Suboptimal nerve end alignment achieved with conventional nerve repair techniques may contribute to poor clinical outcomes. In this study, we introduce Nerve Tape®, a novel nerve repair device that integrates flexible columns of Nitinol microhooks within a biologic backing to entubulate, align, and secure approximated nerve ends. This study compares the repair strength of Nerve Tape with that of conventional microsuture repairs. Thirty small (2 mm) and 30 large (7 mm) diameter human cadaveric nerves were transected and repaired utilizing Nerve Tape or appropriate microsuture technique. Biomechanical testing was performed using a horizontal tensile tester. The repaired nerves were loaded until failure at a distraction rate of 40 mm/min, and the maximum failure load was determined. In the small nerve groups, the load-to-failure for Nerve Tape repairs (2.33 ± 0.66 N) was significantly higher than for suture repairs (1.22 ± 0.52 N; p < 0.05). In the large nerve groups, no significant difference in load-to-failure was found between Nerve Tape (7.45 ± 2.66 N) and suture repairs (5.82 ± 1.59 N: p = 0.12). Suture repairs tended to fail by rupture, whereas Nerve Tape failures resulted from microhook pullout. Nerve Tape is a novel nerve coaptation device that provides mechanical repair strength equal or greater to clinically relevant microsuture repairs.
Impact statement
Peripheral nerve injuries are common and result in devastating functional outcomes. Despite being the established standard of care, microsurgical suture repair is often inconsistent and functional outcomes are suboptimal, leaving long-term deficits. In this study, we have designed a novel nerve coaptation device, Nerve Tape, to provide a simple sutureless solution. Through biomechanical testing, we show that the holding strength of Nerve Tape repairs is comparable with that of microsuture repairs. This study represents one step in establishing Nerve Tape's ease of use and efficacy in peripheral nerve repair.
Get full access to this article
View all access options for this article.
References
1.
SecerHI, DaneyemezM, GonulE, et al.Surgical repair of ulnar nerve lesions caused by gunshot and shrapnel: Results in 407 lesions. J Neurosurg, 2007;107(4):776–783; doi:10.3171/JNS-07/10/0776.
SakellaridesH. A follow-up study of 172 peripheral nerve injuries in the upper extremity in civilians. J Bone Joint Surg Am, 1962;44-A:140–148. PMID: 14038909.
4.
JongenSJ, Van TwiskR. Results of primary repair of ulnar and median nerve injuries at the wrist: An evaluation of sensibility and motor recovery. Neth J Surg, 1988;40(3):86–89. PMID: 3405445.
5.
RuijsAC, JaquetJB, KalmijnS, et al. Median and ulnar nerve injuries: A meta-analysis of predictors of motor and sensory recovery after modern microsurgical nerve repair. Plast Reconstr Surg 2005;116(2):484–494; discussion 495–496; doi: 10.1097/01.prs.0000172896.86594.07.
6.
WhitlockEL, KasukurthiR, YanY, et al. Fibrin glue mitigates the learning curve of microneurosurgical repair. Microsurgery 2010;30(3):218–222; doi:10.1002/micr.20754.
7.
IsaacsJ, SafaB, EvansPJ, et al. Technical Assessment of Connector-Assisted Nerve Repair. J Hand Surg Am 2016;41(7):760–766; doi:10.1016/j.jhsa.2016.04.015.
8.
BernsteinDT, HamiltonKL, FoyC, et al. Comparison of magnification in primary digital nerve repair: Literature review, survey of practice trends, and assessment of 90 cadaveric repairs. J Hand Surg Am 2013;38(11):2144–2150; doi:10.1016/j.jhsa.2013.04.010.
9.
LevinthalR, BrownWJ, RandRW. Comparison of fascicular, interfascicular and epineural suture techniques in the repair of simple nerve lacerations. J Neurosurg 1977;47(5):744–750; doi:10.3171/jns.1977.47.5.0744.
10.
SchmidhammerR, ZandiehS, HopfR, et al. Alleviated tension at the repair site enhances functional regeneration: The effect of full range of motion mobilization on the regeneration of peripheral nerves—histologic, electrophysiologic, and functional results in a rat model. J Trauma 2004;56(3):571–584; doi: 10.1097/01.ta.0000114082.19295.e6.
11.
KechelePR, BertelliJA, DalmarcoEM, et al. The mesh repair: Tension free alternative on dealing with nerve gaps-experimental results. Microsurgery 2011;31(7):551–558; doi:10.1002/micr.20902.
12.
BertelliJA, KechelePR, GhizoniMF, et al. Mesh epineurial splinting for late median nerve repair in older patients: A preliminary report. Microsurgery 2011;31(6):441–447; doi:10.1002/micr.20891.
13.
S. S. The pros and cons of funicular nerve repair. J Hand Surg 1979;4(3):201–211; doi.org/10.1016/S0363-5023(79)80155-0.
14.
MathieuL, AdamC, LegagneuxJ, et al. Reduction of neural scarring after peripheral nerve suture: An experimental study about collagen membrane and autologous vein wrapping. Chir Main 2012;31(6):311–317; doi:10.1016/j.main.2012.10.167.
15.
PrevelCD, EppleyBL, McCartyM, et al. Mechanical anastomosis of nerves: A histological and functional comparison to conventional suturing. Ann Plast Surg 1994;33(6):600–605; doi: 10.1097/00000637-199412000-00006.
16.
OwusuA, MayedaB, IsaacsJ. Surgeon perspectives on alternative nerve repair techniques. Hand (N Y) 2014;9(1):29–35; doi:10.1007/s11552-013-9569-7.
17.
MaraghH, MeyerBS, DavenportD, et al. Morphofunctional evaluation of fibrin glue versus microsuture nerve repairs. J Reconstr Microsurg 1990;6(4):331–337; doi:10.1055/s-2007-1006838.
18.
TempleCL, RossDC, DunningCE, et al. Resistance to disruption and gapping of peripheral nerve repairs: An in vitro biomechanical assessment of techniques. J Reconstr Microsurg 2004;20(8):645–650; doi:10.1055/s-2004-861525.
19.
CruzNI, DebsN, FiolRE. Evaluation of fibrin glue in rat sciatic nerve repairs. Plast Reconstr Surg 1986;78(3):369–373; doi: 10.1097/00006534-198609000-00015.
20.
SamesM, BlahosJJr., RokytaR, et al.Comparison of microsurgical suture with fibrin glue connection of the sciatic nerve in rabbits. Physiol Res, 1997;46(4):303–306. PMID: 9728497.
21.
MoyOJ, PeimerCA, KoniuchMP, et al. Fibrin seal adhesive versus nonabsorbable microsuture in peripheral nerve repair. J Hand Surg Am 1988;13(2):273–278; doi: 10.1016/s0363-5023(88)80063-7.
22.
FreytesDO, BadylakSF, WebsterTJ, et al. Biaxial strength of multilaminated extracellular matrix scaffolds. Biomaterials 2004;25(12):2353–2361; doi:10.1016/j.biomaterials.2003.09.015.
23.
IsaacsJ. Major peripheral nerve injuries. Hand Clin 2013;29(3):371–382; doi:10.1016/j.hcl.2013.04.006.
24.
DucicI, SafaB, DeVinneyE. Refinements of nerve repair with connector-assisted coaptation. Microsurgery 2017;37(3):256–263; doi:10.1002/micr.30151.
25.
KokkalisZT, PuC, SmallGA, et al. Assessment of processed porcine extracellular matrix as a protective barrier in a rabbit nerve wrap model. J Reconstr Microsurg 2011;27(1):19–28; doi:10.1055/s-0030-1267379.
26.
ShabalovskayaSA. On the nature of the biocompatibility and on medical applications of NiTi shape memory and superelastic alloys. Biomed Mater Eng, 1996;6(4):267–289. PMID: 8980835.
27.
ShabalovskayaSA. Surface, corrosion and biocompatibility aspects of Nitinol as an implant material. Biomed Mater Eng, 2002;12(1):69–109. PMID: 11847410.
28.
ReinaMA, LopezA, De AndresJA. [Adipose tissue within peripheral nerves. Study of the human sciatic nerve]. Rev Esp Anestesiol Reanim, 2002;49(8):397–402. PMID: 12455319.
29.
ReinaMA, ArriazuR, CollierCB, et al. Electron microscopy of human peripheral nerves of clinical relevance to the practice of nerve blocks. A structural and ultrastructural review based on original experimental and laboratory data. Rev Esp Anestesiol Reanim 2013;60(10):552–562; doi:10.1016/j.redar.2013.06.006.
30.
SunderlandS. The connective tissues of peripheral nerves. Brain 1965;88(4):841–854; doi:10.1093/brain/88.4.841.
31.
VisserLH, JainS, LokeshB, et al. Morphological changes of the epineurium in leprosy: A new finding detected by high-resolution sonography. Muscle Nerve 2012;46(1):38–41; doi:10.1002/mus.23269.
32.
SelanderD, SjostrandJ. Longitudinal spread of intraneurally injected local anesthetics. An experimental study of the initial neural distribution following intraneural injections. Acta Anaesthesiol Scand 1978;22(6):622–634; doi:10.1111/j.1399-6576.1978.tb01346.x.
33.
RydevikBL, KwanMK, MyersRR, et al. An in vitro mechanical and histological study of acute stretching on rabbit tibial nerve. J Orthop Res 1990;8(5):694–701; doi:10.1002/jor.1100080511.
34.
TillettRL, AfokeA, HallSM, et al. Investigating mechanical behaviour at a core-sheath interface in peripheral nerve. J Peripher Nerv Syst 2004;9(4):255–262; doi:10.1111/j.1085-9489.2004.09411.x.
35.
SunderlandIR, BrennerMJ, SinghamJ, et al. Effect of tension on nerve regeneration in rat sciatic nerve transection model. Ann Plast Surg 2004;53(4):382–387; doi: 10.1097/01.sap.0000125502.63302.47.
36.
RinkerB, VyasKS. Clinical applications of autografts, conduits, and allografts in repair of nerve defects in the hand: Current guidelines. Clin Plast Surg 2014;41(3):533–550; doi:10.1016/j.cps.2014.03.006.
37.
McDonaldDS, BellMS. Peripheral nerve gap repair facilitated by a dynamic tension device. Can J Plast Surg, 2010;18(1):e17–e19. PMID: 21358863; PMCID: PMC2851462.
38.
MathieuL, AddasBMJ, IrimuraSC, et al. Management of sciatic nerve defects: Lessons learned and proposal for a new strategy. Ann Plast Surg 2019;84(5):559–564; doi:10.1097/SAP.0000000000002233. PMID: 31855866.
39.
HentzVR, RosenJM, XiaoSJ, et al. The nerve gap dilemma: A comparison of nerves repaired end to end under tension with nerve grafts in a primate model. J Hand Surg Am 1993;18(3):417–425; doi:10.1016/0363-5023(93)90084-G.
40.
LundborgG, RosenB, DahlinL, et al. Tubular repair of the median or ulnar nerve in the human forearm: A 5-year follow-up. J Hand Surg Br 2004;29(2):100–107; doi:10.1016/j.jhsb.2003.09.018.
41.
BoeckstynsME, SorensenAI, VinetaJF, et al. Collagen conduit versus microsurgical neurorrhaphy: 2-year follow-up of a prospective, blinded clinical and electrophysiological multicenter randomized, controlled trial. J Hand Surg Am 2013;38(12):2405–2411; doi:10.1016/j.jhsa.2013.09.038.
