WO2013087960A1

WO2013087960A1 - Device for generating a synchronizable physiological pulsatile flow for cardiac surgery and extracorporeal cardiac assist

Info

Publication number: WO2013087960A1
Application number: PCT/ES2012/070650
Authority: WO
Inventors: Salvador Merce Vives
Original assignee: Salvador Merce Vives
Priority date: 2011-12-16
Filing date: 2012-09-12
Publication date: 2013-06-20
Also published as: ES2414579A1; ES2414579B1

Abstract

The device comprises: an artificial ventricle (1) that incorporates at least one longitudinal conduit (3) in the form of a resilient module that has a deformable, resilient structure, the internal space of which increases in volume when the blood flow is interrupted at the outlet of the artificial ventricle (1), thereby generating an increase in pressure in said internal space with respect to the pressure outside the longitudinal conduit (3); and an electrovalve (2) that interrupts the continuity of the blood flow at certain time intervals, said electrovalve (2) being located at the outlet of the artificial ventricle (1).

Description

PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE YOU FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE OBJECT OF THE INVENTION

The present invention, as expressed in the statement of this specification, refers to a physiological and synchronizable pulsatile flow generating device for cardiac surgery and extracorporeal cardiac assistance which has the purpose of transforming a linear blood flow obtained with current ones. Extracorporeal perfusion pumps, in pulsatile form in a simple and effective way with results similar to the physiological flow produced by the heart, and much better than those obtained with current systems.

For this, the device of the invention essentially comprises an artificial ventricle and an electrovalve controlled by a conventional electronic console, the assembly of the device of the invention being inserted between the blood supply system (roller pump) and a patient. The electronics that control the solenoid valve also allows the pulsatile blood flow obtained to be synchronized with the electrocardiogram, making the system suitable for long-term cardiac assistance.

BACKGROUND OF THE INVENTION

At present, both blood perfusion during cardiac surgery and for the treatment of heart failure, two types of pumps are used: roller pumps and centrifugal pumps.

Both types of pumps generate a linear or constant flow and, together with their accessories, produce a blood circulation of constant and pulsatile flow very different from the physiological one, replacing the physiological pulsatile flow generated by the heart. It has always been admitted that the ideal flow to perfuse tissues is pulsatile or physiological because the impact produced by each beat improves the perfusion of the finest arteries of vital organs such as the kidney and liver.

Roller pump manufacturers and centrifugal pump manufacturers have sought solutions to transform linear flow into pulsatile, without having achieved satisfactory results.

In the invention patent with publication number

US005458459 was disclosed a centrifugal pump for pumping biological liquids, such as blood, which includes a housing that defines a pumping chamber. The pumping chamber encloses a rotor (propeller) with blades with a distribution such that a spin inductor is formed that helps decrease hemolysis, but generates only non-physiological linear flow.

The invention patent with publication number US6183220 provides a blood pump capable of substantially completely imitating the thrombi that adhere to the bottom or inner part of the shirt without diminishing the antihemolytic characteristic of the blood. It comprises a pump jacket, a suction inlet arranged in the central side part of the jacket, and a flow outlet disposed in the lower peripheral part, with a main rotor to form a centrifugal flow of blood supplied from the inlet. The rotor has a mixer and stirring fins. Nor in this case is pulsatile or physiological flow synchronizable.

The invention patent with publication number in Spain ES 2284396 consists of a centrifugal pump for blood perfusion associated with a hydraulic pulsation device for counterpulsation balloons by means of gases such as helium, which generate the necessary pressure in the own pump to provide the pulsatile movement of this type of pumps.

These devices mentioned with expensive, complex and with very little mobility, using gases or technical fluids that could come into contact with the blood fluid with the consequent fatality that could cause in the patient.

DESCRIPTION OF THE INVENTION

In order to achieve the objectives and avoid the drawbacks mentioned in the preceding sections, the invention proposes a physiological and synchronizable pulsatile flow generating device for cardiac surgery and extracorporeal cardiac assistance that is intended to cause a physiological pulsatile flow in a blood stream before of reaching a patient exposed to a surgical intervention.

It is characterized in principle because it comprises:

- An artificial ventricle that integrates at least one longitudinal duct of elastic and deformable structure, whose internal space increases in volume when blood flow is interrupted at the exit of the artificial ventricle generating an increase in pressure in said internal space with respect to the existing pressure outside such longitudinal duct.

- a solenoid valve connected to the outlet of the artificial ventricle that interrupts the continuity of blood flow at time intervals. Said solenoid valve is controlled by an electronic console capable of synchronizing the pulsatility of the flow with the patient's electrocardiogram, allowing the use of the device in long-term cardiac assistance.

This artificial ventricle incorporates a first carcass in which the longitudinal duct is fixed by thickened end portions, while such an artificial ventricle incorporates a longitudinal chamber delimited between the first carcass and the outer surface of the longitudinal duct. The first housing has a through hole that connects the longitudinal chamber with the outside.

The artificial ventricle also comprises a first tubular body that integrates the through hole and end caps provided with centered through sections in which the end sections of the longitudinal duct are adjusted.

The end caps of the artificial ventricle are coupled to the first tubular body of the first housing by means of a threading with an o-ring seal arranged frontally in a plane perpendicular to the longitudinal direction of the artificial ventricle.

Another feature of the invention is that the longitudinal duct of the artificial ventricle integrates a thickened end portions that fit and fasten in the through sections of the end caps, a part of such end portions greased out to facilitate its connection with the elongated tube of the solenoid valve and other external elements.

Another feature of the invention is that the thickened end portions of the longitudinal duct of rigid structure integrate annular projections that fit into annular channels of the through sections of the end caps.

The second housing that is part of the hydraulic throttle valve comprises a second tubular body and end bases internally embedded in the end sections of the second housing mentioned with interposition of an O-ring and a larger ring of sealing material.

The elongated tube of the hydraulic throttle valve is embedded in openings centered on the end bases of the second housing with interposition of a smaller ring of sealing material. Another feature of the invention is that the elongated tube of the hydraulic throttle valve comprises annular recesses in correspondence with which it fixes the end sections of the tubular membrane.

In one embodiment of the invention, the elongated tube of the hydraulic throttle valve incorporates two facing windows that interrupt the continuity of the wall of the elongated tube, both windows being located within the first coaxial chamber.

Another feature of the invention is that the conduit of the second housing of the hydraulic throttle valve by which a pressure is applied to the interior of the outer coaxial chamber, such conduit comprises a radial junction that starts from the second tubular body of such a second housing. .

The elongated tube of the hydraulic throttle valve integrates in its end sections a first incoming nozzle that connects tightly with the anterior end portion of the longitudinal duct of the artificial ventricle and a second outgoing nozzle through which the blood flow to the patient exits.

With this described arrangement, with the device of the invention it is possible to transform a linear and pulsatile blood flow in a simple way and with a substantially better result than with the current systems.

Next, in order to facilitate a better understanding of this descriptive report and forming an integral part thereof, some figures are attached in which the object of the invention has been shown as an illustrative and non-limiting nature.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1.- Shows a schematic view of the physiological and synchronizable pulsatile flow generating device for cardiac surgery and extracorporeal cardiac assistance, object of the invention. It basically comprises an artificial ventricle and an electrovalve, passing the blood flow, driven by an impulse pump, through both elements, to finally lead to a patient receiving that blood flow he needs.

Figure 2.- Shows a sectional view of the device of the invention according to a particular embodiment.

Figure 3.- Shows a view of a first outer shell that is part of the artificial ventricle.

Figure 4.- Shows an elevation view of an elongated tube that is part of the solenoid valve.

Figure 5.- Shows a sectional view of the elongated tube according to section A-B of the previous figure.

Figure 6.- Shows a view of a longitudinal duct of elastic structure that is part of the artificial ventricle in a deflated or relaxed position.

Figure 7.- Shows a view of the longitudinal duct referred to in the previous figure, in which case such longitudinal duct is in a swollen position.

DESCRIPTION OF AN EXAMPLE OF EMBODIMENT OF THE INVENTION

Considering the numbering adopted in the figures, the physiological pulsatile flow generating system for extracorporeal cardiac assistance contemplates the following nomenclature used in the description:

1.- Artificial ventricle

2. - Solenoid valve

3. - Longitudinal duct

3 '.- Returned extreme portions

4. - First housing

5.- First tubular body 6.- Extreme covers

6 '.- Internships

7.- Annular Highlights

8.- Annular channels

9.- Through hole

10.- Longitudinal chamber

11.- Threading

12.- O-ring

12 '.- - O-ring

13.- Elongated tube

13 '.- - Annular recess

14.- Windows facing each other

14 '.- - Borders

15.- Second housing

16.- Tubular membrane

11.- First coaxial camera

18.- Second coaxial camera

19.- Radial junction

20.- Incoming nozzle

21.- Outgoing nozzle

22.- Second tubular body

23.- Extreme bases

23 '.- - Openings

24.- Major ring

25.- Minor ring

26.- Tubular conduction.

It comprises in principle an artificial ventricle 1 and a hydraulic throttle valve 2, through which the blood flow from the artificial ventricle 1 fed by a linear flow impulsion pump not shown in the figures flows, which is responsible for driving the blood flow to the patient passing through the device of the invention that is responsible for providing a pulsatile blood flow that emulates as much as possible the physiological flow of a patient's heart. The artificial ventricle 1 comprises a longitudinal conduit 3 made of elastic and deformable material that has a thickened end portions 3 'through which the longitudinal conduit 3 is fixed to a first housing 4 formed by a first tubular body 5 and end caps 6 which integrate through sections 6 ', in which the longitudinal conduit 3 is fixed through its end portions, 3' which incorporate annular projections 7 that fit into annular channels 8 in said through sections 6 '.

In turn, the front and rear end portions of the longitudinal conduit 3 protrude outside the through sections 6 'of the end caps 6 of the housing 4.

The tubular body 5 of the first housing 4 is affected by a through hole 9 that communicates the outside with a longitudinal chamber 10 delimited between said first hermetic housing 4 and the longitudinal conduit 3 itself.

At the same time, the end caps 6 are coupled to the tubular body 5 of the first housing 4 by means of a thread 11 and with interposition of an O-ring seal 12 arranged frontally in a section perpendicular to the longitudinal direction of the artificial ventricle 1.

The hydraulic throttle valve 2 comprises:

An elongated tube 13 affected by a pair of facing windows 14 that communicate the interior of said elongated tube 13 with the exterior thereof.

- A second housing 15 along which the elongate tube 13 arranged coaxially with respect to said second housing 15 runs.

- An elastic and deformable tubular membrane 16 tightly fixed by end sections thereof around an annular recess 13 'of the elongated tube 13, delimiting the inner face of such tubular membrane 16 a corresponding first closed coaxial chamber 17 with the facing windows 14, so that such first coaxial chamber 17 is essentially delimited between the edges 14 'that delimit such facing windows 14 and a part of said tubular membrane 16.

In turn, between the outer face of the tubular membrane 16 and the second housing 15 a second coaxial chamber 18 is generated that communicates with a pressure device (not shown in the figures) by means of a radial junction 19 to be introduced by the same an adjustable pressure at regular intervals of time.

The elongate tube 13 further comprises a first inlet nozzle 20 that connects tightly with the anterior end portion of the longitudinal duct 3 of the artificial ventricle 1 and a second protruding nozzle 21 through which the blood flow to the patient exits.

On the other hand, through the posterior terminal portion of the artificial ventricle, blood flow enters the system of the invention by means of the delivery pump not shown in the figures.

The second housing 15 of the hydraulic throttle valve 2 comprises a second tubular body 22 and end bases 23 internally embedded in the end sections of the second housing 15 with interposition of an O-ring 12 'and a larger ring 24 of the sealing material to provide a tight seal.

The end bases 23 have centered openings 23 'in which portions of the nozzles 20-21 of the elongate tube 13 are fitted with interposition of a smaller ring 25 of sealing material to also provide a tight seal.

Obviously, said nozzles, inlet 20 and outgoing 21, protrude outwardly with respect to the end bases 23 to facilitate its connection with the longitudinal duct 3 of the ventricle and with another tubular conduit 26 to drive the blood flow to the patient. The longitudinal duct 3 of elastic material that is part of the artificial ventricle 1, expands increasing its internal space and pressure, as if it were a natural ventricle, when the circulating blood flow is interrupted by the solenoid valve 2.

This pressure rise is generated in a pulsatile manner by the solenoid valve 2, which integrates the second coaxial chamber 18 which, upon receiving pressure from the radial junction 19, deforms and collapses the tubular membrane 16 and throttles the passage of blood flow.

When the passage through said solenoid valve 2 is stopped throttling, then the longitudinal conduit 3 recovers its resting state, applying a pressure pulse, which emulates the physiological pulse of the heart.

It should be taken into account that solenoid valve 2 can operate with hydraulic pulsatile pressure as we see in this embodiment or even with mechanical pressure either by means of solenoids, pressure rollers, etc; that produce the corresponding strangulation of blood flow passage. All controlled by the corresponding electronic manager or control console.

The elasticity of the longitudinal duct 3 and the size of the first carcass 4 of the artificial ventricle 1 constitutes an elastic modulus calculated so that the deformation of said longitudinal duct 3 allows the volume of blood generated by interrupting, for approximately one second, a flow to be stored. blood of approximately 5 liters.

It should be noted that both the first housing 4 of the artificial ventricle 1 and the second housing of the hydraulic throttle valve 2 comprise a transparent material, such as methacrylate.

Claims

1. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, being intended to cause a physiological pulsatile flow in a blood stream before reaching a patient exposed to surgical intervention;

characterized in that it comprises:

an artificial ventricle (1) that integrates at least one longitudinal duct (3) as an elastic module that has an elastic and deformable structure, whose internal space increases in volume when blood flow is interrupted at the outlet of the artificial ventricle (1) , generating an increase in pressure in said internal space with respect to the pressure existing outside such longitudinal conduit (3);

- an electrovalve (2) that interrupts the continuity of blood flow at intervals of time, said solenoid valve (2) being located at the outlet of the artificial ventricle (1).

2. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim

1, characterized in that the artificial ventricle (1) incorporates a first housing (4) in which the longitudinal conduit (3) is fixed by thickened end portions (3 ').

3. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim

2, characterized in that the artificial ventricle (1) incorporates a longitudinal chamber (10) delimited between the first housing (4) and the outer surface of the longitudinal conduit (3).

4. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 3, characterized in that the first housing (4) has a through hole (9) that communicates the longitudinal chamber (10) with the outside

5. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 4, characterized in that the first housing (4) of the artificial ventricle (1) comprises:

a first tubular body (5) that integrates the through hole (9);

- end caps (6) provided with through sections (6 ') centered on which end sections of the longitudinal duct (3) are adjusted.

6. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 5, characterized in that the end caps (6) of the artificial ventricle (1) are coupled to the first tubular body (5) of the first casing (4) by means of a threading (11), with interposition of an o-ring (12) of sealing arranged frontally in a plane perpendicular to the longitudinal direction of the artificial ventricle (1).

7. - PHYSIOLOGICAL PULSATABLE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of claims 5 or 6, characterized in that the longitudinal duct (3) of the artificial ventricle (1) integrates a back end portions ( 3 ') which fit and fasten in the through sections (6') of the end caps (6), a part of such end-portioned portions (3 ') protruding outward.

8. - PHYSIOLOGICAL PULSATABLE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 7, characterized in that the returned end portions (3 ') of the longitudinal assembly (3) integrate annular projections (7) that are they fit into annular channels (8) of the through sections (6 ') of the end caps (6).

9. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims, characterized in that the second housing (15) of the hydraulic throttle valve (2) comprises:

- a second tubular body (22);

- Extreme bases (23) internally embedded in the end sections of the second housing (15) with interposition of an O-ring (12 ') and a larger ring (24) of sealing material.

10. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE YOU FOR CARDIAC SURGERY AND

EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 9, characterized in that the elongated tube (13) is embedded in centered openings (23 ') of the end bases (23) of the second housing (15) with interposition of a minus ring (25 ) of sealing material.

11. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims, characterized in that the elongated tube (13) of the hydraulic throttle valve (2) comprises annular recesses (2) 13 '), in correspondence with which the end sections of the tubular membrane (16) are fixed.

12. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE YOU FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 1, characterized in that the elongated tube (13) of the hydraulic throttle valve (2) incorporates two facing windows (14) that interrupt the continuity of the wall of such an elongated tube (13), being located both windows (14) inside the first coaxial camera (17).

13. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims, characterized in that the conduit of the second housing (15) of the hydraulic throttle valve (2) by the that a pressure is applied to the interior of the outer coaxial chamber (18) comprises such a conduit a radial junction (19) that starts from the second tubular body (22) of such a second housing (15).

14. - PHYSIOLOGICAL PULSE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims, characterized in that the elongated tube (13) integrates a first incoming nozzle (20) that connects tightly with the anterior terminal portion of the longitudinal duct (3) of the artificial ventricle (1) and a second protrusion nozzle (21) through which the blood flow to the patient exits.