Holder unit usable with heart valve prosthesis

FIELD: medical engineering.

SUBSTANCE: device has two leaflets. The leaflets are mounted on finger member allowing rotation about artery axle and have working ends and shank. The working ends have fitting surfaces restricted with thrusting and holding ribs. A holding rib has internal and external end surface. The external end surface of holding rib of each leaflet has protrusions having centering surfaces manufactured as portions of the same revolution surface having diameter of Dc. Revolution surface axis coincides with the central axis of the holder.

EFFECT: excluded valve displacement relative to fibrous ring; reduced risk of canal dysfunction; improved long-term prosthetic operation results.

3cl, 4 dwg

 

The invention relates to medicine, namely to surgical instruments used in surgery for the implantation of artificial heart valves.

Known holder for prosthetic heart valve (A.S. 1568302 the USSR, MKI A 61 F 2/02. The holder of the prosthetic heart valve / Enhancemen, Sevdalinov, Vmentry and others - No 43 61466/28-14; claimed 11.01.88)containing the rod with the Cam and petals with the working ends. The petals are provided with support surfaces configured to interact with the Cam shaft. While the petals are still connected to the tube in which is located the rod with the Cam. The working ends are landing surface is designed as one part of a surface of rotation around the Central axis of the holder with a diameter of D, each of which is limited resistant and holds the shoulder. Thrust collar relative to the Seating surface is located on the side of the sleeve. The retaining flange is on the opposite relative to the Seating surface side of the working end and has an inner and an outer end surface. The inner end surface of the retaining flange associated with the landing surface, and the outer end surface is on the outside relative to the Seating surface side of the working end of the petal.

The prosthesis CL the Pana heart for fastening is mounted on a Seating surface of the working ends of the petals between the resistant and the retaining shoulder. When turning the rod around its axis, the Cam acting on the abutment surface of the petals, Flex their relatively tight seal with the tube. The working ends of the petals are moved radially outward, providing fixation of the prosthetic heart valve holder. After the implant is fixed to the holder of the valve prosthesis at the desired location of the heart unfixing of the valve is as follows. The rod is rotated about its axis until until its Cam will not interact with the support surfaces of the petals. Pogibli fingers petals inside working their ends move radially towards the center of the valve to release the shoulder petals from the interaction with the prosthesis. Then the holder is removed from the zone of operations.

Along with the benefit of the holder, as the possibility of multiple its use for locking and released the valve prosthesis during surgery, it has the following shortcomings that significantly impair its quality.

Bend the petals during installation of the prosthesis and the valve holder causes significant stresses in the place of a hard attach the petals to the tube, which, in turn, can lead to the following:

- the sterilization of prosthetic heart valve in conjunction with the headband is m, the petals of which are in the stressed state, the geometrical dimensions of tense elements of the holder substantially changed, which leads to the violation of the fixation of the prosthesis and may cause it to fall from the holder before or during the operation;

- during long-term storage or transportation of the prosthetic heart valve to the consumer is the gradual change of the geometrical sizes of tense elements of the holder, which leads to the violation of the fixation of the prosthesis and may cause it to fall from the holder before or during surgery, or may break the petals in their rigid adherence to the tube, which also leads to the falling of the valve;

- Podlipki fingers petals holder radially to the center of the valve to release the shoulder petals from the interaction with the prosthesis leads to undesirable interactions of the elements of the holder elements (locking element, limiters and other) of the prosthesis, which may cause damage to these elements, their breakdown and the exit valve of the system;

- multiple pin and released the valve prosthesis can lead to cracks in the hard places of fastening of the petals to the tube and breakage of the holder, which leads to the violation of the fixation of the prosthesis and may lead to his fall from the holder before or during the operation.

For there is this lack can be attributed to the following :

Usually patients are prosthetic heart valves, with cuff fitting surfaces, providing centering the valve in the fibrous ring. This centering in some of the valves is ensured by the construction of the outer surface of the housing. A significant number of patients with the use of valves such structures is undesirable. These patients, whose small size of the annulus, which must dvuhklapannaja prosthesis, with small and/or hypertrophied ventricle, reduced angle between the aortic and mitral valve. To improve the results of the operation of these patients developed valves nickolaos (supra-Annularly) design cuff (Mechanical prosthetic heart valves. The optimal choice for the surgeon in any situation. - Sulser Carbomedics, prospect). However, the lack of centering of such prostheses in the fibrous ring leads to the possibility of displacement bore hole of the valve against the opening of the annulus during the binder. This leads to the possibility of penetration of the structures of the heart into the body that will prevent operation of the locking element and can cause the valve outlet of the system. In addition, the displacement of the valve can lead to deterioration of the hemodynamic efficiency of protezirovanie is, the appearance of the outside of the valve leaks that without surgical intervention leads to death of the patient. All this leads to the need for more accurate setting of the valve prosthesis with nickolaos design of the cuff relative to the hole of the annulus and repeated checks in the process of binder.

Thus, these shortcomings lead to the possibility of damage to the prosthesis, the disadvantage of using this holder during operation, increase the time of surgery, and the possible negative result of prosthetics.

The most successful, according to the authors, is the following mount design (utility model 6515 EN, MKI 6 And 61 F 2/24. A holder for a prosthetic heart valve / pots J.V., Matveev LI, Suhodoev Y.A - 97106727/20 declared 24.04.97 (prototype)). The specified holder contains two lobes. The petals are pivotally mounted on the finger can be rotated around the axis of the hinge, located perpendicular to the Central axis of the holder, and provided with a working end and a shank. The working ends are landing surface is designed as one part of a surface of rotation around the Central axis of the holder with a diameter of Dn, each of which is limited resistant and holds the shoulder. Thrust collar relative to the Seating surface is located on the side of the shank.

The retaining flange is on the opposite relative to the Seating surface side of the working end and has an inner and an outer end surface. The inner end surface of the retaining flange associated with the landing surface, and the outer end surface is on the outside relative to the Seating surface side of the working end of the petal.

The prosthetic heart valve is installed on the Seating surface of the working ends of the petals between the resistant and the retaining shoulder. Petals holder was rotated around the axis of the hinge to the full contact between the Seating surfaces of the shanks with the corresponding support surfaces of the work area of the finger. Further, the shanks are connected to the flexible filiform element in the fuser, which can be used with surgical thread, the free ends of which are knotted site. Immediately before surgery for implantation of the prosthetic heart valve is attached to the holder extension. After the binder is fixed on the holder of the valve prosthesis at the desired location of the heart of the flexible filiform element fixing is cut with a scalpel or surgical scissors, and the holder is removed from the area of operation.

Along with the advantages of the described holding the El, as excluding the possibility of significant stresses in the petals of the holder, their deformation during sterilization and long-term storage, providing independent mobility of each petal holder that eliminates the possibility of damage to the valve elements and their breakage, improved reliability of fastening of the valve, good manufacturability design, it has the following shortcomings that significantly impair its quality.

This construction of the holder at the time of surgery does not provide alignment of the prosthesis with nickolaos (supra-Annularly) design cuff of the fibrous ring. This leads to the possibility of displacement bore hole of the valve against the opening of the annulus during the binder and allows the possibility of the structures of the heart into the body that will prevent operation of the locking element and can cause the valve outlet of the system. In addition, the displacement of the valve can lead to deterioration of the hemodynamic efficiency of the prosthesis, the emergence of walapane leaks that without surgical intervention leads to death of the patient. All this leads to the need for more accurate setting of the valve prosthesis with nickolaos design of the cuff relative to the hole f is sbrosnogo rings and repeated checks in the process of binder.

These drawbacks lead to the inconvenience of using this holder during operation of the prosthetic valve with nickolaos (supra-Annularly) design cuff, increase the time of surgery, the possibility dysfunction incorrectly filed prosthesis and a possible negative result of prosthetics.

The technical object of the present invention is to provide a holder for a prosthetic heart valve in which the constructive execution of its elements will ensure alignment of the prosthesis with nickolaos (supra-Annularly) design cuff of the fibrous ring at the time of surgery that will eliminate the offset bore hole of the valve against the opening of the annulus will increase the usability of such holder, will reduce the time of surgery, will reduce the risk of dysfunction of the prosthesis and to improve prosthetic results.

This objective is achieved in that the known holder for a prosthetic heart valve containing at least two petals, pivotally mounted on the finger can be rotated around the axis of the hinge, located perpendicular to the Central axis of the holder, and provided with a working end and a shank, with the working ends of the landing surface is, designed as one part of a surface of rotation around the Central axis of the holder with a diameter of D, each of which is limited resistant and holds the shoulder, while the thrust collar relative to the Seating surface is located on the side of the shank and the retaining flange is on the opposite relative to the Seating surface side of the working end and has an inner and an outer end surface, with the inner end surface associated with the landing surface, and the outer end surface is on the outside relative to the Seating surface side of the working end of the petal, the outer end surface of the retaining flange of each petal is equipped with at least one protrusion, the protrusions have facing outward relative to the Central axis of the holder centering surface, which is designed as one part of a surface of revolution with diameter d C, the axis of which coincides with the Central axis of the holder.

Note that, since landing on the surface of the working ends of the petals, made in the form of one part of a surface of rotation around the Central axis of the holder with a diameter of D, set the prosthetic heart valve to its inner surface bore holes, the Central axis of the bore hole of the prosthesis with the flows from the Central axis of the holder, consequently, with the axis of the centering surfaces of the projections. Thus, the constructive design of the holder for a prosthetic heart valve according to the invention provides for centering of the prosthetic nickolaos (supra-Annularly) design cuff of the fibrous ring at the time of surgery, which will eliminate the offset bore hole of the valve against the opening of the annulus.

It is advisable that the diameter d C rotation surface of the centering surfaces of the projections was determined from the relationship:

0,8×D≤d C≤1,2×D,

where D - diameter surface of rotation around the Central axis of the holder mounting surface of the working ends equal to from about 8.0 mm to about 40,0 mm

The relationship of the diameter d C rotation surface of the centering surfaces of the projections with a diameter of D surfaces of revolution around the Central axis of the holder mounting surface of the working end, which is almost equal to the diameter of the bore hole of the valve prosthesis, allows you to choose the optimal ratio of these sizes depending on the valve size, providing, on the one hand, the maximum effect of centering, and on the other hand, provides maximum hemodynamic results of prosthesis. At 1.2×D≤d C is the diameter of the hole of the annulus much larger the diameter of the bore hole is installed on the holder of the valve prosthesis. This can lead to large pressure drops on the prosthesis, and therefore, deterioration of hemodynamic characteristics and reduction in the efficiency of operations. When d C<0,8×D the hole diameter of the annulus is significantly smaller diameter bore hole is installed on the holder of the valve prosthesis, which can lead to inaccuracies in the alignment, as well as to the possibility of penetration of the structures of the heart inside the valve body in the area of functioning of the locking element. This, in turn, can lead to dysfunction of the valve. Note that smaller values of d C preferably be used in holders for valves of smaller sizes, with the worst hemodynamic efficiency. Along with this, the valves of small size locking elements are usually better protected from the effects of the structures of the heart to their functioning. For valves larger sizes, with good hemodynamic performance, it is advisable to use large values of d C, thus the optimal alignment and the placement of the prosthesis, wherein operating the locking element most remote from the heart.

It is useful to have in the direction of the Central axis of the holder, the length L of the projections with the centering surfaces ranged from about 2 mm to about 10 mm

This design you shall olnine holder for a prosthetic heart valve allows you to choose the optimal value of the length L of the projections, depending on the valve size, ensure, on the one hand, the maximum effect of centering, and on the other hand, will not prevent the operation.

The use of lower values of the length L of the projections is reasonable holders for valves of smaller sizes, which are, respectively, set in the heart of the small sizes. The use of data in cases of excessively long protrusions may lead to their interaction with the elements of the heart, for example, ventricle, or interventricular septum, which, in turn, may prevent the correct and accurate installation of the prosthesis. However, we note that if the length L of the projections is less than 2 mm effective centering is not achieved.

The use of large values of the length L of the projections is reasonable holders for valves larger sizes, which, respectively, are installed in the large heart. Application in these cases short of projections can lead to significant reduction in the efficiency of centering. Moreover, we note that if the length L of the projections is greater than 10 mm may their interaction with the elements even bigger heart, for example, ventricle, or interventricular septum, which, in turn, may prevent the correct and accurate installation of the prosthesis.

Thus, execution of a holder for a prosthetic heart valve offers on the proposed technical solution, keeping all the positive qualities of the prototype, provides centering of the prosthetic nickolaos (supra-Annularly) design cuff of the fibrous ring at the time of surgery that will eliminate the offset bore hole of the valve against the opening of the annulus. This allows you to expand the scope holder, improves usability, reduces the time of surgery reduces the possible dysfunction of the prosthesis and to improve prosthetic results.

These features of the invention are its differences from the prototype and determine the novelty of the proposal; these differences are significant because 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:

- figure 1 represents a General view of a holder for a prosthetic heart valve made according to the invention (described variant of its execution);

- figure 2 represents a view along arrow a on the holder of the prosthesis (figure 1), made according to the invention;

- figure 3 schematically depicts the process of implantation of aortic valve prosthesis heart snarkalicious (supra-Annularly) design cuff when using the holder, made according to the invention;

- figure 4 schematically depicts the process of implantation of the mitral prosthetic heart valve with nickolaos (supra-Annularly) design cuff when using a holder made according to the invention.

The proposed holder for a prosthetic heart valve contains two petal 1 (figure 1). The number of blades 1, depending on the type of valve may be different and is not the subject of the invention. Petals 1 pivotally mounted on the finger 2 can be rotated around the axis 3 of the hinge 4, which is located perpendicular to the Central axis 5 of the holder, and provided with the working ends 6 and the shank 7. The work ends 6 have Seating surface 8, is designed as one part of a surface of rotation around the Central axis 5 of the holder with a diameter of D, each of which is limited resistant 9 and restraint 10 shoulder. Thrust collar 9 with respect to the landing surface 8 is located on the side of the shank 7. The retaining flange 10 located on the opposite relative to the landing surface 8 side of the working end 6 and has an inner 11 and outer 12 end surface. The inner end surface 11 is associated with the seat surface 8. The outer end surface 12 is located on the outside relative to the landing surface 8 side of the working end is 6 petal 1.

The outer end 12 of the surface of the retaining flange 10 of each petal 1 is equipped with at least one protrusion 13. The tabs 13 are turned outward relative to the Central axis 5 of the holder centering surface 14, which is designed as one part of a surface of revolution with diameter d C, the axis of which coincides with the Central axis 5 of the holder.

In the proposed holder diameter d C rotation surface 14 of the centering surfaces of the projections 13 is determined from the relationship:

0,8×D≤d C≤1,2×D,

where D - diameter surface of rotation around the Central axis 5 of the holder boarding 8 the surface of the working end 6, is equal to from about 8.0 mm to about 40,0 mm

In the holder made according to the invention, in the direction of the Central axis 5 of the holder, the length L of the projections 13 14 centering surfaces is from about 2 mm to about 10 mm

The proposed construction of the holder can be used for prosthetic heart valves all designs, types and positions of the implant, for example, the prosthetic heart valve 15 for the aortic position (figure 3) or prosthetic heart valve 16 for the mitral position (figure 4). The process of installation and fixing of prosthetic valves 15, 16 (figure 3, figure 4) on the holder can be carried out in various ways and is not the subject of the invention. In the described embodiment, de is gates after you install one or the other of the prosthesis 15, 16 on the landing surface 8 between resistant 9 and restraint 10 shoulder work all 6 petals 1 shanks 7 are connected to the flexible filiform element 17 of the fastening, which can be used with surgical thread, the free ends of which are knotted site. This ensures reliable fixation of prosthetic heart valves 15, 16. Immediately before the surgery to implant the holder is attached to the extension tube 18.

The process of applying the described holder during the operation, consider the example of implantation of aortic prosthetic heart valve 15 with nickolaos (supra-Annularly) design cuff (figure 3).

The sleeve 19 of the prosthetic heart valve 15 and the fibrous ring 20 are stitched surgical threads 21, and the valve 15 is moved to the fibrous ring 20. After moving the valve 15 directly into the zone of implantation of the protrusions 13 on the outer end 12 of the surface of the retaining flange 10 of each petal 1 is placed in the hole of the annulus 20. In the process, facing outward relative to the Central axis 5 of the holder centering surface 14 on the ledges 13, interacting with the walls of the annulus 20, and prevent the displacement of the bore hole 22 of the valve 15 against the opening of the annulus 20. In this case, since the centering behavior of the displacement 14 is in the form of one part of a surface of revolution with diameter d C, axis of which coincides with the Central axis of the holder 5 and the Central axis of the bore hole 22 of the prosthesis 15, is provided centered relative to the hole of the annulus 20.

As in the described embodiment, a holder for a prosthetic heart valves diameter d C rotation surface 14 of the centering surfaces of the projections 13 is determined from the relationship:

0,8×D≤d C≤1,2×D,

where D - diameter surface of rotation around the Central axis 5 of the holder boarding 8 the surface of the working end 6, is equal to from about 8.0 mm to about 40.0 mm, the installation process provides the necessary centering of the valve 15 different sizes. When the prosthesis 15 is located so that operating the locking element most remote from the heart. In addition are provided with good hemodynamic characteristics. It will prevent dysfunction of the valve 15 and will improve long-term results of prosthetic.

To improve the efficiency of the alignment of the prosthesis 15 different sizes in the installation process directly in the implant area, excluding the possible interaction of the elements of the holder with elements of the heart, for example, ventricular or interventricular septum, which, in turn, may impede the operation and proper installation of the valve 15, poses the s and the that holder made according to the invention, in the direction of the Central axis 5 of the holder, the length L of the projections 13 14 centering surfaces is from about 2 mm to about 10 mm

After the installation process and the necessary alignment of the prosthetic heart valve 15 surgical sutures 21 fastened nodes, providing the necessary fixation of the valve 15 relative to the annulus 20. Next, the flexible filiform element 17 is cut with a scalpel or surgical scissors, and the holder is removed from the area of operation.

The use of a holder made according to the invention, in the process of implantation of the mitral prosthetic heart valve 16 (figure 4) with nickolaos (supra-Annularly) design cuff is similar to the above process of implantation of the aortic valve 15 (Fig 3).

The proposed holder for a prosthetic heart valve, maintaining such advantages of the prototype, as excluding the possibility of damage to the valve elements and their failures, increased reliability of fastening of the valve, good manufacturability of the design that ensures the centering of the prosthetic nickolaos (supra-Annularly) design cuff of the fibrous ring at the time of surgery that will eliminate the offset bore hole of the valve against the opening of the fibrous who olza. This allows you to expand the scope holder, improves usability, reduces the risk of dysfunction of the prosthesis and to improve long-term results of prosthetic.

It should be noted that the rapid and accurate alignment of the prosthesis with nickolaos (supra-Annularly) design cuff of the fibrous ring during operation, provide a holder made according to the proposed technical solution, reduces the number of manipulations necessary to pay the medical staff during surgery, eliminates excessive nervousness surgeon, the possibility of damage to the prosthetic heart valve, reduces the time spent by the patient under the influence of cardiopulmonary bypass, and therefore, improves the conditions of the transaction and will provide the best clinical effect of prosthesis diseased natural heart valves person.

1. A holder for a prosthetic heart valve containing at least two petals, pivotally mounted on the finger can be rotated around the axis of the hinge, located perpendicular to the Central axis of the holder, and provided with a working end and a shank, with the work ends have Seating surfaces, made in the form of one part of a surface of rotation around the center is the real axis of the holder with a diameter of D, each of which is limited resistant and holds the shoulder, while the thrust collar relative to the Seating surface is located on the side of the shank and the retaining flange is on the opposite relative to the Seating surface side of the working end and has an inner and an outer end surface, with the inner end surface associated with the landing surface, and the outer end surface is on the outside relative to the Seating surface side of the working end of the petal, characterized in that the outer end surface of the retaining flange of each petal is equipped with at least one protrusion, the protrusions are facing outward relative to the Central axis of the holder centering surface that designed as one part of a surface of revolution with diameter d C, the axis of which coincides with the Central axis of the holder.

2. The holder according to claim 1 characterized in that the diameter d C rotation surface of the centering surfaces of the projections is determined from the relationship

0,8×D≤d C≤1,2×D,

where D - diameter surface of rotation around the Central axis of the holder mounting surface of the working ends equal to from about 8.0 mm to about 40,0 mm

3. The holder according to claim 1 characterized in that direction centralnotice holder length L of the projections with the centering surfaces is from about 2 mm to about 10 mm



 

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