JP2022529472A - Naturally designed mitral valve prosthesis - Google Patents

Abstract

A mitral valve prosthesis that is implanted in the heart, an asymmetric ring, sized to mimic the patient's natural mitral annulus and wound around itself towards the outside of the valve. At least an asymmetric ring made of a flexible material and a flexible anterior and posterior apex that are suspended from the asymmetric ring and configured to substantially join each other. Two sets of cords, each pair of cords attached to the anterior or posterior apex at the first end and into the cap at the second end. And, the cap is configured to be attached to the papillary muscle of the heart at another end of the cap.

Description

The mitral valve or left ventricular valve is a bicuspid valve (a valve with two cusps), which is the valve of the heart that separates the left atrium and the left ventricle. The mitral valve allows blood to flow from the left atrium into the left ventricle during ventricular dilation and prevents regurgitation during contraction. The mitral valve of a living body is composed of an annulus, two apex, atrial myocardium, chordae tendineae, papillary muscle, and ventricular myocardium.

Mitral valve replacement is a procedure designed to replace a diseased or dysfunctional valve. In mitral valve replacement, the patient's mitral valve is removed and replaced with an artificial valve. The unique composition of the mitral valve poses a challenge in creating a long-term and normally functioning mitral valve prosthesis.

Biological and mechanical mitral valve prostheses are available on the market. Both biological and mechanical prostheses are rigid and circular, in contrast to the human mitral valve, which is a soft tissue and has an asymmetrical shape. Another drawback of mechanical valves is that blood tends to clot on the mechanical components of the valve, causing valve dysfunction. Patients with mechanical valves should take anticoagulants to prevent the formation of stroke-causing blood clots in the valve. Bioprosthetic valves have a lower risk of thrombus formation, but are less durable than mechanical valves and require frequent replacement. Biological valves, like mechanical valves, have a rigid metal skeleton and include a metal ring covered with silicone or other synthetic material for threading sutures for transplantation.

Currently available mitral valve prostheses are generally made in an unnatural circular shape and are often made of rigid material. Also, the mitral valve often has three symmetrical cusps, whereas a natural human mitral valve has only two cusps, a large anterior leaflet and a small posterior leaflet. Due to its rigid and unnatural structure, such a mitral valve prosthesis distorts the natural anatomy of the heart. The myocardium surrounding such a mitral valve prosthesis is not fully recovered after transplant surgery. The prosthesis lasts only 7 to 10 years on average, and patients need to undergo second and sometimes third surgery in their lifetime, putting them at repeated high risk of thoracotomy.

The prostheses available on the market cannot achieve the hemodynamics of the natural human mitral valve in healthy humans. The result is a significant loss of energy in the left heart chamber, resulting in large strains over time, eventually leading to heart failure and other adverse phenomena.

Several other available mitral valve prostheses can be formed by reinforcing the homograft, as described in Patent Document 1, which allows the physician to find the optimal fit for each patient. This means that it is necessary to scan valves of various sizes at the expense of the animal collecting the valve. Yet another available mitral valve prosthesis can be formed by suturing multiple layers of the pericardium together, as described in Patent Document 2, in which case the region where the plurality of sutures are present. Coagulation may occur in.

Other forms of atrioventricular valve, including the mitral valve, are disclosed in Patent Document 3, where a template of membrane material is sutured to the patient's mitral annulus. Such a valve is characterized by an unnaturally shaped annulus with a height, and the circumference of the artificial valve is bulky and raised like a collar. In addition, the template is provided in standard size and needs to be fine-tuned to fit the patient.

US Pat. No. 6,074,417 US Pat. No. 5,415,667 US Pat. No. 6,358,277

An artificial valve designed to resemble the mitral valve of the patient's body is provided. The two flexible cusps and the asymmetric and flexible ring can move in response to the natural strain of the myocardium during the cardiac cycle. A cord-like body similar to the patient's natural chordae tendineae is included in the prosthetic valve, mimicking the natural prevention of blood regurgitation into the atrium to support the contracting left ventricle.

According to some embodiments, the mitral valve prosthesis implanted in the heart is
An asymmetric ring, which has dimensions that mimic the patient's natural mitral annulus and is composed of a flexible material that is wound around itself toward the outside of the valve.
Flexible anterior and flexible posterior apex suspended from an asymmetric ring and configured to substantially join to each other.
The shape of each of the anterior and posterior apex is configured to mimic the shape of the natural mitral valve, whereby the anterior and posterior apex form an orifice through which blood flows in one direction. , Flexible anterior and flexible posterior apex,
At least two sets of cords, each set of cords attached to the anterior or posterior apex at the first end and attached to the cap at the second end, the cap. It comprises a cord-like body, which is configured to be attached to the papillary muscle of the heart at another end of the cap.

According to some embodiments, the mitral valve prosthesis may continue with each of the anterior and posterior apex and may further comprise a joint surface attached to each set of cords, the joint surface being the monk. It is configured to enhance the tightness of the mitral valve prosthesis.

According to some embodiments, the asymmetric ring may further comprise at least two strands configured in a coiled coil structure.

According to some embodiments, the asymmetric ring comprises two layers of material folded together to provide elasticity and a third layer to provide structural stability.

According to some embodiments, the asymmetric ring comprises two layers of bovine pericardium and a third layer of glycine or proline to increase strength.

According to some embodiments, the layers may be connected together via suture stapler pins, adhesives, or any combination thereof.

According to some embodiments, the asymmetric ring, flexible anterior and posterior leaflets, at least two cords, caps, or any combination thereof, are made of bovine pericardium. May be good.

According to some embodiments, the shape of the apex is extended by 1-5 mm to allow for better joining and attachment of cords.

According to some embodiments, the shape of the apex is designed to be semicircular along half the length of the flexible anterior and posterior apex, when both apex are joined. Form an "S" -shaped seal.

According to some embodiments, the mitral valve may further comprise at least one secondary cord, the at least one secondary cord attached to the middle of the posterior leaflet at one end. And another end may be attached to the middle of the primary cord.

According to some embodiments, at least two sets of cords may be attached to the opening of the cap, which is located in the center of the cap.

According to some embodiments, each of at least two sets of cords may be attached to the middle of the anterior or posterior leaflets to mimic the mitral valve of an organism.

According to some embodiments, the anterior and posterior apex may be made as a single unit, connected to an asymmetric ring and attached to at least two sets of cords.

According to some embodiments, the mitral valve has one end connected to the flexible anterior leaflet and the other end connected to at least two sets of cords, with the flexible anterior leaflet and the flexible posterior. Further may be provided with an extension configured to allow a junction with the apex.

According to some embodiments, the mitral valve prosthesis implanted in the heart is
An asymmetric ring with dimensions that mimic the patient's natural mitral annulus, with an asymmetric ring made of a flexible material wound outward of the valve.
Two cusps suspended from the asymmetric ring, said cusps are configured on opposite sides of an incision made along a material similar to the material in which the asymmetric ring is composed, and the incision. However, with the two cusps forming an orifice through which blood flows in one direction,
At least two sets of cords, each set of cords attached to one of the two apex at the first end and bundled at the second end. Two sets of cords and
It may comprise a cap that is connected to at least two sets of cords at one end of the cap and is configured to be sutured to the papillary muscle of the heart at the other end of the cap.

According to some embodiments, each pair of cords is attached to one of the two cusps via an extension configured to allow joining between the two cusps. ..

According to some embodiments, at least one portion of at least two sets of cords comprises the patient's own born mitral valve cord.

According to some embodiments, at least one part of the two sets of cords is the patient's own natural mitral valve cord and at least a portion of the patient's own natural valve apex. Be prepared.

According to some embodiments, the asymmetric ring further comprises a radiodensity opaque marker filament, which is inserted inside a roll of flexible material.

According to some embodiments, the mitral valve prosthesis further comprises a suture portion made of a radiopermeable suture material, the suture portion being formed via a ring. According to some embodiments, the mitral valve prosthesis implanted in the heart is an asymmetric ring sized to mimic the patient's natural mitral annulus, on the outside of the mitral valve. An asymmetric ring made of a flexible material wound around itself and two cusps suspended from the asymmetric ring, the cusps similar to the material of which the asymmetric ring is made. Consisting on opposite sides of the incision made along the material, the incision is a cusp and at least two sets of cords, each set forming an orifice through which blood flows in one direction. At least two sets of cords attached to one of the two cusps at the first end and attached to the bundle at the second end, and at least two pairs of cords attached at one end of the cap. It comprises a cap configured to be sutured to the papillary muscle of the heart at another end of the cap.

According to some embodiments, each pair of cords is attached to one of the two cusps via an extension configured to allow joining between the two cusps.

According to some embodiments, each set of cords is composed in part from the patient's own natural mitral valve cords.

According to some embodiments, the method of making a mitral valve prosthesis is
Measuring the size and shape of the patient's mitral valve with diagnostic imaging,
Cutting a replica of the subject's mitral valve from one material,
Making a notch along one material creates an orifice for blood flow and two cusps on either side of the orifice.
Measuring the length of the cord required for diagnostic imaging, and
Attaching the cord to one of the two caps,
A flexible ring may be attached to the apex to create and include an entire mitral valve prosthesis that mimics the natural mitral valve of a particular patient.

According to some embodiments, measuring the required cord length can be performed simultaneously with measuring the size and shape of the subject's mitral valve.

According to some embodiments, the method further comprises attaching an extension to each of the two tips to support the cord before attaching the cord to one of the two caps. It may be included.

According to some embodiments, the method may further comprise adding a flexible material to the flexible ring, the flexible ring being at least one layer of the flexible material and one of the materials. Formed from two layers.

According to some embodiments, the method further comprises adding a radiation opaque material to the flexible ring, wherein the flexible ring is one of at least one layer of the radio permeable material and one of the materials. Formed from two layers. The flexible ring may be attached to the apex using an X-ray impermeable suture material.

FIG. 6 depicts a mitral valve prosthesis in an open position, according to some embodiments of the disclosure of the present invention, showing a cord prior to attachment to the apex. Schematic representation of a mitral valve prosthesis in a closed position, according to some embodiments of the disclosure of the present invention, showing the cord after attachment to the apex. FIG. 3 is a schematic representation of an embodiment of the invention implanted in the heart according to some embodiments of the present disclosure. 8 is an image of a 3D reconstruction of the mitral valve region in 3D CT image analysis software according to some embodiments of the present disclosure. It is a photograph of a three-dimensionally printed valve molded product and a valve molded product of a porcine pericardial mitral valve leaflet according to some embodiments of the present disclosure. It is a photograph of a prosthetic valve during an in vitro test according to some embodiments of the present disclosure. FIG. 3 is a schematic lateral view of the anterior and posterior leaflets of a mitral valve prosthesis according to some embodiments of the present disclosure. It is a schematic view of the top view when the anterior and posterior leaflets of the mitral valve prosthesis are joined to each other according to some embodiments of the present disclosure. Schematic of a mitral valve prosthesis looking down from the left atrium to the left ventricle according to an embodiment of the present disclosure (during dilation, when the valve is open to allow blood to enter the left ventricle). be. FIG. 3 is a schematic diagram showing one material with anterior and posterior cusps according to an embodiment of the present disclosure. FIG. 3 is a schematic diagram showing a cap for connecting a cord to the papillary muscle of the heart according to an embodiment of the present disclosure. FIG. 3 is a schematic representation of a mitral valve prosthesis with two caps attached to a cord according to an embodiment of the present disclosure. It is a schematic diagram which shows the possible position of the cord-like body with respect to the apex by some embodiments of this disclosure. FIG. 6 is a schematic diagram showing a cross section of a cord-like body when attached to a tip according to some embodiments of the present disclosure. Schematic representation of a two-pointed mitral valve prosthesis, according to some embodiments of the present disclosure, illustrating a curved (ellipsoidal / droplet) configuration alternative design that magnifies the junction surface. It is a figure. FIG. 6 is a schematic diagram showing a possible joint surface configuration of a two-pointed mitral valve prosthesis according to some embodiments of the present disclosure. FIG. 6 is a schematic diagram showing a measurement copy of a patient's mitral valve obtained from a two-dimensional or three-dimensional echocardiographic image according to some embodiments of the present disclosure. FIG. 6 is a schematic showing the formation of a two-pointed prosthesis according to some embodiments of the present disclosure. It is a schematic diagram which shows the opening formed along the apex according to some embodiments of this disclosure. FIG. 6 is a schematic showing an echocardiographic or MRI scan of a patient's left heart chamber or ventricle according to some embodiments of the present disclosure. FIG. 6 is a schematic diagram showing the left ventricle of a dilated patient according to some embodiments of the present disclosure. FIG. 6 is a schematic diagram showing the left ventricle of a contracting patient according to some embodiments of the present disclosure. FIG. 3 is a schematic showing an extension attached to the anterior leaflet according to some embodiments of the present disclosure. FIG. 3 is a schematic showing an extension attached to the posterior leaflet according to some embodiments of the present disclosure. FIG. 3 is a schematic lateral view of a mitral valve prosthesis with an extension and an attached cord according to some embodiments of the present disclosure. FIG. 3 is a schematic side view of a mitral valve prosthesis with an extension and an attached cord according to some embodiments of the present disclosure during contraction. It is a schematic diagram showing how an asymmetric flexible ring is attached to the outer circumference of a valve prosthesis in order to mimic a natural annulus according to some embodiments of the present disclosure. It is a schematic diagram of an elastic material inserted into a roll-shaped annulus according to some embodiments of the present disclosure, showing a procedure in which a ring is wound around it. It is a schematic diagram of an elastic material inserted into a roll-shaped annulus according to some embodiments of the present disclosure, showing a procedure in which a ring is wound around it. It is a schematic diagram of an elastic material inserted into a roll-shaped annulus according to some embodiments of the present disclosure, showing a procedure in which a ring is wound around it. It is a schematic diagram of an elastic material inserted into a roll-shaped annulus according to some embodiments of the present disclosure, showing a procedure in which a ring is wound around it. It is a schematic diagram of an elastic material inserted into a roll-shaped annulus according to some embodiments of the present disclosure, showing a procedure in which a ring is wound around it. FIG. 3 is a schematic flow chart illustrating a method of making a mitral valve prosthesis according to some embodiments of the present disclosure.

The above will become clear from the following more specific description of the exemplary embodiments of the invention. In the attached drawings, similar reference letters refer to the same part through different drawings. The drawings are not necessarily in scale and the emphasis is on showing embodiments of the present invention.

The mitral valve prosthesis of the present invention is shown in FIGS. 1A and 1B. The mitral valve prosthesis 100 has a physiological shape similar to that of a human mitral valve. The mitral valve prosthesis includes a flexible asymmetric ring 1 and two flexible membrane-like cusps 2 suspended from the asymmetric ring 1. The mitral valve prosthesis also has two sets of chordae tendineae 3 that mimic the chordae tendineae of the heart. Each set of cords 3 is configured to be attached to the edge of the apex 2 and / or the body at one end and converge to the fixation cap 8 at the other end. The fixation cap 8 is configured to be sutured to the papillary muscle of the left ventricle.

The mitral valve 100 is shown in FIG. 1A with the cord 3 not attached to the apex 2 and in FIG. 1B with it attached. The cord 3 may be attached to the apex 2 before the operation or may be attached during the operation. For example, the attachment portion 9 between the cord-like body 3 and the apex 2 may be a suture portion or an integrally artificial object. The mitral valve 100 is shown in the open state in FIG. 1A and in the closed state in FIG. 1B. In the closed state, the cusps 2 are shown joined together.

FIG. 2 shows the mitral valve 100 implanted in the heart. The mitral valve 100 is shown implanted in the location of the natural mitral valve annulus 12, with one side adjacent to the aortic valve 6 where the root of the aorta 7 connects to the left ventricle and another. The side is in contact with the opposing ventricular wall 5. The cord 3 is shown attached to the papillary muscle 4.

The flexible ring 1 can be custom made after ultrasound examination of the patient's heart. In particular, 3D echography can be performed to obtain detailed anatomical measurements, and / or a 3D model of the patient's heart can be rendered from which a customized mitral valve can be obtained. Can be manufactured. The apex 2 and cord 3 can also be customized based on ultrasound imaging of the subject's natural mitral valve and its surrounding anatomy. In addition, a customized mitral valve can be made from data obtained by other diagnostic imaging techniques such as cardiac CT and cardiac MRI that can obtain three-dimensional information. Thus, the mitral valve prosthesis of the present invention can be selected or designed for the particular anatomy of the patient.

The flexible ring 1 can be formed from, for example, an elastic annular ring. The apex 2 can be formed of a natural material or a biocompatible composite material, which is less prone to coagulation and can function like the patient's natural anterior and posterior apex. There are at least two sets of chordae tendineae, the first end attached to one of the two apex and the second end attached to the papillary muscle, configured to function like the patient's natural chordae tendineae. Has been done. The cord 3 connects the apex 2 to the patient's papillary muscle to support the wall of the left ventricle throughout the cardiac cycle and prevent the apex from opening into the atrioventricular cavity.

The mitral valve prosthesis 100, including the flexible ring 1, apex 2, and cord 3, has the same appearance and behavior as a healthy, born mitral valve. Further, the mitral valve prosthesis of the present invention can be made of a natural material and can avoid contamination with foreign substances such as cotton thread. Homograft materials and / or composites, including various combinations of homograft, xenograft, and / or autograft materials, can be used to make flexible rings, cusps, cords, and caps. .. Possible materials for forming the annulus and leaflet include human, bovine, and porcine pericardium, decellularized biomaterials, biodegradable polymer fabrics incorporating cells, and extracellular materials. Not limited to. Biodegradable natural polymers include, but are not limited to, tofibrin, collagen, chitosan, gelatin, hyaluronic acid, and similar materials. Biodegradable synthetic polymer scaffolds capable of infiltrating cells and extracellular matrix materials include poly (L-lactide), polyglycolide, poly (lactic acid-co-glycolic acid), and poly (poly). Caprolactone), polyorthoesters, poly (dioxanone), poly (anhydrous), poly (trimethylene carbonate), polyphosphazene, and similar materials thereof, but are not limited thereto. The flexible ring can be further customized to have flexibility and rigidity tailored to the patient. In addition, some components of the mitral valve prosthesis, including the cord 3, can be formed during surgery by the patient's autologous pericardium.

For example, a mitral valve prosthesis can be made from the patient's own pericardium. Alternatively, a layer of the patient's own cultured cells can be tissue-engineered to create a mitral valve prosthesis on a heterologous material (eg, an existing animal tissue such as a valve).

Artificial valves are often fixed with glutaraldehyde, which is known as a toxin and promotes regeneration. The mitral valve prosthesis of the present invention can be immobilized by a method that does not use glutaraldehyde, such as dye-mediated photoimmobilization. Further, the mitral valve of the present invention is fixed by using an alternative cross-linking agent such as an epoxy compound, carbodiimide, diglycidyl, reuterin, genipin, diphenylphosphoriradide, acyl azide, cyanamide, or by a physical method such as ultraviolet rays or dehydration. You can also do it.

The mitral valve prosthesis, or some component of the prosthesis, can be made directly by biological three-dimensional (3D) printing with biomaterials. Also, some components of the mitral valve prosthesis or prosthesis use templates and moldings constructed by 3D printing based on the detailed dimensions obtained by preoperative 3D imaging. You can also make it.

Also provided is a method of transplanting a mitral valve prosthesis. Prior to transplantation, perform echocardiographic analysis (or other image analysis) of the patient. Image analysis measures the size and movement of the heart chambers. Also, from the acquired images, the detailed dimensions of the patient's mitral annulus, apex, and cord are measured. Furthermore, the valve to be replaced can be described three-dimensionally. From the patient's natural valve measurements and three-dimensional modeling, it is possible to create a mitral valve prosthesis that is similar to the patient's natural mitral valve, modified for existing medical conditions.

Three-dimensional echocardiography can be performed using, for example, a transesophageal echocardiography (TEE) probe or a transthoracic echocardiography (TTE) probe. Each part of the mitral valve is modeled and measured three-dimensionally and four-dimensionally using software such as eSieValves®. (Siemens Medical Solutions USA, Inc., Malvern, PA) Related measurements include annulus outer and inner diameters, annulus area, trigone and commissure distances, anterior and posterior leaflets. There is a length along the axis.

Further, or alternative,, three-dimensional analysis of the mitral valve can be performed using computer tomography (CT) or magnetic resonance imaging (MRI). For example, as shown in FIG. 3, three-dimensional reconstruction of the pig heart was obtained using CT imaging (SOMATOM. RTM, Definition Flash, Siemens Healthcare, Erlangen, Germany). There, the mitral valve region of the heart is visible on the right side of the image. Image analysis software can be used to subdivide the mitral valve region and obtain relevant measurements.

This mitral valve prosthesis can be fully customized for the patient, and each component (ring, apex, cord, cap, etc.) is tailored to the patient's natural valve dimensions. .. For example, as shown in FIG. 4, a three-dimensional printed article of a mitral valve was created based on a three-dimensional reconstruction of the photographed valve. The three-dimensionally printed valve shown in FIG. 4 was modeled during the expansion (opening) period of the cardiac cycle. Further, an artificial valve using this three-dimensional molded product is shown in FIG. This part serves as a guide in cutting the pericardium of the pig to create the apex of the heart and the attachment site for the cord. Alternatively, the prefabricated mitral valve, or prefabricated component of the mitral valve, can be selectively implanted to be closest in shape and size to the patient's natural valve or natural valve component. ..

FIG. 5 shows an image of a prototype of a prosthetic valve sutured in an in vitro test system. A prototype of a valve sutured to the entire removed heart is shown. A bolus of saline is injected into the left ventricle of the heart with a tube and the aorta is clamped to contain the saline in the left ventricle, creating pressure. The injection pressure can be monitored, for example, by a pressure gauge connected to the injection line. Then, the performance of the valve prototype under physiological blood pressure values (eg, no regurgitation or prolapse of the leaflets) can be monitored. Valve performance can be measured or monitored by systolic pressure at which the natural valve closes when the left ventricle is contracting.

6A and 6B are schematic views of the anterior and posterior mitral valve leaflets of the mitral valve prosthesis, respectively, and the tips when joined to each other, according to some embodiments of the present disclosure. .. According to FIGS. 6A and 6B, the artificial mitral valve may be the mitral valve prosthesis 600. According to some embodiments, the valve 600 may comprise two cusps, eg, mitral valve anterior leaflet 602A and mitral valve posterior leaflet 602P. Each of the posterior and anterior leaflets 602P and 602A of the mitral valve is preoperatively as a monocoque structure (single) to fit the patient's specific physiology and anatomy, respectively, based on cross-sectional images of the patient's heart. It may be designed and created in. Using measurements taken from the patient's own heart, the length, width, and height of each of the apex, eg, 602A, 602P, so that each apex is substantially the same as the apex of the patient's body. You may decide. Each of the apex is formed to include a cord (eg, cord 604, 606, 608, 610) and additional material to form a ring portion (eg, anterior ring portion 601A and posterior ring portion 601P). You may try to do it. The length of the cord may be personalized by the surgeon, as described further below. The apex may be cut out of a single material using a knife or scissors, or it may be sutured by the surgeon during mitral valve replacement to form a mitral valve that resembles the mitral valve of the patient's body. good.

For example, the height of the anterior leaflet (AL) can be about 30 mm, the length of the AL can be about 45 mm, the height of the posterior leaflet (PL) can be about 15 mm, and the length of the posterior leaflet can be about 60 mm. As shown in FIG. 6A, in the medical community, 630A is called the height of the anterior apex 602A, 630P is called the height of the posterior apex 602P, and the length of each apex is called a part of the outer circumference of the apex. The length of the anterior apex 602A, 632P, is referred to as the length of the posterior apex 602P.

According to some embodiments, the mitral for transplantation by cutting each of the cusps 602A and 602P separately from the same or different pieces of material, and by cutting each of the ring portions 601A and 601P separately. It makes it easier for someone preparing a valve prosthesis, for example a surgeon. By cutting the apex into two separate parts, cutting the ring part into two separate parts, attaching the apex to the ring, and then attaching a cord to each apex, the apex and the cord are attached. The preparation time and the time required for the surgical procedure for transplanting the artificial valve can be shortened as compared with the case of cutting from one material alone. Cutting the apex and cord as a single body and implanting a single prosthesis is more complex and time consuming than the methodology disclosed herein. This is because high accuracy is required when cutting each of the apex and the cord while maintaining the connection between the apex and the cord.

In some embodiments, each ring portion 601A and 601P has each pointed posterior surface folded or wound over itself towards the outside of the valve 600 (eg, a wound front). 605A, and wound rear 605P), created by winding each apex posterior surface. According to this embodiment, the size of the posterior end of each apex may be increased by an additional material of 5-10 mm, which is a ring portion (mitral valve) around which the posterior end of the apex is wound around itself. It may be used when making the ring portion 601A of the anterior leaflet and the ring portion 601P of the posterior leaflet of the mitral valve. Winding or bending the ring (or each ring portion 601A and 601P) towards the outside of the valve 600 may help avoid the formation of thrombi inside the valve 600. Also, even if a thrombus is formed, it will only appear outside the valve 600 in the crease or winding region of the ring or ring portion, reducing the risk of impairing the efficient operation of the valve 600. According to some additional embodiments, the rings (or ring portions 601A and 601P) may be further enhanced by adding appropriate pieces of material such as biomedical fibers or polymers (not shown). good. Such pieces may be made from pieces of material from which the valve 600 is made and sized to fit within each ring portion 601A, 601P. Such pieces are preferably 1 to 3 mm wide and 10 to 20 mm long. Such a piece of material may be added to the valve 600 when the ring portions 601A, 601P are wound, and the piece of material may be placed in each of the ring portions 601A, 601P. These pieces of material may be elastic and may be made of a variety of compositions such as biocompatible rubber, recoil metal wire, synthetic materials and the like.

According to FIG. 6B, the cusp 602A may be semi-elliptical or plano-convex and the cusp 602P may be plano-concave. In some embodiments, the valve 600 may comprise at least two sets of cords. In some embodiments, each of at least two sets of cords is attached to the middle of each apex to mimic the natural mitral valve. For example, in some embodiments, the apex 602A may comprise at least one set of cords 603A, which typically has a ring portion 601A connected to the apex 602A. One end of the cusp 602A on the opposite side of the end may be connected to the middle portion of the cusp 602A. In some embodiments, at least one set of cords 603A may comprise at least two subsets of cords, such as a subset 604 of cords and a subset 606 of cords 606. According to some embodiments, the subsets 604 and 606 of these cords are spaced so that a gap of about 3-5 mm is maintained between the subsets of the two cords. Efficient joining is possible. The gap between the cord-like subsets 604 and 606 also helps to distribute the apical tension more evenly, potentially reducing wear and tear. These cord-like subsets 604 and 606 may be connected to different separate caps to connect the cord-like subsets to the papillary muscles of the heart, as described in detail with respect to FIGS. 7A and 7B. ..

In some embodiments, the apex 602P may comprise at least one set of cords 603P, which typically has a ring portion 601P connected to the apex 602P. One end of the cusp 602P on the opposite side to the cusp 602P may be connected to the middle portion of the cusp 602P.

In some embodiments, at least one set of cords 603P may comprise at least two subsets of cords, such as a subset 608 of cords and a subset 610 of cords. These cord-like subsets 608 and 610 are spaced so that a gap of approximately 5-8 mm is maintained between the two cord-like subsets, allowing for more efficient joining. ing. These cord-like subsets 608 and 610 may be connected to different separate caps to connect the cord-like subsets to the papillary muscles of the heart, as described in detail with respect to FIGS. 7A and 7B. ..

In some embodiments, the width of the cord 603A and / or the cord 603P may be between 1 mm and 2 mm, but may be implemented in other widths. In some embodiments, the posterior leaflet of the mitral valve 602P may be unilaterally connected to the ring portion 601P of the asymmetric ring. When the ring portion 601A is attached to the ring portion 601P via, for example, a suture portion, a fastener, etc., a completely asymmetric flexible ring can be formed. In some embodiments, the sutures used to attach the ring portion 601A to the patient's annulus are made of a radiopermeable material.

According to some embodiments, the interstitial distance at the mitral valve anterior leaflet 634A may be 8-10 mm. In some embodiments, the interstitial distance at the posterior leaflet of the mitral valve 634P may be between 10 and 15 mm. In some embodiments, the interstitial distance between the anterior and posterior apex at the commissure, described as distance 636 and / or 638, may be between 5 and 7 mm.

According to some embodiments, as shown in FIG. 6B, the anterior leaflet 602A is connected to the posterior leaflet 602P and the ring portion 601A is connected to the ring portion 601P to construct the mitral valve prosthesis 600. May be good. When the apex 602A is connected to the apex 602P, the orifice 620 created between the apex 602A and the apex 602P allows blood to flow in one direction, i.e., from the left atrium to the left ventricle. Therefore, the orifice 620 generated between the apex 602A and the apex 602P may be configured to prevent regurgitation, i.e., regurgitation from the left ventricle to the left atrium. The apex 602A, apex 602P, and the way these apex are connected to each other at a particular junction, as well as the ring portion 601A and the ring portion 601P, so as to mimic the shape, size, and thus function of the mitral valve of a human organism. It may be configured. Specifically, the ring portion 601A may be configured to mimic the anterior annulus, while the ring portion 601P may be configured to mimic the posterior annulus of the mitral valve of a living body. .. In some embodiments, each apex may have an extended shape of about 1-5 mm, located between the ring portion and the cord, thereby better between the two apex. Bonding is possible and the cords can be better attached to each of the apex.

In some embodiments, the anterior apex 602A may comprise at least two cord-like subsets, eg, a cord-like subset 604 and a cord-like subset 606, which have different ends of the apex 602A. The portion may be connected to the cusp 602A. In some embodiments, the posterior apex 602P may comprise at least two cord-like subsets, eg, a cord-like subset 608 and a cord-like subset 610, which have different ends of the apex 602P. It may be connected by a unit. Like the mitral valve of an organism, the cord must be connected to the papillary muscle of the heart. More specifically, in the human mitral valve, each subset of cords is attached to different regions of the papillary muscle. Thus, the artificial mitral valve 600 comprises at least two subsets of cords for each apex, whereby each subset of cords is attached to different papillary muscle regions of the living mitral valve. It will closely mimic the configuration and its behavior. This will be described with reference to FIGS. 6C, 7A and 7B. By connecting each subset of cords to the papillary muscles through a cap, the attachment between the subset of cords and the papillary muscles is easy, yet sufficiently stable and durable. May be good. The number of cords in each subset of cords, eg, 604, 606, 608, 610, may be different or the same. In some embodiments, each subset of cords may comprise at least two cords.

According to some embodiments, the two-piece valve of the present disclosure can ensure a longer junction length between the apex and can accurately copy the subject's own valve from a three-dimensional ultrasonic short-axis view, one-to-one. Can be reproduced with.

FIG. 6C is a schematic top view of a mitral valve prosthesis looking down from the left atrium toward the left ventricle according to an embodiment of the present disclosure. According to FIG. 6C, the posterior apex 602P may be attached to the anterior apex 602A via an attachment line, eg, suture line 609. In some embodiments, the ring portion 601A may be attached to the ring portion 601P, eg, along a wire 609, or may be wound around itself towards the outside of the valve 600. In some embodiments, the anterior leaflet 602A may comprise two subsets of cords, eg, subsets 604 and 606, whereby each of these subsets of cords is a separate cap element. It may be connected to different papillary muscles 720 via 700. Thus, the posterior apex 602P may comprise two cord-like subsets 608 and 610, whereby each subset of cord-like bodies may be attached to the papillary muscle 720 via a different cap element 700. .. For example, the anterior cord 604 may be connected to the first papillary muscle 720 via the first cap 700, while the posterior cord 608 may also be connected to the same first via the same first cap 700. It may be connected to the papillary muscle. Similarly, the anterior cord 606 may be connected to the second papillary muscle 720 via the second cap 700, while the posterior cord 610 is the same via the same second cap 700. It may be connected to the second papillary muscle.

According to FIG. 6D, in some embodiments, the cusps 602P and 602A may be cut from a single monocoque structure and the connection to form a complete valve, eg, suture, is sutured at 609. It may be done along. According to some embodiments, the cords may be adjusted for the recipient / patient's individual optimal cord length based on the patient's preoperative scan.

7A and 7B are schematic views showing a cap for connecting the cord to the papillary muscle of the heart and a mitral valve prosthesis with two caps attached to the cord, respectively, according to an embodiment of the present disclosure. Is. In some embodiments, the shape of the cap 700 in the layout configuration may be the shape of an arc. In some embodiments, the shape of the cap 700 in a closed configuration may resemble the shape of a tapered cone with a small opening 730 at its upper end 702 and a wide opening at its lower end 704. Thereby, surgical sutures 706 may be used to suture the ends of the arcs to each other, or to suture one on top of another to form a closed configuration. The suture 706 may be performed prior to placing the cap 700 on the papillary muscle 720. In some embodiments, the size of the cap 700 is between 5 mm and 10 mm in diameter and 5-10 mm in height. According to some embodiments, the cap 700 may be made of one material in the shape of a cap, whereas according to other embodiments, the cap 700 may have two open tips or the same material. Made of pieces, both of which may be sutured to the papillary muscle at one time. For example, the suture is like starting from one side of two parts of the material of the cap 700, exiting through a part of the cap 700, and attaching the cap 700 to the papillary muscle or the like, the two parts of the cap 700. Repeat until they are fully connected to each other and to the papillary muscles of the heart.

According to some embodiments, the cap 700 of the mitral valve prosthesis 600 may be formed in a closed configuration by winding the pericardium (eg, human-derived, bovine-derived, porcine-derived). In some other configurations, the cap may be made of a biomedical polymer. In some embodiments, the size of the cap 700 may be 5 mm or larger. In some embodiments, the cord of the mitral valve prosthesis may be made of the same material as the apex and / or cap material. In some embodiments, the cord may be of the same origin from which the cap 700, anterior leaflet 602A and posterior apex 602P are harvested, eg, a cord harvested from the same animal, eg, the same cow, cap 700, anterior. The advantage of having the same cell structure and origin as the apex 602A and posterior apex 602P may be added.

When the cap 700 is placed on the papillary muscle 720, the cords such as subsets 604, 608 of the cords are connected to the cap 700 using sutures 710, thereby the cords, cap 700, papilla. The muscles 720 may be connected together. According to some embodiments, the cap opening 730 can fit snugly between the cap 700 and the papillary muscle 720. This is because the cap opening 730 allows the shape of the cap to be adjusted to the shape of the papillary muscle 720. In some embodiments, the cap 700 may be attached, for example, via a suture portion 710 to subsets 604 and 608 of the cords on one end thereof, while the cap 700 may, for example, suture. It may be attached to the papillary muscle of the heart via another, typically contralateral end, of the cap 700, which is close to the lower end 704, via a portion 706. The cap 700 may be connected to the papillary muscle 720 via the entire circumference of the lower end 704 of the cap 700, but in some embodiments, the cap 700 is a specific portion along the circumference of the lower end 704 of the cap 700. It may be connected to the papillary muscle 720 via.

According to some embodiments, the cords may be connected to each other to form a bundle of cords. The cords may be connected as a bundle at the ends of the cords connected to the cap 700 (eg, the ends of the subsets 604 and 608 of the cords connected to the apex 602). According to some embodiments, connecting the cords, eg, subsets 604 and 608 of the cords, to the papillary muscle 720 via the cap 700 is more than connecting the cords directly to the papillary muscle 720. It's easy. This is because the latter requires a wider range of mounting procedures. For example, when the attachment method is suturing, suturing each of the cords to the papillary muscle 720 is to suture the cords to the placed cap 700, or to suture the cap, which is a large element of a single body. It is more complicated and time consuming than suturing 700 to the papillary muscle 720. Patients undergoing the prosthesis of the present disclosure are connected to a heart-lung machine, also commonly known as a heart-lung machine, and therefore mitral valve replacement is preferably performed appropriately.

On the other hand, FIG. 7A shows only a subset 604 of two cords attached to the cap 700 and a subset 608 of the two cords, even if additional cords are connected to the cap 700. Good things should be understood. The subsets 604, 608 of the cords may comprise one or more cords. In some embodiments, as shown in FIG. 6C, four cords 604 from the right fold (scallop scallop) of the anterior leaflet of the mitral valve 602A and the left fold of the posterior leaflet 602P of the mitral valve ( Four cords 608 from scallop) are connected to the cap 700.

In some embodiments, each of the cord-like subsets 604, 606, 608 and 610 may be connected to the cap 700 along the outside of the cap 700. In other embodiments, the prosthesis or at least a portion of the prosthesis may be attached to the cap 700 via an opening 730, which is located centrally to the cap 700. You may. That is, the cord may pass through the opening 730 and be attached to the inside of the cap 700.

In some embodiments, each subset of cords 604, 606, 608 and 610 may first be connected to each other to form a bundle and then to the cap 700.

As shown in FIG. 7B, the mitral valve prosthesis 600 may include a flexible asymmetric ring 601 attached to two cusps (eg, cusps 602A and 602P). In some embodiments, each of the two apex may be fitted with a set of cords, eg, a subset of cords 604 (not shown), 606 (not shown), 608 and 610. good. In some embodiments, each pair of cords of two apex may be attached to a single cap 700, while each cap 700 is each of each subset 610 of cords. The mitral valve prosthesis 600 may be connected to the papillary muscle 720 of the heart via a connection to the cap 700.

As described herein, according to some embodiments, each subset of cords 604 (not shown), 606 (not shown), 608 and 610 are sprouting anterior and posterior apex. It may be made of the same material as the material to be used. Such cords, each believed to be on an extension of the apex 602A, 602P, are sometimes referred to as the primary cord. According to some embodiments, additional cords may be attached to both the anterior leaflet 602A and the posterior leaflet 602P. Each of these secondary cords may be made of a different material than the material used to construct the apex or primary cord. The secondary cord may be configured to connect the underside of each of the apex 602A and 602P to a point along the primary cord. The connection point of the secondary cord along the primary cord may be the center of the primary cord, but another location along the primary cord may be implemented as the connection point to make the point. Better joining may be achieved. The secondary cord may typically be sutured to the anterior leaflet 602A or posterior leaflet 602P at one end and the secondary cord to the primary cord at the other end. good. When attaching the secondary cord to the anterior leaflet 602A or posterior apex 602P, for example via a suture, the outer surface or posterior surface of the anterior leaflet 602A to prevent coagulation along the attachment line, eg suture line. It is necessary to avoid damage to the outer surface of the tip 602P. For example, when microsewn is used, both tips 602A and 602P are less likely to be injured. The purpose of the secondary cord is to further support the prosthetic valve against the pressure exerted on the ventricular side of the prosthetic valve during the contractile phase.

8A and 8B show the possible positions of the secondary cord with respect to the posterior leaflet, as well as the primary and secondary cords when attached to the posterior leaflet, according to some embodiments of the present disclosure. It is a schematic diagram which shows each cross section. As shown in FIG. 8A, the posterior apex 602P may be wound at the posterior end to form the ring 601. In some embodiments, the posterior leaflet of the mitral valve 602P may be divided into several regions. Regions 812 and 814 may be regions to which secondary cords, such as cords 603, are connected. However, there may be a region 816 along the posterior apex 602P, which is preferably free of cords, i.e., secondary cords should not be connected to region 816. This is because the region 816 is a region to which high pressure is applied when the posterior leaflet 602P is connected to the heart as part of the prosthetic valve during the ventricular contractile phase. In some embodiments, the region 816 may include about 2-5 mm to the right of the central line 810 of the posterior apex 602P and about 2-5 mm to the left of the central line 810 of the posterior apex 602P. In some embodiments, the region 816 may be 3 mm to the right and 3 mm to the left of the center line 810 of the posterior apex 602P. The secondary cord may be designed to help further support the posterior apex 602P when the pressure gradient increases during the contractile phase of the ventricles.

In some embodiments, the secondary cord 603 must not reach the ends of regions 812 and 814 of the posterior apex 602P in the placed configuration. In some embodiments, the cord should not be connected to the ends of the regions 812 and 814 in close proximity to the ring 601. For example, the cord may be placed along any of the regions 812 and 814 with respect to the central line 810 of the posterior apex 602P, along about 20 to 70 degrees of the entire layout of the posterior apex 602P. .. Otherwise, the region of the posterior apex 602P located between about 15-20 degrees from both sides of the central line 810 and the central line 810 may remain free of secondary cords.

FIG. 8B schematically shows a cross section of the posterior mitral valve showing the primary and secondary cords when attached to the posterior apex 602P. FIG. 8B shows a primary cord 608 made of the same material as the apex. The primary cord-like body 608, one end of which extends from the posterior apex 602P, has another end attached to the cap 700. In some embodiments, the primary cords 608 may be connected to each other to form a bundle (not shown), in which case the bundle may be connected to the outside of the cap 700. This allows the cap 700 to connect to the papillary muscle 720.

According to some embodiments, the primary cord 608 may be connected to the secondary cord 603, whereby each of the secondary cords 603 is posterior at one end, eg, end 823. It may be connected to the apex 602P or at the opposite end of each of the secondary cords 603, eg, at the end 825, at a point of contact along the primary cord. According to some embodiments, it is desirable that the secondary cord 603 has a thickness and width of about 30-40% as compared to the primary cord 608. Depending on the desired prosthesis, 1 to 4 secondary cords can be used for each fold (scallop Scallop) of the posterior leaflet of the mitral valve (602P).

9A and 9B are a mitral valve prosthesis with two cusps attached in a curved (ellipoid / drop) configuration alternative design that enlarges the joint surface, according to some embodiments of the present disclosure, and a mitral valve prosthesis. It is a schematic diagram which shows each possible joint surface composition. According to FIG. 9A, the mitral valve prosthesis 1100 may include two apex, eg, anterior apex 1602A and posterior apex 1602P, whereby each of the apex 1602A and 1602P has a semicircular shape. Often, these two tips may work together to create a "yin and yang" shape. In some embodiments, the shape of the cusps is designed to be semi-circular along half the length of each cusp, forming an "S" -shaped seal when both cusps join. It may be.

This unique shape allows a sufficient bond between the anterior apex 1602A and the posterior apex 1602P, especially in region 1120. In some embodiments, there may be junctions or overlaps between the anterior apex 1602A and the posterior apex 1602P along the region 1120. Symmetrically, there may be similar junction or overlap regions between the posterior apex 1602P and the anterior apex 1602A (not shown). Similar to the valve 600 detailed herein, each of the cusps may be equipped with its respective rings, eg, rings 601A and 601P, where these rings are the ends of the material in which each of the cusps is composed. It may be formed by winding the portion around itself.

According to FIG. 9B, two junctions may be configured between the anterior apex 1602A and the posterior apex 1602P in close proximity to the area of adhesion. In some embodiments, the prosthesis 1100 may comprise two types of cords, a primary cord and a secondary cord, as with the mitral valve prosthesis 600. According to some embodiments, the primary cord may be configured as an extension to either the anterior leaflet 1602A or the posterior leaflet 1602P, respectively. That is, the primary cords, for example, the primary cords 1102A and 1102P, may be composed of the same material as the apex 1602A and posterior apex 1602P, respectively. The primary cords 1102A and / or 1102P may have one end extending from the middle of each apex and another end connected to the cap. According to some embodiments, the secondary cord-like body, eg, cord-like body 1104P, may be mounted only on the posterior leaflet 1602P. The secondary cord-like body, for example, the cord-like body 1104P, may have one end connected to the middle portion of the posterior leaflet 1602P and the other end connected to the intermediate portion of the primary cord-like body 1102P. According to some embodiments, a secondary cord is added to include a natural mitral valve, i.e., an additional short cord connecting between the posterior leaflet and the posterior primary cord. It may be easier to imitate the mitral valve. The addition of a secondary cord can withstand the pressure exerted on the posterior apex during systole, properly join (or close) the apex during systole of the cardiac cycle, and open the apex during diastole of the heart. become able to.

For example, the posterior apex 1602P may have a secondary cord-like body 1104P attached to the posterior end of the apex 1602P. The secondary cord-like body 1104P may be further connected to the intermediate portion of the primary cord-like body 1102P.

In some embodiments, each bundle of cords and / or each cord may be attached to a cap, eg, cap 700, which connects the cord to the papillary muscle of the heart. You may.

FIG. 10 is a schematic representation of a measurement copy of a patient's mitral valve according to some embodiments of the present disclosure. In some embodiments, apex length, width, and height measurements may be obtained via echocardiography, but other diagnostic imaging methods, such as cardiac CT, or cardiac MRI, may be used. You may use it. Therefore, the dimensions and shape of the mitral valve prosthesis 1200 may be a substantially exact copy of the patient's living body or the natural mitral valve.

FIG. 11 illustrates the formation of a two-pointed prosthesis according to some embodiments of the present disclosure. As shown in FIG. 12, in some embodiments, the base portion, or apex, of the valve may be cut out from one material 1210 based on a cross-sectional image of the intended recipient's heart. The size of the apex may be cut in such a way as to reproduce the prosthesis image at a 1: 1 scale, and may be crescent-shaped or semicircular along the center of the apex to provide the opening 1230. An incision 1220 may be made to demarcate two cusps, such as the anterior apex 1202A and the posterior apex 1202P, as shown in FIG.

FIG. 12 schematically shows an opening formed along the apex according to some embodiments of the present disclosure. In some embodiments, an opening or orifice 1230 may be formed (eg, cut) in one material 1210, and two cusps 1202A and 1202P may be formed on opposite sides of the opening 1230. .. Once the orifice 1230 is present by cutting open one material 1210, the two cusps, such as the anterior cusp 1202A and the posterior cusp 1202P, may be in the form of flaps that fold into the orifice 1230, thereby. , Through the orifice 1230, i.e., further forming blood flow in one direction from the left atrium of the heart to the left ventricle.

FIG. 13 schematically illustrates an echocardiographic or MRI scan of a patient's left heart chamber or ventricle according to some embodiments of the present disclosure. In some embodiments, the patient's left ventricle 1500 may be imaged or scanned by echocardiography, CT or MRI, or other imaging techniques. Such an image or scan of the left ventricle 1500 can provide the exact or substantially exact length of the patient's cord in need, from the tip of the papillary muscle 1520 to the leaflets 1502A and 1502P. .. This allows a customized mitral valve prosthesis to be made according to the patient's anatomical and physiological requirements.

14A and 14B are schematic views of the left ventricle of each patient during dilation and contraction, according to some embodiments of the present disclosure. In some embodiments, the left ventricle during systole, i.e., the left ventricle 1610, is smaller than the annulus diameter 1650 of the left ventricle 1612 during diastole shown in FIG. 14A, as shown in FIG. 14B. It may have a ring diameter of 1640. When blood flows into the left ventricle during dilation, the left ventricle 1612 may be filled with blood, resulting in an increase in annulus diameter 1650. After blood flows from the left ventricle into the patient's body's blood system and reaches the organs, blood exits the left ventricle 1610 during the contractile phase. Therefore, the volume of the left ventricle 1610 during contraction is smaller than the volume of the left ventricle 1612 during expansion, whereby the annulus diameter 1640 during contraction is smaller than the annulus diameter 1650 during expansion.

Since the annulus and apex 1502A and 1502P are required to be flexible when their diameter and size are repeatedly varied in the recurrent state of cardiac function (ie, systole and diastole), the valve. It will be clear that the annulus and apex should be made of elastic material, such as the tissue that makes the mitral valve of a living body. Therefore, prostheses that do not use stents, metal rings, or rigid materials are disclosed, and the materials selected to make the tips 1502A, 1502P and rings require some degree of compliance and elasticity.

15A and 15B are schematic views of extensions attached to the anterior and posterior leaflets, respectively, according to some embodiments of the present disclosure. In some embodiments, as shown in FIG. 15A, the anterior leaflet 1202A may include an extension 1703 with additional material for extending the size of the anterior leaflet 1202A. The extension 1703 is the size of an incision (eg, incision 1220 in FIG. 11) made to form a substantially anterior leaflet with a length of about 1-5 mm and a width of substantially anterior leaflet. In some embodiments, the extension 1703 is sutured to one end of the anterior leaflet 1202A (see incision 1220 in FIG. 11) and the other end is similar to the cords 604, 606 of FIG. 6A. It may be equipped with a cord 1704, which may be.

As shown in FIG. 15B, the posterior apex 1202P may include an extension 1709 made of additional material to extend the size of the posterior apex 1202P. The extension 1709 is the size of an incision (eg, incision 1220 in FIG. 11) made to form a substantially anterior leaflet with a length of about 1-5 mm and a width of substantially anterior leaflet. In some embodiments, the extension 1709 is sutured to one end of the posterior apex 1202P (see incision 1220 in FIG. 11) and the other end is similar to the cords 608, 610 of FIG. 6A. A possible cord-like body 1708 may be provided.

As shown in FIG. 15B, the posterior apex 1202P has an extension 1709 attached to one end (tip) and a cord-like body 1708 attached to the other end. The cord 1708 has one end connected to the extension 109 and the other end connected to the cap 1870, which cap may be similar in structure to the cap described in connection with FIG. 7A. The anterior leaflet 1202A has an extension 1703 attached to one end (tip) and a cord-like body 1704 attached to the other end. The cord 1704 has one end connected to the extension 1703 and the other end connected to the cap 1870, which cap may be similar in structure to the cap described in connection with FIG. 7A.

Each of the cords 1704 and 1708 may comprise a plurality of cords, eg, four primary cords, which are also described herein as primary cords, but the specific requirements of each patient. Other numbers of cords may be implemented depending on the situation. In some embodiments, the cord may comprise a secondary cord (not shown) as described herein.

16A and 16B are schematic side views of a mitral valve prosthesis with an extension and an attached cord according to some embodiments of the present disclosure, respectively, during expansion and contraction. Here, reference to FIG. 16A is a side view of the mitral valve prosthesis showing the profile of the mitral valve prosthesis when the heart is in diastole, and reference to FIG. 16B is a side view of the mitral valve prosthesis when the heart is in diastole. It is a side view of a mitral valve prosthesis. The anterior apex 1202A and the posterior apex 1202P are spaced apart from each other to allow blood to flow into the left ventricle through the orifice between the apex 1202A and 1202P, with extensions 1703, 1709 being valve prostheses. The joining profile of can be enhanced. Each of the apex 1202A and 1202P has extensions 1703, 1709 that provide additional material to the anterior and posterior apex and provide the necessary junctions during contraction, allowing blood to flow back into the atrium. It may be possible to prevent and support the left ventricle during contraction.

In some embodiments, the extension 1703 and extension 1709 are provided in different sizes (eg, length, width, and shape). In some embodiments, the cords 1704, 1708 may be bundled together and secured by suturing prior to attachment to the cap 1870.

Extensions 1703 and 1709 are configured to carry their respective cords (1704, 1708), respectively, which are similar to the cords of the natural heart valve. It is supported, inserted into the heart chamber, and mounted on the wall muscle or papillary muscle of the heart. For example, the extension 1703 may carry a cord or a set of cords 1704, and the extension 1709 may carry a cord or a set of cords 1708. Even if each of the at least two cords is connected to a cap 1870 configured to attach the valve to the papillary muscle at another end (opposite the end connected to each of the extensions). good.

In some embodiments, as shown in FIG. 16A, during the diastolic phase, the cusps 1202A and 1202P, as well as the extensions 1703 and 1709, respectively, are spaced apart from each other so that the blood is left. It flows in one direction from the atrium to the left ventricle.

In some embodiments, as shown in FIG. 16B, during the contractile phase, the tips 1202A and 1202P, and their respective extensions 1703 and 1709, are located in close proximity to each other and thus in opposite directions, i.e. Prevents blood from flowing back or leaking from the left ventricle to the left atrium. According to some embodiments, extensions, such as extensions 1703 and 1709, make the necessary junctions or closures of the valve to prevent blood from flowing back and leaking from the left ventricle to the left atrium.

According to some embodiments, the extension is cut to fit the edge of the apex and may have a different width of 5 mm or more to ensure sufficient bonding. The extension is attached to the apex by suturing, gluing, stapler, or otherwise attaching to the edge of the apex.

According to some embodiments, the cords, eg, cords 1704 and 1708, are individually attached to the heart chamber wall or papillary muscle, depending on the design that is determined to be optimal for a particular patient. For example, they may be sewn together, or they may be bundled together, for example, in pairs.

According to some embodiments, the cord may be asymmetric. That is, the sizes of the cords may be different. This is because there are two papillary muscles in the left heart chamber, and the cords extending from various parts of the apex extension differ in length and distance from the upper end of those muscles. Therefore, each cord-like body or a bundle of cord-like bodies may have a different length individually as compared with another cord-like body. As a result, the artificial valve can be completely closed and a sufficient joint length can be secured.

In some embodiments, the cords arising from the apex extensions, such as the extensions 1703 and 1709, respectively, such as the cords 1704 and 1708, are distributed along the edges of the anterior and posterior apex extensions. As the valves move in vivo, tension may be evenly distributed along the edges of their apex, thus reducing wear and tear of the prosthesis.

FIG. 17 is a schematic diagram showing the attachment of an asymmetric flexible ring to the outer circumference of an artificial valve in order to mimic a natural annulus according to some embodiments of the present disclosure. According to some embodiments, the flexible ring 1901 may be formed by winding a portion of an elongated material over itself and closing it into a ring, or one of the materials with a central hole. The portions may be formed by winding over themselves towards the outside of the material. In some embodiments, the wound ring 1901 is attached to the perimeter of the mitral valve prosthesis 1200 to allow surgical attachment, eg, suturing to the patient's annulus, increasing the stiffness of the annulus. Also, if elastic materials are used, the elasticity may be improved during the cardiac cycle that changes between systole and diastole. The wound ring 1901 may be fitted snugly on the outer circumference of the first cut valve 1200 (FIG. 10). In some embodiments, the suture material used to be surgically attached to form a ring shape is a radiation opaque material. In some embodiments, the suture material that is surgically attached and used to attach the mitral valve prosthesis to the patient's annulus is a radiation opaque material.

According to some embodiments, the outer ring reinforcement 1901 is made of an elastic material with variable elasticity so that the prosthesis can be variably expanded and contracted during the diastolic and systolic cardiac cycles. You may. In some embodiments, the elasticity of the ring 1901 may be obtained by continually studying the patient's natural annulus movement based on three-dimensional echocardiography.

In some embodiments, the stiffening ring 19010 may be exposed to the blood environment inside the heart, or may be wound around and sandwiched by an elastic material, the elastic material having a cusp surrounding it. It may be made from the same material as.

As shown in FIG. 17, the prosthesis 1200 comprises cords 1704 and 1706, with cords 1704 and 1706 attached to the apical tip 1202A (via or without extension). Better yet, with cords 1708 and 1710, cords 1708 and 1710 may be attached to the posterior apex 1202P (via or without extension). As shown in FIGS. 16A and 16B, the cord is attached to at least two caps configured to attach the mitral valve 1200 to the papillary muscle of the heart, thus the particular anatomy of a particular patient. Depending on the physical and physiological requirements, the mitral valve prosthesis 1200 may be adequately fitted to the patient's left ventricle.

18A-18E are schematic views of the elastic material inserted into the wound annulus, respectively, according to some embodiments of the present disclosure, illustrating the procedure by which the ring is wound. It is a figure. According to some embodiments, as shown in FIGS. 18A-18C, the annulus 2201 further comprises an elastic material 2205, with the ring 2201 winding over the elastic material 2205 within the ring 2201. The elastic material 2205 may be configured to be "sandwiched" within the ring 2201. The elastic material 2205 is added within the ring 2201 to provide the ring 2201 with special elasticity, which makes it easier to mimic the elastic properties of the mitral valve of a living body. In some embodiments, the elastic material 2205 may be rubber or any other biocompatible synthetic material. In some embodiments, the shape of the elastic material 2205 is similar to the shape of the ring 2201 into which it is inserted, whereby the elastic material 2205 can be easily inserted into the ring 2201.

According to some embodiments, as shown in FIG. 18B, the ring 2201 (which may be made of the same material as the cusp or is an extension of another material attached to the outer edge of the cusp. May be made from), but may be wound over the elastic material 2205 towards the inside of the synthetic valve, eg, towards the incision 2220, the incision in the center of the apex. Along the crescent or semicircular shape, an opening may be provided between the two apex defined by the incision 2220, eg, anterior apex 2202A and posterior apex 2202P. The incision 2220 is actually the orifice of the actual mitral valve prosthesis through which blood flows from the left atrium to the left ventricle. Thus, the outer edge of the mitral valve prosthesis comprises a ring 2201, which is then connected to the main surface of the apex, eg, apex 2201A and 2202P, which is a cord-like body, eg, cord-like. It is connected to the papillary muscle via the cap 2270 via the body 2204.

According to some embodiments, as shown in FIGS. 18C, 18D, some or all of the elastic material 2205 is made of radiation opaque marker filament 2240. According to some embodiments, a radiation opaque marker filament 2240 is added and placed inside the ring 2201 alongside the elastic material 2205. The radiation opaque marker filament 2240 may be placed inside the elastic material 2205 or may be a separate component placed side by side with the elastic material 2205. The radiation opaque marker filament may be sewn in place using polypropylene suture material 2242 in the ring 2201 so that the ring 2201 wraps over the radiation opaque marker filament. Is "sandwiched" in the ring 2201. In some embodiments, both the radiodensity marker filament and the elastic material 2205 are "sandwiched". In some other embodiments, the radiodensity marker filament 2240 is sutured to the rim of the ring 2201 without the need to wind the ring 2201. The radiodensity marker filament may be sutured in place using a circular suture 2244 or a horizontal suture 2246. The radiation opaque marker filament 2240 may preferably be made of platinum, platinum-iridium, gold, nitinol, tungsten or palladium. The use of the radiation opaque marker 2240 as described herein is useful for any intervention required in the future, such as valve-in-valve for transcatheter prosthesis implantation. If there is a radiodensity marker in the ring 2201 or if it is attached to the ring 2201, visibility with conventional image scans (CT, MRI, X-rays, etc.) will provide guidance to the doctor. At the same time, the mitral valve annulus can be identified.

In some embodiments shown in FIG. 18E, during resection of the natural mitral valve, one or more pieces of the natural mitral valve apex 2250, 2252 are taken from the preoperative patient. Depending on the condition of the patient's natural mitral valve, the healthy part of the patient's natural mitral valve is identified by the surgeon and excised along with the attachment of the healthy cords 2254, 2256. One or more healthy, resected, natural mitral valve leaflets 2250, 2252 with attached cords 2254, 2256 are then preserved and attached, for example, to the posterior leaflet of the mitral valve prosthesis 2202. One or more excised, naturally healthy mitral valve pieces of the natural mitral valve leaflets 2250, 2252 may be connected to the posterior leaflet by suturing or gluing. Also, the cords 2254, 2256 are attached to the patient's papillary muscle 2270 as described herein. The resected, natural mitral valve leaflets and cords depend on the patient's own condition, so the patient has a healthier tissue and is used to build his own mitral valve prosthesis. You will benefit from the materials. Such additional excised, born mitral valve leaflets and cords are supported as secondary cords of the mitral valve prosthesis described herein, reducing shear stress on the prosthesis. As a result, the durability and life of the prosthesis will be extended.

FIG. 19 is a schematic flow chart showing a method of making a mitral valve prosthesis according to some embodiments of the present disclosure. According to some embodiments, method 2000 for making a patient-specific customized mitral valve prosthesis comprises measuring the size and shape of a patient's mitral valve via diagnostic imaging. Obtaining, operation 2002 may be included. As the diagnostic imaging method for measuring the shape and size of the mitral valve of a specific patient, all diagnostic imaging methods such as echocardiography, cardiac CT, and cardiac MRI can be considered. Method 2000 may further comprise operation 2004, which cuts a replica of the patient's mitral valve from one material to a 1: 1 scale. In some embodiments, Method 2000 makes a notch along one material, thereby forming an orifice for blood flow, forming two cusps, one on each side of the orifice, operation 2006. May include. Method 2000 may include motion 2008, which measures the required cord length via a diagnostic imaging method, which, as in motion 2002, is a diagnostic imaging measuring the shape and size of the mitral valve. It may be similar to the law.

In some embodiments, Method 2000 may further comprise motion 2010, in which the cord is attached to one of two caps configured to attach the cord to the papillary muscle of the heart.

In some embodiments, Method 2000 may include movement 2012, which movement involves attaching a flexible ring to the apex, thereby mimicking the natural mitral valve for each particular patient. The entire mitral valve prosthesis may be created.

In some embodiments, Method 2000 may further comprise any motion, which motion has an extension on each of the two apex to support the cord as measured in motion 2008. May include mounting. These extensions help to properly join and close during the contractile phase of the cardiac cycle.

According to some embodiments, any anterior and posterior leaflets disclosed, any ring, any cord (and any subset of cord), any cap, and / or any of them. Any combination can be made from natural materials and can avoid foreign matter such as cotton sprinkling yarn. Further use of homograft materials and / or composites, including various combinations of homograft, xenograft, and / or autograft materials, to make flexible rings, cusps, cords, and caps. good. Materials that form the annulus and apex include human, bovine, and porcine pericardium, decellularized biomaterials, biodegradable polymer fabrics incorporating cells, and extracellular materials. Not limited. Biodegradable natural polymers include, but are not limited to, tofibrin, collagen, chitosan, gelatin, hyaluronic acid, and similar materials. Biodegradable synthetic polymer skeletons (scaffolds) that can infiltrate cells and extracellular matrix materials include poly (L-lactide), polyglycolide, poly (lactic acid-co-glycolic acid), and poly (poly). Caprolactone), polyorthoesters, poly (dioxanone), poly (anhydrous), poly (trimethylene carbonate), polyphosphazene, and similar materials thereof, but are not limited thereto. The flexible ring can be further customized to have flexibility and rigidity tailored to the patient. In addition, some components of the mitral valve prosthesis, including the cord, may be formed during surgery by the patient's autologous pericardium.

According to some embodiments, any of the disclosed asymmetric flexible rings may include an anterior ring portion and a posterior ring portion, or may be made as a single piece, and may be pointed (s). The end of (possible) may be formed by winding or bending around itself. In another embodiment, the flexible ring may further comprise a material of at least two strands or layers, such as human, bovine, porcine pericardium, or any of the above materials, thereby at least two. One strand or layer may be wound around the other, twisted, woven, or looped. A ring made up of a coiled coil is stronger than a ring that simply winds around the end of the tip, but the coiled ring must remain elastic.

According to some embodiments, the ring comprises two strands or layers of material that are bent to provide elasticity and a third layer is added to provide structural stability. .. In some embodiments, the ring comprises two layers made of bovine pericardium, the third strand or layer may be made of glycine or proline to give strength to the ring.

In some embodiments, at least two layers or strands may be attached to each other and, for example, sutured. In some embodiments, the third layer may be attached to at least two layers of the ring, for example sutured.

According to some embodiments, the components of the mitral valve prosthesis can be attached or connected to each other via several connecting methods. For example, the components of the mitral valve prosthesis may be connected to each other via sutures, staplers, adhesives, or other attachment means.

In some embodiments, the suture or stitch may be made of a non-biodegradable synthetic material such as nylon (ethiron), prolen (polypropylene), novalfill, polyester or the like. In some embodiments, the sutures and stitches may be made of a non-biodegradable natural material, such as surgical silk or surgical cotton.

In some embodiments, the stapler pins may be made of a biocompatible material such as stainless steel or titanium.

In some embodiments, the adhesive may be made of a biocompatible material such as an aldehyde-based adhesive, fibrin sealant, collagen-based adhesive, polyethylene glycol polymer (hydrogel), or cyanoacrylate. good.

According to some embodiments, any of the apex, ring, cord (and subset of cord) and / or combinations thereof is of the patient's innate mitral valve and surrounding anatomy. It can be customized for each patient based on ultrasonic diagnostic imaging. In addition, customized mitral valves can be made based on data obtained from other diagnostic imaging techniques that provide three-dimensional information, such as echocardiography, cardiac CT, and cardiac MRI. Thus, the mitral valve prosthesis of the present disclosure may be selected or designed to match the particular anatomy of the patient, whereby the tissue surrounding the patient, such as the myocardium surrounding the prosthesis, is the prosthesis. Can increase the likelihood of accepting.

Mitral valve surgery usually causes the patient's heart to stop in preparation for transplantation into the patient. Upon transplantation, the prosthesis's flexible ring is sutured to the natural annulus and the papilla cap is sutured to the natural papillary muscle. For example, a cap is attached to the muscle with a two-needle suture at the tip of each of the natural papillary muscles. The clinician confirms that the valve opens and closes completely by filling the ventricle with saline at the appropriate pressure and checking the movement and ability of the replaced valve to close under the applied pressure. After transplantation, the heart is closed and the heart beats again, and then the valve is examined by transesophageal echocardiography (TEE).

If desired, the subject can also administer an anticoagulant after transplantation. Considering that the mitral valve prosthesis of the present invention is constructed using natural shapes and natural materials, the amount of anticoagulant used is reduced or anticoagulant is used for most patients. It is expected not to.

The biological and mechanical prostheses currently in use contain bulky foreign bodies, require strong anticoagulants, have a short service life, and require reoperation in case of replacement. There are some drawbacks, such as not effectively supporting the recovery of the heart after transplantation. The present invention provides several advantages over the biological and mechanical prostheses described above. Designed closer to the patient's natural mitral valve, the described mitral valve prosthesis made of natural materials shortens the patient's recovery time, achieves a longer service life, and administers anticoagulants. Is expected to be reduced or omitted.

All patents, published applications, and bibliographical teachings cited herein are incorporated by reference in their entirety.

Although the present invention has been described so far with reference to exemplary embodiments, various changes may be made to the embodiments and details without departing from the scope of the invention included in the appended claims. It will be understood by those skilled in the art that it can be done.

Claims (27)

A mitral valve prosthesis that is transplanted into the heart
An asymmetric ring, sized to mimic the patient's natural mitral annulus, is composed of a flexible material wound around itself toward the outside of the valve. , Asymmetric ring and
Flexible anterior and posterior apex, suspended from the asymmetric ring and configured to substantially join to each other, of the flexible anterior and posterior leaflets. Each shape is constructed to mimic the shape of a natural mitral valve, whereby the flexible anterior leaflet and the flexible posterior leaflet form an orifice through which blood flows in one direction. With a flexible anterior leaflet and a flexible posterior leaflet,
At least two sets of cords, each set of cords attached to the flexible anterior or posterior leaflet at the first end and capped at the second end. Attached, the cap is configured to be attached to the papillary muscle of the heart at another end of the cap.
A mitral valve prosthesis characterized by that. Each of the flexible anterior apex and the flexible posterior apex is continued, further comprising a joint surface attached to each set of cords.
The joint surface is configured to enhance the tightness of the mitral valve prosthesis.
The mitral valve prosthesis according to claim 1. The asymmetric ring further comprises at least two strands configured in a coiled coil structure.
The mitral valve prosthesis according to claim 1. The asymmetric ring comprises two layers of material folded together for elasticity and a third layer for structural stability.
The mitral valve prosthesis according to claim 1. The asymmetric ring comprises two layers of bovine pericardium and a third layer of glycine or proline to increase strength.
The mitral valve prosthesis according to claim 1. The layers are connected together via suture stapler pins, adhesives or any combination thereof.
The mitral valve prosthesis according to claim 5. The asymmetric ring, the flexible anterior and posterior leaflets, the at least two cords, the cap, or any combination thereof, are made of bovine pericardium.
The mitral valve prosthesis according to claim 1. The extension of the tip shape by 1 to 5 mm enables better joining and attachment of the cord.
The mitral valve prosthesis according to claim 1. The shape of the apex is designed to be semicircular along half the length of the flexible anterior apex and the flexible posterior apex, and is "S" when both the apex are joined. It is configured to form a mold seal,
The mitral valve prosthesis according to claim 1. Further equipped with at least one secondary cord
The at least one secondary cord has one end attached to the middle of the flexible posterior apex and the other end attached to the middle of the cord.
The mitral valve prosthesis according to claim 1. The at least two sets of cords are attached to the opening of the cap.
The opening is located in the center of the cap,
The mitral valve prosthesis according to claim 1. Each of the at least two sets of cords is attached to the middle of the flexible anterior or posterior flexible leaflets to mimic the innate mitral valve.
The mitral valve prosthesis according to claim 1. The flexible anterior apex and the flexible posterior apex are made as a single body, connected to the asymmetric ring, and attached to the at least two sets of cords.
The mitral valve prosthesis according to claim 1. One end is connected to the flexible anterior leaflet and the other end is connected to the at least two sets of cords, allowing a bond between the flexible anterior leaflet and the flexible posterior leaflet. Further equipped with an extension configured to
The mitral valve prosthesis according to claim 1. At least a portion of the at least two sets of cords comprises the patient's own natural mitral valve cord.
The mitral valve prosthesis according to claim 1. At least one portion of the at least two sets of cords comprises the patient's own natural mitral valve cord and at least a portion of the patient's own natural valve apex.
The mitral valve prosthesis according to claim 1. The asymmetric ring further comprises a radiodensity marker filament, and the asymmetric ring further comprises.
The radiation opaque marker filament is inserted inside a roll-shaped flexible material.
The mitral valve prosthesis according to claim 1. The mitral valve prosthesis further comprises a suture portion made of a radiodensity opaque suture material.
The suture portion is formed via the ring.
The mitral valve prosthesis according to claim 1. A mitral valve prosthesis that is transplanted into the heart
An asymmetric ring with dimensions that mimic the patient's natural mitral valve annulus, the asymmetric ring made of a flexible material wrapped around itself toward the outside of the mitral valve.
Two cusps suspended from the asymmetric ring, the cusps are configured on opposite sides of an incision made along a material similar to the material to which the asymmetric ring is composed. The incision forms an orifice through which blood flows in one direction.
At least two sets of cords, each set of cords attached to one of the two tips at the first end and bundled at the second end. There are at least two sets of cords and
A cap configured to be connected to the at least two sets of cords at one end of the cap and sutured to the papillary muscle of the heart at the other end of the cap.
A mitral valve prosthesis characterized by being equipped with. Each pair of cords is attached to one of the two apex via an extension configured to allow joining between the two apex.
19. The mitral valve prosthesis according to claim 19. Each set of cords, in part, comprises the patient's own natural mitral valve cord.
20. The mitral valve prosthesis according to claim 20. How to make a mitral valve prosthesis,
Measuring the size and shape of the patient's mitral valve with diagnostic imaging,
Cutting out a replica of the subject's mitral valve from one material,
Making a notch along a piece of the one material creates an orifice for blood flow and two cusps on either side of the orifice.
Measuring the length of the cord required for diagnostic imaging, and
Attaching the cord to one of the two caps
Attaching a flexible ring to the apex creates an entire mitral valve prosthesis that mimics the natural mitral valve of a particular patient.
A method characterized by including. Measuring the required cord length is performed at the same time as measuring the size and shape of the subject's mitral valve.
22. The method of claim 22. Further comprising attaching an extension to each of the two apex to support the cord before attaching the cord to one of the two caps.
22. The method of claim 22. Further including adding a flexible material to the flexible ring,
The flexible ring is formed from at least one layer of the flexible material and one layer of the material.
22. The method of claim 22. Further comprising adding a radiodensity material to the flexible ring,
The flexible ring is formed from at least one layer of the radioimpermeable material and one layer of the material.
22. The method of claim 22. The flexible ring is attached to the apex using a radiation opaque suture material.
22. The method of claim 22.

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