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US6539984B2 Expired / Lapsed US ⏱️ 0.0 years remaining

Method and apparatus for forming a heart valve wireform

Assignee: Edwards Lifesciences Corp
•
Filing: 2001-07-12
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Granted: 2003-04-01
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Expires: 2021-07-12
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Abstract

Abstract A system and method for forming a three-dimensional wireform for heart valves from a two-dimensional starting shape. The wireform has multiple arcuate cusps and oppositely directed commissure tips therebetween, the cusps and commissure tips being oriented generally in a tube about an axis. The two-dimensional wire has three cusps and two commissure tips, with two free ends having bent segments. The wireforming system and process holds the commissure tips, or one commissure tip and one bent segment, and forms the cusp therebetween. The wire is held by two axially-parallel mandrels and cooperating clamps which axially rotate and move toward one another. A forming surface on each mandrel bends one half of the cusp, the forming surfaces being mirror images of one another. The forming surface has a complex curvature specifically designed to shape a particular size of wireform into a desired final three-dimensional shape. After bending all the cusps, the free ends of the wire are joined, such as with a tubular crimp, and the wireform assembled into a tissue-type heart valve.

Inventors

  • 👤 Hung Ly Lam

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 13:13
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415; B; B21; B21F; B21F45/00; B21F45/008

Claims Analysis

Total Claims: 20
Claim 1
Independent Claim 74 words
An apparatus for forming a three-dimensional wireform for use in a heart valve, comprising: a first mandrel having a forming surface with a varying curvature; a second mandrel having a forming surface with a varying curvature; and a forming tool having clamps for cooperating with the mandrels and rigidly holding a two-dimensional wire and displacing the forming surfaces of the mandrels with respect to one another to bend the wire into a three-dimensional shape.
Claim 2
Independent Claim 74 words
An apparatus for forming a three-dimensional wireform for use in a heart valve, comprising: a first mandrel having a forming surface with a varying curvature; a second mandrel having a forming surface with a varying curvature; and a forming tool having clamps for cooperating with the mandrels and rigidly holding a two-dimensional wire and displacing the forming surfaces of the mandrels with respect to one another to bend the wire into a three-dimensional shape.
Claim 3
Dependent Claim 46 words
The apparatus of claim 1 , wherein the forming tool includes first and second shafts arranged to rotate along parallel axes, the mandrels including throughbores sized to receive the respective shafts, wherein rotation of the shafts causes the displacement of the forming surfaces of the mandrels.
Claim 4
Dependent Claim 55 words
The apparatus of claim 2 , wherein the forming tool includes a linear slide for translating one of the shafts in a direction perpendicular to the parallel axes and the displacement of the forming surfaces of the mandrels further includes translating one of the shafts and forming surface toward the other shaft and forming surface.
Claim 5
Dependent Claim 23 words
The apparatus of claim 3 , further including motors coordinated by a programmable controller for rotating the shafts and translating the one shaft.
Claim 6
Dependent Claim 51 words
The apparatus of claim 1 , wherein the two dimensional wire includes alternating arcuate cusps and commissure tips, and the clamps and mandrels cooperate to hold two of the commissure tips with one of the arcuate cusps therebetween, the forming surfaces therefore bending the arcuate cusp of the wire when displaced.
Claim 7
Dependent Claim 46 words
The apparatus of claim 5 , wherein each clamp and mandrel is disposed on a shaft, and either the mandrel or clamp is arranged to slide along the shaft with respect to the other to alternately hold and release the wire between the clamp and mandrel.
Claim 8
Dependent Claim 105 words
The apparatus of claim 6 , wherein the two dimensional wire includes alternating arcuate cusps and commissure tips, and each mandrel includes a channel and cross-bores opening to the channel, each clamp including a recess aligned with the channel, wherein a pair of pins are provided fitting in the crossbores and sized so that one of the commissure tips may be wrapped therearound, the pins projecting into the channel a distance that permits sliding of the mandrel into cooperation with the clamp such that the projections of the pins fit within the clamp recess and the commissure tip is retained between the channel and recess.
Claim 9
Dependent Claim 34 words
A subassembly for bending a wire for a heart valve wireform, the wireform having alternating arcuate cusps and arcuate commissure tips, comprising: a pair of mandrels having forming surfaces that have non-cylindrical cross-sectional shapes.
Claim 10
Dependent Claim 34 words
A subassembly for bending a wire for a heart valve wireform, the wireform having alternating arcuate cusps and arcuate commissure tips, comprising: a pair of mandrels having forming surfaces that have non-cylindrical cross-sectional shapes.
Claim 11
Dependent Claim 57 words
The subassembly of claim 8 , wherein each mandrel includes a throughbore and a keyway, and further including, for each mandrel: a shaft sized to fit within the throughbore having an axial groove; and a key sized to fit within the groove in the shaft and within the keyway and couple rotation of the shaft and mandrel.
Claim 12
Dependent Claim 36 words
The subassembly of claim 9 , further including, for each mandrel, a clamp having a throughbore and a keyway sized to receive the shaft and key, respectively, and couple rotation of the shaft, mandrel and clamp.
Claim 13
Dependent Claim 70 words
The subassembly of claim 10 , wherein each mandrel further includes an axial channel on one side adjacent the forming surface, and the clamp includes an external recess aligned with the channel, the subassembly further including a retaining pin projecting into the channel and sized to receive therearound one of the arcuate commissure tips of the two-dimensional wire, the commissure tip being retained by overlapping of the channel and recess.
Claim 14
Independent Claim 52 words
A method for forming a three-dimensional wireform for use in a heart valve, comprising: bending a wire into a flat (2-dimensional) undulating pattern of the alternating cusps and commissures; and bending the flat pattern into a three dimensional shape using: a pair of mandrels having forming surfaces that have non-cylindrical cross-sectional shapes.
Claim 15
Independent Claim 52 words
A method for forming a three-dimensional wireform for use in a heart valve, comprising: bending a wire into a flat (2-dimensional) undulating pattern of the alternating cusps and commissures; and bending the flat pattern into a three dimensional shape using: a pair of mandrels having forming surfaces that have non-cylindrical cross-sectional shapes.
Claim 16
Dependent Claim 45 words
The method of claim 12 , further including: providing a forming tool having clamps for cooperating with the mandrels and rigidly holding a two-dimensional wire; displacing the forming surfaces of the mandrels with respect to one another to bend the wire into a three-dimensional shape.
Claim 17
Dependent Claim 48 words
The method of claim 13 , wherein the forming tool includes first and second shafts arranged to rotate along parallel axes, the mandrels including throughbores sized to receive the respective shafts, and further including rotating the shafts to cause the displacement of the forming surfaces of the mandrels.
Claim 18
Dependent Claim 55 words
The method of claim 14 , wherein the forming tool includes a linear slide for translating one of the shafts in a direction perpendicular to the parallel axes and the displacement of the forming surfaces of the mandrels further includes: translating one of the shafts and forming surface toward the other shaft and forming surface.
Claim 19
Dependent Claim 26 words
The method of claim 15 , further including: coordinating the rotation of the shafts and translation of the one shaft using motors and a programmable controller.
Claim 20
Dependent Claim 33 words
The method of claim 12 , further including: holding two of the commissures of the wire with a cusp therebetween and using the pair of mandrels to bend one cusp at a time.

References Cited (Backward Citations)

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US2715424A Cited
US3608097A Cited
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US4501030A Cited
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USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2006-03-31 2006-09-30 2007-04-01 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2010-03-31 2010-09-30 2011-04-01 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2014-03-31 2014-09-30 2015-04-01 $7700.00 Window Closed / Lapsed

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