Neuromodulation: Technology at the Neural Interface Received: February 24, 2014

Revised: April 21, 2014

Accepted: May 23, 2014

(onlinelibrary.wiley.com) DOI: 10.1111/ner.12224

Novel Tunneling System for Implantation of Percutaneous Nerve Field Stimulator Electrodes: A Technical Note Andrew Shaw, MD; Ahmed Mohyeldin, MD, PhD; Zion Zibly, MD; Daniel Ikeda, MD; Milind Deogaonkar, MD Introduction: The field of neuromodulation continues to grow, especially in the area of pain management. Percutaneous nerve field stimulation continues to gain significant popularity for chronic, focal, and intractable neuropathic pain. Materials and Methods: Tuohy needles have been traditionally used as the instrument of choice for subcutaneous implantation of peripheral field stimulators. The ON-Q® Tunneling System (Braun Melsungen AG, Melsungen, Germany) provides an adaptable option for subcutaneous implantation of electrodes, with a variety of lengths and gauges available. This system uses a disposable blunt needle and a peel-away sheath and is firm but malleable. Gentle curves can be applied to the stylet prior to implantation. The blunt, malleable nature of the needle and the soft Silastic sheath allow for applications in areas with greater curvature, such as the face, and ensure a subcutaneous placement. Conclusions: The great adaptability of this system allows for implantation of electrodes subcutaneously with efficacy and ease. Here we present a technical note on the use of this system for subcutaneous implantation of peripheral nerve field stimulators. Keywords: Neuromodulation, ON-Q needle, peripheral field stimulation, tunneler Conflict of Interest: Dr. Deogaonkar serves as a consultant for Medtronic, Inc., and has IP with Autonomic Technologies, Inc. The remaining authors declare no conflicts of interest. No financial support was received for this study.

INTRODUCTION

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MATERIALS AND METHODS Tuohy needles were used exclusively at our institution for the placement of peripheral field stimulators until 2012, when the ON-Q Tunneling System was introduced. Since that time, every peripheral nerve, occipital nerve, supraorbital/infraorbital nerve, genitofemoral nerve, and field stimulator implantation has used

Address corresponding to: Milind Deogaonkar, MBBS, 410 W 10th Avenue, Columbus, OH 43210, USA. Email: [email protected] Center for Neuromodulation, Department of Neurological Surgery, Ohio State University Wexner Medical Center, Columbus, OH, USA For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http:// www.wiley.com/bw/submit.asp?ref=1094-7159&site=1

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The application of neuromodulation to the treatment of chronic pain continues to evolve, with increasing utility for previously refractory neuropathic pain syndromes. Patients with severe neuropathic pain are typically trialed with numerous treatment modalities, including narcotics, anticonvulsants, antidepressants, nerve blocks, and destructive procedures, often with limited benefits (1–9). Peripheral nerve field stimulation has been used for the treatment of refractory, focal, chronic pain conditions (1–10). The exact mechanism of pain relief from peripheral field stimulation has not been completely elucidated (2,11). To date, in the published literature, standard percutaneous implantation of subcutaneous cylindrical electrodes has been reported using slightly curved 14–15-gauge Tuohy needles (Fig. 1) (1–9). Historically, field stimulators were placed in an open fashion with associated significant complications and poor efficacy (12,13). Subcutaneous implantation started with tunneling utilizing a curved hemostat (2). Since that time several percutaneous techniques have evolved, including curved Tuohy needles, IV catheters (Abbocath, Abbott, Dublin, Ireland), and the Epimed Coudé (Lubbock, TX, USA) (14,15). The Coudé has been chosen by some implanters, as it allows for improved steering and test stimulation prior to lead implantation (15). However, Tuohy needles continue to be commonly used for the implantation of peripheral nerve stimulator electrodes. These needles are hollow hypodermic needles that may vary in length or gauge. They are frequently used to insert epidural catheters or intradural catheters. With the application of spinal cord stimulator tech-

nology to peripheral field stimulation, Tuohy needles were initially chosen for subcutaneous implantation, as they are of sufficient gauge for electrodes to pass through them. The ON-Q® (Braun Melsungen AG, Melsungen, Germany) Pain Relief System and ON-Q Tunneling System have been used to deliver local anesthesia to provide improved postoperative pain relief from orthopedics to cardiothoracic surgery (16,17). To our knowledge, the application of the ON-Q Tunneling System has not yet been reported as a technique in neuromodulation literature.

SHAW ET AL. a

b

Figure 2. Intraoperative demonstration of ON-Q® Tunneling System being utilized for placement of a supraorbital nerve stimulator.

c

d

Figure 1. ON-Q® Tunneling System with its components compared to a Tuohy needle. a. The ON-Q stylet with an external sheath. b. ON-Q with gentle curve applied to its stylet. c. The ON-Q® needle is malleable, allowing for multiple curves to be applied to the blunt needle, which allows for the tunnelers to follow the natural curvature of the body. d. Tuohy needle (14-gauge).

this tunneling system exclusively. The ON-Q Tunneling System comes as a sterile disposable blunt needle with two peel-away sheaths (Fig. 1a). The ON-Q needles come in a variety of gauges, with the 17-gauge version used exclusively for the peripheral nerve stimulators, as it can accommodate a cylindrical electrode. Further, there are a variety of available lengths, including 3.25″, 5″, 8″, and 12″ to choose from, which can be tailored to the region of interest.

may be applied (Fig. 1b) to follow the contour of the body. The blunt tip is then placed in the subcutaneous tissue, allowing adequate depth to be in the subcutaneous plane while avoiding superficial implantation (Fig. 2). One indicator of the right subcutaneous plane is if the skin can be easily lifted with the tip and there is no dimpling or puckering seen on the skin through the course of the tunneler. With the index and middle finger stabilizing the base of the tunneler, the opposite hand is used to guide the course of the needle subcutaneously. The tip of the tunneler serves as a marker for where the end of the cylindrical electrode will be. After the tunneler crosses the preoperatively demarcated region of pain (so as to allow coverage with the selected electrode), the inner stylet with the base can be withdrawn, leaving a disposable Silastic peel-away sheath in place. If another stimulator is desired, the above procedure can be repeated with a new sheath and the same stylet (Fig. 3a,b). Once the electrodes are confirmed to be in the appropriate location via test stimulation, intraoperative fluoroscopy, or ultrasound, the sheath can be withdrawn, followed by the electrode stylet (Fig. 3c–f ) (15). The same sheaths and stylets can be used again to place multiple electrodes. Alternatively, the peel-away sheath can be separated while maintaining good tactile and visual identification of the subcutaneous electrode to avoid lead migration. At this point, the electrode can be secured for either permanent or temporary trial implantation using 2-0 silk sutures. These tunnelers can then be used again for tunneling to the implantable pulse generator (IPG) if desired. In the case of permanent implantation, a slightly larger incision is made to create a small pocket and relief loop at the site of insertion. The lead is then secured to surrounding tissue (fascia or otherwise depending on location) with a 2-0 silk suture. The lead is then tunneled to the IPG with a shunt passer or the ON-Q needle.

TECHNIQUE OF INSERTION

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When using the ON-Q Tunneling System, the region of pain is demarcated preoperatively with a skin marker. The area of interest should be prepared and draped in the usual sterile fashion. For percutaneous implantation, a stab incision with an 11″ or 15″ blade is made to pass through the dermis to the subcutaneous tissue. Depending on the region of desired stimulation, curves to the needle www.neuromodulationjournal.com

DISCUSSION Tuohy needles are hollow hypodermic needles that are typically used for placement of epidural catheters, epidural electrodes, or intradural catheters. There is a stylet that can be removed and an electrode can be passed through the 14–15-gauge hollow needle.

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ON-Q TUNNELING SYSTEM FOR PNS a

b

c

d

e

f

Figure 3. Example of ON-Q® Tunneling System applied to peripheral field stimulation trial for lower back pain. a. A single stylet used to place multiple sheaths. b. Multiple sheaths in place after stylet removal. c,d. Multiple electrodes were passed through the sheaths to the region of desired stimulation. e. Sheaths and electrode stylets removed and anchoring/securing sutures placed. f. Final appearance of a peripheral field stimulator trial using multiple electrodes following securing sutures and sterile dressing application.

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The ON-Q needle has a blunt inner stylet that, when removed, leaves a soft Silastic sheath in place. Other tunnelers, including Tuohy needles and the Epimed Coudé, leave a pointed instrument in place during the electrode placement. Intravenous cannulas have also been used for electrode placement and require passing a sharp needle prior to leaving a softer cannula. These concerns limit their applicability in certain locations such as the face, trunk, and extremities. The sharp tip carries the risk of superficial implantation from crossing tissue planes and distal skin perforation. In addition, lead shearing may occur if further manipulations are required prior to permanent implantation. These complications may require reoperation for repositioning or may limit therapeutic utility with the inability to use the most distal contacts. The ON-Q needle is the portion of the tunneler that is removed, leaving a soft Silastic sheath in place during performance of further tunneling, implanting, or manipulations. The ON-Q also has the advantage of a rounded blunt tip on the inner stylet. Not only can the needle be conformed to the natural curvature of the body, but it is less likely to produce a distal puncture through the skin or cross tissue planes. Finally, the same blunt needle can be used to pass more than one sheath in the event multiple leads are planned for field

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Tuohy needles have acquired new applications and serve as the standard for subcutaneous implantation of peripheral nerve field stimulators (1–10). Minor modifications have been made to the traditional Tuohy needle by industry, with gentle bends and longer lengths available to facilitate implantation of electrodes in extraspinal locations. In spite of these, the sharp ends of Tuohy needles tend to exit the subcutaneous plane too close to either muscles or skin, giving less than optimal stimulation. In addition, metal stylets are hard to remove from the bent Tuohy needles. The ON-Q Tunneling system has many advantages over both traditional and modified Tuohy needles. The ON-Q needle is firm but malleable and comes with two disposable Silastic sheaths (Fig. 1d). The malleable nature of the needle allows for the tunneler to be shaped to pass along the natural curvature of particular body parts, including the face and thorax. With a Tuohy needle there is only a very slight bend that can be applied prior to the point where removal of the stylet becomes extremely difficult. Modifications to the traditional Tuohy needle have been made to allow for cranial applications. However, peripheral nerve field stimulation remains limited by the implanter’s ability to adapt this needle to other extraspinal locations.

SHAW ET AL. stimulation (Fig. 3c–f ). The availability of multiple options allows for adaptability to the desired clinical application, from the foot to the occiput. This tunneling system provides another tool in the armamentarium of implanters to expand applications of neuromodulation to other body parts.

CONCLUSION Tuohy needles have long been the standard instrument for the percutaneous implantation of subcutaneous electrodes for peripheral nerve field stimulation. The ON-Q Tunneling System provides a safe, effective, and dynamic tool to allow for greater adaptability to the ever-growing list of potential applications of field stimulators in neuromodulation.

Authorship Statement Dr. Shaw drafted and prepared the manuscript for submission. Dr. Mohyeldin created the figures and assisted in drafting the manuscript. Dr. Deogaonkar provided intellectual input and assisted in drafting the manuscript. Drs. Zilby and Ikeda assisted in drafting the manuscript.

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How to Cite this Article: Shaw A., Mohyeldin A., Zibly Z., Ikeda D., Deogaonkar M. 2015. Novel Tunneling System for Implantation of Percutaneous Nerve Field Stimulator Electrodes: A Technical Note. Neuromodulation 2015; 18: 313–316

REFERENCES 1. Oh MY, Ortega J, Bellotte JB, Whiting DM, Alo K. Peripheral nerve stimulation for the treatment of occipital neuralgia and transformed migraine using a c1-2-3 subcutaneous paddle style electrode: a technical report. Neuromodulation 2004;7:103–112. 2. Slavin KV, Wess C. Trigeminal branch stimulation for intractable neuropathic pain: technical note. Neuromodulation 2005;8:7–13. 3. Johnstone CS, Sundaraj R. Occipital nerve stimulation for the treatment of occipital neuralgia: eight case studies. Neuromodulation 2006;9:41–47. 4. Dunteman E. Peripheral nerve stimulation for unremitting ophthalmic postherpetic neuralgia. Neuromodulation 2002;5:32–37. 5. Weiner RL, Reed KL. Peripheral neurostimulation for control of intractable occipital neuralgia. Neuromodulation 1999;2:217–221.

COMMENT Peripheral Nerve filed Stimulation (PNfS) is gradually becoming accepted as an adjunct technique for stimulation. Because of a lack of FDA approval, there has been no work on the part of the three major SCS companies in developing tool-sets that are specific to PNfS. The ON-Q device certainly lends itself to the placement of PNfS leads and has been used for years by many. If the FDA deems the approach safe for human use in the US, I would expect and hope great interest arises not only in the development of deployment systems which ensure reproducibly positive results, but also leads specifically designed for the purpose of stimulation of the peripheral field. William Porter McRoberts, MD Fort Lauderdale, FL, USA

Comments not included in the Early View version of this paper.

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© 2014 International Neuromodulation Society

Neuromodulation 2015; 18: 313–316

Novel tunneling system for implantation of percutaneous nerve field stimulator electrodes: a technical note.

The field of neuromodulation continues to grow, especially in the area of pain management. Percutaneous nerve field stimulation continues to gain sign...
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