CN1131384A

CN1131384A - Implantable heart valve

Info

Publication number: CN1131384A
Application number: CN 94193421
Authority: CN
Inventors: 让-保罗·库蒂尔
Original assignee: Individual
Current assignee: Individual
Priority date: 1993-08-13
Filing date: 1994-08-12
Publication date: 1996-09-18
Also published as: EP0713376A1; AU7501994A; FR2708847B1; CA2169454A1; BR9407256A; JPH09501341A; FR2708847A1; WO1995005133A1

Abstract

Mitral-type implantable heart valve comprising an atrioventricular joining member (1) defining a channel (2)(F) for the blood flow, capable of being sealed by one or more movable membranes (3) fastened to an array of retaining threads (4), the valve being characterized in that said joining member includes a loop (1) which is engaged by the peripheral edge of said membrane (3) upon closure, and a hoop element (5) for anchoring said thread-array (4), provided on the front side of the loops in relation to the anatomical position of the heart in a plane angularly displaced by an angle alpha from the plane of said loop, wherein the hoop ends are integral with said loop (1).

Description

Implantable heart valve

The present invention relates to a kind of mitral configuration implantable heart valve.

WO91/19465 (FRATER) disclosed two sharp heart lobes have an atrioventricular joining member specifically, and in order to constitute the opening of a blood flow, this opening can be closed by at least one best four the movable film body that is contained on row's Muller's fibers.

Fastener wherein is that annular and inflexible Muller's fibers then are sewn on the myocardium wall body.

This structure causes technically much relate to the problem of coordinating between the rigidity of the length of Muller's fibers and fastener.

In the course of the work, cardiac muscle remains under the relaxed state, thereby the length that can not determine fiber exactly is to obtain the operate as normal of heart lobe.

In this case, for settling a kind of like this heart lobe just to obtain the optimum state of mutual coordination with being difficult to repeatability.

In addition, when standard-sized sheet, the tapered path that constitutes by four film bodies can hinder blood from the atrium to the flowing of left ventricle, thereby cause functional problem.

Also make a generation calcification phenomenon that sews up of Muller's fibers in a row in some cases, make described tendering of fiber, thereby influence the reliability of heart lobe.

The objective of the invention is to solve effectively these technical problems.

This purpose can be planted two sharp heart lobes by the following stated and finished, and this heart lobe has an atrioventricular joining member that constitutes blood stream access, and this fastener can be closed by at least one mobile film body.The feature of heart lobe is: described fastener has a ring body and and supports the bow body, and the periphery of described film body abuts in when closing on the ring body, and the bow body is connected with described film body and is arranged at the front side of ring body with respect to the anatomical cardiac position.

As a favourable feature, described ring body has side cheek body, and with so that myocardium wall body on every side separately makes the film body can be free movable, described cheek body can according to circumstances be provided with and limit the angular displacement of film body with limit body.

In first embodiment, described bow body is that a mobile has the structure on the free periphery that can directly be fixed in described movable film body, can do sealing with described ring body and contact when heart lobe is closed.It is described that the structure that body is fixed on the film body periphery is bent in activity is to be made of the vertical slotted hole on the described bow body, the periphery of film body promptly is embedded in this slotted hole, this slotted hole has the inboard that is facing with each other, one of inboard has shaft of rib, another has groove, so that described film body is clipped in the middle when locking together making one of them do quick fastening in another.

In most cases, needn't the restraint film body, because its action of throwing off ring body in ventricle is subjected to the restriction of blood flow and indoor blood convection current between chamber naturally.On also can be in position limit body be set and has certain amplitude to guarantee its action.

The bow body is also used so that the free periphery of movable film body has rigidity and makes its tensioning in order to avoid roll or turn up.In addition, film body can be directly be cut along the bow type, therefore bends body and function and leads the sanction body and prevent mistake in the cutting.

In a second embodiment, described bow body is fixed and is positioned at a plane, and an angle offset is made with the plane that comprises described ring body in this plane, and described movable film body is connected with described bow body by row's Muller's fibers.The length of Muller's fibers abuts on the front face of ring body when film body is closed at stroke terminal.In this case, fixed bow body has through hole that Muller's fibers therefrom pass through and the otch on via openings.

The gradient of Muller's fibers and length preferably make film body 3 become one 40 ° of angles in-90 ° of scopes with the rear face or the tailing edge of ring body when standard-sized sheet.In addition, the end of bow body is fixed on the outer of ring body.

As a distinctive feature, the bow body has certain front and back amount of deflection.Have fixed bow body and in a row among the embodiment of Muller's fibers at this, this amount of deflection is closed and is made Muller's fibers have elasticity when contacting with ring body at film body.That sets up on Muller's fibers like this helps the unlatching of relaxing period film body with the synchronous elasticity tension of Ventricular systole and does the unlatching of relaxing period in advance, like this, the protodiastole of correspondingly just helping via mitral blood flow.

Heart lobe of the present invention thereby can not be subjected to the influence of patient's heart form; Because Muller's fibers no longer are fixed on the ventricle wall, but be fixed on the bow body, bow body itself then is fixed on the ring body that constitutes atrioventricular joining member.

As another favourable feature, the width of ring body rear face is less than or equal to the width of front face.

As a feature again, the radius of curvature of ring body is less than or equal to the radius of curvature of fixed bow body and equals the radius of curvature of movable bow body substantially.

As another feature, the width of ring body front face is done successional variation and is reached maximum in the middle along its periphery.

Equally, the thickness of ring body is done successional variation and is reached maximum in the middle along its periphery, thereby in the angle of formation one in 5 '-20 ' scope between its rear face and the front face.

In first variant embodiment, described ring body is closed-loop shaped and the profile of getting natural Bicuspid valve ring body.

In another variant embodiment, described ring body is to be open loop shape.

In another modification, ring body has the sheath body of biocompatible materials at least in part, closes so that form sealing when contacting with film body.

Also can take measures to make described ring body when distortion, to make strain.

The cross section of fixing bow body is preferably rounded substantially, and its diameter is less than the width of ring body front face.

With regard to movable bow body, its cross section is suitable with the ring body front face to be contacted so that accomplish sealing as far as possible.

In a variant embodiment, the cross section of described ring body is polygon or triangle.

In a further embodiment, the ring body front face have convex and (or) radian of spill.

Described film body is preferably taken from the part pericardium and is done autotransplantation, but also can make of any other flexibility or rigidity biocompatible material.

The annular fastener can be sewn on the natural ring body and be open loop shape.

Equally, pericardium can be sewn on it on natural ring body of patient at another place in order to produce to small part annular fastener sheath body.

In this case, heart lobe has only a movable film body, thereby can avoid any interference to blood flow.

Can do better understanding by following to the present invention by the accompanying drawing illustration, in the accompanying drawing:

Fig. 1 is the perspective view of Bicuspid valve first embodiment of the present invention;

Fig. 2 is the perspective view of Bicuspid valve second embodiment of the present invention;

Fig. 3 is the perspective view of third embodiment of the invention;

Fig. 4 is the midplane profile of heart lobe shown in Figure 2;

Fig. 5 a is the profile of heart lobe fastener first embodiment;

Fig. 5 b is the profile of heart lobe fastener second embodiment;

Fig. 6 is a sketch, and the implantation situation of heart lobe of the present invention is shown.

Heart lobe shown in Fig. 1,2,3 perspective views is in order to place between patient atrium O and the ventricle V on the mitral position of chamber joint, thereby be formed on the blood one-way flow F that is from upstream to the downstream between rear portion or atrial side P and front portion or the ventricular side A, " rear portion " and " front portion " is with respect to the anatomical position of heart.

Bicuspid valve of the present invention has open loop 1 (Fig. 1,2) or closed loop (Fig. 3) shape atrioventricular node component, this fastener constitute the seat of heart lobe and from behind the P of portion to the blood flow F of front face A path 2.

Closed-loop shaped atrioventricular node component and natural Bicuspid valve ring body D word profile substantially are suitable.

Be suitable for at least one movable film body 3 it being closed via the path 2 of open loop or closed loop 1, this film body constitutes the heart lobe with shaped form free margins.

Movable film body 3 is illustrated its opening with solid line, its closed condition shown in broken lines.

Film body 3 is preferably taken from the part pericardium and is done autotransplantation or use flexible biocompatible materials in addition such as politef or manufacturings such as rigid bio material such as titanium.

When atrioventricular joining member was open loop shape, film body 3 was connected with two free ends of ring body 1 and the adjacent part of the natural ring body of patient, otherwise by a band described ring body is connected with patient's natural ring body.When ring body was closed-loop shaped, movable film body 3 was connected with patient's natural ring body and is connected with the adjacent part 1a of closed loop (Fig. 3) along 3a by its built-in edges.

Be to the native annulus body portion to constitute by aorta Bicuspid valve thin film, and be inlaid in film body on this thin film directly be sewn on aortic valve K under.

Film body 3 is moving between the enable possition when is abdicated path 2 (Fig. 1,2,3) by its closed position and one of contacting with ring body 1 front face 12 of periphery by it under the effect of fluid flow blood F.On the contrary, film body 3 along from ventricle V (A side) to the direction of atrium O (P side) from the left side or under the liquid stream F ' of ventricle internal convection promotion, close, this is to close when relaxing period is full of ventricle V with certain cycle and pressure, thereby has limited the unlatching (see figure 6) of film body.

Film body 3 is connected with supporting bow body 5, and this bow body is arranged at the front side A of ring body 1 with respect to the anatomical cardiac position.

In the embodiment shown in fig. 1, ring body 1 be open loop and have an other cheek body 13 of side, with so that heart wall on every side separately and that film body 3 is able to is freely movable.Like this, cheek body 13 just can prevent that cardiac muscle from going out and hinder the activity of film body 3 second month in a season.Cheek body 13 is provided with limit body 14 on the side within it, in order to limit the angular displacement amplitude of film body 3 with respect to ring body 1 front face 12.The displacement amplitude of film body 3 together with bow body 5 determined in the position of limit body 14, also is not subjected to the influence of liquid stream F ' in the ventricle with regard to having determined the best opening angle of heart lobe.Movable in case of necessity film body 3 can be connected with ring body 1, for example, does to sew up connection by the hole 15 that forms on described ring body two ends.Support bow body 5 directly to be contained on the free periphery of whole or part of movable film body 3.Bow body 5 is to be made by rigid material (metal etc.) or semi-rigid material (Derlin acetal resin, polyethylene etc.), and this material is a biocompatibility, uses so that film body 3 peripheral rigidizations.

When heart lobe was closed, bow body 5 contacted with the front face 12 of ring body 1.The cross section of movable bow body 5 contacts sealing as far as possible with suitable the making of the profile of ring body 1 front face 12.The radius of curvature of ring body 1 and width depend on that the radius of curvature of movable bow body 5 is to obtain the contact surface of sealing as far as possible.

The radius of curvature of ring body 1 preferably equals the radius of curvature of movable bow body 5 substantially.

Bow body 5 can be fixed on the film body 3 by sewing up methods such as cutting.(not shown) in one embodiment, described bow body has vertical slotted hole, and the periphery of film body is contained in this slotted hole; Like this, on two inner side edges of described slotted hole, just correspondingly being provided with shaft of rib and groove, lock together in order to do quick fastening each other, thereby it is in place that described film body is pressed from both sides.

In a variant embodiment, the bow body is divided into two parts, has complementary fastening structure fast respectively.Like this, the periphery of film body is clipped between two parts of binary bow body.Certainly, also can make the periphery of movable film body do the sclerosis of certain degree nearby, just adopting certain material to make its hardness is variable by changing its density or thickness on its whole surface partly.

Can take measures to make it to change its thickness continuously for ring body 1, make the intermediate portion have maximum thickness (particularly as shown in Figure 4), thereby be formed on the angle beta in 5 '-20 ' scope between portion 11 and the front face 12 in the back along periphery.

Can make ring body have polygonal cross section, make the width of its front face 12 link the ground variation and reach peak, make the width of ring body 1 rear face 11 be less than or equal to the width of front face 12 and reach minimum in the middle at the middle part along its periphery.In a certain embodiments, make the cross section of ring body 1 form a triangle and make rear face 11 become a tip (Fig. 5 b).Certainly, these features of ring body 1 are equally applicable to shown in other Fig. 2,3 and each embodiment of the following stated.

This configuration can make the rear perimeter of film body 3 have the abutment face of broad, thereby improves the sealing of heart lobe.

In embodiment illustrated in fig. 2, film body 3 is connected with fixed support bow body 5 by row's Muller's fibers 4, and the bow body places the front side A of ring body 1, is positioned at a fixed plane, and an angle [alpha] is departed from the plane that comprises ring body 1 front face 12 in this plane.Bow body 5 is inflexible, and its free end is fixed in the open loop 1, is preferably on the outer of open loop free end 10.

The formed sector angle of range of activity of movable film body 3 depends on the length of Muller's fibers 4.Bow body 5 is positioned at a plane, and free end 10 and film body 3 range of activity that this plane comprises ring body 1 form the covering of the fan angular bisector.

In the bow body 5 pro-back planes be have flexible.

The length of angle [alpha] and fiber 4 should make film body 3 become an angle γ in 40 ° of-90 ° of scopes with respect to the tailing edge of rear face 11 planes or ring body 1 when standard-sized sheet.

Film body 3 is in the terminal of its stroke and abuts on the front face 12 of ring body 1 when closing.

In this case, angle [alpha] equals that (γ-β)/2 is because the bow body should be positioned at the centre of enable possition and closed position.

For film body 3 is passed through in fixed bow body inboard, the radius of curvature of ring body 1 should be less than or equal to the radius of curvature of bending body 5.

Bow body 5 has the circular section, and the cross section internal diameter preferably is about one millimeter much smaller than the width of ring body 1 front face 12.

Muller's fibers 4 are fixed on the bow body 5 by the hole 50 that outwards enters otch 50a or just grip in described otch.

In Fig. 5 a illustrated embodiment, ring body 1 has convex front face 12, but some embodiment also can make it entirely or partly be arcs of recesses in design.

In Fig. 5 b illustrated embodiment, the cross section of ring body 1 is triangular in shape, particularly in the middle, but also can adopt front face with a slope (Fig. 4) in design at the middle part.

The sheath body 6 that ring body 1 has biocompatible materials at least in part with guarantee with the recline hermetically closing of path 2 when contacting of film body 3.

Sheath body 6 can adopt part pericardium or any other flexible biocompatible materials to produce.In this case, sheath body 6 is sewn on patient's the natural ring body and leaves the fillet fixing band 7 of pericardium or biocompatible materials between sheathe ring body and itself and natural ring body suture.This increased at fixed degree of freedom between ring body 1 and the natural lobe ring of patient so as in cardiac cycle, to do distortion, extend and (or) strain in the compression.

Claims

1. mitral configuration implantable heart valve, atrioventricular joining member (1) with formation blood flow (F) path (2), this path can be closed by at least one movable film body (3), the feature of heart lobe is: described fastener has a ring body (1) and and supports bow body (5), to the ring body contact that reclines, the bow body is connected with described film body and places the front side (A) of ring body with respect to the anatomical cardiac position periphery of described film body (3) when closing.

2. by the described lobe of claim 1, it is characterized in that: described ring body (1) has side cheek body (13), so that film body (3) is free movable, described cheek body (13) can have the angular displacement of limit body (14) with restriction film body (3) in order to the heart wall around stopping.

3. by claim 1 or 2 described heart lobes, it is characterized in that: described bow body (5) is that a mobile and having makes it directly be fixed on structure on the free periphery of described film body (3), does to seal with described ring body (1) to contact when heart lobe is closed.

4. by the described heart lobe of claim 3, it is characterized in that: the described structure that movable bow body (5) is fixed on film body (3) periphery is made of a vertical slotted hole in described bow body, the periphery of setting-in film body in this slotted hole, described bow body has the interior side that is facing with each other, one of them has a shaft of rib, another has a groove, with so that one of them quick fastening in another and lock together, even described film body therein.

5. by claim 1 or 2 described heart lobes, it is characterized in that: described bow body (5) is fixed, and being positioned at a plane, an angle (α) is departed from the plane that comprises described ring body (1) in this plane, and described movable film body (3) is connected with described bow body (5) by row's Muller's fibers (4).

6. by the described heart lobe of claim 5, it is characterized in that: the length of Muller's fibers (4) abuts on the front face (12) of ring body (1) film body (3) when the terminal of its stroke is closed.

7. by claim 5 or 6 described heart lobes, it is characterized in that: fixed bow body (5) has through hole (50), and Muller's fibers (4) therefrom pass through.

8. by the described heart lobe of claim 7, it is characterized in that: bow body (5) has otch (50a) at through hole (50) opening part.

9. by the described heart lobe of arbitrary requirement in the claim 5-8, it is characterized in that: when determining the length of angle (α) and Muller's fibers (4), should make film body (3) when standard-sized sheet and the rear face (11) of ring body (1) or the angle γ of tailing edge formation one in 40 ° of-90 ° of scopes.

10. by the described heart lobe of arbitrary requirement in the claim 5-9, it is characterized in that: the end of bow body (5) is fixed on the outer of ring body (1).

11. by the described heart lobe of arbitrary requirement in the claim 5-10, it is characterized in that: the radius of curvature of ring body (1) is less than or equal to the radius of curvature of fixed bow body (5).

12. by the described heart lobe of above arbitrary claim, it is characterized in that: rear face (11) width of ring body (1) is less than or equal to the width of front face (12).

13. by the described heart lobe of above arbitrary claim, it is characterized in that: the width of ring body (1) front face (12) is done successive variation and is reached maximum in the middle along its periphery.

14. by the described heart lobe of above arbitrary claim, it is characterized in that: described ring body (1) is the open loop body.

15. by the described heart lobe of above arbitrary claim, it is characterized in that: ring body (1) has the sheath body (6) of a biological compatibility material at least in part, the sheath body is being made hermetically closing to path (2) with film body (3) when contacting.

16. by the described heart lobe of above arbitrary claim, it is characterized in that: the thickness of ring body (1) is done successive variation and is reached maximum in the middle along its periphery, thereby forms a angle beta in 5 '-20 ' scope between its rear face (11) and its front face (12).

17. by the described heart lobe of above arbitrary claim, it is characterized in that: the cross section of described ring body (1) is polygon or triangle.

18. by the described heart lobe of arbitrary requirement in the claim 1-16, it is characterized in that: the front face (12) of ring body (1) has convex or spill radian.

19. by the described heart lobe of above arbitrary claim, it is characterized in that: described film body (3) done the autotransplantation of taking from the part pericardium.

20. by the described heart lobe of arbitrary requirement in the claim 1-18, it is characterized in that: described film body (3) is produced with the flexibility or rigidity biocompatible materials.

21. by the described heart lobe of above arbitrary claim, it is characterized in that: described ring body (1) can twist strain.

22. by the described heart lobe of above arbitrary claim, it is characterized in that: described ring body (1) is done flexible fastening by the fixedly band (7) of a biological compatibility material on patient's natural ring body.

23., it is characterized in that: have flexible in bow body (5) the pro-back plane by the described heart lobe of above arbitrary claim.