ES2414579B1 - PHYSIOLOGICAL AND SYNCHRONIZABLE PULSE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORE CARDIAC ASSISTANCE - Google Patents

Abstract

Physiological and synchronizable pulsatile flow generating device for cardiac surgery and extracorporeal cardiac assistance. # Includes: # - 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 exit of the artificial ventricle (1), generating an increase in pressure in said internal space with respect to the pressure existing outside such longitudinal duct (3); # - a solenoid valve (2) that interrupts the continuity of blood flow at time intervals, said solenoid valve (2) being located at the outlet of the artificial ventricle (1).

Description

PHYSIOLOGICAL AND PULSE FLOW GENERATOR DEVICE

SYNCHRONIZABLE FOR CARDIAC SURGERY AND ASSISTANCE

EXTRACORPORARY CARDIAC

OBJECT OF THE INVENTION The present invention, as expressed in the statement of this specification, refers to a physiological and synchronous pulsatile flow generating device for cardiac surgery and extracorporeal cardiac assistance which has the purpose of transforming a flow Linear blood obtained with current 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 allow blood flow

pulsatile

obtained can synchronize with he

electrocardiogram,

doing he system suitable for

cardiac assistance of

Long duration.

BACKGROUND

FROM 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 the 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 manufacturers

from

bombs centrifuges have wanted solutions for

transform

he flow linear in pulsatile, without to have

got

results satisfactory

In the invention patent with publication number US005458459 a centrifugal pump for pumping biological liquids, such as blood, which includes a housing defining a pumping chamber was disclosed. 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 lower or inner part of the jacket 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 arranged in the lower peripheral part, with a main rotor to form a centrifugal luxury of blood supplied from the inlet. The rotor has a mixer and stirring fins. Nor in this case is pulsatile or physiological flow synchronized.

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 cited 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 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 reaching a patient exposed to surgery.

It is characterized in principle because it comprises: -An art ificial 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 pressure existing outside such longitudinal duct. -a solenoid valve connected to the outlet of the artificial ventricle that interrupts the continuity of blood flow at intervals of time. 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 delimited longitudinal chamber

between the first housing and the outer surface of the longitudinal duct. The first housing has a through hole that connects the longi tudnal chamber with the outside.

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

The end caps of the artificial ventricle are attached to the first tubular body of the first housing by means of a thread with interposition of an O-ring

from

tightness ready frontally in a flat

perpendicular

to the address longitudinal of the ventricle

artificial.

Other

characteristic of the invention is that he conduit

longitudinal

of the ventricle artificial integra nail

thickened end portions that fit and fasten in the through sections of the end caps, a portion of such thickened end portions protruding outward to facilitate connection with an elongated solenoid valve tube and other exterior 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.

In one embodiment, the solenoid valve is a hydraulic throttle valve that incorporates an elongated tube and a second housing.

This second housing comprises a second tubular body and end bases embedded internally in the end sections of the second mentioned housing with interposition of an O-ring and a larger ring of sealing material.

The elongated tube of the valid 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 end sections of the tubular membrane are fixed, which is elastic and deformable, and which also delimits a first coaxial chamber. where is one located

part

central of the tube elongate, Y a second camera

coaxial

delimited between the membrane tubular Y the second

Case.

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 armature tube, both windows being located in 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 coaxial and outer chamber, such conduit comprises a radial ntronque that starts from the second tubular body of Such a second housing.

The elongated tube of the hydraulic throttle valve integrates in its sections and ends 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

With this described arrangement, with the device of the invention it is possible to transform a linear blood flow into a pulsatile one in a simple way and with a substantially better result than with 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 illustrated and not limited to.

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 a pump

impulse, 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. - It shows a view of a first outer casing that is part of the ventrí c u the arti fícial.

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 the A-S section of the previous figure.

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

Figure 7.- It shows a view of the longitudinal conduit referred to in the previous figure, being in this case such longitudinal conduit in a swollen position.

DESCRIPTION OF AN EXAMPLE OF EMBODIMENT OF THE INVENTION

Considering the numbering adopted in the figures, the physiological pulsatile pulse generator system for cardiac and cardiac assistance includes the following nomencl atura used in the description:

one . -Ventricul or artificial 2.-Solenoid valve 2 ', -Strangulation hydraulic valve

3.-Conduct l ongi tudinal 3 '. - Extreme portions returned

Four . -First housing 5.-First tubular body 6.-End caps 6 '.- Through sections

7. -Rings highlights

8. -Ring channels

9.-Through hole 10.-Longitudinal chamber 11.-Threaded 12.-O-ring 12 '.- O-ring 13.-Elongated tube 13'. -Reset 14.-Windows facing 14 '.-Borders

fifteen . -Second housing

16. - Tubu l ar membrane

17. -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. -Main ring 25.-Minor ring 26.-Tubular conduction.

It comprises in principle an artificial ventricle 1 and an electrovalve 2, through which the flow flows

•

blood from the artificial ventricle fed by a linear flow pump not represented in the figures, which is responsible for driving blood flow to the patient through the device of the invention that is responsible for providing a flow pulsatile blood that emulates as much as possible the physiological flow of a patient's heart. In one embodiment, solenoid valve 2 comprises a hydraulic throttle valve 2 '

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-through sections 6 ', in which the longitudinal duct 3 is fixed through its thickened end portions 3' which incorporate annular projections 7 that fit into annular channels 8 in said through-sections 6 '.

TO

its time, nail portions terminals, previous Y

later,

of the conduit longitudinal 3 stand out for outside

from

the sections interns 6 '  from the tapas extreme 6  from the

Case

Four.

He

body tubular 5 from the first Case 4 is

affected

from a orifice intern 9 that communicate he Exterior

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 l to the longitudinal direction of the artificial ventricle l.

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 casing 15 along which the elongated tube 13 runs coaxially with respect to said second casing 15. -A tubular membrane 16 the attic and deformable fixed in a sealed manner by end sections thereof around a annular recess 13 'of the elongated tube 13, delimiting the inner face of such a tubular membrane 16 a first closed coaxial chamber 17 corresponding with the facing windows 14, so that such first coaxial chamber 17 is essentially delimited between the edges 14' delimiting 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 house car 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 incoming nozzle 20 which connects in a sealed manner 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, blood flow enters the system of the invention through the impeller pump not shown in the figures through the posterior terminal portion of the artificial ventricle.

The second housing 15 of the hydraulic throttle valve 2 'comprises a second tubular body 22 and end bases 23 embedded internally in the end sections of the second housing 15 with interposition

of a gasket <12 'and a larger screw 24 of the sealing material to provide a tight seal.

The outer 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, incoming 20 and outgoing 21, protrude outwardly with respect to the extreme bases 23 to facilitate its connection with the 100gitual duct 3 of the ventricle and with another tubular conduit 26 to drive the blood flow to the patient.

The longitudinal conduit 3 of elastic material that forms 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 hydraulic throttle valve 2 ' .

This pressure rise is generated in a pulsatile manner by the hydraulic throttle 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 flow of blood flow. .

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

It should be taken into account that the hydraulic throttle valve 2 'can operate with hydraulic pulsatile pressure as we see in this embodiment or even with mechanical pressure either by solenoids, pressure rings, 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

5 of the first housing 4 of the artificial ventricle 1 constitutes an elastic modulus calculated so that the deformation of said longitudinal duct 3 allows to store the volume of blood generated by interrupting, for approximately one second, a blood flow of

10 approximately 5 liters. It should be noted that both the first housing 4 of the artificial ventricle 1 and the second housing 15 of the hydraulic throttle valve 2 'comprise a transparent material, such as methacrylate.

Claims (14)

1.-PULSE FLOW GENERATOR DEVICE PHYSIOLOGICAL AND SYNCHRONIZABLE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, being intended to cause a physiological pulsatile flow in a current

blood

before from reach to a patient exposed to a

surgical intervention;

characterized by

that understands :

-

a ventricle initial art (one) that integra to the less a

conduit

l ongitudinal (3) to mode from module elastic that

It has an elastic and deformable structure, the internal space of which increases in volume when blood flow is interrupted at the exit of the artificial ventricle (1), generating an increase in pressure in said internal space with respect to the pressure existing outside of t to the udinal longit duct (3); -a solenoid valve (2) that interrupts the continuity of the blood flow at intervals of time, placing the solenoid valve (2) at the outlet of the artificial ventricle (one) . 2.-PHYSIOLOGICAL PULSATABLE FLOW GENERATOR DEVICE AND SYNCHRONIZE FOR CARDIAC SURGERY AND ASSISTANCE CA.RDIACA EX'l'RACORPOREA, according to claim 1, characterized in that the ventricle or artificial (1) incorporates a first housing (4) in the that the Longitudinal duct (3) by a thickened end portions (3 '). 3. -PHYSIOLOGICAL AND SYNCHRONIZABLE PULSATILE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 2, characterized in that the artificial ventricle (1) incorporates an ongitudinal chamber (10) delimited between the first housing (4) AND the outer surface of the longitudinal duct (3). 4.-PHYSIOLOGICAL AND SYNCHRONIZABLE PULSATILE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 1, characterized in that the first housing (4) has a through hole (9) that connects the longitudinal chamber (10) with the outside. 5 . -PHYSIOLOGICAL AND SYNCHRONABLE PULSATABLE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to the claim

4,

characterized by that the first mere Case (4) of the

artificial ventricle

(one) understands :

a

first body tubular (5) that i ntegra he orifice

intern

(9);

-

nail t apas ext rowing (6) provided from some sections interns

(6 ')

centered in the that be fit some sections extremes

of the

longitudinal duct (3) .

6.

DEVICE GENERATOR FROM FLOW PULSATILE

PHYSIOLOGICAL AND SYNCHRONIZABLE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 5, characterized in that the end caps (6) of the artificial ventricle (I) are coupled to the first t-body (5) of the first housing (4) by means of a screwed (11), with the interposition of a sealing Lórl.ca (12) arranged frontally in a plane perpendicular to the longitudinal direction of the artificial ventricle (1). 7.-PHYSIOLOGICAL AND SYNCHRONIZABLE PULSATILE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of claims 5 or 6, characterized by the fact that the longitudinal duct (3) of the artificial ventricle (1) integrates back end portions (3 ') that fit and fasten in the through sections (6') of the end caps (6), a part of such end portions thrown out (3 ') protruding outward. 8.-PHYSIOLOGICAL AND SYNCHRONIZABLE PULSATILE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 7, characterized in that the end portions returned (3 ') of the longitudinal assembly (3) integrate annular projections (7) that fit into annular channels (8) of the through sections (6') of the end caps (6). 9.-PHYSIOLOGICAL AND SYNCHRONABLE PULSATILE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims, characterized in that the solenoid valve (2) is a valid hydraulic throttle valve (2 ') that incorporates an elongated tube (13) and a second housing (15), which comprises: a second tubular body (22); -a extreme bases (23) embedded internally 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. -PULSATIVE FLOW GENERATOR DEVICE PHYSIOLOGICAL AND SYNCHRONIZABLE 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 extreme bases

(2. 3)

of the second housing (15) with interposition of a smaller ring (25) of sealing material.

eleven . - PHYSIOLOGICAL AND SYNCHRONIZABLE PULSATILE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims 9 to 11, characterized in that the elongated tube (13) of the hydraulic throttle valve (2 ') comprises recesses annular

(13 '), in correspondence with which end sections of an elastic and deformable tubular membrane (16) that delimit a first coaxial chamber (17) are fixed where a central part of the elongated tube (13) is located, and

a

second camera coaxial (18) delimited between the

membrane

tubular (16) Y the second Case (fifteen) .

12.

DEVICE GENERATOR FROM FLOW PULSATILE

PHYSIOLOGICAL AND SYNCHRONIZABLE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to claim 11, 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), both windows (14) being located within the first coaxial chamber (17). 13.-PULSE FLOW GENERATOR DEVICE PHYSIOLOGICAL AND SYNCHRONIZABLE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims 11 or 12, characterized in that the conduit of the second housing (15) of the hydraulic throttle valve (2 ') by which a pressure inside 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 (fifteen) . 14. - PHYSIOLOGICAL AND SYNCHRONIZABLE PULSATILE FLOW GENERATOR DEVICE FOR CARDIAC SURGERY AND EXTRACORPORARY CARDIAC ASSISTANCE, according to any one of the preceding claims 9 to 13, characterized in that the elongated tube (13) integrates a first incoming nozzle (20) that connects tightly with an anterior terminal portion of the longitudinal duct (3) of the artificial ventricle (l) and a second protruding nozzle (2l) through which the blood flow to the patient leaves.