High Strength Multi-layered Biomesh For Hernia MATSE

492W
Repair
LANCE MARX, KEITH OSTROWSKI, LU SONG, IAN MACDOWALL

Executive Summary Every year, over twenty million hernia repairs are performed worldwide. Nearly one third of
patients require secondary operations for hernia recurrence due to inferior mesh design. 1,3 Our proposed biologic will
decrease the infection and adhesion to organs compared to polymer meshes and yield an improved strength profile
compared to biologic meshes. The improved strength and histological response will yield a lower recurrence rate and
better post-surgical outcomes. We request $300,000 to make a working prototype of this mesh.hasdfaklsd fasllk
Technology Need_ Recurrence rates are nearly ⅓ in over one million hernia repairs in the United States, which is
attributed to poor fibrous ingrowth within mesh scaffolding, volatile histological response with synthetic components,
and separation of the mesh from the abdominal wall.2,1 To address the NAE Grand Challenge of building better
medicine, the developed prototype will supercede previous designs in functionality. A multilayered bovine acellular
matrix bordered with lock stitched poly (lactic-co-glycolic acid) (PLGA) and chain stitched with a removable
polypropylene center will ensure a macroporous structure that promotes fibrous ingrowth and reduces seroma
formation while simultaneously increasing resorption time to ensure mesh integrity. For every 1% of hernia recurrence
reduction, an estimated 3.2 million dollars can be saved. 4
Technical Goals _
Primary goal: Develop a multi-layered biologic hernia mesh using a resorbable lockstitch polymer border and
removable chain stitched polymer sewn throughout to improve tensile strength, porosity, and histological response.
This will be accomplished by completion of these three tasks:
1. Develop optimal methods for stitching polymers into the biologic mesh to maximize strength and porosity.
2. Determine optimal number of biologic layers to maximize cost efficiency without sacrificing strength.
3. Perform in vivo trials to evaluate the long-term histological response of the hernia mesh.
Technical Approach
Task 1. Optimize methodology for chain-stitching and lock stitching polymer into biologic for resorbable and
nonresorbable options. Machine optimization will include determining sewing machine size, sewing machine
operation in wet conditions, and minimizing sewing machine deterioration. Thread optimization will entail
configuring the ideal stitch length and thread radii to give maximum macroporosity to mesh strength.
Task 2. Design a biaxial tensile test for different directions to determine the strength of the multilayered biologic
matrix in accordance with ASTM standards to determine the optimal cost to layer ratio. 5
Task 3. Observe the long-term histological response and strength performance in an in-vivo model. A preliminary
animal study will be performed in a rabbit model (common model for hernia repair) and samples will be taken at the
1 month, 3 month, and 6 month mark to evaluate strength performance, tissue ingrowth, and possible adverse reaction
over time. Polymer resorption will be monitored over this time scale using suture testing.
Required Resources A proof of concept can be created with an initial investment of approximately $300,000 in 12
months of time. Funds will be allocated to sewing equipment including a Brother BAS-311HN-05A sewing machine,
bobbins, Polypropylene yarn, PGA yarn and needles. An Instron 3345 Single Column Tensile Tester will be purchased
to perform mechanical testing. Animal tissue will be sourced from a local abattoir, with total 12 month cost not to
exceed $100,000. One technician will be hired for sewing and one engineer hired for mechanical testing of prototypes
and analysis of gathered data ($100,000 for 6 months salary). A biologist will be hired to perform a histological study
in a rabbit model which will be the bulk of the cost of the project ($40,000 for 6 months salary and $40,000 for animal
study).
Deliverables A sewn biologic mesh prototype with increased porosity, increased tensile strength profile, and reduced
propensity for infection and adhesion to organs.

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2019 Materials Selection Competition
 High Strength Multi-layered Biomesh For Hernia MATSE
492W
Repair
LANCE MARX, KEITH OSTROWSKI, LU SONG, IAN MACDOWALL
References:
1. “Hernia Surgical Mesh Implants,” Hernia Surgical Mesh Implants – FDA. Web. 4 Feb. 2019.
<https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurg
icalMesh/default.htm>.
2. C. R. Deeken and S. P. Lake. “Mechanical Properties of the Abdominal Wall and Biomaterials Utilized for
Hernia Repair,” Journal of the Mechanical Behavior of Biomedical Materials. 74 411-427 (2017).
3. A. Kingsnorth and K. LeBlanc. “Hernias: Inguinal and Incisional,” Lancet Infect.Dis. 362 [9395] 1561-1571
(2003).
4. C. Horne and A. Prabhu. “Chapter 26: Recurrent Ventral Hernia Repair,” Page 359 in The SAGES Manual
of Hernia Surgery, Second Edition. Edited by S. S. Davis, Jr, G. Dakin, A. Bates.. Sages University, Los
Angelos, CA and Springer Publishing, New York City, NY, 2018
5. ASTM Standard D638, 2015, “Standard Test Method for Tensile Properties of Plastics,” ASTM
International, West Conshohocken, PA, 2015.

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2019 Materials Selection Competition