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CN-122005155-A - Balloon expanded valve with clamping piece

CN122005155ACN 122005155 ACN122005155 ACN 122005155ACN-122005155-A

Abstract

The invention discloses a balloon expanded valve with a clamping piece, which relates to the technical field of medical appliances and comprises a valve bracket capable of expanding radially, a functional valve arranged at the inner side of the valve bracket and the clamping piece connected with the valve bracket; the clamping piece can move relative to the valve support and is matched with the valve support to clamp the self valve leaflet, the clamping piece comprises a plurality of rebound parts with deformation parts, and the deformation of the deformation parts is used for converting between the bunchy lines and the fan-shaped distribution. The valve stent also comprises a control sleeve, wherein the control sleeve is used for restraining the clamping piece in a conveying state and regulating and controlling the included angle between the clamping piece and the valve stent by changing the restraining degree. The invention effectively prevents left ventricle from flowing out of the obstruction by clamping and shortening the anterior leaflet of the mitral valve through the clamping piece, simultaneously forms stable clamping force with the valve bracket to prevent valve displacement, reduces perivalvular leakage by matching with skirt edge design, has small outer diameter and good trafficability of a conveying system, and is suitable for patients with smaller mitral valve orifice and smaller heart chamber.

Inventors

  • PAN WENZHI
  • ZHOU DAXIN
  • GE JUNBO

Assignees

  • 复旦大学附属中山医院

Dates

Publication Date
20260512
Application Date
20260413

Claims (10)

  1. 1. A balloon expandable valve with a holder, comprising: A radially expandable valve stent (2); a functional valve (3) arranged inside the valve support (2); and the clamping piece (5) is connected to the valve bracket (2), and the clamping piece (5) can move relative to the valve bracket (2) and is matched with the valve bracket (2) to clamp the self valve leaflet.
  2. 2. The balloon expandable valve with clip according to claim 1, wherein the clip (5) comprises a plurality of resilient members having deformations (52), the deformations (52) being located at the connection of the resilient members with the valve holder (2); the resilient member is transformed between an axially collapsed beam-like line and a radially expanded fan-like distribution by deformation of the deformation portion (52).
  3. 3. The balloon expandable valve with a holder according to claim 2, further comprising a movable control sleeve (1), the control sleeve (1) being adapted to constrain the holder (5) in a delivery state and to control its deformation by varying the degree of constraint on the holder (5).
  4. 4. A balloon expandable valve with a holder according to claim 3, characterized in that the angle between the holder (5) and the valve holder (2) is varied between 0 ° -180 ° by varying the extent of the holding of the holder (5) by the control sleeve (1).
  5. 5. The balloon expandable valve with a holder according to claim 2, characterized in that the deformation vectors of the deformation parts (52) of the plurality of resilient members are set differently such that the plurality of resilient members are arranged in an umbrella-like radial distribution with respect to the central axis of the valve holder (2) in a fan-like distribution.
  6. 6. The balloon expandable valve with a holder according to claim 2, wherein the end of the resilient member remote from the deformation (52) has a passivation (51).
  7. 7. The clip-on balloon expandable valve of claim 1, further comprising a delivery system including an inflatable balloon (63) and a catheter (62) connected to a proximal end of the balloon (63); In the delivery state, the valve stent (2) is attached to the outer side of the balloon (63) in a compressed mode, and in the working state, the balloon (63) is filled, so that the valve stent (2) is expanded and radially expanded.
  8. 8. The balloon expandable valve with a holder according to claim 7, characterized in that the catheter (62) has protrusions (61) at both ends of the balloon (63), the distance between two protrusions (61) being larger than the length of the valve stent (2) in the delivered state, and that the balloon (63) adjacent to the holder (5) is provided with indentations (64) for receiving the holder (5).
  9. 9. The balloon expandable valve with clamp according to claim 1, characterized in that the outer periphery of the upper half of the valve holder (2) is provided with a skirt (4).
  10. 10. The balloon expandable valve with clip according to claim 9, characterized in that the skirt (4) is provided on the outside with perivalvular leakage prevention means (7) being two sets of expandable polymeric strips arranged along the longitudinal axis of the valve holder (2), the perivalvular leakage prevention means (7) maintaining an angular difference of 50 ° -80 ° in cross section with the clip (5).

Description

Balloon expanded valve with clamping piece Technical Field The invention relates to the technical field of medical appliances, in particular to a balloon expanded valve with a clamping piece. Background Mitral stenosis is a common heart disease, the main cause of which is rheumatic, which is highly developed in underdeveloped economic developing countries, and which is still highly developed in small towns and remote villages in China, and another important cause of which is calcification, often accompanied by mitral valve annular calcification (MAC), is also increasing in patients with the cause of the disease with aging population. The past treatment modes of mitral stenosis mainly comprise percutaneous bicuspid balloon dilatation and surgical mitral valve replacement operation, and although the percutaneous mitral balloon dilatation is the preferred treatment mode recommended by the current guideline, the restenosis rate of the postoperative valve lesion still continuously progresses to 30% -50% in 5 years, patients need repeated operation, most patients in practice have serious calcification or reflux which is not suitable for the operation, and the surgical mitral valve replacement operation can improve the hemodynamics, but has huge traumatism and high risk. For elderly patients, surgery is not tolerated, and transcatheter mitral valve replacement is therefore a promising development for elderly mitral stenosis. At present, no transcatheter valve replacement apparatus special for mitral stenosis is available at home and abroad, the transcatheter mitral valve replacement apparatus which enters clinical research is designed for mitral regurgitation at present, compared with a patient with mitral stenosis, the valve has an oversized valve, left ventricular outflow obstruction is easy to be caused, a delivery system is too large to damage blood vessels, and an apparatus anchoring mechanism is not suitable for the patient with mitral stenosis. Another approach is to try an interventional valve (balloon-expanded valve) for aortic valve replacement for mitral valve stenosis patients, which valve is easily displaced by the fixation of the valve solely by radial support forces without additional anchoring means, and which circular valve is easily leak-valve due to the non-circular presence of the trigones of the mitral annulus, as such devices are also easily causing left ventricular outflow obstruction. The two devices are not clinically popularized, only individual reports on selective cases are reported, so that a transcatheter replacement artificial valve special for mitral stenosis is clinically needed at present, and the problems that outflow obstruction, valve displacement and paravalvular leakage are easily caused by a non-special valve at present are solved. Disclosure of Invention The invention aims to provide a balloon expanded valve with a clamping piece, which solves the problems that no additional anchoring device is fixed only by radial supporting force, valve displacement is easy to cause, and left ventricular outflow obstruction is easy to cause. The invention solves the technical problems through the following technical proposal, which comprises the following steps: a radially expandable valve stent; a functional valve disposed inside the valve holder; and the clamping piece is connected with the valve bracket, can move relative to the valve bracket and is matched with the valve bracket to clamp the self valve leaflet. Alternatively, the valve support is made of cobalt-chromium alloy or stainless steel, is hollow and cylindrical as a whole, and is formed by interconnecting a plurality of polygonal grid units. In one embodiment, the functional valve is comprised of bovine pericardium, porcine pericardium, or polymeric valve. Preferably, the clamping member comprises a plurality of resilient members having deformation portions, the deformation portions being located at the junctions of the resilient members and the valve holder; The rebound member is transformed between axially collapsed beam-like lines and radially expanded fan-like distribution by deformation of the deformation portion. The deformation part is a core joint for the clamping part to realize the clamping action, and the preset memory form of the deformation part enables the clamping part to spontaneously transition from the longitudinal arrangement of the conveying state to the reverse arrangement of the working state when the clamping part is not constrained by the control sleeve. Preferably, the control sleeve is movable and is used for restraining the clamping piece in a conveying state and controlling deformation of the clamping piece by changing the restraining degree of the clamping piece. Optionally, the control sleeve is a high polymer hollow thin-wall hose. Preferably, by varying the extent of the control sleeve's accommodation of the holder, the angle between the holder and the valve holder varies between 0 ° -180 °. W