Comparison of a Novel Fixation Device With Standard Suturing Methods for Spinal Cord Stimulators

Authors


  • 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

  • Financial Support: R. Bowman and D. Caraway are paid consultants of Anulex Technologies, Inc. Testing and data analysis was conducted by I. Bentley, an Anulex Technologies, Inc. employee.

  • Offprints: Offprints should be sent to the attention of Ishmael Bentley.

  • Conflict of Interest: R. Bowman and D. Caraway are paid consultants of Anulex Technologies, Inc. I. Bentley is a full-time Anulex Technologies, Inc. employee.

Abstract

Introduction: Spinal cord stimulation is a well-established treatment for chronic neuropathic pain of the trunk or limbs. Currently, the standard method of fixation is to affix the leads of the neuromodulation device to soft tissue, fascia or ligament, through the use of manually tying general suture. A novel semiautomated device is proposed that may be advantageous to the current standard. Comparison testing in an excised caprine spine and simulated bench top model was performed.

Materials and Methods: Three tests were performed: 1) perpendicular pull from fascia of caprine spine; 2) axial pull from fascia of caprine spine; and 3) axial pull from Mylar film. Six samples of each configuration were tested for each scenario. Standard 2-0 Ethibond was compared with a novel semiautomated device (Anulex fiXate). Upon completion of testing statistical analysis was performed for each scenario.

Results: For perpendicular pull in the caprine spine, the failure load for standard suture was 8.95 lbs with a standard deviation of 1.39 whereas for fiXate the load was 15.93 lbs with a standard deviation of 2.09. For axial pull in the caprine spine, the failure load for standard suture was 6.79 lbs with a standard deviation of 1.55 whereas for fiXate the load was 12.31 lbs with a standard deviation of 4.26. For axial pull in Mylar film, the failure load for standard suture was 10.87 lbs with a standard deviation of 1.56 whereas for fiXate the load was 19.54 lbs with a standard deviation of 2.24.

Conclusions: These data suggest a novel semiautomated device offers a method of fixation that may be utilized in lieu of standard suturing methods as a means of securing neuromodulation devices. Data suggest the novel semiautomated device in fact may provide a more secure fixation than standard suturing methods.

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