The prosthetic heart valve

 

(57) Abstract:

The invention relates to medicine, namely to surgery, and can be used to replace a diseased natural heart valves person. The prosthetic heart valve includes a housing and a locking element associated with the housing with means for its rotation. The outer surface of the housing is fitted with a mounting element and a sleeve which is provided with a collet element with flexible wings with seizures and skin. The outer surface of the housing is fitted with a locking element made in the form of a ledge and provided with support and locating surfaces. The installation element is made convex relative to the outer surface of the shell. Reinforcing element is placed on its inner surface for mounting the surface mounting element with the possibility of sliding of these surfaces relative to each other. The end of the reinforcing element provided with a thrust surface that interacts with the bearing surface of the locking element. Flexible petals collet element provided with a recess in which is mounted an annular retainer. The invention solves the task of creating a prosthetic heart valve in which the valve; the possibility of orientation of the valve during the operation; the improvement of manufacturability. 6 C.p. f-crystals, 7 Il.

The invention relates to medical engineering, in particular to prosthetic heart valve, and can be used to replace a diseased natural heart valves person.

The prosthetic heart valve is a check valve providing direct blood flow at the opening of the locking element and prevents the backward flow of blood (regurgitation) when closed, the closing element.

One of the main requirements for prosthetic heart valves, are the demands on their reliability and durability, to ensure their high hemodynamic characteristics - maximum stroke volume and the minimum amount of reverse leakage (regurgitation), excluding the impact of design features of the valve of the surrounding structure of the heart.

To increase the reliability and durability of the valves it is necessary to exclude the possibility of loss of valve elements because of their unreliable fastening, to reduce their deterioration and destruction by creating a superior work environment interacting elements of cleaneahtioga orientation of the valve during implantation, which is produced by rotation of the housing relative to the sleeve around its Central axis. This will reduce the possibility of impact on the operability of the valve elements from the action of the radial loads from the surrounding structures of the heart and will prevent interference with the opening and closing of the disk locking element from fabrics, not removed completely by surgery during implantation (deposits of calcium, nessecery fragments of the fibrous ring, tendon threads, and so on), which, in turn, will prevent the possibility of disruption to the locking element and the output of prosthesis failure.

Because of the nature of valves of various designs through their blood stream is deflected in one direction or another, affecting the surrounding structures of the heart. This leads to the possibility of various modifications of the natural geometry of the different tissues of the heart and the appearance of aneurysms. The possibility of orientation of the valve by rotation of the housing relative to the sleeve around its Central axis during operation will reduce the likelihood of these postoperative complications.

Uluchshennyh conditions of functioning of the locking element, did not lead to the deterioration of the hemodynamic efficiency of the cardiac valve prosthesis due to an excessive increase in the thickness of the valve elements.

Famous prosthetic heart valve [1], comprising an annular body having an inner surface which is placed in the locking element associated with the housing, with means for its rotation from the position of closure in the open position and back, and the outer surface of the annular groove. In an annular groove of the installed sleeve of elastic material. On the surface of the sleeve is fixed to the seat.

As known in the prosthetic heart valve mounted in an annular groove in the outer surface of the casing sleeve made from a polymeric material, during operation of the valve can cause the following negative consequences.

The radial stiffness of the body, especially when performing prosthesis of carbon materials, in many cases, it may be insufficient, which could lead to the next.

During surgery to implant a possible deformation of the housing and the loss of his wings.

- In the operation of the valve body on his body by the heart muscle function Zn is the deterioration of working conditions interacting elements of the valve and increase their wear the possibility of jamming of the locking element, the loss of the locking element and the valve outlet of the system.

-Increase the radial stiffness of the body in a known cardiac valve prosthesis is only possible by increasing the shell thickness, which reduces the hemodynamic efficiency of the valve and to the deterioration of the prosthetic results in the postoperative period.

Performing sterilization known cardiac valve prosthesis before implantation because of the action of increased temperature may be a considerable shrinkage of the sleeve of polymer material that will increase the effort required to rotate the housing relative to the sleeve around its axis, and the impossibility of orientation of the valve during implantation. The lack of orientation of the valve will result in incorrect orientation of blood flow behind the valve and can cause the appearance of aneurysms, as well as potential impacts to the surrounding tissue of the heart valve elements that will disrupt the functioning of the locking element and the output of prosthesis failure.

In the long term after the prosthesis due to im her alternating loads when the prosthesis, may change the geometry of the sleeve, a violation of the reliability of the installation sleeve in an annular groove in the outer surface of the shell cracks and the destruction of the sleeve. This, in turn, will lead to walapane leakage of blood and the possibility of loss of housing and the valve outlet of the system.

Attempt to eliminate these disadvantages was undertaken following the development of prosthetic heart valves.

Known cardiac valve prosthesis [2], comprising an annular body having an inner surface which is placed in the locking element associated with the housing, with means for its rotation from the position of closure in the open position and back, and the outer surface. On the outer surface of the housing is stationary relative to the outer surface of the shell is hardening element. Reinforcing element has two end face and outer surface. Both ends of reinforcing element holding surfaces.

In a known cardiac valve prosthesis the outer surface of the annular body and the reinforcing element can be implemented in two variants.

The first option. The outer surface of the annular body of sleep is pus - in the form of an annular groove and provided with a mounting surface on which its inner surface is stationary placed the annular reinforcing element.

This embodiment of the known prosthetic heart valve provides the necessary radial rigidity of the Cabinet without significantly increasing its thickness and does not worsen the hemodynamic efficiency of the valve. However, the installation of the reinforcing element by this option may be made only by significant heating ring (around 500o(C) that it has expanded to the required size. This method of installation requires special precision of the mating elements, because if not the exact implementation is possible, on the one hand, a very close fit of the ring on the body, causing it to elevated stresses that can cause the destruction of housing and the valve outlet of the system. On the other hand, there may be a significant gap between the ring and the housing that when the valve causes movement of these elements relative to each other and may lead to their increased wear, which will cause the valve outlet of the system. In addition, during the Assembly process, Yes is essentially cannot be removed and can cause a variety of complications in the postoperative period.

In addition, the presence of grooves on the outer surface of the shell leads to the reduction of the cross-section of its walls and the appearance of additional stress that can cause the destruction of housing and the valve outlet of the system.

The second option reinforcing element provides for its design in the form of a protrusion on the outer surface of the shell is made in one piece with the housing. When you known prosthetic heart valve to provide sufficient radial stiffness of the body cross-section of the reinforcing element must have a significant radial dimensions, which reduces hemodynamic efficiency of the valve and to the deterioration of the prosthetic results in the postoperative period.

In the known prosthetic heart valve to the outer surface of annular body mounted sleeve having external and internal surfaces. The cuff is provided with a collet element with flexible wings with seizures, and skin. The inner surface of the cuff provided with a thrust part, the mounting part and the retaining part. Cuff interacts resistant part of its inner surface with retaining the item, and holding a part - holding surface of the other end of the reinforcing element.

In a known cardiac valve prosthesis portion of the inner surface of the cuff interact with the surfaces of the reinforcing element, which is fixed relative to the outer surface of the shell. However, since landing the cuffs on reinforcing element should prevent unwanted radial and axial her movements relative to each other, which can lead to wear of the surfaces of the interacting elements cuffs and reinforcing element, the violation of reliability under the action of alternating loads arising when the opening and closing of the locking element, the emergence of walapane leaks and the valve outlet of the system, in a known design of prosthetic heart valve between the surfaces of the inner surface of the cuff and strengthening element there are significant at the magnitude of the friction force, which lead to increased efforts required to rotate the housing relative to the sleeve around its axis, and the impossibility of carrying out the necessary orientation of the valve during implantation. The lack of orientation of the valve leads is also the possibility of impacts to the surrounding tissue of the heart valve elements, to the appearance from the undeletable completely surgically tissues (deposits of calcium, nessecery fragments of the fibrous ring, tendon threads, and so on) interference with the opening and closing of the disk locking element that will disrupt the functioning of the locking element and the output of prosthesis failure.

Installation of the cuff in the manufacture of the described prosthesis is made by its axial movement by a retaining part to the position in which the grippers on the flexible petals will be behind the second end of the reinforcing element. When this occurs, the flexible bending of the petals and the movement of the grippers from the body axis by an amount equal to the amount of extension of the reinforcing element, and when the clamps on the flexible petals will be behind the second end of the reinforcing element, due to the elastic properties of flexible petals moves the grippers in the direction of the axis of the housing.

Fixation of the cuff from moving in the axial direction is provided by the interaction of resistant and retaining parts of its inner surface with the respective retaining surfaces of the ends of the reinforcing element.

In the known prosthesis CL which may reach significant values, so as to ensure a reliable connection requires a sufficient amount of area of contact between the retaining surface of the first end of the reinforcing element and the holding part of the inner surface of the cuff, the value of which is determined by the radial dimensions of the grips. It is possible that residual (plastic) deformation of the flexible petals, eliminating the possibility of a full refund capture the original state, which greatly reduces the value of the above-mentioned contact area. This leads to a reduction in the reliability of connection of the cuff with the body that can cause stress in the body in the cuff and the emergence oculocephalic leaks, the emergence of high wear surfaces of the valve and drop the case. To reduce or virtually eliminate the residual (plastic) deformation of flexible petals can decrease their thickness. However, reducing the thickness of the flexible petals in a known cardiac valve prosthesis will lead to their deformation when a load is applied to the cuff, for example, in the process of binder valve during the operation or after implantation when exposed to a surrounding valve of the heart tissue. This will lead to disturbed the different consequences.

The most successful, according to the authors, is the design of the prosthetic heart valve disclosed in [3] (prototype) and is a development of the above-described structure [2].

The specified prosthetic heart valve includes an annular body having an inner surface which is placed in the locking element. The locking element is connected with the housing by means of its rotation from the position of closure in the open position and back.

The outer surface of the annular body provided with a mounting element. The installation element is made concave relative to the outer surface of the shell is in the form of an annular groove and provided with a mounting surface on which its inner surface is stationary placed the annular reinforcing element. Reinforcing element is designed in the form of a metallic ring has two end face and outer surface. Both ends of reinforcing element holding surfaces.

This embodiment of the known prosthetic heart valve provides the necessary radial rigidity of the Cabinet without significantly increasing its thickness and does not worsen the hemodynamic efficiency of the valve. However, installation of reinforcing cell battery (included) the 0o(C) that it has expanded to the required size. This method of installation requires special precision of the mating elements, because if not the exact implementation is possible, on the one hand, a very close fit of the ring on the body, resulting in the case of high voltages that can cause the destruction of housing and the valve outlet of the system. On the other hand, there may be a significant gap between the ring and the housing that when the valve causes movement of these elements relative to each other and may lead to their increased wear, which will cause the valve outlet of the system. In addition, during Assembly, the further manufacture and storage of the valve in the gaps inevitably accumulates unwanted dirt that can not be removed and may cause various complications in the postoperative period.

It should be noted that in the known prosthetic heart valve tool rotation locking element is located axially outside of the reinforcing element. That is, the reinforcing element does not protect against radial load those parts of the outer surface of the shell, at the level of which in the axial NDI outer surface of the shell during the operation or after implantation on the part of the heart muscle, which can be considerable radial load, which, in turn, can lead to undesirable deformations of the housing. Deformation lead to the deterioration of working conditions interacting elements of the valve and increase their wear, the possibility of jamming of the locking element, the loss of the locking element, the breakage of the casing and the valve outlet of the system.

In addition, the presence of grooves on the outer surface of the shell leads to the reduction of the cross-section of its walls and the appearance of additional stress that can cause the destruction of housing and the valve outlet of the system.

In the known prosthetic heart valve to the outer surface of annular body mounted sleeve having external and internal surfaces. The cuff is provided with a collet element with flexible wings with seizures, and skin. The inner surface of the cuff provided with a thrust part, the mounting part and the retaining part. Cuff interacts resistant part of its inner surface with the holding surface of the first end of the reinforcing element, the installation part with the outer surface of the UPA.

In a known cardiac valve prosthesis portion of the inner surface of the cuff interact with the surfaces of the reinforcing element, which is fixed relative to the outer surface of the shell. However, since landing the cuffs on reinforcing element should prevent unwanted radial and axial her movements relative to each other, which can lead to wear of the surfaces of the interacting elements cuffs and reinforcing element, the violation of reliability under the action of alternating loads arising when the opening and closing of the locking element, the emergence of walapane leaks and the valve outlet of the system, in a known design of prosthetic heart valve between the surfaces of the inner surface of the cuff and strengthening element there are significant at the magnitude of the friction force, which lead to increased efforts required to rotate the housing relative to the sleeve around its axis, and the impossibility of carrying out the necessary orientation of the valve during implantation. The lack of orientation of the valve leads to incorrect orientation of the flow of blood for the valve and can cause the possibility of the emergence of aniu not completely removed surgically tissues (deposits of calcium, nessecery fragments of the fibrous ring, tendon threads, and so on) interference with the opening and closing of the disk locking element that will disrupt the functioning of the locking element and the output of prosthesis failure.

Installation of the cuff in the manufacture of the described prosthesis is made by its axial movement by a retaining part to the position in which the grippers on the flexible petals will be behind the second end of the reinforcing element. When this occurs, the flexible bending of the petals and the movement of the grippers from the body axis by an amount equal to the amount of extension of the reinforcing element, and when the clamps on the flexible petals will be behind the second end of the reinforcing element, due to the elastic properties of flexible petals moves the grippers in the direction of the axis of the housing.

Fixation of the cuff from moving in the axial direction is provided by the interaction of resistant and retaining parts of its inner surface with the respective retaining surfaces of the ends of the reinforcing element.

In a known cardiac valve prosthesis movement of the grippers in the direction from the axis of the housing, and hence the bending killed the sufficient size of the area of contact between the retaining surface of the first end of the reinforcing element and the holding part of the inner surface of the cuff, the value of which is determined by the radial dimensions of the grips. It is possible that residual (plastic) deformation of the flexible petals, eliminating the possibility of a full refund capture the original state, which greatly reduces the value of the above-mentioned contact area. This leads to a reduction in the reliability of connection of the cuff with the body that can cause stress in the body in the cuff and the emergence oculocephalic leaks, the emergence of high wear surfaces of the valve and drop the case. To reduce or virtually eliminate the residual (plastic) deformation of flexible petals can decrease their thickness. However, reducing the thickness of the flexible petals in a known cardiac valve prosthesis will lead to their deformation when a load is applied to the cuff, for example, in the process of binder valve during the operation or after implantation when exposed to a surrounding valve of the heart tissue. This may lead to violation of the reliability of the connection of the cuff with the valve body, to cause distortion of the body in the cuff, the occurrence oculocephalic leaks, the emergence of high wear surfaces during operation of the valve, loss of housing and CA, in which constructive execution of the outer surface of its body, hardening element, elements cuffs and the relationship of the location and dimensions of all elements would be:

- body geometry that does not contain additional stress concentrators and ensuring higher reliability of fixing and creating improved working conditions interacting elements of the valves, which will increase the reliability of the valve and will reduce the wear and tear of its elements, will eliminate the possibility of distortion of the body in the cuff and the emergence oculocephalic leaks, to avoid the possibility of jamming and/or loss of elements of the valve and outlet valve of the system, while maintaining the necessary high hemodynamic efficiency of the valve;

- guaranteed the possibility of orientation of the valve by rotation of the housing relative to the sleeve around its Central axis during operation, which will reduce the probability of occurrence of aneurysms and to exclude possibility of impact on the valve elements from both the surrounding tissues of the heart and hand of fabrics, fully uninstallable surgically (deposits of calcium, nessecery a portion of the photo, the locking element, that, in turn, will prevent the malfunction of the locking element and the output of prosthesis failure;

- improving the manufacturability of the cardiac valve prosthesis, eliminating the accumulation of the undesirable dirt that will reduce the possibility of complications in the postoperative period.

This object is achieved in that the prosthetic heart valve containing an annular body having an inner surface which is placed in the locking element associated with the housing, with means for its rotation from the position of closure in the open position and back, and an outer surface provided with a mounting element on the Seating surfaces which its inner surface is placed an annular reinforcing element having two end of the first holding surface and an outer surface, the outer surface of the annular body mounted cuff, having inner and outer surface and provided with a collet element with flexible wings with seizures, and skin, in addition, the inner surface of the cuff provided with a thrust part, interacting with the retaining surface of the first end of the number is different reinforcing element, and the retaining part, the outer surface of the annular body provided with at least one fixing element made in the form of a ledge and provided with support and locating surfaces, and the installation element is made convex relative to the outer surface of the shell, while the annular reinforcing element is placed on its inner surface for mounting the surface mounting element with the possibility of sliding of these surfaces relative to each other, and the second end of the annular reinforcing element provided with a thrust surface that interacts with the bearing surface of the locking element, when the cuff is installed with the possibility of interaction between the retaining part of its inner surface with the holding surface of the locking element, and flexible petals collet element from the outer surface of the cuff provided with recesses, in which is mounted an annular retainer.

This constructive design of prosthetic heart valve, wherein the outer surface of the annular body provided with at least one fixing element made in the form of a ledge and provided with supporting and holding the, the e reduces the cross-section of the wall, eliminates the appearance of additional stress, which reduces the likelihood of breakage of the casing under the influence of alternating loads. In addition, this embodiment increases the radial stiffness of the hull, which ensures the reduction of the possible deformation of the housing against radial loads acting on the outer surface of the body during surgery or after implantation on the part of the heart muscle, and improved working conditions interacting elements of the valve, which reduces wear, eliminates the possibility of jamming of the locking element, the loss of the locking element, the broken body and the valve outlet of the system. It should be noted that this embodiment does not affect the level of hemodynamic efficiency of the valve.

Since the annular reinforcing element is placed on its inner surface for mounting the surface mounting element with the possibility of sliding of these surfaces relative to each other, the cardiac valve prosthesis according to the invention allows rotation of the body around its axis relative to the annular reinforcing ele and the possibility of conducting the necessary orientation of the valve during implantation. This is to prevent the possibility of an aneurysm, the influence of the surrounding tissue of the heart valve elements, the possibility of side uninstallable completely surgically tissues (deposits of calcium, nessecery fragments of the fibrous ring, tendon threads, and so on) interference with the opening and closing of the disk locking element, the possibility of disruption to the locking element. This provides this required close fit on the external surface of the annular reinforcing element cuffs, interacting with it in the installation part of its inner surface, eliminating the possibility of radial and axial movement of the elements relative to each other. This eliminates the wear of interacting surfaces of the cuff and the reinforcing element, the violation of reliability under the action of alternating loads arising when the opening and closing of the locking element, the distortion of the hull and the emergence of walapane leaks, loss of housing.

Placing the annular reinforcing element inner surface on the Seating surface of the installation element with vozmojnogo element provided with a thrust surface, interacting with the bearing surface of the locking element, when the cuff is installed with the possibility of interaction between the retaining part of its inner surface with the holding surface of the locking element, provides the necessary landing elements on the housing, reliable their fixation in the axial and radial directions. This eliminates the occurrence in the case of high voltages from overly dense planting reinforcing element on the housing and the destruction of the body, and also the presence of a significant gap between the reinforcing element and the housing, which, in turn, are excluded radial movement of these elements relative to each other and the appearance of their increased wear. In addition, it is possible to perform the Assembly process all of these items at the very final stages of manufacture of the valve in a clean environment. This improves the manufacturability of the prosthetic heart valve, prevents the accumulation of unwanted dirt, which reduces the possibility of complications in the postoperative period.

The performance of prosthetic heart valve according to the invention so that the flexible petals collet element from the outer top
- on the one hand, the ability to perform flexible petals with such cross-sectional sizes, which provide for the necessary flexibility and deflection during Assembly, is required to move the grippers, the radial dimensions of which will provide sufficient reliability of connection in the direction from the axis of the housing and back, practically excluding the possibility of residual (plastic) deformation of flexible petals;

on the other hand, the presence of the annular retainer, covering and compressing the flexible petals toward the axis of the valve, will allow to exclude the possibility of deformation of the flexible petals when a load is applied to the cuff, for example, in the process of binder valve during the operation or after implantation when exposed to a surrounding valve of the heart tissue.

This improves the reliability of connection of the cuff with the valve body, eliminates the possibility of misalignment of the housing in the cuff, the occurrence of oculocephalic leaks, the emergence of increased wear of the surfaces during the operation of the valve, loss of housing and the valve outlet of the system.

It is advisable that the protrusion of the locking element was made ring-shaped and was the size of lichnosti of manufacture and Assembly, but

increases the radial stiffness of the hull, which ensures the reduction of the possible deformation of the housing against radial loads acting on the outer surface of the body during surgery or after implantation on the part of the heart muscle, and improved working conditions interacting elements of the valve, which reduces wear, eliminates the possibility of jamming of the locking element, the loss of the locking element, the broken body and the valve outlet of the system. It should be noted that this embodiment does not affect the level of hemodynamic efficiency of the valve.

It is useful to deepen were performed on all flexible petals collet element and were located relative to the reinforcing element for holding the surface of the locking element. This implementation will allow to increase the reliability of the installation of the clamp on the flexible petals collet element and to increase the reliability of the gearing holding portion of the inner surface of the cuff with the holding surface of the protrusion of the locking element. It will protect from the possibility of deformation of the flexible petals when a load is applied to the cuff, for example, in the process of binder clap is lit to enhance the reliability of connection of the cuff with the valve body, eliminate the possibility of distortion of the body in the cuff, the occurrence of oculocephalic leaks, the emergence of increased wear of the surfaces during the operation of the valve, loss of housing and the valve outlet of the system.

It is advisable that at least a part of the rotation locking element is positioned between the retaining surface of the first end of the reinforcing element and the locking element. The relationship of the location of these elements allows you to place a reinforcing element in the axial direction so that it is protected from radial load those parts of the outer surface of the shell, at the level of which in the axial direction are the means of the rotation of the locking element. This eliminates the possibility of impacts on these areas of the outer surface of the body during surgery or after implantation on the part of the heart muscle and unwanted deformation of the body, which improves the conditions of the interacting elements of the valve and reduces wear, eliminates the possibility of jamming of the locking element and drop it, preclude the possibility of fracture of the casing and the valve outlet of the system.

Useful to the annular retainer was execute elements of the valve slightly to reduce the radial dimensions of the retainer by a slight heating of the product, which can be carried out simultaneously with the operations of the temperature control and/or sterilization. Reducing the radial dimensions of the annular retainer will provide an increase in compressive flexible petals toward the axis of the valve efforts that, in turn, will provide a more tight fit on the outer surface of the annular reinforcing element cuffs, interacting with it in the installation part of its inner surface, and will increase the reliability of the gearing holding portion of the inner surface of the cuff with the holding surface of the protrusion of the locking element. It will protect from the possibility of deformation of the flexible petals when a load is applied to the cuff, for example, in the process of binder valve during the operation or after implantation when exposed to a surrounding valve of the heart tissue, which will increase the reliability of connection of the cuff with the valve body, eliminate the possibility of distortion of the body in the cuff, the occurrence of oculocephalic leaks, the emergence of increased wear of the surfaces during the operation of the valve, loss of housing and the valve outlet of the system.

It is advisable that the annular retainer is made of polyester yarn. It is but to choose the amount you want to shrink and reduce the radial dimensions of the latch, therefore, to regulate the magnitude of the compressive force.

Useful for plating was performed completely covering the collet member. This allows for the flexibility of the cladding material to compensate for inaccuracies of manufacture and to improve the manufacturability of the valve.

Alternative useful for plating was performed partially covering the collet element from its outer surface, with one end of the casing is located between the retaining surface of the locking element and the grips flexible petals and provided with annular liner and the other end of the casing is interoperable with the holding surface of the first end of the reinforcing element and provided with the annular liner. This embodiment allows to improve hemodynamic efficiency of the prosthetic heart valve.

The prosthetic heart valve made according to the invention allows to increase the reliability of the valve, which allows the orientation of the valve during implantation, has a high hemodynamic efficiency and has good processability.

These features of the invention are E. the time they enable the creation of achievable technical result reflected in the technical task, and are absent in the known technical solutions.

The invention will become more clear from the following specific examples of its implementation and the accompanying drawings, on which:

Fig.1 depicts a prosthetic heart valve made according to the invention (described variant of its execution), in a longitudinal section along the axis of the housing;

Fig. 2 depicts a view I of Fig.1 of the prosthetic heart valve in an enlarged scale;

Fig.3 depicts a fragment of the annular body of the prosthetic heart valve of Fig.2 without the other details of construction;

Fig. 4 depicts a fragment of the reinforcing element of the prosthetic heart valve of Fig.2 without the other details of construction;

Fig. 5 depicts a fragment of a cuff of the prosthetic heart valve of Fig.2 without the other details of construction;

Fig. 6 depicts a collet element of the prosthetic heart valve of Fig.1 without the other details of construction;

Fig. 7 depicts a view I of Fig.1 prosthetic heart valve (option of the cuff in an enlarged scale.

Following the design of the prosthetic heart valve provides for its execution that contains the cuff, the design and configuration which is intended for using adsto rotation of the locking element from its closed to open position and back made in the form of a protrusion and a groove. The design and configuration of these elements are not the subject of this invention and known from many sources. Note that the described in the present invention is a technical solution applicable to prosthetic heart valves for different positions of the implant, with various sizes, designs and configurations of locking elements, and means for rotating them.

The proposed prosthetic heart valve includes an annular housing 1 (Fig. 1) having an inner surface 2, in which the locking element 3 associated with the housing 1 by using 4 rotate from the position of closure in the open position and back, and the outer surface 5, provided with a mounting element 6 (Fig.2). On the Seating surface 7 (Fig.3) installation of item 6 of its inner surface 8 (Fig.4) posted annular reinforcing element 9 (Fig.2). The annular reinforcing element 9 (Fig.4) has two end 10, 11, the first 10 of which holding surface 12 and outer surface 13. On the outer surface 5 (Fig.1) annular housing 1 a sleeve 14 having inner and outer surfaces 15, 16 (Fig.5). The sleeve 14 is provided with a collet element is eleesa mainly by the size of the valves and may be different. The inner surface 16 (Fig. 5) cuff 14 is equipped with a thrust part 21 that communicates with the holding surface 12 (Fig.4) of the first end 10 of the annular reinforcing element 9, the installation part 22 (Fig.5), which interacts with the outer surface 13 (Fig.4) the annular reinforcing element 9, and the holding part 23 (Fig.5).

The outer surface 5 (Fig. 1) the annular body 1 is equipped with at least one locking element 24 is made in the form of the protrusion 25 and provided with a support 26 (Fig.3) and the retaining surfaces 27. The adjusting element 6 is made convex relative to the outer surface 5 of the housing 1. The annular reinforcing element 9 (Fig.2) is placed on its inner surface 8 on the Seating surface 7 of the installation element 6 with the possibility of sliding of these surfaces 7, 8 relative to each other. The second end face 11 (Fig. 4) the annular reinforcing element 9 provided with a thrust surface 28 that interacts with the support surface 26 (Fig.3) the locking element 24. The sleeve 14 (Fig.5) installed with the possibility of interaction between the retaining part 23 of its inner surface 16 with the holding surface 27 (Fig.3) the locking element 24. Flexible Le is which has a ring-shaped retainer 30.

In the described embodiment of the invention, the projection 25 (Fig.1) the locking element 24 is made annular and placed around the perimeter of the outer surface 5 of the annular body 1. The recess 29 (Fig.6) performed on all flexible petals 18 collet element 17 and are located relative to the reinforcing element 9 for retaining surface 27 (Fig.3) the locking element 24. At least part of the means 4 (Fig.1) rotation of the locking element 3 is located between the holding surface 12 (Fig.4) of the first end 10 of the reinforcing element 9 and the locking element 24 (Fig.1). The annular retainer 30 is made of heat shrinkable material. A possible embodiment of the annular retainer 30 from polyester yarn.

In the proposed prosthetic heart valve, the casing 20 is made completely covering the collet element 17. Possible valve design, in which the casing 20 (Fig. 7) partially covering the collet element 17 from the outer surface 15, with one end 31 of the casing 20 is located between the retaining surface 27 of the locking element 24 and the hooks 19 of flexible petals 18 and is provided with an annular liner 32 and the other end 33 of the casing 20 is located with the annular liner 34.

In the proposed prosthetic heart valve installation annular reinforcing element 9 (Fig.2) on the adjusting element 6, the Assembly and installation of the cuff 14 to the outer surface 5 of the annular body 1 is carried out in clean conditions at the final stages of production. The build process is not the subject of the invention and may be achieved by different methods, however, preferred are the following options.

If the casing 20 of the cuff 14 of the prosthetic heart valve according to the invention is made completely covering the collet element 17, the first inside collet element 17 is placed in the casing 20, which is typically implemented in the form of a tube. Further, the side clamps 19 to the inside of the cuff 14 is placed an annular reinforcing element 9 to the interaction of the retaining surface 12 (Fig.4) of the first end 10 of the thrust part 21 (Fig.3) cuff 14 and the outer surface 13 (Fig.4) the annular reinforcing element 9 from the installation part 22 (Fig.5) the inner surface 16 of the cuff 14. Then in the recesses 29 of flexible petals 18 collet element 17 from the outer surface 15 of the cuff 14 is mounted an annular retainer 30, which may be made of polyester neath what Emesene their side holding part 23 of the inner surface 16 of the cuff 14 along the axis of the valve mounted on the outer surface 5 (Fig.2) the annular casing 1 to the interactions of the thrust surface 28 (Fig. 4) of the second end face 11 of the annular reinforcing element 9 with the supporting surface 26 (Fig.2) the locking element 24, and the retaining part 23 (Fig.5) the inner surface 16 of the cuff 14 with the retaining surface 27 (Fig. 2) the locking element 24. When this happens move the grippers 19 from the axis of the housing 1 and back radial dimensions which will ensure sufficient reliability of the connection. Note that the annular retainer 30, made of polyester yarns, which have the ability to be stretched by the same amount under the application of a certain load and restore the original dimensions after removal, allows the necessary movement of the grippers 19. The final operation of the Assembly is temperature control. This operation ensures that after the Assembly of the elements of the valve reducing the radial dimensions of the annular retainer 30 by slight heating products as polyester fibers have the ability to heat shrinkage. Reducing the radial dimensions of the annular retainer 30 will provide an increase in compressive flexible petals 18 in the direction of the axis of the valve efforts that, in turn, will provide a more tight fit on the outer powerhost 22 (Fig.5) its inner surface 16, and will increase the reliability of the gearing holding portion 23 of the inner surface 16 of the cuff 14 with the retaining surface 27 (Fig.2) of the protrusion 25 of the locking element 24.

When performing a ring-shaped retainer 30 from materials that do not have the ability to be stretched by the same amount under the application of a certain load and restore the original dimensions after removal, the Assembly process may change somewhat. In particular, the installation operation of the annular retainer 30 and forming the outer surface 15 of the cuff 14 are made after the installation operation of the cuff 14 and the annular reinforcing element 9 on the outer annular surface 5 of the housing 1.

If according to the invention carried out the design of the prosthetic heart valve in which the casing 20 (Fig.7) partially covering the collet element 17 from the outer surface 15, with one end 31 of the casing 20 is located between the retaining surface 27 of the locking element 24 and the hooks 19 of flexible petals 17 and is provided with an annular liner 32 and the other end 33 of the casing 20 is interoperable with the holding surface 12 of the first end 10 of the panel is accordingly. The end 33 of the casing 20, provided with annular liner 34, are placed inside a collet element 17. Inside of the cuff 14 is placed reinforcing element 9 to the interaction of its holding surface 12 of the first end 10 of the thrust part 21 of the cuff 14. Next, the inside of the collet element 17 is placed the end 31 of the casing 20, provided with annular liner 32. The liners 32 and 34 can be made of a split resilient material or the continuous elastic material. Other operations of Assembly of the elements correspond to the above.

Regardless of the implementation of the Assembly may be noted the following positive qualities, which are provided when performing cardiac valve prosthesis according to the invention.

Because the installation element 6 (Fig.1) is made convex relative to the outer surface 5 of the housing 1 and the annular reinforcing element 9 is placed on its inner surface 8 (Fig.2) on the Seating surface 7 of the installation element 6 with the possibility of sliding of these surfaces 7, 8 relative to each other, the Assembly is performed by simply moving the annular reinforcing element 9 on the Seating surface 7 of the installation element 6 to necessarysee element 9. While landing slip eliminates the occurrence of case 1, elevated stress from excessive tension and destruction of the housing 1, and also excludes the presence of a significant gap between the reinforcing element 9 and the housing 1, which, in turn, are excluded radial movement of these elements relative to each other and the appearance of their increased wear during subsequent operation of the valve. In addition, the possibility of the build process, all items on the very final stages of manufacture of the valve in a clean environment. This improves the manufacturability of the prosthetic heart valve, prevents the accumulation of unwanted dirt, which reduces the possibility of complications in the postoperative period.

As flexible petals 18 collet element 17 from the outer surface 15 of the cuff 14 is provided with a recess 29 in which is mounted an annular retainer 30, it is possible to perform flexible petals 18 of such size cross-section, in which during Assembly virtually eliminates the possibility of residual (plastic) deformation of flexible petals 18 and eliminates the possibility of deformation when a load is its annular element 24 and placing it around the perimeter of the outer surface 5 of the ring-shaped housing 1 allows not only to increase the rigidity of the structure, but to apply for the manufacture of widely used grinding, lathe, etc. equipment, while ensuring the required precision. In addition, this embodiment eliminates the need for any special orientation of the elements of the valve during Assembly. This improves the manufacturability of the product.

Because the recess 29 is performed on all flexible petals 18 collet element 17 and are located relative to the reinforcing element 9 for the holding surface 21 of the locking element 24, it increases the reliability of the installation annular retainer 30 on the flexible petals 18 collet element 17 and increases the reliability of the gearing holding portion 23 of the inner surface 16 of the cuff 14 with the retaining surface 27 of the locking element 24. It will protect from the possibility of deformation of the flexible petals 18 when a load is applied to the cuff 14, for example, in the process of binder valve during the operation or after implantation when exposed to a surrounding valve of the heart tissue, which will increase the reliability of connection of the cuff 14 with the housing 1 of the valve, eliminates the possibility of misalignment of the housing 1 in the cuff 14, the occurrence of oculocephalic leaks, the appearance of raised annular retainer 30 of the heat shrinkable material after the Assembly of the elements of the valve to reduce the radial dimensions by slight heating of the product. Reducing the radial dimensions of the annular retainer 30 will provide an increase in compressive flexible petals 18 in the direction of the axis of the valve efforts that, in turn, will provide a more tight fit on the outer surface 13 of the annular reinforcing element 9 of the cuff 14, interacting with it in the installation part 22 of its inner surface 16, and will increase the reliability of the gearing holding portion 23 of the inner surface 16 of the cuff 14 with the retaining surface 27 of the protrusion 25 of the locking element 24.

- Execution of the annular retainer 30 from polyester yarns, which have the ability to be stretched by the same amount under the application of a certain load and restore the original dimensions after removal, allows the cuff Assembly 14 and the annular reinforcing element 9 separately from the valve, and then assembled to install and securely fasten them to the annular housing. This improves the manufacturability of the product. In addition, because the polyester filaments possess the ability of thermal shrinkage, this embodiment increases the compressive flexible petals 18 in the direction of the axis of the valve force that, in turn, will provide more dps is with her installation part 22 of its inner surface 16, and will increase the reliability of the gearing holding portion 23 of the inner surface 16 of the cuff 14 with the retaining surface 27 of the protrusion 25 of the locking element 24. The value of force is governed by the number of turns of polyester threads.

- Ensures implementation of the build process all of these items at the very final stages of manufacture of the valve in a clean environment. This improves the manufacturability of the prosthetic heart valve, prevents the accumulation of unwanted dirt, which reduces the possibility of complications in the postoperative period.

The methodology and technique of implantation of the prosthetic heart valve surgery are not the subject of the present invention and are known from numerous publications. Note that, as in the cardiac valve prosthesis according to the invention the annular reinforcing element 9 is placed on its inner surface 8 on the Seating surface 7 of the installation element 6 with the possibility of sliding of these surfaces 7, 8 relative to each other provides the ability to rotate the annular body 1 around its axis relative to the annular reinforcing element 9, which interacts with its external surface is about the orientation of the valve during implantation. This is to prevent the possibility of an aneurysm, the influence of the surrounding tissue of the heart valve elements, the possibility of side uninstallable completely surgically tissues (deposits of calcium, nessecery fragments of the fibrous ring, tendon threads, and so on) interference with the opening and closing of the locking element 3, the possibility of disruption to the locking element 3. We also note that the above implementation of the cardiac valve prosthesis according to the invention provides a reduction in the possible deformation of the annular body 1, eliminates deformation and/or damage to the flexible petals 18 collet element 17 from the radial loads acting on the outer surface of the body during surgery. This will prevent distortion of the housing 1 in the cuff 14, the occurrence of oculocephalic leaks, the emergence of an increased wear of the surfaces when the valve falling out of the housing 1 and the outlet valve malfunction during further operation.

If excessive pressure at the inlet of the prosthetic heart valve locking element 3 turns and opens the valve, allowing the passage of the direct flow of cu which is in the opposite direction and closes the valve, preventing the backward flow of blood (regurgitation). During subsequent cycles of contraction and relaxation of the ventricles operation of the valve prosthesis is repeated. We note the following.

This constructive design of prosthetic heart valve according to the invention, in which the outer annular surface 5 of the housing 1 is equipped with at least one locking element 24 is made in the form of the protrusion 25 and is provided with the abutment 26 and the retaining surfaces 27 and the adjusting element 6 is made convex relative to the outer surface 5 of the housing 1, does not reduce the cross-section of the walls of the housing 1, eliminates the appearance of additional stress, which reduces the likelihood of breakage of the housing 1 under the influence of alternating loads. In addition, this embodiment increases the radial stiffness of the housing 1, which ensures the reduction of the possible deformation of the housing against radial loads acting on the outer surface of the housing 1 after implantation on the part of the heart muscle, and improved working conditions interacting elements of the valve, which reduces wear, eliminates the possibility of jamming of the locking element 3, loss of locking the level of hemodynamic efficiency of the valve.

During cyclical contractions of the ventricles of the heart and the cardiac valve prosthesis excludes the occurrence of case 1, elevated stress from overly dense planting reinforcing element 9 in the housing 1 and the destruction of the housing 1. Along with this provides the necessary landing elements on the housing 1, a reliable fixing them in the axial and radial directions than excluded radial movement of these elements relative to each other and the appearance of their increased wear and destruction. This is achieved by the fact that the prosthetic heart valve according to the invention the annular reinforcing element 9 is placed on its inner surface 8 on the Seating surface 7 of the installation element 6 with the possibility of sliding of these surfaces 7, 8 relative to each other, the second end face 11 of the annular reinforcing element 9 provided with a thrust surface 28 that interacts with the support surface 26 of the locking element 9, the cuff 14 is installed with the possibility of interaction between the retaining part 23 of its inner surface 16 with the holding surface 27 of the locking element 9. In addition, the process of Assembly of all these elements at the very final stages of manufacture of the valve clean operatsionnyi period.

When the prosthesis increased reliability of the connection of the cuff 14 with the housing 1 of the valve according to the invention is ensured by the fact that the flexible petals 18 collet element 17 from the outer surface 15 of the cuff 14 is provided with a recess 29 in which is mounted an annular retainer 30, and the recess 29 can be performed on all flexible petals 18 collet element 17 and are located relative to the reinforcing element 9 for retaining surface 27 of the locking element 24, what increases the reliability of the installation annular retainer 30 on the flexible petals 18 collet element 17 and the reliability of the gearing holding portion 23 of the inner surface 16 of the cuff 14 with the retaining surface 27 of the locking element 24, and an annular retainer 30 can be made of heat shrinkable material, in particular, of polyester staple fibers, which can after Assembly of the elements of the valve to reduce the radial dimensions by slight heating of the product than the reduced radial dimensions of the annular retainer 30 is provided to increase the compressive flexible petals 18 in the direction of the axis of the valve efforts that, in turn, provides a more tight fit on NR is part 22 of its inner surface 16, and improves the reliability of the gearing holding portion 23 of the inner surface 16 of the cuff 14 with the retaining surface 27 of the protrusion 25 of the clamping element 24, eliminates the possibility of misalignment of the housing 1 in the cuff 14, the occurrence of oculocephalic leaks, the emergence of an increased wear of the surfaces when the valve falling out of the housing 1 and the valve outlet of the system.

In addition to the above, we note that, since the prosthetic heart valve made according to the invention, the protrusion 25 of the locking element 24 is made annular and placed around the perimeter of the outer surface 5 of the ring-shaped housing 1, which increases the radial stiffness of the housing 1, and at least a part of the 4 rotation locking element 3 is located between the holding surface 12 of the first end 10 of the reinforcing element 9 and the locking element 24 that protects against radial loads are those areas of the outer surface 5 of the housing 1, at the level of which in the axial direction are means of turn 4 (Fig.1) the locking element 3, when cyclical contractions of the ventricle and the cardiac valve prosthesis excludes undesirable deformation of the housing 1 from the action of the heart muscle. This improves the conditions R the I locking element 3 and its loss, preclude the possibility of fracture of the body 1 and the valve outlet of the system.

The prosthetic heart valve made according to the invention, allows to increase the reliability of the design, to reduce the likelihood of changes to the natural geometry of the different tissues of the heart, has a high hemodynamic characteristics and has good processability due to:

- create an improved work environment, interacting with each other, the valve elements and the lack of case 1, additional stress, which will reduce the wear and tear of its elements, to eliminate the possibility of misalignment of the housing 1 in the cuff 14 and the emergence oculocephalic leaks, to avoid the possibility of jamming and/or loss of elements of the valve, break the shell and the valve outlet of the system, while maintaining the necessary high hemodynamic efficiency of the valve;

- ensure the possibility of orientation of the valve by rotation of the housing 1 relative to the cuff 14 around its Central axis during operation, which will reduce the probability of occurrence of aneurysms and to exclude possibility of impact on the valve elements from both the surrounding tissues ser the cops of the annulus, tendon threads, and so on) that will allow you to prevent interference with the opening and closing of the locking element, which, in turn, prevents malfunction of the locking element and the output of prosthesis failure;

- allow for the possibility of the build process of all these elements in the final stages of manufacture of the valve in a clean environment, which improves the manufacturability of the prosthetic heart valve, prevents the accumulation of unwanted dirt and reduces the possibility of complications in the postoperative period.

All this will have a positive impact on improving long-term results of prosthetic diseased natural heart valves person.

Sources of information

1. EPS 0443994 B1, Int. Cl.: A 61 F 2/24. A heart valve prostheses. - Appl. no: 91830058.3; Date of filing: 20.02.91; Date of publication of the patent specification: 19.01.94.

2. USP 4535483, Int. CL. F 61 F 1/22. Suture rings for heart valves. - Appl. no: 458,618; Filed: 20.02.91; Date of Patent Aug. 20, 1985.

3. EP 0522048 Bl. Int. cl. F 61 F 2/24. Mechanical heart valve with compliant sewing ring. - Appl. no: 91907391.6; Date of filing: 26.03.91.; Date of publication: 28.06.95. (prototype).

1. The prosthetic heart valve containing an annular body having an inner surface which is placed in the locking element, svyazannyi outer surface, equipped with a mounting element on the Seating surfaces which its inner surface is placed an annular reinforcing element having two end surface, the outer surface of the annular body mounted sleeve having inner and outer surface and provided with a collet element with flexible wings with seizures and skin, in addition, the inner surface of the cuff provided with a thrust part, interacting with the retaining surface of the first end of the annular reinforcing element, the installation part, interacting with the outer surface of the annular reinforcing element, and the holding part, wherein the outer surface of the annular body provided with at least one locking element, made in the form of a ledge and provided with support and locating surfaces, and the installation element is made convex relative to the outer surface of the shell, while the annular reinforcing element is placed on its inner surface for mounting the surface mounting element with the possibility of sliding of these surfaces relative to each other, and the second end of concealer the irradiation element, when the cuff is installed with the possibility of interaction between the retaining part of its inner surface with the holding surface of the locking element and the flexible petals collet element from the outer surface of the cuff provided with recesses, in which is mounted an annular retainer, and the protrusion of the locking element is made annular and placed around the perimeter of the outer surface of the annular body.

2. The prosthetic heart valve under item 1, characterized in that the grooves are relatively reinforcing element for holding the surface of the locking element.

3. The prosthetic heart valve under item 1, characterized in that at least a part of the rotation locking element is located between the retaining surface of the first end of the reinforcing element and the locking element.

4. The prosthetic heart valve under item 1, characterized in that the annular retainer is made of heat shrinkable material.

5. The prosthetic heart valve under item 4, characterized in that the annular retainer is made of polyester threads.

6. The prosthetic heart valve under item 1, characterized in that the covering is made provitamina partially covering the collet element from its outer surface, at one end of the casing is located between the retaining surface of the locking element and the grips flexible petals and provided with annular liner and the other end of the casing is interoperable with the holding surface of the first end of the reinforcing element and provided with the annular liner.

 

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FIELD: medical engineering.

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FIELD: medical engineering.

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FIELD: medical engineering.

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2 ex

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