Measurement and simulation device used for aortic valve-sparing root replacement operations

Abstract

This invention is related to the device used in the valve sparing aortic root replacement which is a special operation aimed at the root of the main vessel—aorta originating from the heart or known as ‘David Procedure’ (Re-implantation technique) in the literature.

Claims

1. A valve sparing aortic root replacement device for use in an operation of valve sparing aortic root replacement for protecting the aortic root of a patient, comprising: an adjustable circle configured for being clamped to commissures of the aortic root, the adjustable circle having an adjustable diameter; legs configured for allowing placement of the valve sparing aortic root replacement device on the aortic root, the legs being connected to the adjustable circle and being fixable around the aortic root; slit surgical tubes configured for holding operation sutures, the slit surgical tubes being further configured for fixing the legs between the slit surgical tubes and the aortic root tissue by means of tensing the operation sutures; and a cusp caliper configured for allowing measurement of an aortic leaflet height after the placement of the valve sparing aortic root replacement device on the aortic root.

2. The valve sparing aortic root replacement device according to claim 1, comprising a window displaying a graft diameter scale that defines a diameter of a graft to be chosen based on a position of aortic leaflets after the placement of the valve sparing aortic root replacement device on the aortic root.

3. The valve sparing aortic root replacement device according to claim 1, comprising commissure holders configured for being attached to the commissures of the aortic root.

4. The valve sparing aortic root replacement device according to claim 1, comprising support elements positioned on an inner surface of the adjustable circle, the support elements being configured for ensuring perpendicular positioning of the legs.

5. The valve sparing aortic root replacement device according to claim 1, comprising leg stabilizer clips that fit into grooves on the legs, the leg stabilizer clips being configured for ensuring fixation of the legs in the grooves.

6. The valve sparing aortic root replacement device according to claim 5, comprising clip stabilizers configured for disabling the leg stabilizer clips.

7. The valve sparing aortic root replacement device according to claim 1, comprising leg springs configured for pushing the adjustable circle from the aortic valve in order to lift the aortic leaflets.

8. The valve sparing aortic root replacement device according to claim 1, comprising suture holes configured for ensuring the fixation of the legs at the level of the operation suture tensed by the slit surgical tubes.

9. The valve sparing aortic root replacement device according to claim 1, comprising leg connectors configured for allowing a vertical movement of the adjustable circle on the legs.

10. The valve sparing aortic root replacement device according to claim 1, comprising a surgical teflon pledget configured for preventing the operation suture from cutting the aortic root tissue.

11. The valve sparing aortic root replacement device according to claim 1, comprising a cusp caliper pin having a millimeter scale, the cusp caliper pin being configured for measuring the heights of the lowest and highest levels of the aortic leaflets.

12. The valve sparing aortic root replacement device according to claim 11, comprising a cusp caliper clip configured for fixing the cusp caliper pin.

13. The valve sparing aortic root replacement device according to claim 11, comprising a pin ending configured for performing the measurement by touching the aortic leaflet.

14. The valve sparing aortic root replacement device according to claim 13, comprising a pin-pulling spring configured for pulling the pin ending to an initial position.

15. The valve sparing aortic root replacement device according to claim 1, comprising a circle screw configured for changing the diameter of the adjustable-diameter circle.

Description

DESCRIPTION OF THE FIGURES

(1) FIG. 1 Perspective view of the invention subject valve protective aortic root replacement device

(2) FIG. 2 Top view of the invention subject valve protective aortic root replacement device

(3) FIG. 3 Side view of the invention subject valve protective aortic root replacement device

(4) FIG. 4 Disassembled view of the invention subject valve protective aortic root replacement device

(5) FIG. 5 Perspective view of the commissure holders in the invention subject valve protective aortic root replacement device

(6) FIG. 6 Disassembled view of the commissure holders of the invention subject valve protective aortic root replacement device

(7) FIG. 7 Perspective view of the window showing the graft diameter scale on the invention subject valve protective aortic root replacement device

(8) FIG. 8 Disassembled view of the window showing the graft diameter scale on the invention subject valve protective aortic root replacement device

(9) FIG. 9 Detailed view of the invention subject valve protective aortic root replacement device

(10) FIG. 10 Detailed view of the invention subject valve protective aortic root replacement device

(11) FIG. 11 Disassembled view of the screw of the adjustable diameter ring on the invention subject valve protective aortic root replacement device

(12) FIG. 12 Detailed view of the measuring legs on the invention subject valve protective aortic root replacement device

(13) FIG. 13 Another perspective view of the invention subject valve protective aortic root replacement device

REFERENCE NUMBERS

(14) 1. Adjustable circle 1.1 Circle Screw 1.2 Window showing graft diameter 1.3 Commissure holders 2. Legs 2.1 Support Element 2.2 Leg stabilizer clips 2.3 Clip stabilizers 2.4 Leg springs 2.5 Suture holes 2.6 Leg connectors 3. Slit surgical tubes 3.1 Surgical teflon pledget 3.2 Surgical tube stopper 3.3 Operation Suture 4. Cusp caliper (effective height caliper) 4.1 Cusp caliper pins 4.2 Cusp caliper clips 4.3 Pin-pulling springs 4.4 Pin endings 5. Functional Aortic Annulus 5.1 Aortic commissure 5.2 Aortic Leaflet

DETAILED DESCRIPTION OF THE INVENTION

(15) In this detailed description, the invention subject innovation is explained by examples that will not create any limiting effects, solely as aimed for the subject to be understood better.

(16) The invention is the valve sparing aortic root replacement device used in the operation for valve sparing aortic root replacement, which is a special operation aimed for the root of the main aorta exiting from the heart, or known as the ‘David Procedure’ in the literature, and its feature is characterized by; an adjustable circle (1) that determined the graft diameter with the circle screw (1.1) located on it, legs (2) connected to the referred adjustable circle (1) that are clamped on the referred aortic root and allow the placement of the valve sparing aortic root replacement device on the aortic root, slit surgical tube (3) that can hold the operation suture (3.3) that is passed through the aortic root without cutting the needles and prevent the unintended escape of the referred operation suture (3.3) thanks to the spiral slit on it that extends from end to end, surgical tube stopper (3.2) that wraps the output end of the referred operation suture (3.3) from the outside and forms a support, and the cusp caliper (effective height caliper) (4) that is placed on the top edge of the referred adjustable circle (1) and ensures the positioning of the pin ending (4.4) on it as perpendicular to the aortic root under all positions, and allows the measurement of the height difference between the lowest and highest levels of the aortic leaflets (5.2) with a totally geometric approach.

(17) The perspective view of the invention subject valve sparing aortic root replacement device is illustrated in FIG. 1.

(18) The top view of the invention subject valve sparing aortic root replacement device is illustrated in FIG. 2.

(19) The side view of the invention subject valve sparing aortic root replacement device is illustrated in FIG. 3.

(20) The disassembled view of the invention subject valve sparing aortic root replacement device is illustrated in FIG. 4.

(21) The perspective view of the commissure holders on the invention subject valve sparing aortic root replacement device is illustrated in FIG. 5.

(22) The disassembled view of the commissure holders on the invention subject valve sparing aortic root replacement device is illustrated in FIG. 6.

(23) The perspective view of the window showing the graft diameter scale on the invention subject valve protective aortic stem replacement device is illustrated in FIG. 7.

(24) The disassembled view of the window showing the graft diameter scale on the invention subject valve sparing aortic root replacement device is illustrated in FIG. 8.

(25) The detailed view of the invention subject valve sparing aortic root replacement device is illustrated in FIG. 9.

(26) The detailed view of the invention subject valve sparing aortic root replacement device is illustrated in FIG. 10.

(27) The detailed view of the screw of the adjustable circle on the invention subject valve sparing aortic root replacement device is illustrated in FIG. 11.

(28) The detailed view of the legs on the invention subject valve sparing aortic root replacement device is illustrated in FIG. 12.

(29) Another perspective view of the invention subject valve sparing aortic root replacement device is illustrated in FIG. 13.

(30) The main parts constituting the invention subject valve sparing aortic root replacement device are: an adjustable circle (1), legs (2), slit surgical tubes (3), cusp caliper (effective height caliper) (4).

(31) The main parts composing the referred adjustable circle (1) are: commissure holders (1.3) clamped to the commissure (5.1) which is the point where the aortic leaflets (5.2) interconnect, circle screw (1.1) that allows for the referred commissure holders (1.3) to approach or move away from each other by changing the diameter of the adjustable-diameter circle (1), and window (1.2) that shows the graft diameter scale, the number written on which at the position where the aortic leaflets (5.2) are positioned at the appropriate value is determined as the diameter of the artificial vessel to be chosen.

(32) The main parts composing the referred legs (2) are: support element (2.1) the convex surface of which sits on the inner surface of the referred adjustable circle (1) and ensures the perpendicular positioning of the legs, leg stabilizer clips (2.2) that fit into the parallel grooves on the legs (2) and ensure fixation, clip stabilizer (2.3) that disables the referred leg stabilizer clips (2.2) and allows the continuous movement of the legs (2), leg springs (2.4) that fulfill the pushing function so as to push the referred adjustable circle (1) from the aortic valve, suture holes (2.5) that ensure the referred legs (2) to stay fixed on the operation suture (3.) that has been tensed by the slit surgical tubes (3), and the leg connectors (2.6) that allows the vertical movement of the adjustable circle (1) on the legs (2).

(33) The main parts composing the referred slit surgical tube (3) are: the operation suture (3.3), surgical teflon pledget (3.1) placed as spongy support material preventing the referred operation suture (3.3) from cutting the tissue, the surgical tube stopper that wraps the output end of the referred operation suture (3.3) from the outside and forms support.

(34) The main parts composing the referred cusp caliper (effective height caliper) (4) are: cusp caliper pins (4.1) that have millimeter scale placed on them, cusp caliper clips (4.2) that fixes the referred cusp caliper pins (4.1), cusp caliper pins (4.1) that perform measurement for each aortic leaflet (5.2) and pin pulling springs (4.3) that fulfill the function of pulling the referred pin endings (4.4).

(35) The main parts composing the referred aortic annulus (5) are: aortic leaflets (5.2) that connect at the center point and form the aortic valve and commissure (5.1) connected as the binary connection places of the referred aortic valves (5.2).

(36) Before the invention subject valve protective aortic root replacement device is placed on the patient, the adjustable circle (1) is brought to the maximum width using the circle screw (1.1). By pressing on the leg stabilizer clips (2.2) on the referred legs (2), each leg stabilizer clips (2.2) is placed in the clip stabilizers (2.3) groove that has been made for it by turning clockwise. The referred leg springs (2.4) push the adjustable-circle (1) so as to move it away from the aortic valve.

(37) The strength of the referred leg springs (2.4) is equal to the force by which the surgeon lifts the aortic leaflets (5.2) by pulling with handle forceps and the suture. In other words, they do not have a suspension force that will make any damages in the tissues.

(38) In this circumstance, the referred legs (2) are in continuously movable position. From the 12 operation sutures (3.3) placed as standard, total 10 needles of the 5 critical operation sutures (3.3) that are always fixed and selected for every patient are passed through the suture holes (2.5) on the 5 legs (2) that correspond to them, and are suspended. The referred surgical teflon pledget (3.1) is positioned as the spongy support material that prevents the operation suture (3.3) from cutting the tissue.

(39) The invention subject valve sparing aortic root replacement device is suspended, and moved to the aortic root as guided by the operation suture (3.3). The referred slit surgical tubes (3) are placed on the referred 5 operation sutures (3.3).

(40) The referred slit surgical tubes (3), are moved through the suture holes (2.5) on the referred legs (2) and the surgical tube stopper (3.2) are closed. Under these circumstances, there are 5 slit siners (3) on the 5 measuring legs (2). But, the referred slit surgical tubes (3) have not yet been tightened.

(41) The referred adjustable circle (1) is slowly contracted and pushed towards the root tissue through the tensing of the operation sutures (3.3) by all slit surgical tubes at the point where the suture holes (2.5) on all legs (2) touch the aortic root tissue. Thus, the 5 legs (2) are fixed between the slit surgical tubes (3) and the root tissue, at the level of the operation suture (3.3).

(42) The referred adjustable circle (1) is pushed towards the aortic root and the commissure holders (1.3) are fixed to the aortic leaflet connections called aortic commissure (5.1).

(43) The referred valve sparing aortic root replacement device is slowly released so that it is positioned. The aortic commissures rise and remain suspended, and at this point, the movement of the device is limited at the point where the referred commissure holders (1.3) suspend the aortic commissures (5.1).

(44) Upon the positioning of the referred valve sparing aortic root replacement device, the leg stabilizer clips (2.2) on each leg (2) are released and it is ensured that each leg (2) is fixed. Now, the aortic valve is suspended with its three-dimensional structure, as it should naturally be.

(45) The central coaptations of the aortic leaflets (5.2) are ensured by narrowing the adjustable circle (1). In this operation that will be made step by step, the height of the aortic leaflet (5.2) (effective height value) is measured over and over again using the cusp caliper (effective height caliper) (4).

(46) When the cusp caliper pins (4.1) of the referred cusp caliper (effective height caliper) are pressed from above, and the pressure is relieved at the moment the pin endings (4.4) touch the aortic leaflets (5.2), the cusp caliper pins (4.1) are fixed at that position. In addition, when the cusp caliper clips (4.2) are pressed, it is ensured that the legs (2) are returned to their initial positions for a new measurement.

(47) The referred pin pulling springs (4.3) operates by pulling the pin endings (4.4). When the cusp caliper clips (4.2) is pressed, the pin endings (4.4) are positioned at the farthest point to the aortic leaflets (5.2), and resume their starting positions for a new measurement.

(48) This measurement is made for each aortic leaflet (5.2) using the pin endings (4.4). The values are taken by the millimeter scale on the cusp caliper pins (4.1).

(49) The process is completed at the moment when this height is 9 mm. Now the effective height that is the most important measurement for the success of the David Procedure has been measured with precise accuracy and the appropriate graft (artificial vessel) diameter is displayed on the window showing the graft diameter scale (1.2).

(50) The referred legs (2) are fixed and, thus show the positions of the 5 operation sutures (3.3). The referred commissure holders (1.3) are opened and the aortic valve structure is released.

(51) The referred surgical tube stoppers (3.2) are opened and the slit surgical tubes (3) are taken off the operation sutures (3.3). The referred device is detached from the operation sutures (3.3) and moved away from the patient.

(52) In this condition, the valve sparing aortic root replacement device holds all the measurements. The graft taken at the diameter indicated by the valve sparing aortic root replacement device is passed through the legs (2) of the device that are in the hand of the surgeon and attached to the commissure holders (1.3) at the same depth (5 mm).

(53) Using a surgical marker pen, the suture holes (2.5) on the legs (2) are marked on the graft.

(54) In addition, the places where the 3 aortic commissures (5.1) will be sutured on the graft are defined by marking the bottom points of the commissure holders (1.3). The graft is removed from the referred device, the other sutures are placed sequentially in between the points marked on the graft.

(55) The referred functional aortic annulus (5) has a 3-dimensional structure. The referred aortic commissure (5.1) and aortic leaflets (5.2) are structures of the referred functional aortic annulus (5).

(56) The referred three aortic commissures (5.1) and the three aortic leaflets (5.2) are connected as binary connection.

(57) As required by the standard operation technique, the referred functional aortic annulus (5) is fully inserted into the artificial vessel (graft). The three commissures (5.1) are suspended in the artificial vessel and sutured. In this way, the three-dimensional structure is reconstructed.

(58) The referred aortic leaflets (5.2) coapt at the center point and form the aortic valve. The referred aortic leaflets (5.2) prevent blood from regurgitating into the heart after the heart has pumped the blood.

(59) The referred support element (2.1) is tightened by the referred leg connectors (2.6). The referred legs (2) move inside the leg connectors (2.6). The tightening strength of the support element (2.1) and the leg connector (2.6) allows horizontal movements inside the groove.

(60) The convex surface of the referred support element (2.1) sits on the inner surface of the adjustable circle (1). The concave surface of the leg connector (2.6) sits on the outside of the adjustable circle. The tightening of the support element (2.1) and the leg holder (2.6) does not prevent the horizontal movements in the groove. However, due to the tight contacts of the 3 curved surfaces with each other, the leg connector (2.6) always remains perpendicular and keeps the legs (2) always perpendicular.