WO2000041652A1 - Prosthetic heart valve implantable by catheter insertion or surgically - Google Patents

Prosthetic heart valve implantable by catheter insertion or surgically Download PDF

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Publication number
WO2000041652A1
WO2000041652A1 PCT/FR2000/000051 FR0000051W WO0041652A1 WO 2000041652 A1 WO2000041652 A1 WO 2000041652A1 FR 0000051 W FR0000051 W FR 0000051W WO 0041652 A1 WO0041652 A1 WO 0041652A1
Authority
WO
WIPO (PCT)
Prior art keywords
structure
prosthetic valve
characterized
expandable structure
stiffeners
Prior art date
Application number
PCT/FR2000/000051
Other languages
French (fr)
Inventor
Brice Letac
Original Assignee
Brice Letac
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to FR99/00416 priority Critical
Priority to FR9900416A priority patent/FR2788217A1/en
Application filed by Brice Letac filed Critical Brice Letac
Publication of WO2000041652A1 publication Critical patent/WO2000041652A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/243Deployment by mechanical expansion
    • A61F2/2433Deployment by mechanical expansion using balloon catheter

Abstract

The invention concerns a prosthetic heart valve implantable by catheter insertion or surgically, comprising a rigid expansible structure (2) and a valvular structure (3) integral with the expansible structure (2) and capable of being deformed to pass alternately from an open state to a closed state. The valvular structure (3) in integrated at one end of the expansible structure (2), and extends externally thereto.

Description

VALVE PR0THE7I0UE CATHETERIZATION IMPLANTABLE BY OR SURGICALLY.

The present invention relates to an implantable prosthetic valve catheter i ems, or chi rurg i cal ly.

In the case of a stenosis, that is to say, the narrowing of an organic hole, it is necessary to intervene to remove this narrowing and when the stenosis occurs at a valve, this must be replaced ch i rurg i cal ly by a prosthetic valve.

notarnmenl aortic stenosis is known, which can result from fibrosis and calcification of the sigmoid valves, and requires removal of the aortic valve and replacing it with a prosthetic valve.

A prosthetic valve is being implanted chi rurg i cal ly. However, some patients can not be made, particularly because of their advanced age, knowing that aortic stenosis reached Principa ly seniors.

To overcome this drawback it has been proposed to implant the prosthetic valve catheter i ems, that is to say to bring it to the core by the arterial route, passing through the femoral artery until the aorta without opening the chest.

An implantable prosthetic valve catheter i sm is described in document EP 0 850 607, it comprises an expandable structure and a structure have re vul val. The expandable structure consists of a lattice of metal son, preferably steel, having a tubular shape whose expansion in the radial direction under the action of pressure, allows it to reach a predetermined diameter, more corresponds to an optimum rigidity of said lattice. The expandable structure is intended to be positioned at the location of the stenosed valve, and to be blocked by its expansion.

The valvular structure is tronco- Hyperbol i form and is made of a flexible and resistant fabric. It is fixed with its end of larger diameter to the inner wall of the expandable structure, substantially in the central region thereof, or near an end thereof to extend inside. More specifically, the valve structure is integral with a tubular casing which covers the inner wall of the expandable structure and ensures tightness cel e thereof.

Thus, the valve structure may be deformed to pass al ernati no way from a closed state to an open state in the expandable structure, that is to say its end of smaller diameter can be widened or narrowed for alternati ement , opening and passing a flux and close the orifice to prevent regurgitation.

In addition, for guider- its movement during the transition from the open state to the closed state, the valvular structure has preformed longitudinal reinforcements.

In practice, after a widening of the stenosis by means of a balloon carried by arterial route, the prosthetic valve is fed through the same path to said stenosis and then carries out the expansion of the expandable structure by the strong swelling of a balloon placed inside thereof. The expandable structure is thus securely anchored in its rigid configuration, and the valve structure is functi onal 1e. Or this prosthetic valve has a drawback. Indeed, upon inflation of the balloon, given that the pressure required for the expansion of the expandable structure is in the order of 4 bars, the valve structure is highly likely to be damaged by being pressed against said expandable structure, which may result in piercing or tearing of ti ssue.

On the other hand, the valvular structure being attached to the casing, this sol i dar his i ti on is not reliable over time, there may be a separation due to the movement of said valve structure with respect to said casing .

The present invention aims to provide a prosthetic valve to remedy these various drawbacks, particularly an improvement to the prosthetic valve described above.

The prosthetic valve object of the present invention comprises an expandable rigid frame and a valvular structure fastened to said expandable structure and capable of being deformed to switch between an open Etot to a closed state, and is characterized in that said valvular structure is secured to one end of said expandable structure, and extends externally thereto.

According na additi nal characteristic of the prosthetic valve according to the invention, the expandable st ucture comprises a lattice of metal son having a tubular shape.

According to another additional characteristic of the prosthetic valve according to the invention, the expandable structure in its present expanded configuration in its central region a smaller diameter than those of end edges.

According to another additional characteristic of the prosthetic valve according to the invention, the valvular structure consists of a shaped part tronco- Hyperbol ic, made of a flexible and durable fabric and is secured to the expandable structure with its end of larger diameter .

According to another additional characteristic of the prosthetic valve according to the invention, the expandable structure comprises a casing which internally covers made of a flexible and durable fabric, and one end of which is secured to it the valve structure.

According to another additional charact istics of the prosthetic valve according to the inven ion, the valvular structure has preformed stiffeners to remind el ast i quernent said valvular structure green- its closed state.

According to a first embodiment of the prosthetic valve according to the invention, the stiffening of the valve structure are such that they tend to approach each other to come into contact with each other.

According to a second embodiment of the prosthetic valve according to the invention, the valvular structure has two opposed stiffeners Diamet alement which tend to move away from each other.

According to an additional characteristic of the second embodiment of the prosthetic valve according to the i vention, valvular structure comprises stiffeners which tend to approach each other until contact.

The advantages and features of the present invention will produce more emerged clearly from the following description which refers to the attached drawing, which represents several embodiments not

1 imi tati fs.

In the accompanying drawing:

- Figures 1a, 1b and 1c each show a perspective view of a first embodiment of a prosthetic valve according to the invention at three stages of its operation.

- Figures 2a, 2b and 2c show schematic sectional views respectively of Figs 1a, 1b and 1c, according to a median longitudinal plane.

- Figure 3 shows a schematic view of a portion I the same prosthetic valve according to a first variant.

- Figure 4 shows a schematic perspective view of a portion of the prosthetic valve according to a second variant inertia.

- Figures 5a, 5b and 5c show perspective views of a second embodiment of a prosthetic valve according to the invention at three stages of its onment Func. - Figures 6a, 6b and 6c show partial top views respectively of Figures 5a, 5b and 5c.

- the figure; - 7a and 7b show perspective views in different rep ésentations of a prosthetic valve according to the invention during its AnTat impl i on.

- Figures 8a and 8b show perspective views in different representations Here same prosthetic valve at its establishment. Referring to Figures 1a, 1b, 1c, 2a, 2b and 2c there is shown a first embodiment of a prosthetic valve 1 according to the invention which comprises a rigid expandable structure 2 and a valvular structure 3.

The expandable structure 2, as can be seen only in Figures 1a, 1b and 1c, comprises a mesh 20 of metal son 21, shaped as a tube adapted to be irreversibly deformed in the radial direction, while maintaining its shape tubu ire.

the expandable structure 2 it is noted that in these figures is in its expanded configuration, which corresponds to an optimum rigidity.

Son metal 21 are interwoven in an arrangement to move from a compressed state to an expanded state. In the case of a prosthetic valve 1 to replace the semilunar valves, the diameter of the expandable structure 2 in the folded state is of the order of 4 to 8 mm, while in the expanded state i is from 20 to 23 mm depending on the size of the patient.

Here the inner wall of expandable structure 2 is covered with a tubuldire casing 4 which is secured to it and realizes 1 'étctnchéi tee. The envelope 4 is able to follow the movement of expansion of the expandable structure 2, it may for this purpose be, for example shirred when the expandable structure is in its state repl ied. Valvular structure 3 consists of a fabric

30 formed into a hyperbolic truncated cone, that is to say that its wall is concave, the base 31, which corresponds to the largest diameter of the truncated cone is secured to an end edge of one 'envel oppe 4, while the end 32, corresponding to the smallest diameter, extends 1 'Exterior i Eur.

The fabric 30 may be made of plastic such as polyurethane treated to prevent calcification, or pericardium also treated against calcification, or any other equivalent material.

Note that when the valve structure 3 is made of polyurethane, it may advantageously make a single piece with the casing 4.

The fabric 30 is reinforced stiffeners 33 that extend from the base 31 to the tip 32. They are arranged, as shown, by curves generatrices of the truncated cone, but may however be arranged hel i coïdalement.

The stiffeners 33 can consist of material which is made of beads valvular structure, or son metal such as steel, and are preferably the number 3 or 4 in this con guration i.

The stiffeners 33 are formed of origin to constrain the valvular structure 3 to the closure as shown in Figures 1c and 2c, that is to say they are curved toward the main e has the prosthetic valve 1, and tend to approach each other. Their riyidité is limited to allow the opening of the valvular structure 3 by a flux as is ep ESENTE in Figures 1a and 2a, Figures 1b and 2b showing an intermediate step.

Stiffeners 33 may be integral with the expandable structure 2 and come into support against the external valve structure Ξ in which they are ground idarisés suture when it is performed by means of pericardium. In the case of valvular structure made of polyurethane, the stiffeners 33 may advantageously be embedded there.

In the case of a prosthetic valve 1 to replace the semilunar valves, valvular structure 3 is disposed on the side of the aorta, so that during systole ass ri wind have re strong systolic pressure of blood flow generated by contraction Fri tr ass i have re done to open the valve structure 3 while during diastole the stiffeners 33 and reversal of blood pressure close.

The shape onco-tr i hyper bowl as the valvular structure 3 enables the closure to be achieved not only at its end 32 but, because the ends of the stiffeners 33 come into contact tangent, on a portion substantially representative one third of its height, so as to obtain a perfect seal thus preventing regurgitation.

Referring to Figure 3, it is seen that alternatively, the expandable structure 3 may, when expanded, take a concave forine so as to appear in its middle region a retro écissement 34 adapted to promote fate centering at the place of its location.

Referring to Figure 4, it can be seen that in another embodiment, the centering of the expandable structure 3 is facilitated by the presence throttling If we re fe re now to Figures 5a, 5b, 5c, 6a, 6b and 6c , there is shown a second embodiment of a prosthetic valve 1 'according to the invention. This prosthetic valve 1 'also includes an expandable structure 2 covered Internal ieuremen an envelope 4 and a valvular structure 3 of frustoconical shape.

Valvular structure 3 is equipped with six regularly spaced stiffeners, two stiffeners 36, opposite Diamé rattle, and four stiffeners 37.

As can be seen in Figures 6a, 6b and 6c, the stiffeners 36 are configured to move away from each other, while the stiffeners 37 are formed to approach each other. The realization point of view, for example, the stiffeners 36 SONL arranged within the valve structure 3 while i aidisseurs 37 are placed at 1 'Exterior them.

Figures 5a and 6a, which represent a systole ventr ire ass. valvul ire structure 3 is op under the thrust F of blood flow. Ptr against in Figures 5c and 6c, which represent a diastole, after a first step in ediate shown in Figures 5b and 6b, the valvular structure 3 closes as two layers joined to one another, in that the stiffeners 36 pulling the fabric 30 outwardly while les, stiffeners 37 are joined in pairs, resulting in association with aortic blood pressure P, the flattening of the valvular structure 3. the structure 3 valvular flattened ¬ tensioned by the stiffeners 36 and contiguous to itself over a large area, has no p nt is likely to create leaks engeridrant regurgitation as in the first embodiment. Note that according to a variant, not shown, the valvular structure 3 may comprise only two stiffeners 36. In this QC, during diastole, the raidisseurs-. 36 by élcignant from one another behind the valve structure 2, and aortic blood pressure P which completes the flattening and closure. If reference is now made to Figures 7a and 7b, there is shown a prosthetic valve 1 during implantation, knowing that impl ntation a prosthetic valve 1 'is performed in the same manner.

The expandable structure 2 is folded back, and is mounted on a set of elements for performing its expansion. This assembly comprises a sensor 5 which is threaded on a rod 50 having near its end a balloon 51 that takes place within the expandable structure 2, against the casing 4, and so it does not overflow above the junction of one igneous valvular structure 3 to the casing 4.

The rod 50 comprises two pipes, not shown, in one of which passes the probe 5, while the other opens into the balloon 51 to permit inflation thereof.

If reference is now made to Figures 8a and 8b, it can be seen that inflation of the balloon 51 allows the expansion of the expandable structure 2.

The balloon 51 is only in contact with the casing 4 so that the valve structure 3 does not risk being damaged by the swelling.

On the other hand, the position of the balloon. 51 below the connecting line of the valvular structure 3 with the cover 4 avoids the risk of damage at the junction and of the valvular structure flaring

3.

Moreover, as previously seen, the valvular structure 3 can not be damaged during its introduction, the prosthetic valve 1 according to the invention has many advantages over existing Prosthetic valves and in particular that described in EP 0,850,607.

Thus, the extension of the casing 4 by the valvular structure 3 and Sol i dar i sati on of the latter to the expandable structure 2 results in easier manufacture and greater reliability in time.

On the other hand, the transition from the open state to the closed state, and vice versa, is easier, due to a greater freedom of movement of the valvular structure 3 of the casing 4.

The prosthetic valve according to the invention is intended to be implanted catheter as has been seen, however, it can be implanted chi rurgi cally open heart having advantages over conventional prosthetic valves.

Thus, the metal structure 2 expandable prosthetic valve according to the invention can, after its insertion into the valvular orifice, possibly by means of a dilatation balloon, be sutured around the circumference of the valve annulus.

Advantageously, the prosthetic valve according to the invention does not include the large Teflon ring conventional Prosthetic valves, which is intended to allow the suture, so that the opening size is much higher. For example, a prosthetic valve according to the invention has an opening of between 3.1 and 4.1 cm 2, while that of a conventional prosthetic valve is of one order of 2 cm 2.

Claims

1) Valve implantable prosthetic by catheterization, or chi rurgi cally. comprising a rigid expandable structure (2) and a valve structure (3) secured to said expandable structure (2) and adapted to be deformed to pass al ter nati veinent from an open state to a closed state, characterized in that said structure valve (3) is secured to one end of said expandable structure (2), and extends externally thereto. 2) prosthetic valve of claim 1, characterized in that the expandable structure (2) comprises a lattice (20) of metal son (21) having a tubular shape.
3) prosthetic valve of claim 2, characterized in that the expandable structure (2) in its deployed configuration has in its central region a smaller diameter than those of end edges.
4) The prosthetic valve according to claim 3, characterized in that the wall of the expandable structure (2) is concave so that ladi an expandable structure has a narrowing (34) in its middle region.
5) The prosthetic valve according to claim 3, characterized in that the expandable structure (2) has a constriction (35) in its middle region. 6) prosthetic valve according to any one of the preceding claims, characterized in that the valvular structure (3) consists of a shaped part tronco-Hyperbol that i, made of a fabric (30) flexible and resilient, and is attached to the expandable structure (2) by its end (31) of larger diameter.
7) prosthetic valve according to any one of the preceding claims, characterized in that the expandable structure (2) comprises a casing (4) which ι: i térieurement covers made of a flexible and resistant fabric at one end of which is secured to it the val ular structure (3).
S) prosthetic valve according to any one of the preceding claims, characterized in that the valve structure (3) has stiffeners (33, 36,
37) preformed to remind el quemen L if said valvular structure (3) towards its closed state.
9) The prosthetic valve according to claim 8, characterized in that the stiffeners (33) of the valvular structure (3) are such that they tend to approach each other.
10) The prosthetic valve according to claim 8, characterized in that the valve structure (3) comprises two stiffeners (36) diametrically opposite that tend to move away from each other.
11) The prosthetic valve according to revendi ation 10, characterized in that the valve structure (3) includes stiffeners (37) which tend to approach each other.
12) prosthetic valve according to any one of claims 8 to 11, characterized in that the stiffeners (33; 36, 37) consist of material which is made of beads valvular structure (3), or the son of metal.
12) prosthetic valve of claim 12, characterized in that the stiffeners (33; 36, 37) are metal son integral with the expandable structure (2).
PCT/FR2000/000051 1999-01-12 2000-01-12 Prosthetic heart valve implantable by catheter insertion or surgically WO2000041652A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
FR99/00416 1999-01-12
FR9900416A FR2788217A1 (en) 1999-01-12 1999-01-12 Implantable prosthetic valve by catheterization, or surgically

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU30529/00A AU3052900A (en) 1999-01-12 2000-01-12 Prosthetic heart valve implantable by catheter insertion or surgically

Publications (1)

Publication Number Publication Date
WO2000041652A1 true WO2000041652A1 (en) 2000-07-20

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Country Status (3)

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AU (1) AU3052900A (en)
FR (1) FR2788217A1 (en)
WO (1) WO2000041652A1 (en)

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