St. Jude Medical 3046, Руководство для клиницистов

Страница: 8 / 20

Directions for Use
Carefully review the following suggested guidelines for implantation of percutaneous trial leads. If
implanting multiple leads, repeat the appropriate steps for each lead. For directions for use for
other system components not covered in this document, see the clinician’s manual for the
appropriate device.
Placing Percutaneous Leads
Percutaneous trial leads are designed for use during a trial implantation period not to exceed 30
days . They are designed for introduction into the dorsal epidural space using a special needle,
guide wire, and the optional Introde-AK™ lead introducer. Each lead is packaged with the
accessories required to place the lead percutaneously. See Appendix A (page 10) for
specifications.
The following are suggested guidelines for placing percutaneous leads. For these instructions, use
fluoroscopy as needed to assist in placing a device.
1.
Externally measure and determine the length of lead required to extend from the appropriate
spinal level to the predetermined location of the implanted IPG. The appropriate vertebral
level for needle entry should be identified and marked (see the following figure) to allow
approximately 20 cm (8 in) of the lead to lie in the epidural space. This will facilitate
stabilization of the lead and electrodes following implantation. Typical entry levels for lead
target sites include the following.
Figure 1. Suggested vertebral entry levels based on target sites
Lead Target Site Entry Level
T8-T9 T11-T12
T9-T10 T12-L1
T10-T11 L1-L2
T11-T12 L2-L3
T1-T2 T4-T6
C3-C5 T1-T3
C1-C2 C6-C7
CAUTION: Handle the lead with care. The lead can be damaged by mishandling,
such as sharp bending, kinking, applying excessive traction, or contact with sharp
instruments. Carefully examine each component upon removal from its sterile
container. A lead exhibiting signs of damage should not be used.
2.
After appropriate skin prepping, draping, and injection of local anesthetic, insert the epidural
needle. A paramedian approach is recommended, and the needle angle should not be
greater than 30° (see the following figures). Angles greater than 30° increase the risk of
damage to the lead during insertion and manipulation.
4