BG109148A - Serial multichamber intraluminal energy transformer - Google Patents

Abstract

The transformer is applied by implanting it in the lumen of the aorta or in any other big artery. It compensates the reduced elasticity of the blood vessels and reduces the sequences of any local eddy current and oscillations of the blood flow and from any local jumping of the blood pressure. The transformer comprises multiple compact cameras (2) arranged in sequence and filled by shrinkable fluid (11) under pressure. Each chamber (2) practically contains a constant quantity of shrinkable fluid (11) at least during the time of a cardiac cycle. Across the systole, simultaneously with the expansion of the aorta (102), chambers (2) shrink and absorb any jumps in the pressure by taking up of the impact volume. Across the diastole chambers (2) release and the energy of the compressed shrinkable fluid (11) is transformed back into energy of the blood pressure and the blood flow. Each chamber (2) absorbs locally by protecting the appurtenant aorta sector from any mechanical effect of the blood flow and the blood pressure by also assisting the cardiac perfusion.

Description

SERIES MULTI-CHAMBER INTRA-LUMINAL ENERGY TRANSFORMER

TECHNICAL FIELD

The invention relates to a serial multi-chamber intra-luminal energy transformer (hereinafter referred to as SMILET or device) for implantation along a patient's arterial lumen. The device is designed to reduce the damaging mechanical effects of local swirls and oscillations of blood flow, as well as local spikes in blood pressure.

BACKGROUND OF THE INVENTION

[1] describes a method and device for supporting cardiac activity in cardiac patients. The device contains an elongated intra-aortic balloon.

It is centrally located at one end of a catheter, which catheter includes multiple openings. The unit contains a pump and a control unit

- 2 devices located outside the patient's body, connected to the balloon by a flexible tube. The possibility of controlled inflation and release of the balloon in synchronization with the work of the heart has been created.

[2] described an intra-aortic balloon pump to support cardiac function in cardiac patients. The balloon is divided into three separate chambers connected to each other through openings in a centrally located catheter - at least one opening in each chamber. A characteristic feature is that the opening to the middle chamber is larger than others. The device includes an external pump, a control unit and a flexible hose joint common to the three chambers. The possibility of inflating and releasing the chambers in a certain sequence (first the middle chamber) was made, in synchronization with the work of the heart. The inflated midline chamber acts as a valve element that prevents blood from flowing to / from the periphery. Other cameras play

the role of a pumping element, for pumping blood to the heart, respectively to the periphery, after the valve chamber is already inflated.

[3] describes an intra-arterial cardiac support system comprising several intra-aortic balloons. The device includes at least one valve balloon located at the far end of the heart and one balloon operating as a pump element and located closer to the heart. The balloons are located in the descending aorta and are independently inflated / discharged from an external device via separate flexible tubes. An opportunity for consistent pumping action has been created in synchronization with the work of the heart.

[4] described an intra-aortic balloon pump to support cardiac function in cardiac patients. The device'includes a pump and control device located outside the patient's body, connected to the balloon by a flexible tube. The possibility of controlled inflating / releasing of the balloon in synchronization with the work of the heart has been created. This construction prevents a possible delay in the pressure drop in the balloon, for example caused by a local drop in blood pressure. This is achieved by means of a sleeve arranged around a centrally elastic catheter cable and fluidly connected to the catheter tube.

- 3 The sleeve and the close to the heart end are centrally located in the balloon. The sleeve has multiple openings for connecting the balloon to the catheter tube. The use of a sleeve eliminates obstruction of the fluid channel from possible unwanted collapse or contraction of the balloon in some areas. [5] describes a tubular device for assisting the circulation of a pulsating flow. The device includes a collapsible tube made up of at least three collapsible chambers. They are housed respectively in fluid-filled, fluid-filled inlet, discharge, and outlet chambers for

providing hydraulic or pneumatic compression of the collapsible chambers. The collapsible chambers are pressed and contracted sequentially over time, the contractions being controlled by an external pump and a control device synchronous with the work of the heart to provide a general pulsating nature of the contraction along the contraction tube.

[6] describes a device and a method for longitudinally separating a single-chamber intra-aortic balloon device into at least two separate chambers operating in conjunction. Each camera is smaller than the single camera, but the combination of the two may be larger than the single camera. The device includes a pump and a control unit located outside the patient's body, connected to the cameras via flexible tubes. The possibility of controlled inflating / releasing of the balloon in synchronization with the work of the heart has been created. The design allows for easier implantation and removal, especially in the presence of a plaque. Another advantage is the ability to more accurately match the required total volume of the chambers, as well as the facilitated blood flow around the chambers.

[7] described a device and method for the complete temporary replacement of the left ventricle in cardiac patients whose heart is unable to provide pressure adequate to maintain the inside of the aortic wall. The method includes a movable sealing means with an outer profile to maintain the aortic wall from the inside. The internal profile of the agent is a central opening allowing blood to flow freely through the aorta. The sealing agent is

- 4 spiral-shaped inflatables, inside which there are two intra-aortic balloons - a valve (farther from the heart) and a pump (closer to the heart). The device includes an external pump, control unit and connecting flexible pipes. An opportunity has been created to maintain the aortic lumen and self-inflate / inflate the two intra-aortic balloons, to simulate systole and diastole in one working heart.

[8] describes an intra-aortic pump to support cardiac activity in cardiac patients. The device includes a multi-chamber balloon located in the aorta lumen. A common hollow catheter is located centrally along the chambers. The chambers are fluidly connected only by radially connecting openings to the catheter openings - at least one opening in each chamber. The chambers are of increasing length and the connecting holes are decreasing in size in the direction of blood flow (from the heart to the periphery). The device includes a pump, a control device, a gas tank and an electrocardiographic sensor located outside the patient's body. Enable consistent inflating / dropping of cameras, synchronous with heart rate, using only

a single catheter lumen.

[9] describes a method and device for reducing the damage to the circulatory system by: reducing the maximum value of systolic blood pressure; and reducing blood flow acceleration This is done by passively absorbing some of the blood pressure through the systole phase. The apparatus contains an expandable / collapsible chamber, such as a balloon filled with pressurized gas. The chamber is made of flexible non-stretchable material and is implanted in the aorta or other large artery of elastic type. It shrinks as blood pressure rises through the systole phase and expands as it drops through diastole. When constricted, the camera absorbs some of the systolic pressure and reduces the rate of change (acceleration) of blood flow. When enlarged, the camera returns to its original shape, releasing the absorbed part

- 5 of the blood pressure. In this way, average blood flow and blood pressure are maintained throughout. An anchorage device for securing the chamber to a suitable location of the blood vessel is described, as well as a skeletal device for keeping the chamber in an upright position against the influencing blood flow and blood pressure. Embodiments including a second chamber fluidly coupled to the first one and located outside the body of the patient are discussed.

The disadvantages of each of the devices described in documents [1] to [8] are:

1. Inability to protect the endothelial layer from the aortic wall and other large arteries of elastic type - especially in case of oscillations and jumps in the instantaneous pressure value at the already started calcification of the wall.

2. The devices described do not increase the volume of the so-called. A "compression chamber" (aka Windkessel model) that improves cardiac perfusion.

3. Availability of an external device that makes the prophylactic use of the ill or a healthy person inconvenient. This type of intra-aortic balloon pump has been used to temporarily support cardiac perfusion (up to several weeks), for example in post-operative stabilization or post-infarction resuscitation.

The disadvantage of the devices described in [9] is the ineffective functioning due to some characteristic features of the actual circulatory system. For example, in an inelastic mechanical system (made up of rigid tubes, for example), systolic pressure will increase almost immediately and everywhere with the same value. In such a system, the shape and location of the absorption chamber described above is irrelevant - it will absorb in any case. However, in the actual circulatory system, the aorta and large arteries are elastic (even with reduced elasticity), which causes the presence of so-called. pulse wave. In this way an area of high pressure is formed at each systole. An important feature is the enlarged area

- 6 blood flow pressure (aorta and other major arteries). In the aorta, the front of this area moves sequentially from the heart to the periphery of the circulatory system at a speed of about 4-6 m / s (average in healthy people) to 10-20 m / s and more in people with advanced atherosclerosis. In this way, the pulse wave impact on the vascular wall is initially in the area immediately adjacent to the aortic valve, then in the next section, etc. in the course of blood flow in

the aorta and subsequent arteries of elastic type, this being done in the order of milliseconds (especially with a solid wall). The insufficient efficiency of the devices described in [9] is as follows:

1) When the pulse wave front reaches the beginning of the chamber, this part will deform (burst), and the pressure in the undeformed part will increase according to the Boyle-Mariot law for the isothermal process:

Pi .Vi = ₽2 .V2 at T = const, where:

Pi, Vi - are pressure and volume in the deformed part of the chamber; P2, V2- are the pressure and volume in the undistorted part of the chamber; T - is the gas temperature in the chamber.

As the front progresses, the pressure in the undistorted part will increase at a non-linear law more and more rapidly. Moreover, if the pressure in the chamber is suitably selected for efficient absorption at the beginning of the deformation, it will prove to be inappropriately high at the end of the chamber; conversely, if the pressure in the chamber is appropriately selected at the end of the deformation, then it will be inappropriately low at the beginning of the process. This will only absorb a small fraction of the time and only in the area where the pressure in the chamber is appropriate.

2) This negative effect can be reduced by coupling with a second chamber (described in [9]) with a much larger volume than the first one and located outside the patient's body, but there is an inconvenience of carrying this camera.

3) For each patient, the dependence pi = f (t), (where pi is the instantaneous pressure value at the i-th section, ate time) for the different sections of the aorta / artery is different. The devices and methods described in [9] do not allow modeling of the aortic pressure (or other artery of elastic type) pressure absorption process according to these dependencies.

SUMMARY OF THE INVENTION

Introduction

The widespread spread of vascular disease and its aftermath makes it the number one killer worldwide. As is known, the loss of aortic elasticity and other large arteries of elastic type leads to an increase in the pulse wave velocity and an increase in pulse pressure. Disorders of lipid and protein metabolism alone cannot cause atherosclerosis as a common disease, nor can atherosclerotic plaques. It is known that atherosclerotic plaques rarely develop in essential hypercholesterolemia. This testifies to the role of elasticity of the large arteries in: local hemodynamic processes; local blood pressure jumps; and overall reduction of the elasticity of the wall - the so-called. a mechanical factor in atherogenesis.

1) Local hemodynamics - Research done over the last decade has shown an increased tendency for atherosclerosis in areas where swirls or oscillations of flow occur and rapid changes in pressure. These are places around bifurcations, sharp curves, plaque, stenoses, stents, bypasses and more. These sections are several millimeters to several centimeters long and may vary depending on the hemodynamic conditions in the arterial system. Many studies have focused on the effect of shear stress, a consequence of longitudinal friction between the blood flow and the vascular wall. According to them, places with manifestations of turbulence (Reynolds number greater than 200) are characterized by vortices, oscillations, and bidirectional flow, with little longitudinal stress. In these places the lesions are larger, and vice versa - the places with unidirectional pulsating flow and large values of longitudinal stress are free of atheromatous plaques.

- 8 2) Local blood pressure jumps - Many authors have observed atherosclerotic lesions in those sections of the large arteries that

undergo significant dynamic changes in local blood pressure. They emphasize the importance (especially in combination with hypertension) of local blood pressure jumps for damage to the vascular endothelial layer and for possible subsequent complications - atherosclerosis of the aorta, carotid and coronary arteries (ischemic heart and cerebrovascular disease) diabetes mellitus, renal failure, left ventricular hypertrophy, aortic valve damage (calcification), vascular aneurysms. Returning so on. reflected pulse wave occurs from the periphery of the arterial system having increased hemodynamic resistance - due to the small arteries and arterioles. During the pulse wave, a rapid jumble (peak) of blood pressure occurs, with lesions large in areas of the abdominal aorta (around the renal arteries) where the right and reflected pulse wave occur. In case of advanced hardening of the vascular wall, this meeting occurs earlier - in the thoracic descending aorta during the late systole. Increased transmural pressure (eg, a consequence of filling) further impedes absorption of local blood pressure jumps.

3) Overall reduction of elasticity of the wall - Even in healthy people, who are absent of atherosclerotic changes, with advancing age decreases the elasticity of the aorta and other large arteries of elastic type. Therefore, it reduces the volume of the aortic compression chamber (ie, the volume of blood stored in the aorta due to stretching at the systole, etc. Windkessel effect) - by an average of 30 cm ³ at ages 16-39. to an average of 16 cm ³ at the age of 60-83g. [13]. Such a nearly twofold reduction in the volume of blood stored results in decreased cardiac muscle perfusion through the diastole phase, which causes ischemia and heart failure, even with low physical activity. Currently used drugs (such as ACE inhibitors, beta blockers, nitrates, statins, diuretics and

- 9 others) have no satisfactory effect in terms of improving coronary perfusion.

Tasks to solve

The above examples demonstrate the need to delay or compensate for the hardening of the aorta and other large arteries of elastic type (hereinafter only the aorta). There is a need to create a device for implanting an aortic lumen of a patient (human or animal) in order to passively (i.e., completely at the expense of the energy of blood pressure and blood flow) multilocal absorption of part of the systolic blood pressure and blood flow. Later, it is mainly through the diastole that release of this absorbed part (stored energy) is required.

The tasks solved by the device described are:

- reduction of local vortices and fluctuations of flow;

- reduction of jumps in the instantaneous value of blood pressure, separately for each protected area of the aorta;

- enlargement of the compression chamber, i. of the volume of blood stored

any systole in the large elastic arteries.

After implanting the device, the following are expected:

- improved cardiac perfusion - as is known, the heart is mainly irrigated through diastole through blood stored in the compression chamber;

- reduced left ventricular hypertrophy - due to slow pulse wave velocity, it is expected that the right and reflected pulse wave will occur through the diastole when the aortic valve is closed;

- remission of existing atherosclerotic plaques - due to increased local longitudinal values and improved hemodynamics;

- prevention, delay or remission of plaques not only in the aorta but also in the elastic arteries close to the device - coronary, carotid, renal, or iliac;

- Prevention of atherosclerotic changes in the subsequent middle arteries of the muscular type. This expectation is related to the fact that when sufficient

- 10 aortic elasticity (even in the elderly) in arteries of the muscular type virtually absent atherosclerotic changes;

- improving limb irrigation.

Description of the solution

The problem is solved with the described Serial MultiCamera Intra-Luminal

Power Transformer (SMILET). It contains an absorbent body of flexible material that is tolerated by the body. The absorbent body is disposed

entirely in the aortic lumen and having a length several times its transverse size. SMILET includes a means of attachment at a selected location to the aortic wall, as well as a means of implantation into the patient's body. SMILET is happy

having a structure adapted for implantation into the aorta by means of a specially designed catheter placement. It is convenient to implant the device transcutaneously directly into the aorta or through a cut in the arteria femoralis.

A characteristic feature of SMILET is that the absorbent body consists of a plurality of chambers, all of which are located in the aortic lumen and are arranged sequentially (serially) one after the other at least along the aorta. Compact-shaped cameras are desirable, each having a commensurate overall dimension along its x, y, z axes. They are filled with compressible fluid under pressure and contain practically constant amounts (masses) of that compressible fluid for at least one systole-diastole cycle. Maintaining a practically constant amount of fluid in each chamber is accomplished by: a) complete fluid isolation of the chambers from each other; (b) Connecting cameras through openings with small sections - small enough to not allow a significant change in the amount of compressible fluid in each of them for times of the order of fractions of a second.

Each chamber has a volume many times (at least 10x) smaller than the total volume of the absorbent body, having a shape and size,

- 11 allowing blood to move freely between its outer surface and the aortic wall at all times and in all possible conditions of the patient. This includes the various conditions of physical or mental strain, rest, as well as some special cases related to changes in atmospheric pressure - travel by plane, climb a mountain, dive underwater, enter a chamber.

The absorbent body also comprises flexible material couplings for joining adjacent chambers at least along the aorta. It is advantageous to use an absorbent body containing cameras made of flexible polymeric material. SMILET is suitable, the absorbent body of which is made partly or wholly of an elastomeric polymeric material, such as silicone. Another solution is a convenient absorbent body comprising rubber or rubber.

In most applications, the compressible fluid is a gas or gas mixture. In some embodiments, the cameras are very small and not interconnected. In these cases, a gel-like polymer was used as the compressible fluid. This polymer comprises a gas or a mixture of gases in the form of multiple gas bubbles representing the individual chambers.

A solution containing cross-sectional cameras having the shape of a three-beam (or larger beam) star is appropriate. Applications containing sections such as rays or transitions between beams are rounded are suitable. Cameras containing such sections provide free movement of blood in the space between the vascular wall and indentations between the rays of that star - even with a significant decrease in blood pressure or changes in atmospheric pressure (and a corresponding increase in the cross section of the chambers). .

The absorbent body includes differently shaped and sized chambers - to protect the adjacent aortic region adequately to the hemodynamic features in it (pressure peaks, presence of

- 12 oscillatory swirls, speed and acceleration of blood flow). Some embodiments provide cameras having circular cross sections of different diameters.

SMILET, having a streamlined shape of the absorbent body or of individual chambers, is desirable to reduce turbulent vortices that burden the heart to overcome additional resistance. In this case, SMILET contains cameras with a streamlined / pointed front (close to the heart) end.

In other cases, to reduce the overall hemodynamic resistance, the absorbent body includes a) helical grooves, "incised" around one or more chambers; b. cameras (or parts thereof) with cross-sections rotated relative to one another ("twisted around their axis") like a smooth screw line. Such rotation is also advantageous in a plane perpendicular to the longitudinal axis in which each chamber or portion of the chamber is rotated at a different angle from the previous one, similar to a cut screw line. These decisions are due to the fact that normally in a healthy patient, blood moves in the aorta in a helical fashion. Here and everywhere in this description, the longitudinal axis of the chamber coincides or is parallel to the longitudinal axis of the respective vessel in which that chamber was implanted.

SMILET's suitable solution involves the use of connecting units for the mechanical connection of adjacent chambers in series. Connecting units made of the same material as the cameras are suitable. In this case, the connecting members represent dense portions of the absorber body made with cross-sections many times smaller than the maximum cross-sections of the adjacent chambers. The couplings have a relatively small length relative to the length of the chambers and have a different shape and cross-section size than that of the chambers - to allow curvature of the absorbent body precisely in the coupling units. Thus, after implantation, the absorbent body follows the aortic curvature such as pressure and friction exerted by the chambers on the vessel.

- 13 walls are small and applied at points of contact with a small common surface. This reduces the damage to the vascular endothelial layer as well as the risk of rupture and rupture of the vessel wall.

In some embodiments, it is advantageous to use one or more hollow connecting members. Thus, in addition to being mechanically coupled, the chambers are fluidly coupled one after the other. Thus, for a short pulse wave shock time, each of the chambers is a virtually self-contained sealing vessel that absorbs efficiently while maintaining an approximate constant amount (mass / number of molecules) of compressible fluid. On the other hand, through these small openings in the connecting units, it is possible to conveniently initialise (inflate) and simultaneously change the pressure for all the cameras connected in this way. Suitable joints (solid or hollow) made of the same material as the cameras. For hollow joints, a wall thickness greater than the thickness of the chamber wall is appropriate. Thus, bending and pressure changes practically do not change the cross-section of the opening.

Another suitable solution is a common elastic manifold (shaped like a thick-walled tube of elastic material) - for parallel connection of cameras. This resilient manifold is arranged longitudinally around or inside some / all of the chambers and / or their respective connecting units. The places of passage of the elastic manifold through the chambers and openings of the connecting units are made soldered or glued during production, which provides the necessary tightness between the chambers. One or more connecting openings connecting the volume of each of these chambers is the longitudinal opening of the resilient manifold and through it to the volumes of the other chambers. Thus, the cameras are connected to each other only through their respective connecting holes and the opening of the elastic manifold. In some cases, the elastic collector also performs a skeletal function, transmitting the effort from the frontal pressure of the blood

- 14 flow to subsequent chambers or anchorage respectively to the aortic wall.

In the embodiment comprising hollow connecting members, each of them has a cross-section of the opening, many times less than the cross-section of any of the adjacent chambers in an arbitrarily rotated plane in which the longitudinal axis of the chamber lies. In an embodiment comprising an elastic collector, each connecting hole has a cross-section that is many times less than an arbitrary longitudinal section of any adjacent chamber. The diameters of the hollow joints or connecting holes (in the case of an elastic manifold) are made sufficiently small, which means that the chambers are fluidly coupled for relatively slow change in pressure when filling with compressible fluid or when adjusting its pressure. Conversely, for a relatively rapid change in pressure within a single cardiac cycle, the same chambers appear virtually fluidly insulated.

Suitable and SMILET containing means for securing the absorbent body to the vessel wall. In some applications, this is an elastic manifold, in which one or more metal guides are provided longitudinally, providing an elastic compression of the chambers to the aortic wall. In these cases, the guides perform the function of a locking device or are part of it. In other cases, they provide a flexure of the end-to-heart end of the absorbent body according to the aortic curves - for convenient implantation guidance, sometimes in combination with a catheter insertion. After implantation, the insertion catheter is removed and the guides remain in the wall of the elastic collector and play the role of a skeletal or spring function. It is convenient to use three guide rails, symmetrically mounted in the wall of the elastic manifold through 120 °.

SMILET is hit, whose mounting means includes a plurality of elements for securing the absorbent body to a specific location in the aorta and preventing it from spontaneously moving. It is appropriate

- 15 a solution according to which these elements are ribs of elastic polymeric material located on the surface of the wall inside or outside the interior of one or more chambers. Embodiments where these fins are of the same material as the chambers are made of or made of as a whole are advantageous. The ribs are transverse

section providing spring-loaded pressures to the aortic wall. The attachment is due to the increased friction force. A suitable embodiment comprising cameras is a cross-section similar to a three-pointed star and such fixing ribs located inside the cameras below their edges. A suitable solution includes an elastic manifold and associated ribs made of an elastic polymeric material. In other cases, the mounting means includes an elastic manifold springing up the chambers to the wall of the arched aortae like an arched rod.

Another solution provides a SMILET containing a fastening means comprising elastic members, conventionally called fastening whiskers. They are at least several in number, securing the absorbent body

to the aortic wall, in some cases - and symmetrical position relative to the lumen of the vessel. It is conveniently an absorbent body containing dense mustaches made of the same material and as a whole being chambers or connecting links. The mustache is the shape and size of the cross-section that allows a spring press against the aortic wall. It is appropriate to make them inclined to the longitudinal axis of the absorbent body - for easy placement of SMILET in the lumen of the vessel and for stability against blood pressure at work. An embodiment wherein the whiskers are constructed as extending from connecting units is desirable. Thus, the pressure exerted by the mustache on the aortic wall is weakly dependent on the deformation of the adjacent chambers, especially when the connecting members have a thickened and less elastic wall relative to the wall of the adjacent chambers. In other cases, the attachment means has sharpened hook elements for attachment at selected locations of the aorta.

- 16 In many applications, the implant-assisting agent in the patient's body includes a means of initially detecting or altering the contraction fluid pressure. This means of initialisation or modification of compressible fluid pressure (hereinafter referred to as "initialisation means only") allows the absorbent body chambers to be filled with compressible fluid during or after implantation, as well as to correct (if necessary) the pressure value of this fluid during operation. In some of the solutions this tool includes

valve for filling and correcting the pressure by means of an external device. In other cases, this means comprises a thick section for filling and changing the pressure by means of a syringe or other device using a hollow needle. It is advantageous to initially adjust or modify the pressure of a contractible fluid containing a thin, flexible, non-expandable tube. The upper end of the tube is connected to the absorbent body located in the aorta. The lower end of the tube is located in the arteria femoralis and ends with a valve or a thick section for manipulation of a hollow needle. The tube has a small outer diameter (which does not impede the movement of blood in the arteria femoralis), with the valve or the thickened area located in the groin area (inguinal fold) - for convenient access when needed. During operation or correction, the valve / thick section does not exit the artery. In this way, the relative comfort of initial contraction / change in the pressure of the compressible fluid is provided, due to the small section / opening in the arteria femoralis. The described means for initially adjusting or modifying the pressure of the compressible fluid is suitable in the case of an absorbent body containing chambers coupled to an elastic manifold or hollow couplings.

As an additional aid for implantation into the patient's body, it is a suitable absorbent body comprising a region adapted to be gripped by a specially designed insertion catheter. In some cases, the front end of the first chamber is made bold to grip by

- 17 catheters. In the case of an absorbent body comprising an elastic manifold, a catheter extending through the longitudinal orifice of this is suitable.

elastic manifold.

Action

For a short time of damaging action within a single cardiac cycle (under the influence of a pulse wave, local swirls or oscillations), each chamber is virtually fluidly isolated from the rest. Each camera is provided with the possibility of independent deformation and thus for efficient local absorption.

As a result of the pulse wave, the aorta dilates successively along its entire length, absorbing a certain volume of blood. At the same time, the pulse wave consistently shrinks the chambers of the absorber body to a certain extent. As the pulse wave front advances, the corresponding section of the aorta expands and enlarges its cross-section, and its corresponding chamber (s) located in that section contract. This expansion / contraction occurs sequentially over the entire length of the aorta throughout each cardiac cycle. In addition to the volume taken up by the aorta (and other large elastic arteries), an additional volume of blood is added as a result of the contracted absorbent body. Thus, the insufficient volume of blood absorbed by the aorta through the systole phase is compensated for by its reduced elasticity. Part of the systolic energy (kinetic - of blood flow and potential - of blood pressure) is converted into the potential energy of the contracted fluid (as well as the potential energy of the dilated aorta). Further, it is mainly through the 'diastole' phase that the aorta shrinks by elastic forces together with the expansion of the absorbent body of the contracted fluid, thereby displacing the amount of blood stored through the systole, i.e. conversion of potential energy back into kinetic energy of blood flow and potential - of blood pressure (diastolic pressure). At work, SMILET compensates for reduced aortic elasticity, helping to increase the volume of absorption through the

- Phase 18 blood stool and its subsequent ejection. This leads to a decrease in the value of your metabolic pressure, an increase in diastolic pressure, and a decrease in the acceleration of blood flow not only in the aorta, but also in subsequent major arteries - coronary, carotid, renal, iliac, and others.

The influence of local oscillations and eddies of the flow is reduced or eliminated due to absorption by close-up chamber (s), and this also affects the overall (total) picture of blood flow in the arterial system. In this way, SMILET implanted in the aorta reduces turbulence and damage in the arteries following the aorta.

A feature of the device is the ability to automatically change the absorptive capacity, depending on the value of the pressure in the aorta of the patient (systolic and / or diastolic). This is possible through appropriate material selection and sizing of individual elements (mainly cameras). The use of three-pointed star-like cross-sectional chambers ensures that the aorta is leaked and not obstructed, even if their volume is increased by 50%. With the SMILET designed in this way, it is possible to automatically change the absorptive capacity according to the aortic pressure:

1. If, for all other things being equal, the systolic pressure drops for some reason, then the volume of the absorbent body during the systole phase (and the pressure in it) should increase. This results in a "softer" operation of the absorbent body, which is deformed and absorbed efficiently, starting from lower values of systolic pressure (ie, greater absorbed volume is possible).

2. If, for all other things being equal, the systolic pressure rises for some reason, then the volume of the absorbent body during the systole phase (and the pressure therein) will decrease. This results in a “stiffer” operation of the absorbent body, which is deformed and absorbed effectively, starting from higher values of systolic pressure (ie no greater absorbed volume is possible).

3. If, for all other things being equal, the diastolic pressure drops for some reason, this allows a larger increase in the volume of the absorbent body and leads to an increase in the total volume of blood expelled during this phase. This compensates for the reduced blood volume displaced through the diastole.

4. If, for all other things being equal, the diastolic pressure is increased for any reason, it prevents the volume of the absorbent body from increasing further and results in a decrease in the total volume of blood expelled during this phase. This compensates for the increased volume of blood displaced through the diastole.

When both types of pressure are combined - systolic and diastolic, the value of the pulse pressure changes depending on the signs and their magnitudes. SMILET counteracts the predominant factor - as the pulse pressure rises, it tends to reduce it, and accordingly, as the pulse pressure decreases, it tends to increase it. In a healthy aorta, the auto-regulation described above

is at the expense of the elastic forces of the aortic wall.

In the above-described embodiments of SMILET, opportunities have been created to: deform each chamber depending on the qt instantaneous value of the local blood pressure around it; converting (for each chamber) a portion of the energy through the systole phase (potential energy of blood pressure or kinetic energy of blood flow) into potential energy of compressed compressible fluid; reversing this potential energy of compressed compressible fluid into kinetic energy of blood flow and / or potential energy of blood pressure.

By means of a means of initialisation and change of pressure, and through the connecting openings in the chambers, it is possible to first fill and correct the pressure (if necessary) in the absorbent body.

- 20 Advantages

Advantages for a patient with implanted SMILET in the aorta compared to a patient without such a device are: reduction of local turbulence and blood pressure jumps, adequate for each protected area of the vessel adjacent to the respective chamber; reducing the speed of the pulse wave; reduction of acceleration (acceleration and deseleration) of blood flow; assisting the body's autoregulatory function in regulating blood pressure (namely by automatically changing the rate of absorption).

Reducing the local jumps of the instantaneous value of blood pressure and local accelerations of the flow leads to a decrease in the perpendicular force applied to the arterial wall. This helps to preserve the integrity of the endothelial layer (a factor in atherogenesis). Blood moves pulsating in one direction, as in healthy elastic arteries, increasing the value of longitudinal tension - a consequence of longitudinal rubbing of blood against the vessel wall.

The consequences of these benefits are:

Decrease in the rate of damage in their endothelial layer in the aorta and adjacent large arteries due to the reduced shock load on the vessel wall and reduced values of oscillations and eddies of flow. Remission of atheromatous plaques due to increased longitudinal tension and the establishment of pulsed unidirectional flow.

Because of the systole shrinkage, SMILET lowers the systolic pressure. Due to the expansion (mainly through the diastole) and the displacement of additional blood at the expense of restoring its original volume, SMILET raises the diastolic pressure, thereby lowering the pulse pressure. Generally, with advancing age, the pulse pressure increases for various reasons - such as loss of vascular elasticity, hypertension and other diseases. An important consequence is the ability to protect multiple sections along the aorta, since, as with hemodynamic conditions, oscillations

- 21 both the eddies and the venue of the rights meeting and the reflected pulse wave may change.

Heart-friendly conditions have been created by reducing the age-related increase in heart volume (left ventricular hypertrophy) due to reduced heart loading - from reduced aortic pressure and reactive force through the systole phase. Due to the decrease in the speed of the pulse wave, the meeting of the straight and reflected pulse wave occurs during the diastole phase when the aortic valve is closed. This also reduces left ventricular hypertrophy.

Coronary perfusion is improved due to the increased volume of expelled blood through the diastole phase. The development of heart failure and ischemic heart disease is delayed. Reduces the deposition of atheromatous plaques in the coronary arteries. For these reasons, the risk of obstruction of the coronary arteries (partial or complete) and the corresponding complications - chest frog, myocardial infarction, sudden death, are also reduced. Reduces the risk of stroke:

hemorrhagic because of lower systolic pressure; ischemic due to flooding blood flow and reduced risk of embolism. Reduces the possibility of the formation of vascular aneurysms, most commonly occurring in mechanically weak areas or places with increased hemodynamic loading - bifurcations, folds, outside of curves, and places with small or negative longitudinal stress values. The device inhibits the development of some diseases related to high systolic or pulse pressure - diabetes mellitus, renal failure and others.

Limb deworming is also improving.

SMILET contacts the aortic wall and the atheromatous plaques accumulated on it in a relatively small area. Thus, it is practically not difficult to wash the wall from the blood flow and does not increase the risk of breakage of a blood clot. The ability to automatically change the absorbency of the device depending on the value of no

- 22 The aortic pressure of the patient through the phases of systole and / or diastole enables effective support to the body's regulatory functions concerning the regulation of blood pressure. Assistance is done in a manner similar to the natural one, such as with a preserved elastic aorta. Another feature is the ability to easily change the pressure when needed. SMILET practically does not increase the resistance of the circulatory system - due to the large section of the aorta (further increased in calcification) its resistance has the least influence (less than 5% - [13]) in the total resistance of the circulatory system.

The compact dimensions of the chambers and the multiple contact points contribute to the small tensile stresses arising in their walls, as well as the small forces of pressure and friction with the vessel wall. The device is operated in a non-aggressive environment at constant temperature. These factors determine the long life and safe operation of SMILET. The manipulations associated with insertion, correction of pressure, or removal of the device are similar to procedures known in the art, such as coronary catheterization, angioplasty, and intra-aortic ballooning. In general, these manipulations do not require surgery and implantation is by a specially designed catheter through arteria femoralis in the inguinal area.

EXPLANATIONS OF THE FIGURES Attached

FIG. 1-3 show the movement of a pulse wave in human aorta 102 from the heart to the periphery according to [13].

FIG. 4 is a graph of pressure-volume curves for human aorta 102 according to [13]. You can see the increased volume and decreased elasticity of the aorta, as well as the volume of AV stored at different ages.

FIG. 5 shows an example of a possible implementation of a SMILET implanted in a human aortic lumen 102 including an elastic collector 4, connecting members 7, and chambers 2 resting on the wall 104 ends. There is a construction

low hemodynamic resistance, the anchoring being entirely due to the friction generated by the pressure at multiple points 208 of the chambers 2 to the inner layer of the vessel wall 104. An embodiment whose chambers 2 include cross sections in the form of a three-pointed round star and transitions between beams.

Figure 6 shows section 219-219 of Figure 5. The cross-sectional area of chamber 2 in systole and diastole are shown, as well as their difference, which causes a change in the volume V i of the chambers.

7 shows a section 220-220 of FIG. 5. The cross-sectional area of chamber 2 at systole and diastole is shown, as well as their difference causing the change in volume V i of the chamber.

Fig. 8 shows a longitudinal section of an arbitrary chamber 2 of Fig. 5, and four randomly selected cross sections 221-221 to 224-224 thereof.

FIG. 9 shows a longitudinal section of several successive chambers 2 of FIG. 5 at the time of the passage of the pulse wave. Shown is a deformation of the aorta 102 and a portion of the chambers 2, causing a longitudinal deformation 203 of the absorbent body 1. Due to the small section of openings 6, the amount of fluid flowing 11 from / to the chambers 2 for the passage of the pulse wave (tenth or hundredths of a second) ) is negligible.

FIG. 10 shows a longitudinal section of an arbitrary chamber 2 made of an elastic polymeric material at two different times. The dashed line shows the moment of aortic lumen expansion and contraction of chamber 2 through the systole. This is the moment of energy absorption and fluid shrinkage 11. The continuous line shows the moment of aortic lumen shrinkage and the expansion of the chamber through the diastole. In doing so, energy is released. A characteristic feature of this construction is that the selected material, shape, and dimensions of chamber 2 provide contact with wall 104 throughout the cardiac cycle.

FIG. 11 shows a section 225 of FIG. 10. The moment of absorption of energy from the compressible fluid 11 through the systole phase is depicted. Under the influence of

- 24 the local blood pressure value of the aorta 102 expands and chamber 2 shrinks. Arrows 204 indicate the normal blood pressure 101 applied to the aortic wall endothelial layer 104 and chamber 2,

generating their potential energy supply.

FIG. 12 shows a section 225 of FIG. 10 at the time of energy release. Under the action of elastic forces 202, the aorta 102 shrinks, and under pressure 205 of the compressed fluid 11, chamber 2 expands.

Here, arrows 202 and 205 indicate the movement that generates the reverse conversion of stored potential energy (of the enlarged aorta 102 and collapsed chambers 2) into energy of blood flow (kinetic) and diastolic pressure (potential). 207 shows the difference in sections of camera 2 in energy absorption and emission. This difference 207 determines 1 volume of blood V stored in the absorbent body, added through the diastole to the volume of blood stored in the aorta 102.

FIG. 13 shows an example of a possible implementation of SMILET implanted in the lumen of human aorta 102, including an elastic manifold 4, chambers 2, connecting members 7 and fixing whiskers 9. A series of chambers 2 representing the absorbent body 1 is shown.

Figures 14-19 refer to the example of Figs. 13 as follows: FIG. 14 shows an enlarged section 226-226.

FIG. 15 shows an enlarged section 227-227.

FIG. 16 shows an enlarged section of 228-228 and 229-229.

FIG. 17 shows an enlarged section 230-230.

FIG. 18 shows an enlarged section of a thick section 16 adapted for manipulation of a hollow needle.

FIG. 19 shows an enlarged cross section 231-231. In the vicinity of the resilient manifold 4, the mounting faces 9 are depicted as lying in the plane of the section.

Fig. 20 shows an example of a possible implementation of a SMILET implanted in the lumen of a human aorta 102 including connecting units 7, connecting holes 8 and fixing pins 9. In the shown case, SMILET is entirely

made of one material. The sequence of chambers 2 representing the absorber body 1 is shown.

Fig. 21 shows a SMILET design for self-implantation - ie. without the need for a special implant catheter. In this case, the elastic manifold 4 and the means 12 for initially adjusting or changing the pressure of the compressible fluid 11 are made of a suitable wire, allowing the SMILET to move up the aorta 102. The introduction into the artery 113 (arteria femoralis) is via a funnel-shaped guide 17. In the distant ( upper) end of elastic collector 4 is a metallic or non-metallic marker 19, visible through non-invasive (tomographic, ultrasound, radiographic) observation during the implantation process. In some applications, this marker is curved to facilitate tracking of the aorta / artery bends (for example, by rotating the tool 12 on its axis at implantation). Fig. 22 shows implantation using funnel-shaped guide means 17, followed by inflating with compressible fluid 11.

Fig. 23 shows the cut-off after implantation of the excess part 211 of the means 12 for initially adjusting or changing the pressure of the compressible fluid 11.

FIG. 24 shows means 12 in operation of SMILET. The incision for implantation 212 in artery 113 is shown. The enlarged image shows an example of a metal stopper 13 permitting correction of the pressure of contractible fluid 11 during operation. The stopper 13 includes an elastic sealing material 14 and a conical surface to facilitate finding and correcting the pressure with a hollow needle through the artery wall 113. The used stopper 13 allows the hollow needle demand to be monitored by non-invasive (tomographic, ultrasound, radiographic) means. .

FIG. 2 5 shows a control device 18 for controlling an implantable catheter 15. Upon implantation, a catheter 15 is inserted into an opening 5 of an elastic manifold 4. The device controls the movement of a catheter 15 (respectively

26 absorbent body 1) via a movable tip 20 along the Y and Z axes, accompanied by manual insertion along the aorta 102 (conventionally depicted as the X axis). For this purpose, the control unit 18 includes at its bottom a gripping handle (in the case of the right hand). The device comprises means 21 for controlling the movable tip 20 along said Y and Z axes by means of three movable shafts 27 mounted in the longitudinal orifice of the catheter 15. The control device 18 is also intended to initially fill and / or adjust the compression fluid pressure 11. For this purpose, a shrinkable compression fluid reservoir 22 is mounted in the handle. A longitudinal orifice in catheter 15 is used to feed the compressible fluid 11, with fluid 11 extending from the distal end of catheter 15 (position 215). At the top of the device 18 is a display 26 for monitoring the pressure of the compressible fluid 11 in the absorber body 1 and buttons 23, 24, 25 for controlling this pressure. In this case, the button 25 switches on the power, the buttons 24 raise / lower the pressure, the button 23 switches on the mode of automatically maintaining the selected pressure until the catheter 15 is removed.

FIG. 26 shows the removal of an implantation catheter 15 from an elastic manifold 4 in the case of the use of a control device 18 in FIG. After being filled with fluid 11, the chambers 2 are pressed into a plurality of individual points of contact 208 against the inner layer 104 of the vessel wall. The friction between absorbent body 1 and aorta 102 increases. This allows the removal of catheter 15, shown by arrows 217 without loss of pressure (enlarged image). The movable tip 20 (FIG. 25) has a larger diameter than the outlet of the means 12, which allows the catheter 15 to be fully pulled to the end of the means 12. This is followed by: removal of the funnel guide 17; squeezing and cutting off the excess portion (Fig. 23) of the means 12 near the section 212 (Fig. 24); inserting a cap 13 into the longitudinal opening of means 12 (FIG. 24); sewing / closing otherwise cut 212. The method allows the use of relatively soft (non-spun) materials

- 27 for elastic manifold 4 and / or means 12 for initial setting or changing of pressure.

FIG. 27 and FIG. 2 8 show partial longitudinal sections of cameras 2 with cross-sections similar to a three-pointed star. In this case, the resilient manifold 4 contains fixing ribs 10 for pressing the chambers 2 to the aortic wall at any time. An opportunity has been made for the production of cameras 2 made of flexible inelastic polymer (not elastomer), with low gas permeability, respectively, and increased shelf life of SMILET. This maintains good flow and low hemodynamic resistance.

EXAMPLES FOR THE IMPLEMENTATION OF THE INVENTION

Technical descriptions

A first embodiment of a SMILET implanted in aorta 102 per person is shown in FIG. The device comprises an absorbent body 1 (Fig. 13, Fig. 20) made of a synthetic biocompatible elastomer. It is intended for the passive absorption of energy - wholly at the expense of part of the energy of blood pressure and / or blood flow. Absorber body 1 is a plurality of chambers 2 arranged one after the other. The SMILET design selected includes cross-section © 2 cameras that resemble a three-beam rounded star and rounded transitions between beams - similar to those shown in FIG. 8 cross sections. This cross-sectional shape provides a symmetrical arrangement with respect to the aorta wall 104 and allows the blood to flow freely 101, accompanied by small friction losses. Chambers 2 are of different sizes and shapes depending on their location in the aorta 102 to provide a constant spring compression against its wall 104, similar to the compression depicted in FIG. 10. The selected shape of the chambers 2 allows for each of them to be pressed at three points equally spaced 208 to the aorta wall 104.

all points 208 are small compared to the total inner surface of the aorta 102 to protect most of the endothelial layer. Due to the large number of touch points 208, the friction force is sufficient to secure the SMILET in the selected location. The first cardiac chamber 2 has a pointed anterior end to reduce the hemodynamic resistance exerted on blood flow. An elastic manifold 4 is arranged along the entire length of the absorbent body 1. It is a relatively thick tube made of an elastomeric polymeric material and passes in series along the longitudinal axis of all the chambers 2. The places of passage of the elastic manifold 4 through the openings of chambers 2 are thermally soldered during manufacture by means of hermetic solders 3, ensuring tightness between each of the two adjacent chambers 2. Connecting holes b are made radially in the elastic manifold 4 (see also enlarged part of Fig. 13) located one inside each chamber 2. Each connecting hole 6 is intended to connect the volume of the respective chamber 2 to the longitudinal opening 5 of the resilient manifold 4 and hence to the volumes of the other chambers 2. Thus, chambers 2 are connected in parallel through the collector 4. Characteristic of the connecting holes 6 is that their diameters are many times smaller than the diameter of the longitudinal opening 5. The last chamber 2 is located just before the bifurcation 110. SMILET also contains means 12 for initial setting / changing the pressure of the compressible fluid 11. This means 12 includes a thick, flexible outer tube having a small outer diameter that connects a longitudinal opening 5 of an elastic manifold 4 extending from the last chamber 2 with a thick section 16 designed and adapted to insert a hollow needle. The means 12 is located in the artery 111 and extends to the artery 113 (Figure 21). For reasons of technological convenience, the flexible tube of means 12 is made of the material of an elastic manifold 4 and is shaped as an extension thereof. The interior of: each chamber 2, of the elastic manifold 4, and of the means 12 contains a compressible fluid 11. In this case, sterile inert gas is used as such compressible fluid. He is

- 29 filled under pressure immediately after implantation of SMILET. In the working position, a thick section 16 is located inside the artery 113 (FIG. 24) in the area of the patient's inguinal fold - for convenient access when the pressure is changed or the SMILET is removed from the patient's body. Multiple pressure adjustments are possible with minimal intervention - only by pricking is a hollow needle and adding / removing contractible fluid 11. Division 16 includes elastic material 14 - to ensure tightness after removal of the hollow needle (due to elastic forces). Section 16 further includes a funnel-shaped portion for pointing the hollow needle and facilitating the piercing of elastic material 14. The connecting members (tightness) between two adjacent chambers 2 allow the absorbent body 1 to bend and follow the curves of the aorta 102 without The chambers themselves are deformed 2. In addition to the fluid coupling of the chambers 2, the second purpose of the elastic manifold 4 is to provide mechanical resistance to the absorbent body 1 and elastic pressure against the wall 104 of the aorta 102 - similar to a tight elastic rod. In this way, a constant pressure of the upper (according to FIG. 5) parts of the chamber 2 on the aortic wall 104 is ensured, especially in the bend of the aorta 102 - the so-called. arcus aortae. On the other hand, the pressure of the compressed fluid 11 provides additional compression of the tips of the chambers 2 along the absorbent body 1 to the wall 104 - three contact points 208 for each chamber 2. The two together - the clamping like a contracted elastic rod and the compression of the tips of the chambers 2 of the compressible contraction fluid 11 is a means of securing to the aorta wall 104 104. This means allows reliable attachment of SMILET to a pre-selected location for all possible operating conditions (increased metabolic and / or pulse pressure no, increased minute volume of expelled blood, a combination of them and others). The purpose of the connecting holes 6 is to provide an opportunity for initial filling with compressible fluid 11 and any subsequent adjustments to the pressure during operation. The holes 6 are small in diameter - for elimination

- 30 the possibility of a significant change in the amount of contractible fluid 11 from chamber 2 over the course of a single cardiac cycle. In this way, the chambers 2 are fluidly coupled to each other during the filling / adjusting of the pressure (due to the relatively slow change in the pressure of the compressible fluid 11). Conversely, due to the relatively slow change in the pressure of the compressible fluid 11, the chambers 2 are virtually fluidly separated: during the passage of the pulse wave; at local fluctuations of flow; at local blood pressure jumps.

According to a second example (FIG. 26) for the implementation of the SMILET absorbent body 1 contains chambers 2 of a flexible but non-stretchable polymer, having the shape as in the example of FIG. 5, and an elastic manifold 4 made of a resilient polymeric material. A curved metal marker is mounted at the end of the elastic collector 4 to facilitate the tracing of vessel bends and radioscopic (X-ray) implantation monitoring. After the last chamber 2, the elastic manifold 4 seamlessly passes into a thin, thick-walled tube - means 12 for initially adjusting or changing the pressure of a contractible fluid 11. The free end of the means 12 is closed by means of a stopper 13 (Fig. 24) after implantation. The selected compressible fluid is sterile oxygen.

Implantation into the patient's body

In the first example considered, the implant is intended to be performed without the use of an implantable catheter 15. In this case, the elastic manifold 4 is made of relatively rigid and durable material that allows movement to the intended location in the aorta 102. The total length of SMILET is individually selected for the particular patient. after examination, using a special measuring catheter or non-invasively by ultrasound, tomography or x-ray. During implantation, SMILET has extracted air from the internal volume, as shown in Figure 21 - to reduce the size. After inserting into

- 31 the site selected follows the filling of the contracting fluid with a hollow needle. Inflating an absorbent body 1 is done in one of the following ways:

a) By introducing a predetermined amount of shrinkage fluid

11. This allows fluid 11 to be inserted before inserting the last 2-3 inches of the means 12 into the artery 113.

b) By reaching a predetermined pressure of fluid 11. In this case, the means 12 is fully inserted into the artery 113 and the opening 212 (Fig. 24) is sewn / pressed.

The implantation of the SMILET of the second example is performed using a specially designed implantation catheter 15 driven by a control device 18, Fig. 25. This device contains controls 21, 23, 24, 25 located outside the body of the patient. The implantation catheter 15 is located in the longitudinal opening 5 of the elastic manifold 4 and in the longitudinal opening of the initial pressure setting / changing means 12. In doing so, SMILET is in an implant position - with extracted air from the internal volume. This makes it easier to pass through the arterial lumen. The position of the implantation catheter 15 has been made possible by observing portions of it using non-invasive monitoring devices. The construction of the implant catheter 15 permits the initial filling of oxygen immediately after SMILET placement at the selected location of the aorta 1 through an opening in the implant catheter 15. Due to the pressure at multiple points 208, the friction force between the wall 104 and the absorbent body 1 increases. This provides the opportunity for stable SMILET retention at the selected location and removal of the implant catheter 15. This is followed by removal of the catheter 15, Fig. 2b. The excess length of the means 12 is cut off as shown in FIG. 23 and a cap 13 is inserted, as shown in FIG. 24. A hollow needle is used in the process of changing the operating pressure.

The manipulation is performed by means of non-invasive monitoring.

- 32 For both examples: SMILET can be removed, if necessary, by draining the compressible fluid 11 outside the patient's body and pulling it through a means 12 through an opening or a longitudinal section in an artery 113.

Action (for both examples)

As blood pressure increases through the systole, the aorta 102 expands sequentially along its entire length, absorbing a certain volume of blood 101. At the same time, the SMILET absorbent body 1 shrinks consecutively along its entire length (Figs. 10-12). absorbs additional blood volume (pos. 207, Fig. 12) to compensate for insufficient volume due to decreased elasticity of the aorta 102 and / or other large arteries. Thus, during the systole phase, some of the systolic energy (kinetic - blood flow, and potential blood pressure) is converted into the potential energy of compressed fluid 11 air, and also into the potential energy of the dilated aorta 102. Subsequent (mainly through diastole) contraction of the aorta 102, accompanied by a corresponding expansion of the absorbent body 1, thereby displacing the amount of blood stored through the systole. In other words, the potential energy of compressed fluid 11 is converted back into kinetic energy of blood flow and / or potential energy of blood pressure. A characteristic feature of the action is that each chamber is capable of independent deformation and absorbs pressure jumps in the adjacent section of aortic length 102. The device also absorbs local irregularities of blood flow in and around places where it is swirling, bidirectional, or oscillating. SMILET helps to: increase the volume of blood absorbed through the systole phase, followed by the administration of this absorbed amount, and also to reduce local accelerations of blood flow. As a consequence, the systolic and diastolic pressure increase, the blood pressure jumps are reduced and the flow in the places with increased turbulence is uniform.

- 33 Advantages of the examples considered

Advantage for the devices of both examples over the patient is reduced aortic elasticity, but without SMILET: As a result of using the device, one-way pulsating laminar flow in the large arteries is obtained in a natural way similar to the way nature solved the problem in healthy people .

The devices of the two examples considered allow the use of camera material 2 which has low gas permeability.

Advantage of the two examples shown in FIG. 5 (before implementation of FIG. 20) is the possibility of independence in the degree of deformation of individual chambers 2 at the same time. In other words, the cameras are virtually independent of each other and can deform each according to the specific pressure around it. This is due to the independent parallel fluid coupling of the chambers 2 to the aperture 5 of the elastic manifold 4, where the pressure is averaged.

Advantage of the two examples shown in FIG. 5 (prior to the embodiment of Fig. 13) is the small hemodynamic resistance and the smaller secondary vortices of the flow caused by the fixing mustaches 9. The advantage of the first considered example over the second is the possibility of:

(a) direct implantation without the use of a special implantation catheter;

(b) a simplified construction of tool 12;

(c) a simplified implantation procedure

An advantage of the second example considered above the first is the ability to easily find a cap 13 in pressure correction. This is done using a non-invasive real-time monitoring tool.

SUMMARY OF THE INVENTION

The use of SMILET for permanent or temporary protection is envisaged instead of or in combination with drugs, angioplasty, coronary / other stents, intra-aortic balloon pumps, prevention of restenosis.

- 34 It is appropriate to implant SMILET at a certain, relatively early stage in the development of changes in the vascular wall 104, before the development of major atherosclerotic changes. A possible avenue involves transdermal aortic implantation, also used in intra-aortic ballooning / pumping.

Pressure correction is required when the hemodynamics of the large vessels change - an increase in systolic / pulse pressure, a greater degree of calcification, or at the dissolution / disappearance of atherosclerotic plaques - remission.

In some embodiments, the means 12 is housed in an absorbent body 1, which in this case contains a reservoir with a redundant compressible fluid 11 under pressure. It is thus possible to design a means 12 for adjusting or changing the pressure, including a receiver of an electromagnetic, ultrasonic or other signal for carrying out the respective action: raising - by adding fluid 11 from the tank to an absorbent body 1; lowering by the discharge of fluid 11 from an absorbent body 1. It is advisable to include a substance / element in the construction of a substance / element to facilitate monitoring by non-invasive methods - metallic elements, special powder or colorant.

From a manufacturing and practical point of view, it is apparent the convenience of the SMILET construction, in which at least one absorbent body 1 has circular symmetry prior to implantation. This eliminates the need for adjustment by rotating the axis of the absorbent body 1, simplifies production and provides greater versatility in implantation.

There is a wide variety of sizes and shapes of sections of the aorta 102 in different sections along its length - for example, as a result of accumulated atheromatous plaques. It is known that the instantaneous values of blood pressure and velocity are different in different regions, and in different patients the respective regions are different. This requires the use of an individual patient for each individual patient

- 35 absorbent body 1 comprising chambers 2 of suitably selected shape and dimensions according to the respective portions of the aorta 102.

When designing SMILET the parameters for change are:

- materials for the individual parts

- shape of cameras 2 (including cameras with different cross-sections, circular sickle or other)

- wall dimensions and thickness for each camera

- diameter for each connecting point 7 and the opening 8

- dimensions of elastic manifold 4 and hole 5, number and diameters of connecting holes b

- average compressed fluid pressure 11

- material and dimensions of the mounting pins 9 / the mounting ribs 10 and / or the dimensions of the tapered edges of the chambers 2 adjacent to the aorta 102 at points 208.

It is possible to model the absorption process over time for different sections of the aorta 102. It is appropriate to develop a full range of SMILETs with different sizes and properties, providing better choice for the needs of each individual patient / patient group.

Suitable for series production as a single piece of material - chambers 2, connecting units 7, fastening devices 9, 10, means 12 for changing the pressure and others.

The implementation of SMILET is appropriate, in which at least part of the device is visible from non-invasive monitoring and diagnostics equipment (X-ray, ultrasound, etc.), which helps with implantation and / or alteration of the contraction fluid pressure. contrast agent, metallic constituents, markings or details for non-invasive (tomographic, ultrasound, x-ray) monitoring of the procedure.

In conditions of large-scale production of SMILET containing hollow connecting units 7 (instead of elastic manifold 4), a one-step production method is possible. In this case, the device is made of sheets

- 36 materials by different methods of combined molding. In the case of a SMILET incorporating an elastic manifold 4, a two-step method is appropriate: Stage one: Elastic manifold 4 together with anchoring means (if present - pins 9 or ribs 10). This may be a polymer extrusion method or a molding method (including under pressure / vacuum). Step 2: The blank for chamber 2 is prepared by extrusion as a thin-walled tube or by calendering of a sheet polymer material. The completed elastic manifold 4 (with fabricated openings 6) is inserted together with the chamber blank 2 into one half of the molding die and closed. The following is formed by one of the known methods, for example, by supplying pressurized air from the inside of the future chambers (through the opening 5 of the collector 4) combined with a vacuum from the outside. This is followed by heat treatment, chamber formation and vulcanization.

POSITION INDEX xx. Components of the device

-absorbent body for energy absorption

-A random camera (randomly selected)

- airtight solder

-elastic collector for fluid connection of cameras

longitudinal opening of elastic manifold 4

connection hole for fluid connection 5 to the interior of chamber 2

-Connector for mechanical connection of cameras 2

- aperture of a connecting unit for fluid connection of cameras 2

anchorage bar for attachment to a desired location in the aorta 102

anchorage rib, for attachment to a desired location in the aorta 102

- shrink fluid

- means for initial filling or correcting fluid pressure 11

- stopper of means 12

- Elastic material for tightness

- implant catheter

- a thick section adapted for subcutaneous manipulation of a hollow needle

- funnel-shaped guiding means

- control device for gripping and controlling the hand

- marker to monitor the position of the absorbent body 1

- movable tip

- controls for the movable tip 20

- a reservoir containing compressible fluid 11 under pressure

- shrink fluid filling button 11

- Inflatable button

- Button for reducing the pressure or removing the compressible fluid 11

- digital display

- movable core

1xx. Parts of the circulatory system

101 - blood

102 - the aorta

103 - aortic valve

104 - Internal aortic wall

105 - truncus brachiocephalicus

106 - arteria carotis communis sinistra

107 - arteria subclavia sinistra

108 - arteria renalis sinistra

109 - arteria renalis dextra

110 - aortic bifurcation

111 - arteria iliaca communis dextra

112 - arteria iliaca communis sinistra

113 - arteria femoralis dextra

2xx. Ancillary positions

201 are elastic forces extending the aorta 102 through the systole

202 - elastic forces contracting the aorta 102 through the diastole

203 - deformation of absorbent body 1

204 - blood pressure on the arterial wall and SMILET

205 - compressive fluid pressure 11

206 is a cross-sectional view of chamber 2, collapsed

207 - change in cross-sectional area of chamber 2 as a result of periodic contraction / loosening during operation

208 - point of contact between attachment means and aortic wall 102

209 - air extraction section prior to implantation

210 - SMILET implant movement direction

211 - implantation shortening zone 12

212 - implant section

213 - axis shift ± Y

214 - axis shift ± Z

215 - compressible fluid 11 exiting pressure upon filling

216 - directions for possible movement of a movable tip 20

217 - direction of removal of catheter 15 from elastic manifold 4

218 - arrow showing an enlarged part of a figure

219 to 231 - planes of sections

REFERENCES ·

Patents [1] US pat. 3266487 Watkins DH., Klink EJ. "Heart pump augmentation system and apparatus"; US Class 600/18; 604/914 [2] U.S. Pat. 3504662 Jones RT., “Intra-arterial blood pump”; US Class: 600/18; 601/149; 604/914, IPC: A61b 19/00; A61m 1/00.

[3] U.S. Pat.4902272 Milder FL., Kung Robert T.V., Lederman DM., Singh PI. "Intra-arterial cardiac support system"; US Class: 600/18; 600/16; 600/17; 604/914; IPC: A61B 019/00.

[4] US Pat.4931036 Kanai N., Suzuki A. "Intra-aortic balloon pump"; U.S. Class: 600/18; 604 / 99.02; 604/914; 604/920; IPC: A61M 029/02 [5] US Pat. 5643172 Kung Robert T. V., Champsaur G. “Tubular circulatory assist device”; U.S. Class: 600/16; IPC: A61M 001/12 [6] US Pat. 5910103 Saper L., Rowe S., Leschinsky B., “Device and method for IAB assisted with multiple balloons”; U.S. Class: 600/18; IPC: A61M 001/12 [7] US Pat. 6228018 Downey HF., Bian X., “Removable left ventricular assist device with an aortic support apparatus”; US Class: 600/18; 623 / 3.1; IPC: A61M 001/10 [8] US Pat. 6468200 Fischi MC., “Segmented peristaltic intra-aortic balloon pump”; US Class: 600/18; 623 / 3.16; IPC: A61M 001/10 [9] US Pat. 5409444 Kensey K., Nash J., “Method.and apparatus to reduce injury to the vascular system”; US Class: 600/18; 600/16; 604/907; IPC: A61M 001/12

Books [10] P. Mironov “Atherosclerosis”, Plovdiv, Hr.Danov, 1960, p.29;

[11] Orbetzov, M. “Hypertension and atherosclerosis”, Sofia, Medicine and Physical Culture, 1981, p.66;

[12] "Internal diseases", pp. 1- Propedeutics of internal diseases, ed. Maleev, Sofia, Medicine and Physical Culture, 1988, pp.215-223.

[13] "Physiology of Man", vol. 3, ed. Schmidt and G. Tevsa, Moscow, Mir, 1986, p. 120, fig. 18-12;

[14] "Physiology", ed. N. Nachev, N. Boshev, Sofia, Medicine and Physical Education, 1980.

[15] G. Galabov, V. Vankov, Human Anatomy, Sofia, Medicine and Physical Education, 1982.

[16] Sinelnikov R.D. Atlas of Human Anatomy, vol.2, Moscow, Medicine, 1979.

[17] M. Gusiyska, M. Ivanova, “Interpretive Medical Dictionary”, 1st ed., Sofia, ET FORKOM, 199bg.

Articles [18] Messerli FH., Frohlich ED., Ventura HO. "Arterial compliance in essential hypertension". J Cardiovasc Pharmacol. 1985; 7 Suppl 2: S33-5.

[19] Seely S. “Atherosclerosis or hardening of the arteries?”. Int J Cardiol. 1989 Jan; 22 (1): 5-12.

[20] Levy BI. "Aging of the arterial system" .Presse Med. 1992 Jul 22; 21 (26): 1200-3 [21] Belz GG. "Elastic properties and Windkessel function of the human aorta". Cardiovasc Drugs Ther. 1995 Feb; 9 (1): 73-83.

[22] Macdonald PS., O'Rourke MF. "Cardiovascular age and heart failure." Med J Aust. 1998 Nov 2; 169 (9): 480-4.

[23] Safar ME. "Pulse pressure, arterial stiffness, and cardiovascular risk." Curr Opin Cardiol. 2000 Jul; 15 (4): 258-63.

[24] Greenwald SE. "Pulse pressure and arterial elasticity." QJM. 2002 Feb; 95 (2): 107-12.

[25] Safar ME. "Hemodynamic changes in elderly hypertensive patients". Am J Hypertens. 1993 Mar; 6 (3 Pt 2): 20S-23S.

[26] O'Rourke MF. “Towards optimization of wave reflection: therapeutic goal for tomorrow?”; Clin Exp Pharmacol Physiol. 1996 Aug; 23 (8): SI 1-5.

[27] Jay N. Cohn, M.D. “It starts in the wall”; University of Minnesota Medical School, Cardiovascular Division, Minneapolis, Minnesota, 1999 [28] Safar H., Mourad J.J., Safar M., Blacher J. "Aortic pulse wave velocity, an independent marker of cardiovascular risk." Arch Mai Coeur Vaiss. 2002 Dec; 95 (12): 1215-8.

[29] Malek AM, Alper SL, Izumo S. "Hemodynamic shear stress and its role in atherosclerosis". JAMA. 1999 Dec 1; 282 (21): 2035-42.

[30] Shaaban AM., Duerinckx AJ. "Wall shear stress and early atherosclerosis: a review." AJR Am J Roentgenol. 2000 Jun; 174 (6): 1657-65.

[31] Mazzag BM., Tamaresis JS, Barakat Al. A model for shear stress sensing and transmission in vascular endothelial cells. Biophys J. 2003 Jun; 84 (6): 4087-101.

[32] Salsac Anne-Virginie L.B. , Lasheras JC. , Sparks SR. "Mechanical wall stress as a possible genesis of abdominal aortic aneurysms"; 2003 Summer Bioengineering Conference, June 25-29, Sonesta Beach Resort in Key Biscayne, Florida [33] Grabowski EF. Thrombolysis, flow, and vessel wall interactions. J Your Interv Radiol. 1995 Nov-Dec; 6 (6 Pt 2 Su): 25S – 29S.

[34] Van Langenhove G., Wentzel JJ., Krams R., Slager CJ., Hamburger JN., Serruys PW. "Helical velocity patterns in human coronary artery: a threedimensional computational fluid dynamic reconstruction showing the relation with local wall thickness." Circulation. 2000 Jul 18; 102 (3): E22-4.

[35] Zarins CK. , Xu C., Taylor CA., Glagov S., Part I “Vascular pathology and physiology”, 2004-09; Chapter 5: “Localization of atherosclerotic lesions” [36] Thubrikar MJ., Deck JD., Aouad J., Chen JM. “Intramural stress as a causative factor in atherosclerotic lesions of the aortic valve”. Atherosclerosis. 1985 Jun; 55 (3): 299-311.

[37] Levenson J., Pithois-Merli I., Simon A. "Mechanical factors in large artery disease and antihypertensive drugs". Am J Cardiol. 1990 Sep 25; 66 (9): 39C42C.

[38] Thubrikar MJ., Robicsek F. “Pressure-induced arterial wall stress and atherosclerosis”. AnnThorac Surg. 1995 Jun; 59 (6): 1594-603.

[39] Hazel AL., Pedley TJ. "Vascular endothelial cells minimize the total force on their nuclei." Biophys J. 2000 Jan; 78 (1): 47-54.

[40] O'Rourke MF. “Arterial mechanics and wave reflection with antihypertensive therapy” .J Hypertens Suppl. 1992 Jul; 10 (5): S43-9.

[41] Heintz B., Gillessen T., Walkenhorst F., vom Dahl J., Dorr R., Krebs W., Hanrath P., Sieberth H.G. '' Evaluation of segmental elastic properties of the aorta in normotensive and medically treated hypertensive patients by intravascular ultrasound ''. J Hypertens. 1993 Nov; 11 (11): 1253-8.

[42] Van Bortel LM., Kool MJ., Boudier HA., Struijker Boudier HA. "Effects of antihypertensive agents on local arterial distensibility and compliance." Hypertension. 1995 Sep; 26 (3): 531-4.

[43] Bank AJ. "Physiological aspects of drug therapy and large artery elastic properties". Your Med. 1997; 2 (1): 44-50.

[44] Topouchian J., Brisac A.M., Pannier B., Vicaut E., Safar M., Asmar R. “Assessment of acute arterial effects of converting enzyme inhibition in essential hypertension: a double-blind, comparative and crossover study ". J Hum Hypertens. 1998 Mar; 12 (3): 181-7.

[45] Van Bortel LM., Spec JJ. “Influence of aging on arterial compliance”. J Hum Hypertens. 1998 Sep; 12 (9): 583-6.

[46] Tham DM., McNulty MB., Wang Y., Da Cunha V., Wilson DW. , Athanassious CN. , Powers AF., Sullivan ME. , and Rutledge JC .;

"Angiotensin II injures the arterial wall causing increased aortic stiffening in apolipoprotein E-deficient mice". Am J Physiol Regul Integr Comp Physiol 283: R1442 – R1449, 2002.

[47] Resnick LM, Lester MH. "Differential effects of antihypertensive drug therapy on arterial compliance." Am J Hypertens. 2002 Dec; 15 (12): 1096-100.

[48] Weber T., Auer J., Eisserer G., Berent R., Eber B., O'Rourke M.F. "Arterial stiffness and cardiovascular drugs". Curr Pharm Des. 2003; 9 (13): 1049-63.

[49] Boutouyrie P., Bussy C., Lacolley P., Girerd X., Laloux B., Laurent S. “Association between local pulse pressure, mean blood pressure, and large artery remodeling”. Circulation. 1999 Sep 28; 100 (13): 1387-93.

[50] Resnick N., Einav S., Chen-Konak L., Zilberman M., Yahav H., Shay-Salit A. "Hemodynamic forces as a stimulus for arteriogenesis". Endothelium. 2003; 10 (4-5): 197-206.

Claims (10)

Patent Claims 1. Serial multi-chamber intraluminal energy transformer (SMILET) for implantation into a lumen of the aorta (and / or other artery, hereinafter aorta only) of a patient for the purpose of passive absorption of a part of the systolic blood pressure is the subsequent release of that absorbed part, which SMILET contains an absorbent body of flexible material biologically tolerated by the body, the absorbent body being located entirely within the aortic lumen; has a length exceeding the transverse dimension many times over; contains a means of securing it at the desired location to the aortic wall; contains a means of implantation in the patient's body; characterized in that: absorbent body 1 comprises a plurality of chambers 2 all of which: are located in the aorta lumen 102; are arranged alternately at least along the aorta 102; are compact in shape; are filled with compressible fluid 11 under pressure; contain substantially constant amounts (masses) of contractible fluid 11 for at least one cardiac cycle; have volumes many times smaller than the total volume of the absorbent body 1; having shapes and sizes allowing blood to flow freely 101 between their outer surface and the aortic wall 104 at any time; absorbent body 1 comprises connecting members 7 of a flexible material for mechanically joining adjacent chambers 2 at least along the aorta 102. A SMILET according to claim 1, characterized in that the absorbent body 1 contains chambers of flexible polymeric material. SMILET according to claim 1, characterized in that it contains the compressible fluid 11 representing a gas, a gas mixture or a polymer with a jelly-like consistency, including many bubbles. The SMILET according to claim 1, characterized in that it contains chambers 2 with a cross section in the form of a three-pointed star. The SMILET according to claim 1, characterized in that it comprises connecting members 7 with cross-sections many times smaller than the maximum cross-sections of adjacent chambers 2. 6. The SMILET according to claim 1, characterized in that it comprises hollow connecting members 7. 7. The SMILET according to claim 1, characterized in that it comprises an elastic manifold 4 arranged longitudinally around or inside the chambers 2, comprising airtight joints 3 and connecting holes 6. The SMILET according to claim 6 or 7, characterized in that it comprises an opening 8 of a hollow connecting member 7 or a connecting opening 6 of an elastic collector 4 with a cross-section that allows fluid isolation of the respective chamber within at least one cardiac cycle. 9. The SMILET according to claim 1, characterized in that the fastening means comprises fastening ribs 10 or fastening whiskers 9 made of an elastic polymeric material. A SMILET according to claim 1, characterized in that the implant-assisting agent in the patient's body includes means 12 for initially detecting or altering the pressure of the contractible fluid 11.