MXPA02002942A - Mitral valve annuloplasty ring and method - Google Patents

Mitral valve annuloplasty ring and method

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Publication number
MXPA02002942A
MXPA02002942A MXPA/A/2002/002942A MXPA02002942A MXPA02002942A MX PA02002942 A MXPA02002942 A MX PA02002942A MX PA02002942 A MXPA02002942 A MX PA02002942A MX PA02002942 A MXPA02002942 A MX PA02002942A
Authority
MX
Mexico
Prior art keywords
section
annuloplasty ring
needle
mitral valve
ring
Prior art date
Application number
MXPA/A/2002/002942A
Other languages
Spanish (es)
Inventor
L Cox James
Original Assignee
Cardiac Concepts Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cardiac Concepts Inc filed Critical Cardiac Concepts Inc
Publication of MXPA02002942A publication Critical patent/MXPA02002942A/en

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Abstract

A mitral valve annuloplasty ring (30) and method for implanting a mitral valve annuloplasty ring (30) to treat mitral insufficiency by reestablishing the normal shape and contour of the mitral valve annulus. The annuloplasty ring (30) is flexible and can be readily adjusted to different sizes and shapes. The method substantially eliminates scarring subsequent to the annuloplasty procedure to maintain flexibility of the ring and the annulus (34) indefinitely.

Description

METHOD AND MITRAL VALVE ANULOPLASTY RING BACKGROUND OF THE INVENTION The present invention relates to a mitral valve annuloplasty ring and to a method for implanting a mitral valve annuloplasty ring for the treatment of mitral regurgitation in a patient. Mitral regurgitation, also known as mitral regurgitation, is a common cardiac abnormality in which the mitral valve of the heart does not close properly. In a normally functioning heart, oxygenated blood passes from the left atrium, through the open mitral valve into the left ventricle, when this left ventricle is in a releavened state. When the left ventricle contracts, the blood is pushed out of it, thereby closing the mitral valve to prevent the blood from flowing back or regurgitating in the left atrium. From the left ventricle, the oxygenated sac is pumped out of the heart and directed towards the rest of the body. In mitral regurgitation, the mitral valve does not close completely and a portion of blood spills back into the left atrium when the left ventricle contracts. As a result, the heart has to work harder when pumping or just its blood volume REF 137024 regular, but also the additional volume of blood that regurgitates back to the left atrium. The additional workload increased undue tension in the left ventricle. This tension eventually wears out the heart and results in death when this disorder is prolonged and severe enough. Consequently, an appropriately functioning mitral valve is critical for the pumping efficiency of the heart. Mitral valve annuloplasty is a well-known procedure for the treatment of mitral regurgitation, although other treatments are used, including mitral valve replacement, repair of the mitral valve leaflets, and shortening or replacement of the mitral valves. Tendinous cords Mitral valve annuloplasty is the reparation of the mitral valve annulus or ring to effect a complete closure of the leaves, restoring the tanna and the shape of the normal mitral valve anulus Such annuloplasty should commonly incorporate the use of a ring of mitral annuloplasty, where the ring is implanted in the mitral valve anulus. There are three basic types of mitral annuloplasty used in the annuloplasty procedures. These include a rigid ring, a flexible ring and a ring combined that has both a flexible component and a rigid component. Due to its inflexibility, rigid rings dictate the shape and contour of the mitral valve. The ring of the native mitral valve flexes in response to the movement of the heart. However, with a rigid ring it is not able to flex normally or move freely with the action of pumping the heart. As a result of stiffness, the physiological factors that normally shape the mitral valve annulus are not allowed to proceed to shape the valve. Another drawback of rigid rings is that they can induce a cardiac disorder known as anterior cystolic movement in patients who have a posterior leaf of the mitral valve that is too "high". During ventricular confraction, the posterior leaf pushes the anterior leaf in a direction opposite to the normal movement of the anterior leaf, resulting in obstruction of the external flow tract of the left ventricle. In general, rigid annuloplasty rings do not allow the mitral valve ring to re-establish its normal shape and adopt the conformation dictated by the action of heart pumping. The shape and contour of the ring is established by jThe inflexible shape of the ring same. Flexible rings made of dacron fabric, unlike rigid rings, they can allow the valve annulus to move and flex as the heart contracts and relaxes. However, there are still several drawbacks. The proper shape and contour of the ring are necessary in order for the mitral valve leaflets to close effectively. One drawback of the flexible ring is its predisposition to shirring during implantation. The puckering can be harmful to the valve annulus, sometimes resulting in a mitral orifice that is too small. This can cause valve stenosis. In addition, neither the flexible rings nor the combined rings will remain indefinitely flexible after the annuloplasty.
Since the rings are secured in place by a line of sutures attached directly to the ring, scarring inevitably develops and a resultant rigidity of the ring occurs. This loss of flexibility prevents normal fexion and movement of the heart, particularly in the left ventricle and, therefore, the heart can not function optimally. SUMMARY I > E THE INVENTION The annuloplasty ring of the present invention is a combined ring comprising a first section that is substantially rigid and a second flexible section. The ring can easily be adjusted to fit the anulus or ring of any particular patient. The annuloplasty ring implant method of the present invention comprises installing a ring within the fatty pad of the atrioventricular groove surrounding the annulus or annulus of the mitral valve. The method does not require a series of sutures that extend through the mitral valve anulus tissue to hold the ring in place. The healing and stiffness resulting in the anulus, therefore, are substantially eliminated. The ring of the present invention, when combined with the method of the present invention, is positioned in the fatty pad of the atrioventricular groove adjacent to the antrum of the mitral valve. The fiexible section of the annulus extends adjacent to the flexible posterior portion of the annulus, while the rigid section of the annulus extends substantially over the intertrigonal section of the annulus.
Since the flexible section of the annulus is maintained in the atrioventricular groove of the posterior section of the anulus, it is not necessary to suture the flexible section directly into the annulus of the mitral valve. As a result, healing of the anulus is eliminated substantially, thus allowing the ring and anulus to remain flexible indefinitely. As in the normal heart, this flexibility makes it possible for the mitral valve anulus to flex in several planes during the contraction and relaxation of the heart. The result is a better postoperative functioning of the mitral valve and a better postoperative functioning of the left ventricle as well. An object of the present invention is to provide an annuloplasty ring that restores the normal shape and contour of the mitral valve annulus or ring. Another object of the present invention is to provide a method for performing an annuloplasty that substantially eliminates tissue healing of the mitral valve annulus, to prevent loss of flexibility after annuloplasty. Another objective of the present invention is to provide a method for implanting the annuloplasty ring that allows said ring to maintain flexibility indefinitely. A further object of the present invention is to provide a ring annuloplasty that is flexible enough to allow the mitral valve and the anulus to flex in different planes, but being positioned in such a way as to restore the shape and contour of a normal mitral valve anulus. Another object of the present invention is to provide a flexible annuloplasty ring that does not shirk during its implantation. Another object of the present invention is to provide an annuloplasty ring that can flex from any macerate in which the native mitral valve anulus is flexed. Another objective of the present invention is to provide an annuloplasty ring and a method of implanting the ring that maintains the flexibility of the same and of the annulus of the valve: nitral, indefinitely. Another object of the present invention is to provide a method for implanting the annuloplasty ring, which minimizes scarring of the mitral valve anulus and the nearby tissue. A further objective of the present invention is to provide an annuloplasty ring that assumes the shape of the normal mitral valve anulus, to allow effective operation of the valve. Another object of the present invention is to provide an annuloplasty ring and a method of implanting the annulus, which results in a coaptation of the anterior and posterior mitral valve leaf. Another objective of the present invention is provide an annuloplasty ring and a method of implanting an annuloplasty ring, which does not impede the movement of the base of the left ventricle when the ventricle contracts and relaxes, thus allowing the effective functioning of the left ventricle. Another object of the present invention is to provide an annuloplasty ring and a method of implanting a ring of ahuloplasty, which allows the base of the left ventricle to assume its full range of motion when it contracts and relaxes, to allow effective operation of the heart. left ventricle, Another objective of the present invention is to provide an annuloplasty ring that allows the left ventricle to be renewed naturally as the heart pumps and allows the mitral valve anulus to flex freely in response to movement of the left ventricle. Another object of the present invention is to provide an annuloplasty ring and an annuloplasty ring implant method, which does not require a plurality of sutures along the posterior portion of the mitral valve annulus to secure the annulus in place. Another object of the present invention is to provide an annuloplasty ring that can be easily adjusted in size Another objective of the present invention is to provide an annuloplasty ring that can be easily adjusted in shape, by adjusting the circumference of said ring. Another objective of the present invention is to provide a pa package to an annuloplasty ring, which restores the normal shape and contour of the mitral valve anulus. BRIEF DESCRIPTION OF THE DRAWINGS Figures IA-1F are sectional views of the heart, as seen from the atrial position, illustrating a preferred method of implanting the annuloplasty annulus of the mitral valve in the atrioventricular groove. Figure 2A is a top view of a preferred embodiment of the mitral valve annuloplasty ring of the present invention, in a closed configuration. Figure 2B is a side view of the mitral valve annuloplasty ring, in a closed configuration. Figure 3 is an exploded view of the mitral valve annuloplasty ring with needle, Figure 4 is a cross section schematic of the side seen from a portion of the heart, illustrating an atrioventricular groove with annuloplasty ring implanted therein. Figure 5 is a view of the mitral valve annuloplasty ring in a surgical configuration. Figure 6 is a view of the mitral valve annuloplasty annulus in an open configuration, DETAILED DESCRIPTION OF THE INVENTION The left ventricle is the main chamber for pumping the heart. Oxygenated blood from the lungs enters the left atrium and passes to the left ventricle through the mitral valve. Blood is pumped from the left ventricle to the rest of the body. As shown in Figures 1A-1F, the mitral valve (30) is a valve. the passive unidirectional comprising a pair of sheets including the large anterior sheet (32) and a smaller posterior sheet (33). The leaves open and close in response to pressure differences in the heart (5) on either side of the mitral valve (30).
The base of each anterior (32) and posterior (33) leaf is attached to the mitral valve anulus (34) The contour of the annulus or annulus of the mitral valve (34) refers to the external line or shape of the anulus (34). ) when observed in the general plane of the anulus (34). The shape of the anulus (34) is that shape seen from the auricular side of the mitral valve (30), looking down "on the mitral valve anulus (34) .The mitral valve anulus (34) includes a posterior portion (35) and anterior portion (36) The anterior portion (36), also known as the segment or intertrigonal section, is a generally straight segment, substantially rigidThe posterior portion (35) of the anulus (34) is a flexible curvilinear segment that encompasses a larger portion of the circumference of the anulus than the anterior portion (36) The right (37) and left (38) fibrous fibrils mark the ends of the anulus. generally straight segment and define the points of intersection between the posterior (35) and anterior (36) portions. With reference to Figures 2A and 2B, a preferred embodiment of the annuloplasty ring (10), comprising the present invention, is shown, The ring (10) comprises a first section (11) and a second section (fifteen) . The first section (.1) has a first end (12) and a second end (13), while the second section (15) includes a proximal end (16) and a distal end (17). A means to size the annuloplasty ring (10) includes the measurement indicia (18) extending inward from an outer end of the distal end of the second section (17). The annuloplasty ring (10) also includes a detachable needle (20) having a tip (7 '2) and a joining end (73), as shown in Figure 3. The arugplasty ring (10) comprises a first element to join the second end of the first section to the distal end of the second section and a second element for joining the first end of the first section to the proximal end of the second section. The ring (10) also comprises a third element for joining the second end of the second section to the needle. In a preferred embodiment, the first element for joining the second end of the first section to the distal end of the second section, the second An element for joining the first extrusion of the first section to the proximal end of the second section and the third element for joining the second end of the second section to the needle comprise frictional couplings. Frictional couplings include a hollow internal portion (19) in the second section (15), which has the outer openings (71) at the proximal (16) and distal (17) ends. The internal hollow portion (19) can extend the length complete of the second section (15) or, alternatively, may be limited to the ends (16, 17) of the second section (15). The hollow portion (19) has an internal diameter that is approximately equal to the external diameter c.the first (12) and second (13) ends of the first section (11) and which is also approximately equal to the outer diameter of the joining end (73) of the needle (20) The outer openings (71) of the internal hollow portion (19) of the proximal end (16) of the second section (15), receive the first end (12) therein, while the outer opening (71) of the hollow internal portion (19) at the distal end (17) receives the second end (13 of the first section and, alternatively, the union end (73) of the needle (20) When the ends (12, 13) of the first section (11) are inserted through the outer openings (71) of the internal hollow portion (19), a frictional coupling is created between the respective internal and external diameters. , which secures the ends of the sections (11, 15) together, similarly, when the connecting end (73) of the needle (20) is inserted through the outer opening (71) of the internal hollow portion ( 19) of the distal end (17), the needle (20) is held within the hollow internal portion (19) by frictional engagement. Although the first element for joining the second end of the first section to the distal end of the second section, the second element for joining the first end of the first section to the proximal end of the second section and the third element for joining the second section end of the second section to the needle comprise frictional couplings, instead you can use any type of suitable elements and separately, The first (11) and second (15) sections are lengthened In a preferred embodiment, the first section (11) has an arc or curvature (70) in the central region.
The arc (70) is about 1.0 mm away from a reference plane in which the first (12) and second (13) ends are located. In another preferred embodiment, the first section of the ring is straight and does not have an arc. The first section (11) is made of a substantially rigid material. It is preferable that the material be able to maintain its rigidity indefinitely and it is also preferred that it be inert or compatible with body tissues. Examples of materials that could be used for the first section (11) are titanium, stainless steel, pyrolytic carbon and various plastics. Likewise, other suitable materials can also be used. The material that dominates the second section (15) is flexible and has the ability to be fixed to the first section.Preferably, the material is inert or compatible with the tissues of the body.Examples of materials that could be (used for the second section includes silastic, polyethylene, dacron and teflon, and other suitable materials can also be used. The anucleoplasty ring (10) of the present invention restores the normal shape and contour of the mitral valve anulus! (3. 4). The first section (11) of the annuloplasty ring (10) is adjacent to the intertrigonal section (36) after the implant, as shown in Figures 1A-LF.The curvature of the arch (70) is oriented to conform to the portion of the mitral valve anulus (34) which is located adjacent to the root of the aortic valve, both the first section (11) and the intertrigal section (36) are substantially rigid, since the intertrigonal section (36) normally does not it curves in response to movements of the heart, therefore the first section (11) is not required to curve or flex The second section (15) is implanted adjacent to the posterior portion (35) of the anulus. the posterior portion (35) as the second section (15) are flexible and, as a result, can flex and move with the natural movements of the heart, as the left ventricle shrinks and shrinks. implant d the annuloplasty ring within the fatty pad (40) of the atrioventricular groove (39), as shown in Figure 4, ensures that the anulus and the second section (15) of the ring (10) will remain flexible indefinitely With reference numerally to Figures 1A-1F, the needle (20) acts as a leader guide for implanting the ring (10) at the appropriate location and position in the atrioventricular groove (39) around the mitral valve anulus (34). The tip (72) of the needle is preferably a round needle that has a sufficient edge to penetrate the tissue for the implant, but is sufficiently blunt [to maneuver into the atrioventricular groove without damaging critical areas. The size and shape of the annuloplasty ring (10) can be adjusted. Using the measurement indicia (18) in the second section (15) as a guide, the approximate length of the section is established, then any unnecessary length of the second section (15) can be removed by a cut, as shown in Figure ID. By changing the length of the second section (15), the circumference of the annuloplasty ring also changes. As shown in Figure 2A, the second element for joining the first end of the first section to the proximal end of the second section and the first element for joining the second end of the first section to the distal end of the second section, ensure the ends (12, 13) of the first section (11) to the respective ends (16, 17) of the second section (15) to form a closed handle In a preferred embodiment in which the first and second joining elements comprise 1 section (11) with relation? to the length of the intertrigonal portion (36). The lengths of the two sections may vary one relative to the other, in order to achieve various shapes for the closed loop of the annuloplasty ring (10). For example, by lengthening the first section (11) relative to the length of the second section (15), the annuloplasty ring will become "flatter", characterized by a shorter anterior to posterior distance. In a preferred embodiment of the present invention, the first section (11) has a length of about 1.5 cm and an overall diameter of about 6 mm. However, the diameter may vary as it adjusts to the anulus of the mitral valve being repaired and prevents inadvertent deformation or rupture of the annulus. In a preferred embodiment, indicia (18) are separate indicia at intervals of approximately 1.0 m. However, the intervals can be spaced any desired distance, extending by any desired length along the second section (15). An open configuration of the annuloplasty ring (10) is shown in Figure 6, wherein the first section (11) has its first end (12) attached to the 0 proximal end (16) of the second section. The second end (13) of the first section (11) and the distal end (17) of the second section (15) are not joined. A closed configuration, shown in the Figure 2A, comprises the first end (12) of the first section (11) attached to the proximal end (16) of the second section (15) and the second end (13) of the first section (11) attached to the distal end 17) of the second section (15).
In the closed configuration, the annuloplasty ring (10) forms the closed handle. After the annuloplasty procedures, the ring (10) is in its closed configuration. In Figure 5, the annuloplasty ring (10) of the present invention is shown in a surgical configuration, in which the first end (12) of the first section (11) is attached to the proximal end (16) of the second section (15) and the needle (20) is attached to the distal end (17) of the second section (15). The second end (13) of the first section (11) is not joined. The surgical configuration is designed primarily for use during the annuloplasty procedure. After the annuloplasty ring (10) is implanted as in Figure IE, the first section (11) is in alignment with the intertrigonal section (36) of the mitral valve anulus (34), such that the arch (70) forms the contour of the anulus (34) adjacent to the root of the aortic valve. The intertrigonal section (36) that extends between the fibrous triangles left (38) and right (37), is substantially rigid, as is the first section (11) of the lillo. The second section (15) is implanted mainly around the posterior portion (35) of the anulus (34) and inside the fatty pad (40) of the atrioventricular groove (39), as shown in the Figure. Together with the posterior portion (35) of the anulus (34), the second section (15) can move and flex freely according to the movements of the heart. With reference to Figures 1A-1E, the annuloplasty ring (10) is installed adjacent to the antrum of the mitral valve (34) and inside the fatty pad (40) of the atrioventricular groove (39). After the ring (10) is implanted, the second section (15) is cut to the appropriate size for the patient. The distal end (17) of the second section (15), subsequently, is joined to the first section (11). Preferably, the ring (10) is sutured to the anulus in the left and right fibrous trigones. However, this suture can be avoided if it is not considered necessary. To implant annuloplasty ring in a patient, the needle (20) is attached to the distal end (17) of the second section (15) and the first end (12) of the first section (11) is attached to the proximal end (16) of the second section (15), as shown in the surgical configuration of Figure 5 In a preferred embodiment, the needle is joined by inserting its union end (73) into the outer opening (71) of the hollow inner portion (19) of the second section (15). The tip of the agjija (20) is passed through the endocardium (65) and the left atrial myocardial wall (46) from the endocardial aspect in the right fibrous trigone (37), as shown in Figure IA, simultaneously pulling the first (11) and second (15) sections of the ring (10) behind it, such that a portion of the second section (15) eventually passes through the myocardial wall of the left atrium (46). ), as in Figure IB. The needle (20) is passed in a posterior direction just external and parallel to the anulus of the mitral valve (34). The tip of the needle (20) is passed around the external curvature of the antrum of the mitral valve (34) and inside the fatty pad 40) of the atrioventricular groove (39). The needle (20) moves in a clockwise direction, towards the left fibrous trigone (38). In the left fibrous trigone (38), the tip of the needle. (72) is passed back through the myocardial wall of the left atrium (46) from the epicardium (60) and back through the endocardium (65) in the left fibrous triangle .38), thus pulling the first section (11) to its position along the anterior portion (36) and pulling the second section. (15) to its position within the atrioventricular groove (39), so that the second section (15) is adjacent to the posterior portion (35) of the mitral valve anulus (34), as shown in: Figure 1C. With reference to Figure ID, the annuloplasty ring (10) is given a size using the measurement indicia (18) to determine the appropriate length of the second section (15) and thus the appropriate circumference for the ring annuloplasty (10). The distal end (17) can be cut to size, if required, by cutting the second section (15) at a selected location in the second section (15). The needle (20) can be removed before size and / or cut the second section (15) or, alternatively, it can remain attached to the ring 10) during the size and / or cutting process. The distal end (17) of the second section (15), subsequently, joins the second end (13) of the first section (11). In a preferred embodiment, as shown in Figure 1, the second end (13) and the distal end (17) are joined by a coupling frictional wherein the second end (13) of the first section (11) is inserted into the hollow internal portion (19) of the second section, until the distal (17) and proximal (16) ends of the second section (15) ) approach each other at a central point approximately of the first section (11) In another embodiment of the method of implanting the annuloplasty ring, the procedure is performed in the reverse direction, wherein the tip (72) of the needle (20) ] is first passed through the endocardium (75) and the myocardial wall of the left atrium (46) from the endocardial aspect in the left fibrous trigone (38) and is passed in a posterior direction substantially parallel to the anulus (34) The needle (20) moves in the opposite direction to the hands d = l clock around the anulus (34) towards the right fibrous trigone (37) Here, in the right fibrous trigone (37, the tip of the the needle (72) is passed back through the myocardial wall of the left atrium (36) from the epicardium (60) and through the endocardium (65). Entences the procedure continues as in the previous procedure in the opposite direction and against the hands of the clock. After the annuloplasty ring is in place, the sutures (80, 81) shown in Figure 1F can be added to secure the annuloplasty ring to the anulus. A plurality of sutures (80) may be used to secure the ring (10) to the intertrigonal section (36), preferably in the left and right fibrous trigones. Since the intertrigonal section (36) is substantially rigid in the annulus of the native mitral valve, any scarring that may result from these sutures (80) would not substantially interfere with the normal flexion of the rest of the anulus or with the movement of the antrum. left ventricle, In addition, when a suture (81) can be used to fix the second section (15) inside the atrioventricular groove (39), as an additional precaution to protect against a possible slip of the ring (10) after it is implanted This suture (81) would preferably be located near the midpoint of the second section (15). Preferred embodiments of the present invention allow the anulus of the mitral valve to maintain its normal flexion, which, in turn, makes it possible for the left ventricle to move normally as it contracts and relaxes. In addition, the implant method allows the annuloplasty ring and anulus also to maintain indefinitely their flexibility after annuloplasty, since it is not necessary to secure the ring in place by a suture line through Í a > . ~, -x * of the tissue of the ppsterior portion of the mitral valve anulus. The ring in addition? restores the normal shape and contour of the mitral valve anulus, which allows effective coaptation of the anterior and posterior leaflets of the valve. Additionally, the size and shape of the ring can be adjusted, making it easily adaptable to 1 different patients. In an example, the annuloplasty ring of the present invention can be manufactured using a flexible material that is also elastic, to comprise the second section. The elasticity of the annulus would accommodate the expansion of the mitral annulus during relaxation of the left ventricle and would accommodate the contraction of the annulus during the contraction of the left ventricle. In other words, the annulus would expand and contract, in addition to flexion, according to the expansion and contraction of the left ventricle. In another example, the first (11) and second (15) sections are integrally joined in the respective first end (12) and proximal end (16), wherein the first section remains substantially rigid and the second section (15) remains flexible. The integral union of the two sections can be done by coextrusion, molding or other suitable manufacturing technique of choice.
Although the present invention has been described in considerable detail with reference to certain preferred versions thereof, other versions are possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of preferred versions contained herein. It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects to which it relates.

Claims (30)

  1. CLAIMS Having described the invention as an antecedent, the content of the following claims is claimed as property 1. An annuloplasty ring for repairing a valve in the heart of a patient, characterized in that the annuloplasty ring comprises (a) a first section to be implanted adjacent to the valve; and (b) a second flexible section to be implanted within a fatty pad of an atrioventricular groove in the heart.
  2. 2. The annuloplasty ring according to claim 1, wherein the second flexible section comprises a proximal end and a distal end and an element for attaching the distal end to a needle. The annuloplasty ring according to claim 2, characterized in that it further comprises a needle having a joining end with an external diameter. The annuloplasty ring according to claim 3, characterized in that the element for joining the end distal to the needle comprises a frictional coupling. The annuloplasty ring according to claim 4, characterized in that the first section further comprises a first and a second end, wherein the first and second ends have an external diameter; the annuloplasty ring further comprises: element for attaching the distal end of the second flexible section to the second end of the second section; and (b) a second element for attaching the proximal end of the second flexible section to the first end of the first section. The annuloplasty ring according to claim 5, characterized in that the first connecting element comprises a frictional coupling and the second connecting element comprises a frictional coupling. annuloplasty according to claim 6, provided that the external diameter of the first and second ends are approximately equal to the internal diameter of the internal hollow portion and the frictional coupling of the first joint is between the internal diameter of the internal portion hollow at the distal end and the outer diameter of the second end, and the Erictional coupling of the second element The connection between the internal diameter of the internal hollow portion at the proximal end and the external diameter of the first end. 8. The annuloplasty ring according to claim 5, characterized in that it further comprises: (a) an open configuration in which the first section is joined to the second section by the second joint element and the second end of the first section section and the distal end of the second flexible section are not joined; (b) a closed configuration wherein the first section is joined to the second section by the first and second joint elements, thereby forming a handle; and (c) a surgical configuration wherein the first section is joined to the second section by the first joining element and the second, flexible section is attached to the needle by the connecting element of the distal end of the second flexible section to the needle. The annuloplasty ring according to claim 4, characterized in that the distal end of the flexible section further comprises a hollow internal portion with an internal diameter approximately equal to the outer diameter of the connecting end of the needle and the frictional coupling is: a between the internal diameter and the external diameter of the joining end. The annuloplasty ring according to claim 1, characterized in that the first section is rigid, wherein the first and second ends are substantially rectcs, the first section also having an arc between the first and second ends. The annuloplasty ring according to claim 1, characterized in that it also comprises an element for giving size to the ring. 12. A method for implanting an annuloplasty ring in the heart: of a patient, characterized in that it comprises: implanting a flexible section of the annuloplasty ring in the fatty pad of the atrioventricular groove of the heart; positioning a rigid section of the annuloplasty ring adjacent to the valve e.nnulus; and give a closed handle to the annuloplasty ring. 13. The method according to claim 12, characterized in that the ring of Annuloplasty includes a needle attached to the flexible section. The method according to claim 13, characterized in that the steps of implanting a substantial portion of the annuloplasty ring in the fatty pad of the atrioventricular groove, further comprises: inserting the tip of the needle through the endocardium and the myocardial wall of the left atrium from the endocardial aspect in the right fibrous trigone; passing the needle and a portion of the annuloplasty ring through the endocardium and the myocardial wall of the left atrium from the endocardial aspect, in the right fibrous trigone; passing the needle and a portion of the annuloplasty ring in a posterior direction, external to and parallel to the annulus of the mitral valve; and inserting the tip of the needle through the myocardial wall of the left atrium from the epicardial aspect and back through the endocardium into the left fibrous trigone; passing the needle and a portion of the annuloplasty ring back through the myocardial wall of the left atrium, from the epicardial aspect and back through the endecardium in the left fibrous trigone. liAít í: 15. The method according to claim 14, characterized in that the positioning of the rigid section further comprises: positioning the flexible section in a substantially parallel orientation with the posterior portion of the annulus of the mitral valve, pulling the needle; align the rigid section of the annuloplasty ring along an anterior portion of the annulus of the mitral valve; and positioning the aric of the rigid section to conform to a concussion of the annulus of the mitral valve adjacent to the root of the aortic valve. 16. The method according to claim 17, characterized in that it further comprises: determining the appropriate size of the annuloplasty ring after implantation and the positioning of the ring and before shaping the ring of a closed handle; and cut the annuloplasty ring to the appropriate size. The method according to claim 16, characterized in that it further comprises: detaching the needle from the annuloplasty ring after implanting and positioning the ring and before determining the appropriate size. The method according to claim 1, characterized in that the step of giving a closed loop shape to the annuloplasty ring further comprises: joining a second end of the rigid section to a distal end of. the flexible section, inserting the second end of the rigid section into a hollow internal portion of the distal end of the flexible section. 19. The method according to claim 12, characterized in that it further comprises: suturing the annuloplasty ring to the annulus of the valve in the left and right fibrous trigones. 20. The method according to claim 19, characterized in that it further comprises: suturing the annuloplasty ring within the fatty pad of the atrioventricular groove. 21. A packet of an annuloplasty ring, characterized in that it comprises: (a) a first action; (b) a second flexible section having a proximal end and a distal end; (c) an element for joining the distal end of the second flexible section to a needle, 22. The package for an annuloplasty ring according to claim 21, characterized in that it further comprises a needle having a connecting end with an external diameter. 23. The package for an annuloplasty ring according to claim 22, characterized in that the connection element of the end distal to the needle comprises a functional coupling 24. The package for an annuloplasty ring according to claim 23, characterized because the first section further comprises a first end and a second end, wherein the first and second ends have an outer diameter and the annuloplasty ring further comprises: (a) a first element for joining the distal end of the second flexible section to the second end of the first section; and (b) a second element for attaching the proximal end of the second flexible section to the first end of the first section, 25. The package is an annuloplasty ring according to claim 24, characterized in that the first connecting element it comprises a frictional coupling and the second connecting element comprises a frictional coupling, wherein the second flexible section includes a hollow internal portion at the distal and proximal ends, wherein the internal hollow portion has an internal diameter approximately equal to the external diameters of the first and second ends of the first section, wherein the frictional engagement of the first attachment element is between the internal diameter of the hollow internal portion at the distal end and the external diameter of the second end, and the frictional engagement of the second attachment element is between the internal diameter of the inner portion hollow at the proximal end and the outer diameter of the first end. 26. The package for an annuloplasty ring according to claim 23, characterized in that the distal end of the second flexible section further comprises a hollow internal portion with an internal diameter approximately equal to the external diameter of the needle-joining element. , and the frictional coupling of the junction element of the distal extrusion to the needle is between the internal diameter and the external diameter of the joining end. 27. The package for an annuloplasty ring according to claim 21, characterized in that the second flexible section further comprises an element for giving size to the anille 28. An annuloplasty ring for use in an annuloplasty surgical procedure to correct mitral regurgitation in a patient by restoring the mitral valve annulus to its normal shape and flexibility, which are determined by the movement of the left ventricle, the mitral valve and mitral valve annulus, characterized in that said annuloplasty ring comprises: a first rigid section having a first end, a second end and a length, wherein the first and second ends they have an external diameter; a second flexible section having a distal end, a proximal end, a length, an element for size of the ring and at least a hollow internal portion with an outer opening at the proximal and distal ends, and an internal diameter; a round tip needle having a tip and a connecting end with an outer diameter; a first element for joining the distal end of the second section to the second end of the first section; a second element for joining the proximal end of the second section to the first end of the first section; a third element to join the distal end of the second section to the agu a; wherein the outer diameters of the first section and the outer diameter of the joining end are approximately equal to the internal diameter of the internal hollow portion and the length of the second flexible section is greater than the length of the first rigid section; the first connecting element comprises a frictional coupling between the internal diameter of the internal hollow portion at the distal end and the external diameter of the second end; the second joint element comprises a frictional coupling between the internal diameter of the hollow internal portion at the proximal end and the external diameter of the first end; and the third joint element comprises a frictional coupling between the internal diameter of the hollow internal portion at the distal end and the external diameter of the needle joining end; the element for giving the ring size also comprises indications of measurement at the distal end of the second section; the first rigid section is substantially straight and further comprises an arc positioned between the first and second ends; the annullasty ring further comprises (1) An open configuration defined by the first section being joined to the second section by the second joining element, wherein the outer opening and the internal hollow portion at the proximal end of the second section, they receive the first end of the first section within them, where the first end and «I the proximal end are held together by the frictional coupling and the second end and the distal end are not joined; (2) a surgical configuration defined by the first section being attached to the second section and the needle by the second and third joining elements, wherein the outer opening and the inner hollow portion at the proximal end of the second section receive the first end of the first section therein, wherein the first end and the proximal end are held together by the frictional engagement of the second junction element and the distal end of the second section, and the outer opening of the internal hollow portion at the distal end of the second section, receive the needle attachment end therein, where the distal end and the joining end are held together by the frictional coupling of the third connecting element; and (3) a closed configuration defined by the first section being joined to the second section by the first and second joining elements, wherein the outer opening and the internal hollow portion at the proximal end of the second section receive the first end of the first tooth section thereof, wherein the proximal end and the first end are held together by the frictional coupling of the second connecting element, and the outer opening and the internal hollow portion at the distal end of the second section, receive the second end of the first section therein, wherein the distal end and the second end they are held together by the frictional coupling of the first connecting element; wherein the first rigid section is implanted adjacent to an anterior portion of the annulus of the mitral valve and the second section is implanted in the fatty pad of the atrioventricular groove. 29. A method for implanting an annuloplasty ring in a patient's heart to correct mitral regurgitation where the mitral valve annulus is restored to its normal shape and flexibility determined by the movement of the left ventricle, the mitral valve, and the mitral valve. the anus of the mitral valve, characterized in that it comprises the steps of: .1) providing an annuloplasty ring having an elongate flexible section attached at one end to a rigid section with an arch and attached at an opposite end to a needle with a round tip; 2) Insert the tip of the needle through the endocardium and the myocardial wall of the left atrium of the heart, from the endocardial aspect in the right fibrous trigone; (3) passing the needle and a portion of the annuloplasty ring through the endocardium and myocardial wall of the left atrium of the heart, from the endplacid aspect in the right fibrous trigone; 10 (4) making the needle passif and a portion of the annuloplasty ring in a posterior direction; external and parallel to the annulus of the mitral valve;: 5) passing the needle and a portion of the 15 annuloplasty ring around the external portion of the mitral valve annulus in the fatty pad of the atrioventricular groove, clockwise to the trigone 20 fibrous left; (6) Insert the tip of the needle back through the myocardial wall of the left atrium and the endocardium from the epicardial aspect, into the left fibrous trigone; 25 (7) passing the needle and a portion of the ring of ahuloplasty back through the myocardial wall of the left atrium from the epicardial aspect and back through the endocardium, in the left fibrinous triangle; (8) positioning the flexible section substantially parallel to a posterior portion of the annulus of the mitral valve; .9) aligning the rigid section along an anterior portion of the annulus of the mitral valve; (10) positioning the arch of the rigid section according to an annulus contour of the mitral valve adjacent to the root of the aortic valve and further positioning the flexible section around a posterior portion of the annulus of the mitral valve; (11) detach the needle from the flexible section; (12) determine the appropriate size of the annuloplasty ring: (13) cut the flexible section of the annuloplasty ring to an appropriate size; (14) close the annuloplasty ring by fixing the distial end of the flexible section to the second end of the rigid section, inserting the rigid section into the hollow inner portion of the flexible section; (15) suture the ring of annuloplasty to the annulus of the valve, in the left and right fibrous trigones; 16) Suture a point along the posterior section of the annulus of the mitral valve to the flexible section of the annuloplasty ring, 30. A package for an annuloplasty ring, to be used in ur surgical procedure of annuloplasty to correct the insufficiency mitral valve in a patient by restoring the mitral valve annulus in its normal form and flexibility, which are determined by the movement of the left ventricle, the mitral valve and the mtLtral valve annulus, characterized in that the annuloplasty ring comprises: a first rigid section having a first end, a second end, a length and an external diameter; a second flexible section having a distal end, a proximal end, a length, an element for size of the ring and at least a hollow internal portion with an outer opening at the distal and proximal ends, and an internal diameter; union end of the needle, when the two ends meet.
MXPA/A/2002/002942A 1999-09-17 2002-03-15 Mitral valve annuloplasty ring and method MXPA02002942A (en)

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US09399444 1999-09-17

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MXPA02002942A true MXPA02002942A (en) 2003-11-07

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