Surgical device

Technical area

0001The present invention relates in particular to a surgical device that can be used in particular for the installation of mitral cord prosthesis. Furthermore, the present invention also relates to a method for laying a mitral cord prosthesis using the device according to the invention.

0002The mitral valve is a valve that separates the left atrium from the left ventricle. It is more particularly constituted of a fibrous ring, of two leaflets, connected to the muscle of the left ventricle by muscular piers, by means of fibrous cords.

0003The opening or closing of the mitral valve is triggered by the pressure difference between the left atrium and the left ventricle. During the dilatation phase of the ventricle, the valve is open allowing the passage of blood from the atrium to the ventricle. At the beginning of the ventricle contraction, the pressure rises suddenly, the valve closes and prevents reflux.

0004Mitral insufficiency is a common pathology of heart valves caused by poor closure of the two leaflets of these, resulting in a reflux of blood from the left ventricle into the left atrium during the expulsion phase of the blood. Severe forms of mitral insufficiency may necessitate surgery.

0005The main causes of mitral insufficiency are coronary artery disease, cardiomyopathies, or mitral prolapse. It can also appear during other congenital malformations of the heart.

0006Treatment depends on the size of the leak, its impact on the left ventricle and the terrain.

0007The surgical treatment may consist of either a valve reconstruction (mitral plasty) or a replacement of the mitral valve by a prosthesis (artificial valve): mechanical valve or valve bioprosthesis.

0008As part of a mitral plasty, the surgeon carefully inspects the damage of the mitral valve. Depending on the nature of the damage to the mitral valve, the surgeon proceeds to sew this valve or repair the valve ropes. A ring is often placed around the valve so that the leaflets of the valve are tight. Sometimes, when the valve is perforated, the surgeon makes a patch (small membrane) with a piece of pericardium (tissue that surrounds the heart) that it takes from the patient during the procedure.

0009As part of this procedure, it may be necessary to replace the mitral cordage with a prosthesis in the form of a goretex cord.

0010There is therefore a need for a device for introducing the prosthesis at the heart and insert it on the mitral valve.

0011<patcit id="pcit0001" dnum="US2005251177A1"><text>US 2005/251177 A1</text></patcit> discloses a surgical device comprising a hollow cylinder, a jaw composed of two jaws and a hollow tube wherein said jaws each comprise a passage and wherein the hollow tube is associated with one of the jaws so that said hollow tube opens into said passage and into that the distal end of said hollow tube is rotatably mounted around an axis perpendicular to the longitudinal axis of said passage, between an upper position where the distal end of said hollow tube is in the extension of said passage and a low position wherein the distal end of said hollow tube is disposed perpendicular to said passage.<patcit id="pcit0002" dnum="WO2012096280A1"><text>WO 2012/096280 A1</text></patcit> discloses a surgical device comprising the features of the preamble.

Summary of the invention

0012The present invention relates in particular to a surgical device, as claimed in the first claim, comprising a hollow cylinder, a jaw composed of two jaws, comprising an outer surface and an inner surface, pivotally mounted relative to an axis perpendicular to the longitudinal axis said hollow cylinder between an open position and a closed position, wherein the jaw is disposed in the extension of the distal end of said hollow cylinder and two hollow tubes, characterized in that said jaws each comprise a passage from said outer surface to said surface internal,said passages being arranged vis-à-vis when said jaw is in the closed position and in that each of said hollow tubes is respectively associated with one of the jaws so that said hollow tube opens into said passage.

0013According to a preferred embodiment of the invention, said hollow tubes are flexible.

0014According to a preferred embodiment of the invention, said hollow tubes are housed partly inside said hollow cylinder.

0015According to the invention, the distal end of said hollow tubes is mounted in rotation, about an axis perpendicular to the longitudinal axis of said passage, between an upper position where the distal end of said hollow tube is in the extension of said passage and a low position where the distal end of said hollow tube is disposed perpendicular to said passage.

0016According to an even more preferred embodiment of the invention, the outer surface of said jaws comprises on its outer surface a groove for receiving the distal portion of said hollow tube when it is in the low position.

0017According to a preferred embodiment of the invention, the rotation of said jaws is driven by a rod, placed wholly or partly in said hollow cylinder, the proximal end of which opens at the proximal end of said hollow cylinder and whose end distal is associated with the proximal end of said jaws.

0018According to a preferred embodiment of the invention, the inner surface of said jaws comprises splines.

0019According to an even more preferred embodiment of the invention, said grooves have in cross section a triangular profile.

0020According to a preferred embodiment of the invention, said hollow cylinder comprises at its distal end an opening disposed in the extension of said groove and intended to allow the passage of said hollow tube from the inside to the outside of said cylinder.

0021According to a preferred embodiment of the invention, said hollow cylinder comprises at its proximal portion openings intended to allow the passage of said hollow tubes from the inside to the outside of said hollow cylinder.

0022According to a preferred embodiment of the invention, the distal end of said jaw has, in longitudinal section, a curved profile.

0023According to a preferred embodiment of the invention the end of said jaw has, in longitudinal section, a hemi-circular profile in the closed position.

0024According to a preferred embodiment of the invention, said jaw is associated with said hollow cylinder via an intermediate piece comprising a proximal portion, inserted into the distal end of said hollow cylinder, and a distal portion comprising recesses able to receive the axis guiding in rotation said jaws.

Brief description of the drawings

0025<ul><li>The <figref idref="f0001">figure 1</figref> shows a top view of an embodiment of a device according to the invention.</li><li>The <figref idref="f0001">figure 2</figref> shows a longitudinal sectional view of the embodiment of the invention presented in the <figref idref="f0001">figure 1</figref>.</li><li>The <figref idref="f0002">figure 3</figref> presents a perspective view of a device according to the invention with the jaws in the open position.</li><li>The <figref idref="f0003">figure 4</figref> presents a perspective view of a device according to the invention with the jaws in the closed position.</li></ul>

Description of the embodiments

0026With reference to <figref idref="f0001">Figures 1 and 2</figref>, the device 1 according to the invention comprises from its proximal end to its distal end: the free end of the rod 2, the closure cap 3, the hollow cylinder 4 having, on its upper face and on its lower face, an opening in the form of an oblong hole 5 and a groove 6 in the axis of the oblong hole, the intermediate piece 7 supporting the axis 8 around which the jaws 9, 10 are rotated.

0027The groove 6 extends to the distal end of said hollow cylinder and then to the intermediate part 7 and then to the outer surface of the adjacent jaw 9. This groove 6 and intended to receive a hollow tube 12, 13 when the latter is in the down position. Thus, it is understood that when the jaw 11 is closed, and the hollow tubes 12, 13 in the low position, the entire device 1 according to the invention is totally in a cylinder of diameter equal to that of said hollow cylinder.

0028With reference to the <figref idref="f0001">figure 2</figref>, the closure cap 3 preferably comprises a groove 301 which is inserted inside the cylinder and a shoulder 302 bearing on the proximal end of the cylinder. This closure plug 3 comprises a bore 303 allowing the passage of the rod 2. The sealing plug 3 is preferably made of a material for sealing at the bore / rod junction 2. It allows closing the hollow cylinder 4 and maintaining the rod 2 along an axis parallel to the longitudinal axis of the hollow cylinder 4.

0029The hollow cylinder 4 has a diameter preferably between 3 and 10 millimeters. Its distal end is closed by the intermediate piece 7, the proximal part of which forms a plug 701 which fits inside the hollow cylinder 4. The external part of this plug 701 has a diameter equivalent to the diameter of the hollow cylinder 4. plug is bored to allow the passage of the rod 2, this rod 2 is supported both by the closure plug 3 at the proximal portion of the hollow cylinder 4 and the intermediate piece 7 located at the distal portion of said cylinder hollow 4. The bore 702 of said intermediate piece 7 is preferably covered with a cylindrical seal 703.

0030The intermediate piece 7 further comprises a second portion consisting of two blades 704, 705 extending towards the jaw 11 and supporting the axis 8 for holding the jaws 9, 10. The axis 8 is maintained at the its ends, in a drilled hole 706, 707 in each of said blades 704, 705. The space between the two blades is located in the extension of the groove 6, present on the first part of the intermediate piece 7.

0031The jaw 11 thus consists of two jaws 9, 10 held in rotation about the axis 8 between an open position and a closed position. The passage from the open position to said closed position is preferably carried out via the rod 2, the distal end of which is associated with the jaws 9, 10 of the jaw 11 by a rod / groove type association.

0032The outer surface of said jaws 9, 10 comprises a groove 901, 1001 placed in the extension of the space between the two blades 704, 705 of the intermediate piece 7. The inner surface of said jaws 9, 10 comprises grooves 902, 1002 allowing to improve the maintenance of the jaw 11 at the valve when said jaw 11 is in the closed position. Said grooves 902, 1002 preferably have, in cross-section, a triangular profile. However, it is understood that said profile can be modified as needed.

0033In order to facilitate the penetration of the device 1 according to the invention into the body of the patient to be treated, the distal end of the jaw 11 preferably has a curved surface and even more preferably a hemispherical surface.

0034Each of the two jaws 9, 10 comprises an inner surface and an outer surface and a passage 903, 1003 from its outer surface to its inner surface arranged such that said passages 903, 1003 are facing each other when the jaw 11 is in the closed position.

0035The device 1 according to the invention further comprises two hollow tubes 12, 13 open at each of their ends. Each of said hollow tubes 12, 13 is housed partly inside the hollow cylinder 4 and comprises a free end 121, 131, opening outwardly of the hollow cylinder 4 via the oblong hole 5 placed at the proximal portion of the hollow cylinder 4, and an end associated with a jaw 9, 10 of the jaw 11. In order to seal the hollow cylinder 4, said oblong hole 5 and / or said groove 6 are closed by a seal allowing the passage of said hollow tube 12, 13.

0036The association between the end of the hollow tube 12, 13 and the jaw 9, 10 is made such that the opening of the tube 12, 13 at this end is in line with the passage 903, 1003 of said jaw, when said hollow tube 9, 10 is in the high position, such that said hollow tube 9, 10 opens into said passage 903, 1003.

0037Advantageously, the distal end of the hollow tubes 12, 13 is mounted in rotation about an axis perpendicular to the longitudinal axis of said passage 903, 1003, between an upper position where the distal end of said hollow tube 12, 13 is in the extension of said passage 903, 1003 and a low position or the distal end of said hollow tube 12, 13 is disposed perpendicular to said passage 903, 1003. Preferably, this association is achieved via a cylindrical head 14, 15 having a bore in which the distal end of said hollow tube 12, 13 is inserted. This cylindrical head comprises two lugs 16, 17, disposed co-axially on either side of its external surface, coming to fit into two congruent housings 18, 19 disposed within said passage 903, 1003.It is thus understood that the cylindrical head 14, 15 will be able to pivot about the axis defined by the lugs 16, 17 between a high position and a low position.

0038The association between the distal end of the hollow tube 12, 13 and the bore of the cylindrical head 14, 15 is preferably made by gluing. Preferably, one of the two cylindrical heads, said emission head 15, is associated with the distal end of the hollow tube 13 over the entire length of its bore. The distal end of the hollow tube 13 thus flush with the distal end of the cylindrical head 15. The other cylindrical head, called the receiving head 16, comprises, from its proximal end towards its distal end, a bore extended by a groove flaring towards the distal end of said receiving head 16. In this case, the distal end of the hollow tube 12 is associated with the bore of said receiving head 16 and comes flush with the level of the

0039The distal end of said cylindrical heads 14, 15 preferably has a hemispherical surface.

0040In the low position, the distal end of said hollow tube 12, 13 is placed perpendicular to the longitudinal axis of the passage 9003, 1003 connecting the inner surface to the outer surface of the jaw 9,10. The hollow tube 12, 13 is thus housed entirely inside the groove 901, 1001 present on the outer surface of said jaw and then in the space between the two blades of the intermediate piece 7 and then in the groove 6 on the surface of the first part of said intermediate piece 7. In this position, said hollow tube 12, 13 is fully housed inside the parts constituting the rest of the device 1 according to the invention.

0041In the high position, the distal end of said hollow tube 12, 13 is in the extension of said passage 903, 1003 connecting the outer surface to the inner surface of said jaw 9, 10. The passage from the high position to the lower position is done in pushing on the free end 121, 131 of said tube 12, 13 which will cause the rotation of the cylindrical head 14,15 around its lugs 16, 17. The passage from the high position to the low position is by a reverse movement .

0042The device 1 according to the invention operates as follows:<ol id="ol0001" compact="compact" ol-style=""><li>1. The practitioner brings the jaw 11 into the patient's heart with the hollow tubes 12, 13 in the low position (see <figref idref="f0002">figure 3</figref>).</li><li>2. He opens the jaws 9,10 to seize the mitral valve.</li><li>3. It locks the jaw 11 in the closed position on the mitral.</li><li>4. It pushes on the hollow tubes 12, 13 to put them in the high position.</li><li>5. He then passes a thin flexible rod to which is attached the rope prosthesis goretex in the following elements in order:<ol id="ol0002" compact="compact" ol-style=""><li>at. The hollow tube 13 associated with the cylindrical emission head 15</li><li>b. The cylindrical emission head 15</li><li>c. The first bit 10</li><li>d. The mitral valve: it passes through (the tip of the thin flexible needle rod)</li><li>e. The second bit 9</li><li>f. The cylindrical receiving head 14</li><li>g. The hollow tube associated with the cylindrical receiving head 12</li></ol></li><li>6. On tire ensuite sur la tige pour positionner le cordage synthétique et retirer la tige-aiguille.</li></ol>