Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
1998-11-16
2001-02-06
Thaler, Michael H. (Department: 3731)
Surgery
Instruments
Internal pressure applicator
Reexamination Certificate
active
06183494
ABSTRACT:
The invention concerns a microcommissurotomy device with levers, in other words an apparatus serving as a cardiac catheter intended to eliminate the stenosis of cardiac valvulae by separation of the valvular commissures by means of a levered retractor under manual control.
FR-A-2.071.338 describes an apparatus of this type comprising a resilient base traversed by an axial shaft for the maneuvering. At the proximal end of the resilient base is arranged a handle for manual control. At the distal end, the resilient base is integral with a tubular casing or a socket in which can slide a slide member affixed to the end of the axial shaft. A retractor constituted of two parallel arms is arranged around the socket-slide assembly. Each of the two arms is retained at its proximal end by a helical spring attached to a ring integral with the resilient base. This spring is intended to prevent the arm from catching on the cardiac tissue. At its distal end, each arm is articulated on the end of a lever of which the other end is articulated on the socket member integral with the resilient base. This lever is articulated at its midpoint on a second lever of which one end is articulated on the slide attached to the end of the axial shaft, and of which the other end slides without obstruction in the arm of the side of its proximal part.
This apparatus is arranged for engagement in the heart by the finger of the surgeon, then it is set in action by the manual control which assures a relative movement of the axial shaft and the resilient base, in other words including the slide and the socket. In the course of this movement, the points of articulation of the two levers of each arm situated respectively on the slide and the socket come closer together. The result is a distancing of their mutual point of articulation and a distancing of the arm in relation to the axial shaft and the resilient base. The distancing movement is symmetrical and the two arms are separated from another while remaining parallel to one another. This movement suffices to eliminate the stenosis of the cardiac valvulae.
This apparatus is intended to be inserted into the heart through the wall of one auricle, by means of the finger of the surgeon, and that is why it is limited to use in cases of invasive procedures.
Besides, when this apparatus is closed, the three points of articulation of the levers of one arm, in other words the point of articulation of the first lever on the socket, the point of articulation of the second lever on the slide, and the point of mutual articulation of the two levers on one another, essentially at their midpoint, are in alignment for all practical purposes. The result is that the opening of the arms of the retractor is generally sudden or abrupt, which can negatively influence the precision required for this type of intervention.
One object of the present invention is to propose a microcommissurotomy device not requiring invasive intervention.
Another object of the invention is to provide an arrangement of levers which avoids any shock or sudden stoppage upon opening of the retractor.
Still another object of the invention is to propose an accessory arrangement for opening the retractor.
Finally, another object of the invention is to propose an apparatus which can be located and pin-pointed precisely by imagery techniques.
The object of the present invention is a microcommissurotomy device with levers, comprising a retractor with two active sides being displaced symmetrically and essentially parallel to the axis of the retractor, the opening of the retractor being assured by manual control by movement of the distal end of the retractor in relation to its proximal end socket, characterized in that the retractor is mounted at the distal end of a catheter, and characterized in that, in closed position, the retractor has a radial bulk or extension essentially equal to that of the catheter.
According to other characteristics of the invention:
the retractor is constituted of two symmetrically deformable parallelograms which are symmetrically deformable in relation to the axis of the retractor, of which the first side is constituted by the proximal end socket of the retractor and the second side by the active side;
the third side of the parallelogram is articulated on the socket and carries a plate spring which, when the retractor is in closed setting, pulls said third side toward the exterior;
the fourth side of the parallelogram, in the vicinity of its midpoint, presents an articulation point for a small rod which is articulated at its other end on the distal end of the retractor;
the two articulation points of the small rod are situated on one and the other side of the axis of the retractor;
the small rods of each of the two symmetrical parallelograms of the retractor are intersecting;
the distal end of the retractor is carried by a tube sliding in the proximal socket of the retractor;
the tube is connected to a traction wire and slides in a flexible internal member within the catheter, the forces of traction and compression being transmitted from the proximal end to the distal end of the catheter by virtue of the combination of the traction wire and the flexible internal member within the catheter;
the tube opens at the distal end of the retractor to constitute a passage to a guide in the form of metal wire for the guiding of the retractor as far as the site of the commissurotomy;
the guide in the form of metal wire carries a flexible end, which is atraumatic and, to the right of the connection between the guide and its flexible end, a separate olivary member with the capacity to cooperate with the distal end of the retractor to secure complete opening of the retractor;
the catheter secures the longitudinal positional maintenance of the retractor at the site of the commissurotomy;
when the retractor is in open position, its distal end is located between the two active sides of the retractor;
the active sides of the retractor are covered with a slide prevention covering;
the retractor is constituted of one or more materials which are capable of assuring that it can be precisely located by imagery techniques using X-rays or ultrasound;
the retractor and the catheter are covered with a biologically compatible covering.
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Amor Georges
Cribier Alain
Letac Brice
Rimlinger Thierry
Ho Tan-Uyen T.
Medicorp S.A.
Roylance Abrams Berdo & Goodman L.L.P.
Thaler Michael H.
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