Abstract
An implantable sealing device is disclosed herein and includes an elongated elastic member having distal and a proximal ends, at least one sealing element including braiding having outside and inside faces. The braiding can include of a plurality of fine threads of a memory metal alloy and wherein at least one face of the braiding is coated by a membrane. The braiding can also include a fixing member positioned at one of the distal and proximal ends of the elastic member and being positioned opposite to the braiding.
Claims
1. A method for sealing an apical access opening of a left ventricle previously created by a trocar tube and for simultaneous cardiac pacing, the method comprising: inserting a trocar tube within a patient's left ventricle and guiding the trocar tube under an aortic valve to be replaced; slipping a three lumen catheter over the trocar tube, the catheter including a tubular body defining a first inner lumen extending longitudinally there through for slipping the catheter over the trocar tube and a second and third lumen which run along each side of the inner lumen respectively allowing temporary electrodes to pass therethrough, inserting a pre-shaped stylet in the second lumen and in the third lumen and guiding the stylet through a myocardium; inserting temporary myocardial electrodes in the second lumen and in the third lumen and guiding the electrodes via the stylet to both sides of a left ventricle apex; connecting the electrodes to an external pacemaker; performing high frequency ventricular pacing with the electrodes; inserting a balloon catheter through the trocar tube to expand the aortic valve to be replaced; implanting new aortic valve; reducing the heart rate with the electrodes; and withdrawing the trocar tube partly to the left ventricle apex and inserting a sealing device comprising: i) an elongate elastic member having a distal end and a proximal end; ii) at least one sealing element having an umbrella shaped braiding with outside and inside faces, the braiding extending radially from the elastic member, the braiding being positioned at the distal end of the elastic member, wherein the braiding includes a plurality of threads of shape memory metal alloy and wherein at least one face of the braiding is coated by a membrane; a fixing member positioned at the proximal end of the elastic member opposite to the braiding; and a double thread positioned at the proximal end of the elastic member; wherein the sealing device is inserted by pushing the braiding out of the trocar tube so that the braiding moves from a folded umbrella configuration into a deployed umbrella configuration whereas the fixing member remains inside the trocar tube; stretching the elastic member by using the double thread, pulling the trocar tube down beneath the left ventricle apex whereby the elastic member remains stretched, and pulling the stretched elastic member out of the apical opening whereby the fixing member moves from a folded position into a deployed position; removing tension from the elastic member whereby the fixing member anchors to a tissue of the myocardium; and removing the trocar tube completely from the patient.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) So that those skilled in the art to which the subject disclosure appertains will readily understand how to make and use the devices and methods of the subject disclosure without undue experimentation, embodiments thereof will be described in detail herein below with reference to certain figures, wherein:
(2) FIG. 1 is a schematic illustration of the transapical valve insertion technique;
(3) FIG. 2 shows the sealing device, sealing the inner myocardium;
(4) FIG. 3 show the sealing device, sealing the outer myocardium;
(5) FIG. 4 is a view corresponding to FIG. 1 and in addition shows temporary electrodes inserted for heart stimulation;
(6) FIGS. 5a to 5d show the placing and the affixing of the stimulation electrodes;
(7) FIG. 6 shows a stimulation electrode in detail;
(8) FIGS. 7a, 7b and 7c show the sealing system in detail; and
(9) FIGS. 8, 8a, 9, 9a and 10, 10a, show the steps of placing and affixing the sealing system.
DETAILED DESCRIPTION OF THE INVENTION
(10) Reference will now be made to the drawings wherein like reference numerals identify similar structural features or aspects of the subject disclosure. FIG. 1 is a schematic illustration of the transapical valve insertion technique and shows the balloon catheter used to insert new artificial heart valves during Transapical Aortic Valve Implantation (TAAVI) according to the state of the art. Trocar tube 1 is inserted into the left ventricle 3 of the heart through the myocardium 2. A compressed valve prosthesis constructed from a stainless steel stent with an attached artificial valve 4 is placed on the balloon catheter 5, inserted into the apex of the left ventricle, and positioned directly inside the diseased aortic valve. Once in position, the balloon is inflated to secure the valve in place. The balloon is then deflated and removed leaving the new valve to function immediately.
(11) FIG. 2 shows the sealing device sealing the opening in the myocardium. Trocar tube 1, via which the sealing device had been inserted, is retracted behind the ventricular apex. The opening in the tissue is tightly sealed by the membrane coated braiding 7 which is positioned at the inner myocardium at the distal end of the elastic member 6. As shown in the embodiment of FIG. 2, the elastic member 6 includes a coil spring. The braiding 7 is adapted to the anatomical shape of the apex of the left ventricle.
(12) The flexible braiding 7 tightly closes the inner tissue of the heart and is anchored by the fixing member which is operatively associated with the coil spring of elastic member 6. The coil spring is stretched by pulling the double thread 9 down. After the placement of the sealing device, the thread 9 may be removed by pulling down one side of the thread 9 so that the thread 9 may slip out.
(13) FIG. 3 shows the sealing device sealing the outer myocardium. The sealing device can be positioned the other way around as described above should the anatomical shape of the left ventricular apex not allow sealing of the inner myocardium. In this case the membrane coated braiding 7 is positioned at the outer myocardium.
(14) FIG. 4 is a view corresponding to FIG. 1 and in addition shows temporary electrodes (heart wires) inserted for heart stimulation. Heart wires are normally placed in open heart surgical procedures and are attached to the epicardium to synchronize the heart after the surgery. The embodiment according to FIG. 4 provides a possibility to attach heart wires even if the heart is not exposed.
(15) An additional catheter 10 is slipped over the trocar tube 1. The catheter 10 is a three-lumen device which comprises a tubular body defining a first inner lumen extending longitudinally there-through for slipping the catheter over the trocar tube and a second and third lumen 11, 12 which run along each side of the inner lumen allowing temporary electrodes to pass therethrough. A Nitinol-stylet 13, which is preferably pre-shaped, is first inserted within said lumen for assisting in steering of the stimulation electrode when implanted.
(16) FIGS. 5a to 5d show insertion of an electrode within the myocardium of the heart. A pre-shaped stylet 13 is first inserted within lumen 11 or 12 and guided from outside of the heart into and through the myocardium. The tip of the stylet 13 leaves the tissue of the myocardium. A coil 14 is then guided over the stylet towards its tip. The stylet 13 is then withdrawn and the temporary electrode 15 is inserted via the lumen of the coil 14. The proximal portion of electrode 15 is connected to an external pacemaker. The stimulating procedure is the same procedure as the placing of heart wires which are used in open heart surgical procedures if it is expected that the patient will need stimulation for a limited time after the surgery. After completion of temporary stimulation the heart wires are removed by pulling.
(17) FIG. 6 shows a stimulation electrode comprising, at its distal end, a loop 16 and a fixing member. The stimulation electrode is inserted by means of coil 17.
(18) FIGS. 7a, 7b and 7c show the sealing system in detail. FIG. 7a is a top view of the umbrella shaped braiding 7. In some embodiments, the braiding can include about 80 Nitinol threads having a diameter of about 0.1 mm. FIG. 7b is a side view of the sealing device. Coil spring of elastic member 6 is attached to the braiding 7 at its distal end. The fixing member 8 is operatively associated with the coil spring at its proximal end. Loop 73 allows double thread 9 to pass therethrough. Socket 72 may hold the ends of the braiding threads. In unfolded condition the braiding 7 can be umbrella shaped or any other suitable shape. The coating is positioned at the outside face 70 or at the inside face 71 of the braiding 7, preferably at the outside face. If desired, both sides of the braiding 7 may be coated. FIG. 7c shows the braiding 7 in the shape adapted to the anatomical shape of the apex of the left ventricle as shown in use in FIG. 2.
(19) FIGS. 8, 9, and 10 show the steps of placing and affixing the sealing system. FIG. 8 shows the sealing device positioned inside trocar tube 1 before placing the device into the left ventricle. Braiding 7 and fixing member 8 are folded. The stick 20 is for pushing out the sealing device. The folding may be upwards (FIG. 8) or downwards (FIG. 8a).
(20) FIGS. 9 and 9a show the trocar tube placed in the myocardium functioning as a portal for the subsequent placement of the sealing device. The braiding 7 is pushed out of the trocar tube 1 and is unfolded. The fixing member 8 is inside the tube 1 and thus still protected. FIG. 9 and FIG. 9a differ in the anatomical shape of the apex of the left ventricle and show the adaption of the shape of the braiding 7 to the different anatomical shapes.
(21) FIGS. 10 and 10a show the sealing device placed and the trocar tube 1 removed. By pulling double thread 9 downwards coil spring of the elastic member 6 is pre-stretched. The pre-stretched coil spring is pulled downwards out of the opening in the myocardium. After removing the trocar tube 1 whereby the double thread is still stretched the fixing member 8 moves from a folded into a deployed position and anchors in the myocardium tissue.
(22) While the apparatus and methods of the subject disclosure have been shown and described with reference to embodiments, those skilled in the art will readily appreciate that changes and/or modifications may be made thereto without departing from the spirit and scope of the subject disclosure.
