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BR-122021018888-B1 - VALVE AND SYSTEM REPAIR DEVICE

BR122021018888B1BR 122021018888 B1BR122021018888 B1BR 122021018888B1BR-122021018888-B1

Abstract

The present invention relates to a valve repair device (602) for repairing a patient's native valve comprising a pair of paddles (606), a pair of retaining members (608), and a spacer element (3800). The paddles (606) are movable between an open and a closed position. The paddles (606) and the retaining members (608) are configured to lock onto the patient's native valve. The spacer element (3800) is configured to close a gap in the patient's native valve when the valve repair device (601) is locked onto the native valve.

Inventors

  • ASHER L. METCHIK
  • GREGORY SCOTT TYLER II
  • MATTHEW T. WINSTON
  • Sergio Delgado
  • LAUREN R. FRESCHAUF
  • ERIC R. DIXON
  • ALEXANDER J. SIEGEL

Assignees

  • EDWARDS LIFESCIENCES CORPORATION

Dates

Publication Date
20260310
Application Date
20190108
Priority Date
20180109

Claims (18)

  1. 1. Valve repair device (602), comprising: a shaft (603); a coupler (605) movably attached to the shaft (603) so that the coupler (605) can be moved along the shaft (603); a pair of blades (606) articulatedly coupled to the coupler (605); wherein the movement of the coupler (605) in a first direction along the shaft (603) causes the pair of blades (606) to move to the closed position, and the movement of the coupler (605) in a second direction causes the pair of blades (606) to move to the open position; wherein the valve repair device (602) is characterized in that it comprises at least one expansion spacer element (3800) which is disposed around at least a portion of the shaft (603), wherein: the expansion spacer element (3800) is configured to expand as the blades (606) close, wherein the blade pair (606) and the expansion spacer element (3800) are configured to engage with each other when the blade pair (606) is in the closed position.
  2. 2. Valve repair device (602), according to claim 1, characterized in that it further comprises a pair of retaining members (608) attached to the shaft (603).
  3. 3. Valve repair device (602), according to claim 1, characterized in that the pair of retaining members (608) are integrally formed.
  4. 4. Valve repair device (602), according to claim 1, characterized in that each of the retaining members (608) is disposed between one of the blades of the blade pair (606) and the expansion spacer element (3800).
  5. 5. Valve repair device (602), according to claim 1, characterized in that it further comprises a movable latch (607) between a locked condition and an unlocked condition, wherein the latch (607) is configured to lock the coupler (605) in a stationary position on the shaft (603) when the latch (607) is in the locked condition.
  6. 6. Valve repair device (602), according to claim 1, characterized in that it further comprises a plurality of articulation connections that are articulated to the coupler (605), wherein each of the blades of the blade pair (606) is fixed to one of the articulation connections.
  7. 7. Valve repair device (602), according to claim 6, characterized in that the plurality of articulation connections includes a first connection (1021, 2721, 4521, 4621), a second connection (1022, 2722, 4522, 4622), a third connection (1023, 2723, 4523, 4623), a fourth connection (1024, 2724, 4524, 4624) and a fifth connection (1025, 2725, 4525, 4625).
  8. 8. Valve repair device (602), according to claim 7, characterized in that: the first connection (1021, 2721, 4521, 4621) is articulated to the coupler (605); the second connection (1022, 2722, 4522, 4622) is articulated to the coupler (605); the fifth connection (1025, 2725, 4525, 4625) is fixed to a more distant end of the shaft (603); the second connection (1022, 2722, 4522, 4622) is articulated to the first connection (1021, 2721, 4521, 4621) and articulated to the fifth connection (1025, 2725, 4525, 4625); The third connection (1023, 2723, 4523, 4623) is articulated to the second connection (1022, 2722, 4522, 4622) and articulated to the fifth connection (1025, 2725, 4525, 4625).
  9. 9. Valve repair device (602), according to claim 1, characterized in that the expansion spacer element (3800) is made of at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial tissue.
  10. 10. System comprising: an application device (601) having at least one lumen; a valve repair device (602) configured to be applied through the lumen of the application device (601), the valve repair device (602) comprising: a coupler (605) movably attached to the shaft (603) such that the coupler (605) can be moved along the shaft (603); a pair of blades (606) articulately coupled to the coupler (605); wherein movement of the coupler (605) in a first direction along the shaft (603) causes the pair of blades (606) to move to the closed position, and movement of the coupler (605) in a second direction causes the pair of blades (606) to move to the open position; wherein the system is characterized by comprising at least one expansion spacer element (3800) disposed around at least a portion of the shaft (603), wherein the expansion spacer element (3800) is configured to expand as the blades (606) close, wherein the pair of blades (606) and the expansion spacer element (3800) are configured to couple to each other when the pair of blades (606) is in the closed position.
  11. 11. System according to claim 10, characterized in that it further comprises a pair of retaining members (608) attached to the shaft (603).
  12. 12. System according to claim 11, characterized in that the pair of retaining members (608) are integrally formed.
  13. 13. System according to claim 12, characterized in that each of the retaining members (608) is disposed between one of the blades of the blade pair (606) and the expansion spacer element (3800).
  14. 14. System according to claim 10, characterized in that it further comprises a movable latch (607) between a locked condition and an unlocked condition, wherein the latch (607) is configured to lock the coupler (605) in a stationary position on the shaft (603) when the latch (607) is in the locked condition.
  15. 15. System according to claim 10, characterized in that it further comprises a plurality of articulation connections that are articulated to the coupler (605), wherein each of the blades of the blade pair (606) is fixed to one of the articulation connections.
  16. 16. System according to claim 15, characterized in that the plurality of articulation connections includes a first connection (1021, 2721, 4521, 4621), a second connection (1022, 2722, 4522, 4622), a third connection (1023, 2723, 4523, 4623), a fourth connection (1024, 2724, 4524, 4624) and a fifth connection (1025, 2725, 4525, 4625).
  17. 17. System according to claim 16, characterized in that: the first connection (1021, 2721, 4521, 4621) is articulated to the coupler (605); the second connection (1022, 2722, 4522, 4622) is articulated to the coupler (605); the fifth connection (1025, 2725, 4525, 4625) is fixed at a more distant end of the shaft (603); the second connection (1022, 2722, 4522, 4622) is articulated to the first connection (1021, 2721, 4521, 4621) and articulated to the fifth connection (1025, 2725, 4525, 4625); The third connection (1023, 2723, 4523, 4623) is articulated to the second connection (1022, 2722, 4522, 4622) and articulated to the fifth connection (1025, 2725, 4525, 4625).
  18. 18. System according to claim 10, characterized in that the expansion spacer element (3800) is made of at least one material selected from the group of materials consisting of braided mesh, fabric, biocompatible material, foam, and pericardial tissue.

Description

RELATIVE REQUEST [001] This patent application is a division of BR 11 2020 010855-3, filed on 08/01/2019. [002] This application claims the benefit of U.S. Provisional Application Serial Number 62/615213, filed January 9, 2018, entitled "Native Valve Repair Devices and Procedures", which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [003] The present invention generally relates to prosthetic devices and related methods for assisting to seal native heart valves and prevent or reduce regurgitation through them, as well as devices and related methods for implanting such prosthetic devices. BACKGROUND OF THE INVENTION [004] The native heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in ensuring the direct flow of an adequate blood supply through the cardiovascular system. These heart valves can be damaged, and thus rendered less effective, by congenital malformations, inflammatory processes, infectious conditions, or diseases. Such valve damage can result in serious cardiovascular compromise or death. For many years, the definitive treatment for such damaged valves was surgical repair or replacement of the valve during open-heart surgery. However, open-heart surgeries are highly invasive and prone to many complications. Therefore, elderly and frail patients with defective heart valves were often left untreated. More recently, transvascular techniques have been developed to introduce and implant prosthetic devices in a manner that is far less invasive than open-heart surgery. One specific transvascular technique used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, ascending the inferior vena cava and into the right atrium. The septum is then punctured and the catheter passed into the left atrium. [005] A healthy heart has a generally conical shape that tapers to a lower apex. The heart has four chambers and comprises the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomy than other native heart valves. The mitral valve includes an annular space portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair of cusps, or leaflets, that extend down from the annular space into the left ventricle. The mitral valve annular space may form a "D", oval, or otherwise non-round cross-section shape that has major and minor geometric axes. The front leaflet may be larger than the back leaflet, forming a generally "C"-shaped boundary between the free, overlapping edges of the leaflets when they are closed together. [006] When operating properly, the anterior and posterior leaflets function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole" or "diastole"), the oxygenated blood that is collected within the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also referred to as "ventricular systole" or "systole"), the increased blood pressure within the left ventricle forces the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsed under pressure and folding back through the mitral annular space toward the left atrium, a plurality of fibrous cords called chordae tendineae support the leaflets in papillary muscles within the left ventricle. [007] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows into the left atrium from the left ventricle during the systolic phase of cardiac contraction. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, dysfunctional papillary muscles, and/or stretching of the mitral valve annular space resulting from left ventricular dilation. Mitral regurgitation in a central portion of the leaflets may be referred to as central jet mitral regurgitation, and mitral regurgitation closer to a commissure (i.e., location where the leaflets meet) of the leaflets may be referred to as eccentric jet mitral regurgitation. For central jet regurgitation, the edges of the leaflets do not meet in the middle. Therefore, the valve does not close, and regurgitation is present. [008] Some earlier techniques for treating