HEART

FIKLD OF THK INVENTION

The present invention relates to a medical invention in the field of heart diseases, and more generally relates to a medical implant designed to be surgically implanted intracardiac (Id) or cxtracardiac (ΤΛΙΙ) for the aim of permanently treating heart failure patients and it can be used to treat patients with intractable serious ventricular dysrhythmias whether isolated or in the course of heart failure.

BACKGROUND OK THK INVENTION

The currently available methods to treat heart failure are numerous. However they present less hope to survival and quality of life than expected. Among the newest tools in lighting heart failure there stands stem cell therapy. Stem Cell Therapy aims at the rejuvenation of the inactive weak cardiac muscle cells.

Another relatively recent method is cardiac resynchronisalion therapy 'CRT ^' . This entails the introduction of a third lead in a position behind the left ventricle where it can be paced. Through this timed event, the intraventricular as well as the interventricular dyssynchrony may be corrected. Cardiac transplantation is a more sol id treatment option of adding somebody's heart to replace another heart, a human heart from a dead donor to a heart failure recipient. There are a wealth of di fficulties to the donor and recipient. Difficulties to the donor include a rarity of donor's hearts which is < 3000/ year worldwide, heart preservation, transportation, laboratory tests, intrinsic heart disease, ABO blood type eompatabil ity, Donor- Recipient si/e disparity, transmissible diseases, a 2-5 fold mortality risk to recipient with higher donor age, coronary artery disease, allograft rejection, al lograft vasculopathy, and transplanted organ rejection. Difficulties to the recipient include immunosuppressive and cytotoxic medications that lead to malignancy and multi system organ fai lure, right ventricular (RV) failure, and absence of chronotropic response with the dennervated transplanted heart. Most patients awaiting a heart transplant are awarded a pretransplant procedure; a ventricular assist device ' VAD' . They are either short term, or long-term, i) Pulsatile; or ii) Non-Pulsatile.

They are temporarily placed and lasting in proper function from few months to a maximum of 3 years. In fection is common, some require adequate intrathoracic space to accommodate. Pulsatile devices need inflow and outflow valves. This method introduced abnormal metabolic and neurohumoral changes with the nonpulsatile devices. This pump operation will will not solve any cardiac serious dysrhythmias; a common event in such terminal patients. Lastly, two common shared difficulties to both VAD's and heart transplantation have been clearer; both can help systolic dysfunction, but not diastolic dysfunction or diastolic heart failure. Both are helpless when cardiac dysrhythmias ( Brady-, or Tachycardia) occur. They are unable to deliver DC shock, defibrillate or pace the slowing heart.

In developed countries, around 1-2% of adults suffer from heart failure, with an estimated annual mortality of approximately 21% in men and 17% in women. In the USA there are more than 5 million patients under treatment from congestive heart failure, with an estimated 55(f 000.00 new cases occureach year. Approximately one-half of the patients have moderately to severely reduced left ventricle (l.V) systolic function. Approximately, these patients will need more than medical control to gain a better quality of life. The figure waiting for artificial hearts &or cardiac transplantation is very huge.

The Id TAH embodiment targets patients with diseased heart muscle. Not only those with systolic failure who benefit from this embodiment, but patients with diastolic failure as well. Therefore, it targets the patient with right ventricular (RV) and/or I V Dilated-, Restrictive, and/or Hypertrophic Cardiomyopathy as well as other patients with serious pathology (e.g. native orprosthetie valvar pathology, septal defects, aneurysmal chamber dilatation, CABG-difficull patients) associated with heart failure. Patients as well with primary cardiac tumours will benefit from the embodiment. Also patients with critical intractable supraventricular or ventricular dysrhythmia, whether isolated or in the course of cardiomyopathy, will be candidates for the embodiment. Finally, installation includes; a stepped approach. First through surgical implantation by means of open heart surgery, with a second, more advanced, step of percutaneous catheter implantation that follows, when ^" Ι(Ί" is planned. Λ step, through transapical installation is another option. Lastly, the embodiment can be applied cxtrapcricardiac utilizing the concertina or FM sheets mechanism of operation.

BRIEF SUMMARY OF THE INVENTION :

The biomaterial-made Id and/or ΤΛΙ I embodiment is targeting the patient with heart failure and/or intractable dysrhythmia. The I(T embodiment is to be implanted inside the cardiac cavity(ies), with the option of removing all inner chamber structures and implanting an artificial valve, a surrogate valve (vis infra) or keeping the atrioventricular valve and apparatus. The ΤΛΙΙ embodiment is replacing the diseased removed chambers. The embodiment can thus be implanted in one or more units according to the demand of each patient's diseased cardiac status. The ΤΛΠ embodiment is connected to the existing cardiac outgoing and incoming vessels and stabilized in place to and within the thoracic cage by means of optional cords and/or threads which back up the basement of the embodiment, illustrated as layer 1 (16).

The ΤΛΗ embodiment in the coming text has all the applications of the IC1 embodiment with the following differences that do not apply to the ΤΛΙ I

embodiment: no percutaneous application (i.e. no space to terminate in, when using the vascular route); no patchy application (i.e. no native heart tissue to implant on); and no DC shock/ Defibrillation facility (i.e. no intervening heart tissue to deliver the shock).

When a chamber is nominated in the context oflCI embodiment, it implies its position in the ΤΛΙΙ embodiment, for example when left ventricle 'LV (4) is mentioned with the Κ embodiment, the corresponding term is still LV but only its position is implied because the LV in itself is removed and replaced with the ΤΛΙΙ unit in the LV position. The same applies when mentioning interatrial or

interventricular septum where the ΤΛΙΙ embodiment septum will mean the embodiment artificial wall.

Lach embodiment unit consists of 2 layers. Layer 1 (16), immobile and adherent to the endocardium (when ICI) or optional stabilising cords (when ΎΛΙ I). Layer 2 ( 17) reflects from layer 1 and faces the cardiac cavity. Layer 2 moves inwards ( systole) and backwards (diastole) by one or a combination of the following: i ) Conccrtina-like elastic fibers and/or spring (22), ii) crossing diagonal elastic fibers

(27) , with or without simple nodc(s) 'SN' (28) or electromagnetic nodc(s) ' HMN\

(28) that cross diagonally from one surface to the opposing, and/or ii i ) Sheets made of electromagnetic ΊΐΜ ' coil(s) (29 and 30). These sheets are adherent to the inside of layers 1 and 2.

The mechanism of separation (systole) and attraction (diastole) ol ^' layers 1 and 2, is pulsatile and is through electromagnetic coils (34) which obey the law of attraction between di fferent polarities and repulsion between simi lar polarities. All parts of the embodiment are shielded and insulated to guard against electromagnetic field dispersion into the surrounding media.

A baltery/programmer/pacer/DC shock/defibrillator (2 1 ), (referred to as "battery' in the whole text), feeds the embodiment through one or more cable leads emerging from the battery, and relay in one point of enlry onto the desired unit(s). The battery is in fraclavicularly implanted or miniaturized and situated between both layers, externally or internally rechargeable through thermocouple technology.

Hemodynamic data in formation from the circulation, heart and body dynamics as wel l as battery programmable parameters are transmitted between the embodiment and the battery through one or more cables leads ( 13 , 14, and 20) as mentioned above.

Hach embodiment connects internally through a network of fine cables between its both layers, with many electrodes ( 18) that serve as sensors, relay stations and booster to signal and power. The electrodes intcrmittnetly lie along the course of these fine cables. Hach embodiment unit connects to its neighboring one, through bridging cables ( 1 9); either horizontal; when side-by-side units ( 1 and 2//3 and 4) or vertical; when longitudinal units ( 1 and 3//2 and 4).

The embodiment paces in single chamber and up to quadrichamber mode. Also a deflb/DC shock facility when ICI. All programmable features will control systole and diastole as regards rate (r), power (p), duration (d) and distance o f movement (d) ("collectively referred to as "ddrp") according to the sensed hemodynamics. Unlike pacemakers which allow rate response only to native heart tissue, the embodiment allows "ddrp ^" response to an authentic guaranteed-response non-native tissue.

BRIEF DESCRIPTION OF DRAWINGS :-

Th present invention is illustrated and described herein with reference to the various drawings, in which like reference numbers denote like method steps and/or system components, respectively, and in which:

FIG.1 is a schematic diagram for an intra cardiac plant-total artificial heart (Κ - ΤΛΠ) and the application sites and connections with preservation ofthe inner structures o the application chamber.

FIG.2 is a schematic diagram ofthe KT-TAII embodiment of the present invention using built-in electrodes, fine cable connections within and to all chambers.

FIG.3 is a perspective view of a longitudinal spring or elastic fibers in a concertina manner.

FIG.4 is a perspective view of crossing diagonal bands of fibers.

FIG.5 is a perspective view of diagonal crossing intersecting band of elastic fibers of an exemplary embodiment ofthe present invention, showing "SNVHMN" FIG.6 is a perspective view of sheets with KM Coils that are adhered to both layers internally ol ^' the present invention.

FIC.7 is a perspective view of the operating parts that constrict at the level of the absent mitral valve to prevent mitral re urge in systole. The left heart is turned into a single chamber.

FIG.8 is a perspective view of the electromaganetic system that operates the concertina elastic fibers and/or spring, the elastic crossing diagonal libers, the elastic crossing diagonal intersecting fibers with KM node or SN node and sheets of KM coils.

DETAILED DESCRIPTION OF THE INVENTION :-

Referring now specifically to the drawings, and specifically to the medical implant of the present invention as illustrated in Fig. 1, the body (1 ) is formed of 2 layers consisting of layer 1 (16) and layer 2(17). Layer 1 (16) rests on the cardiac endocardium (when Id but not when TAII) (12). Kaycr 2 (17) reflects from layer 1 and faces the cardiac cavity (when ICI) or the replaced chamber cavity (when ΤΛ11) from inside; right atrium (1 ), left atrium (2), right ventricle (3) or left ventricle (4), or a combination of more than one. The cardiac epicardium (11 ) is free from any attachments. The interatrial septum (9) permits a connecting bridging cable ( I 9) to single station and the interventricular septum (10) also permits a connecting bridging cable (19) to a single station; both to LA (2) and LV (4) units respectively These cables permit the left-sided embodiment to connect to the battery (21 ) with or without right-sided embodiment implantation. A separate cable lead (13) from the battery (21 ) supplies the right atrium (RA) (1 ) and/or the left atrium (LA) (2) units. Another separate cable lead (14) from the battery (21 ) supplies the RV (3) and/or the LV (4) units. Both cable leads (13 and 14) reach the heart through the superior vena cava (5) while the inferior vena cava (6) holds none.

Looking at the internal attachment; the "ICI" embodiment can be attached to the "whole" inner chamber cavity, with preservation of the inner structures. The traction and release offered by the device movement to the ventricular myocardium will spontaneously initiate opening and closure of the mitral valve (8), through pressure gradient, thus permitting normal mitral diastolic properties.

One embodiment of the present invention is illustrated in figure 2 connects to all units through a single cable lead (20) connecting the battery (21 ) to a single station electrode ( 18) in RA unit ( 1 ). This cable lead (20) leaves the Battery (21 ) to the SVC (5) where it terminates in RA unit electrode(s) (18). From this clectrode(s) ( 1 8), data is interchanged between the embodiment and the Battery (2 1 ), as well as power supply source. These electrodes ( 1 8) interchange data as well with other cardiac chamber un its through bridging cables ( 1 9) that cross from one chamber unit to another. Bridging cables ( 19) cross from RA unit ( 1 ) to LA unit (2) through interatrial septostomy (9) and from RV unit (3) to LV unit (4) through

interventricular septostomy ( 10) all at single point in each location. Llectrodes ( 1 8) serve as hemodynamic and static/dynamic sensors, relay and booster stations: to data in both directions, and power source.

As shown in Figure 3, clastic fibers and/or spring 'concertina' (22) attach to layer 1 ( 1 6) from one end (23 ) and to layer 2 ( 1 7) from the other end (24). The end (23) of concertina (22) lying on layer 1 ( 1 6) connects to the Battery ( 2 1 ) and the other free end (24) compresses and springs out. The spring out (25 ) expresses the cardiac contraction in systole, while the compression of the concertina (26) expresses cardiac diastole. Both can be to variable programmable distances, hach elastic fiber or spring (22), contains several connected operating parts from inside. These parts are elastic element (reference numeral 33 in Fig. 8), electromagnetic coil (reference n umeral 34 in Fig. 8), ferromagnetic core (reference numeral 35 in Fig. 8 ) and spring (reference numeral 36 in Fig. 8) shown and explained in Fig. 8. The FF, FMC & FMC can be arranged in several layers of sheets (not shown) instead of spanning the distance between layers 1 & 2 in a single application. This multilayercd-shcets with the HM appl ication upon, has the advantage of providing an integrated force with less HM field dispersion into the suurounding media. f igure 4 illustrates crossing diagonal band(s) of elastic fibers (27) from one point on layer 2 ( 1 7) to the facing point on an opposing elastic fiber (27). Figure 4 illustrates the alternating polarity which allows traction (black arrows inside fibers show direction in systole). Diastole (not shown by the arrows inside the fibers) is caused by release in the opposite direction to systole. Tastic fibers (27 ) are attached to the surface of layer 2 ( 17) or from inside layer 2 (not shown). Finally the battery

( 2 1 ) connects to the base of one or more fibers (27). Hach clastic fiber or spring

(22) , contains several connected operating parts from inside. These parts arc elastic element (reference numeral 33 in Fig. 8), electromagnetic coil ( reference numeral 34 i n Fig. 8), ferromagnetic core (reference numeral 35 in Fig. 8) and spring (reference numeral 36 in Fig. 8) shown and explained in Fig. 8.

Crossing diagonal band(s) of clastic fibers (27) from one point on layer 2 ( 1 7) to the opposite facing fiber is illustrated in Figure 5. These fibers (27) meet and intersect at an electromagnetic node ' HMN' (28) or being a simple node 'SN ' (28) serving only as a meeting point. This F ^' MN (28) has a fixed polarity but with variable programmable magnitude. These fibers (27) arc attached to the surface of layer 2 (17) or from inside layer 2 (not shown). Finally the battery (21 ) connects to the base of one or more fibers (27)through electrodes and fine cable network. The electromagnetic variation delivered to these fibers changes their polarity. This results in their attraction to the HMN (28) 'systole ¹ (black arrows inside fibers show direction in systole) representing systole. Repulsion from the HMN (28) 'diastole' (not shown by the arrows inside the fibers) is caused by release in the opposite direction to systole. Λ sheet (29) of HM coil(s) (as explained in the next figure) may be applied on the inner wall of layer 1 (16). This sheet contains HM coils (34) with polarities similar to that on layer 2 (17) -attached fibers. The effect of this similar polarities is smoothing the return of layer 2 (17) in diastole so that it does not push layer 1 (16) further outside from the center of the cavity. During systole, this similar polarity will help push layer 2 (17) towards the cavity center. The magnitude of polarity of this sheet may be variable. The SN (28) functions as a point of intersection where all crossing fibers (27) meet. The SN (28) is a central station that allows crossing fibers (27) to shorten their limbs equally without having one limb shortening more pronounced than the other. As a result of the almost equidistant shortening and lengthening of each limb of each fiber (27), the corresponding layer 2 ( 17) is attracted and repelled to and from the center of the cavity. Hach elastic liber or spring (22), contains several connected operating parts from inside. These parts are elastic element (reference numeral 33 in Fig.8), electromagnetic coil (reference numeral 34 in f ig. 8), ferromagnetic core (reference numeral 35 in Fig.8), and spring (reference numeral 36 in Fig.8) shown and explained in (Fig. 8).

Figure 6 illustrates sheets with EM coils that are adherent to both: layer 1 and layer 2. Layer 1 ( 16) of embodiment contains an internal sheet of material (29) composed of FM coils (reference numeral 34 in Fig.8). Layer 2 ( 1 7) also holds another internal sheet (30) of LM coils (reference numeral 34 in Fig.8) (as explained in Fig.8). Both FM coils are set up facing each other. One sheet (29 ) has a fixed bul v ariable programmable magnitude of LM coil polarity. The other sheet (30) has alternating LM coil polarity with variable magnitude as programmed. With both sheets (29 and 30) having the same FM coil polarity, one sheet (30), with its corresponding attached layer ( 1 7), is shifted away causing systole. When both sheets (29 and 30) have different LM coil polarities, the same sheet (30), with its corresponding attached layer ( 1 7), moves towards the other ( 1 6) causing diastole. Magnitude of electromagnetic field polarity determines the extent and distance, layer 2 ( 17) is moving. Electromagnetic Field magnitude and direction is supplied through the battery (21 ) which connects to the sheets (29 and 30) from inside through electrodes and fine cable network. Each elastic fiber or spring (22), contains several connected operating parts from inside. These parts arc elastic clement (reference numeral 33 in Fig.8), electromagnetic coil (reference numeral 34 in Fig.8), ferromagnetic core (reference numeral 35 in Fig.8) and spring (reference numeral 36 in Fig.8) shown and explained in Fig. 8).

The operating parts constrict at the level of the absent excised mitral valve to prevent mitral regurgc in systole, also known as MV surrogate. For example and as illustrated in Fig. 7, The embodiment layer 2 ( 17) opposing walls at the level of the absent mitral valve (8), approximate with more inward protrusion towards the cav ity center (32) in ventricular systole causing a constriction (32 ) that represents functional and positional mitral valve (8), also known as MV surrogate. This prevents the escape of blood in systole, from FV (4) into the FA (2) and permits full How of blood into the aorta (3 1 ). Programming the constriction (32) is del ivered through the embodiment connection to the battery (2 1 ). In diastole, (not shown), the constriction (32) disappears. Same applies to the right heart.

In Fig. 8, Λ illustrates a diastole that is caused by electrical connection to the ferromagnetic part (35) and FM coil (34). Each elastic element (33) shortens by the effect of FM forces. Similar polarities repel and di fferent polarities attract each other. This mechanism suits the crossing elastic fibers (reference numeral 27 in Figs. 4 and 5) with (Fig. 5) or without (Fig. 4) the intersecting electromagnetic node (28) or the simple node (28). This is also suitable for the elastic fibers (reference numeral 22 in Fig. 3 ).

In Figure 8, B illustrates systole that is caused by electical connection to the ferromagnetic part (35) and HM coil (34). Fach elastic element (33 ) lengthens by the effect of HM forces. Similar polarities repel and different polarities attract each other. This mechanism suits the crossing elastic fibers (27 in figs. 4&5) with (fig. 5) or without ( fig. 4) the intersecting electromagnetic node (28) or the simple node (28). Also suits the elastic fibers (22 in fig. 3).

In Figure 8, C illustrates the mechanism of clastic fiber/spring (22 in fig. 3 ) shortening and lengthening through the spring (36) between the 2 fibers. The movement starts with the electromagnetic application and depends upon the intensity of the current. The electric current direction is fixed, thus feeding the HM coils (34) at the 2 ends of the spring (36), each with a fixed but di fferent polarity than its neighbor, i.e. one end is always 'North', the other end is always 'South'. Because this polarity is always different in the adjacent coils, the springs (36) and fibers (33 ) shorten (i.e. contract). The resultant shortening initiates and maintains diastole. When one keeps the same electric current direction, (i.e. both ends of the spring (36) maintain their unl ike polarities), but with less intensity, the spring (36) lengthens, initiating and maintaining systole. In the present application, the springing out of the fibers (33 ) or spring (36), need be stronger to face the high blood pressure, the polarity of one end of the spring (36) shi fts between similar and dissimilar to the other. In such a case, when similar polarities exist between both ends of the spring (36) and l ber (33 ), repulsion occurs and systole is maneuvered. When both ends of the FM coils (34) are dissimilar, attraction occurs and diastole ensues. This mechanism also suits the elastic crossing fibers (reference numeral 27 in Fig. 4) and the elastic crossing intersecting fibers (reference numeral 27 in Fig. 5 ).

In f igure 8, D the HM coils (34) illustrated show repulsion when their polarities are similar causing systole. They show attraction when their FM coils (34) arc different, causing diastole. This mechanism suits the sheets of material (reference numerals 29 and 30 in Fig. 6).

All operations in the above mentioned applications depend upon the electric current connected to the electromagnetic coils (34).

The functions and programmable parameters in the embodiment include: Native Heart Rhythm (NHR) (with ICI embodiment): Sensing and tracking intrinsic "P" and "R" waves. Where a sensed event initiates a movement that augments the sensed signal. This forti fies systole and increases cardiac output (COP). In case, native signal is sensed, the embodiment functions as the ordinary pacemaker but in a continuous pacing mode.

Regular Implant Rhythm (RIR) Where no intrinsic electrical event, the embodiment Hres a signal to drive the heart. This dominates until sensing of an event ( with ICI) sh i ts the embodiment to the Nl IR once more. In such a condition , LV (4) fi l l ing will be reduced to only "Adequate Filling Phase" comprising the whole diastole. There will be no Rapid, Slow or Diastasis.

Defibrillation and DC shock deliveiy (with Id) Upon sensing a supraventricular (RA/LA) or a ventricular (RV/LV) tachycardia or fibrillation, the embodiment attempts to terminate it by delivering a programmable number of DC/Defibril lation shocks. Once the atlempl(s) succeed, the ICI embodiment drives the heart in NHR. Upon failure of reversion, the ICI embodiment ignores the dysrhythmia and switches to the RIR. There is no more immediate benefit from reverting to sinus rhythm. The ICI will function as a native heart muscle pump. More attempts of cardioversion may be delivered at a later programmable time that ranges from minutes to days. The application of an ICI embodiment in one chamber and not the neighboring chamber mandates dysrhythmia termination in the free chamber. I f a dysrhythmia emerges in a free chamber while its neighboring chamber casts an embodiment unit, one chamber will function properly and the other free chamber will function in dyssynchrony with its neighboring chamber. So this cadioversion illustrates the importance of dysrhythmia termination otherwise neighboring side-by side, chamber installation, of the embodiment is mandatory to guarantee intcr-chamber synchrony.

In case both side-by side chambers hold an embodiment, ignoring the dysrhythmia ( wi th I(T) is an advantage once cardioversion attempts have fai led. In such a case all embodiment units will function as one electric and synchronous unit.

Restoration of normal Λ V valvar sequence Ventricular Systole; eg.; on left heart; wi l l close the mitral val ve (8 ) because the pressure in the LV (4) at this stage will be higher than the LA (2) pressure and this permits mitral valve closure. Diastole will open the mitral valve, because at this stage, the LA increasing pressure will force the mitral valve open. The embodiment will deliver an atrial k ick (atrial systole) upon a programmed interval (similar to dual chamber pacers). In case where the mitral valve (8) is absent, the embodiment itsel f wil l serve as a functional and anatomical mitral valve; MV surrogate. It protrudes more at the site of the absent mitral valve forming a constriction replacing the valve in systole. In diastole, the reverse occurs. The same applies to the right heart.

Correction of Dyskinesia, Intra-, and Interventricular dyssynchrony The embodiment application solves the problem of dyskinesis in wall motion due to control led timing and 'ddrp' of systolic contraction and diastol ic relaxation along the different sites of application. SYNCHRONY can be restored between and within the various chambers, (i.e. Inter-, and Intrachambers Rcsynchronisation

This embodiment, unlike pacemakers which electrify the native heart muscle tissues, delivers its pacing to artificial tissue with artificial conducting system under programmable control . This function is not affected by the seventy of native heart pathology. The systole/diastole; start, duration, rate, programmable response, amplitude of movement, force, function and sequence can thus be fully controlled in the desired segments of the embodiment. It can be programmed to mimic exactly the native healthy conduction; thanks to its network of fine cables embedded inbetwecn the 2 layers ( 1 6 and 1 7). Exclusion of ventricular aneurysmal bulge, when covered with the "Id" embodiment, will rid of its mechanical/electrical deleterious effects.

Diastolic function Diastolic dysfunction as well will be completely abol ished and this term will be abandoned. With embodiment, the diastolic duration and extent can be manipulated as desired. The more retraction (relaxation ) done by Layer 2 ( 1 7), the more the accommodated diastolic blood volume.

Optimising venous return and cardiac output Through electrode ( 1 8) scnsor(s) embedded in the walls of the atrial un it of the embodiment and connected to the battery circuitry, it can regulate the early and late diastolic ventricular filling.

During ventricular systole, blood volume and pressure in LA (2 ) are rising due to pulmonary venous drainage, lasting until the end of isovolumic relaxation phase. The sensor would now feel the weight and pressure of blood column in the LA and causes the MV barrage (native, artificial, or surrogate) to open. This opening will be maintained for a period of approximately a little >0.3 sec (the normal rapid ventricular and reduced ventricular filling) after which the atrial kick is delivered by the embodiment. The embodiment unit atrial kick starts by sensing the fall down in LA pressure during reduced ventricular diastasis, that normally gives way to the native atrial systole. Same appl ies to right heart side.