(19)
(11)EP 3 539 118 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
02.12.2020 Bulletin 2020/49

(21)Application number: 17805282.5

(22)Date of filing:  14.11.2017
(51)Int. Cl.: 
G09B 23/30  (2006.01)
A01N 1/02  (2006.01)
(86)International application number:
PCT/IB2017/057098
(87)International publication number:
WO 2018/087733 (17.05.2018 Gazette  2018/20)

(54)

TEST BENCH ASSEMBLY FOR THE SIMULATION OF CARDIAC SURGERY AND/OR INTERVENTIONAL CARDIOLOGY OPERATIONS AND/OR PROCEDURES

PRÜFSTANDANORDNUNG ZUR SIMULATION VON HERZCHIRURGISCHEN UND/ODER INTERVENTIONELLEN KARDIOLOGISCHEN OPERATIONEN UND/ODER VERFAHREN

ENSEMBLE BANC D'ESSAI POUR LA SIMULATION DE CHIRURGIE CARDIAQUE ET/OU D'OPÉRATIONS ET/OU DE PROCÉDURES DE CARDIOLOGIE INTERVENTIONNELLE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 14.11.2016 IT 201600114762

(43)Date of publication of application:
18.09.2019 Bulletin 2019/38

(73)Proprietors:
  • Politecnico Di Milano
    20133 Milano (IT)
  • Universita' degli Studi di Milano
    20122 Milano (IT)

(72)Inventors:
  • FIORE, Gianfranco Beniamino
    20133 Milano (IT)
  • REDAELLI, Alberto Cesare Luigi
    20133 Milano (IT)
  • VISMARA, Riccardo
    20133 Milano (IT)
  • ANTONA, Carlo
    20122 Milano (IT)
  • GELPI, Guido
    20146 Milano (IT)
  • LEMMA, Massimo Giovanni
    20122 Milano (IT)
  • MANGINI, Andrea
    20152 Milano (IT)

(74)Representative: Crippa, Paolo Ernesto 
Jacobacci & Partners S.p.A. Via Senato, 8
20121 Milano
20121 Milano (IT)


(56)References cited: : 
US-A1- 2014 370 490
  
  • ANDREW L RICHARDS ET AL: "A Dynamic Heart System to Facilitate the Development of Mitral Valve Repair Techniques", ANNALS OF BIOMEDICAL ENGINEERING, KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NE, vol. 37, no. 4, 18 February 2009 (2009-02-18), pages 651-660, XP019668350, ISSN: 1573-9686 cited in the application
  
Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


Description

Field of the invention



[0001] • The present invention relates to a test bench assembly for the simulation of cardiac surgery and/or interventional cardiology operations and/or procedures.

Background art



[0002] • One of the purposes of training for cardiac surgeons and for interventional cardiologists is to provide clinical personnel with a certain familiarity and acquaintance with the particular physiological conditions they will have to confront in the course of an intervention which involves the beating heart of a living patient. The aspects which can mainly interfere with the intervention of the clinical operator are of a fluid dynamic nature and due to blood circulation, to the opening and closing of the heart valves and to the deformation of the organ during the cardiac cycles. Hence, there is a need to provide a test bench able to faithfully replicate the physiological conditions of the cardiac cycle.

[0003] . The four cardiac chambers comprise two atria and two ventricles, in which each atrium receives the blood coming from body tissues and flows in a ventricle which in turn flows in an artery. The left atrium and the left ventricle, separated by the mitral valve, form the left heart, which receives blood from the lungs and pumps it in the body, while right atrium and right ventricle form the right heart which receives blood from the body and transmits it to the lungs.

[0004] . Generally, known test benches comprise a heart from a human or animal donor, for example hearts of porcine origin. This heart is generally explanted by cutting the blood vessels directly connected to the atria and to the ventricle but leaving intact a section of the veins and of the arteries as well as the native cardiac valves. Such an explanted heart is incapable of contracting spontaneously to pressurize the fluid received in the cardiac chambers which determines the opening of the cardiac valves to carry out the pumping action for which it is intended in vivo. Therefore, said explanted heart is connected to a pumping system provided in the test bench and comprising one or more pulsatile pumps, as well as a system of hydraulic conduits and containers which simulate the hydraulic impedances out of the heart and into the heart.

[0005] . Usually, the pumping system is connected to the explanted heart by making a hole in the wall of the heart, usually in the apical portion of the heart, and providing a conduit which flows directly into the ventricular chamber. Through this piping the pumping system pressurizes fluid within the ventricular chamber to determine the opening of the aortic outflow valve, out of the left ventricle. Downstream of the aortic valve out of the left ventricle, a piping is provided being connected to a hydraulic impedance and an afterload container, in order to simulate the systemic impedance seen by the heart when it ejects the blood.

[0006] . Known test bench solutions have been designed to model by means of a system of four impedances and four respective containers both the fluid dynamic impedance which the heart sees during the ejection of blood from the ventricle, known as afterload, and the pressure due to the blood returning to the atria, known as preload. In these known solutions, it has been opted to realize as many impedance simulation systems as there are cardiac chambers, because the preload pressure of the fluid flowing into the atria is far lower than the afterload pressure which the blood sees in ejection. For example, solutions of this type are shown in the documents US-2011-0217684, US-2013-0288218, US-2014-0370490, US-2014-0099620, US-2015-0024362 and the non-patent disclosure Andrew L. Richards et al.: " A Dynamic Heart System to Facilitate the Development of Mitral Valve Repair Techniques" (ANNALS OF BIOMEDICAL ENGINEERING, KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NE, Vol. 37 No. 4. 18 February 2009).

[0007] . Solutions of this kind impose large dimensions of the test bench and require the presence of highly qualified personnel to manage them during the installation and utilization of the test bench. These aspects make the test bench difficult to transport, forcing the heart surgeon to go to the place where the test bench is installed. At the same time, this type of test benches is substantially impossible to put in operation without the intervention of specialized technical personnel, forcing the technical personnel to go to the place where the test bench is installed.

[0008] . Thus, there is a strongly felt need to provide a test bench solution which faithfully reproduces the physiological conditions without thereby being bulky or complicated to operate.

[0009] . There is a need to provide a test bench solution which allows to reduce the installation and operation costs of the test bench compared to known solutions, without thereby resulting in diminished functionality or reliability.

[0010] . There is a need to provide a test bench with a reduced number of components and with reduced size compared to known solutions, without thereby resulting in diminished functionality or reliability.

[0011] • There is a strongly felt need to provide a test bench solution which faithfully reproduces the physiological conditions while allowing to reduce the costs associated with the procedures for training the heart surgeon/interventional cardiologist.

Solution



[0012] • It is one object of the present invention to overcome the drawbacks of the prior art mentioned hitherto and to provide a solution to the needs stated with reference to the background art.

[0013] • This and other objects are achieved by an assembly according to claim 1.

[0014] • Some advantageous embodiments are set forth in the dependent claims. The aspects and embodiments of the invention as described hereafter are provided for illustrative purposes and for a better understanding of the invention which is defined solely by the claims. According to an aspect of the invention, a test bench assembly for the simulation of cardiac surgery and/or interventional cardiology operations comprises: a passive heart, in which said passive heart is an explanted or artificial or hybrid heart, said passive heart having at least one pair of cardiac chambers, comprising an atrial chamber and a ventricular chamber;
a reservoir, adapted to house the working fluid; a pressure generator, adapted to provide the pumping function to said passive heart by pumping said working fluid, said pressure generator being fluidically connected both to at least one ventricular chamber of said passive heart and to said reservoir by means of first fluid connection means; a pressure regulation device which provides the working fluid in input to the atrial chamber with the preload pressure, and the working fluid in output from the ventricular chamber with the afterload pressure, said pressure regulation device being fluidically connected both to said atrial chamber of said passive heart and to said ventricular chamber of said passive heart by means of second fluid connection means.

[0015] . According to an aspect of the invention, said pressure regulation comprises a single compliant element for each pair of cardiac chambers, which provides the working fluid with both the preload and the afterload pressures.

[0016] . According to an aspect of the invention, said pressure generator comprises at least one flow intercepting element, for example a solenoid valve, which selectively allows direct fluid connection between said passive heart and said reservoir.

[0017] . According to an aspect of the invention, said pressure generator comprises a kinetic stationary flow rate pump, for example a centrifugal pump.

[0018] . According to an aspect of the invention, said first fluid connection means comprise at least one conduit which flows into the interior of said ventricular chamber of the passive heart, and said conduit comprises an anchoring plug which can be fitted by acting only from the exterior of said ventricular chamber. For example, said anchoring plug comprises a deformable anchoring device adapted to elastically deform to fit into an inlet opening formed in the heart wall which delimits the ventricular chamber of the passive heart to be engaged in undercut against a face of the heart wall arranged in undercut with respect to the outer face of the passive heart.

Drawings



[0019] • Further features and advantages of the invention shall become readily apparent from the following description of preferred embodiments thereof, provided by way of non-limiting example, with reference to the accompanying drawings, in which:

• - figure 1 is a diagrammatic depiction of a test bench assembly, in accordance with one embodiment;

• - figure 1bis is a diagrammatic depiction of a test bench assembly, in accordance with one embodiment;

. - figure 2 is a diagrammatic depiction of a test bench assembly, in accordance with one embodiment;

. - figure 3 is a diagrammatic depiction of the operation during the systole phase of a test bench assembly in left heart configuration;

. - figure 4 is a diagrammatic depiction of the operation during the diastole phase of a test bench assembly in left heart configuration;

• - figure 5 is an axonometric view of an anchoring plug, in accordance with one embodiment.


Description of some preferred embodiments



[0020] • In accordance with a general embodiment, a test bench assembly 10 is provided for the simulation of cardiac surgery and/or interventional cardiology operations and/or procedures. Said test bench assembly 10 is particularly suitable to enable the execution of prosthesis tests, tests of new surgical therapies and the training of a cardiac surgeon/interventional cardiologist, avoiding acting on a living being.

[0021] • Said test bench assembly 10 comprises a passive heart 12. Said passive heart 12 is an explanted or artificial or hybrid heart. For example, said passive heart 12 is a heart from an animal donor, for example porcine or ovine, or it is a heart from a human donor, or it is an artificial heart. The term "passive" means that said heart does not carry out the pumping action spontaneously. Said passive heart 12 has at least one pair of heart chambers 14, 16; 114, 116, said pair of cardiac chambers comprising one atrial chamber 14; 114 and one ventricular chamber 16; 116.

[0022] . In accordance with one embodiment, said passive heart 12 comprises at least one heart valve 18; 19; 118. Said heart valve 18; 19; 118 is a native valve, or it is an artificial valve, or it is a hybrid valve. For example, said heart valve 18; 118 is a mitral valve 18, interposed between left atrial chamber 14 and left ventricular chamber 16. In this case, said test bench assembly 10 simulates the left heart.

[0023] . Preferably, said heart valve 18; 19; 118 is an outflow valve 19, preferably an aortic valve 19 positioned at the output from the left ventricular chamber 16. In accordance with one embodiment, said cardiac valve is an outflow valve 19, preferably a pulmonary valve, positioned at the output from the right ventricular chamber 116. In accordance with one embodiment, said passive heart 12 comprises at least one section of blood vessel. In accordance with one embodiment, said passive heart 12 comprises a section of aorta and a cardiac valve 19 positioned between the left ventricular chamber 16 and the section of aorta, to simulate the aortic valve. Preferably, said passive heart 12 comprises at least one outflow valve 19 positioned downstream of a ventricular chamber of the passive heart 12, for example positioned in said at least one section of blood vessel. Preferably, said outflow valve 19 is adapted to selectively allow the flow of the working fluid 72 out of the ventricular chamber of said at least one pair of cardiac chambers of the passive heart 12.

[0024] . For example, said passive heart 12 comprises a section of aortic arch, or a section of pulmonary artery, or it comprises a section of vena cava. In accordance with one embodiment, said passive heart 12 comprises two pairs of heart chambers 14, 16, 114, 116 each comprising one atrial chamber 14; 114 and one ventricular chamber 16; 116, an interatrial septum 68 which divides the atrial chambers 14, 114 and an interventricular septum 70 which divides the ventricular chambers 16, 116, one heart valve 18; 118 interposed between each atrial chamber 14; 114 and each ventricular chamber 16; 116 and sections of blood vessels connected to each of the ventricular chambers 16; 116.

[0025] . Said test bench assembly 10 further comprises a reservoir 20, adapted to house the working fluid 72. Preferably, said working fluid 72 is a liquid. For example, said working fluid 72 is a liquid having the viscosity of blood. For example, said working fluid 72 is water or an aqueous solution. The provision of such a test bench assembly 10 to simulate cardiac surgery and/or interventional cardiology operations avoiding the need to use blood as a working fluid 72.

[0026] . Said test bench assembly 10 further comprises a pressure generator 22, adapted to provide the pumping function to said passive heart 12 by pumping said working fluid 72, Said pressure generator 22 is fluidically connected both to said ventricular chamber 16 of said passive heart 12 and to said reservoir 20 by means of first fluid connection means 66.

[0027] . Said test bench assembly 10 further comprises at least one pressure regulation device 24 which provides the working fluid 72 in input to the atrial chamber 14 with the preload pressure and the working fluid in output from the left ventricular chamber 16 with the afterload pressure. Preferably, said at least one pressure regulation device 24 provides the working fluid 72 in input to the left atrial chamber 14 with the preload pressure, and the working fluid in output from the left ventricular chamber 16 and downstream of the outflow valve 19, for example the aortic valve 19, with the afterload pressure.

[0028] . Said at least one pressure regulation device 24 is fluidically connected both to said left atrial chamber 14 of said passive heart 12 and to said left ventricular chamber 16 of said passive heart 12 by means of second fluid connection means 64.

[0029] . In accordance with one embodiment, said test bench assembly 10 further comprises at least one additional pressure regulation device 124 which provides the working fluid in input to the right atrial chamber 114 with the preload pressure, and the working fluid at the output from the right ventricular chamber 116 with the afterload pressure, in which said at least one additional pressure regulation device 124 is fluidically connected both to said right atrial chamber 114 of said passive heart 12 and to said right ventricular chamber 116 of said passive heart 12 by means of second fluid connection means 64. Preferably, said at least one additional pressure regulation device 124 provides the working fluid 72 in input to the right atrial chamber 114 with the preload pressure, and the working fluid 72 at the output from the right ventricular chamber 116 and downstream of the outflow valve, for example the pulmonary valve, with the afterload pressure.

[0030] . Said at least one pressure regulation device 24 allows to regulate the pressure of the working fluid both at the input and at the output from the passive heart 12, to simulate the fluid dynamic impedance of the preload and afterload pressures observed in vivo.

[0031] . In accordance with a preferred embodiment, said at least one pressure regulation device 24 comprises a single compliant element 26 for each pair of cardiac chambers 14, 16; 114, 116, which provides the working fluid 72 with both the preload and the afterload pressures. Preferably, said compliant element 26 is a container.

[0032] . Advantageously, said single compliant element 26 for each pair of heart chambers 14, 16 provides the working fluid 72 with both the preload and the afterload pressures while having reduced size compared to known solutions which instead use a first compliant element to provide the preload and a second compliant element to provide the afterload pressure. This allows to make the test bench assembly 10 easily transportable.

[0033] . The provision of a transportable test bench assembly 10 allows to reduce the operating costs of the test bench, because it is not necessary for clinical personnel, who generally have high hourly costs, to travel to the place where the test bench assembly 10 is installed, but it allows to take the test bench to the place where the clinical personnel is located. In accordance with one embodiment, said test bench assembly 10 comprises a support dolly comprising wheels, so as to facilitate transporting said test bench assembly 10.

[0034] . With additional advantage, said single compliant element 26 for each pair of heart chambers 14, 16; 114, 116 allows to provide a pressure regulation device 24 which self-regulates at steady state. This allows to avoid associating electronic sensors and/or control devices with the at least one pressure regulation device 24; 124. In other words, the provision of such a single compliant element 26 for each pair of cardiac chambers 14, 16; 114, 116 allows to provide a self-controlled pressure regulation device 24.

[0035] . In accordance with one embodiment, said compliant element 26 acts as an expansion vessel or tank. Preferably, the hydrostatic head of said compliant element 26 varies when using the test bench assembly 10 to allow the circuit to self-regulate.

[0036] . In accordance with a preferred embodiment, said at least one pressure regulation device 24 comprises an afterload resistance 30 which regulates the afterload pressure. By way of non-limiting example, the afterload pressure is between approximately 50 mmHg (millimeters of mercury) equivalent to approximately 67 millibar and approximately 100 mmHg equivalent to approximately 133 millibar, and the preload pressure is between approximately 5 mmHg equivalent to approximately 7 millibar and approximately 15 mmHg equivalent to approximately 20 millibar.

[0037] . The provision of said afterload resistance 30 allows to generate a systolic pressure in the ventricular chamber 16; 116, for example the left ventricular chamber 16 of the left heart, which is higher than the afterload pressure, so that the mitral valve 18 closes during the systolic phase.

[0038] . In accordance with one embodiment, said second fluid connection means 64 comprise a systole branch 32 which fluidically connects, through said outflow valve, for example said aortic valve 19, said ventricular chamber 16; 116 of said passive heart 12 to said at least one pressure regulation device 24; 124, and a diastole branch 34 which fluidically connects said at least one pressure regulation device 24; 124 to said at least one atrial chamber 14; 114 of said passive heart 12. In accordance with one preferred embodiment, said pressure regulation device 24 allows to regulate pressure in the segment of the systole branch 32 which is between the outflow valve 19 and the afterload resistance 30, both when the aortic valve 19 is closed and when the aortic valve 19 is open. Preferably, said segment of the systole branch 32 which is between the outflow valve 19 and the afterload resistance 30 is positioned downstream of the outflow valve 19, or aortic valve 19, along said systolic path S-S.

[0039] . In accordance with one embodiment, said systole branch 32 comprises said afterload resistance 30.

[0040] . In accordance with one embodiment, said systole branch 32 and said diastole branch 34 join in a section 46 which flows into said compliant element 26.

[0041] . In accordance with one embodiment, said compliant element 26 is a free surface vessel. In accordance with one embodiment, said compliant element 26 is a closed pressurized tank.

[0042] . Preferably, the working fluid in said compliant element 26 has higher pressure than the working fluid in said reservoir 20. The provision of such a pressure gradient favorably allows to determine a movement by gravity of the working fluid towards said reservoir 20. Thereby, it is possible to simulate the diastole phase in a passive manner, in other words avoiding supplying energy to determine the movement of the working fluid along the diastolic path D-D.

[0043] . In accordance with one preferred embodiment, said compliant element 26 is a free surface vessel and it is positioned higher than said passive heart 12 which in turn is positioned lower than said reservoir 20. In this way, it is possible to maintain the working fluid under pressure, preventing air from entering into the fluid when the test bench assembly 10 is not in use.

[0044] . A first height difference z1 between the hydrostatic head of said compliant element and said passive heart 12, and a second height difference z2 between said passive heart 12 and the hydrostatic head of said reservoir 20, and a third height difference z3 between the hydrostatic head of said compliant element 26 and the hydrostatic head of said reservoir 20. Preferably, said first height difference z1 is equal to the sum of said second height difference and of said third height difference z2+z3.

[0045] . In accordance with a preferred embodiment, said pressure generator 22 comprises at least one flow intercepting element 28, which selectively enables direct fluid connection between said passive heart 12 and said reservoir 20.

[0046] . Preferably, said at least one flow intercepting element 28 comprises at least one active valve. Preferably, said at least one active valve is at least one solenoid valve. The provision of a solenoid valve allows to obtain rapid response times of the fluid intercepting element 28.

[0047] . In accordance with an embodiment, said flow intercepting element 28 comprises a two-way solenoid valve. In accordance with an embodiment, said flow intercepting element 28 comprises a three-way solenoid valve.

[0048] . In accordance with an embodiment, said active valve is a hydraulic control valve. In accordance with an embodiment, said active valve is a pneumatic control valve.

[0049] . In accordance with a preferred embodiment, said pressure generator 22 comprises a kinetic stationary flow rate pump 48. The provision of a kinetic stationary flow rate pump 48 which cooperates with a flow intercepting element 28 allows to simulate the pressures of the cardiac cycle, without thereby using a programmable pulsatile pump. In this way, a simplified activation of the test bench is allowed, as well as a simplified control in operating conditions, which allows even operators who are not qualified in engineering matters to control the activation and operation of the test bench. This allows to reduce the operating costs of the test bench.

[0050] . In accordance with an embodiment, said first fluid connection means 66 comprise a reservoir conduit 74, which fluidically connects said reservoir 20 to said pressure generator 22, said reservoir conduit 74 flowing by means of a bifurcation 76 into a pump branch 78, which flows into said kinetic stationary flow rate pump 48, and a shunt branch 80, which flows into said flow intercepting element 28 avoiding traversing said kinetic stationary flow rate pump 48. Preferably, said kinetic stationary flow rate pump 48 is fluidically connected to said flow intercepting element 28 by means of a generator conduit 82.

[0051] . Such a test bench assembly 10 allows to simulate the systolic phase and the diastolic phase. As shown for example in figure 3, during the systolic phase, the pressure generator 22, thrusting the working fluid 72 into the ventricular chamber 16; 116, generates a pressure increase in the ventricular chamber 16; 116 which determines the opening of the outflow valve 19, for example the aortic valve 19 in the case of left heart, where present, and thrusts the working fluid 72 towards at least one pressure regulation device 24; 124. In particular, the flow of working fluid 72 passes in the systolic branch 32 of said second fluid connection means 66 and reaches the compliant element 26. The systolic path S-S of the working fluid is indicated with the arrow S-S in figure 3.

[0052] . As shown for example in figure 4, during the diastolic phase, the working fluid 72, by effect of gravity, reaches the atrial chamber 14; 114 raising pressure inside the atrial chamber 14; 114 which determines the opening of the cardiac valve 18; 118, for example the mitral valve in the case of left heart. Hence, the working fluid 72 reaches the ventricular chamber 16; 116 and, again by gravity, traverses the ventricular conduit 36 of said first fluid connection means 66, traverses said flow intercepting element 28, flows through said shunt branch 80 and reaches the reservoir 20 flowing through said reservoir conduit 74. The diastolic path D-D of the working fluid is indicated in figure 4 with the arrow D-D.

[0053] . In accordance with an embodiment in which said passive heart 12 lacks an artificial or natural aortic valve, the provision of said afterload resistance 30 avoids having the diastolic path D-D of the working fluid 72 include the systole branch 32.

[0054] . In accordance with an embodiment in which said passive heart 12 comprises an artificial or natural aortic valve 19 adapted to direct the path of the working fluid 72 during the diastolic phase, the closure of the aortic valve 19 avoids having the diastolic path D-D include the systole branch 32.

[0055] . The provision of said flow intercepting element 28, for example a solenoid valve, allows, during the systolic phase, to connect the kinetic stationary flow rate pump 48 to the fluid circuit, and, during the diastolic phase, to disconnect said kinetic stationary flow rate pump 48, to allow the flow towards the reservoir 20. In accordance with an embodiment, the expression "fluid circuit" indicates the useful path through which the working fluid can travel in the test bench assembly 10.

[0056] . In accordance with one embodiment, said pressure generator 22 comprises a recirculation circuit, which allows, during the diastolic phase, to maintain the kinetic stationary flow rate pump 48 active without thereby increasing pressure within the fluid circuit. The provision of said recirculation circuit allows to obtain a variable flow rate of working fluid 72 within the ventricular chamber 16 without deactivating said stationary flow rate pump 48 cooperating with said flow intercepting element 28.

[0057] . In accordance with one embodiment, said kinetic stationary flow rate pump 48 is a centrifugal pump. This allows to maintain low the installation costs of the test bench assembly 10, without thereby resulting in a decrease in reliability.

[0058] . In accordance with an embodiment, said test bench assembly 10 comprises a feedback conduit 62, which connects said compliant element 26 and said reservoir 20, so that, when the working fluid reaches a predefined value of pressure inside said compliant element 26, a portion of the working fluid is sent back into the reservoir 20. This improves the self-regulation of the fluid circuit.

[0059] . In accordance with an embodiment, said test bench assembly 10 comprises a control and drive unit 60 associated with said pressure generator 22 and comprising at least one programmable logic controller. Preferably, said control and drive unit 60 is adapted to control the activation of the flow intercepting element 28, for example a solenoid valve, to simulate the cardiac cycle. Preferably, said control and drive unit 60 is associated with said pressure generator 22 by means of an electromagnetic connection 84. In accordance with an embodiment, said control and drive unit 60 associated with said pressure generator 22 by means of a wireless electromagnetic connection 84. This allows to control said pressure generator 22 remotely.

[0060] . In accordance with an embodiment, said test bench assembly 10 comprises an image acquisition system having at least one probe positioned internally to at least one between said atrial cavity 14 and said ventricular cavity 16. Preferably, said image acquisition system comprises a video probe, adapted to acquire a video of the operation of portions of the test bench, for example the operation of at least one cardiac valve 18. Alternatively or additionally, said test bench assembly 10 is suitable for displaying with a fluoroscopy acquisition system, adapted to acquire fluoroscopic images. Alternatively or additionally, said test bench assembly 10 is suitable for displaying with an ultrasound scan acquisition system, adapted to acquire echocardiographic and/or echo Doppler images.

[0061] . In accordance with a preferred embodiment, said first fluid connection means 64 comprise at least one ventricular conduit 36 which flows into said ventricular chamber 16 of the passive heart 12, and in which said ventricular conduit 36 comprises an anchoring plug 38 which can be fitted by acting only from the exterior of said ventricular chamber 16. The provision of such an anchor plug 38 makes the operation of connecting the passive heart 12 to said first fluid connection means 66 of the test bench quicker compared to known solution, and reliable as well. In addition, avoiding the need for typically surgical procedures to connect the ventricular conduit 36 to the passive hear 12, for example sutures of the ventricular conduit 36 to the passive heart 12, enables personnel who are not qualified, and hence have lower hourly cost than a cardiac surgeon/interventional cardiologist, to connect the passive heart 12 to the fluid circuit.

[0062] . In accordance with an embodiment, said anchoring plug 38 comprises a deformable anchoring device 40, adapted to elastically deform to fit into an inlet opening formed in the heart wall 50 which delimits the ventricular chamber 16 of the passive heart 12 to be engaged in undercut against a face of the heart wall 50 arranged in undercut with respect to the outer face of the passive heart. The provision of such an anchoring plug 38 makes the operations for connecting the passive heart 12 to the fluid circuit highly rapid and simple, for example of the "plug-and-play" type. Preferably, said anchoring plug 38 is applied in the apical portion of the passive heart 12.

[0063] . Preferably, said test bench assembly 10 comprises a collection tank, adapted to collect any fluid leaks. Generally, fluid leaks are prevalently located in the connecting portion between said first fluid connection means 64 and said passive heart 12. The provision of said anchoring plug 38, allowing to avoid connection sutures, allows to significantly reduce fluid leaks compared to known solutions.

[0064] . In accordance with one embodiment, said anchoring plug 38 comprises a stem 52 which is internally hollow to allow the passage of the working fluid, at least one translating fastening ring nut 54 mounted on said stem 52 and adapted to clamp between the heart wall 50 between a support surface 58 of said ring nut and a fastening surface 56 of said deformable anchoring device 40, to determine the secure anchoring of the anchoring plug 38 to the passive heart 12. In accordance with an embodiment, said stem 52 is externally threaded and said fastening ring nut 54 acts as a translating leadscrew.

[0065] . In accordance with an embodiment, said anchoring plug 38 comprises a threaded stem which cooperates with a threaded nut delivered into the ventricular chamber 16.

[0066] . A method for using a test bench shall be described below.

[0067] . In accordance with a general embodiment, a method for using a test bench assembly for the simulation of cardiac surgery and/or interventional cardiology operations and/or procedures comprises the following steps.
  • providing a passive heart 12;
  • providing a pressure generator 22;
  • providing a reservoir 20 fluidically connected to said pressure generator 22;
  • making a hole in the heart wall 50 which delimits a ventricular chamber 18;
  • connecting said pressure generator 22 to said passive heart 12;
  • using a single compliant element 26 connected to an atrial chamber and a ventricular chamber to provide the working fluid with the preload pressure and the afterload pressure.


[0068] . In accordance with a possible operating mode, said method comprises the additional step of connecting an anchoring plug 38 to said ventricular chamber 16 through said hole in the heart wall 50 acting only from the exterior of the passive heart 12.

[0069] . In accordance with a possible operating mode, said method comprises the additional step of using a stationary flow rate pump 48 cooperating with a flow intercepting element 28 to simulate the cardiac flow rate.

[0070] . Such a test bench assembly 10 is particularly suited, but not univocally intended, to allow in non-invasive manner and with no need to intervene on living being in any way, to train cardiac surgeons/interventional cardiologists on at least one of the following medical-surgical therapies:

. - transcatheter aortic valve implantation through a dummy femoral artery;

. - transcatheter aortic valve implantation through a dummy ascending aorta;

. - transcatheter aortic valve implantation from the left ventricle;

. - percutaneous mitral valve implantation from the left ventricle;

. - transcatheter implantation of mitral neochordae from the left ventricle;

. - percutaneous mitral valve implantation from the fossa ovalis directly or through a virtual vena cava;

. - transcatheter mitral valve implantation directly from the left atrium;

. - transcatheter introduction of occluder of the left auricle from the interatrial septum directly or through virtual vena cava;

. - transcatheter procedures of the tricuspid valve;

. - transcatheter procedures of pulmonary valve;

. - reparative beating heart surgical procedures.



[0071] . Thanks to the features described above separately or jointly with each other in particular embodiments, it is possible to obtain a test bench assembly, as well as a method, which at the same time satisfies the mutually contrasting needs described above, and the aforementioned desired advantages, and in particular:

. - it is possible to faithfully reproduce the physiological conditions of beating heart and of blood circulation without thereby making the test bench assembly 10 bulky or complicated to operate;

. - it is possible to reduce the installation and operation costs of the test bench assembly relative to known solutions, without thereby diminishing functionality or reliability;

. - it is possible to reduce the number of components and the size of the test bench assembly relative to known solutions, without thereby diminishing functionality or reliability;

. - it is possible to reproduce the physiological conditions of beating heart and blood circulation and at the same time to reduce the costs associated with the procedures to train cardiac surgeons/interventional cardiologists.



[0072] . Those skilled in the art may make several changes and adaptations to the embodiments described above in order to meet contingent and specific needs, and can replace elements with others which are functionally equivalent, without however departing from the scope of the following claims.

LIST OF REFERENCES



[0073] 
10
Test bench assembly
12
Passive heart
14
Left atrial chamber
16
Left ventricular chamber
18
Mitral heart valve, or mitral valve
19
Outflow valve, or aortic heart valve, or aortic valve
20
Reservoir
22
Pressure generator
24
Pressure regulation device
26
Compliant element
28
Flow intercepting element
30
Afterload resistance
32
Systole branch
34
Diastole branch
36
Ventricular conduit
38
Anchoring plug
40
Deformable anchoring device
46
Section
48
Kinetic stationary flow rate pump
50
Heart wall
52
Stem
54
Fastening ring nut
56
Fastening surface
58
Ring nut support surface
60
Control and drive unit
62
Feedback conduit
64
First fluid connection means
66
Second fluid connection means
68
Atrial septum
70
Ventricular septum
72
Working fluid
74
Reservoir conduit
76
Bifurcation
78
Pump branch
80
Shunt branch
82
Generator conduit
84
Electromagnetic connection
114
Atrial chamber, or right atrial chamber
116
Ventricular chamber, or right ventricular chamber
118
Tricuspid heart valve, or tricuspid valve
124
Additional pressure regulation device
S-S
Systole path
D-D
Diastole path
z1
First height difference
z2
Second height difference
z3
Third height difference



Claims

1. A test bench assembly (10) for the simulation of cardiac surgery and/or interventional cardiology operations and/or procedures, comprising:

- a passive heart (12), wherein said passive heart (12) is an explanted or artificial or hybrid heart, said passive heart (12) having at least one pair of cardiac chambers (14, 16; 114, 116) comprising an atrial chamber (14; 114) and a ventricular chamber (16; 116); said passive heart (12) further comprising at least one outflow valve (19) positioned at the outlet of said ventricular chamber of said at least one pair of cardiac chambers; each of said pair of cardiac chambers being separated by at least one heart valve (18; 118), which closes when the pressure in the ventricular chamber (16; 116) is higher than the pressure in the atrial chamber (14; 114) and which opens when the pressure in the atrial chamber (14; 114) is higher than the pressure in the ventricular chamber (16; 116);

- a reservoir (20), adapted to house working fluid;

- a pressure generator (22), adapted to provide said passive heart (12) with a pumping function by pumping said working fluid, said pressure generator (22) being fluidically connected both to said ventricular chamber (16; 116) of said passive heart (12) by means of at least one ventricular conduit (36) and to said reservoir (20) by means of a reservoir conduit (74);

- at least one pressure regulation device (24; 124) which provides the working fluid (72) in input to the atrial chamber (14; 114) with a preload pressure and the working fluid (72) in output from the ventricular chamber (16; 116) and downstream of the outflow valve (19) with an afterload pressure;

said at least one pressure regulation device (24; 124) being fluidically connected both to said atrial chamber (14; 114) of said passive heart (12) by means of a diastole branch (34) and to said ventricular chamber (16; 116) of said passive heart (12) through said outflow valve (19), by means of a systole branch;
characterized in that
said at least one pressure regulation device (24; 124) comprises a single compliant element (26) for each pair of cardiac chambers (14, 16; 114, 116), said single compliant element (26) acting as an expansion vessel, said single compliant element (26) providing the working fluid (72) with both the preload pressure and the afterload pressure.
 
2. A test bench assembly (10) according to claim 1, wherein said at least one pressure regulation device (24; 124) comprises an afterload resistance (30) which regulates the afterload pressure.
 
3. A test bench assembly (10) according to claim 1 or 2, wherein said compliant element (26) is a free surface vessel or a closed pressurized tank.
 
4. A test bench assembly (10) according to any one of the preceding claims, wherein said outflow valve (19) is an aortic valve (19) or is a pulmonary valve.
 
5. A test bench assembly (10) according to any one of the preceding claims, wherein the working fluid (72) in said compliant element (26) has a higher pressure than the working fluid (72) in said reservoir (20).
 
6. A test bench assembly (10) according to any one of the preceding claims, wherein said systole branch (32) comprises said afterload resistance (30).
 
7. A test bench assembly (10) according to any one of the preceding claims, wherein said systole branch (32) and said diastole branch (34) are joined in a section (46) which flows into said compliant element (26).
 
8. A test bench assembly (10) according to any one of the preceding claims, wherein said pressure generator (22) comprises at least one flow intercepting element (28), which selectively allows the direct fluid connection between said passive heart (12) and said reservoir (20).
 
9. A test bench assembly (10) according to claim 8, wherein said at least one flow intercepting element (28) comprises at least one active valve.
 
10. A test bench assembly (10) according to claim 9, wherein said at least one active valve is at least one solenoid valve.
 
11. A test bench assembly (10) according to any one of the preceding claims, wherein said pressure generator (22) comprises a kinetic stationary flow rate pump (48).
 
12. A test bench assembly (10) according to claim 11, wherein said kinetic stationary flow rate pump (48) is a centrifugal pump.
 
13. A test bench assembly (10) according to any one of the preceding claims, wherein said ventricular conduit (36) comprises an anchoring plug (38) which can be fitted by acting only from the exterior of said ventricular chamber (16; 116).
 
14. A test bench assembly (10) according to claim 13, wherein said anchoring plug (38) comprises a deformable anchoring device (40) adapted to elastically deform to fit into an inlet opening formed in the heart wall (50) which delimits the ventricular chamber (16; 116) of the passive heart (12) to be engaged in undercut against a face of the heart wall (50) arranged in undercut with respect to the outer face of the passive heart (12).
 
15. A test bench assembly (10) according to any one of the preceding claims, comprising a control and drive unit (60) associated with said pressure generator (22) and comprising at least one programmable logic controller.
 


Ansprüche

1. Testbank-Anordnung (10) für die Simulation einer kardialen Chirurgie und/oder von interventionellen Kardiologie-Operationen und/oder Prozeduren, umfassend:

- ein passives Herz (12), wobei das passive Herz (12) ein explantiertes oder künstliches oder hybrides Herz ist, wobei das passive Herz (12) wenigstens ein Paar von kardialen Kammern (14, 16; 114, 116) aufweist, welche eine Vorhof-Kammer (14; 114) und eine Ventrikel-Kammer (16; 116) umfassen; wobei das passive Herz (12) ferner wenigstens ein Ausfluss-Ventil (19) umfasst, welches an dem Auslass der Ventrikel-Kammer des wenigstens einen Paares von kardialen Kammern positioniert ist; wobei jede des Paares von kardialen Kammern durch wenigstens ein Herz-Ventil (18; 118) getrennt ist, welches schließt, wenn der Druck in der Ventrikel-Kammer (16; 116) höher ist als der Druck in der Vorhof-Kammer (14; 114), und welches öffnet, wenn der Druck in der Vorhof-Kammer (14; 114) höher ist als der Druck in der Ventrikel-Kammer (16; 116);

- ein Reservoir (20), welches dazu eingerichtet ist, ein Arbeitsfluid aufzunehmen;

- einen Druck-Generator (22), welcher dazu eingerichtet ist, das passive Herz (12) mit einer Pumpen-Funktion durch Pumpen des Arbeitsfluids bereitzustellen, wobei der Druck-Generator (22) mit sowohl der Ventrikel-Kammer (16; 116) des passiven Herzens (12) mittels wenigstens einer Ventrikel-Leitung (36) als auch mit dem Reservoir (20) mittels einer Reservoir-Leitung (74) fluidisch verbunden ist;

- wenigstens eine Druck-Regulation-Vorrichtung (24; 124), welche das Arbeitsfluid (72) in Eingabe an die Vorhof-Kammer (14; 114) mit einem Vorlast-Druck und das Arbeitsfluid (72) in Ausgabe von der Ventrikel-Kammer (16; 116) und stromabwärts des Ausfluss-Ventils (19) mit einem Nachlast-Druck bereitstellt;

wobei die wenigstens eine Druck-Regulation-Vorrichtung (24; 124) mit sowohl der Vorhof-Kammer (14; 114) des passiven Herzens (12) mittels einer Diastole-Abzweigung (34) als auch mit der Ventrikel-Kammer (16; 116) des passiven Herzens (12) durch das Ausfluss-Ventil (19) mittels einer Systole-Abzweigung fluidisch verbunden ist;
dadurch gekennzeichnet, dass
die wenigstens eine Druck-Regulation-Vorrichtung (24; 124) ein einzelnes entsprechendes Element (26) für jedes Paar von kardialen Kammern (14, 16; 114, 116) umfasst, wobei das einzelne entsprechende Element (26) als ein Expansion-Gefäß wirkt, wobei das einzelne entsprechende Element (26) das Arbeitsfluid (72) mit sowohl dem Vorlast-Druck als auch dem Nachlast-Druck bereitstellt.
 
2. Testbank-Anordnung (10) nach Anspruch 1, wobei die wenigstens eine Druck-Regulation-Vorrichtung (24; 124) einen Nachlast-Widerstand (30) umfasst, welcher den Nachlast-Druck reguliert.
 
3. Testbank-Anordnung (10) nach Anspruch 1 oder Anspruch 2, wobei das entsprechende Element (26) ein Gefäß einer freien Fläche oder ein geschlossener Drucktank ist.
 
4. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, wobei das Ausfluss-Ventil (19) ein Aorta-Ventil (19) oder ein Lungen-Ventil ist.
 
5. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, wobei das Arbeitsfluid (72) in dem entsprechenden Element (26) einen höheren Druck aufweist als das Arbeitsfluid (72) in dem Reservoir (20).
 
6. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, wobei die Systole-Abzweigung (32) einen Nachlast-Widerstand (30) umfasst.
 
7. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, wobei die Systole-Abzweigung (32) und die Diastole-Abzweigung (34) in einem Abschnitt (46) verbunden sind, welcher in das entsprechende Element (26) fließt.
 
8. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, wobei der Druck-Generator (22) wenigstens ein Strömung-abfangendes Element (28) umfasst, welches selektiv die direkte Flugverbindung zwischen dem passiven Herzen (12) und dem Reservoir (20) erlaubt.
 
9. Testbank-Anordnung (10) nach Anspruch 8, wobei das wenigstens eine Strömung-abfangende Element (28) wenigstens ein aktives Ventil umfasst.
 
10. Testbank-Anordnung (10) nach Anspruch 9, wobei das wenigstens eine aktive Ventil wenigstens ein Magnetventil ist.
 
11. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, wobei der Druck-Generator (22) eine kinetisch stationäre Strömungsraten-Pumpe (48) umfasst.
 
12. Testbank-Anordnung (10) nach Anspruch 11, wobei die kinetisch stationäre Strömungsraten-Pumpe (48) eine zentrifugale Pumpe ist.
 
13. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, wobei die Ventrikel-Leitung (36) einen Anker-Stopfen (38) umfasst, welcher durch Einwirken nur von der Außenseite der Ventrikel-Kammer (16; 116) eingepasst werden kann.
 
14. Testbank-Anordnung (10) nach Anspruch 13, wobei der Anker-Stopfen (38) eine deformierbare Anker-Vorrichtung (40) umfasst, welche dazu eingerichtet ist, sich elastisch zu deformieren, um in eine Einlass-Öffnung zu passen, welche in der Herz-Wand (50) gebildet ist, welche die Ventrikel-Kammer (16; 116) des passiven Herzens (12) begrenzt, um in einem Hinterschnitt gegen eine Fläche der Herz-Wand (50) eingegriffen zu sein, welcher in Bezug auf die äußere Fläche des passiven Herzens (12) hinterschnitten angeordnet ist.
 
15. Testbank-Anordnung (10) nach einem der vorhergehenden Ansprüche, umfassend eine Steuer- und Antrieb-Einheit (60), welche dem Druck-Generator (22) zugeordnet ist und wenigstens eine programmierbare logische Steuereinheit umfasst.
 


Revendications

1. Ensemble banc d'essai (10) pour la simulation de chirurgie cardiaque et/ou d'opérations et/ou de procédures de cardiologie interventionnelle, comprenant :

- un cœur passif (12), le cœur passif (12) étant un cœur explanté ou artificiel ou hybride, le cœur passif (12) ayant au moins une paire de chambres cardiaques (14, 16 ; 114, 116) comprenant une chambre auriculaire (14 ; 114) et une chambre ventriculaire (16 ; 116), le cœur passif (12) comprenant en outre au moins une valve de sortie (19) positionnée à la sortie de la chambre ventriculaire de ladite au moins une paire de chambres cardiaques, chacune de ladite paire de chambres cardiaques étant séparées par au moins une valve cardiaque (18 ; 118) qui ferme lorsque la pression dans la chambre ventriculaire (16 ; 116) est supérieure à la pression dans la chambre auriculaire (14 ; 114) et qui ouvre lorsque la pression dans la chambre auriculaire (14 ; 114) est supérieure à la pression dans la chambre ventriculaire (16 ; 116) ;

- un réservoir (20) adapté pour contenir un fluide de travail ;

- un générateur de pression (22) adapté pour donner au cœur passif (12) une fonction de pompage en pompant le fluide de travail, le générateur de pression (22) étant connecté de manière fluidique aussi bien à la chambre ventriculaire (16 ; 116) du cœur passif (12) par au moins un conduit ventriculaire (36) qu'au réservoir (20) par un conduit de réservoir (74) ;

- au moins un dispositif de régulation de pression (24 ; 124) qui donne au fluide de travail (72) entrant dans la chambre auriculaire (14 ; 114) une pression de précharge et au fluide de travail (72) sortant de la chambre ventriculaire (16 ; 116) et en aval de la valve de sortie (19) une pression postcharge ;

ledit au moins un dispositif de régulation de pression (24 ; 124) étant relié de manière fluidique aussi bien à la chambre auriculaire (14 ; 114) du cœur passif (12) par une branche de diastole (34) qu'à la chambre ventriculaire (16 ; 116) du cœur passif (12), via la valve de sortie (19), par une branche de systole ;
caractérisé en ce que
ledit au moins un dispositif de régulation de pression (24 ; 124) comprend un seul élément compatible (26) pour chaque paire de chambres cardiaques (14, 16 ; 114, 116), ledit seul élément compatible (26) agissant comme un vase d'expansion, ledit seul élément compatible (26) donnant au fluide de travail (72) aussi bien la pression de précharge que la pression de postcharge.
 
2. Ensemble banc d'essai (10) selon la revendication 1, caractérisé en ce que ledit au moins un dispositif de régulation de pression (24 ; 124) comprend une résistance de postcharge (30) qui règle la pression de postcharge.
 
3. Ensemble banc d'essai (10) selon la revendication 1 ou 2, caractérisé en ce que l'élément compatible (26) est un contenant à surface libre ou un réservoir pressurisé fermé.
 
4. Ensemble banc d'essai (10) selon l'une des revendications précédentes, caractérisé en ce que la valve de sortie (19) est une valve d'aorte (19) ou une valve pulmonaire.
 
5. Ensemble banc d'essai (10) selon l'une des revendications précédentes, caractérisé en ce que le fluide de travail (72) dans l'élément compatible (26) présente une pression plus grande que le fluide de travail (72) dans le réservoir (20).
 
6. Ensemble banc d'essai (10) selon l'une des revendications précédentes, caractérisé en ce que la branche de systole (32) comprend une résistance de postcharge (30).
 
7. Ensemble banc d'essai (10) selon l'une des revendications précédentes, caractérisé en ce que la branche de systole (32) et la branche de diastole (34) sont jointes dans une section (46) qui afflue à l'élément compatible (26).
 
8. Ensemble banc d'essai (10) selon l'une des revendications précédentes, caractérisé en ce que le générateur de pression (22) comprend au moins un élément d'interception de flux (28) qui permet sélectivement la connexion de fluide directe entre la cœur passif (12) et le réservoir (20).
 
9. Ensemble banc d'essai (10) selon la revendication 8, caractérisé en ce que ledit au moins un élément d'interception de flux (28) comprend au moins une valve active.
 
10. Ensemble banc d'essai (10) selon la revendication 9, caractérisé en ce que ladite au moins une valve active est une électrovanne.
 
11. Ensemble banc d'essai (10) selon l'une des revendications précédentes, caractérisé en ce que le générateur de pression (22) comprend une pompe cinétique (48) à débit stationnaire.
 
12. Ensemble banc d'essai (10) selon la revendication 11, caractérisé en ce que la pompe cinétique (48) à débit stationnaire est une pompe centrifuge.
 
13. Ensemble banc d'essai (10) selon l'une des revendications précédentes, caractérisé en ce que le conduit ventriculaire (36) comprend une cheville d'ancrage (38) qui peut être posée an agissant uniquement à partir de l'extérieur de la chambre ventriculaire (16 ; 116).
 
14. Ensemble banc d'essai (10) selon la revendication 13, caractérisé en ce que la cheville d'ancrage (38) comprend un dispositif d'ancrage déformable (40) adapté pour se déformer élastiquement pour passer dans une ouverture d'entrée formée dans la paroi de cœur (50) qui délimite la chambre ventriculaire (16 ; 116) du cœur passif (12) destinée à être engagée en contre-dépouille par rapport une face de la paroi de cœur (50) agencée en contre-dépouille par rapport à la face extérieure du cœur passif (12).
 
15. Ensemble banc d'essai (10) selon l'une des revendications précédentes, comprenant une unité de commande et d'entraînement (60) associée au générateur de pression (22) et comprenant au moins une commande logique proprammable.
 




Drawing





















REFERENCES CITED IN THE DESCRIPTION



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Patent documents cited in the description




Non-patent literature cited in the description