Tapered Looped Suture with Shape Memory Polymer
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Solution Overview
Problem
The existing methods for forming loops in sutures often result in a doubled suture diameter, increasing the force required to pass through tissue, which can lead to tissue trauma during surgical procedures.
Innovation Solution
A looped suture with a shape memory polymeric material that radially contracts and axially lengthens, allowing the loop to expand or contract, and potentially release therapeutic agents, while minimizing tissue trauma by adjusting its configuration from a temporary to a permanent state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a loop is formed in a suture using adhesive, heat or ultrasonic energy, then the suture can be secured to tissue, but the diameter of the suture is doubled where the two suture portions overlap, increasing the amount of force necessary to pull the loop through tissue
Solution Approach 1:
The suture is divided into two distinct portions: a monofilament portion for insertion and a loop portion with a different cross-sectional geometry (flat, oval, or rectangular) that allows the loop to form without doubling the diameter. This segmentation enables the loop to be created while maintaining a smaller profile that reduces tissue trauma and insertion force requirements.
Solution Approach 2:
Different portions of the suture have different geometric properties optimized for their specific functions. The insertion portion is monofilament for minimal tissue disruption, while the loop portion has a flat, oval, or rectangular cross-section that allows loop formation without diameter doubling. This local differentiation resolves the contradiction between loop security and insertion force.
2Reliability
If a loop is formed in a suture to secure tissue, then tissue can be held together, but the doubled diameter of the suture may cause tearing or other unnecessary trauma to the tissue being sutured
Solution Approach 1:
The suture is segmented into an insertion portion and a loop portion with different geometries. The loop portion's flat, oval, or rectangular cross-section allows it to form a secure loop without doubling the overall diameter, thereby reducing the harmful effect of tissue trauma while maintaining reliable tissue securing.
Solution Approach 2:
The loop portion of the suture has a specialized local geometry (flat, oval, or rectangular cross-section) that differs from the monofilament insertion portion. This local quality change allows the loop to provide secure tissue holding without the diameter doubling that would cause tissue tearing, thus resolving the contradiction between securing reliability and minimizing tissue trauma.
3Ease of manufacture
If a loop is formed in a suture using conventional methods, then the suture structure is created, but the process requires handheld instruments and additional steps in the operating room
Solution Approach 1:
The loop is pre-formed in the suture during manufacturing using a die or mold that creates the specific cross-sectional geometry (flat, oval, or rectangular) in the loop portion. This preliminary action eliminates the need for handheld instruments and additional formation steps in the operating room, resolving the contradiction between loop formation capability and device complexity.
Solution Approach 2:
The suture is manufactured with a specific cross-sectional geometry parameter change along its length - the loop portion has a flat, oval, or rectangular cross-section while the insertion portion is monofilament. This parameter change, built into the manufacturing process, allows the loop to form automatically during insertion without requiring additional instruments or steps, thus resolving the contradiction between loop capability and procedural complexity.
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 shape memory polymeric material allows for reduced resistance when passing through tissue and enhanced security post-insertion, while also enabling the release of therapeutic agents, thereby minimizing trauma and ensuring secure tissue engagement.
Implementation Method 1
At least a portion of the loop includes a shape memory polymeric material. The shape memory polymeric material is configured to radially contract and axially lengthen when transitioning from a temporary configuration to a permanent configuration.
Implementation Method 2
Radially contracting and axially lengthening of the shape memory polymeric material causes expanding of the loop and release of a therapeutic agent from the loop.
Data Source
Figure 1~1A
Figure 2~3
Figure 4A~4D
AI summary
A suture comprising an elongate body including a proximal end and a distal end, a loop integrally formed on the distal end of the elongate body, wherein at least a portion of the loop includes a shape memory polymeric material and wherein the shape memory polymeric material is configured to radially contract and axially lengthen when transitioning from a temporary configuration to a permanent configuration, and the radial contraction and axial lengthening causes expanding of the loop.