TW201904530A - Custom prosthetic valve, valve stent, designing method and computer program product - Google Patents

Abstract

Embodiments disclose a custom prosthetic valve, valve stent, designing method and computer program product. The prosthetic valve is a trileaflet polytetrafluoroethylene valved conduit. The method includes: first measuring a diameter D' of an artery and determining a design diameter D equal to from 1.1 to 1.2 times the diameter D'; determining a circumference P of a circle, where P=[pi] D, and computing a width W of a valve of the trileaflet polytetrafluoroethylene valved conduit, where W=P/3; taking the width W as a length of an chord of a second circle and determining a diameter H, which is normal to a midpoint of the chord, and a distance H1, which is the shortest distance between the midpoint of the chord and a first interception point on a short arc of the second circle; drawing a lower-half-moon shape by connecting end points of the chord and the first interception point, where the lower-half-moon shape is symmetric with the first interception point as the center and the distance H1 is between 3cm and 5cm; determining a distance H2, which is the shortest distance between the midpoint of the chord and a second interception point on a long arc of the second circle; and drawing a upper-half-moon shape by connecting the end points of the chord and the second interception point, where the upper-half-moon shape is symmetric with the second interception point as the center.

Description

Customized artificial valve and design method thereof, program product for performing the design method and artificial bracket combined with the artificial valve

The present invention relates to a customized artificial valve and a design method thereof, a program product for performing the design method, and an artificial stent incorporating the artificial valve, and more particularly to an artificial valve having a first half moon cup and a lower half moon cup.

Some children have complex congenital heart disease after birth, such as right ventricular outlet obstruction (RVOT), which causes their pulmonary atresia.

In 2000, Bonhoeffer et al. first proposed the placement of a biological valve at the location of the pulmonary artery to treat the disease. This concept also evolved into a transcatheter pulmonary valve that was later used in RVOT. However, due to its size limitations, it is not possible to use RVOT patients with pulmonary arteries over 22 mm.

Professor Zhang Deyi and Professor Zhang Chongyi proposed "An efficient way to make a trileaflet conduit for pulmonary valve replacement" in 2013, which revealed the artificial trilobal valve valve tube, which can solve the above problems. Referring to Figures 7 through 9, the artificial trilobal valve valve tube includes three meniscus valves (A).

In order to make the valve matching effect better, the inventor of the present case, Gan Zongdan, proposed another novel artificial trilobal valve valve tube in 2014. Referring to Figures 10 to 12, each valve (B) of the artificial trilobal valve tube has a lower half moon cup (B1) and a upper half moon cup (B2). Through the new lower half of the moon cup (B1), the effect of better valve matching is produced.

The present invention further designs the artificial trilobal valve valve tube previously proposed by the inventor. Therefore, the present invention is a method for designing a customized artificial valve, which is a trilobal valve valve tube, and the design method Includes the following steps:

A. Measuring one artery width D' of a patient, taking 1.1 times to 1.2 times the width of the artery width D' is a design width D; B. forming a circumference of one circle with the design width D as a diameter is P=πD Therefore, a valve width of one of the valves of the trilobal valve valve tube is W=P/3; C. with the valve width W being a chord of another circle, one of the bisectors of the other circle perpendicular to the chord is obtained. a diameter H at which a vertical distance of the bisector of the chord and a first contact of the short arc of the chord is H1, according to the end of the chord and the first joint a half moon cup, the lower half moon cup is symmetrically centered on the first contact point, and the vertical distance H1 is between 3 cm and 5 cm; the bisector of the string and the string constitute one A vertical distance of a second contact of the long arc is H2, and an upper half moon cup is drawn according to the end point of the string and the second contact point, and the upper half moon cup is symmetrically centered on the second contact point .

Further, the arc C1 of the lower half moon cup is , , W1=W/2; the arc C2 of the upper half of the moon cup is , k = 1.4 to 1.9. Where D: an arc curve drawn with a diameter D; D _ref : an arc curve drawn with a diameter D _ref .

Further, D _ref is 20.

Further, when the design width D is less than 25 mm, let H = H1 + H2.

Further, when the design width D is larger than 25 mm, let H = H1 + 0.2887 πD.

The invention further proposes a customized artificial valve, which is a trilobal valve valve tube designed by the above-mentioned customized artificial valve design method.

The invention further provides an artificial stent combined with a prosthetic valve, comprising a stent body, and the aforementioned artificial valve is coupled to the stent body.

The invention further proposes a program product, which is installed in a computer and executes the design method of the above-mentioned customized artificial valve.

According to the above technical features, the following effects can be achieved:

1. According to the arterial width of different patients, the invention can customize the artificial valve and artificial stent of different sizes to better adapt to the patient's body.

2. The artificial valve of the present invention has a better matching effect through the design of the arc C1 of the lower half moon cup of each valve and the arc C2 of the upper half moon cup of the present invention.

In combination with the above technical features, the main effects of the customized artificial valve of the present invention, the design method thereof, the program product for performing the design method, and the artificial stent incorporating the artificial valve will be clearly shown in the following embodiments.

The customized artificial valve design method of this embodiment includes:

A. Referring to the first figure, one artery width D' of one patient is measured, and 1.1 to 1.2 times the width of the artery width D' is taken as a design width D.

B. The circle having one circle formed by the design width D is P=πD, and the diameter of the circle is the diameter of the stent actually placed in the artery, so one of the valves of the trilobal valve tube Valve width W = P / 3 = π D / 3.

C. Referring to the second to fourth figures, with the valve width W being a chord of another circle, a diameter H perpendicular to the bisector of the chord on the other circle is obtained, at which the chord The vertical distance between the bisector and a first contact of the short arc of the chord is H1, and the vertical distance between the bisector of the chord and a second joint of the long arc of the chord is H2. According to the second figure, W1=W2=1/2W=πD/6; θ1= , θ2=180°-2θ1=180°-2 . According to the third figure, D1 × sin(θ2) = W1, D1 = W1/sin(θ2); L1 = L2 = D1 × sin(θ2), L = L1 + L2 = 2 × D1sin(θ2). According to the fourth figure, H2= , H2= =0.2887πD.

Wherein, when the design width D is less than 25 mm, let H=H1+H2; when the design width D is greater than 25 mm, let H=H1+0.2887πD.

Referring to the fifth to fifth C diagrams, a half moon cup C1 is drawn according to the end point of the string and the first contact point, and the lower half moon cup is symmetrically centered on the first contact point, and The value of the vertical distance H1 is between 3 cm and 5 cm; an upper half moon cup C2 is drawn according to the end point of the string and the second contact point, and the upper half moon cup C2 is centered on the second contact point Symmetrical form. Preferably, the upper half moon cup further comprises a rectangular area, and the height of the rectangular area is between 3 cm and 5 cm.

Among them, according to the basic formula of the arc curve: , D: arc curve drawn with diameter D, D _ref : arc curve drawn with diameter D _ref . The circle formed by the diameter D and the diameter D _ref is a concentric circle. Because the diameter of the artery is small, the diameter of the stent is small, generally about D _ref = 20mm, so the formula is set to 20mm, based on D _ref as the reference, the arc curve can be set to the diameter D, and the ratio is enlarged and reduced, each arc curve Still concentric. (D / D _ref ) is based on the diameter of the child's arteries, and the ratio is enlarged and reduced. The ± k parameter determines the arc curve with the opening up or down. +k indicates that the arc curve opening is upward, and -k indicates that the arc curve opening is downward. The basic formula draws an arc curve, and draws the arc curves of the first and second quadrants to the left and right based on the origin 0, that is, x Î [-W1 , +W1].

Therefore, the arc C1 defining the lower half of the moon cup is , The arc C2 of the first half moon cup is For children, the k value is between 1.90 and 1.75, and for adults, the k value is between 1.75 and 1.40.

Where the C2 arc curve is in the third and fourth quadrants, After finding the minimum value of the arc curve, move the C2 arc curve to the first and second quadrants.

Because there are three artificial valves, it is necessary to design the joint, and then move the C2 arc curve to a height of about 2H1 to form a rectangular area. Therefore, the arc C2 of the upper half of the moon cup is corrected to .

Referring to Figures 6A and 6B, the pressure and flow rate curves of the blood flowing through the normal valve, the prosthetic valve of the present invention, and the insufficiency of the valve are simulated, and the pumping rate is 80 bpm. The volume (pumping SV, stoke volume) was tested at 40 ml. Wherein, the valve of the present invention is relatively incompletely blocked, the average pulmonary artery pressure can be increased from 10.2 mmHg to 14.4 mmHg, and the artificial valve of the present invention can effectively reduce the backflow condition in terms of the flow rate.

The above method can be written as an application for execution by a computer, and the application is a program product of the present invention.

The artificial trilobal valve valve tube designed and manufactured by the above method is the artificial valve of the present invention.

The artificial valve of the present invention is combined with a stent body to constitute the artificial stent of the present invention, and the combined relationship is as shown in the eleventh and twelfth figures of the artificial valve proposed by the inventors of the present invention, and thus the depiction is not repeated.

In view of the foregoing description of the embodiments, the operation and the use of the present invention and the effects of the present invention are fully understood, but the above described embodiments are merely preferred embodiments of the present invention, and the invention may not be limited thereto. Included within the scope of the present invention are the scope of the present invention.

(A) ‧ ‧ half-moon valve

(B) ‧ ‧ valves

(B1)‧‧‧The second half of the cup

(B2) ‧ ‧ first half of the month cup

[First figure] is a developed plan view of the artificial trilobal valve valve of the present invention.

[Second Picture] is one of the schematic diagrams for calculating H2 in the design method of the present invention.

[Third image] is the second schematic diagram of calculating H2 in the design method of the present invention.

[Fourth figure] is the third schematic diagram of calculating H2 in the design method of the present invention.

[fifth A] is one of the schematic diagrams of obtaining the upper half moon cup and the lower half moon cup of the artificial valve by the arc curve formula.

[Fifth B] is the second schematic diagram of the upper half moon cup and the lower half moon cup of the artificial valve obtained by the arc curve formula.

[Fifth C] is the third schematic diagram of the upper half moon cup and the lower half moon cup of the artificial valve obtained by the arc curve formula.

[Sixth A] is a pressure curve simulating blood flow through a normal valve, a prosthetic valve of the present invention, and a valve with incomplete locking.

[Sixth B] is a flow rate graph simulating the flow of blood through a normal valve, the prosthetic valve of the present invention, and the insufficiency of the valve.

[Seventh] is a developed plan view of a conventional trilobal valve valve tube having three half-moon valves.

[Eighth image] is a schematic view of one of the perspectives of a conventional trilobal valve valve tube having three half-moon valves.

[Ninth view] is another schematic view of a conventional trilobal valve valve tube having three half-moon valves.

[10th] is a developed plan view of the artificial trilobal valve valve tube proposed by the inventor of the present invention.

[11th] is a schematic view of one of the perspective views of the artificial trilobal valve valve tube proposed by the inventor of the present invention.

[Twelfth Figure] is a schematic view of another perspective view of the artificial trilobal valve valve tube proposed by the inventor of the present invention.

Claims (7)

A method for designing a customized artificial valve, the artificial valve being a trilobal valve valve tube, the design method comprising the following steps: A. measuring an artery width D' of a patient, taking the artery width D' 1.1 The width to 1.2 times is a design width D; B. The circumference of one circle formed by the design width D is P=πD, so a valve width of one of the valves of the trilobal valve tube is W=P/3 C. taking the valve width W as a chord of another circle, obtaining a diameter H perpendicular to the bisector of the chord on the other circle, at which the bisector of the chord and one of the chords are formed A vertical distance of a first contact of the short arc is H1, and a half moon cup is drawn according to the end point of the string and the first contact point, and the lower half moon cup is symmetrically centered on the first contact point. The vertical distance H1 has a value between 3 cm and 5 cm; a perpendicular distance between the bisector of the string and a second contact of the long arc of the chord is H2, according to the end of the chord Forming a first half moon cup with the second joint, the upper half moon cup being symmetrically centered on the second joint, wherein: the lower half moon cup Arc C1 is , , W1=W/2; the arc C2 of the upper half of the moon cup is , k = 1.4 to 1.9; D: arc curve drawn with diameter D; D _ref : arc curve drawn with diameter D _ref . The method for designing a customized artificial valve according to claim 1, wherein D _ref is 20. The method for designing a customized artificial valve as described in claim 1, wherein when the design width D is less than 25 mm, let H = H1 + H2. The method for designing a customized artificial valve as described in claim 1, wherein when the design width D is greater than 25 mm, let H = H1 + 0.2887 πD. A custom-made prosthetic valve is a trilobal valve valve tube designed by a method for designing a customized prosthetic valve according to any one of claims 1 to 4. An artificial stent incorporating a prosthetic valve, comprising a stent body, and a prosthetic valve as described in claim 5 of the patent application is incorporated on the stent body. A program product is a method of designing a customized prosthetic valve as described in any one of claims 1 to 4 after being installed in a computer.