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4 Hernia Materials: Fundamentals of Prosthetic Characteristics

Table 4.4 (continued)

Diameter

Veritas Collagen

Diameter of

pores (mm)

Area of pores (mm

of bers

(μm)

)

n/a n/a n/a 0.80 n/a [64]

Thickness (mm)

Density (g/

)

References

Matrix XenMatrix

n/a n/a n/a 1.95 n/a [64] Surgical Graft

Physical characteristics vary widely between designs, and many designs have yet to be evaluated Terms of Use: This table is licensed under a Creative Commons Attribution 4.0 License (https://

creativecommons.org/licenses/by/4.0/) attributed to Corey Deeken and Spencer Lake. The original

version can be found here: https://doi.org/10.1016/j.jmbbm.2017.05.008. The content of the table is reprinted here without modication to the original work [4]

Table 4.5 Summary of the mechanical properties of a subset of available hernia repair materials derived from suture retention, tear resistance, ball burst, uniaxial, and planar biaxial testing

Suture retention (N)

Tear resistance (N)

Uniaxial tensile strength (MPa) References

L T L T L T

Permanent synthetic meshes Bare

Bard Mesh 50.78 66.8 46.84 38.36 11.64 0.16 [8, 14] Bard Soft Mesh [14] Dyna-Mesh [23] INFINIT 26.71 32.36 14.29 16.35 13.6 7.36 [8, 14, 23] Optilene Mesh [23] Parietex Flat Sheet 2D

51.4 58.38 32.66 28.6 6.63 15.51 [8]

Mesh (TEC) PROLENE Mesh 61.2 70.49 33.66 39.33 0.76 16.06 [8, 14] ProLite Mesh 48.75 57.71 33.35 33.10 11.64 0.16 [8, 14] ProLite Ultra Mesh 36.07 23.89 19.27 17.84 11.40 4.90 [8, 14] Surgipro [23]

Permanent barrier, noncomposite

DUALMESH

65.18 72.95 30.47 41.28 7.52 5.52 [7, 14]

Biomaterial

Permanent barrier, composite

Composix E/X 70.47 60.28 30.14 48.75 1.44 10.74 [7] Composix L/P 34.04 48.58 32.76 16.96 6.10 1.48 [7]

Resorbable barrier, composite

C-QUR Mesh 41.78 62.75 25.79 30.79 1.73 4.74 [7, 14] Parietex Composite

28.15 36.32 19.74 16.21 2.56 1.03 [7, 14]

(PCO) PHSIOMESH [14]

(continued)

C. R. Deeken and S. P. Lake

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Table 4.5 (continued)

Suture retention (N)

Tear resistance (N)

Uniaxial tensile strength (MPa) References

L T L T L T PROCEED 34.06 41.62 19.84 20.19 4.44 4.78 [ Sepramesh IP Composite 99.22 85.89 51.07 54.18 4.38 2.64 [ Ventralight ST [

Resorbable coating

C-QUR Lite Mesh

22.86 33.83 19.36 18.35 1.11 2.56 [

(≤6in.) C-QUR Lite Mesh

61.83 40.00 35.04 42.77 13.75 3.52 [8]

(>6in.)

Biological tissue-derived barrier

OviTex 1S ~60 [26] OviTex 2S ~75 [

Resorbable bers

ULTRAPRO 15.08 16. 10.47 5.07 13.52 0.08 [

Resorbable Synthetic Bare

BIO-A Tissue

~45 16.6 ~4.5 [22]

Reinforcement TIGR Matrix Surgical

~45 59.0 ~30 33.3 ~7 0.2 [22, 23]

Mesh VICRYL 39.4 ~25 145.2 [22] PHASIX Mesh 59.2 49.1 30.3 29.5 [

Biological tissue-derived Bare

AlloDerm Tissue Matrix 127.2 84.73 20.32 [64] AlloMax Surgical Graft 29.09 16.86 14.36 [ CollaMend Implant 47.90 17.13 11.48 [ CollaMend FM Implant 37.53 13.21 10.65 [ FlexHD Acellular Dermis 55.34 31.05 14.36 [ Peri-Guard Repair Patch 30.54 14.34 21.51 [ Permacol Surgical

23.75 10.1 8.22 [64]

Implant Strattice Reconstructive

63.76 27.54 9.92 [64]

Tissue Matrix SurgiMend Collagen

87.85 27.86 28.54 [

Matrix Surgisis/Biodesign

50.29 32.13 2.53 [64]

Hernia Grafts Veritas Collagen Matrix 23.92 15.06 9.38 [ XenMatrix Surgical Graft 99.74 24.5 11.95 [64]

Reinforced Permanent

bers

OviTex Reinforced

~42 [26]

BioScaffold with Permanent Polymer

7, 14] 7] 14]

26]

8, 14, 23]

18]

64] 64] 64] 64] 64]

64]

4 Hernia Materials: Fundamentals of Prosthetic Characteristics

Table 4.5 (continued)

Suture retention (N)

L T L T L T

Resorbable bers

Permanent synthetic meshes Bare

Bard Mesh 157.7 10.76 75.69 37.53 2.03 [8, 14] Bard Soft Mesh 124.53 52.89 2.36 [14] Dyna-Mesh 190.1 100.1 1.84 [23] INFINIT 9.25 n/a 168.40-

Optilene Mesh 191.1 100.1 1.82 [23] Parietex Flat Sheet 2D

Mesh (TEC) PROLENE Mesh 156.60 5.27 180.04 143.42 1.26 [8, 14] ProLite Mesh 138.00 9.61 106.19 82.97 1.29 [8, 14] ProLite Ultra Mesh 50.72 16.35 92.24 76.36 1.21 [8, 14] Surgipro 148.7 128.5 1.18 [23]

Permanent barrier, noncomposite

DUALMESH Biomaterial 97.76 10.24 137.59 125.97 1.08 [7, 14]

Permanent barrier, composite

Composix E/X 237.8 9.62 [7] Composix L/P 76.77 11.06 [7]

Resorbable barrier, composite

C-QUR Mesh 144.30 9.07 177.00 177.78 1.00 [7, 14] Parietex Composite (PCO) 38.87 6.46 178.13 119.34 1.50 [7, 14] PHSIOMESH 168.91 151.62 1.12 [14] PROCEED 52.60 7.25 129.72 128.34 1.01 [7, 14] Sepramesh IP Composite 200.7 3.68 [7] Ventralight ST 123.57 50.82 2.43 [14]

Resorbable coating

C-QUR Lite Mesh (≤6in.) 50.53 13.22 [8] C-QUR Lite Mesh (>6in.) 170.00 11.32 [8]

Biological tissue-derived barrier

OviTex 1S [26] OviTex 2S [26]

Resorbable bers

ULTRAPRO 35.50 16.23 98.63-

OviTex Reinforced BioScaffold with Resorbable Polymer

~42 [26]

Ball burst Planar biaxial tensile Tensile

strength (N/cm)

112.90 3.49 [8]

Tear resistance (N)

Strain (%)

Stiffness (N/cm)

479.1

171.2

Uniaxial tensile strength (MPa) References

Stiffness (N/cm)

119.83-

139.7

53.01-

79.6

Anisotropy index References

1.42-3.3 [8, 14, 23]

1.87-2.17 [8, 14, 23]

(continued)

C. R. Deeken and S. P. Lake

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Table 4.5

(continued)

Ball burst Planar biaxial tensile Tensile

strength (N/cm)

Strain (%)

Stiffness (N/cm)

Anisotropy index References

Resorbable synthetic Bare

BIO-A Tissue

74.9 7.3 [

Reinforcement TIGR Matrix Surgical

86.5 <10 409.2 272.4 1.47 [22, 23]

Mesh VICRYL ~70 5.8 [22] PHASIX Mesh 140.7 15.4 [

Biological tissue-derived Bare

AlloDerm Tissue Matrix 1028.00 17.02 [64] AlloMax Surgical Graft 290.80 26.22 [ CollaMend Implant 110.3 5.85 [ CollaMend FM Implant 86.18 13.58 [ FlexHD Acellular Dermis 929.50 21.20 [ Peri-Guard Repair Patch 99.05 20.05 [ Permacol Surgical Implant 66.23 13.1 [ Strattice Reconstructive

270.5 9.59 [

Tissue Matrix SurgiMend Collagen

432.4 6.41 [64]

Matrix Surgisis/Biodesign Hernia

200.2 13.57 [64]

Grafts Veritas Collagen Matrix 128.6 25.6 [ XenMatrix Surgical Graft 377.0 11.59 [

Reinforced Permanent

bers

OviTex Reinforced

[26]

BioScaffold with Permanent Polymer

Resorbable bers

OviTex Reinforced

[26]

BioScaffold with Resorbable Polymer

22]

18]

64] 64] 64] 64] 64] 64] 64]

64] 64]

Many current mesh materials meet or exceed the threshold mechanical strength values previously recommended by our group, but it remains unclear whether these characteristics represent the optimal match to the nuanced and complex mechanical properties of the human abdominal wall Terms of Use: This table is licensed under a Creative Commons Attribution 4.0 License (https://

creativecommons.org/licenses/by/4.0/) attributed to Corey Deeken and Spencer Lake. The original

version can be found here: https://doi.org/10.1016/j.jmbbm.2017.05.008. The content of the table is reprinted here without modication to the original work [4]

4 Hernia Materials: Fundamentals of Prosthetic Characteristics

anisotropy, nonlinearity, and hysteresis [14]. Guidelines for these parameters have not yet been established, and studies in this area represent the next signicant advancement in understanding and optimizing the mechanical match of hernia repair materials to repair-site tissue. Additionally, direct comparisons across studies are limited due to differences in specimen dimensions/orientation, testing rate, and equipment setup, as well as differences in data analysis and reporting. While it is clear that many current mesh materials meet or exceed the threshold values previously recommended by our group—suture retention and tear resistance strength >20 N, ball burst strength >50 N/cm, and strain in the range of 10–30%—it is unclear whether these characteristics represent the optimal match to the nuanced and complex mechanical properties of the human abdominal wall. Furthermore, mechanics of human tissue are likely to vary with patient demographics (i.e., age, gender, BMI) and clinical state (i.e., healthy, brotic, herniated), thereby increasing the challenge of matching mesh mechanical properties to specic properties of individual patients.

Many factors such as mesh-defect overlap [42–45], surgical technique (e.g., closure of the anterior myofascial layer) [42–45], xation strategy [45, 46], and wound healing/inammatory response [47–50] have been identied as factors impacting the success of a particular hernia repair, yet, the impact of a mechanical match between the implanted device and the properties of the human abdominal wall is nearly devoid of research. We have previously presented a comprehensive review of the anatomy and mechanics of both animal and human abdominal wall tissues in an effort to understand the potential mismatch of mechanical properties between tissues and biomaterials [4]. A full discussion is outside the scope of the current chapter; however, a few key points are summarized here. When human abdominal tissues were tested in a longitudinal (i.e., cranial-caudal) orientation, the linea alba exhibited greater compliance [51], the intact abdominal wall exhibited greater strain [16], and the rectus sheath and umbilical fascia both exhibited greater stiffness compared to tissues tested in a transverse (i.e., medial-lateral) orientation [52–57]. When tested in the transverse orientation, the linea alba sustained greater stresses than the longitudinal orientation [52, 58, 59]. Taken together, these ndings suggest that meshes should be oriented in the body with the most compliant axis in the longitudinal orientation and the strongest axis in the transverse orientation. As mentioned previously, the impact of mismatched anisotropy is currently unknown, but it cannot be ignored that anisotropy ratios of 8–9 have been reported for human abdominal wall tissues [60] compared to values of 1–3 reported for many biomaterials [4, 14]. This represents an area of potential mechanical mismatch between mesh and tissue which should be explored in future studies. Studies have also shown that tissues such as linea alba [52, 58–60], rectus sheath [53, 54, 61], and the intact abdomen [16, 62, 63] exhibit many differences in mechanical properties, suggesting that implantation location may also play a key role in the success or failure of a biomaterial. In summary, the mechanical characteristics of both the human abdominal wall and hernia biomaterials are incompletely understood, and additional studies are warranted to establish guidelines for the ideal characteristics of these biomaterials, such as anisotropy, compliance, strength, and hysteresis.

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Conclusions

C. R. Deeken and S. P. Lake

Hernia repair materials have advanced over the past 80years to include over 150

designs at present. The structural scaffold element of these biomaterials includes

permanent synthetic polymers, resorbable polymers, and biological tissue-

derived materials, and various designs also contain coatings, barrier layers, or

reinforcing materials. Physical characteristics such as pore size/lament diame-

ter, thickness, and area density vary widely between designs and have previously

been classied along a continuum of increasing material to provide insight into

the amount of material in a given design. Although many current mesh materials

meet or exceed the threshold mechanical strength values previously recom-

mended by our group, it is unclear whether these characteristics represent the

optimal match to the nuanced and complex mechanical properties of the human

abdominal wall. It is unlikely that any single biomaterial design encompasses all

of the ideal physical and mechanical characteristics required to fully match the

properties of the human abdominal wall. A complete set of guidelines, including

strength, compliance, anisotropy, nonlinearity, and hysteresis should be estab-

lished through continued testing of human abdominal wall tissue specimens and

sophisticated modeling efforts.

Disclosures Dr. Deeken is an employee of, and Dr. Lake is a consultant for, Covalent Bio, LLC

(St. Louis, MO). The preparation of this work was supported by funding from Colorado Therapeutics LLC (Broomeld, CO), C.R. Bard, Inc./Davol (Warwick, RI), Johnson & Johnson Medical GmbH (Norderstedt, Germany), and TELA Bio (Malvern, PA).

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4 Hernia Materials: Fundamentals ofProsthetic Characteristics

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Permanent Prosthetics: Polypropylene,

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

Polyester, ePTFE, andHybrid Mesh

SeanB.Orenstein

Introduction

While primary suture repair remains an option for select hernias, mesh prosthetics have shown to greatly reduce the incidence of hernia recurrence [1, 2]. Because of this signicant benet, the vast majority of modern hernia repairs utilize some form of mesh reinforcement. Surgeons strive to nd and utilize the “ideal” mesh. Up until relatively recently, little has changed over the last half century with regard to the evolution of mesh. Dr. Francis Usher popularized the use of polypropylene mesh in the 1950s, [3] while Dr. René Stoppa and Dr. Jean Rives published their use of polyester meshes in the 1980s, among other great surgeons using various mesh prosthetics [4]. Currently, polypropylene and polyester remain the most commonly utilized materials in modern meshes, with a reduction in the use of expanded polytetrauorethylene (ePTFE). Newer synthetic materials have been developed, including polyvinylidene uoride (PVDF); however, long-term data is still being accrued. A variety of composite and hybrid meshes have also been developed that share characteristics of different materials to aid in mesh integration, impede adhesion formation, and/or provide some degree of resorption.

Mesh prosthetics strengthen hernia repairs and reduce hernia recurrences via two principal mechanisms: structural support and as a scaffold for ingrowth. The rst mechanism is obvious—the mesh acts as a physical barrier to prevent herniation of contents. But, it also acts as a load-bearing structure, taking tension off the hernia upon fascial closure. Additional strength of the repair is aided by cellular ingrowth within the mesh. By allowing an inux of cellular components, the mesh facilitates broblast proliferation with neovascularization, followed by brotic scar formation, thus assisting with mesh incorporation and overall strength of the repair. While this

S. B. Orenstein Division of Gastrointestinal and General Surgery, Department of Surgery, Oregon Health and Science University, Portland, OR, USA e-mail: orenstei@ohsu.edu

https://doi.org/10.1007/978-3-319-78411-3_5

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