KR-20260066811-A - SYSTEMS AND METHODS FOR SIZING AND IMPLANTING PROSTHETIC HEART VALVES

Abstract

A method for implanting an artificial heart valve includes the step of selecting an artificial heart valve. The selected artificial heart valve has a nominal diameter that is 40% or less larger than the natural valve annulus diameter. The method further includes the steps of compressing the selected artificial heart valve into a radial compression configuration in which the selected artificial heart valve has a first diameter smaller than the nominal diameter, placing the selected artificial heart valve within the natural valve annulus, and expanding the selected artificial heart valve from the radial compression configuration into a radial expansion configuration in which the selected artificial heart valve has a second diameter that is 10% or less smaller than the nominal diameter and larger than the first diameter.

Inventors

• 비알리스 마이클 알
• 제라드 로버트 제임스
• 세네쉬 길

Assignees

• 에드워즈 라이프사이언시스 코포레이션

Dates

Publication Date

20260512

Application Date

20190828

Priority Date

20190826

Claims (1)

1. This is a method of selecting an artificial heart valve by a computing system: Step of taking an image of the natural heart valve annulus; A step of obtaining measurements of the natural heart valve annulus from an image and calculating the natural valve annulus area and natural valve annulus diameter based on the obtained measurements; A step of determining which of the multiple artificial heart valves covers the determined natural valve annulus area; A step of analyzing the hemodynamic data of each artificial heart valve among a plurality of artificial heart valves covering a determined natural valve annulus area; It includes the step of selecting an artificial heart valve based on analyzed hemodynamic data, and A method in which an artificial heart valve is balloon-inflatable, and a step of determining which of a plurality of artificial heart valves covers a determined natural annulus area includes determining an artificial heart valve having an expansion diameter larger than the determined natural annulus diameter.

Description

Systems and Methods for Size Determination and Implantation of Prosthetic Heart Valves The present disclosure relates to an artificial heart valve as well as an embodiment of a system and method related thereto. The human heart can suffer from various valvular diseases. These valvular diseases can lead to significant heart dysfunction and ultimately require the replacement of natural valves with artificial valves. There are a large number of known artificial valves and a large number of known methods for human implantation of these artificial valves. FIGS. 1a and FIGS. 1b are perspective views of an artificial heart according to one embodiment. Fig. 1c is an enlarged perspective view of the region below one of the commissures of the artificial heart valves in Fig. 1a and Fig. 1b. Figure 2 is a side elevation view of the sealing member of the artificial heart valve of Figure 1. Figure 3 is a cross-sectional perspective view of the sealing member of Figure 1. Figure 4 is a cross-sectional view of the artificial heart valve of Figure 1, illustrating the flow of reverse blood through the valve. Fig. 5 is an enlarged perspective view showing a portion of the inner side of the artificial heart valve of Fig. 1. FIG. 6 illustrates a strip of fabric that can be used to form a sealing member, such as the sealing member of FIG. 3. FIGS. 7a and 7b are perspective views of an exemplary tubular body that can be used to form a sealing member for an artificial heart valve. FIG. 8 is a perspective view of a partially assembled artificial heart valve illustrating the attachment of a valve tip using a connecting skirt according to one embodiment. Fig. 9 is a plan view of the valve tip and connecting skirt used in the artificial heart valve of Fig. 8. FIGS. 10, FIGS. 10a, FIGS. 11a, and FIGS. 11b are various drawings illustrating the attachment of the valve tip and connecting skirt of FIG. 9. FIGS. 12, FIGS. 12a, and FIGS. 12b are various drawings illustrating the connection of the connecting skirt of FIG. 9 to the frame of the artificial valve of FIG. 8. FIG. 13a is a perspective view of a frame of an artificial heart valve and a valve tip mounted inside the frame, according to one embodiment. Fig. 13b is an enlarged view of part of the frame of Fig. 13a and one of the valve tips. FIG. 14 is a plan view of a valve tip that can be used in an artificial heart valve according to one embodiment. FIGS. 15a, FIGS. 15b, FIGS. 15c, FIGS. 15d, FIGS. 16, FIGS. 17, FIGS. 18, FIGS. 19, FIGS. 20, FIGS. 21, FIGS. 22, and FIGS. 23 illustrate various ways of connecting the apex of a valve tip to the frame of an artificial heart valve using a connecting skirt. FIG. 24 is an enlarged perspective view of the inner side of an artificial heart valve illustrating a different method of connecting the apex of the valve tip to the frame of the valve. FIGS. 25a, FIGS. 25b, FIGS. 26, FIGS. 27, FIGS. 28, FIGS. 29, FIGS. 30, FIGS. 31, and FIGS. 32 illustrate alternative methods of connecting the apical soft portion of the valve tip to the frame of an artificial heart valve, with and without a connecting skirt. FIG. 33 is a plan view of a valve tip that can be used in an artificial heart valve according to one embodiment. FIGS. 34, 35, and 36 illustrate the formation of a single-half body of a joint using the valve tip of FIG. 33 according to one embodiment. FIG. 37 is a cross-sectional view of a joint formed with two valve tips of the type shown in FIG. 33, according to one embodiment. FIG. 38 is a cross-sectional view of a joint formed with two valve tips of the type shown in FIG. 33, according to another embodiment. FIG. 39 is a plan view of a valve tip that can be used in an artificial heart valve according to another embodiment. FIG. 40 is a plan view of a valve tip that can be used in an artificial heart valve according to another embodiment. FIGS. 41, FIGS. 42, FIGS. 43, FIGS. 44, and FIGS. 45 illustrate the formation of a joint formed by two valve tips of the type shown in FIG. 40, according to one embodiment. FIG. 46 is a cross-sectional view of a joint formed with two valve tips of the type shown in FIG. 40, according to one embodiment. FIG. 47 is a cross-sectional view of a joint formed with two valve tips of the type shown in FIG. 33, according to another embodiment. FIG. 48 is a cross-sectional view of a joint formed with two valve tips of the type shown in FIG. 40, according to another embodiment. FIG. 49 is a plan view of a valve tip that can be used in an artificial heart valve according to another embodiment. FIGS. 50 and 51 are cross-sectional views of two embodiments of a joint formed with two flap tips of the type shown in FIG. 49. FIGS. 52, FIGS. 53, FIGS. 54, and FIGS. 55 are various drawings illustrating the attachment of the artificial heart valve frame of FIG. 50 or FIG. 51 to the commissure of FIG. 51 using a commissure attachment member. FIG. 56 is a cross-sectional view of another embodiment of a joint formed with two valve tip