Surgical device

Technical area

p0001The present invention particularly relates to a surgical device that can be used in particular for laying rope mitral prosthesis. Furthermore, the present invention also relates to a method for laying a rope mitral prosthesis using the device according to the invention.

p0002The mitral valve is a valve which separates the left atrium from the left ventricle. It is more particularly constituted by a fibrous ring, two sheets, connected to the left ventricular muscle by muscle pillars, through fiber ropes.

p0003The opening or closing of the mitral valve is triggered by the pressure difference between the left atrium and the left ventricle. During the expansion phase of the ventricle, the valve is open allowing the passage of blood from the atrium to the ventricle. At the beginning of the contraction of the ventricle, the pressure is back suddenly, the valve closes and prevents reflux.

p0004Mitral insufficiency is a common disease of the heart valves caused by improper closure of two sheets of them, causing a reflux of blood from the left ventricle into the left atrium during the blood expulsion phase. Severe forms of mitral insufficiency may necessitate surgery.

p0005The main causes of mitral regurgitation are coronary artery disease, cardiomyopathy, or mitral valve prolapse. It can also appear in other heart birth defects.

p0006Treatment depends on the size of the leak, its repercussions on the left ventricle and terrain.

p0007Surgical treatment may consist of a valve reconstruction (mitral valve repair) or replacement of the mitral valve with a prosthesis (artificial valve): mechanical valve or bioprosthetic valve.

p0008As part of a mitral valve repair, the surgeon minutely inspects the damage to the mitral valve. Depending on the nature of the degradation of the mitral valve, the surgeon proceeds to a seam of this valve or repair on the cords of the valve. A ring is very often set up around the valve so that the valve leaflets are tight. Sometimes, when the valve is perforated, the surgeon performs a patch (small membrane) using a piece of pericardium (tissue that surrounds the heart) it collects on the patient during the procedure.

p0009As part of this procedure, it may be necessary to replace the mitral rope with a prosthesis in the form of a wire Goretex.

p0010There is therefore a need for a device for introducing the prosthesis to the heart and inserting on the mitral valve.

Summary of the Invention

p0011The invention concerns in particular a surgical device including a hollow cylinder, a jaw consisting of two jaw comprising an outer surface and an inner surface, pivotally mounted relative to an axis perpendicular to the longitudinal axis of said hollow cylinder between an open position and a closed position, where the jaw is disposed in the extension of the distal end of said hollow cylinder and two hollow tubes, remarkable in that said jaws each comprise a passageway from said outer surface to said inner surface, said passages being disposed face -to-screw 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.

p0012According to a preferred embodiment of the invention, said hollow tubes are flexible.

p0013According to a preferred embodiment of the invention, said hollow tubes are accommodated in part within said hollow cylinder.

p0014According to a preferred embodiment of the invention, the distal end of said hollow tubes is rotatably mounted, about an axis perpendicular to the longitudinal axis of said passage, between a high position where the distal end of said hollow tube is in the extension of said passage and a lower position where the distal end of said hollow tube is arranged perpendicularly to said passageway.

p0015According to one embodiment even more preferred of the invention, the outer surface of said jaws includes on its outer surface a groove for receiving the distal portion of said hollow tube when the latter is in the low position.

p0016According to a preferred embodiment of the invention, the rotation of said jaws is driven by a rod, placed totally or partially within said hollow cylinder, whose proximal end opens at the proximal end of said hollow cylinder and whose end is associated with the distal end proximal of said jaws.

p0017According to a preferred embodiment of the invention, the inner surface of said jaws has grooves.

p0018According to one embodiment even more preferred of the invention, said grooves have in cross section a triangular profile.

p0019According 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 passage of said hollow tube from the inside to the outside of said cylinder.

p0020According to a preferred embodiment of the invention, said hollow cylinder comprises in its proximal part openings to allow passage of said hollow tubes from the inside to the outside of said hollow cylinder.

p0021According to a preferred embodiment of the invention, the distal end of said jaw presents a longitudinal section, a curved profile.

p0022According to a preferred embodiment of the invention the end of said jaw presents a longitudinal section, a semicircular profile in the closed position.

p0023According to a preferred embodiment of the invention, the jaw is associated with said hollow cylinder via an intermediate part comprising a proximal portion, which is inserted into the distal end of said hollow cylinder, and a distal portion including recesses adapted to receive the guiding axis rotating said jaws.

Brief Description of Drawings

p0024<ul><li>The <figref idrefs="f0001">figure 1</figref> presents a top view of one embodiment of a device according to the invention.</li><li>The <figref idrefs="f0001">2</figref> shows a view in longitudinal section of the embodiment of the invention shown in <figref idrefs="f0001">figure 1</figref>.</li><li>The <figref idrefs="f0002">3</figref> shows a perspective view of a device according to the invention seen with the jaws in open position.</li><li>The <figref idrefs="f0003">4</figref> shows a perspective view of a device according to the invention seen with the jaws in closed position.</li></ul>

Description of embodiments

p0025With reference to <figref idrefs="f0001">Figures 1 and 2</figref>, The device 1 according to the invention has its proximal end to its distal end: the free end of the rod 2, the stopper 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 slot, the intermediate part 7 supporting the axis 8 about which the jaws 9, 10 are rotated.

p0026The groove 6 extends to the distal end of said hollow cylinder and at the intermediate part 7 and on 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 low 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 completely inscribed within a cylinder of diameter equal to that of said hollow cylinder.

p0027Referring to <figref idrefs="f0001">2</figref>, The closure cap 3 preferably has a groove 301 which is inserted inside the cylinder and a shoulder 302 bearing against the proximal end of the cylinder. This stopper 3 has a bore 303 allowing passage of the rod 2. The stopper 3 is preferably made of a material to ensure the sealing at the junction bore / rod 2. It thus allows plugging of the hollow cylinder 4 and the maintenance of the rod 2 along an axis parallel to the longitudinal axis of the hollow cylinder 4.

p0028The hollow cylinder 4 has a diameter preferably between 3 and 10 millimeters. Its distal end is closed by the intermediate member 7, the proximal portion forms a plug 701 being inserted one inside the hollow cylinder 4. The outer part of this stopper 701 has a diameter equivalent to the diameter of the hollow cylinder 4. This cap is bored to allow the passage of the rod 2, the rod 2 is therefore supported both by the stopper 3 to the proximal portion of the hollow cylinder 4 and the intermediate part 7 located at the distal portion of said cylinder 4. The hollow bore 702 of said intermediate member 7 is preferably covered by a cylindrical seal 703.

p0029The intermediate part 7 further comprises a second portion consisting of two blades 704, 705 extending towards the jaw 11 and the supporting shaft 8 for holding the jaws 9, 10. The shaft 8 is held at the level of its ends in a 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.

p0030The jaw 11 thus consists of two jaws 9, 10 maintained 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 done via the rod 2 whose distal end is connected to the jaws 9, 10 of the jaw 11 by a rod type association / groove.

p0031The outer surface of said 9,10 jaws comprises a groove 901, 1001 placed in the extension of the space between the two plates 704, 705 of the intermediate part 7. The inner surface of said jaws 9, 10 includes grooves 902, 1002 to to improve retention of the jaw 11 at the valve when said jaw 11 is in the closed position. Said splines 902, 1002 preferably have, in cross section, a triangular profile. However, it is well understood that said profile can be modified as needed.

p0032To facilitate penetration of the device 1 according to the invention inside the patient's body to be treated, the distal end of the jaw 11 preferably has a curved surface and still more preferably a hemispherical surface.

p0033Each of the two jaws 9, 10 comprises an inner surface and an outer surface and a passage 903, 1003 to its outer surface to its inner surface arranged such that said passages 903, 1003 are vis-a-vis when the jaw 11 is in the closed position.

p0034The 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 to the outside of the hollow cylinder 4 via the oblong hole 5 positioned 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 slot 5 and / or said groove 6 are sealed by a seal 12 allowing the passage of said hollow tube, 13.

p0035The association between the end of hollow tube 12, 13 and the jaw 9, 10 is made so that the tube opening 12, 13 at this end is in line with the passageway 903, 1003 of said jaws, when said hollow tube 9, 10 is in the high position, so that said hollow tube 9, 10 opens into said passageway 903, 1003.

p0036Advantageously, the distal end of the hollow tubes 12, 13 is rotatably mounted, about an axis perpendicular to the longitudinal axis of said passage 903, 1003, between a high position where the distal end of said hollow tube 12, 13 is in the extension of said passageway 903, 1003 and a low position or the distal end of said hollow tube 12, 13 is disposed perpendicularly to said passageway 903, 1003. Preferably, this combination is performed via a cylindrical head 14, 15 having a bore in which is inserted the distal end of said hollow tube 12, 13. the cylindrical head has two lugs 16, 17, arranged coaxially on either side of its outer surface, which is inserted in two congruent housing 18, 19 arranged inside said passage 903, 1003. It is thus understood that the cylindrical head 14, 15 is able to pivot around the axis defined by the pins 16, 17, between a high position and a low position.

p0037The association between the distal end 12 of hollow tube 13 and the bore of the cylindrical head 14, 15 is preferably performed by bonding. Preferably, one of the two cylinder heads, called transmission head 15, is associated with the distal end of the hollow tube 13 along the entire length of its bore. The distal end of hollow tube 13 thus coming flush with the level of the distal end of the cylindrical head 15. The other cylindrical head, said receiving head 16 comprises, from its proximal end towards its distal end a bore extended by a countersink flaring towards the distal end of said receiver head 16. in this case, the distal end 12 of the hollow tube is associated with the bore of said receiver head 16 and is flush at the entrance to the recess .

p0038The distal end of said cylindrical heads 14, 15 preferably has a hemispherical surface.

p0039In the low position, the distal end of said hollow tube 12, 13 is placed perpendicularly to the longitudinal axis of the passageway 9003, 1003 connecting the inner surface to the outer surface of the jaws 9,10. The hollow tube 12, 13 is thus entirely housed within the groove 901, 1001 present at the outer surface of said jaws and in the space between the two plates of the intermediate member 7 and the groove 6 on the surface of the first portion of said intermediate member 7. in this position, said hollow pipe 12, 13 is fully housed inside the parts constituting the rest of the device 1 according to the invention.

p0040In the high position, the distal end of said hollow tube 12, 13 is in the extension of said passageway 903, 1003 connecting the outer surface to the inner surface of said jaws 9, 10. The passage from the high position to the low position is in pushing on the free end 121, 131 of tube 12, 13 which will cause rotation of the cylindrical head 14,15 around the protrusions 16, 17. the passage from the high position to the low position is effected by a reverse movement .

p0041The device 1 of the invention operates as follows:<ol><li>1. The practitioner brings the jaw 11 in the patient's heart with the hollow tubes 12, 13 in the low position (see <figref idrefs="f0002">3</figref>).</li><li>2. It opens the jaws 9.10 to enter the mitral valve.</li><li>3. It locks the jaw 11 in the closed position on the mitral.</li><li>4. It grows on the hollow tubes 12, 13 to put them in the top position.</li><li>5. It then passed a thin flexible rod to which goretex string of the prosthesis is attached in the following in order:<ol><li>at. The hollow tube 13 associated with the cylinder head emission 15</li><li>b. The cylindrical head 15 Issue</li><li>c. The first jaw 10</li><li>d. The mitral valve: we cross it (the tip of the flexible thin rod for needle)</li><li>e. The second jaw 9</li><li>f. The cylindrical head receiving 14</li><li>g. The hollow tube associated with the cylindrical head receiving 12</li></ol></li><li>6. then drawn on the rod for positioning the synthetic rope and remove the needle rod.</li></ol>