Unitary surgical device and method

Abstract

Unitary surgical devices ( 10 ) are disclosed. One group of the illustrated devices has a pair of biocompatible, bioresorbable anchors ( 16,18 ) connected to fixed lengths suture. The anchors ( 16,18 ) and fixed length of suture are connected to each other prior to surgery. Another group of unitary surgical devices has a pair of fixating mechanisms ( 15,17 ) connected to a base ( 21 ) prior to surgery. The second group of illustrated devices generally includes extracellular matrix material either as part of the base ( 21 ) or supported on the base ( 21 ). The extracellular matrix material serves as tissue regenerating material. In the second group of unitary surgical devices, the fixating mechanisms illustrated generally comprise suture, anchors or pre-formed holes in the base. All of the illustrated unitary surgical devices are useful in repairing a damaged meniscus. The first group of unitary surgical devices can be used to approximate inner surfaces of a tear in the meniscus. The second group of devices can be used either as an insert to be placed between and approximated to the inner surfaces of the tear or as an insert to replace a void in the meniscus left after a meniscectomy.

1 . A unitary surgical device for surgical implantation in a patient for regenerating tissue in the patient, the unitary surgical device comprising a tissue repair element and a fixating member, the tissue repair element comprising a base and a mass of tissue regeneration material fixed to the base, wherein the fixating member is associated with at least one of the base and the tissue regeneration material. 
     
     
         2 . The unitary surgical device of  claim 1  wherein the fixating member includes at least one of the following:
 a biocompatible anchor fixed to the base;   a biocompatible anchor fixed to the tissue regeneration material;   a length of suture fixed to the base; and   a length of suture fixed to the tissue regeneration material.   
     
     
         3 . The unitary surgical device of  claim 1  wherein the base comprises a panel with upper and lower surfaces. 
     
     
         4 . The unitary surgical device of  claim 3  wherein the panel has a V-shaped configuration in cross-section and wherein the upper and lower surfaces meet along an apex portion, the upper and lower surfaces having end portions spaced distally from the apex portion and from each other to provide a gap and wherein the tissue regeneration material is positioned between the two surfaces of the panel. 
     
     
         5 . The unitary surgical device of  claim 4  wherein the fixating member is associated with an end portion of the panel. 
     
     
         6 . The unitary surgical device of  claim 4  wherein the tissue regeneration material comprises a wedge of ECM material. 
     
     
         7 . The unitary surgical device of  claim 6  wherein the tissue regeneration material comprises an ECM foam. 
     
     
         8 . The unitary surgical device of  claim 1  further including a package holding the device, wherein the device is sterile. 
     
     
         9 . A unitary surgical device for surgical implantation in a patient for regenerating fibrocartilage tissue in the patient, the unitary surgical device comprising:
 a base having at least two layers; and   a length of suture positioned between two of the layers of the base;   at least part of the unitary surgical device being made from ECM material.   
     
     
         10 . The unitary surgical device of  claim 9  wherein at least part of the unitary surgical device is made from a biocompatible bioresorbable polymer. 
     
     
         11 . The unitary surgical device of  claim 9  wherein the ECM material includes at least one of the following:
 laminar ECM;   formed ECM;   ECM fibers;   ECM foam;   ECM wovens;   ECM non-wovens;   braided ECM; and   cross-linked ECM.   
     
     
         12 . The unitary surgical device of  claim 9  wherein the length of suture includes two exposed ends, the unitary surgical device further comprising an anchor at each exposed end of the suture. 
     
     
         13 . A method of repairing a tear in the meniscus in the knee of a patient, the meniscus having an articulating surface and a non-articulating surface, the tear resulting in the meniscus having two inner surfaces, the method comprising the acts of:
 providing a unitary surgical device having a pair of resorbable anchors and a fixed length of suture connecting each of the anchors;   locating the tear in the meniscus;   implanting the unitary surgical device to approximate the two inner surfaces of the meniscus at the tear, with suture extending across the articulating surface of the meniscus across the tear and the resorbable anchors being spaced from the tear.   
     
     
         14 . The method of  claim 13  wherein at least one of the resorbable anchors is positioned against a non-articulating surface of the meniscus. 
     
     
         15 . A method of preparing a unitary surgical device for use in surgery comprising the acts of: providing a first biocompatible anchor including at least one of the following:
 a bioresorbable barbed dart;   a bioresorbable tack;   a bioresorbable backstop; and   a bioresorbable male locking member;   providing a second biocompatible anchor including at least one of the following:   a bioresorbable barbed dart;   a bioresorbable tack; a bioresorbable backstop; and   a bioresorbable female locking member; and   providing a biocompatible tissue repair material including at least one of the following:   a fixed length of suture;   a sheet of collagen-containing material;   laminar ECM material;   formed ECM material;   comminuted ECM material;   ECM fiber; ECM foam material;   cross-linked ECM material;   a sheet of bioresorbable material; and   a base and a different material secured to the base, at least one of the base and the different material including ECM material;   securing the biocompatible tissue repair material to the first anchor and to the second anchor to form a unitary device; and   sterilizing the unitary surgical device.   
     
     
         16 . The method of  claim 15  further comprising packaging the unitary surgical device prior to sterilizing the unitary surgical device.