Surgical device for implanting an artificial mitral valve chordae tendineae

Abstract

The invention relates to a device (1) for the placement of an artificial mitral valve cord (30), comprising: a central body (10); two end parts (12, 14), arranged on either side of the central body (10), each having a through opening (122, 142), and having two jaws (124, 144) delimiting the corresponding opening (122, 142); each end part (12, 14) being able to be placed in two distinct configurations: - a first configuration, in which the jaws are in a closed position, a position in which a strand of artificial cord passing through the corresponding opening (122, 142) cannot pass between the corresponding jaws (124, 144); - a second configuration, in which the jaws are in an open position, in which a strand of artificial rope passing through the corresponding opening (122, 142) can pass between the corresponding jaws. Figure 1.

Description

Title of the invention: Surgical device for implanting an artificial mitral valve chordae tendineae. Technical field

[0001] The present invention relates to the field of medical devices, and more particularly to a surgical device facilitating the placement of artificial cords, or neo-cords, in order to reinforce or replace broken or damaged native cords. Prior art

[0002] The heart is an intrathoracic organ whose function is to ensure the circulation of blood throughout the body. It acts as a four-chambered pump with two atria, two ventricles, and four valves. These chambers are separated and isolated from each other by watertight partitions called septa. There is a septum between the atria, called the interatrial septum, and a septum between the ventricles, called the interventricular septum. The valves allow for the temporary closure and opening of the chambers during the systolic-diastolic cardiac cycle.

[0003] The mitral valve is located between the left ventricle and the left atrium. It comprises two leaflets (an anterior and a posterior leaflet) connected to the walls of the left ventricle, inside the cavity, by two papillary muscles and numerous fibrous chordae tendineae. During contraction of the left ventricle, the mitral valve closes. This closure is achieved by tensioning the two leaflets under the action of the chordae tendineae. Under the effect of this tension, the leaflets unfold, like a parachute, to come into contact at their respective free edges, thus ensuring occlusion and sealing of the system by coaptation.

[0004] The chordae tendineae can break due to weakening and lead to mitral regurgitation, meaning that the mitral valve no longer closes properly. This generally results in blood flowing back from the left ventricle into the left atrium, which obviously impairs the proper functioning of the heart. Mitral regurgitation requires surgical repair, the indication for which is based on recognized and approved international guidelines.

[0005] In cardiac surgery, mitral valve repairs are performed using numerous techniques initiated by pioneers over the past 50 years. These techniques have demonstrated excellent results compared to mitral valve replacements.

[0006] To date, mitral valve repair techniques essentially include: - techniques for partial resection of mitral valve tissue concerning altered or damaged parts of the mitral valve leaflets, or more recently; - techniques for replacing, with artificial neo-cords made of Goretex, the elongated or broken native fibrous cords responsible for mitral insufficiency.

[0007] In recent years, techniques for replacing damaged native chordae tendineae have superseded mitral valve resection techniques. These techniques employ sutures (generally made of Gore-Tex), called neo-chordae, as replacements for ruptured, elongated, or weakened native chordae tendineae. This technique involves fixing the Gore-Tex suture to one of the anterior and / or posterior papillary muscles of the mitral valve, possibly supported by a Teflon splint or an autologous pericardial patch to avoid weakening the mitral papillary muscle, which is a muscular and fleshy structure. After fixation to the mitral papillary muscle, this neo-chordae consists of two strands or heads emerging from the mitral papillary muscle. Each neo-chordae is then fixed to the free edge of the everted or prolapsed segment of the mitral valve leaflet by tying the two heads together, after carefully determining the desired length of the two heads.

[0008] Determining the length of a neochord is crucial. Indeed, it is essential that each neochord be of an appropriate length to ensure the proper tensioning of the valve leaflet. Thus, a neochord that is too short or too long risks impairing mitral valve function. Currently, when implanting a neochord, surgeons are forced to estimate the required length "by eye," or approximately, which inevitably leads to recurring inaccuracies. While techniques exist to precisely determine the required length for a neochord to be implanted, they do not allow for the accurate translation of this measured length into the actual length of the neochord used. Implantation of the neochord requires a specific technique to ensure that, once implanted, the neochord will be of the correct length.

[0009] The invention thus aims to overcome the disadvantages of the prior art, and in particular those set out above, by proposing a surgical device enabling a surgeon to reliably, precisely and repeatably place a neochord of a determined length. Description of the invention

[0010] To this end, the invention relates to a surgical device for the placement of an artificial mitral valve chordae tendineae, the device comprising: - a central body, extending along a longitudinal direction; - two end parts, arranged on either side of the central body in the longitudinal direction, each end part having an opening through the corresponding end part in the longitudinal direction, each end part having two jaws delimiting the corresponding opening; each end part being able to be put into two distinct configurations: - a first configuration, or closed configuration, in which each end part is naturally located, and in which the jaws of the end part are in a closed position, a position in which a strand of artificial rope passing through the corresponding opening cannot pass between the corresponding jaws; - a second configuration, or open configuration, in which each end part can be put in place by pinching a part of the central body, and in which the jaws of the end part are in an open position, a position in which a strand of artificial rope passing through the corresponding opening can pass between the corresponding jaws.

[0011] Thus, the device according to the invention makes it possible to place an artificial cord of the required length by acting as a spacer positioned between the cord's attachment point on the mitral papillary muscle and the cord's attachment point on the mitral valve leaflet. The device is very simple to use and inexpensive. The device according to the invention thus facilitates and accelerates the placement of an artificial cord, making these operations precise and repeatable.

[0012] According to other features of the invention, the device according to the invention comprises one or more of the following optional features considered alone or according to all possible combinations.

[0013] According to one feature, the device is configured so that each end part passes spontaneously, in the absence of external action on the central body, from the open configuration to the closed configuration.

[0014] According to one characteristic, the spontaneous transition from the open configuration to the closed configuration is obtained by elasticity.

[0015] According to one feature, the central body and the end parts are at least partially made of an elastic material.

[0016] According to one feature, the central body has two longitudinal sides, each longitudinal side extending along the longitudinal direction and connecting the two end parts, the two longitudinal sides being connected to each other by two connecting parts each disposed at one longitudinal end of the central body, each connecting part being configured to form a flexible hinge.

[0017] According to one feature, pinching the central body at one of the longitudinal ends allows the selective passage into open configuration of the end part located at the corresponding longitudinal end.

[0018] According to one feature, the opening of at least one of the end parts has dimensions allowing the passage of at least one knot formed from two strands of the artificial rope.

[0019] According to one feature, for each pair of jaws, the closing plane or the closing line is secant with the longitudinal direction of the central body.

[0020] According to one feature, for each pair of jaws, the closing plane or the closing line is parallel to the longitudinal direction of the central body.

[0021] According to one feature, one of the end parts is intended to be positioned on the side of the mitral valve leaflet when an artificial cord is being placed, each jaw of this end part having a slot allowing the jamming of a strand of artificial cord.

[0022] According to one feature, each end part has slots allowing the jamming of a strand of artificial rope.

[0023] According to one feature, each end part of the device has a surface extending in a plane perpendicular to the longitudinal direction and forming a support surface.

[0024] According to one characteristic, the device having a symmetrical shape with respect to a median plane perpendicular to the longitudinal direction.

[0025] According to one characteristic, the distance between the bearing surfaces corresponds to the total length of the device, and is preferably between 5 and 40 mm.

[0026] According to one characteristic, the device being made of a biocompatible material, in particular by molding.

[0027] The invention also relates to a kit for laying an artificial rope, the kit comprising several devices conforming to that defined above of different sizes, the size increment between two devices being between 1 and 5 mm.

[0028] According to one feature, the kit further includes a measuring tool, allowing the length of the device to be determined according to the distance between the point of attachment of the artificial cord on the mitral pillar and the mitral ring.

[0029] The invention also relates to a surgical treatment method implementing a device conforming to that defined above. Brief description of the drawings

[0030] [Fig-1] Fig. 1 is a schematic perspective view of a device conforming to the invention.

[0031] [Fig.2] The [Fig.2] is a schematic perspective view of the device of the [Fig.1].

[0032] [Fig.3] The [Fig.3] is a schematic perspective view of the device of the [Fig.1], showing more specifically the central body.

[0033] [Fig.4] Fig.4 represents a measuring tool according to the ongoing invention of use.

[0034] [Fig. 5] [Fig. 5] is a schematic view showing the use of the device in accordance with the invention, an artificial rope being laid.

[0035] [Fig.6] [Fig.6] is a view analogous to the view in [Fig.5], showing the step removal of the device according to the invention, after final fixing of the corresponding artificial rope.

[0036] [Fig.7] [Fig.7] is a view analogous to [Fig.5], showing the artificial rope after removal of the device conforming to the invention.

[0037] [Fig.8] Fig.8 is a perspective view of a device according to the invention presenting a symmetrical shape. Detailed description

[0038] Figures 1 to 3 depict a surgical device 1 according to the invention. The device 1 is intended to be temporarily implanted in the heart during a surgical procedure aimed at replacing and / or reinforcing damaged or ruptured natural chordae tendineae, according to a method that will be detailed below. The device 1 is intended, in particular, to facilitate the surgeon's procedure by allowing them to ensure that each artificial chordae tendineae implanted is adjusted to the required length.

[0039] As can be seen in Figures 1 to 3, the device 1 comprises a central body 10, extending along a longitudinal direction L. The device 1 comprises a first and a second end portion 12, 14, arranged on either side of the central body 10 along the longitudinal direction L. Each end portion 12, 14 has, along the longitudinal direction L, a free end 120, 140, forming respectively one of the longitudinal ends of the device 1. Each of the free ends 120, 140 is formed by a bearing surface 120a, 140a extending in a plane perpendicular to the longitudinal direction L, and each forming a bearing surface of the device 1. The distance D between the two bearing surfaces 120a, 140a thus corresponds to the total length of the device 1.

[0040] Each end portion 12, 14 has an opening 122, 142 passing through the corresponding end portion in the longitudinal direction L. The dimensions of each opening 122, 142 are compatible with the passage, through the opening, of at least one strand (or leader) of artificial rope, preferably with the passage of at least two strands. In addition, at least one of the end portions 12 has an opening 122 allowing the passage of one or more knots formed by strands of artificial rope. In the case where, as shown in Figures 1 to 3, the shape of the The two end portions 12, 14 are not identical; the end portion 12, which has an opening 122 allowing the passage of knots formed by the artificial cord, will be, as explained below, the one positioned on the mitral pillar side. Preferably, the dimensions of the cross-section of the opening 122 are greater than or equal to 1.5 mm, and for example, between 2 and 3 mm. In the case where the opening 122 has a cylindrical shape, the diameter of the opening 122 is preferably between 1.5 and 4 mm, and for example, between 2 and 3 mm.

[0041] Each opening 122, 142 of the end portions is delimited by two peripheral walls forming opposing jaws 124, 144.The jaws 124, 144 are in a normally closed configuration, in which they are joined and define the corresponding opening 122, 142 around its entire circumference (around an axis parallel to the longitudinal direction L). The jaws 124, 144 can, however, be placed in an open configuration by a user, in which they are no longer joined, and in which the corresponding opening 122, 142 is no longer closed around its entire circumference (around an axis parallel to the longitudinal direction L). The transition from the closed to the open configuration of the jaws 124, 144 is achieved thanks to the flexibility of the material constituting the device 1.

[0042] Thus, the device 1 according to the invention is configured so that each end part 12, 14 can be put into two distinct configurations: - a closed configuration, in which the respective jaws 122, 124 of the end part are joined and prevent a strand of artificial rope passing through the corresponding opening from passing between the jaws; - an open configuration, in which the respective jaws 122, 124 of the end part are sufficiently separated to allow one or more strands of artificial rope to pass through the corresponding opening.

[0043] As mentioned above, the device 1 is configured so that, in the absence of external action, each end portion 12, 14 is normally in its closed configuration. The transition from the closed to the open configuration is advantageously achieved by pinching (or crushing) the central body 10, for example, using surgical forceps, as shown in [Fig. 2]. [Fig. 2] shows that applying a pinching force F to the central body 10 near one of its longitudinal ends 104 causes the nearest end portion to flex in the direction of the jaw opening E.

[0044] The central body 10 preferably comprises two opposing longitudinal flanks 100, each extending along the longitudinal direction L. Each longitudinal flank 100 connects each of the two end portions 12, 14. More precisely, each longitudinal flank 100 is connected to one of the jaws 122, 142 of each end portion 12, 14, and is not connected to the opposite jaw. The longitudinal sides 100 are further connected to each other by two connecting parts 102, each located at a longitudinal end 104 of the central body 10. Each connecting part 102 is configured to form a flexible hinge. In addition, the longitudinal sides 100 are connected to each other by a joining part 106, located at a lateral edge of each longitudinal side 100, on the side opposite the connecting parts 102. In the example, the joining part 106 connects the longitudinal sides 100 along their entire length, from one end part 12, 14 to the other. In an unrepresented variant, the connecting parts 102 can be configured to be contiguous, the longitudinal sides 100 then being connected to each other along their entire length by the connecting parts 102.

[0045] As described above, the configuration of the device 1, combined with the flexibility and elasticity of the material constituting it, allows a user to control the opening of the jaws 124, 144 of an end portion 12, 14 by applying a pinching action to the central body 10 near this end portion. To facilitate the opening movement of the jaws 124, 144, each end portion 12, 14 may be provided with a thinned portion 126, 146 at the junction between the jaws 124, 144.

[0046] The device 1 according to the invention will preferably be made in one piece, for example by molding. The device 1 is made of a biocompatible material having the required flexibility and elasticity characteristics. By way of example, the following materials may be used: biocompatible polyethylene type PE2410T, polypropylene 1013H1, polypropylene HP840MO, etc.

[0047] The main steps of using the device according to the invention are described below, in the context of replacing a broken native rope with an artificial rope, in relation to figures 4 to 7.

[0048] The first step in installing an artificial cord consists of determining the required length of this new cord once it is in place. As mentioned above, this determination is, in the prior art, rather imprecise, as it depends on the location on the mitral pillar where the artificial cord will be attached. The following describes how the device according to the invention, combined with a measuring tool according to the invention, makes it possible to reliably and accurately measure the length of an artificial cord and to install this cord to the required length.

[0049] Figure 4 partially represents a cardiac organ on which an artificial cord implantation procedure is underway. More specifically, Figure 4 represents the step of measuring the required length of the artificial cord being implanted, using a measuring tool 20 according to the invention.

[0050] In [Fig.4], a cardiac organ 200 can be seen partially represented. The cardiac organ 200 comprises a left atrium 202 and a left ventricle 204. The mitral valve is located between these two chambers 202, 204. The mitral valve consists of two mitral papillary muscles 206 and two mitral leaflets 208. The two mitral leaflets 208 are attached to the inner wall of the left atrium at the level of a mitral annulus 210. In [Fig. 4], it can be observed that a first step in the placement of an artificial chordae tendineae 30 has been carried out. This step consists of fixing the artificial chordae tendineae 30 to the corresponding mitral papillary muscle 206, possibly using a splint. Once this first step is completed, the measuring tool 20 allows for the measurement of a gross length Lb.The gross length Lb is measured between the mitral annulus 210 and the attachment point 206a of the artificial chordae tendineae 30 on the mitral papillary muscle 206, by positioning the measuring tool 20 so that it joins the attachment point 206a of the artificial chordae tendineae 30 and the original attachment point of the ruptured native chordae tendineae 40 on the corresponding mitral valve leaflet 208. This gross length Lb allows the effective length Le of the artificial chordae tendineae 30 to be obtained by subtracting the desired coaptation height, that is, the length over which the two opposing mitral valve leaflets 208 overlap when the mitral valve is closed. The coaptation height is generally estimated to be between 8 and 10 mm. The method for determining the effective length of the artificial chordae tendineae 30 is rigorous, standardized, and reproducible for all surgeons.

[0051] As can be seen in [Fig. 4], the measuring tool 20 according to the invention advantageously comprises a gripping portion 20a, a first rod 20b, and a second rod 20c sliding within the first rod 20b. The free end of the first rod 20b has a stop 20d allowing it to be positioned on the mitral annulus in a repeatable manner. The gross length Lb thus corresponds to the distance between the stop 20d located at the free end of the first rod 20b and the free end of the second rod 20c. Advantageously, a dial 20e allows the measurement of the total length Lb to be displayed on the gripping portion 20a.

[0052] Once the useful length Le of the artificial cord has been determined, the surgeon chooses a device 1 according to the invention having a total length equal to or very close to the length Le. The device 1 is advantageously designed for a range of lengths (between 5mm and 40mm) with an increment between 1 and 5 mm, in particular between 1 and 3 mm, and for example equal to about 2 mm.

[0053] Once the artificial chordae tendineae is fixed to the mitral papillary muscle and the length of device 1 is chosen, device 1 is installed in the left ventricle by sliding it along the artificial chordae tendineae. More precisely, device 1 is threaded around the artificial chordae tendineae being implanted, so that the latter is trapped in the two openings 122, 142 of device 1, and then the latter is slid along the chordae tendineae. artificial, until device 1 is resting on the mitral papillary muscle, as shown in [Fig. 5]. The surgeon can then perform the operation of fixing the artificial chordae tendineae to the corresponding mitral valve leaflet, and more specifically to the valve tissue. During this step, by ensuring that the device is gripped between the mitral papillary muscle on one side and the mitral valve leaflet on the other, the surgeon ensures that the artificial chordae tendineae will be positioned at the required length, that is, the length determined using the method detailed above. It is understood that device 1 according to the invention then acts as a spacer.

[0054] Once the artificial corset is fixed to both the mitral papillary muscle and the corresponding mitral valve leaflet, the surgeon can proceed with the removal of the device 1 according to the invention. As shown in [Fig. 6], and as explained above, the removal of the device is carried out simply and easily by releasing each end of the device one after the other, pinching the central body 10 with surgical forceps to allow the opening of the corresponding jaws 124, 144 and thus releasing the artificial chord of the device 1.

[0055] After the removal of the device, as seen in [Fig.7], the laying of the artificial rope is completed, and the latter is laid respecting the useful length Le determined beforehand.

[0056] Advantageously, for each pair of jaws 124, 144, the closing plane or line 124a, 144a intersects the longitudinal direction L of the central body 10. In other words, the closing plane or line 124a, 144a of the jaws of the end portions 12, 14 is inclined with respect to the longitudinal direction L. Such a configuration prevents the spontaneous extraction of a strand of artificial rope trapped in the opening of an end portion of the device. Thus, the retention of the device in position once it is installed is reinforced.

[0057] Advantageously, for the end portion 12 intended to be positioned on the side of the mitral valve leaflet during the implantation of an artificial chordae tendineae, each jaw 124 of this end portion 12 has a slot 124b allowing a strand of the artificial chordae tendineae to be wedged in place. This configuration prevents any spontaneous extraction of a chordae tendineae strand during the surgical procedure, when the chordae tendineae is not yet fixed to the mitral valve leaflet.

[0058] Figure 8 shows a device 1 according to the invention having, unlike device 1 of Figures 1 to 3, a symmetrical shape with respect to a median plane perpendicular to the longitudinal direction L. Thus, the end portions are symmetrical with respect to each other, as are their respective openings 122, 142. This configuration has the advantage that the device does not have to be positioned in a particular orientation, each end portion being able to be positioned on the side of the mitral papillary muscle or the mitral valve leaflet. In the example of Figure 8, Each end part 12, 14 has slots 124b, 144b allowing a strand of rope to be wedged in.

Claims

Demands

1. Surgical device (1) for the placement of an artificial mitral valve chord (30), the device (1) comprising: - a central body (10), extending in a longitudinal direction (L); - two end parts (12, 14), arranged on either side of the central body (10) in the longitudinal direction (L), each end part (12, 14) comprising an opening (122, 142) passing through the corresponding end part (12, 14) in the longitudinal direction (L), each end part (12, 14) comprising two jaws (124, 144) delimiting the corresponding opening (122, 142);each end part (12, 14) can be put into two distinct configurations: - a first configuration, or closed configuration, in which each end part (12, 14) is naturally located, and in which the jaws (124, 144) of the end part (12, 14) are in a closed position, a position in which a strand of artificial rope passing through the corresponding opening (122, 142) cannot pass between the corresponding jaws (124, 144); - a second configuration, or open configuration, in which each end part (12, 14) can be put in place by pinching a part of the central body (10), and in which the jaws (124, 144) of the end part (12, 14) are in an open position, a position in which a strand of artificial rope (30) passing through the corresponding opening (122, 142) can pass between the corresponding jaws (124, 144).

2. Device (1) according to the preceding claim, wherein the device (1) is configured so that each end part (12, 14) passes spontaneously, in the absence of external action on the central body, from the open configuration to the closed configuration.

3. Device (1) according to the preceding claim, wherein the spontaneous transition from the open configuration to the closed configuration is achieved by elasticity.

4. Device (1) according to the preceding claim, wherein the central body (10) and the end parts (12, 14) are at least partially made of an elastic material.

5. Device (1) according to any one of the preceding claims, wherein the central body (10) has two longitudinal flanks (100), each longitudinal flank (100) extending along the longitudinal direction (L) and connecting the two end parts (12, 14), the two longitudinal flanks (100) being connected to each other by two connecting parts (102) each disposed at a longitudinal end (104) of the central body (10), each connecting part (102) being configured to form a flexible hinge.

6. Device (1) according to the preceding claim, wherein pinching the central body (10) at one of the longitudinal ends (104) allows the selective passage in open configuration of the end part (12, 14) located at the corresponding longitudinal end (104).

7. Device (1) according to any one of the preceding claims, wherein the opening (122) of at least one of the end parts (12) has dimensions allowing the passage of at least one knot formed from two strands of the artificial rope (30).

8. Device (1) according to any one of the preceding claims, wherein, for each pair of jaws (124, 144), the closing plane (124a, 144a) or the closing line is secant with the longitudinal direction (L) of the central body (10).

9. Device (1) according to any one of claims 1 to 8, wherein, for each pair of jaws (124, 144), the closing plane (124a, 144a) or the closing line is parallel to the longitudinal direction (L) of the central body (10).

10. Device (1) according to any one of the preceding claims, wherein one of the end parts (12, 14) is intended to be disposed on the side of the mitral valve leaflet during the placement of an artificial cord (30), each jaw (124) of this end part (12) having a slot (124b) allowing the jamming of a strand of artificial cord (30).

11. Device (1) according to the preceding claim, wherein each end part (12, 14) has slots (124b, 144b) allowing the jamming of a strand of artificial rope (30).

12. Device (1) according to any one of the preceding claims, wherein each end part (12, 14) of the device (1) has a surface (120a, 140a) extending in a plane perpendicular to the longitudinal direction (L) and forming a support surface.

13. Device (1) according to any one of the preceding claims, the device (1) having a symmetrical shape with respect to a median plane perpendicular to the longitudinal direction (L).

14. Device (1) according to any one of claims 11 and 12, wherein the distance (D) between the bearing surfaces (120a, 140a) corresponds to the total length of the device (1), and is preferably between 5 and 40 mm.

15. Device (1) according to any one of the preceding claims, the device (1) being made of a biocompatible material, in particular by molding.

16. Kit for laying an artificial rope (30) comprising several devices (1) conforming to one of the preceding claims of different sizes, the size increment between two devices being between 1 and 5 mm.

17. Kit according to the preceding claim, further comprising a measuring tool (20), enabling the length of the device (1) to be determined as a function of the distance between the attachment point of the artificial cord (30) on the mitral pillar and the mitral ring.

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