Prosthetic heart valve using pericardium and method for manufacturing same
Inventors
Shin, Kyong Min • Hong, Kang Sun
Assignees
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Publication Number
US-10485659-B2
Publication Date
2019-11-26
Expiration Date
Abstract
A prosthetic heart valve using a pericardium is disclosed where: three hetero-biological tissue slices, which are extracted in a quadrangular shape from a bovine pericardium or a porcine pericardium, are prepared; each hetero-biological tissue slice is folded so as to form an inner tissue slice inside and an outer tissue slice outside, the outer tissue slice being longer than the inner tissue slice; each of the inner tissue slice and outer tissue slice is coupled by sewing in a semicircular shape with a first coupling thread such that each inner tissue slice forms a pulmonic valve slice inside the first coupling thread and a fixing slice outside the first coupling thread such that each hetero-biological tissue slice is formed in a cylindrical shape by allowing each slice to be adjacent to each other. The disclosed prosthetic heart valve has increased durability and prevents reverse blood flow.
Core Innovation
The invention relates to a method for manufacturing a prosthetic heart valve using a pericardium extracted in a quadrangular shape from bovine pericardium or porcine pericardium. Three heterogeneous tissue pieces are prepared, and each tissue piece is folded to form an inside tissue piece on an inside and an outside tissue piece on an outside, where the outside tissue piece has a greater length than the inside tissue piece. The inside and outside tissue pieces are connected by sewing with a first connecting thread along a semicircular shape having one side open, forming a valve piece on an inside of the first connecting thread and a securing piece on an outside of the first connecting thread.
The heterogeneous tissue pieces are arranged next to one another to form a cylindrical form, with both ends placed in contact with one another and exposed outward for connection by sewing with a second connecting thread along a vertical direction. The heterogeneous tissue pieces are folded at both ends to complete a valve conduit having folded portions. A wire stent is prepared by intertwining wires made of a superelastic shape-memory alloy along a circumferential direction and a lengthwise direction of a cylinder in a network form, where the wire stent includes a cylindrical body with a plurality of spaces and expanding portions expanding outward from both sides of the cylindrical body.
The valve conduit is inserted into an inside of the wire stent, and the spaces, the outside tissue pieces, and the securing pieces are connected by sewing with a third connecting thread along a horizontal direction to complete a valve conduit stent. The valve conduit stent is compressed by a commonly used crimper and latched onto a hook portion of a catheter, and it is inserted into an outer tube of the catheter by a movement of the hook portion. The patent additionally describes latching and catheter-hook structures and functional behavior, including prevention of reverse blood flow and differences between forward flow and reverse blood flow.
Claims Coverage
Independent claim clm-00001 covers a method for manufacturing a prosthetic heart valve using pericardium and includes six inventive features.
Method using quadrangular bovine or porcine pericardium tissue pieces
Preparing three heterogeneous tissue pieces extracted in a quadrangular shape from a bovine pericardium or a porcine pericardium.
Folding and semicircular one-side-open sewing to form valve and securing pieces
Folding each heterogeneous tissue piece to form an inside tissue piece on an inside and an outside tissue piece on an outside, and connecting the inside and outside tissue pieces by sewing with a first connecting thread along a semicircular shape having one side open, such that each inside tissue piece has a valve piece formed on an inside of the first connecting thread and a securing piece formed on an outside of the first connecting thread.
Cylindrical arrangement with vertical end sewing and folded valve conduit portions
Arranging the heterogeneous tissue pieces next to one another to form a cylindrical form, placing both ends in contact with one another and exposing outward, and connecting by sewing with a second connecting thread along a vertical direction, then folding the heterogeneous tissue pieces at both ends to complete a valve conduit having folded portions.
Superelastic shape-memory alloy wire stent with spaces and expanding portions
Preparing a wire stent by intertwining wires made of a superelastic shape-memory alloy along a circumferential direction and a lengthwise direction of a cylinder in a network form, the wire stent comprising a cylindrical body having a plurality of spaces formed therein and expanding portions expanding outward from both sides of the cylindrical body.
Horizontal sewing connection into the wire stent to complete a valve conduit stent
Inserting the valve conduit into an inside of the wire stent and connecting the spaces and the outside tissue pieces and the securing pieces by sewing with a third connecting thread along a horizontal direction to complete a valve conduit stent.
Crimp-compressed catheter latching and outer tube insertion via hook movement
Compressing the valve conduit stent by a commonly used crimper and latching onto a hook portion of a catheter, and inserting into an outer tube of the catheter by a movement of the hook portion.
The independent claim structure is grounded in a pericardium-based, folding-and-sewing formation of a cylindrical valve conduit, coupled to a superelastic shape-memory alloy wire stent with spaces and expanding portions, and finished with catheter hook latching and outer tube insertion by hook movement.
Stated Advantages
Improved durability through resistance to tearing under blood pressure.
Reduced gaps and leakage.
Prevention of reverse blood flow.
Easier and less time-consuming catheter latch/unlatch.
More stable positioning.
Documented Applications
Delivery and functional behavior of the prosthetic heart valve under forward flow and reverse blood flow, including aortic delivery and pulmonic delivery via catheter.
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