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geometric prosthetic heart valve

A technology for heart valves and prostheses, applied in the field of synthetic flexible leaflet-type prosthetic heart valve devices, which can solve problems such as damage to synthetic valves and failure to become an option for heart valve replacement

Active Publication Date: 2017-07-21
EDWARDS LIFESCIENCES CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, synthetic leaflet prosthetic heart valves have not yet become an effective heart valve replacement option because of suboptimal design and lack of durable synthetic materials, among others, which lead to premature failure of the synthetic valve

Method used

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  • geometric prosthetic heart valve
  • geometric prosthetic heart valve
  • geometric prosthetic heart valve

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0153] A prosthetic heart valve is produced having polymeric leaflets formed from a composite material with an expanded fluoropolymer septum and elastomeric material bonded between two collapsible metal frames.

[0154] The leaflet frame and outer frame are laser machined from a length of SS316LVM tube, which is hard tuned to have an outer diameter of 23.0mm and a wall thickness of 0.65mm, and is in Figure 9A The shape illustratively shown and generally indicated in . Electropolishing of the leaflet frame 130 and outer frame 120 resulted in removal of 0.0127 mm of material from each surface and rounded edges.

[0155] Fluorinated ethylene propylene (FEP) powder (Daikin America, Orangeburg, NY) is then applied to leaflet frame 130 and outer frame 120 . More specifically, the FEP powder is agitated to form an airborne "cloud" in a closed blending device, such as a standard kitchen-type blender, with the leaflet frame and outer frame suspended in the cloud middle. The leaflet...

example 2

[0212] Another prosthetic heart valve was as described in Example 1 with the following differences.

[0213] Initial assembly and thermal process cycle

[0214]The leaflet frame and outer frame were slightly expanded in diameter and received on the wound mandrel with a space of 16 mm between them, resulting in rotational alignment of the leaflet frame with the outer frame.

[0215] Final Assembly and Thermal Process Cycles

[0216] Use a scalpel to cut the mechanically connected piece from above. The sheet is deformed to connect the leaflet frame to the outer frame.

[0217] The resulting prosthetic heart valve 100 includes leaflets 140 formed from a composite material having more than one fluoropolymer layer with a plurality of pores and substantially all of the pores present in the more than one fluoropolymer layer inner elastic. Each leaflet 140 can be Figure 3B Closed position shown with Figure 3A Movement is shown between an open position in which blood is substan...

example 3

[0220] Example 3 (Single Leaflet Frame Prosthetic Heart Valve)

[0221] In an exemplary embodiment, a prosthetic heart valve having polymeric leaflets formed of composite material with an expandable fluoropolymer septum and elastomeric material bonded to a semi-rigid, Non-collapsible metal frame and also features strain relief:

[0222] The leaflet frame was laser machined from a length of MP35N cobalt-nickel tubing that was hard-tuned to an outer diameter of 26.0 mm and a wall thickness of 0.6 mm. The leaflet frame was electropolished, resulting in removal of 0.0127 mm of material from each surface and rounding of the edges. The leaflet frame undergoes a surface roughening step to improve the adhesion of the leaflets to the leaflet frame. The leaflet frames were cleaned by immersion in an ultrasonic bath of acetone for approximately five minutes. The entire metal leaflet frame surface is then subjected to plasma treatment using instruments and methods generally known to th...

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PUM

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Abstract

The described embodiments are directed to specific shapes of prosthetic heart valve leaflets that control the bending characteristics. According to one embodiment, a prosthetic heart valve includes a leaflet frame having a generally tubular shape with an attached membrane. The leaflet frame defines a plurality of leaflet windows. The membrane defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment area on the leaflet frame has a substantially isosceles trapezoidal shape with two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, which is substantially flat.

Description

technical field [0001] The present disclosure relates generally to prosthetic heart valves, and more particularly to synthetically flexible leaflet-type prosthetic heart valve devices, systems, and methods. Background technique [0002] Bioprosthetic heart valves have been developed that attempt to mimic the function and performance of native valves. Flexible valve leaflets are fabricated from biological tissue such as bovine pericardium. In some bioprosthetic heart valve designs, biological tissue is sutured to a relatively rigid frame that supports the valve leaflets and provides dimensional stability upon implantation. Although bioprosthetic heart valves provide excellent hemodynamic and biomechanical performance in the short term, they are prone to calcification and cusp tearing, among other modes of damage, requiring reoperation and replacement. [0003] Attempts have been made to use synthetic materials, such as polyurethane, as a substitute for biological tissue to ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F2/24
CPCA61F2/2415A61F2/2418A61F2/2412A61F2/2433
Inventor W·C·布鲁奇曼C·L·哈特曼
Owner EDWARDS LIFESCIENCES CORP