CORING DEVICE AND CORING AND INSERTION ASSEMBLY COMPRISING SUCH A DEVICE

Abstract

A coring device, for forming an opening in a tissue wall, includes a body having a proximal end, a distal end and an internal housing, a coring head having a transection blade and being movable between a rest position and an actuated position, an actuation mechanism for moving the head between the positions and having an actuation rod, at one end of which the head is placed, a lumen extending through at least the proximal end of the body, actuation rod and coring head in order to allow passage of a flexible guide element, and the distal end of the body forms a support for a surgical tool configured to receive a hollow surgical tool with a positive fit and to support this tool to permit linear guiding of the surgical tool during the movement of the latter toward the outside of the coring device.

Claims

1. A coring device for forming an opening in a tissue wall, this device comprising: a body having a longitudinal axis, said body having a proximal end and a distal end, said body having an internal housing, a coring head having a transection blade, this head being movable between a rest position and an actuated position, an actuation mechanism for moving said head between said positions, said mechanism having an actuation rod, at one end of which said movable head is placed, and the distal end of said body forms a support for a surgical tool, this tool support being configured, on the one hand, to receive a hollow surgical tool by positive engagement and to support this tool, this tool surrounding the distal end of said body when it is placed on said tool support, by being coaxial with said coring axis, and, on the other hand, to permit linear guiding of said surgical tool during the movement of the latter toward the outside of the coring device, and in that, said tool support has an outer peripheral wall which is tubular and of a diameter equal to or substantially equal to the diameter of said transection blade.

2. The device as claimed in claim 1, characterized in that said device comprises a lumen extending through at least the proximal end of said body, said actuation rod and said coring head in order to allow the passage of a flexible guide element.

3. The device as claimed in claim 1, characterized in that, with said tissue wall being a wall of a beating heart intended to receive an anchoring device of a cardiac pump comprising a flange, or collar, intended to be pressed against the outer surface of said wall of the beating heart, the length of said tool support is at least equal to the sum of the thickness of said tissue wall and the thickness, or longitudinal dimension, of said flange, or collar, intended to be placed against the outer surface of the wall of said heart.

4. The device as claimed in claim 1, characterized in that it has one part of an indexing means, said surgical tool being intended to carry the complementary part of this indexing means, in order to align said surgical tool on said support.

5. The device as claimed in claim 1, characterized in that it has a stop for stopping the movement of said surgical tool along said longitudinal axis and in the direction of said proximal end, such that the surgical tool remains positioned on said tool support.

6. The device as claimed in claim 1, characterized in that said body has two body parts engaged one inside the other, a first body part being movable in translation relative to the other body part, such that its movement in and out of the other body part causes the translation movement of said coring head.

7. The device as claimed in claim 6, characterized in that each body part has a gripping handle.

8. The device as claimed in claim 6, characterized in that said actuation mechanism comprises a guide carriage supporting said actuation rod and received in said inner housing, this housing being configured to form a guide rail for translation of said guide carriage, said guide carriage being rigidly connected to said first body part movable in translation.

9. An assembly for placing a tool or a surgical accessory in a tissue wall, characterized in that it comprises: a coring device as claimed in claim 1, and a hollow surgical tool or accessory configured to be engaged on the distal end of said coring device while leaving said coring head free.

10. The assembly as claimed in claim 9, characterized in that said surgical tool or accessory has, at its distal end, a tubular or substantially tubular portion configured to maintain the shape and diameter of the opening formed by coring in the tissue wall.

11. The assembly as claimed in claim 10, characterized in that said tubular or substantially tubular portion has a length at least equal to the thickness of the tissue wall.

12. The assembly as claimed in claim 9, characterized in that, with the body of the coring device having one part of an indexing means, said surgical tool or accessory has a complementary part of this indexing means, in order to align said surgical tool or accessory on said tool support.

13. The assembly as claimed in claim 9, characterized in that, with said surgical tool or accessory being a tool for assisting the placement of a device for anchoring a cardiac pump through an opening made by coring in a wall of a heart, said hollow assistance tool delimits an internal channel for the passage of said anchoring device, the diameter of which is substantially equal to the diameter of this opening.

14. The assembly as claimed in claim 13, characterized in that, with a flange, or collar, being intended to be placed against the outer surface of the wall of said heart, and with this flange comprising at least one protrusion, or stub, placed on its lateral face, said assistance tool has, for each protrusion, an open groove intended to receive said corresponding protrusion, or stub, said groove being configured to ensure, by rotation of said surgical tool about the coring axis, a locking of said surgical tool on said flange or collar.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0069] Other advantages, aims and particular features of the present disclosure will become clear from the following description, which is provided for explanatory purposes and is non-limiting and in which reference is made to the accompanying drawings, in which:

[0070] FIG. 1 shows schematically a coring device for making an opening in a ventricular wall of a beating heart, according to a particular embodiment of the present disclosure;

[0071] FIG. 2 shows the coring device from FIG. 1, an accessory for assistance in the placement of an anchoring ring being received at the distal end thereof in order to define an assembly for coring and for inserting a part of an anchoring ring of a ventricular assist device;

[0072] FIG. 3 is a partial and enlarged view of the assembly illustrated in FIG. 2, showing an indexing means for aligning the accessory for placement assistance;

[0073] FIG. 4 is a schematic representation of the assembly from FIG. 2, the coring head being in its actuated position for its insertion into a small orifice, previously made with a cutting tool, in the ventricular wall of the heart;

[0074] FIG. 5 is a perspective and sectional view of the assembly from FIG. 2, just after the cut has been made in the ventricular wall;

[0075] FIG. 6 is a partial top view of the assembly from FIG. 2, during the connection of the assistance accessory to the flange previously connected to the outer surface of said ventricular wall, the distal end of the assistance accessory then being inserted into the opening that is formed;

[0076] FIG. 7 is a longitudinal sectional view of the assembly from FIG. 2 and of the apex of the heart, the coring device being in the course of being withdrawn, the distal end of the assistance accessory, inserted in the formed opening, being exposed;

[0077] FIG. 8 is a perspective view of the assistance accessory from FIG. 2 connected to a flange rigidly connected to the apex of the heart, a part of an anchoring ring having a flange in its deformed configuration being inserted into this assistance accessory by means of a pusher device;

[0078] FIG. 9 is a longitudinal sectional view of the elements illustrated in FIG. 8;

[0079] FIG. 10 is a longitudinal sectional view of the elements illustrated in FIG. 8, the flange in its deformed configuration being inserted into the ventricular chamber by means of the pusher device;

[0080] FIG. 11 is a longitudinal sectional view of the elements illustrated in FIG. 8, the flange being in its initial configuration in order to define a collar, the placement assistance accessory having been disconnected from the flange mounted on the outer surface of the ventricular wall and being in the course of being withdrawn;

[0081] FIG. 12 is a perspective view of the elements illustrated in FIG. 8, the assistance accessory having been withdrawn, a seal and a nut being engaged on the pusher device in order to lock the anchoring ring in position;

[0082] FIG. 13 is a perspective view of the anchoring ring from FIG. 12 mounted in its opening and supporting a cardiac pump.

DETAILED DESCRIPTION

[0083] Firstly, it will be noted that the figures are not to scale.

[0084] FIGS. 1 to 7 show schematically a coring device 10 for making an opening in the ventricular wall of a beating heart, according to a particular embodiment of the present.

[0085] This coring device 10 has two body parts 11, 12 which are engaged one inside the other in such a way that one of these parts is mounted slidably in the other body part. This device has a proximal end and a distal end.

[0086] In the context of the present, the term proximal means the position closest to the healthcare professional or practitioner, while the term distal must be understood here as meaning farthest away from this professional. In other words, the distal end of a component is the end that would be engaged first in the beating heart, while the proximal end of said component would be the last end to be engaged therein.

[0087] This coring device 10 comprises a coring head 13 having a tip with a frustoconical shape, at its distal end, in order to facilitate its insertion through an incision, made with a cutting tool such as a scalpel, in the ventricular wall of this beating heart. This head 13 also has a transection blade 14 placed at its proximal end. This transection blade 14 has a straight cross section of circular shape, although it could have other appropriate shapes, for example oval.

[0088] This coring head 13 is movable between a rest position, in which the transection blade 14 is pressed against, or is placed near, the distal end of the main body of the coring device 10, and an actuated position, in which the transection blade 14 is placed at a distance from the distal end of the main body of the coring device 10.

[0089] More precisely, this coring head 13 is actuated by an actuation mechanism comprising an actuation rod 15, at the end of which this head 13 is mounted, this rod 15 being coupled to an internal housing of the main body of the coring device 10.

[0090] This main body here has two body parts 11, 12 engaged one inside the other, a first body part being movable in translation relative to the other body part, such that its movement in and out of the other body part causes the translation movement of said coring head 13.

[0091] Each body part has a gripping handle 16, 17 having a longitudinal axis Z. These handles 16, 17 are here arranged in such a way that their longitudinal axis is perpendicular to the longitudinal axis defined by the body of the coring device 10.

[0092] Thus, the practitioner can hold with one hand a handle 16 of a first body part 11, while his other hand holds the handle 17 of the other body part 12, in order to easily move these two body parts relative to each other and thus cause the movement of the coring head 13.

[0093] Advantageously, the geometric axis or coring axis of the coring device 10 is that of the actuation rod 15 on which the coring head 13 is centered.

[0094] The actuation mechanism also comprises a guide carriage 18 supporting the actuation rod 15 and received in the internal housing 19 of the main body. The actuation rod 15 is advantageously centered.

[0095] With the guide carriage 18 being rigidly connected to the first body part movable in translation, this internal housing 19 defines a guide rail for translation of this guide carriage.

[0096] A lumen 20 extends through the proximal end of the main body of the coring device 10, the actuation rod 15 and the coring head 13 in order to allow the passage of a guide 37. This guide 37 is intended for guiding, in particular aligning, the coring head 13 as the latter approaches the ventricular wall in order to form an opening by coring.

[0097] More precisely, this guide 37 is intended to pass through the aortic valve in order to guide the coring device 13 and thus fix the orientation of the opening, to be made by coring, relative to the anatomical location of the aortic valve (or the pulmonary valve if this coring device 13 is used for the right ventricle).

[0098] Advantageously, the distal end of the main body of the coring device 10 also forms an accessory support 21.

[0099] This accessory support 21 has a tubular outer peripheral wall whose outer diameter is equal to the diameter of the transection blade 14.

[0100] An assistance accessory 22, for assisting in the placement of a part of an anchoring ring of a cardiac pump, is received by positive engagement on this accessory support 21. This assistance accessory 22 is hollow and has a sheath 23 extending from an intermediate portion thereof toward its distal end.

[0101] As is shown in FIG. 5, while the coring head 13 is still partially placed in the ventricular chamber, the practitioner can insert, into the opening made in the ventricular wall, a part of the assistance accessory 22, in particular its sheath 23, by moving it in translation on the accessory support 21, which ensures linear guiding.

[0102] With this assistance tool being made of a rigid material such as titanium, its sheath 23 maintains the opening at its maximum extension and, with its internal channel, delimits a path for the free passage of an anchoring ring part comprising a tubular portion and, at the distal end of the latter, a self-expanding membrane 24 in its first configuration, i.e. a deformed configuration, in which it has a tubular or substantially tubular shape. This self-expanding membrane 24 is made of Nitinol, for example.

[0103] Another flange, or second flange 25, of the anchoring ring having been previously connected, for example by suturing, to the outer surface of the ventricular wall, the assistance accessory 22 has, at its proximal end, a hollow cylindrical connection head 26 forming a protrusion of the sheath 23, partially surrounding the latter. This connection head 26 is intended to be connected to this second flange 25 in order to achieve a removable coupling of the accessory to the assembly composed of the second flange and the apex of the heart. This second flange 25 is made of Dacron, for example.

[0104] As is illustrated in FIG. 6, with this second flange 25 being pressed against the outer surface of the ventricular wall, it comprises at least one stub 35 positioned on its lateral wall, the connection head 26 of the assistance accessory 22 having, for each stub 35, a coupling groove 36 placed on its edge and configured to receive this corresponding stub. More precisely, each groove 36 opens out at the distal end of this connection head 26, in such a way that, with the latter partially covering the second flange 25 of the anchoring ring, each stub 35 is engaged in its corresponding groove.

[0105] Each groove 36 also has the same curved shape so that, by rotation of the assistance accessory 22 around the coring axis, this assistance accessory 22 is locked on the second flange 25.

[0106] This assistance accessory 22 also has a sealing element for sealing the assembly composed of connection head 26 and second flange 25, when the one or more stubs have been brought to the bottom of their corresponding groove on the connection head 26.

[0107] FIG. 7 is a sectional view of the coring device, the coring head being set back from the opening made in the ventricular wall, and, more precisely, being placed in the internal housing of the body of the coring device. The sheath 23 of the assistance accessory 22 has been inserted through this opening into the ventricular chamber, and the connection head 26 is connected to the second flange 25 of the anchoring ring outside the heart. The practitioner can then withdraw the coring device 10 without risking a displacement of the assistance accessory 22 from the opening made in the ventricular wall.

[0108] The sheath 23 of this assistance accessory 22 makes it possible to keep this opening fully accessible in order to ensure the free passage of the anchoring ring part comprising a tubular portion 27 and, at the distal end thereof, a self-expanding membrane 24 in its first configuration.

[0109] This withdrawal of the coring device 10 causes the first loss of leaktightness at the ventricular wall, such that the practitioner must quickly connect to this hollow accessory a pusher device 28 carrying this anchoring ring part for the insertion of its end into the ventricular chamber 29.

[0110] Having inserted the self-expanding membrane 24 into this ventricular chamber, and said membrane having adopted its second configuration in which it defines a flange, or collar, extending radially from the tubular portion 27, the practitioner draws back the pusher device 28 in order to press this flange against the inner face of the ventricular wall 29 of the beating heart.

[0111] Thus, with the two flanges 24, 25 being pressed on either side against this ventricular wall 29, the practitioner simply has to engage a sealing element 30 such as an O-ring seal and a clamping means 31 on the pusher device 28 and slide them along the outer surface of this pusher device 28 in order to lock the anchoring ring in position. This clamping means 31 finalizes the assembly of the anchoring ring by blocking any movement of the flanges 24, 25 relative to each other. This results in a strong mechanical connection of the anchoring ring and the apex of the heart and also its sealing.

[0112] This clamping means 31 can be a nut if the outer surface of the tubular portion 27, or hollow body, has a thread or, as is illustrated in FIG. 13, a clamping ring. The latter presses the sealing element 30 against the second flange 25 connected to the outer surface of the ventricular wall 29.

[0113] Advantageously, the assembly composed of tubular portion 27 and self-expanding membrane 24 comprises a second sealing element comprising an anti-reflux valve (not shown) placed in the internal channel delimited by this tubular portion 27. By way of example, it is a self-repairing membrane, also called a self-sealing membrane, integrated in the internal channel delimited by the tubular portion 27, or hollow body, of the anchoring ring. This anti-reflux valve prevents any leakage of blood through this internal channel. After removal of the coring device, it thus makes it possible to restore the leaktightness by placing the anchoring device on the heart.

[0114] Purely by way of illustration, this anti-reflux valve is made of silicone.

[0115] This clamping ring 31 has, on its lateral wall, an orifice 32 receiving a fastener 33 for locking in position a cardiac pump 34 inserted into the internal channel delimited by the hollow body of the anchoring ring, the distal end of this cardiac pump 34 being engaged in the ventricular chamber of the beating heart. Upon removal of the cardiac pump 34 from the heart, for example for handling, received in the tubular portion 27, this second sealing element closes and becomes leaktight again.