Two-piece tissue fastener with coinable leg staple and retaining receiver and method and instrument for applying same

Claim 2

1'. A fastener adapted to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener comprising: an open loop fastening member, said fastening member comprising a pair of legs adapted to penetrate said tissue portions and a link connecting said legs that is adapted to lie substantially against one of said tissue portions; a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member, said receiver having means for receiving said fastening member legs after said legs have been inserted through said tissue portions; at least a portion of each of said legs or at least a portion of said receiver consisting of a material that is initially deformable under the application of a predetermined amount of pressure to effect engagement of the fastening member legs and receiver after the tissue portions have been penetrated by said fastening member legs and after said legs have been received in said receiver

Claim 3

The fastener in accordance with claim . 1 in which said fastening member is a generally U-shaped member, in which each of said legs has a generally solid cylindrical shape, and in which the end of each leg opposite said link has a generally conical configuration to aid in tissue penetration.

Claim 4

The fastener in accordance with claim 1 or claim 2 in which said legs are generally parallel to each other and are generally perpendicular to said link.

Claim 5

The fastener in accordance with any one of claims 1 to 3, in which said fastening member is molded from a thermoplastic polymer and in which said receiver is molded from a thermoplastic polymer.

Claim 6

The fastener in accordance with claim 4, in which said receiver is molded from nylon.

Claim 7

The fastener in accordance with an/one of claims 1 to 3, .in which said fastening member is molded from a thermoplastic polymer in a heated mold, in which said fastening member is post-scoured, and in which said fastening member is annealed.

Claim 8

The fastener in accordance with any one of claims 1 to 6, in which said receiver includes a central member joining a pair of leg receiving members.

Claim 9

The fastener in accordance with any one of claims 1 to 7, in which each said leg receiving member defines at least one passage for receiving one of said fastening member legs.

Claim 10

The fastener in accordance with claim 8 in which each said passage is a generally cylindrical bore.

Claim 11

The fastener in accordance with claim 8 or claim 9, In which each said receiving member defines a first aperture communicating from the exterior of the receiving member with the interior of said passage and a second aperture opposite the first aperture communicating from the exterior of said receiving member with the interior of said passage.

Claim 12

11", The fastener in accordance with claim 10 in which each said aperture has a generally right rectangular configuration.

Claim 13

A fastener adapted to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener comprising a fastening member having a pair of legs adapted to penetrate said tissue portions and a link connecting said legs that is adapted to lie substantially against one of said tissue portions; said fastener further comprising a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member, said receiver having receiving means for receiving and encompassing a portion of each of said fastening member legs after said legs have been inserted through said tissue portions, at least a portion of each of said legs consisting of a material that is initially deformable under the application of a predetermined amount of pressure exerted by a tool or instrument to deform said material against portions of said receiver adjacent said receiver receiving means to thereby effect engagement of the fastening member legs and the receiver after the tissue portions have been penetrated by said fastening member legs and after said legs have been received in said receiver receivings means.

Claim 14

A fastener adapted to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener comprising a fastening member having a pair of legs adapted to penetrate said tissue portions and a link connecting said legs that is adapted to lie substantially against one of said tissue portions; said fastener further comprising a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member, said receiver having receiving means for receiving and encompassing a portion of each of said fastening member legs after said legs have been inserted through said tissue portions, at least a portion of each of said legs consisting of a material that is initially deformable under the application of a predetermined amount of pressure exerted by a tool or instrument to deform said material against portions of said receiver adjacent said receiver receiving means to thereby effect engagement of the fastening member legs and the receiver after the tissue portions have been penetrated by said fastening member legs and after said legs have been received in said receiver receivings means.

Claim 15

An instrument for applying at least one fastener to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener including an open loop fastening member that comprises a pair of legs adapted to penetrate said tissue portions and a link connecting said legs that is adapted to lie substantially against one of said tissue portions, said fastener further including a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member and adapted to accept the legs of the fastening member, said instrument comprising: a first jaw for holding said fastening member on one side of said tissue portions with said legs oriented at an appropriate angle to penetrate said tissue portions; a second jaw for holding said receiver on said other side of said tissue portions opposite said fastening member and generally in alignment with said fastening member legs; means for moving said first and second jaws between an open position for receiving said tissue portions therebetween and an at least partially closed position; means for moving said fastening member relative to said first jaw to penetrate said tissue- portions with the legs of said fastening member and to locate at least portions of said legs of said fastening member within said receiver in said second jaw; a deforming member movable relative to said second jaw member for being urged against the fastening member legs, the receiver, or both to deform the fastening member legs, the receiver, or boch to thereby effect an engagement of the fastening member legs and receiver; and means for moving said deforming member to e: ect said deformation.

Claim 16

An instrument for applying at least one fastener to hold together separated portions of mammalian tissue, such as are defined by a wound or incision, to facilitate healing of the wound or incision, said fastener including an open loop fastening member that comprises a pair of legs adapted to penetrate said tissue portions and a link connecting said legs that is adapted to lie substantially against one of said tissue portions, said fastener further including a receiver adapted to be disposed against the other of said tissue portions opposite said fastening member and adapted to accept the legs of the fastening member, said instrument comprising: a first jaw for holding said fastening member on one side of said tissue portions with said legs oriented at an appropriate angle to penetrate said tissue portions; a second jaw for holding said receiver on said other side of said tissue portions opposite said fastening member and generally in alignment with said fastening member legs; means for moving said first and second jaws between an open position for receiving said tissue portions therebetween and an at least partially closed position; means for moving said fastening member relative to said first jaw to penetrate said tissue- portions with the legs of said fastening member and to locate at least portions of said legs of said fastening member within said receiver in said second jaw; a deforming member movable relative to said second jaw member for being urged against the fastening member legs, the receiver, or both to deform the fastening member legs, the receiver, or boch to thereby effect an engagement of the fastening member legs and receiver; and means for moving said deforming member to e: ect said deformation.

Claim 17

14 . The instrument in accordance with claim 13 further including first and second handle levers connected for relative movement toward and away from each other, said fastening member moving means being mounted to and extending from said first handle lever, said second jaw being mounted to and extending from said second handle lever, and said first jaw being mounted to said instrument for movement relative to both said fastening member moving means and said second jaw.

Claim 18

The instrument in accordance with claim 13 or claim 14 in which first jaw includes a channel for frictionally receiving said fastening member and in which said fastening member moving means includes a pusher member for engaging said fastening member and being received in said first jaw channel adjacent said fastening member.

Claim 19

The instrument in accordance with any one of claim 13 to 15, further including a movable anvil member in said second jaw for engaging a portion of said receiver and said fastening member legs and further including means for biasing said anvil member into engagement with said receiver and said fastening member legs.

Claim 20

The instrument in accordance with any one of claim 13 to 16. further including a cutting blade associated with said second jaw and further including means for moving said blade relative to said second jaw adjacent said receiver to cut off portions of said fastening member legs extending beyond said receiver when said jaws are in said at least partially closed position.

Claim 21

The instrument in accordance with claim 17, in which said instrument is adapted to apply one fastener at a time and in which said instrument includes a reciprocative actuating member slidably disposed within said second jaw; in which said deforming member and said cutting blade are unitary with said reciprocative actuating member; in which said instrument includes a handle lever pivotally mounted to said second jaw; in which said instrument further includes handle lever biasing means for biasing said handle lever into a first position relative to said second jaw; and in which said actuating member includes a drive member adapted to be engaged by said handle lever when sufficient force is applied to said handle lever to overcome said handle lever biasing means and move said handle lever relative to said second jaw away from said open position for engaging said drive member to thereby move said actuating member relative to said second jaw to effect the deformation with said deforming member and the cutting off of said fastening member legs with said cutting blade.