Minimally invasive method for implanting a sacral stimulation lead

• US 6,971,393 B1
• Filed: 11/15/2000
• Issued: 12/06/2005
• Est. Priority Date: 11/15/2000
• Status: Expired due to Term

• Current Assignee: Laura Mamo, Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Laura Mamo
• Inventors: Spinelli, Michele, Mamo, George
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H.
• Application Number:
  US09/713,598
• Time in Patent Office: 1,847 Days
• Field of Search: 128/898, 607/40, 607/41, 607/117, 607/126
• US Class Current: 128/898
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

Method embodiments to implant a stimulation lead in a patient'"'"'s sacrum to deliver neurostimulation therapy can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A method embodiment begins by inserting a needle posterior to the sacrum through an entry point. The needle is guided into a foramen along an insertion path to a desired location. The insertion path is dilated with a dilator to a diameter sufficient for inserting a stimulation lead. The needle is removed from the insertion path. The stimulation lead is inserted to the desired location. The dilator is removed from the insertion path. Additionally if the clinician desires to separately anchor the stimulation lead, an incision is created through the entry point from an epidermis to a fascia layer. The stimulation lead is anchored to the fascia layer. After the stimulation lead has been anchored, the incision can be closed, or the stimulation lead proximal end can be tunneled to where an implantable neurostimulator is located and then the incision can be closed. A implanted sacral stimulation lead can be connected to the neurostimulator to delivery therapies to treat pelvic floor disorders such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain.

Claims

1. A method for minimally invasive sacral stimulation lead implantation in a patient, comprising:

inserting a needle posterior to the sacrum through an entry point;

guiding the needle into a foramen along an insertion path to a desired location;

sensing a needle position in the patient by applying an electrical signal to the needle to evoke a patient response related to the needle position;

dilating the insertion path with a dilator to a diameter sufficient for inserting a stimulation lead;

removing the needle from the insertion path;

inserting the stimulation leads through the dilator to the desired location; and

removing the dilator from the insertion path.

2. A method for minimally invasive sacral stimulation lead implantation in a patient, comprising:

inserting a needle posterior to the sacrum through an entry point;

guiding the needle into a foramen along an insertion path to a desired location;

sensing a needle position in the patient by applying an electrical signal to the needle to evoke a patient response related to the needle position;

dilating the insertion path with a dilator to a diameter sufficient for inserting a stimulation lead;

removing the needle from the insertion path;

inserting the stimulation leads through the dilator to the desired location; and

removing the dilator from the insertion path; and

validating that the stimulation lead is placed in the desired position.