Methods and Materials for Connective Tissue Repair

Abstract

Methods for tendon and ligament repair using a scaffolding matrix material. The scaffolding matrix material is an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens, and to promote natural healing of soft tissue via revascularization and repopulation. The scaffolding matrix material is used to join ruptured tendons or ligaments together and to join ligaments to bone.

1 . A method for repairing a tendon in a patient, the tendon having ruptured into a first tendon portion having a first end portion and a second tendon portion having a second end portion, comprising:
 providing a scaffolding matrix material, said scaffolding matrix material consisting of an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens and to promote natural healing of soft tissue via revascularization and repopulation, said scaffolding matrix material having a shelf life of at least 2 years,   accessing the tendon,   joining the first end portion to the second end portion by attaching said scaffolding matrix material to the first and the second tendon portions.   
   
   
       2 . The method of  claim 1 , wherein said step of joining the first end portion to the second end portion is carried out by passing said scaffolding matrix material through the first end portion and the second end portion. 
   
   
       3 . The method of  claim 2 , wherein said step of joining the first end portion to the second end portion further comprises supplementing said scaffolding material with a suture. 
   
   
       4 . The method of  claim 3 , wherein said suture passes through said scaffolding matrix material to thereby assist in attaching said scaffolding matrix material to the first and the second tendons with a suture. 
   
   
       5 . The method of  claim 1 , wherein the tendon is in a hand of the patient. 
   
   
       6 . The method of  claim 5 , wherein the tendon is a flexor tendon of the hand, and said scaffolding matrix material is placed inside of said first and said second tendons, such that said scaffolding matrix material does not add bulk to the outside of the tendon so as not to inhibit movement of the tendon as the tendon moves through the hand. 
   
   
       7 . The method of  claim 1 , wherein said scaffolding matrix material was extra-operatively prepared according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616. 
   
   
       8 . The method of  claim 1 , wherein said scaffolding matrix material is from a human source. 
   
   
       9 . The method of  claim 1 , wherein said scaffolding matrix material is from a non-human source. 
   
   
       10 . The method of  claim 9 , wherein said non-human source is porcine. 
   
   
       11 . The method of  claim 1 , wherein said scaffolding matrix material has a width of about 2 mm, a height of about 2 mm, and a length substantially greater than both said width and said height. 
   
   
       12 . The method of  claim 1 , wherein said scaffolding matrix material has a width of about 3 mm, a height of about 2 mm, and a length substantially greater than both said width and said height. 
   
   
       13 . A method for repairing a tendon in a patient, the tendon having ruptured into a first tendon portion having a first end portion and a second tendon portion having a second end portion, and in which the first and second end portions cannot be re-approximated due to a gap between the first and second end portions, comprising:
 providing a scaffolding matrix material, said scaffolding matrix material consisting of an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens and to promote natural healing of soft tissue via revascularization and repopulation, said scaffolding matrix material having a shelf life of at least 2 years,   accessing the tendon,   attaching said scaffolding matrix material to the first end portion and to the second end portion such that said scaffolding matrix material spans the gap, thereby joining the first and second end portions together via said scaffolding matrix material, and   allowing new connective tissue from the patient to first repopulate and then build upon said scaffolding matrix material.   
   
   
       14 . The method of  claim 13 , wherein said step of joining the first end portion to the second end portion further comprises supplementing said scaffolding material with a suture. 
   
   
       15 . The method of  claim 13 , wherein said scaffolding matrix material was extra-operatively prepared according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616. 
   
   
       16 . A method of repairing and augmenting a detached ligament in a joint of a patient, the ligament being naturally attached to a first bone of the joint but detached from a second bone of the joint, comprising:
 providing a scaffolding matrix material, said scaffolding matrix material consisting of an off-the-shelf organic dermis from an unknown source which has been extra-operatively prepared so as to be devoid of viable cells which normally express antigens and to promote natural healing of soft tissue via revascularization and repopulation, said scaffolding matrix material having a shelf life of at least 2 years,   accessing the joint,   attaching said scaffolding matrix material to the second bone portion from which the ligament has become detached; and   attaching said scaffolding matrix material along the ligament such that the ligament is augmented by said scaffolding matrix material and such that the first and second bones of the joint are attached to one another via said scaffolding matrix material and the ligament.   
   
   
       17 . The method of  claim 16 , further comprising attaching said scaffolding matrix material to the first bone portion. 
   
   
       18 . The method of  claim 16 , wherein said step of attaching said scaffolding matrix material to the ligament comprises placing said scaffolding matrix material parallel and next to the ligament and suturing said scaffolding matrix material to the ligament. 
   
   
       19 . The method of  claim 16 , wherein the joint is in a finger or a thumb of the patient. 
   
   
       20 . The method of  claim 16 , wherein said scaffolding matrix material was extra-operatively prepared according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616.