Fabricating equipment for tissue type heart valve

Claim 1

Apparatus for manufacturing a replacement heart valve from a prepared stent and a plurality of strips of animal tissue, each strip having a pretrimmed inner edge, an inner portion adjacent said inner edge, and an outer untrimmed portion, said apparatus including in combination: stable stationary support means, spindle housing means supported by said support means and rotatable with respect thereto over an arc of about 90* , a spindle extending through said housing means and rotatable therewith between a vertical position and a horizontal position and rotatable with respect thereto about the axis of said spindle, a plurality of complementary clamping and molding members mating with each other into a generally cylindrical shape and each having a pair of intersecting axially and radially extending inner surfaces for receiving the inner portion of a said tissue strip and a radially extending end surface across which the tissue strip can extend, first actuating means supported by said spindle and supporting said clamping and molding means and serving to move them apart from each other for emplacing the tissue strips with their inner portions covering said inner surfaces and for moving them together for clamping the inner portions of said strips against each other and for holding a stent in place adjacent said strips, a plurality of complementary trim guide means corresponding in number to said clamping and molding means, arranged around a circle and spaced radially away from said clamping and molding means and having a face on about the same plane as the end surfaces of said clamping and molding means, said trim guide means having means for retaining in place the outer portion of each said tissue and having a radially inner arcuate trim guiding edge, second actuating means supported by said spindle and supporting said trim guide means and for moving them radially inwardly and outwardly, and releasable means enabling synchronization of said second actuating means with said first actuating meanS during earlier stages of manufacture of each said valve, so that said trim guide means are kept at a constant spacing from said clamping and molding means, and enabling movement of said second actuating means independent of said first actuating means during later stages thereof, so that said trim guide means can be moved farther away from said clamping and molding means after trimming to afford better access to the tissue on said clamping and molding means.

Claim 11

A device for application of a strip of tissue to a valve ring to form a replacement heart valve comprising in combination: a base and a support thereon having a stop pin affixed thereon, a generally circular rotatable disc rotatably connected to said support and provided with an arcuate slot through which said stop pin extends to determine the limits of travel of said rotatable disc, a spindle housing affixed to said disc and rotatable therewith about a central axis, a rotatable spindle within said housing and having an outer end beyond one end of said spindle housing, a threaded portion extending towards the other end, and terminating in a first collar, carrying a set of first pivots, a hand-operable control wheel detachably affixed to said outer end, an actuating sleeve threadedly connected to the threaded inner portion of said spindle and having a smooth cylindrical outer surface, a second collar mounted around said smooth surface of said sleeve for fore-and-aft movement with said sleeve while not rotated by it, a set of links pivoted to said second collar and extending radially and axially of said spindle and having a second set of pivots at their outer ends, a first set of arms pivoted to both said first and second set of pivots and extending radially and axially of said spindle, a plurality of tissue-molding means, one on the end of each of said first set of arms, a second set of arms pivoted to said first set of pivots, a plurality of arcuate trim guide members carried on said second set of arms and spaced from said tissue-molding means, concentric with said central axis, and each having an end surface co-planar with an end surface of said tissue-molding means, each said trim guide member also having an arcuate trim guiding inner edge, a plurality of pins arcuately disposed on each said trim guide member and adapted to pierce and engage a later-applied tissue, and quickly releasable means for joining each second arm to a first arm for simultaneous movement therewith for keying during that time-constant spacing between said tissue molding means and said trim guide members, and for disconnecting said second arm from said first arm for separate movement of each said trim guide member relative to said tissue-molding means.

Claim 12

A device for application of a strip of tissue to a valve ring to form a replacement heart valve comprising in combination: a base and a support thereon having a stop pin affixed thereon, a generally circular rotatable disc rotatably connected to said support and provided with an arcuate slot through which said stop pin extends to determine the limits of travel of said rotatable disc, a spindle housing affixed to said disc and rotatable therewith about a central axis, a rotatable spindle within said housing and having an outer end beyond one end of said spindle housing, a threaded portion extending towards the other end, and terminating in a first collar, carrying a set of first pivots, a hand-operable control wheel detachably affixed to said outer end, an actuating sleeve threadedly connected to the threaded inner portion of said spindle and having a smooth cylindrical outer surface, a second collar mounted around said smooth surface of said sleeve for fore-and-aft movement with said sleeve while not rotated by it, a set of links pivoted to said second collar and extending radially and axially of said spindle and having a second set of pivots at their outer ends, a first set of arms pivoted to both said first and second set of pivots and extending radially and axially of said spindle, a plurality of tissue-molding means, one on the end of each of said first set of arms, a second set of arms pivoted to said first set of pivots, a plurality of arcuate trim guide members carried on said second set of arms and spaced from said tissue-molding means, concentric with said central axis, and each having an end surface co-planar with an end surface of said tissue-molding means, each said trim guide member also having an arcuate trim guiding inner edge, a plurality of pins arcuately disposed on each said trim guide member and adapted to pierce and engage a later-applied tissue, and quickly releasable means for joining each second arm to a first arm for simultaneous movement therewith for keying during that time-constant spacing between said tissue molding means and said trim guide members, and for disconnecting said second arm from said first arm for separate movement of each said trim guide member relative to said tissue-molding means.

Claim 13

A method of applying animal tissue to a fabric-covered stent having a ring base, a sewing flange thereon and a plurality of struts, to form a replacement heart valve, which comprises: approximately sizing and trimming along one edge a plurality of selected strips of said tissue to form a plurality of valve cusp sections, draping and securing each of said formed sections in unstretched state so that the portion adjacent to the trimmed edge lies along two meeting planes, all planes extending radially of the same cylindrical volume, clamping together the tissue sections lying along said planes, so that in each instance two planar tissue portions are brought together, inserting said stent with said struts adjacent surfaces of said clamped sections, suturing a portion of each said section partially around each said strut, precisely trimming said sections to provide an outer edge with an outer portion adjacent thereto, folding said outer portion around said sewing flange, sewing said folded outer portion to said sewing flange, and completing suturing of said sections over said ring base, said tissue covering all surfaces of said stent to form said replacement valve.

Claim 14

A method of applying animal tissue to a fabric-covered stent having a ring base, a sewing flange thereon and a plurality of struts, to form a replacement heart valve, which comprises: approximately sizing and trimming along one edge a plurality of selected strips of said tissue to form a plurality of valve cusp sections, draping and securing each of said formed sections in unstretched state so that the portion adjacent to the trimmed edge lies along two meeting planes, all planes extending radially of the same cylindrical volume, clamping together the tissue sections lying along said planes, so that in each instance two planar tissue portions are brought together, inserting said stent with said struts adjacent surfaces of said clamped sections, suturing a portion of each said section partially around each said strut, precisely trimming said sections to provide an outer edge with an outer portion adjacent thereto, folding said outer portion around said sewing flange, sewing said folded outer portion to said sewing flange, and completing suturing of said sections over said ring base, said tissue covering all surfaces of said stent to form said replacement valve.

Claim 17

A method of applying animal tissue to a fabric-covered stent having a ring base, a sewing flange thereon, and a plurality of struts, to form a replacement heart valve, comprising:

Claim 18

A method of applying animal tissue to a fabric-covered stent having a ring base, a sewing flange thereon, and a plurality of struts, to form a replacement heart valve, comprising: