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Publication Number
US-12377193-B2
Publication Date
2025-08-05
Expiration Date
Abstract
Methods and devices for the repair of a torn or injured ligament or tendon are provided. The methods include the use of multiple scaffolds, e.g., beads. The multiple scaffolds may be positioned along a suture or other device such that they are moveable with respect to one another or the injured tissue.
Core Innovation
The disclosure relates to devices and methods for indirect intra-articular ligament or tendon repair, including anterior cruciate ligament (ACL) repair. A fixation device forms a stable attachment to a first bone while a suture is attachable to a ruptured end of a ligament or tendon that is configured to be connected to a second bone. Multiple distinct biodegradable collagen scaffolds are positioned along the length of the suture at the ruptured end into a gap between the ruptured ligament or tendon and the first bone.
The scaffold set is configured to regulate cell function at a target site and, in certain embodiments, comprises scaffolds that have resistance to degradation by synovial fluid. The fixation device is attached only indirectly to the scaffold, and the suture extends through the multiple distinct collagen scaffolds along the lengths of the scaffolds, allowing the suture to be slidable along the scaffolds.
Distinct biodegradable collagen scaffolds may be positioned outside of ligament insertion sites and can be delivered as separated or fragmented pieces rather than a single continuous scaffold. The disclosure further specifies scaffold composition and structure parameters, including collagen concentration greater than 400 mg/mL and, in some embodiments, greater than 400 mg/mL and less than or equal to 500 mg/mL, with scaffold configurations such as collagen sponges and beads.
Claims Coverage
The document includes three independent device claims covering ligament or tendon repair using multiple distinct biodegradable collagen scaffolds with indirect fixation to the scaffolds, a set of 2-30 distinct biodegradable collagen scaffolds with defined size and blood-absorption capability positioned in a ligament or tendon gap and held by threaded sutures and a bone fixation device, and a scaffold set including at least first and second distinct scaffolds with defined collagen-concentration and dimensional constraints and resistance to synovial-fluid degradation.
Multiple distinct biodegradable collagen scaffolds positioned along a slidable suture with indirect fixation
A ligament or tendon repair device comprising a fixation device capable of forming a stable attachment to a first bone; a suture attachable to a ruptured end of a ligament or tendon configured to be connected to a second bone; multiple distinct biodegradable collagen scaffolds positioned along the length of the suture at a ruptured end into a gap between the ruptured ligament or tendon and the first bone; wherein the fixation device is attached only indirectly to the scaffold; the suture extends through the multiple distinct collagen scaffolds along the lengths of the scaffolds and is slidable along the scaffolds; and the multiple distinct collagen scaffolds are configured to regulate cell function at a target site.
A set of 2-30 distinct biodegradable collagen scaffolds threaded by a suture and positioned in the ruptured gap
A ligament or tendon repair device comprising a set of distinct biodegradable scaffolds comprising 2-30 scaffolds, each scaffold having a collagen concentration of greater than 400 mg/mL, a length of 1-20 mm, a width less than 50 mm, and a volume less than 100 mL, and each scaffold being capable of absorbing at least 5 mL of blood, wherein the scaffold is configured to be positioned at a ruptured end into the gap between the ruptured ligament or tendon and a bone; at least one fixation device configured to be secured to the bone; and a suture threaded along the length of each scaffold of the set of distinct biodegradable scaffolds to position the scaffold between the ruptured end of the ligament or tendon and the bone.
Distinct biodegradable scaffolds with synovial-fluid resistance and defined collagen-concentration range
A ligament or tendon repair device comprising a suture having a first end and a second end attachable to a ruptured end of a ligament or tendon connected to a bone; a set of multiple distinct biodegradable scaffolds having resistance to degradation by synovial fluid and configured to regulate cell function at a target site; wherein the set includes a first scaffold and a second scaffold, each positioned along the length of the suture at a ruptured end into the gap between the ruptured ligament or tendon and a bone, and each scaffold has a collagen concentration of greater than 400 mg/mL and less than or equal to 500 mg/mL and defined length, width, and volume constraints.
Overall, the independent claims focus on placing multiple distinct biodegradable collagen scaffolds in the ligament or tendon gap using sutures, with defined collagen-concentration thresholds, and in certain claims controlling scaffold quantity and size and requiring resistance to degradation by synovial fluid, while using a fixation device to secure the repair to a bone.
Stated Advantages
Improved biomechanical strength and ACL healing when scaffolds are delivered in multiple pieces (reported in the document through biomechanical testing and MRI healing).
Scaffold-associated cell composition, including monocytes and basophils, is linked to predicted healing strength.
Documented Applications
Indirect intra-articular ligament or tendon repair, notably anterior cruciate ligament (ACL) repair, using multiple distinct biodegradable collagen scaffolds positioned along a containment device at the ruptured end into a gap between ligament or tendon and bone.
Meniscus and articular cartilage context is included as intra-articular tissue references in the disclosure.
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