Luggage Tag Suture Assembly for Knotless Tissue-to-Bone Fixation
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Solution Overview
Problem
Existing soft-tissue-to-bone reattachment procedures, such as rotator cuff repair, face issues with knotless techniques allowing relative movement between tendon and suture, suture slippage due to diminished bone density, and anchor pullout, especially in patients with age-related or disease-induced bone density loss, along with the formation of undesirable flaps or folds.
Innovation Solution
The use of a 'luggage tag' configuration with sutures, including various suture designs and anchor systems, to secure tissue to bone, utilizing a luggage tag configuration by passing one end through the other to form a secure attachment, often with an anchor to prevent slippage and using a suture engagement feature for interference fit.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If knotless repair technique is used, then ease of operation is improved and technical expertise required is reduced, but relative movement between tendon and suture occurs and reliability deteriorates
Solution Approach 1:
A secondary suture or locking mechanism is introduced as an intermediary element to prevent relative movement between the tendon and the primary suture in knotless repair techniques, thereby maintaining reliability while preserving ease of operation
Solution Approach 2:
Pre-formed loops, bars, or locking structures are incorporated into the suture system before implantation, allowing the suture to automatically lock or secure the tendon without requiring complex knot-tying procedures during surgery
2Device complexity
If interference fit between suture anchor and bone is used to reduce device complexity, then device complexity is reduced, but suture slippage occurs in patients with diminished bone density and reliability deteriorates
Solution Approach 1:
The suture anchor is designed with locally enhanced features such as expanded distal ends, flared geometries, or localized locking structures that increase bone engagement and prevent suture slippage in patients with diminished bone density without requiring overall system complexity
Solution Approach 2:
The suture anchor system combines multiple materials with complementary properties, such as a rigid anchor body for bone engagement and a flexible suture component for tissue attachment, creating a composite system that maintains reliability across varying bone densities
3Reliability
If traditional knotted repair technique is used, then reliability is improved by securing tendon to bone, but knots become bulky and cause impingement of tendon on bone creating harmful factors
Solution Approach 1:
The knot-tying step is extracted and replaced with alternative securing mechanisms such as pre-formed loops, barbed sutures, or interference-fit anchors that achieve reliable tendon-to-bone fixation without creating bulky knots that cause impingement
Solution Approach 2:
Instead of creating a knot to secure the suture, the system inverts the approach by using a suture design or anchor mechanism that inherently prevents suture withdrawal or slippage without requiring a knot, thereby eliminating the impingement problem
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The luggage tag configuration provides a secure and stable attachment of tissues, reducing relative movement and suture slippage, especially in patients with diminished bone density, and enhances the fixation of tissues to bones, improving the quality of repair.
Implementation Method 1
a suture engagement feature for interference fit
Data Source
AI summary
Methods of repairing tissue include obtaining a suture including a first end defining an opening and a second end capable of passing through the opening; passing the first end through the tissue at a first location; passing the second end through the tissue at a second location; forming a luggage tag configuration by passing the second end through the first end; and securing the luggage tag configuration against the tissue. In some examples, the suture is a continuous closed loop, and in others the suture has a barbell configuration, with a linear central portion and a loop at each end. In still examples, the suture has a loop at one end and a tail at the other. The suture may be used without an anchor or may be part of a suture assembly including a suture anchor and, optionally, at least one other suture.