Minimally invasive surgical techniques for implanting devices that deliver stimulant to the nervous system

• US 6,360,750 B1
• Filed: 01/21/2000
• Issued: 03/26/2002
• Est. Priority Date: 04/29/1999
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin Theodore, Sherman, Michael C.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Koh, Choon P.
• Application Number:
  US09/489,544
• Time in Patent Office: 795 Days
• Field of Search: 128/898, 623/902, 600/235, 600/377, 600/104, 600/135, 600/201, 600/207, 604/891.1, 607/41, 607/115-118
• US Class Current: 128/898
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: Y10S 623/902 Method of implanting

Abstract

Devices are currently implanted in patients to treat pain and other conditions including incontinence by delivering stimulants to the nervous system. Surgical methods are improved for implanting the devices. The soft tissues of the body are dilated above the site of device implantation, for example, above the sacrum, to create an annulus of dilated soft tissues. The tissues are dilated by introducing into the soft tissue sequentially larger cannulated dilating devices. A tubular retractor is then passed over the largest introduced dilating device and at least a number of the dilating devices are retracted. This establishes a tubular device insertion corridor through the dilated soft tissues to the site of implantation, for example, the foramen of the sacrum. The device to be implanted, such as an electrical lead, is then inserted through the corridor. The device is tested in situ. Finally, such other method steps are performed, including closing the corridor, as implantation requires. As preferred, when establishing a corridor through the tissues, a corridor is established sufficient in size for insertion of an endoscope; and the endoscope is inserted and utilized for visual imaging as needed. Also as preferred, the nervous system of the body is tested for appropriate reaction to the stimulant through insertion and manipulation of testing implements through the corridor before performing other method steps. As further preferred, the device to be implanted is anchored through insertion and manipulation of anchoring implements through the corridor. The device is also connected to associated equipment, such as an implantable pulse generator, by tunneling through the soft tissues and passing an extension, a cable, from the lead to the site of implantation of the other equipment, such as in the abdomen.

Claims

1. In a surgical method for implanting a device in a living body for delivering a stimulant to the nervous system of the body, the improvement comprising:

dilating the soft tissues of the body at a site of device implantation to create dilated soft tissues, through the introduction into the soft tissue of sequentially larger cannulated dilating devices, ending in a largest introduced dilating device;

passing a tubular retractor over the largest introduced dilating device and retracting a number of the dilating devices, thereby establishing a tubular device insertion corridor through the dilated soft tissues to the site of device implantation;

inserting the device to be implanted through the operative corridor to the site of device implantation;

testing the device to be implanted substantially in situ; and

closing the operative corridor.

2. In a surgical method for implanting a device in a living body for delivering a stimulant to the nervous system of the body, the improvement of claim 1 further comprising:

when retracting a number of the dilating devices, retracting all the dilating devices.

3. In a surgical method for implanting a device in a living body for delivering a stimulant to the nervous system of the body, the improvement of claim 1 further comprising:

when establishing a tubular device insertion corridor through the dilated tissues to the site of device implantation, establishing a corridor sufficient in size for insertion of an endoscope to the site of device implantation;

inserting the endoscope through the corridor to adjacent the site of device implantation; and

utilizing the endoscope for visual imaging as needed during the method.

4. In a surgical method for implanting a device in a living body for delivering a stimulant to the nervous system of the body, the improvement as in claim 1 further comprising:

testing the nervous system of the body for appropriate reaction to the stimulant through insertion and manipulation of testing implements through the corridor before testing the device and before performing other method steps.

5. In a surgical method for implanting a device in a living body for delivering a stimulant to the nervous system of the body, the improvement as in claim 1 further comprising:

anchoring the device at the site of device implantation through insertion and manipulation of anchoring implements through the corridor before closing the corridor.

6. In a surgical method for implanting an electrical stimulation lead in a living body for delivering electrical stimulation to the nervous system of the body, the improvement comprising:

dilating the soft tissues of the body at the site of lead implantation to create dilated soft tissues, through the introduction into the tissue of sequentially larger cannulated dilating devices, ending in a largest introduced dilating device;

passing a tubular retractor over the largest introduced dilating device and retracting a number of the dilating devices, thereby establishing a tubular lead insertion corridor through the dilated tissues to the site of lead implantation;

inserting the lead through the operative corridor to the site of lead implantation;

testing the lead substantially in situ; and

closing the operative corridor.

7. In a surgical method for implanting an electrical stimulation lead in a living body for delivering electrical stimulation to the nervous system of the body, the improvement of claim 6 further comprising:

when retracting a number of the dilating devices, retracting all the dilating devices.

8. In a surgical method for implanting an electrical stimulation lead in a living body for delivering electrical stimulation to the nervous system of the body, the improvement of claim 6 further comprising:

when establishing a tubular device insertion corridor through the dilated tissues to the site of lead implantation, establishing a corridor sufficient in size for insertion of an endoscope to the site of lead implantation;

inserting the endoscope through the corridor to adjacent the site of lead implantation; and

utilizing the endoscope for visual imaging as needed during the method.

9. In a surgical method for implanting an electrical stimulation lead in a living body for delivering electrical stimulation to the nervous system of the body, the improvement of claim 6 further comprising:

testing the nervous system of the body for appropriate reaction to the electrical stimulation through insertion and manipulation of testing implements through the corridor before testing the lead and before performing other method steps.

10. In a surgical method for implanting an electrical stimulation lead in a living body for delivering electrical stimulation to the nervous system of the body, the improvement of claim 6 further comprising:

anchoring the lead at the site of lead implantation through insertion and manipulation of anchoring implements through the corridor before closing the corridor.

11. In a surgical method for implanting an electrical sacral nerve stimulation lead in a living human patient for delivering electrical stimulation signals to the sacral nerves of the patient, for the treatment of incontinence and/or other medical conditions, the improvement comprising:

locating the sacrum under the skin of the patient;

dilating the soft tissues of the back of the living human patient from the skin above the sacrum to the sacrum through the introduction into the soft tissues of sequentially larger cannulated dilating devices, ending in a largest introduced dilating device;

passing a tubular retractor over the largest introduced dilating device and retracting the dilating devices, thereby establishing an operative corridor through the dilated soft tissues to the foramen of the sacrum;

inserting the lead through the operative corridor to the foramen of the sacrum;

testing the device substantially in situ; and

closing the operative corridor.

12. In a surgical method for implanting an electrical sacral nerve stimulation lead in a living human patient for delivering electrical stimulation signals to the sacral nerves of the patient, for the treatment of incontinence and/or other medical conditions, as in claim 11, the improvement comprising:

when retracting a number of the dilating devices, retracting all the dilating devices.

13. In a surgical method for implanting an electrical sacral nerve stimulation lead in a living human patient for delivering electrical stimulation signals to the sacral nerves of the patient, for the treatment of incontinence and/or other medical conditions, as in claim 11, the improvement comprising:

when establishing an operative corridor through the dilated tissues to the site of lead implantation, establishing a corridor sufficient in size for insertion of an endoscope to the site of lead implantation;

inserting the endoscope through the corridor to adjacent the site of lead implantation; and

utilizing the endoscope for visual imaging as needed during the method.

14. In a surgical method for implanting an electrical sacral nerve stimulation lead in a living human patient for delivering electrical stimulation signals to the sacral nerves of the patient, for the treatment of incontinence and/or other medical conditions, as in claim 11, the improvement comprising:

testing the sacral nerves for appropriate reaction to the electrical stimulation through insertion and manipulation of testing implements through the corridor before testing the lead and performing other steps.

15. In a surgical method for implanting an electrical sacral nerve stimulation lead in a living human patient for delivering electrical stimulation signals to the sacral nerves of the patient, for the treatment of incontinence and/or other medical conditions, as in claim 11, the improvement comprising:

anchoring the lead at the site of implantation through insertion and manipulation of anchoring implements through the corridor before closing the corridor.