 199 of the curvature vector 8 originates approximately in the center of the receptacle 190 of the S-ICD (in the longitudinal direction). The first endpoint of the vector in this embodiment comprises the distal end 200 of the receptacle 190 of the S-ICD and the second endpoint of the vector comprises the proximal end of the receptacle 190 of the S-ICD. In certain embodiments, the curvature vector 8 has a degree of separation between 30 degrees and 180 degrees. For example, a housing 192 of the receptacle having a degree of separation of 180 degrees is flat. The decrease in the degree of curvature 8 causes the receptacle housing to have a more arcuate shape.

In alternative embodiments, the origin 199 of the curvature vector 8 may originate at a point other than the center of the receptacle 190 of the S-ICD produces areas of greater curvature, and also zones of less curvature in the same receptacle 190 of the S-ICD. The origins 199 displaced from the center of the receptacle 190 of the S-ICD produce in the same receptacle 190 of the S-ICD some areas of great curvature as well as other areas of less curvature. Similarly, a receptacle 190 may have several curvature vectors 8 having origins 199 along the length of the receptacle 190 of the S-ICD. Several curvature vectors 8 produce various non-linear or non-symmetric curves that, in certain circumstances, generally continue to have an arc shape. Receptacle housings having several curvature vectors 8 are particularly suitable for positioning receptacle 190 of the S-ICD near the patient's sides (generally in the area under the patient's arms where the thorax has a degree of curvature more marked). Receptacle housings 192 that incorporate a non-symmetrical curvature are generally longer S-ICD receptacles 190 that extend over the front and sides of the patient's rib cage. In particular, these receptacles 190 extend over areas of the rib cage 216, which are generally flat (around the patient's sternum 212), as well as over areas that are very curved (generally in the area under the patient's arms).

The curved receptacle housings 192 are generally for S-ICD receptacles 190 that extend longitudinally, or almost horizontally, along the length of the ribs in the rib cage

216. However, for certain embodiments it is convenient to longitudinally orient the receptacle 190 of the S-ICD so that it is perpendicular to the longitudinal direction of the ribs in the rib cage 216. A receptacle 190 of the S-ICD oriented perpendicularly generally requires very little curvature. , if you need it, to adapt to the rib cage 216.

Figures 23A-26C represent particular designs of receptacle 190 of the S-ICD. In each of these particular designs of the S-ICD receptacle 190 the various structures, dimensions and curvatures, discussed in detail above, can be incorporated into each S-ICD receptacle design. In addition, certain aspects of each S-ICD receptacle design, in whole or in part, can be incorporated into another design represented by the S-ICD receptacle.

Turning now to Figure 23A, a receptacle 220 of the S-ICD is shown having a housing 222 shaped like a duckbill of the receptacle. The duck-like housing 222 of the receptacle has a proximal end 226 and a distal end 234. The proximal end 226 of the housing 222 of the duck-shaped receptacle further includes a main member 228 of the housing and a distal member 230 of accommodation. The distal member 230 of the housing is an elongated segment that extends distally from the distal end of the main member 228 of the housing. Although the two segments differ in size and shape, the distal member 230 of the housing and the main member 228 of the housing are generally contiguously and fluidly connected to each other and can be formed from a single mold. However, in alternative embodiments the distal member 230 of the housing may be hinged to the main member 228 of the housing. The distal member 230 of the housing also generally comprises a material having a composition similar to that formed by the main member 228 of the housing. However, in alternative embodiments, the distal member 230 of the housing may include a material that has improved electrical insulation characteristics.

The main member 228 of the housing generally houses the circuits, batteries and operating capacitors of the duck-shaped receptacle 220 of the S-ICD. The width and length of the main member 228 of the housing allow said main member 228 of the housing to house batteries and capacitors to release an energy for cardiac stimulation by shock of approximately 50 J, 75 J, 100 J, 125 J and 200 J.

Although a specific number of batteries and capacitors are required to release these charges, their placement within the housing 222 of the receptacle is highly modifiable. More specifically, the width of the main member 228 of the housing can be modified to accommodate a longer or shorter receptacle. For example, the width of the main member 228 of the housing can be increased in order to obtain a main housing 228 of the receptacle of a smaller length. Modifying the sizing and orientation of the main member 228 of the housing allow manufacturers to create a variety of S-ICD duck-shaped receptacles 220 with different dimensions. The greater specificity in the shape and size of the receptacle housing increases the comfort and wear resistance of the receiving patient.

In general, the width of the main member 228 of the housing is approximately 10 cm or less. Similarly, the length of the main member 228 of the housing is approximately 20 cm or less. In certain embodiments the width of the main member 228 of the housing is 4 cm. In an alternative embodiment, the width of the main member 228 of the housing is 8 cm.

The distal member 230 of the housing is an elongated segment of the receptacle housing that has a width that differs from that of the main member 228 of the housing. The width of the distal housing member decreases as the distal housing member 230 extends distally. This narrowing of the width results in the formation of a shoulder area 232. In certain embodiments, the speed with which the width decreases when the proximal member 230 of the housing extends distally is constant. In alternative embodiments, the speed is variable. A variable narrowing of the shoulder area 232 advances with a narrowing speed where a unit of narrowing of the width is not directly related to a unit of length in the distal direction.

However, in any of the embodiments, bilateral symmetry is maintained throughout the length of the distal member 230 of the housing.

The region 232 of the scapula is generally a rounded and smooth area of the housing 222 of the receptacle. As discussed in detail above, rounding the edges along the surface of the receptacle improves the insertion of the receptacle 220 of the S-ICD. Rounded edges also reduce abrasion and inflammation associated with wear resistance in the short and long term.

Extending distally beyond the shoulder area 232 is the distal head 234 of the distal member 230 of the housing. The distal head 234 is the distal termination point of the receptacle 220 of the duck-shaped S-ICD. The distal head 234 includes a generally rounded end. In one embodiment, illustrated in Figure 23B, the distal head 234 has a width greater than the width at a location within the area 232 of the shoulder of the distal member 230 of the housing. In alternative embodiments, the width of the distal head is equal to, or less than, the width at any point in the area 232 of the shoulder of the distal member 230 of the housing, as illustrated in Figure 23A.

The length of the receptacle 220 of the duck-shaped S-ICD may depend largely on the shape and size of the distal member 230 of the housing. In certain embodiments, the receptacle 220 of the S-ICD shaped like a duckbill is approximately 30 centimeters or less in length. In alternative embodiments, the receptacle 220 of the S-ICD shaped like a duck's beak is approximately 10 centimeters or less in length. In certain embodiments, the length of the S-ICD receptacle 220 in the shape of a duckbill may be curved, or alternatively, or a part of the length (i.e., the area 232 of the scapula and the distal head 234) are curved.

The electrode 236 of the receptacle 220 of the S-ICD shaped like a duckbill is generally placed within a part of the distal member 230 of the housing. Figure 23A depicts in a broken line diagram the approximate location of an electrode 236 in the housing 222 of the duck-shaped receptacle. Although electrode 236 is represented as generally circular in shape (in Figure 23B), the electrode may also have a "blade shape" (shown in Figure 23A), a thumbnail, square, rectangular, triangular or ellipsoidal. The electrode 236 is electrically coupled to the operating circuits within the main member 228 of the receptacle housing 220 of the S-ICD. In certain embodiments an associated feature of electrode 236 at the distal end is the presence of a margin of insulated material 237 around active electrode 236. The margin of isolated material 237 can help direct the energy emitted from electrode 236 inward to the heart. of the patient instead of dispersing the energy outside towards the wall of the patient's chest. This margin of insulated material 237 is normally between 1 and 5 mm wide and can extend towards the margin of the housing. In addition, in certain embodiments, the margin of insulated material 237 comprises a ceramic material or other material designed to facilitate the focus of the current entering the heart.

In certain embodiments the electronic components (for example, the circuits, batteries and capacitors) of the receptacle 220 of the S-ICD are missing in the distal member 230 of the housing. Therefore, the depth of the distal member 230 of the housing can be greatly reduced. In these embodiments, a depth of approximately 1 millimeter can be obtained at the distal head 234 of the duck-like receptacle 220 of the S-ICD.

The duck-shaped distal limb 230 of the housing improves navigation during implantation of the receptacle. The distal head 234 of the distal member 230 of the housing is blunt at its end to reduce the trauma suffered by the surrounding tissue during the advance or during chronic implantation of the S-ICD receptacle. Similarly, the narrower distal head 234 (in the direction of width and in the direction of depth) is easier to control during the advancement procedure. The smaller distal head 234 also allows a physician to navigate the smaller and more compact tissues adjacent to the sternum, which with a larger head would be impossible. In addition, the narrowest distal head 234 can be advanced to a place very close to the heart 218 of the recipient patient without danger of deforming or stressing the skin in the left parasternal area.

The closer the electrode 236 of the patient's heart 218 is, the less energy is needed to achieve an appropriate electric field or current density to defibrillate the heart. A convenient anatomical position to reduce this necessary energy is precisely the lateral sternum 212 of the patient. The area surrounding the patient's sternum 212 generally lacks a considerable accumulation of body tissue. Therefore, the subcutaneous placement of the S-ICD receptacle 190 on the sternum 212, or somewhere else just above the ribcage 216, provides a significant decrease in the energy required due to the proximity to the heart 218 and a reduction in surrounding obstacle tissue. However, the placement of an ICD receptacle with a normal contour in this area has proved difficult, and it is also aesthetically unpleasant. However, the reduced profile of the duck-like receptacle 220 provides an optimal placement of electrode 236 in a more aesthetic and less physically obstructive manner.

Structurally, a reduction in energy needs frees space within the housing 222 of the receptacle. This space was previously occupied by batteries and capacitors necessary for greater energy needs. However, this space is no longer necessary. Therefore, the duck-like receptacle 220 of the S-ICD may be smaller in length, width and depth. The elimination of batteries and capacitors also reduces the weight. As described above in detail, reducing the weight of the S-ICD receptacle improves the comfort of the receiving patient.

Figure 24A illustrates another embodiment of an S-ICD receptacle having a housing 240 generally rectangular in shape. The housing 240 of the rectangular-shaped container includes an upper surface 241, a lower surface (not shown) and surrounding sides 248 connecting these two surfaces. The rectangular housing 240 of the receptacle further includes a distal end 242 and a proximal end 244. The electrode 246, shown in a broken line, is generally positioned either at the distal end 242 or at the proximal end 244 of the housing 240 of the receptacle. In alternative relationships, the rectangular housing 240 of the receptacle may include two or more electrodes 246. When the two electrodes are used, an electrode is placed at the distal end 242 of the housing 240 of the receptacle, while the second electrode is located at the proximal end 244 of the housing 240 of the receptacle.

The length of the rectangular housing 240 of the receptacle is approximately 30 centimeters. In alternative embodiments, the rectangular housing 240 of the receptacle has an approximate length of 10 centimeters or less. The width of the rectangular housing 240 of the receptacle is approximately 3 centimeters to approximately 10 centimeters.

Figures 24B and 24C represent additional embodiments of an S-ICD receptacle that generally have a 250 square-shaped housing of the receptacle. Said square housing 250 of the receptacle includes an upper surface 251, a lower surface (not shown) and the surrounding sides 252 connecting these two surfaces. The sides 252 of the square-shaped housing of the receptacle are generally the same length. The electrode 254, shown in a broken line, is generally placed in the center and on one side of the square housing 250 of the receptacle. A triangular-shaped electrode 254 in the corner of the square-shaped housing 250 of the receptacle is specifically illustrated in Figure 24B. However, in alternative embodiments the electrode 254 may be placed towards the center of one of the sides 252 of the housing 250 square-shaped of the receptacle, or in the center of the housing 250 square-shaped of the receptacle, or more rotated. A square-shaped electrode 257 is specifically illustrated on the side of the housing 250 of the receptacle in Figure 24C.

The length and width of the housing 250 of the receptacle in Figure 24C is approximately a length and width of approximately 8 centimeters.

Figure 25A represents another embodiment of an S-ICD receptacle having a housing 260 of the "medical spatula-shaped" receptacle. The housing 260 of the medical spatula-shaped receptacle includes an upper surface 261, a lower surface (not shown) and surrounding sides 262 connecting these two surfaces. The housing 260 of the medical spatula shaped receptacle further includes a distal end 264 and a proximal end 266. However, the distal end 264 and the proximal end 266 of the housing 260 of the medical spatula shaped receptacle are rounded. In one embodiment, the rounded ends extend outwardly away from the housing 260 of the receptacle in the corresponding distal or proximal direction. Rounded ends generally have circular arc-shaped curves, although rounded ends can also be elliptical or non-symmetrical arc-shaped curves.

The electrode 268, shown in a broken line, is generally placed at the distal end 264 or at the proximal end 266 of the housing 260 of the receptacle. In alternative embodiments, the housing 260 of the medical spatula-shaped receptacle may include two or more electrodes 268. When two electrodes are used, an electrode is located at the distal end 264 of the housing 260 of the receptacle while the second electrode is located at the proximal end 266 of the housing 260 of the receptacle.

The housing 260 of the medical spatula-shaped receptacle has a length of approximately 30 centimeters or less. In alternative embodiments, the medical spatula-shaped housing 260 of the receptacle has an approximate length of 15 centimeters or less. The width of the housing 260 of the medical spatula-shaped receptacle is between about 3 centimeters and about 10 centimeters.

With reference now to Figure 25B, there is shown a modified housing 270 of the medical spatula shaped receptacle. The housing 270 of the modified medical spatula shaped receptacle is similar to the medical spatula shaped receptacle 260 of the S-ICD shown in Figure 25A, although the housing 270 of the modified medical spatula shaped receptacle comprises only a single distal end rounded 272. The proximal end 274 of the housing 270 of the medical spatula-shaped receptacle is generally square.

Figures 26A-26C illustrate another embodiment of an S-ICD receptacle having a multi-segment housing 280 of the receptacle. The multi-segment housing 280 of the receptacle includes at least two segments of the receptacle housing that are coupled together. The S-ICD receptacle shown in Figures 26A, 26B and 26C specifically has a distal segment 282 and a proximal segment 284 hinged, or also coupled together.

The distal segment 282 includes an upper surface 292, a lower surface (not shown) and surrounding sides 286 connecting these two surfaces. The most distal end 288 of the distal segment 282 comprises a rounded area. An electrode 290 is disposed within this rounded area of distal segment 282 (shown in dashed line). Electrode 290 generally follows the contour of the rounded area of the most distal end 288 of the receptacle housing, although electrode 290 may have other shapes and sizes.

In one embodiment of the multi-segment housing 280 of the receptacle, the electrode 290 and the electronics are disposed within the distal segment 282. In alternative embodiments the electrode 290 is disposed within the distal segment 282 and the electronics are located within the proximal segment 284 of the multi-segment housing 280 of the receptacle.

Figure 26B shows the distal segment 282 of the multi-segment housing 280 of the receptacle, which is curved to mimic the shape of the anatomy of the rib cage 216 of a recipient patient. In the embodiment shown, the upper surface 292 and the lower surface 294 of the proximal segment 282 are curved. However, the curvature differs at the most distal end 288 of the distal segment 282. At the most distal end 288 of the distal segment, the upper surface 292 of the distal segment narrows down toward the lower surface of the distal segment 294. This narrowing causes that the most distal segment 288 of the distal segment 282 is narrower than the distal end 296 of the distal segment. In certain embodiments this depth narrowing may be gradual along the length of the distal segment 282, or alternatively the narrowing may be limited to a given area.

The proximal segment 284 also includes an upper surface 298, a lower surface 300 and surrounding sides 302 connecting these two surfaces. However, the proximal segment 284 shown in Figure 26B is generally flat. In the alternative embodiments shown in Figure 26C, the proximal segment 284 may also be curved and may also have a different curvature than the distal segment.

The length of the multi-segment housing 280 of the receptacle is approximately 30 centimeters or less. In alternative embodiments, the multi-segment housing 280 of the receptacle is approximately 20 centimeters or less. In yet another embodiment, the multi-segment housing 280 of the receptacle is approximately 12 centimeters or less. The width of the multi-segment housing 280 of the receptacle is between about 3 centimeters and about 10 centimeters.

With reference now to Figure 27, there is shown an embodiment of receptacle 310 of the US-ICD. In this embodiment, the receptacle 310 of the US-ICD comprises a proximal end 312, a distal end 314 and two electrodes, a first electrode 316 and a second electrode 318. The first electrode 316 is shown with a thumbnail shape and is located near the most distal end of receptacle 310 of the US-ICD. Although a thumbnail is represented for the first electrode 316, other alternative forms (described in detail above) are also suitable for the present invention.

The second electrode 318 shown in Figure 27 is disposed at the proximal end 312 of the receptacle 310 of the US-ICD. More specifically of the illustrated embodiment, the second electrode 318 is located just distally from the most proximal end of the receptacle 310 of the US-ICD. This placement of the second electrode 318 allows the accommodation of a connection port 320 in the receptacle 310 of the US-ICD. Similar to the first electrode 316, however, the second electrode 318 is also generally represented as following the contour of the receptacle housing.

Connection port 320 couples auxiliary devices with the operating circuits housed inside receptacle 310 of the US-ICD. In certain embodiments, the connection port 320 couples the operating circuits to a conductor cable 328, and finally to an electrode 330 of the conductor cable, of which the part of the electrode is shown in broken line in Figure 27. Although Figure 27 depicts the connection port 320 at the most proximal end of the receptacle 310 of the US-ICD, the connection ports 320 can be placed anywhere along the receptacle housing. However, in certain embodiments the connection ports 320 are located at the distal end 314 or at the proximal end 312 of the receptacles 310 of the US-ICD. In additional embodiments, the connection ports 320 may be placed at the distal end 314 and at the proximal end 312 of the receptacle 310 of the US-ICD.

In the embodiment of the connection port 320 shown in Figure 27, the connection port 320 comprises, in part, a female plug 322. The female plug 322 of the connection port 320 acts as a receptacle for auxiliary devices. More specifically, the female plug 322 is coupled with a part of the auxiliary device to allow the flow of electrical information between the receptacle 310 of the US-ICD and the auxiliary device. In the embodiment shown in Figure 27, a part of the conductor cable 328 is coupled into the female socket 322 of the connection port 320.

In certain embodiments, the fitting of the conductor cable 328 with the female plug 322 forms a friction-tight seal. In many cases this friction adjustment closure prevents unintentional decoupling of the auxiliary device from the female socket 322. However, in alternative embodiments additional mechanical means can be used to ensure against such an accidental decoupling. An example of additional means for securing the connection between the auxiliary device and the female plug 322 is by means of an adjustment screw. When properly advanced against an object, an adjustment screw applies a positive pressure that prevents the movement of that object. In the present invention the adjustment screw is used to provide a positive pressure against an auxiliary device once properly inserted into the female socket 322 of the connection port. Additional securing means, which are known in the art, are additionally incorporated herein as within the scope of the present invention.

To further form a seal between the auxiliary device and the receptacle 310 of the US-ICD, certain embodiments further comprise a housing 324 fitted on a part of the female plug 322. The housing 324 includes an opening 326 that helps guide the auxiliary device to the female plug 322 of the connection port. In certain embodiments, the opening 326 also forms a closure around the auxiliary device when the auxiliary device passes through the opening 326 of the housing. More specifically, the housing 324 provides a tight seal that prevents bodily fluids from entering through the opening 326 and the connection port 320.

In certain embodiments, the material that forms the housing 324 of the connection port 320 is translucent. Using a translucent material for the housing 324 a doctor can visually check if an appropriate connection has been made between the auxiliary device and the female plug 322. Therefore, suitable materials to form the housing 324 of the connection port generally include polymeric materials. . Polymeric materials suitable for the housing 324 of the connection port of the present invention include polyurethanes, polyamides, polyether ketones (PEEK), polyether block amides (PEBA), polytetrafluoroethylene (PTFE), polyethylene, silicones, and mixtures thereof.

The use of auxiliary devices in conjunction with a receptacle 310 of the US-ICD allows a physician to improve the care provided to his recipient patients. In particular, the use of a receptacle 310 of the US-ICD with an additional auxiliary device (for example, electrode 330 of the conductor cable) allows operating circuits in receptacle 310 of the US-ICD to use various electrodes and detectors. This allows the regular doctor to better treat the particular condition experienced by a receiving patient. For example, a physician may use the first electrode 316 and the second electrode 318 in the receptacle 310 of the US-ICD for cardiac stimulation by shock and cardiac stimulation with pacemakers, while electrode 330 of the conductive cable is used for detection. In particular, electrode 330 of the conductive cable can be used to monitor blood glucose level, respiration, blood oxygen content, activity, blood pressure and / or cardiac output of the patient, and as an accelerometer while the first electrode 316 and the second electrode 318 are used in cardiac stimulation with pacemakers.

Since the length between each electrode is different in the embodiment shown in Figure 27, at least three depolarization vectors can be formed. In the illustration the first electrode 316 and the second electrode 318 in the receptacle 310 of the US-ICD form a first depolarization vector; the first electrode 316 and the electrode 330 of the conductor cable form a second depolarization vector; and the second electrode 318 and the electrode 330 of the conductor cable form a third depolarization vector. In addition, all electrodes can be used at the same time for cardiac stimulation by shock. In these embodiments two of the electrodes form an additional depolarization vector with the third electrode. As a consequence, three more depolarization vectors are created. If several auxiliary devices are connected to receptacle 310 of the US-ICD, the number of depolarization vectors increases accordingly. In addition, the US-ICD electronic circuits can use the two electrodes, which thus form the most effective depolarization vector for cardiac stimulation by shock, while the remaining electrode is used for detection functions. In these arrangements, all electrodes are capable of performing cardiac detection and stimulation functions by shock, and these functions may alternate when the US-ICD programming determines the best arrangement for the particular needs of the receiving patient.

The electronic circuits contained within receptacle 310 of the US-ICD can use these various depolarization vectors when attempting to recover a patient's heart rhythm, or in other cardioversion-defibrillation therapies. Electronic circuits can be programmed before implantation or in a subsequent examination. If the electronic circuits are programmed before implantation, the doctor can indicate which depolarization vectors can be used, or alternatively which set of depolarization vectors the circuits should use when treating the particular state of the receiving patient. The physician should also identify what screening functions, and in what arrangement, should be used in monitoring the condition of the recipient patient.

In an alternative treatment method the doctor can improve on the initial programming of the electronic circuits in a subsequent examination. During subsequent examinations, the physician can reprogram the electronic circuits externally by means of devices known in the art (for example, a programmer). These devices allow the physician to adjust the programming of the US-ICD to better treat the specific needs of the patient. For example, this procedure of new programming of follow-up may imply that the physician uses new depolarization vectors in the treatment of the patient's condition. Alternatively, the doctor may wish to monitor certain physiological activities. The new programming of electronic circuits allows the US-ICD to adjust the detection and perception of these physiological activities and the corresponding response of cardiac stimulation by shock or cardiac stimulation with pacemakers.

In another method of alternative treatment, electronic circuits are programmed to detect particular physiological states and automatically respond to these states. For example, if necessary, a depolarization vector fails in the recovery of the patient's heart rhythm, the US-ICD programming would automatically initiate the use of one of the alternative depolarization vectors to perform this recovery function. Such programming would allow the US-ICD to detect and stimulate through shocks in a set of patterns to better meet the needs of a particular patient. In this way, the programming could detect the difference between AF and VF and use the most appropriate depolarization vector. Therefore, the inclusion of an auxiliary device to a receptacle of the US-ICD allows great flexibility in the programming of the US-ICD, and finally in the rigorous monitoring of possible treatments and responses of an implanted US-ICD.

In the foregoing description, numerous features and advantages of the invention covered by this document have been set forth. However, it is understood that this description in many respects is only illustrative. Changes in details can be made, especially in terms of shape, size and arrangement of parts without exceeding the scope of the invention. The scope of the invention is defined, of course, as expressed in the appended claims.

Claims (14)

1. An implantable cardioverter-defibrillator, comprising the implantable cardioverter-defibrillator: a housing that has a first end and a second end; a first electrode disposed at the first end of the housing; a second electrode disposed at the second end of the housing; an electrical circuit located inside the housing, and configured to provide cardioversion-defibrillation energy; Y an electrode of the conductor cable electrically coupled to the electrical circuit located inside the housing, whereby the implantable cardioverter-defibrillator is configured for subcutaneous placement on a patient's ribcage; the electrical circuit is coupled to the first and second electrodes and the electrode of the conductor cable; characterized: because the housing is sized so that the first and second electrodes in the housing are separated to provide a defibrillation vector between them; Y because the lead wire electrode with the first and second electrodes in the housing form a second and third defibrillation vectors, and the electrical circuit is programmed to select from the second and third defibrillation vectors a defibrillation vector for use.

2.

 The implantable cardioverter-defibrillator of claim 1, wherein the lead wire electrode is coupled to the electrical circuit located inside the housing through a connection port.

3.

 The implantable cardioverter-defibrillator of claim 1, wherein the first electrode, the second electrode and the lead wire electrode can emit energy to stimulate a patient's heart by shock.

Four.

 The implantable cardioverter-defibrillator of claim 3, wherein the first electrode, the second electrode and the lead wire electrode can also receive sensory information.

5.

 The implantable cardioverter-defibrillator of claim 4, wherein the sensory information that can be received refers to the patient's blood glucose level.

6.

 The implantable cardioverter-defibrillator of claim 4, wherein the sensory information that can be received refers to the patient's breathing rate.

7.

 The implantable cardioverter-defibrillator of claim 4, wherein the sensory information that can be received refers to the oxygen content in the patient's blood.

8.

 The implantable cardioverter-defibrillator of claim 4, wherein the sensory information that can be received refers to the patient's blood pressure.

9.

 The implantable cardioverter-defibrillator of claim 4, wherein the sensory information that can be received refers to the patient's activity.

10.

 The implantable cardioverter-defibrillator of claim 4, wherein the sensory information that can be received refers to the patient's cardiac output.

eleven.

 The implantable cardioverter-defibrillator of claim 1, wherein the electrical circuit is programmed before implantation in the patient.

12.

 The implantable cardioverter-defibrillator of claim 11, wherein the electrical circuit can be programmed after implantation in the patient.

13.

 The implantable cardioverter-defibrillator of claim 1, wherein the electrical circuit can also provide pacemaker stimulation with a multiphasic waveform to the patient's heart.

14.

 The implantable cardioverter-defibrillator of claim 1, wherein the electrical circuit can also provide a pacemaker stimulation with a monophasic waveform to the patient's heart.