JP5298132B2 - Heart compression system - Google Patents

Description

  The present invention relates to a cardiac compression system, and in particular to a cardiac resynchronization compression sack system.

(Direct heart compression)
The concept of morphology as a circulatory support for a direct cardiac compression (DCC) system comes from emergency resuscitation of the heart and lungs. Compared to other existing assistive heart devices (Venticular Assist Devices, VAD), the most unique advantage of DCC is that it does not come into contact with blood. By applying pressure directly to the heart that has lost compression, the external DCC device can increase ventricular contraction and increase cardiac output. The DCC can be realized by the following method (but not limited to this).

  (A) Skeletal muscle pump: This dynamic cardiomyoplasty uses the left latissimus dorsi muscle membrane to compress the decompensated heart. This requires time for muscle training and conversion, so the patient's condition is less urgent and requires sufficient transient time to make the muscle membrane functionally effective after surgery. Dynamic cardiomyoplasty is no longer used because of the short muscle compression time. The main problems of muscle anti-fatigue and skeletal muscle conversion to myocardium have not been solved.

  (B) Mechanical pump device: This type includes devices such as, for example, Anstad Cup, CardioSupport System, Heart Booster, Heart Patch. A biocompatible material is used to form a sac or cuff-like device for applying a compression force from the outside. The main design issue is how to mount and secure the device on the surface of the heart. Usually continuous adsorbing force, adhesive bonding, or fixed sutures are used. Injury complications include myocardial contusion, ischemia caused by coronary squeezing, and frequent arrhythmias due to asynchronous mechanical compression. Despite considerable efforts to extend the duration of use of DCC, so far DCC devices have been used only in a short-term manner. On the other hand, the cardiac patch DCC uses a stand-alone non-enclosed patch placed on the ventricular free wall. Epicardial adhesion due to tissue penetration of porous silicon material used as a membrane in contact with the heart is observed. Such an immobilization method can avoid the use of continuous adsorption force and can be intended for long-term use. Every DCC device shows an effective increase in cardiac output. Nevertheless, long-term efficacy has not been shown, and complications that may arise due to improper fixation and epicardial actuation require further study.

(C) Passive mechanical restraint: This type of device only provides a restraining force to prevent further dilation of the heart. Avoidance of pathological increases in diseased hearts has been set as a design goal. Enhanced cardiac contraction is severely limited by the small amount of elastic energy the sac stores in diastolic structural deformation. Acron heart assist device (
The Cardiac Support Device (CDS) is a typical device. Acron CDS is an elastic fiber net wound around two ventricles below the atrioventricular groove. Long-term clinical trials have shown that Acron nets fuse with the epicardium to cause myocardial fibrosis, leading to reduced cardiac contractility.

(Heart resynchronization therapy)
Cardiac resynchronization therapy (CRT) has emerged as a novel and less traumatic treatment for congestive heart failure (CHF). About 30% of CHF patients suffer from dilated or ischemic cardiomyopathy, of which myocardial conduction delay appears in the form of a left leg block, and conduction heterogeneity is often observed. Electrical stimulation allows the CRT to readjust the contractile synchronization between the left and right ventricles and between muscle segments in the left ventricle (LV). Biventricular and left ventricular pacing modes have been found to be most effective in short-term studies and long-term CRT tests. With the exception of refractory advanced heart failure, patients with conduction impairment who have undergone CRT generally exhibit improved heart failure functional severity classification, quality of life, and cardiac ejection fraction.

  After short-term ventricular pacing, short-term hemodynamic improvements were observed, including increased LV pressure range dp / dt, increased aortic pulse pressure, and increased mean systolic pressure. A 6-month long-term CRT study, tested on 25 patients, showed a reduction in left ventricular volume in most advanced heart failure patients. A similar large randomized CRT study in 453 patients with moderate to severe heart failure (randomly classified into control and CRT groups) also showed improved hemodynamics and functional severity classification of heart failure It was. Confirming that CRT leads to reverse cardiac remodeling requires a longer study period for larger patient groups, but reduces wall stress, myocardial oxygen consumption, and mitral regurgitation The results of this treatment have already proved the overall effect of CRT.

  Pathologically dilated ventricles not only reduce myocardial contractility, but also cause uneven interventricular and intraventricular conduction delays, leading to inefficient use of muscle energy during systole. Pacing with controlled atrioventricular conduction delay can reduce this heterogeneity and does not cause an increase in LV oxidative metabolism. With the exception of severely damaged myocardium, CRT increases pulse pressure and pulse strength in certain patients and is shown in terms of higher dp / dt in addition to improving overall symptoms and ejection fraction. The therapeutic principle supporting this conduction readjustment is clear. Myocardial contraction, the end point of electrical stimulation, is resynchronized and functions in a more efficient manner, reducing abnormal contraction loads and myocardial metabolic oxygen demand.

  Electrophysiological alterations are often observed in patients with advanced heart failure who have long-term left ventricular assist device (LVAD) circulatory support. Reportedly, LVAD support has led to shortening of the QRS width on the EKG waveform, indicating a change in myocardial stress state. In addition, the QT interval that reflects the repolarization of the reflecting muscle cells initially shows a short-term extension and subsequently a long-term shortening. Both QT prolongation and dispersion, and increased QRS duration are abnormal action potential characteristics associated with chronic heart failure. LVAD assisted circulation that immediately reduces pathologic myocardial stretch caused by overload conditions creates short-term changes in inward current across the ion channel, which may lead to an extension of the initial QT interval is there. However, reverse myocardial repolarization occurs after weeks or months in a sustained cardiac assisted circulation. In many LVAD assisted circulation patients, it has already been shown that muscle cell hypertrophy, ion homeostasis, cell relaxation, and adrenergic responsiveness have been remodeled in reverse. It is not clear whether reversal of these electrophysiological trends is caused by shortening the myocardium or increasing conduction velocity, but mechanically assisted circulation is a key role in reverse remodeling of heart failure consistently assisted by its LVAD Is shown.

  The object of the present invention is to avoid the disadvantages associated with the previously developed DCC devices, provide therapeutic cardiac contraction assistance and relaxation suppression in the long term, and support advanced heart failure. It is an object of the present invention to provide a cardiac compression system in which an implanted device can be applied in the long term without complications and can be easily removed at the end of support.

  The design of the Cardiac Resynchronization Compression Sac System (CRCSS) of the present invention aims to avoid the disadvantages associated with the previously developed DCC devices. The CRCSS of the present invention is intended to provide long-term therapeutic cardiac contraction assistance and relaxation inhibition to support advanced heart failure. The design goal is bridge-to-recovery, which requires that the implanter be applicable in the long term without complications and easy to remove at the end of support. For this reason, hard fixation methods, such as continuous vacuum suction, suturing, epicardial adhesion fixation, etc., have been abandoned because they do not meet the design goals of the present invention for long-term application and bridging recovery. Instead, a new “soft-fixation” design concept is proposed as described below.

  The heart compression system of the present invention includes an outer shell customized to substantially match the shape of a part of the heart acquired by an imaging system, and a pericardial fluid delivery provided on the outer shell. And at least one inflatable balloon attached to at least one predetermined location on the inner surface of the outer shell, wherein the outer shell is naturally positioned in the pericardial space It is not necessary to use an artificial force to prevent detachment from the heart, and the inflatable balloon is inflated to compress at least one ventricular free wall of the heart.

  The selection of the DCC location in the CRCCS of the present invention is based to some extent on the clinical results obtained during cardiac resynchronization therapy (CRT). In the CRCSS device of the present invention, the ventricular free wall section is selected as the location for applying epicardial compression force. For this reason, the applied pressure not only adds mechanical energy to the bloodstream, but also acts as a mechanical stimulus for resynchronization of the myocardial contraction, hopefully in the long-term diseased heart electrophysiological reverse. It is also possible to induce remodeling.

The sac design of the present invention plays multiple roles in facilitating having the diseased heart perform reverse remodeling. In addition to passive mechanical suppression achieved during diastole, cardiac contraction support via epicardial compression promotes hemodynamic and electrophysiological trend reversal. In the treatment of conduction abnormalities, the action of biventricular compression on the free walls of the right and left ventricles is particularly important, as implied in electrical CRT therapy. The mechanical and electrical behavior of the heart is interactive. With the exception of refractory heart failure, the mechanically assisted circulation of the diseased heart can be returned to a healthier state in which the action potential dysfunction associated with maladaptive muscle cells has been restored. In addition, by synchronous stimulation of the myocardium in the interventricular or intraventricular manner, the electrical conduction retraction can promote more uniform cardiac contraction, leading to higher contraction efficiency.

  Implementation of DCC by increasing the overall ventricular contractile force externally, rather than by reducing the vascular afterload, may also create a myocardial assisted circulation environment. That is, reverse remodeling reflected in electrophysiological changes caused by reduced vascular postload observed in the LVAD support group is expected to appear in patients with DCC assistance, regardless of the different application forces . Epicardial compression can effectively reduce or cancel transmural tension on the contacting epicardial region. Actuation of free-wall DCC can immediately relieve myocardial stress conditions around the most conductive sensitive areas, thus leading to therapeutic electrophysiological stimulation leading to cellular remodeling in moderately diseased hearts It is assumed that DCC is the best application method.

  For ventricles with infarcted myocardium with scar tissue, pacing CRT may not correct intraventricular conduction delay and dispersion. If the myocardial conduction network is damaged and cannot be bypassed by initiating another independent stimulus that ignores the external route or conduction block area, pacing-induced synchronous contraction is in principle not feasible. However, there is no such limitation in the mechanical CRCSS. As long as the sack compression is activated by setting an appropriate timing, the assisting myocardium as a whole follows the DCC force rhythm based on EKG, whether or not the conduction network is healthy. When the heart is supported by the CRCCS means of the present invention, electrophysiological reverse remodeling should appear, which is a value-added result rather than a resynchronized, stress-relieving myocardial contraction factor Is considered.

The CRCSS of the present invention makes extensive use of these electromechanical interactions associated with cardiac cell behavior. From either the mechanical or conductive perspective, the ventricular free wall is the best candidate area for DCC applications. In order to keep the CRCSS in the correct position at all times and to accurately press the free walls of the two ventricles, the CRCSS requires special force alignment and structural arrangement, where a fixed design is essential. In the present invention, soft adaptation (
a soft-fitness) strategy, which is enhanced by an EKG reference feedback control system. Special attention is paid to CRCCS drive line and fluid supply control designs to provide synchronized simultaneous compression for the right and left ventricles.

1 is a schematic diagram of an exemplary embodiment of the present invention (cardiac resynchronization compression sack, CRCS) and components. FIG. 6 is a schematic diagram of another embodiment (cardiac resynchronization compression sack, CRCS) and components of the present invention. It is a three-dimensional view which shows soft fixation when CRCS is attached on the heart. It is sectional drawing in the AA line | wire at the time of the end of the diastole of CRCS of FIG. 1A. It is sectional drawing in the AA line of the cardiac contraction period of CRCS of FIG. 1A. It is sectional drawing in the AA line | wire at the time of the end of the diastole of CRCS of FIG. 1B. It is sectional drawing in the AA line of the cardiac systole of CRCS of FIG. 1B. It is the perspective view of the drive line pressure regulator attached on CRCS, an enlarged view, and the three-dimensional perspective sectional view in the BB line. It is a block diagram which shows control of a CRCS system (a solid line is a drive line, a dotted line is a control line).

  This specification includes drawings to illustrate certain elements of the invention, and these drawings are appended to and constitute a part of this specification. Reference will now be made more clearly to the specific concepts of the present invention and of the system components and operations provided by the present invention with reference to the illustrative (and thus non-limiting) examples of the drawings. The same reference numbers in these drawings represent the same member (if they appear in more than one drawing). The invention can be more clearly understood with reference to one or more of these drawings in combination with the description herein.

(CRCS design goals and examples)
The main problems associated with CRCS implementation are fixation and synchronous sac actuation in response to cardiac contraction and relaxation. Pump stimulation should be applied over the ventricular free wall area to stimulate electrophysiological reverse remodeling. The CRCS design of the present invention is intended to provide biventricular epicardial compression in synchrony with the cardiac rhythm, of which atrioventricular conduction delay control and simultaneous left and right heart assistance are design goals for realization. Hereinafter, the fixation method and the cardiac resynchronization pump design will be described.

  (A) Soft-fixation: Here, hard fixing methods such as vacuum suction, adhesive bonding, and suture fixing are excluded. Instead, consider a soft fixation strategy in which a non-interfering sac can be placed near the heart. Soft fixing means a fixing method in which a device is positioned or wound around a target object with a low contact pressure and a minimum allowable gap. Based on this definition, when the device is mounted on its target object, soft anchoring does not violate the original functional goals and does not induce bad side effects due to the excessively close contact that occurs during the mounting. Wearing shoes is a good example of this. The shoe is intended to be worn on the foot without interfering with or interfering with the function of walking. A suitable space is maintained between the shoe and the foot, which protects the foot from injury-causing contact and makes walking a comfortable experience. If the gap is too large, the shoes will come off, and if it is too small, it may cause trauma or ecchymosis due to compression or friction. For this reason, the form's properness and fitness are important factors for successful good soft fixation.

Viewed from the heart's anatomy, the heart is surrounded by a fluid-filled pouch called the pericardium. The natural space between the heart and pericardium is where the CRCS is attached.
In the CRCS design of the present invention, accurate replication of the heart shape at the end of diastole is the key to successful soft fixation. The shape and volume of the CRCS must not prevent the right and left ventricles from filling during diastole. Prior to surgery, an imaging system (eg, X-ray, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (preferential echocardiography)) is used to pre-define cardiac anatomy. Imaging can be useful for mapping a diseased heart. The outer shell of the CRCS is formed using a proportional form that is similar but slightly larger in geometry created from the imaged contours of the heart of interest. A clear space (usually 5 cc to 15 cc) formed between the natural heart and the CRCS shell is reserved for compatibility adjustments, as described below. Customization of the pre-shaped shape allows the CRCS to be securely placed in the patient's thoracic cavity. Thus, when resecting the incised pericardium, the best soft fixation is obtained if the CRCS implant is wrapped as closely as possible to the heart anatomy. By sandwiching the CRCS between the surface of the heart and the pericardium, the pericardial space can be used as a natural cradle to accommodate the implanted sac. During the healing process, pericardial fluid is produced and this interstitial fluid acts as a lubricant to protect the heart surface from damaging contact during sack operation.

  At the time of construction of the CRCS outer shell, the thickness of the outer shell is determined by the non-extensible requirement. For example, when biocompatible polyurethane is used as a sack material, a thickness of 0.2 to 1.5 mm is usually sufficient. This anatomically conformable non-extensible shell helps the compression force be applied directly to the heart when applying an external force. It should be noted that the constructed CRCS is generally deformable and has shape retention. During insertion, after several pump strokes, the sac is stabilized in its most suitable position. A suitable CRCS implant does not affect diastolic filling, which is reflected in venous return pressure. Such automatic sack placement and incoherent support related to cardiac function has been confirmed in animal experiments conducted in the inventor's laboratory. By adjusting the volume of buffer fluid derived by observing venous pressure or atrioventricular pressure before and after surgery on the left and right hearts, it can be fine-tuned for optimal suitability.

1A and 1B show two embodiments of the CRCS designs 100A and 100B of the present invention.
The conical shape reinforces the structure around the highest point of the CRCS. This highest point portion with enhanced hardness serves to facilitate the insertion of the CRCS into the incised pericardial space and is an ideal location for the exit of the drive line 105. A Teflon (registered trademark) cuff can be attached around the connection point between the sack and the drive line. When closing the pericardium, suturing this cuff over the pericardium can provide additional assurance for soft fixation.

  Similar image rendering and manufacturing methods can be utilized to create the CRCS diaphragm 102. The CRCS diaphragm 102 is thin and is typically about 10-100 microns thick. This shape-retaining flexible CRCS diaphragm 102 can be easily deposited on the surface of the heart, especially when an inert polymer material is used as the diaphragm material. In contrast to conventional DCC devices, the fluid (liquid or gas) contained within the space defined by the outer shell 101 and the CRCS diaphragm 102 is not used as a direct force transmitting medium. This fluid acts as a buffer or buffer that can be adjusted to achieve optimal anatomical compatibility either before or after surgery. The drain tube 107 and skin button assembly can be connected to the CRCS shell (see the embodiment of FIG. 1A), so that buffer adjustments outside the body can be made when needed. 3 and 4 illustrate the relationship between the systole and diastole pericardium, ventricle, CRCS diaphragm 102, balloons 103 and 104, and outer shell 101, respectively. FIG. 1B is another embodiment that does not require buffer adjustment. An opening 101a (for example, a penetration hole) opened in the outer shell allows pericardial fluid to freely pass through the sac wall surface. This design allows automatic adjustment of the buffer in 1 beat units.

  In the application of DCC, ischemic complications have been reported because epicardial compression may compress the coronary vascular bed during assisting contractions. The present sac design can alleviate this complication. With the exception of the free wall area, the soft contact provided by the coating with the non-pressurized septum does not affect most coronary arteries when a compression force is applied.

  (B) Cardiac resynchronization DCC support: A pair of balloons 103, 104 are used to implement the DCC of the CRCS design of the present invention. FIG. 2 shows the placement position of the balloon relative to the shape of the heart receiving assistance. These left and right balloons are mounted on the inner surface of the outer shell, and are arranged so that the center of gravity of the balloon is aligned with the center of the free wall of the left and right ventricles. A balloon stroke volume (20-80 cc) can be selected based on the specific heart condition of each patient at different implantation stages. In the initial assist period, full capacity can be provided, for example to increase to the required cardiac output. However, when the heart recovers with a decrease in ventricular volume and muscle mass, the stroke volume of the balloon can be reduced accordingly, which allows a step-by-step reduction to the heart until the support of the sac is broken. is there. Adjustment of the stroke volume of the balloon requires special consideration of the contractile action of the ventricle. For example, in a situation where the heart contracts during recovery, the gap between the CRCS shell 101 and the epicardium increases so that a certain stroke volume pump gradually loses its DCC pumping efficacy. Whether the pumping stroke volume should be changed after CRCS transplantation is determined by the actual patient condition and treatment plan by the physician.

  The balloon pumping of the present invention is designed to place the compression force on the most important ventricular free wall area. In response to the balloon actuation, the buffer solution between the outer shell 101 and the CRCS diaphragm 102 is redistributed to negate the space replaced by balloon inflation. Since the cardiac output is usually greater than the balloon output, the inward movement of the outer shell 101 has some effect on the fluid volume adjustment, but further ventricular contraction beyond the CRCS stroke limit is caused by pericardial fluid. It is necessary to flow into the empty space and fill it. The synergistic action of this buffer and pericardial fluid movement and outer shell deformation makes the septum a lining attached adjacent to the epicardium, thereby making other types of poor "diaphragm suction". The phenomenon can be avoided. This phenomenon may interfere with myocardial shortening or ventricular contraction during the systolic ejection period of the heart. The embodiment of FIG. 1B is a more preferred design that allows rapid distribution of epicardial fluid through a plurality of openings 101a in the CRCS shell. It should be noted that in the embodiment of FIG. 1A, the balloon is not in direct contact with the heart surface, but is moved relative to the sac's CRCS diaphragm 102, and thus relative to the effect of DCC actuation and epicardial movement. Movement can be minimized. This unique feature can improve frictional contusion and myocardial fibrosis due to the long-term injured contact of the sac that moves relative to the epicardium.

  It should be noted that the CRCS of the present invention is intended to form a kick-off type DCC support to assist systolic contraction. Usually, the stroke volume of the balloon is set smaller than that of the ventricle and is generally 20% to 50% of the natural stroke volume. The operation of a balloon that sets the time by combining QRS intervals only enhances the contraction movement from the start of isovolumetric contraction to at most peak ejection. Thus, epicardial compression assist is reduced to a minimum before reaching maximum contraction, and cardiac relaxation is not affected during diastole. Electrophysiologically, this can minimize the interference experienced by externally applied compression of action potential repolarization. In addition, the kick-off type DCC support provides auxiliary circulation to the heart only in the initial myocardial shortening stage, and contraction is left to the heart itself after the kick-off strengthening period. This partial support feature forms a natural rehabilitation mechanism that prevents the heart from fully committing to mechanically assisted circulation. The complete mechanical assisted circulation of the heart can prevent subsequent myocardial recovery and escape from the device.

  (C) CRCS pumping control: CRCS pumping requires external energy supply. Extracorporeal or internal energy supply systems can be considered. The difference is in the characteristics of the working fluid to be adopted and the drive line 105. For convenience, the operating principle will be described using an extracorporeal air pressure system provided with a percutaneous drive line 105.

  Assume that an extracorporeal drive system with a percutaneous drive line 105 is used for the reciprocal transport of pressurized fluid to an actuated balloon. The left and right balloons 103, 104 can be actuated individually or collectively. Individual balloon drives (not shown) require two percutaneous lines, each with its own pressure source and associated controller. The drive pressure level and synchronous pumping control can be assisted separately for the left or right ventricular characteristics. However, the collective balloon drive is equipped with only one set of drive line and controller system as shown in FIGS. 1A and 1B. After entering the thoracic cavity or pericardium, the percutaneous drive line 105 is divided into a left branch line 105a and a right branch line 105b, each carrying the drive fluid to the required destination. Note that the balloon pressure increase is determined by the inertia and resistance associated with the drive line 105, and the reactant pressure applied by the ventricular wall receiving assistance. In order to achieve simultaneous biventricular pumping, the length and lumen diameter of the right branch line 105b and the left branch line 105a need to be adjusted appropriately. This differential inertia / resistance design may be able to perform collective left and right cardiac assist with better cardiac contraction and relaxation synchrony.

  An advantage associated with the single drive line 105 design is that there is only one percutaneous penetration so that the risk of infectious complications after surgery can be minimized. However, the drawback is in the control aspect, and in assisting the two ventricles, it is possible to achieve optimal pumping level and peak pressure timing control of the two left and right ventricles using only one pressure supply and timing control in principle. This is because it cannot be done. The best CRCS embodiment employs a single drive line 105 design as shown in FIGS. 1A and 1B. Sub-optimal control is set as the control target to be pursued. The pressure level and peak pressure timing are determined primarily based on the left ventricular DCC requirement. However, the right cardiac control parameter is determined by adjusting the length and lumen diameter of the drive line 105 to obtain an appropriate pumping pressure level and a discrepancy between the systolic peak pressures associated with the left and right heart supports, respectively. Can be minimized.

  Fine tuning of the pumping synchrony can be achieved using a pressure regulator 108 that includes a pair of pressure regulator screws 108a mounted on the branch junction of the drive line 105, as shown in FIG. By crushing or releasing the drive line lumen, the delivered flow rate and pressure can be varied. In general, left-right pumping synchrony is pre-determined with a prior analysis on the best assignment of different right-left inertia / resistance parameters. Fine adjustments can be made when the sac is implanted, providing the surgeon freedom in pre- and post-operation adjustments and finding optimal cardiac contraction synchrony.

  FIG. 8 shows the design of synchronous pumping control. Both the left and right CRCS balloons 803 and 804 have pressure sensors. During surgery, pressure waveforms can be acquired and displayed on a monitor. For example, even when skin cathodes are used, the EKG signal 801 can be acquired and transmitted to the CRCS controller 805. An algorithm for detecting the R wave and the balloon pressure peak value converts the left and right DCC assistance into a time delay for the R wave. A periodic atrioventricular conduction delay time 802 electrically coupled to the CRCS controller 805 instructs the CRCS pumping console 806 to deliver pressurized fluid to the actuation balloon. The synchronization of the left and right pumping can be controlled manually by adjusting the pressure regulator 808. The objective is to minimize the gap that appears in relation to the pressure waveform of the left and right balloons at the deflation peak. In the CRCS control design of the present invention, unless a specific problem occurs, the stroke volume of the balloon is predetermined and set as a fixed value, and is usually selected within a range of about 20 to 80 cc. For this reason, the magnitude of the console driving pressure mainly controls the inflation rate of the balloon. Thus, there are no problems with excessive ventricular pressure.

  An implementation combining kick-off DCC and adaptation to the heart rhythm is useful for realizing the concept of soft fixation presented by the present invention. The kick-off support can minimize fixation interference to the assisted heart and can contract the heart muscle to the maximum extent according to its natural heart dynamics. The kick-off DCC assistance provided by the CRCS design of the present invention offers the unique advantage that it can make an important contribution in promoting the recovery of the mechanical and electrophysiological functions of the diseased heart.

100A, 100B CRCS
101 Outer shell 101a Opening 102 CRCS diaphragm 103, 104 Balloon 105 Drive line 105a Left branch line 105b Right branch line 107 Drain pipe 108 Pressure regulator 108a Pressure regulator screw 801 EKG signal 802 Atrioventricular conduction delay time 803, 804 CRCS balloon 805 CRCS controller
806 CRCS pumping console 808 pressure regulator

Claims (11)

A cardiac compression system, the outer shell being customized to substantially match the shape of the end diastole profile acquired by the imaging system;
At least one opening provided on the outer shell and used for delivery of pericardial fluid;
At least one inflatable balloon attached to at least one predetermined location on the inner surface of the outer shell, wherein the outer shell is naturally positioned in the pericardial space, with the aid of artificial force A cardiac compression system, wherein there is no need to prevent withdrawal from the heart and the inflatable balloon is inflated to compress at least one ventricular free wall of the heart. The heart compression system according to claim 1,
A cardiac compression system characterized in that the contour of the outer shell can be substantially retained. The heart compression system according to claim 1,
The outer shell has a conical shape;
A heart compression system characterized by wrapping around the highest point of the heart. The heart compression system according to claim 1,
A cardiac compression system, wherein the inflation volume of the at least one inflatable balloon is controllable. The heart compression system according to claim 1,
A cardiac compression system, characterized in that the inflation of the at least one inflatable balloon starts at the beginning of isobaric contraction and ends before the peak ejection of the heart. The heart compression system according to claim 1,
The cardiac compression system, wherein the at least one inflatable balloon includes a first inflatable balloon and a second inflatable balloon, and compresses the left and right ventricular free walls, respectively. The heart compression system according to claim 6,
A heart compression system, wherein the inflation volume and timing of the first inflatable balloon and the second inflatable balloon can be individually controlled. The heart compression system according to claim 6,
The heart compression system according to claim 6, wherein inflated volumes and timings of the first inflatable balloon and the second inflatable balloon are collectively controllable. The heart compression system according to claim 1,
A cardiac compression system, wherein the at least one inflatable balloon is inflated through a medium selected from the group consisting of a liquid and a gas. The cardiac compression system according to claim 1, further comprising an elastic diaphragm having a contour similar to the outer shell,
The elastic diaphragm is connected to the inner surface edge of the outer shell, and covers the inflatable balloon,
When implanting the cardiac compression system,
A cardiac compression system, characterized in that only the elastic diaphragm and the heart surface have substantial contact. The heart compression system according to claim 1,
A cardiac compression system, wherein the imaging system is selected from the group consisting of X-rays, computed tomography (CT), magnetic resonance imaging (MRI), and ultrasound.

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