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US 2017/0224344 A1 Zheng (43) Pub US 20170224344A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2017/0224344 A1 Zheng (43) Pub. Date: Aug. 10, 2017 (54) SUTURELESS REPAIR OF SOFT TISSUE A6L 27/50 (2006.01) A6IL 27/24 (2006.01) (71) Applicant: ORTHOCELL LIMITED, Murdoch (52) U.S. Cl. (AU) CPC .......... A61B 17/II (2013.01); A61B 17/1128 (2013.01); A61B 17/1146 (2013.01); A61L (72) Inventor: Ming Hao Zheng, City Beach (AU) 27/24 (2013.01); A61L 27/58 (2013.01); A61L 27/50 (2013.01); A61B 2017/1107 (2013.01); (73) Assignee: ORTHOCELL LIMITED, Murdoch A61B 2017/1132 (2013.01); A61 L 2430/34 (AU) (2013.01); A61 L 2430/10 (2013.01) (21) Appl. No.: 15/514,799 (22) PCT Filed: Oct. 12, 2015 (57) ABSTRACT (86). PCT No.: PCT/AU201S/OOO612 The present invention relates to a sutureless method of S 371 (c)(1), repairing soft tissue defects in Soft tissue including liga (2) Date: Mar. 27, 2017 ments such as anterior cruciate ligaments (ACLS). In par ticular, the present invention relates a Sutureless method of (30) Foreign Application Priority Data repairing soft tissue defect comprising: (i) providing a collagen-containing patch adapted to enclose at least a Oct. 10, 2014 (AU) ................................ 2O14904.054 portion of said soft tissue defect; (ii) contacting said soft tissue defect and/or collagen-containing patch with a sensi Publication Classification tizer, (Hi) enclosing said soft tissue defect in said collagen (51) Int. Cl. containing patch to produce a bioactive chamber; and (iv) A6 IB 7/II (2006.01) adhering said collagen-containing patch to said soft tissue A6L 27/58 (2006.01) defect without sutures. Patent Application Publication Aug. 10, 2017 Sheet 1 of 3 US 2017/0224344 A1 Figure l Patent Application Publication Aug. 10, 2017. Sheet 2 of 3 US 2017/0224344 A1 Patent Application Publication Aug. 10, 2017 Sheet 3 of 3 US 2017/0224344 A1 Feref patee (normally in center of knee Peterof rit garnerFor HSASal Merses Lignment SHSAEW at 2 Patern state SH “32 air: y cigarheftr bua i. Figure 3 US 2017/0224344 A1 Aug. 10, 2017 SUTURELESS REPAIR OF SOFT TISSUE 0004 Reconstruction of soft tissue disruptions using col lagen fibers, biodegradable polymers and composites have FIELD been used as well as three-dimensional scaffolds made of protein, hydrogel or collagen. However, generally, all of 0001. The present invention relates to a sutureless these procedures require some form of Suturing. method of repairing soft tissue defects in Soft tissue includ 0005. A surgical technique that eliminates the need for ing ligaments such as anterior cruciate ligaments (ACLS). Sutures and avoids collateral tissue damage is an unmet goal The repair includes repairing tears, partial or complete. In for microSurgical repair of ligaments, tendons, vessels and particular, the present invention relates to a Sutureless nerves. The placement of sutures in delicate structures like method of repairing soft tissue defects comprising adhering ligaments and tendons inevitably causes ongoing problems. a collagen-containing patch to the site of the soft tissue For example, the presence of permanent Sutures leads to defect using a sensitizer wherein a bioactive chamber is immunological reactions including inflammation and scar formed around the soft tissue defect which provides a ring at the repair site. Suture material also creates irregu microclimate conducive to the repair of the tissue. larities of the endothelium with a consequent prothrombotic effect. In addition, the presence of sutures does not provide BACKGROUND an instantaneous water-tight seal as shown by relatively low leak point pressures in comparison to other sealant tech 0002 Tendon tissue, ligament tissue, vascular tissue, nologies. dermal tissue and the like are often collectively referred to 0006. In an attempt to overcome some of the limitations as Soft tissue. Ligaments are specialized connective soft of Suture repair of ligaments, tendons, vessels, nerves and tissues that connect different organs or tissues and attach the like previous researchers have used rings, clips, glues bone to bone. In the latter case, ligaments provide stability and laser welding. Some of these methodologies are dis to joints by being flexible enough to allow natural movement cussed in Zeebregts et al. (2003), Br J Surg, 90:261-271; of the bones yet also are strong and inextensible to prevent however, all of these alternative methods have significant resistance to applied forces. Tendons connect muscle to bone drawbacks related to the substantial foreign body reaction or and are capable of withstanding tension. In addition, tendons associated tissue injury that have prevented widespread passively modulate forces during locomotion, providing clinical adoption. additional stability with no active work. Their elastic prop 0007 Laser assisted repair has been the subject of erties allow tendons to store and recover energy at high research for over 25 years and involves delivery of laser efficiency. In tendons and ligaments, bundles of collagen energy to heat the repair site to form a “weld” (Wolf-de fibers are embedded in a connecting matrix made of pro Jonge et al. (2004), Eur.I Vasc Endovasc Surg., 27:466-476). teoglycans components. These bundles of collagen fibers Since the late 1970s there have been numerous reports of provide the load carrying elements. In tendons, the collagen welding of tissue using argon, CO, near, infrared diode and fibers are arranged in nearly parallel formation, thus Nd:YAG lasers (see, for example, Gelli et al. (1997), J. enabling them to withstand high unidirectional loads. In Reconstr. Microsurg, 13:199-205: Jain & Gorisch (1979), ligaments, the collagen fibers are arranged in a less parallel Surgery, 85:684-688; Lewis & Uribe (1993), Laryngoscope, formation, thereby enabling them, to withstand predominant 103:850-853: Neblett et al. (1986), Neurosurgery, 19:914 tensile stresses in one direction and Smaller stresses in other 934; Samonte & Fried (1991), Lasers Surg Med., 11:511 directions. 516; Serure et al. (1983), Surg. Forum, 34:634–636; Tang et 0003. Every year, hundreds of thousands of people al. (1994), Lasers Surg Med., 14:229-237; Vale et al. (1986), sprain, tear, or rupture ligaments in particular in the knee, Plast. Reconstr. Surg., 77:759-766). In these reports and shoulder, and ankle or suffer from injuries to tendons of the many others the laser energy is converted to heat to raise the upper and lower extremities, in particular in the shoulder, local tissue temperature and denature extracellular matrix knee, foot, and ankle. One such ligament often affected by proteins which results in tissue welding and repair. these types of injuries is the anterior cruciate ligament 0008. In spite of the many theoretical benefits of laser (ACL) of the knee. The ACL serves as a primary stabilizer welding, the technique has not been adopted clinically. The of anterior tibia translation and as a secondary stabilizer of reasons are many, but heating of the tissues necessarily valgus-Varus knee angulation, and is often susceptible to causes injury and thus, despite all, the pre-clinical research rupture or tear resulting from a flexion-rotation-valgus force in the area of laser welding, application in the clinical realm associated with sports injuries and traffic accidents. Rup has not been realized. tures or tears often result in: severe limitations in mobility; 0009. Thus, there remains a need for a method of repair pain and discomfort; and an inability to participate in sports ing soft tissue defects including defects in tendon tissue, and exercise. More than 200,000 people in the U.S. alone ligament tissue, vascular tissue, dermal tissue and the like tear or rapture their ACL each year, leading to costs of which alleviates or at least works towards overcoming the approximately $3 billion for ACL reconstructive surgery and issues identified with using scaffolds and Sutures. extensive rehabilitation. It is widely known that the ACL has poor healing capabilities. Total Surgical replacement and SUMMARY reconstruction are required when the ACL Suffers a signifi cant tear or rapture resulting in joint instability. The most 0010. In a first aspect, the present invention provides a common practice is to reconstruct a torn ACL by Substituting Sutureless method of repairing soft tissue defect comprising: the torn ligament with the patients own tissue, also known 0011 (i) providing a collagen-containing patch adapted as an autograft. Other options for Substitute ligaments to enclose at least a portion of said soft tissue defect; include donor tissues from another organism, also known as 0012 (ii) contacting said soft tissue defect and/or colla allografts, as well as synthetic grafts. gen-containing patch with a sensitizer; US 2017/0224344 A1 Aug. 10, 2017 0013 (iii) enclosing said soft tissue defect in said colla thick. In some embodiments, the collagen-containing patch gen-containing patch to produce a bioactive chamber; and is between 30 um and 180 um thick. In other embodiments, 0014 (iv) adhering said collagen-containing patch to said the collagen-containing patch is between 35 um and 170 um soft tissue defect without sutures. thick. In still other embodiments, the collagen-containing 0.015. In some embodiments the soft tissue defect is in a patch is between 40 um and 160 um thick. In still other Soft tissue selected from the group consisting of ligament embodiments, the collagen-containing patch is between 45 tissue, tendon tissue, venous tissue, arterial tissue and nerve um and 150 um thick. In still other embodiments, the tunnel tissue. In some embodiments the soft tissue defect is collagen-containing patch is between 50 Lum and 140 um in a ligament such as anterior cruciate ligament (ACL). thick. In still other embodiments, the collagen-containing 0016. It will appreciated by those skilled in the art, patch is between 50 um and 100 um thick.
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