Heart valve holder and method of use

Abstract

A heart valve holder for holding a prosthetic heart valve and a method for implanting a prosthetic heart valve are disclosed, the heart valve holder comprising a hollow structure having a cross-section mimicking the shape of the annulus of the prosthetic heart valve and including a top surface, a platform extending from at least one wall of the hollow structure and including a first connecting element, and at least one fixation element formed in the top surface of the hollow structure and including at least one fixation hole for suturing the prosthetic heart valve to the heart valve holder.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to Singapore Application No. 10202110635Q filed on September 24, 2021, the entire disclosure of which is incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices for holding prosthetic heart valves. In particular, the present disclosure relates to a heart valve holder for holding a prosthetic heart valve and a method of using the heart valve holder. [Background technology]

[0003] In heart valve replacement surgery, an artificial heart valve, also known as a prosthetic heart valve, is attached to the annulus of a human heart to replace a native valve in the human heart that is not functioning properly. A heart valve holder is used to prevent contamination and ensure patient safety when introducing or implanting a new prosthetic heart valve during surgery. The heart valve holder is used to transport the prosthetic heart valve from its packaging and place it in the heart for implantation. The heart valve holder also provides support for the surgeon to hold the prosthetic heart valve in the correct position as it replaces the native heart valve.

[0004] Existing artificial heart valve holders are designed to be used in combination with existing biological and mechanical heart valve prostheses, which have rigid circular annuli and do not contain chordae, whereas natural human heart valves have an asymmetric shape, are not rigid, and have chordae that connect the valve cusps to the papillary muscles.

[0005] The applicant's U.S. Patent No. 10,709,560, granted on July 14, 2020, and U.S. Patent Publication No. 2019 / 0321168, published on October 24, 2019, describe a naturally designed prosthetic mitral heart valve, the disclosures of which are incorporated herein by reference. This naturally designed prosthetic mitral heart valve is designed to mimic the natural mitral heart valve and includes two flexible leaflets and an asymmetric, flexible, flexible ring, which can move with the natural distortion of the myocardium during the cardiac cycle. A cord similar to the patient's natural chordae tendineae is incorporated into the prosthetic mitral heart valve to mimic the natural prevention of blood backflow into the atrium and provide support to the left ventricle during systole. However, existing prosthetic heart valve holders are not suitable for use with such naturally designed prosthetic mitral heart valves designed to mimic the natural mitral heart valve because their shape is not natural and they cannot accommodate the cord. Additionally, a naturally designed prosthetic mitral heart valve must have minimal physical connections to any external products and must not have any contact with the area where the prosthesis is implanted.

[0006] It is therefore desirable to provide an improved heart valve holder and valve deployment system for use with prosthetic heart valves designed to mimic a native heart valve. Summary of the Invention

[0007] The present disclosure discloses a heart valve holder and a container for storing the heart valve holder. The heart valve holder and container have several advantages over existing heart valve holders and containers. First, the disclosed heart valve holder provides stable support and can be placed in the container without moving to prevent damage during transportation. The disclosed heart valve holder and container are easy for the manufacturer to assemble and easy for the surgeon to disassemble during surgery. Furthermore, the disclosed heart valve holder does not physically contact the portion of the heart where the prosthetic mitral heart valve is attached.

[0008] According to one embodiment of the present disclosure, a heart valve holder for holding a prosthetic heart valve is provided. The heart valve holder includes a hollow structure having a cross section that mimics the shape of the annulus of the prosthetic heart valve and includes a top surface, a platform extending from at least one wall of the hollow structure and including a first connecting element, and at least one fixation element formed on the top surface of the hollow structure and including at least one fixation hole for suturing the prosthetic heart valve to the heart valve holder. Optionally, the cross section may be D-shaped to mimic the shape of the annulus of the prosthetic heart valve, and the annulus of the prosthetic heart valve mimics the shape of a mitral valve annulus. Optionally, the heart valve holder may be dimensioned to fit within the prosthetic heart valve. Optionally, the hollow structure may be a tapered tube that tapers from the top of the hollow structure to the bottom of the hollow structure. Optionally, the at least one fixation element may be positioned to correspond to an anterior commissure, a posterior commissure, a midpoint of a posterior leaflet, or a midpoint of an anterior leaflet.

[0009] According to some embodiments, the heart valve holder may further comprise at least one leg at the bottom of the hollow structure, the at least one leg comprising at least one fixation hole for suturing the prosthetic heart valve to the heart valve holder. Optionally, the at least one leg may be positioned to correspond to a papillary muscle of the left ventricle of the heart.

[0010] According to some embodiments, the heart valve holder may further include a handle including a second connection element connected to the first connection element. Optionally, the handle may include a rod. Optionally, the handle may include a flexible section. Optionally, the handle may include a ruler section. Optionally, the second connection element may include a threaded portion for attachment to the first connection element. Optionally, the platform may further include a third connection element. Optionally, the heart valve holder may further include a support structure including a fourth connection element connected to the third connection element. Optionally, the fourth connection element may include a threaded top for attachment to the third connection element. Optionally, the fourth connection element may include a recess for receiving the third connection element. Optionally, the third connection element may include an extension arm for securing the fourth connection element.

[0011] According to one embodiment of the present disclosure, a method for implanting a prosthetic heart valve is provided, comprising the steps of: setting a heart valve holder for holding the prosthetic heart valve, the heart valve holder having a cross section that mimics the shape of the annulus of the prosthetic heart valve, the heart valve holder including a hollow structure having an upper surface, a platform extending from at least one wall of the hollow structure and including a first connection element, and at least one fixing element formed on the upper surface of the hollow structure, the platform including at least one fixing hole for suturing the prosthetic heart valve to the heart valve holder; setting a handle including a second connection element, connecting the handle to the heart valve holder, mounting the prosthetic heart valve to the heart valve holder, attaching at least one suture wire between the heart and the prosthetic heart valve, and sliding the prosthetic heart valve into the heart along the at least one suture wire. Optionally, the step of mounting the prosthetic heart valve may include attaching the prosthetic heart valve to the heart valve holder using a single suture. Optionally, the method may further include measuring the heart using a ruler on the handle. Optionally, the method may further include positioning the prosthetic heart valve in the heart using marked landmarks on a native valve annulus, and tying the at least one suture wire to attach the prosthetic heart valve to the heart. [Brief description of the drawings]

[0012] In order to better understand the present disclosure and appreciate its practical application, the following drawings are provided and referenced below. It should be noted that these drawings are provided by way of example only and are not intended to limit the scope of the present invention.

[0013] [Figure 1] 1A-1D are schematic diagrams illustrating a device for holding and transporting a prosthetic heart valve according to some embodiments of the present disclosure. [Figure 2A] FIG. 2 is a schematic diagram of a front perspective view of a heart valve holder according to some embodiments of the present disclosure. [Figure 2B]FIG. 1 is a bottom perspective view of a heart valve holder according to some embodiments of the present disclosure. [Figure 3A] FIG. 1 is a schematic diagram of a top view of a prosthetic heart valve mounted on a heart valve holder according to some embodiments of the present disclosure. [Figure 3B] FIG. 1 is a schematic diagram of a front perspective view of a prosthetic heart valve mounted on a heart valve holder according to some embodiments of the present disclosure. [Figure 4] 1 is a schematic diagram of a tapered portion of a heart valve holder according to some embodiments of the present disclosure. [Diagram 5] FIG. 2 is a schematic diagram of a vertical cross section of a first alternative heart valve holder according to some embodiments of the present disclosure. [Figure 6] FIG. 13 is a schematic diagram of a top perspective view of a second alternative heart valve holder according to some embodiments of the present disclosure. [Figure 7A] FIG. 13 is a schematic diagram of a front perspective view of a third alternative heart valve holder according to some embodiments of the present disclosure. [Figure 7B] FIG. 13 is a schematic representation of a top view of a third alternative heart valve holder. [Figure 7C] FIG. 13 is a schematic diagram of a vertical cross-sectional view (section DD) of a third alternative heart valve holder according to some embodiments of the present disclosure. [Figure 8] FIG. 1 is a schematic diagram of a handle according to some embodiments of the present disclosure. [Figure 9] FIG. 1 is a schematic diagram of a first alternative handle according to some embodiments of the present disclosure. [Figure 10] FIG. 13 is a schematic diagram of a second alternative handle according to some embodiments of the present disclosure. [Figure 11] FIG. 13 is a schematic diagram of a third alternative handle according to some embodiments of the present disclosure. [Figure 12] 1 is a schematic diagram of a support structure for supporting a heart valve holder according to some embodiments of the present disclosure. [Figure 13] 1 is a schematic diagram of a support structure for supporting a heart valve holder according to some embodiments of the present disclosure. [Figure 14] 1 is a schematic diagram of a support structure and a heart valve holder inserted into a container for shipping according to some embodiments of the present disclosure. [Figure 15A] FIG. 1 is a schematic diagram of a first alternative support structure for supporting a heart valve holder according to some embodiments of the present disclosure. [Figure 15B] 1 is a schematic diagram of a first alternative support structure according to some embodiments of the present disclosure. [Figure 16A] FIG. 13 is a schematic diagram of a front perspective view of a second alternative support structure for supporting a heart valve holder according to some embodiments of the present disclosure. [Figure 16B] FIG. 13 is a schematic diagram of a vertical cross section of a second alternative support structure showing a heart valve holder held by the second alternative support structure. [Figure 16C] FIG. 13 is a schematic diagram of a vertical cross section of a second alternative support structure showing the heart valve holder with the tip of the handle. [Figure 16D] FIG. 13 is a schematic diagram of a vertical cross section of a second alternative support structure showing a heart valve holder having an extension arm disengaged from the second alternative support structure according to some embodiments of the present disclosure. [Figure 16E] FIG. 13 is a schematic diagram of a vertical cross section of the second alternative support structure, showing a heart valve holder removed from the second alternative support structure, according to some embodiments of the present disclosure. [Figure 17] 1A-1D are schematic diagrams of a process of implanting a prosthetic heart valve in a patient's heart using a heart valve holder according to some embodiments of the present disclosure.

[0014] Identical or overlapping or equivalent or similar structures, elements or parts that appear in more than one drawing are generally labeled with the same reference numeral, may be labeled with an optional additional character to distinguish between similar entities or variations of entities, and may not be repeatedly labeled or described. References to previously presented elements are implicit without necessarily further citation to the drawing or description in which they appear. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. Additionally, detailed descriptions of well-known methods, procedures, components, modules, units and / or circuits are omitted so as not to obscure the present invention.

[0016] Dimensions of components and features shown in the figures have been chosen for convenience or clarity of presentation and are not necessarily shown to scale or according to actual perspective. For convenience or clarity, some elements or structures are not shown or are shown only in part and / or in a different perspective or from a different viewpoint.

[0017] As used herein, the terms "plurality" and "a plurality" may include, for example, "multiple" or "two or more than two", although embodiments of the present invention are not limited thereto. The terms "plurality" and "a plurality" may be used throughout this specification to describe two or more components, devices, elements, units, parameters, etc. Unless expressly stated, the method embodiments described herein are not limited to a particular order or sequence. Furthermore, some of the described method embodiments or elements thereof may occur or be performed simultaneously, contemporaneously, or synchronously. Unless otherwise stated, the conjunction "or" as used herein is to be understood as inclusive (any or all of the described alternatives).

[0018] With particular reference to the drawings in detail, it is emphasized that the particulars shown are given by way of example and for the purpose of an illustrative discussion of embodiments of the present disclosure, in which regard the description together with the drawings will make apparent to those skilled in the art how embodiments of the present disclosure may be practiced.

[0019] FIG. 1 is a schematic diagram of a device 100 for holding and transporting a prosthetic heart valve according to some embodiments of the present disclosure. An operator uses the device 100 to load and transport a prosthetic heart valve. The device 100 can be used to transport the prosthetic heart valve from its packaging and load it into the heart for implantation. The device 100 can include a heart valve holder 200 and a handle 700. The heart valve holder 200 and the handle 700 can be removably attached to each other using a threaded mechanism or any other suitable mechanism. In some embodiments, the heart valve holder disclosed in the present disclosure, such as the heart valve holder 200, can be designed to be suitable for holding any prosthetic heart valve, including biological and mechanical heart valves. In some embodiments, the prosthetic heart valve can be a mitral valve prosthesis that mimics the native mitral valve, the mitral valve prosthesis having an annulus that mimics the shape of the native mitral valve annulus. In some embodiments, the prosthetic heart valve may be attached to the heart valve holder 200 using a suture, such as a single safety suture 320 (see FIGS. 3A and 3B). In some embodiments, an operator can attach a handle 700 to the heart valve holder 200 and hold the handle 700 to transport the heart valve holder 200 with the prosthetic heart valve attached. The handle 700 allows the surgeon or user to control the heart valve holder 200 to precisely deliver, handle, and implant the prosthetic heart valve.

[0020] FIG. 2A is a schematic diagram of a front perspective view of a heart valve holder 200 according to some embodiments of the present disclosure, and FIG. 2B is a bottom perspective view of the heart valve holder 200 according to some embodiments of the present disclosure. The heart valve holder 200 holds a prosthetic heart valve for transport to a heart for implantation during a heart valve replacement procedure. The heart valve holder 200 may be made of materials such as polypropylene, polyetherketoneketone, acrylonitrile-butadiene-styrene, or ABS and Delrin (a synthetic polymer or polyoxymethylene from DuPont). In some embodiments, the polypropylene, polyetherketoneketone, ABS and Delrin (polyoxymethylene) may be medical grade polypropylene, polyetherketoneketone, ABS and Delrin (polyoxymethylene). In some embodiments, the polypropylene, polyetherketoneketone, ABS and Delrin (polyoxymethylene) may be biocompatible polypropylene, polyetherketoneketone, ABS and Delrin (polyoxymethylene). In some embodiments, the biocompatible material may conform to United States Pharmacopoeia (USP) Class VI or ISO 10993-1. The heart valve holder 200 is a hollow structure with a cross-section that mimics the shape of the annulus 308 of the prosthetic heart valve 304 (see FIGS. 3A and 3B). In some embodiments, the heart valve holder 200 may have a cross-section that mimics the shape of the annulus of the prosthetic heart valve, which mimics the shape of the annulus of the native heart valve. In some embodiments, if the heart valve holder 200 is configured to hold a mitral valve prosthesis, the heart valve holder 200 may have a D-shaped cross-section that mimics the shape of the annulus of the mitral valve prosthesis, which mimics the shape of the native mitral valve annulus. In some embodiments, the heart valve holder 200 may have a non-circular cross-section. In some embodiments, the heart valve holder 200 may be a hollow tapered tube with a horizontal cross-section that mimics the general shape of the annulus of a prosthetic heart valve with an annulus that mimics the shape of the annulus of the native heart valve.In some embodiments, the heart valve holder 200 may include an anterior side 204 that mimics the anterior annulus of a mitral valve prosthesis having an annulus that mimics the shape of the native mitral valve annulus, and a posterior side 208 that mimics the posterior annulus of a mitral valve prosthesis having an annulus that mimics the shape of the native mitral valve annulus, tapering from an apex 212 of the heart valve holder 200 to a bottom 216 of the heart valve holder 200. When orienting the heart valve holder 200, the midpoint of the anterior side 204 may be defined as the 12 o'clock position of the heart valve holder 200, and the midpoint of the posterior side 208 may be defined as the 6 o'clock position of the heart valve holder 200. In some embodiments, the cross section of the heart valve holder 200 may uniformly taper between the apex 212 and the bottom 216. In other embodiments, the cross section of the heart valve holder 200 may taper at various gradients between the apex 212 and the base 216 (see FIG. 4). In some embodiments, the heart valve holder 200 may be sized to fit within the prosthetic heart valve 304 such that the prosthetic heart valve 304 may be suspended outside the heart valve holder 200 when secured to the heart valve holder 200 (see FIGS. 3A and 3B). In some embodiments, the heart valve holder 200 may have a height between 20-30 mm, preferably 28 mm, from the apex 212 to the base 216. In some embodiments, the heart valve holder 200 may have a wall thickness between 0.5-2 mm, preferably 1 mm. In some embodiments, the cross section of the apex 212 of the heart valve holder 200 for a mitral valve prosthesis that mimics the native mitral valve may have a width that mimics the anterior-lateral-posterior-medial diameter distance of the mitral valve and a length that mimics the anterior-posterior diameter of the mitral valve annulus. In some embodiments, the apex 212 may be between 18-30 mm wide, preferably 25 mm. In some embodiments, the heart valve holder 200 may be 28 mm wide at the apex 212 for a CC36 size heart valve, and 25 mm wide for a CC32 size heart valve. In some embodiments, the heart valve holder 200 may be between 20-35 mm long, preferably 26 mm long.

[0021] In some embodiments of the present disclosure, the top 212 of the heart valve holder 200 may include a platform 220 extending into the hollow heart valve holder 200 from at least one wall of the hollow heart valve holder 200. In some embodiments, the platform 220 may start at the front side 204 of the heart valve holder 200. In other embodiments, the platform 220 may start at the rear side 208 of the heart valve holder 200. In other embodiments, the platform 220 may extend from the front side 204 to the rear side 208 of the heart valve holder. Alternatively, the platform 220 may be positioned laterally on the heart valve holder 200. Preferably, the platform 220 is at the same level as the top 212 of the heart valve holder 200 and does not protrude above the top 212 of the heart valve holder 200, but in some embodiments, the platform 220 may also protrude above the top 212 of the heart valve holder 200. In some embodiments, the platform 220 may include a first connecting element 224 for connecting to a second connecting element 728 of the handle 700 (see FIGS. 7-10). In some embodiments, the first connecting element 224 may be a threaded hole 224 and the second connecting element 728 may be a threaded portion 728, the threaded hole 224 adapted to receive the threaded portion 728 of the handle 700 (see FIGS. 7-10). The threaded hole 224 may have an internal thread adapted to receive the external thread of the threaded portion 728 and may be shaped to connect and fasten the handle 700 to the heart valve holder 200 by rotating the handle 700 clockwise. In some embodiments, the platform 220 may have a length between 12-23 mm, preferably 16.5 mm. In some embodiments, the platform 220 may have a thickness between 5-10 mm, preferably 6.5 mm. In some embodiments, the platform 220 may have a width between 5-15 mm, preferably 8 mm. In some embodiments, the screw holes 224 may extend through the thickness of the platform 220, but in other embodiments, the screw holes 224 may also terminate within the platform 220 (see FIG. 5).In some embodiments, the threaded hole 224 may be between 3-8 mm in diameter, preferably 4 mm. In some embodiments, the platform 220 may have a ridge 232 extending below the platform 220, the ridge 232 including a third connection element 236 for connecting to a fourth connection element 1108 of the support structure 1100 (see FIGS. 11 and 12). In some embodiments, the third connection element 236 may be aligned with the first connection element 224. In some embodiments, the third connection element 236 may be a threaded hole 236 and the fourth connection element 1108 may be a threaded top 1108 on the post 1104, the threaded hole 236 adapted to receive the threaded top 1108 of the post 1104 of the support structure 1100 (see FIGS. 11 and 12). Preferably, the threaded hole 236 has an internal thread adapted to receive the external thread of the threaded top 1108. In some embodiments, the threaded hole 236 may have a diameter corresponding to the diameter of the screw hole 224. Alternatively, the threaded hole 236 may have a diameter different from the diameter of the screw hole 224. The threaded hole 236 may have a diameter larger or smaller than the diameter of the screw hole 224. In some embodiments, the screw hole 224 may have a diameter of 4.7 mm and the threaded hole 236 may have a diameter of 4.7 mm. In some embodiments, the third connection element may include an extension arm that can be deflected outwardly when fastening the connection between the first connection element and the second connection element (see FIGS. 16B-16E). In such embodiments, the arm of the third connection element disengages the third connection element from the fourth connection element, thereby allowing the valve holder or the valve holder and prosthetic valve to be lifted and removed from the support structure. It should be understood that in such embodiments, the third connection element may be made of a flexible material that allows for deflection as described above and may be shaped to allow for deflection as described above. In some embodiments, the support structure as defined herein may be referred to as a "carrier."

[0022] In some embodiments of the present disclosure, the top 212 of the heart valve holder 200 may further include at least one fixation element 240 formed on the top surface 238 of the top 212. The fixation element 240 may be shaped as a block or other suitable shape. In some embodiments, there may be three fixation elements 240a, 240b and 240c. In some embodiments, there may be a fourth fixation element 240d. In some embodiments, the fixation elements 240 may extend 1-3 mm, preferably 2 mm, above the top surface 238 of the heart valve holder 200. In other embodiments, the fixation elements 240 may be embedded within the top 212 or the body of the heart valve holder 200. The fixation elements 240 may each include at least one fixation hole 244. In some embodiments, the fixation elements 240a and 240b may each have two fixation holes 244, and the fixation element 240c may have four fixation holes 244. In other embodiments, the fixation element 240a, the fixation element 240b, and the fixation element 240c may each have four fixation holes 244. Preferably, when the fixation element 240 has multiple fixation holes 244, the fixation holes 244 of the fixation element 240 are arranged parallel to the top 212 of the heart valve holder 200. In some embodiments, the first fixation element 240a may be located at a 10 o'clock position on the heart valve holder 200, the second fixation element 240b may be located at a 2 o'clock position on the heart valve holder 200, and the third fixation element 240c may be located at a 6 o'clock position on the heart valve holder 200. In some embodiments, the first fixation element 240a may be located at a position corresponding to the anterior commissure of the native mitral valve, the second fixation element 240b may be located at a position corresponding to the posteromedial commissure of the native mitral valve, and the third fixation element 240c may be located at a position corresponding to the midpoint of the posterior leaflet of the native mitral valve. In other embodiments, the fourth fixation element 240d may be at a location corresponding to the midpoint of the anterior leaflet of the native mitral valve.Preferably, the fixation holes 244 of the fixation element 240 are adapted to receive security sutures 320 used to attach the annulus 308 of the prosthetic heart valve 304 to the heart valve holder 200, thereby firmly securing the prosthetic heart valve 304 to the heart valve holder 200 (see Figures 3A and 3B).

[0023] In some embodiments of the present disclosure, the bottom 216 of the heart valve holder 200 may include at least one leg 248. The at least one leg 248 may be between 5-10 mm in length, preferably 8 mm. The at least one leg 248 may include a hole to advantageously reduce the total weight of the heart valve holder 200. Preferably, if there are two legs 248, the legs 248 are located on either side of the width of the bottom 216 of the heart valve holder 200 such that the tips 252 of the legs 248 are aligned with the positions of the papillary muscles of the heart. In some embodiments, the distance between the legs 248 may be between 12-24 mm, preferably 20 mm. In some embodiments, each of the legs 248 may be aligned with the positions of the papillary muscles of the left ventricle of the heart. In some embodiments, the first leg 248a may be aligned with the posterior papillary muscle of the left ventricle and the second leg 248b may be aligned with the anterior papillary muscle of the left ventricle. In some embodiments, each of the at least one leg 248 may include two fixation holes 244 that are adapted to receive a security suture 320 used to attach the cord 316 of the prosthetic heart valve 304 to the leg 248, thereby securely securing the cord 316 of the prosthetic heart valve 304 to the heart valve holder 200 (see Figures 3A and 3B).

[0024] 3A is a schematic diagram of a top view of a prosthetic heart valve 304 mounted on a heart valve holder 200 according to some embodiments of the present disclosure, and FIG. 3B is a schematic diagram of a front perspective view of a prosthetic heart valve 304 mounted on a heart valve holder 200 according to some embodiments of the present disclosure. The prosthetic heart valve 304 may include an annulus 308, cusps 312 and cords 316. The prosthetic heart valve 304 may be attached to the heart valve holder 200 via a safety suture 320 that passes through various fixation holes 244 in the prosthetic heart valve 304 and the heart valve holder 200. The safety suture 320 may be a loop that attaches the prosthetic heart valve 304 to the heart valve holder 200. In some embodiments, the safety suture 320 may be looped from the first fixation element 240a, through the first leg 248a, the third fixation element 240c, the second leg 248b, the second fixation element 240b, the third fixation element 240c, and back to the first fixation element 240a. In some embodiments, the security suture 320 first enters the annulus 308 of the prosthetic heart valve 304 through the fixation hole 244a of the first fixation element 240a, passes inwardly towards and out of the fixation hole 244b of the first leg 248a to secure the chord 316 of the prosthetic heart valve 304, passes inwardly through the fixation hole 244k of the first leg 248a, passes outwardly through the fixation hole 244i of the third fixation element 240c to secure the annulus 308 of the prosthetic heart valve 304, passes inwardly through the fixation hole 244h of the third fixation element 240c, and passes outwardly through the fixation hole 244f of the second leg 248b to secure the chord 316 of the prosthetic heart valve 304. The safety suture 320 may be connected to the start of the safety suture 320 in the fixing hole 244a of the first fixation element 240a, passing inward through the fixing hole 244c of the second leg 248b, passing outward through the fixing hole 244d of the second fixation element 240b to secure the annulus 308 of the prosthetic heart valve 304, passing inward through the fixing hole 244e of the second fixation element 240b, passing outward through the fixing hole 244g of the third fixation element 240c to secure the annulus 308 of the prosthetic heart valve 304, passing inward through the fixing hole 244j of the third fixation element 240c, passing outward through the fixing hole 2441 of the first fixation element 240a. Preferably, the safety suture 320 should be straight and taut to secure the prosthetic heart valve 304 to the heart valve holder 200 and prevent movement.Once the prosthetic heart valve 304 has been transplanted into the patient's heart, the surgeon can retract the entire device 100 along the security sutures 320 by cutting the security sutures 320 .

[0025] FIG. 4 is a schematic diagram of a tapered portion of a heart valve holder 200 according to some embodiments of the present disclosure. The heart valve holder 200 may taper with a first slope X between the top 212 and a midpoint 404 of the heart valve holder 200 where the legs 248 are connected to the heart valve holder 200. The heart valve holder 200 may further taper with a second slope Y between the midpoint 404 and a bottom 216 of the heart valve holder where the tip 252 of at least one leg 248 is located. In some embodiments, the first slope X may be different between the front side 204 and the rear side 208 of the heart valve holder 200. In some embodiments, the first slope X may be between about 5° and about 15°, preferably 10.47°, at the front side 204 of the heart valve holder 200, while the first slope X may be between about 5° and about 15°, preferably 10.78°, at the rear side 208 of the heart valve holder 200. In some embodiments, the second gradient Y may be different between the front side 204 and the rear side 208 of the heart valve holder 200. In some embodiments, the second gradient Y may be between about 5° and about 25°, preferably 21.52°, at the front side 204 of the heart valve holder 200, but between about 10° and about 30°, preferably 26.99°, at the rear side 208 of the heart valve holder 200. In other embodiments, the first gradient X may be the same at the front side 204 and the rear side 208 of the heart valve holder 200. In yet other embodiments, the second gradient Y may be the same at the front side 204 and the rear side 208 of the heart valve holder 200.

[0026] 5 is a schematic diagram of a vertical cross section of a first alternative heart valve holder 200a according to some embodiments of the present disclosure. Such an embodiment is similar to the embodiment of FIGS. 2A and 2B, except that the first alternative heart valve holder 200a includes screw holes 224a that terminate within the platform 220a and do not extend through the entire thickness of the platform 220a, and the first alternative heart valve holder 200a does not include ridges or threaded holes. In some embodiments, the platform 220a may be 7 mm thick and 7 mm wide, while the screw holes 224a may be 5 mm deep and have an "M3×0.5" type configuration.

[0027] 6 is a schematic diagram of a top perspective view of a second alternative heart valve holder 200b according to some embodiments of the present disclosure. Such an embodiment is similar to the embodiment of FIGS. 2A and 2B, except that the second alternative heart valve holder 200b includes a platform 220b that extends from the anterior side 204b to the posterior side 208b of the heart valve holder 200b, and the second alternative heart valve holder 200b does not include a ridge or a threaded hole. In some embodiments, the platform 220b may be 5 mm thick and 12 mm wide.

[0028] FIG. 7A is a schematic diagram of a front perspective view of a third alternative heart valve holder 200c according to some embodiments of the present disclosure. FIG. 7B shows a schematic diagram of a top view of the third alternative heart valve holder 200c. Such an embodiment is similar to the embodiment of FIGS. 2A and 2B, except that the platform 220c of the third alternative heart valve holder 200c may have a ridge 232c extending below the platform 220c (see FIG. 7C). As can be seen in FIG. 7C, the ridge 232c includes a third connecting element 236c for connecting to the fourth connecting element 1108b of the support structure 1100b (see FIGS. 16A-16B). As can be seen in FIG. 7B, the third connecting element 236c may be provided in the form of an extending arm. Such an arm may engage the fourth connecting element 1108b via a snap-fit ​​mechanism, since the ridge 232c and the extending arm 236c may include a flexible material. Prior to engaging the fourth connection element 1108b, the extension arm may bend or deflect to widen the distance between the tips of the two arms to accommodate the fourth connection element 1108b (see FIG. 16D). In some embodiments, other suitable fastening mechanisms, such as a threaded top for attachment to the third connection element, may also be used. In some embodiments, the third connection element 236c may be aligned with the first connection element 224c. In some embodiments, the platform 220c may include an opening. The valve holder 200c according to some embodiments of the present disclosure may be designed to mimic the contours of the valve prosthesis to hold the prosthesis in place. With this unique and ingenious design, the valve holder 200c may advantageously minimize or avoid the risk of the valve prosthesis slipping off the D-shaped cross section of the valve holder during implantation of the valve.

[0029] 8 is a schematic diagram of a handle 700 according to some embodiments of the present disclosure. The handle 700 may include a solid circular rod 704 with a body, a proximal end 708 adapted to be held by a surgeon, and a distal end 712 including a second connection element 728 adapted to be connected to the heart valve holder 200 via the first connection element 224 (see FIG. 2A). In some embodiments, the handle 700 may include a hollow circular rod 704 with a body, a proximal end 708 adapted to be held by a surgeon, and a distal end 712 including a second connection element 728 adapted to be connected to the heart valve holder 200 via the first connection element 224 (see FIG. 2A). The handle 700 may be made of stainless steel, polypropylene, polyetherketoneketone, acrylonitrile butadiene styrene, Delrin (or polyoxymethylene), or other similar or suitable materials. The handle 700 may be between about 5 and about 15 mm in diameter, preferably 8 mm. The handle 700 may be between about 5 and about 20 cm in length, preferably 15 cm. In some embodiments of the present disclosure, the second connecting element 728 may be a threaded portion 728 at the distal end 712, which is complementary to the first connecting element or threaded hole 224 of the heart valve holder 200 and adapted to be inserted into the threaded hole 224 of the heart valve holder 200. The threaded portion 728 may have any dimension depending on the thickness and width of the platform 220.

[0030] 9 is a schematic diagram of a first alternative handle 700a according to some embodiments of the present disclosure. Such embodiment is similar to the embodiment of FIG. 8, except that the first alternative handle 700a further includes a flexible portion 716 and a roughened portion 720. The flexible portion 716 may be a portion along the first alternative handle 700a proximate the distal end 712a of the first alternative handle 700a and has a narrower diameter compared to the distal end 712a and proximal end 708a of the first alternative handle 700a. In some embodiments, the distal end 712a and proximal end 708a of the first alternative handle 700a may be about 6.2 mm in diameter, while the flexible portion 716 may be about 3.1 mm in diameter. In some embodiments, the handle 700 may be approximately 240 mm long from the proximal end 708a to the distal end 712a, and the flexible portion 716a may be approximately 60 mm long and located approximately 30 mm from the distal end 712a. The flexible portion 716 is advantageous for allowing the first alternative handle 700a to bend, allowing the surgeon to bend the first alternative handle 700a to his or her liking and reach difficult angles during surgery. In some embodiments of the present disclosure, the first alternative handle 700a further includes a second connection element 728a, which may be a threaded portion 728a at the distal end 712a, which is complementary to the first connection element or threaded hole 224 of the heart valve holder 200 and adapted to be inserted into the threaded hole 224 of the heart valve holder 200. The threaded portion 728a may have any dimension depending on the thickness and width of the platform 220.

[0031] In some embodiments of the present disclosure, the first alternative handle 700a may further include a roughened portion 720 proximate the proximal end 708a. The roughened portion 720 may include knurling or a checkered pattern to provide friction and enhance the surgeon's grip on the first alternative handle 700a. In some embodiments, the roughened portion 720 may be located approximately 6.9 mm from the proximal end 708a of the first alternative handle 700a and may be approximately 80 mm in length.

[0032] FIG. 10 is a schematic diagram of a second alternative handle 700b according to some embodiments of the present disclosure. Such an embodiment is similar to the embodiment of FIG. 9, except that the second alternative handle 700b advantageously includes a ruler portion 724, thereby eliminating the need for the surgeon to use a separate measuring tool to perform measurements. The ruler portion 724 may be used to measure any distance required by the surgeon, including the distance between the valve annulus and the midline of the papillary muscles. The ruler portion 724 may be located on the distal end 712b of the second alternative handle 700b and between the flexible portion 716b and the distal end 712b. The ruler portion 724 may begin at the tip of the threaded portion 728b and may be approximately 40 mm in length. The ruler portion 724 may include markings in the form of lines representing linear graduations of measurement units (e.g., centimeters or inches), with the marking associated with the number "0" located near the distal end 712b. In some embodiments, the markings may indicate the distance of the threaded portion 728b, beginning at the tip 732 of the threaded portion 728b. The markings may indicate a distance of between about 2 and about 8 mm, preferably 4 mm. In use, the surgeon may advantageously guide the tip 732 to contact a papillary muscle of the patient's heart, which will be the starting point for measurements. Once the tip 732 contacts the papillary muscle of the patient's heart, the handle 700b should not be moved. The surgeon may also use the ruler portion 724 of the handle 700b to make any necessary measurements before proceeding with the implantation.

[0033] FIG. 11 is a schematic diagram of a third alternative handle 700c according to some embodiments of the present disclosure. Such an embodiment is similar to the embodiment of FIG. 9, except that the third alternative handle 700c does not have a roughened portion and has a channel (not shown) in the third handle 700c to receive the inner rod 736. The third alternative handle 700c may be between about 300 and about 360 mm in length, preferably 330 mm. The channel (not shown) may extend from the proximal end 708c through the flexible portion 716c, the distal end 712c, and the threaded portion 728c. The proximal end 708c may be shaped as a flat rectangular parallelepiped shape with a width between about 10 and about 30 mm, preferably 20 mm, a length between about 10 and about 50 mm, preferably 30 mm, and a thickness of about 1 to 5 mm, preferably 3 mm. The proximal end 708c may include a ruler section 724c including markings in the form of lines representing linear graduations in units of measurement (e.g., centimeters or inches), with the smallest marking associated with the number "0" located proximal to the proximal end 708c. The markings may indicate a distance between about 2 and about 8 mm, preferably 6 mm. In some embodiments, the inner rod 736 may be connected to a slide portion 740 that surrounds the ruler section 724c on the proximal end 708c. The slide portion 740 advantageously fits to correspond to the markings on the ruler section 724c of the proximal end 708c and to indicate to the surgeon the distance from the end 744 of the inner rod 736 to the tip 732c of the threaded portion 728c. For example, the markings on the ruler portion 724c of the proximal end 708c may be such that when the end 744 of the inner rod 736 is aligned with the tip 732c of the threaded portion 728, the slide portion 740 is aligned with the markings on the ruler portion 724c associated with the number "0." When the slide portion 740 moves toward the distal end 712c of the third alternative handle 700c, the inner rod 736 protrudes from the tip 732c of the threaded portion 728. The markings on the ruler portion 724c of the proximal end 708c that correspond to the slide portion 740 represent the distance that the end 744 of the inner rod 736 protrudes from the tip 732c of the threaded portion 728c. For example, the surgeon may align the tip 732c of the handle 700c with the mitral valve annulus of the patient.Alternatively, the surgeon may slide the sliding portion 740 of the third alternative handle 700c until the end 744 of the inner rod 736 is aligned with the patient's papillary muscle, which advantageously allows the surgeon to intuitively measure the distance between the patient's papillary muscle and the valve annulus.

[0034] In some embodiments, the flexible portion 716c of the third alternative handle 700c may have a narrower diameter compared to the distal end 712c of the third alternative handle 700c. For example, the distal end 712c of the third alternative handle 700c may be about 4 mm in diameter, while the flexible portion 716c may be about 2 mm in diameter. The flexible portion 716c may be about 20 to about 50 mm in length, preferably 30 mm, and may be located about 10 to about 20 mm, preferably 15 mm, from the distal end 712c.

[0035] FIG. 12 is a schematic diagram of a support structure 1100 supporting a heart valve holder 200 according to some embodiments of the present disclosure. In some embodiments, the support structure 1100 may be made partially or entirely of the same materials as the valve holder 200 described in the present disclosure. In some embodiments, the support structure 1100 may be made of polypropylene, polyetherketoneketone, ABS, and Delrin (polyoxymethylene). In some embodiments, the polypropylene, polyetherketoneketone, ABS, and Delrin (polyoxymethylene) may be medical grade polypropylene, polyetherketoneketone, ABS, and Delrin (polyoxymethylene). In some embodiments, the polypropylene, polyetherketoneketone, ABS, and Delrin (polyoxymethylene) may be biocompatible polypropylene, polyetherketoneketone, ABS, and Delrin (polyoxymethylene). In some embodiments, the biocompatible materials may conform to United States Pharmacopeia (USP) Class VI or ISO 10993-1. FIG. 13 is a schematic diagram of a support structure 1100 supporting a heart valve holder 200 according to some embodiments of the present disclosure. FIG. 14 is a schematic diagram of the support structure 1100 and the heart valve holder 200 inserted into a container 1304 for shipping according to some embodiments of the present disclosure. The support structure 1100 supports the heart valve holder 200 in the container 1304 to prevent any damage and accidental dropping during shipping. The support structure 1100 may be shaped as a hollow cylinder with an inner diameter of between about 40 to about 70 mm, preferably 50 mm, a wall thickness of between about 1 to about 4 mm, preferably 1 mm, and a height of between about 40 to about 70 mm, preferably 59 mm. Alternatively, the support structure 1100 may be a structure of any shape as long as it adequately supports the valve holder 200 in the container 1304 (see, for example, FIG. 16A). In some embodiments, the support structure 1100 may be a hollow structure of any shape. Preferably, the support structure 1100 has a sufficient width so that its walls do not contact the heart valve holder 200. In some embodiments, the support structure 1100 may have at least one opening 1112 along its wall to reduce the weight of the support structure 1100.

[0036] In some embodiments of the present disclosure, the support structure 1100 may include a base structure 1116 at the bottom of the support structure 1100, the base structure 1116 having a length corresponding to the diameter of the support structure 1100. In some embodiments, the base structure 1116 may have a width between 5-20 mm, preferably 8 mm, and a thickness between 2-5 mm, preferably 3 mm. The base structure 1116 may further include a fourth connection element 1108. The fourth connection element 1108 may be a threaded top 1108 of a vertical post 1104 extending from the center of the support structure 1100, the threaded top 1108 being shaped to be complementary to the threaded hole 236 and / or the threaded hole 224 of the heart valve holder 200. Thus, the vertical post 1104 receives and supports the heart valve holder 200 (see FIG. 13). Preferably, the threaded top 1108 includes male threads that correspond to the female threads of the threaded hole 236 and / or the threaded hole 224 and is configured to connect and fasten the heart valve holder 200 to the support structure 1100 by rotating the heart valve holder 200 counterclockwise.

[0037] In some embodiments of the present disclosure, the support structure 1100 with the heart valve holder 200 may be held in a container 1304 that includes a receptacle 1308 and a lid 1312 (see FIG. 14). The receptacle 1308 and the lid 1312 may provide a surface for attaching a label. Such a label may include the product name, copyright, and design. Such a label may further include a Quick Response Code (QR Code) that includes patient information, such as the patient name and identification number, and product details, such as size and date of manufacture, which aids in easy tracking of the product. Other labels that may be included are product specifications and manufacturer information. To assemble the support structure 1100 and the heart valve holder 200 in the container 1304, the user may remove the lid 1312 of the container 1304. The user may then secure the handle 700 to the heart valve holder 200 by inserting the threaded portion 728 into the threaded hole 224 and rotating the handle 700 clockwise. The user may then secure the heart valve holder 200 to the support structure 1100 by inserting the threaded holes 236 and / or the screw holes 224 into the threaded top 1108 and rotating the heart valve holder 200 counterclockwise while holding the handle 700. The user may then detach the heart valve holder 200 from the handle 700 by rotating the handle 700 counterclockwise. The user may then close the container 1304 by fastening the lid 1312 onto the receptacle 1308.

[0038] 15A is a schematic diagram of a first alternative support structure 1100a supporting a heart valve holder 200 according to some embodiments of the present disclosure, and FIG. 15B is a schematic diagram of the first alternative support structure 1100a when a cap 1404 closes the support structure 1100a to support the valve holder 200 according to some embodiments of the present disclosure. Such an embodiment is similar to the embodiment of FIG. 12, except that the fourth connection element 1108a is a recess 1108a on a post 1104a adapted to receive a platform 220 of the heart valve holder 200. The first alternative support structure 1100a may further include a cap 1404. The cap 1404 may fit onto the support structure 1100a such that a bottom edge of the cap 1404 and a top edge of the support structure 1100a are flush with each other. The cap 1404 may include an extension 1408 including a pin (not shown) that fits into a screw hole 224 of the heart valve holder 200.

[0039] FIG. 16A is a schematic diagram of a second alternative support structure 1100b supporting the heart valve holder 200. As can be seen in FIG. 16A, the second alternative support structure 1100b includes a plurality of separate walls that define an opening for receiving the heart valve holder 200. The second alternative support structure 1100b may include a fourth connection element that is connected to the third connection element of the valve holder 200. In some embodiments, the fourth connection element is a post 1104b that is attached to a second platform 1116b that connects the plurality of walls, such that the fourth connection element 1108b is positioned in the center of the opening. Each of the plurality of walls separated from each other may be provided with a support to stabilize the support structure 1100b. As can be appreciated, the second alternative support structure 1100b including a plurality of separate walls connected by a second platform may form a unitary structure. In some embodiments, the post may include a top having a shape complementary to the extension arm of the third connection element 236c. FIG. 16B shows the heart valve holder 200 supported by a second alternative support structure 1100b with posts 1104b. To secure the valve holder 200 to the second alternative support structure 1100b, the user may align the third connection element 236c and the fourth connection element 1108b. The user may then rotate the assembly of the handle and the valve holder holding the artificial valve clockwise until the arms 236c of the third connection element deflect outwardly, thereby accepting the fourth connection element 1108b, to secure the valve holder 200 to the second alternative support structure 1100b. The user may then rotate the handle 700 counterclockwise to release the handle 700 from the valve holder 200. To retrieve the artificial valve held by the valve holder 200, the user may use the handle 700 to connect the handle 700 to the valve holder 200 by rotating the rod clockwise to a fully screwed position (see FIG. 16C). Further rotation of the handle 700 in the same direction causes the extension arms 236c of the third connecting element to be deflected outward (increasing the distance between the tips of the extension arms), disengaging the valve holder 200 from the support structure 1100b. The user may then lift the valve holder 200 off the support structure 1100b (see FIGS. 16D-16E).To facilitate bending or deflection of the extension arm 236c, such arm may have a tapered inner surface, which is the inner surface that may come into contact with the second connection element. As mentioned above, the shape of the support structure supporting the heart valve holder is not limited to that of Fig. 16A, and the support structure may be provided in other suitable shapes.

[0040] 17A, 17B, 17C, 17D and 17E are schematic diagrams of a process of implanting a prosthetic heart valve 304 in a patient's heart 1504 using a heart valve holder 200 according to some embodiments of the present disclosure. Prior to implantation, the practitioner may use the handle 700b or 700c of an embodiment including a ruler portion 724 to measure the dimensions of the patient's heart valve and native valve annulus 1508 and select an appropriate valve for implantation. The practitioner may also use the ruler portion 724 to measure the height of the valve annulus and adjust the length of the cord 316 on the prosthetic heart valve 304. Prior to implanting the selected prosthetic heart valve, the practitioner may select the heart valve holder 200 by determining the size of the patient's heart valve annulus that will receive the prosthetic heart valve. The practitioner may also use a prolene suture to mark certain landmarks on the patient's native valve annulus 1508 to assist in the orientation and subsequent attachment of the annulus 308 of the prosthetic heart valve 304 to the patient's native valve annulus 1508. In some embodiments, the mitral annulus landmarks may be the left and right commissures and the midpoint of the posterior annulus, i.e., the 2 o'clock position on the mitral annulus corresponding to the right fibrous trigone, the 10 o'clock position on the mitral annulus corresponding to the left fibrous trigone, and the 6 o'clock position on the mitral annulus corresponding to the midpoint of the posterior annulus. In some embodiments, the mitral annulus landmarks may be the 2 o'clock position on the mitral annulus corresponding to the right fibrous trigone, the 4 o'clock position on the mitral annulus corresponding to the point between the middle of the posterior leaflet and the posterior scallop, the 8 o'clock position on the mitral annulus corresponding to the point between the anterior and middle sail of the posterior leaflet of the mitral valve, and the 10 o'clock position on the mitral annulus corresponding to the left fibrous trigone.

[0041] 17A, the lid 1312 is removed from the receptacle 1308. The practitioner may connect the handle 700 to the heart valve holder 200 by inserting the threaded portion 728 of the handle 700 into the threaded hole 224 and rotating the handle 700 clockwise. The practitioner may continue to rotate the handle 700 clockwise to rotate the heart valve holder 200 and remove the heart valve holder 200 from the support structure 1100.

[0042] 17B, ​​the practitioner may remove the device 100, including the heart valve holder 200 and the handle 700, from the receptacle 1308 and attach, mount or secure the prosthetic heart valve 304 to the heart valve holder 200. The prosthetic heart valve 304 may be attached, mount or secure to the heart valve holder 200 with the security sutures 320 as described above.

[0043] As shown in FIG. 17C, the practitioner may use a Prejade Gore-Tex suture with a double-arm needle to place a horizontal mattress from the tip of the corresponding papillary muscle 1512 to within about 5 mm of the tip of the corresponding cord 316 of the prosthetic heart valve 304. The practitioner may further place the horizontal mattress from the patient's native annulus 1508 to a corresponding location on the annulus 308 of the prosthetic heart valve 304. The practitioner may place at least one suture wire 1520 to connect the patient's heart 1504 to the prosthetic heart valve 304 through a designated surgical opening (not shown) on the patient's heart 1504. In some embodiments, the practitioner may place four suture wires 1520, two suture wires 1520 connecting the papillary muscle 1512 to the corresponding cord 316 on the prosthetic heart valve 304 and two suture wires 1520 connecting the native annulus 1508 to the annulus 308 of the prosthetic heart valve 304. Preferably, the two suture wires 1520 connecting the native annulus 1508 to the annulus 308 of the prosthetic heart valve 304 are connected to two commissure points on the native annulus 1508 .

[0044] As shown in FIG. 17D, the practitioner may use a gentle gliding manoeuvre to slide the prosthetic heart valve 304 along the at least one suture wire 1520 and insert the device 100 and prosthetic heart valve 304 into the heart 1504 through a designated surgical opening (not shown). The practitioner may tighten the at least one suture wire 1520 connected to the cord and the papillary muscle, tie the at least one suture wire 1520 with a knot to secure the prosthetic heart valve 304 in place, and trim the excess suture wire 1520. Optionally, the practitioner may use a hand knot to secure the cord 316 to the papillary muscle 1512. The practitioner may tighten together the at least one suture wire 1520 connecting the annulus 308 of the prosthetic heart valve 304 to the patient's native annulus 1508 to secure the annulus 308 of the prosthetic heart valve 304 firmly in place. Optionally, the practitioner may use prolene sutures that create specific landmarks on the patient's native annulus 1508 to orient the prosthetic heart valve annulus 308 and secure the prosthetic heart valve 304 to the native annulus 1508.

[0045] As shown in Fig. 17E, after implanting the prosthetic heart valve 304 into the patient's heart 1504, the practitioner may cut the safety suture 320 at any visible location and remove the safety suture 320. The practitioner may then withdraw the device 100 from the patient's heart 1504 through a designated surgical opening (not shown). The practitioner may further tie a knot at the tip of the papillary muscle 1512 to secure the cord 316 to the papillary muscle. The practitioner may then thread commissural stitches around the entire circumference of the native annulus 1508 and the annulus 308 of the prosthetic heart valve 304 and tie them together where they meet. Preferably, the commissural sutures come continuously from each side.

[0046] It should be understood that the methods and apparatus described above can be modified in many ways, including omitting or adding steps, changing the order of steps, and the types of devices used. It should be understood that different features can be combined in different ways. In particular, not all of the features illustrated above in a particular embodiment are required in all embodiments of the present disclosure. Further combinations of the above features are also considered to be within the scope of some embodiments of the present disclosure.

[0047] Persons skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above, but rather the scope of the present invention is defined solely by the following claims.

Claims

1. A heart valve holder for holding a prosthetic heart valve, a hollow structure having a cross section that mimics the shape of the annulus of the prosthetic heart valve and including an upper surface; a platform extending from at least one wall of the hollow structure and including a first connecting element; and at least one fixation element formed on the upper surface of the hollow structure, the fixation element including at least one fixation hole for suturing the prosthetic heart valve to the heart valve holder.

2. 2. The heart valve holder of claim 1, wherein the cross section is D-shaped to mimic the shape of the annulus of the prosthetic heart valve, the annulus of the prosthetic heart valve mimicking the shape of the mitral valve annulus.

3. The heart valve holder of claim 1 , wherein the heart valve holder is sized to fit within the prosthetic heart valve.

4. 2. The heart valve holder of claim 1, wherein the hollow structure is a tapered tube that tapers from the top of the hollow structure to the bottom of the hollow structure.

5. The heart valve holder according to claim 1 , wherein the at least one fixation element is positioned to correspond to the anterior commissure, the posterior commissure, the midpoint of the posterior leaflet, or the midpoint of the anterior leaflet.

6. 2. The heart valve holder of claim 1, further comprising at least one leg at the bottom of the hollow structure, the at least one leg including at least one fixation hole for suturing the prosthetic heart valve to the heart valve holder.

7. The heart valve holder of claim 6 , wherein the at least one leg is positioned to correspond to a papillary muscle of the left ventricle of the heart.

8. The heart valve holder of claim 1 , further comprising a handle including a second connecting element connected to the first connecting element.

9. The heart valve holder of claim 8 , wherein the handle comprises a rod.

10. The heart valve holder of claim 8 , wherein the handle includes a flexible portion.

11. The heart valve holder of claim 8 , wherein the handle includes a ruler portion.

12. The heart valve holder of claim 8 , wherein the second connecting element includes a threaded portion for attachment to the first connecting element.

13. The heart valve holder of claim 1 , wherein the platform further comprises a third connecting element.

14. The heart valve holder of claim 13 , further comprising a support structure including a fourth connecting element connected to the third connecting element.

15. 15. The heart valve holder of claim 14, wherein the fourth connecting element includes a threaded top for attachment to the third connecting element.

16. The heart valve holder of claim 14 , wherein the fourth connecting element includes a recess for receiving the third connecting element.

17. The heart valve holder of claim 14 , wherein the third connecting element includes an extension arm for securing the fourth connecting element.

18. 1. A method of implanting a prosthetic heart valve, comprising: (i) a step of placing a heart valve holder for holding the prosthetic heart valve, the heart valve holder comprising: a hollow structure having a cross section that mimics the shape of the annulus of the prosthetic heart valve and including an upper surface; a platform extending from at least one wall of the hollow structure and including a first connecting element; at least one fixation element formed on the upper surface of the hollow structure, the fixation element including at least one fixation hole for suturing the prosthetic heart valve to the heart valve holder; (ii) providing a handle including a second connecting element; (iii) connecting the handle to the heart valve holder; (iv) mounting the prosthetic heart valve on the heart valve holder; (v) attaching at least one suture wire between the heart and the prosthetic heart valve; (vi) sliding the prosthetic heart valve into the heart along the at least one suture wire.

19. 20. The method of claim 18, wherein the step of attaching the prosthetic heart valve comprises attaching the prosthetic heart valve to the heart valve holder using a single suture.

20. 20. The method of claim 18, further comprising measuring the heart using a ruler on the handle.

21. (vii) positioning the prosthetic heart valve within the heart using marked landmarks on the native annulus; 20. The method of claim 18, further comprising the step of: (viii) tying the at least one suture wire to attach the prosthetic heart valve to the heart.

Images