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Design Innovation Paper

Creating a Small Anchor to Eliminate Large Knots in Mesh and Tape Suture

[+] Author and Article Information
Jason L. Green

Duke University School of Medicine,
487 Medical Science Research Building 1,
203 Research Drive,
Durham, NC 27710
e-mail: jason.l.green@duke.edu

Richard Glisson

Department of Mechanical Engineering and
Material Science,
Duke University,
P.O. Box 90300,
Durham, NC 27708
e-mail: r.r.glisson@duke.edu

Jane Hung

Optum,
4242 Six Forks Road,
Suite 1100,
Raleigh, NC 27609
e-mail: jane.hung@optum.com

Mohamed Ibrahim

Division of Plastic, Maxillofacial, and Oral Surgery,
Duke University Medical Center,
DUMC 3181,
Durham, NC 27710
e-mail: Mohamed.ibrahim@duke.edu

Alfredo Farjat

Department of Biostatistics and Bioinformatics,
Duke University,
11028F Hock Plaza,
Box 2721,
Durham, NC 27710
e-mail: alfredo.farjat@duke.edu

Beiyu Liu

Department of Biostatistics and Bioinformatics,
Duke University,
11028B Hock Plaza,
Box 2721,
Durham, NC 27710
e-mail: beiyu.liu@duke.edu

Ken Gall

Department of Mechanical Engineering and
Material Science,
Duke University,
Durham, NC 27708;
Edmund T. Pratt Jr. School of Engineering,
Duke University,
Box 90300 Hudson Hall,
Durham, NC 27708
e-mail: kag70@duke.edu

Howard Levinson

Division of Plastic, Maxillofacial, and Oral Surgery,
Duke University Medical Center,
Durham, NC 27710;
Division of Surgical Sciences,
Department of Surgery and Pathology,
DUMC 3181,
Durham, NC 27710
e-mail: howard.levinson@duke.edu

1Corresponding author.

Manuscript received September 6, 2017; final manuscript received April 29, 2018; published online July 13, 2018. Assoc. Editor: Chris Rylander.

J. Med. Devices 12(3), 035001 (Jul 13, 2018) (9 pages) Paper No: MED-17-1303; doi: 10.1115/1.4040186 History: Received September 06, 2017; Revised April 29, 2018

Wide mesh or tape sutures are used to close high-tension wounds such as in hernia or tendon repair. However, wide sutures produce large knots that are susceptible to increased palpability, infection, and foreign body response. To prevent such adverse events, we developed a small suture anchor to replace wide suture knots. The suture anchor was iteratively developed using three-dimensional (3D) design software and produced via 3D printing. Anchor prototypes underwent monotonic, cyclic fatigue, and stress-life testing in a benchtop soft tissue suture model. Results were compared to a standard of care knot and alternative suture fixation devices. The final anchor design was selected based on minimal size and mechanical performance. The size of the final anchor (200 mm3) was 33% smaller than a tape suture knot and 68% smaller than a mesh suture knot. Monotonic testing of mesh and tape sutures revealed a significantly greater anchor failure load compared to knot and alternative fixations (p < 0.05). Additionally, all anchors successfully completed cyclic fatigue testing without failure while other fixations, including knot, failed to complete cyclic fatigue testing multiple times. Stress-life testing demonstrated durable anchor fixation under varying tensile stresses. Failure mode analysis revealed anchor fracture and tissue failure as modes of anchor failure, each of which occurred at supraphysiologic forces. We created a small suture anchor that significantly outperforms knot and alternative suture fixations in benchtop testing and addresses concerns of increased palpability, infection, and foreign body response from large suture knots.

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References

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Figures

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Fig. 1

Setup for monotonic, cyclic fatigue, and stress-life testing. Benchtop model for (a) monotonic and cyclic fatigue testing utilizing silicone and (b) stress-life testing using polycarbonate.

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Fig. 2

Mesh and tape suture fixation devices. Representations of how the anchor and each control fixation device were applied to mesh and tape suture for performance testing. (a) Anchor, (b) knot, (c) staple, (d) corkscrew, (e) tack, and (f) strap.

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Fig. 3

Prototype iteration and final anchor design. (a) Example of 3D design iterations of various anchor prototypes made using fusion360 software. (b) Anchor prototypes were produced by 3D printing using a Carbon 3D® printer. (c) The final anchor consists of two interlocking male/female components. The male component has two lateral locking projections and a single midline projection that provides primary suture fixation. The middle projection penetrates through large suture and joins into the female component. This enables suture fixation at the anchor–tissue interface. In addition to locking, the lateral projections provide secondary suture fixation in mesh sutures.

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Fig. 4

Anchor application to mesh and tape sutures. (a) and (b) demonstrate the application of the male component into mesh and tape sutures, respectively. (c) and (d) demonstrate the joining of the male and female components around the suture, creating the complete anchor fixation.

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Fig. 5

Size comparison. (a) Anchor height is 2.5 mm and length is 10 mm. (b) Anchor width is 8 mm. (c) Volume comparisons of QuikCord tape suture, innovative anchor, and mesh suture. The anchor size is 33% smaller than a tape suture knot and 68% smaller than a mesh suture knot.

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Fig. 6

Monotonic performance of fixation devices in mesh and tape suture. (a) In mesh sutures, the anchor had a significantly greater failure load (49±4 N) compared to knot (32±14 N), staple (14±3 N), corkscrew (12±8 N), tack (18±4 N), and strap (19±5 N) fixations (p < 0.05, n = 6). (b) In tape sutures, the anchor failure load (49±7 N) was significantly greater than knot (22±5 N), staple (13±6 N), corkscrew (11±11 N), tack (23±4 N), and strap (13±3 N) (p < 0.05, n = 6).

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Fig. 7

Cyclic fatigue testing of fixation devices in mesh and tape sutures. (a) In mesh sutures, the anchor (200 cycles) completed more cycles in comparison with knot (133), strap (134), tack (1), corkscrew (36), and staple (0) fixations (n = 6). (b) In tape sutures, the anchor (200 cycles) also completed more cycles in comparison with knot (103), strap (1), tack (57), corkscrew (69), and staple (0) fixations (n = 6). The anchor was the only fixation to complete cyclic testing in both suture types.

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Fig. 8

Failure mode analysis. (a) The primary modes of failure in mesh sutures were anchor fracture (50%) and tissue failure (50%) (n = 12). (b) In tape sutures, the only failure mode was anchor fracture (100%) as tissue failure, disassembly, and suture failure did not occur (n = 12). Each of these failure modes occurred at supraphysiologic (> 16 N/cm) forces.

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Fig. 9

Stress-life testing of anchor in tape sutures. The maximum stress amplitude was 50.3 N (corresponding to a sinusoidal load of 60.3–110.6 N) at which 12 cycles were completed. The minimum stress amplitude was 12.5 N (load 22.4 N to 34.9 N) at which the anchor life exceeded 100,000 cycles (n = 6).

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