Device and Method for Transcatheter Heart Valve Repair under Triangular Resection Technique

Abstract

Medical device for transcatheter heart valve repair comprising a grasping tweezer (1) and a plicating tweezer (2), said grasping tweezer (1) being adapted to grasp a leaflet rim (3) and said plicating tweezer (2) comprising two rotatable flaps (4,5) and a central shaft (6) around which said flaps (4,5) may rotate in a “butterfly manner”, in such a way that the plicating tweezer (2) may adopt a closed or an open configuration. The invention also relates to a method for using this medical device.

Claims

1-12. (canceled)

13: A medical device for transcatheter heart valve repair comprising: a grasping tweezer configured to grasp a leaflet rim; and a plicating tweezer including two rotatable flaps and a central shaft around which the two rotatable flaps are configured to rotate in a butterfly manner such that the plicating tweezer can adopt a closed configuration or an open configuration.

14: The medical device according to claim 13, wherein each flap has a substantially triangular shape.

15: The medical device according to claim 14, wherein a first side of a triangle that forms the triangular shape is mainly defined by the central shaft, and a second side is located on a proximal end of the plicating tweezer, and a third side is located on a distal end of the plicating tweezer.

16: The medical device according to claim 15, wherein the central shaft and the third side form an angle between 0° and 90°.

17: The medical device according to claim 16, wherein the angle is between 15° and 35°

18: The medical device according to claim 13, wherein each flap is includes a plurality of segments.

19: The medical device according to claim 18, wherein the plurality of segments are covered by a mesh.

20: The medical device according to claim 13, wherein at least one flap includes a releasable tissue fixing means.

21: The medical device according to claim 13, wherein at least one flap includes a tissue-cutting device.

22: The medical device according to claim 13, wherein the central shaft is made rotatable with respect to a main axis of the plicating tweezer.

23: The medical device according to claim 20, wherein the releasable tissue fixing means includes staples.

24: A method for using a medical device for transcatheter heart valve repair, the medical device including a grasping tweezer configured to grasp a leaflet rim of a leaflet, and a plicating tweezer including two rotatable flaps and a central shaft around which the two rotatable flaps are configured to rotate in a butterfly manner such that the plicating tweezer can adopt a closed configuration or an open configuration, the method comprising the steps of: grasping the leaflet rim; and triangular plicating a region of the leaflet.

25: The method according to claim 24, further comprising a step of: cutting the plicated region of the leaflet; and removing the plicated region.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0014] To better disclose the invention, some illustrated but non-limiting examples are provided in the present chapter.

[0015] FIG. 1 illustrates a first example of a device according to the invention

[0016] FIG. 2 illustrates the plicating tweezer of FIG. 1 in an open configuration and forming an angle of 25° with respect to the tweezer main axis.

[0017] FIG. 3 illustrates the plicating tweezer of FIG. 1 in an open configuration and forming an angle of 90° with respect to the tweezer main axis.

[0018] FIG. 4 illustrates the plicating tweezer of FIG. 1 in an closed configuration and forming an angle of 25° with respect to the tweezer main axis.

[0019] FIGS. 5a01 to 5a16 show different steps of one surgical method according to the invention, taken from a first point of view.

[0020] FIGS. 5b01 to 5b16 show different steps of the method illustrated in FIGS. 5a01 to 5a16, but taken from another point of view.

NUMERICAL REFERENCES USED IN THE FIGURES

[0021] 1 Grasping tweezer [0022] 2 Plicating tweezer [0023] 3 Tissue prolapsed portion or tissue rim [0024] 4 First flap [0025] 5 Second flap [0026] 6 Central shaft [0027] 7 First long segment of first flap [0028] 8 Second long segment of first flap [0029] 9 Short segment of first flap [0030] 10 First long segment of second flap [0031] 11 Second long segment of second flap [0032] 12 Short segment of second flap [0033] 13 Mesh [0034] 14 Catheter [0035] 15 Grasping tweezer main axis [0036] 16 Plicating tweezer main axis [0037] 17 Mitral valve [0038] 18 Plicating tweezer rotation axis

[0039] FIG. 1 illustrates a mitral valve 17 having a leaflet containing a prolapsed portion 3.

[0040] The device comprises a tissue grasping tweezer 1 and a plicating tweezer 2, both tweezers 1,2 are moved to the operating field within a single catheter 14.

[0041] The grasping tweezer 1 forms a variable angle with respect to the grasping tweezer main axis 15.

[0042] The plicating tweezer 2 is made of a central shaft 6 around which two triangular shaped flaps 4,5 can rotate. Each flap 4,5 comprises two main segments 7,8,10,11 which, together with the central shaft 6, form a triangular element. All the segments 7-12 are furthermore covered by a mesh 13.

[0043] In addition, or in replacement to the mesh 13, the segments 7-12 may be covered by a metallic layer, a synthetic layer or a biological tissue.

[0044] The catheter 14 is inserted at the level of the diseased valve 17 in correspondence of the prolapsed portion of the leaflet 3 (FIG. 5 a01, FIG. 5 a02, FIG. 5 b01 and FIG. 5 b02). The grasping tweezer 1 is extracted from the catheter 14 and under fluoroscopy and Echo 3D guidance is remotely actuated by the operator in a way to grab the central portion of the prolapsed portion 3 for an extension going from the free edge towards the mitral annulus (typically a length ranging from 0.5 to 2.5 cm) (FIGS. 5 a03 to a08 and FIGS. 5 b03 to b08).

[0045] The plicating tweezer 2 is then extracted from the catheter 14, rotated around an axis 18, opened and placed parallel to an ideal valve plan, in touch with the prolapsed portion 3 (FIGS. 5 a09 to a12 and FIGS. 5 b09 to b12).

[0046] When the device is stable the grasping tweezer 1, still grabbing the prolapsed portion 3, is moved slightly upward creating a tensioned flap corresponding to the prolapsed portion 3. In this setting the plicating tweezer 2 is closed, over the grasping tweezer 1, to plicate and pinching triangular shaped prolapsed portion 3 (FIG. 5 a13 and FIG. 5 b13).

[0047] At this stage, before to proceed cutting out the prolapsed portion 3, the online control with an Echo 2D or better 3D may confirm that the residual regurgitation is negligible or eliminated.

[0048] If the hemodynamic conditions of the mitral valve 17 are considered suboptimal the procedure can be repeated retracting the plicating tweezer 2 and using the grasping tweezer 1 to pinch more or less leaflet tissue or to slightly change position to better pinch the prolapsed portion 3. When the grasping tweezer 1 pinches the leaflet again the procedure can be allover repeated.

[0049] The plicating tweezer 2, when open, has a polygonal shape (FIG. 5 a11) made by a plurality of segments 6-12 which substantially form two triangular frames hinged at level of the central shaft 6. More precisely, each substantial triangular frame is formed by three long segments 6-8 & 6,10,11 (that form the general triangular shape) and one short segment 9,12. The shape and dimensions of the triangular frames can be variable in order to treat a different degree of leaflet prolapse. A thin mesh of tissue 13 made of biological, polymeric or metallic material covers the triangular frames. The purpose of the mesh coverage is to avoid the accidental embolization of blood clots, calcific fragments or leaflet's portions during the transcatheter mitral repair procedure.

[0050] Once a satisfactory result is reached the arms of the plicating tweezer 2 are closed over the folded prolapsed leaflet 3. The flap sides 8,11 of the plicating tweezer 2 which are in contact with the tissue can deliver a series of staples, stitches, thermal treatment, radiofrequency, cryo-therapy treatment or any other system to fix together the two portions of the prolapsed leaflet 3. In alternative constructive solution the portions of the leaflet could be glued together by injecting glue, polymers or any other biocompatible glue material through the arms of the tweezer (FIG. 5 a12, a13 and FIG. 5 b12, b13).

[0051] The pinched leaflet portion will be on the atrial side however the repair procedure could be also performed upside down in a way that the pinched portion of the leaflet is oriented toward the ventricle and placed below the valve plane. This is useful especially, but not exclusively, in patients with complete flail (complete chordae rupture).

[0052] The procedure can be completed with the resection of the plicated and pinched portion in both the above-described procedural situations. The flap sides 8,11 of the plicating tweezer 2 which are in contact with the tissue are equipped with a system making a triple function. One is aimed at locking the base line of the plicated, triangular shape, portion of the leaflet, the second one to deliver staples or stitches and the third one at cutting the plicated leaflet portion just above the suture line (FIG. 5 a14 e FIG. 5 b14).

[0053] At the end of the procedure the arms of the plicating tweezer 2 are maintained closed over the leaflet tissue fragment and retrieved into the catheter together with the first tweezer (FIG. 5 a15 e b15).

[0054] The procedure is completed when the entire catheter is fully retrieved out of the patient (FIG. 5 a16 e b16).

[0055] Both tweezers 1,2 can be realized with different materials including various metals alloys such as Nitinol, Stainless steel, Cobalt-Chromium or plastic polymers. The articulation and the remote control of the tweezers can be realized adopting several mechanical, pneumatic, hydraulic or electrical solutions also using memory shape alloys such as the Nitinol. The arms of the tweezers 1,2 can be straight or curved with different length depending the final adopted solution.

[0056] One way to perform the “plication” is achieved with a surgical stapler together with surgical staples. The staple line may be straight, curved or circular. The instruments may be used in either open or thoracoscopic surgery or full transcatheter, and different instruments can be used for each application. Transcatheter staplers must be longer, thinner, and may be articulated to allow for access from the peripheral veins or arteries.

[0057] Some device can incorporate a knife, to complete excision of the prolapsed segment of the mitral leaflet and anastomosis in a single operation.

[0058] The surgical staples can be made of titanium, namely a material that induces less reaction with the immune system and, being non-ferrous, does not interfere significantly with MRI scanners. Synthetic absorbable or non-absorbable materials could also be used.

[0059] The invention is of course not limited to the device presented in the previous example. The device according to the invention may be used for plication only, i.e. without removal of the prolapsed part of the leaflet.