SYSTEMS AND METHODS FOR IMPLANTING PADDLE LEAD ASSEMBLIES OF ELECTRICAL STIMULATION SYSTEMS

• US 20120209285A1
• Filed: 02/13/2012
• Published: 08/16/2012
• Est. Priority Date: 02/16/2011
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael, Howard, Joshua Dale
• Application Number:
  US13/371,824
• Publication Number:
  US 20120209285A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

An insertion kit for percutaneously implanting an electrical stimulating paddle lead into a patient includes a paddle lead introducer. The paddle lead introducer facilitates percutaneous implantation of a paddle lead into the patient. The paddle lead introducer includes a sheath and a dilator. The sheath is insertable into the patient. The sheath is configured and arranged to receive a paddle lead during implantation of the paddle lead into the patient. The sheath can divide into at least two parts for removal of the sheath from the paddle lead upon implantation of the paddle lead. The dilator is insertable into the sheath. A first end of the dilator defines an aperture at a tip of the first end. The first end of the dilator has a transverse circumference that increases from the tip towards a second end.

Claims

1. An insertion kit for percutaneously implanting an electrical stimulating paddle lead into a patient, the insertion kit comprising:

a paddle lead introducer configured and arranged for facilitating percutaneous implantation of a paddle lead into the patient, the paddle lead introducer comprising

a sheath insertable into the patient, the sheath having a first end, an opposing second end, and a longitudinal length, wherein the sheath is configured and arranged to receive a paddle lead during implantation of the paddle lead into the patient, wherein the sheath is configured and arranged to divide into at least two parts for removal of the sheath from the paddle lead upon implantation of the paddle lead into the patient, and

a dilator insertable into the sheath, the dilator having a first end, an opposing second end, and a longitudinal length, the first end of the dilator defining an aperture at a tip of the first end, wherein the first end of the dilator has a transverse circumference that increases from the tip towards the second end.

2. The insertion kit of claim 1, wherein the sheath has an oval-shaped transverse cross-section.

3. The insertion kit of claim 1, wherein the dilator has an oval-shaped transverse cross-section.

4. The insertion kit of claim 1, wherein the first end of the sheath is beveled.

5. The insertion kit of claim 1, wherein the first end of the sheath has a sharp surface.

6. The insertion kit of claim 1, wherein the sheath comprises at least two pull-apart tabs disposed at opposite sides of the second end of the sheath.

7. The insertion kit of claim 6, wherein the sheath further comprises at least one scored or perforated line extending along at least a portion of a longitudinal length of the sheath from between the at least two pull-apart tabs, the at least one scored or perforated line configured and arranged for separating when the at least two pull-apart tabs are pulled apart from one another.

8. The insertion kit of claim 1, further comprising an epidural needle having a first end, an opposing second end, and a longitudinal length, wherein the epidural needle is insertable into the dilator such that the first end of the epidural needle extends outwardly from the aperture at the tip of the first end of the dilator.

9. The insertion kit of claim 8, wherein the epidural needle is a 14-gauge epidural needle.

10. The insertion kit of claim 8, wherein the epidural needle comprises a luer hub disposed at the second end of the epidural needle.

11. The insertion kit of claim 8, further comprising a lead blank insertable into the epidural needle.

12. The insertion kit of claim 1, further comprising a paddle lead, the paddle lead comprising

a paddle body having a first major surface, an opposing second major surface, and a longitudinal length;

an aperture defined in the paddle body, wherein the aperture extends along the entire longitudinal length of the paddle body, the aperture configured and arranged to receive a lead blank;

at least one lead body, each of the at least one lead bodies having a proximal end and a distal end, the distal end of the at least one lead body being coupled to the paddle body;

a plurality of electrodes disposed on the first major surface of the paddle body;

a plurality of terminals disposed at the proximal ends of each of the at least one lead bodies; and

a plurality of conductive wires coupling the plurality of electrodes electrically to the plurality of terminals.

13. The insertion kit of claim 12, wherein at least one of the at least one lead bodies defines a lumen configured and arranged to receive a stylet.

14. An electrical stimulating system comprising:

the insertion kit of claim 12;

a control module configured and arranged to electrically couple to the proximal ends of the at least one lead bodies of the paddle lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the paddle lead, the connector comprising

a connector housing defining at least one port for receiving the proximal ends of the at least one lead bodies of the paddle lead, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to the plurality of terminals disposed at the proximal ends of the at least one lead bodies.

15. A method for percutaneously implanting an electrical stimulation paddle lead into a patient, the method comprising:

providing the insertion kit of claim 1;

inserting the dilator of the insertion kit into the sheath such that the first end of the dilator extends axially from the first end of the sheath;

inserting an epidural needle into the dilator such that a first end of the epidural needle extends axially from the first end of the dilator;

guiding the sheath, dilator, and epidural needle to a target stimulation location within the patient;

removing the epidural needle and dilator, leaving the sheath in the patient;

inserting the paddle lead into the sheath and guiding the paddle lead to the target stimulation location, the paddle lead comprising a paddle body having a first major surface, an opposing second major surface, a longitudinal length, at least one lead body, each of the at least one lead bodies having a proximal end and a distal end, the distal end of the at least one lead body being coupled to the paddle body, a plurality of electrodes disposed on the first major surface of the paddle body, a plurality of terminals disposed at the proximal ends of each of the at least one lead bodies, and a plurality of conductive wires coupling the plurality of electrodes electrically to the plurality of terminals; and

removing the sheath from the paddle lead, leaving the paddle lead implanted in the patient.

16. The method of claim 15, wherein removing the sheath from the paddle lead comprises separating the sheath into at least two parts along the longitudinal length of the sheath.

17. The method of claim 16, wherein separating the sheath into at least two parts along the longitudinal length of the sheath comprises pulling the at least two pull-apart tabs apart from one another.

18. The method of claim 15, wherein inserting the paddle lead into the sheath and guiding the paddle body to the target stimulation location comprises inserting a lead blank into the sheath and threading the paddle body along the lead blank through an aperture in the paddle body.

19. The method of claim 15, wherein inserting the paddle lead into the sheath and guiding the paddle body to the target stimulation location comprises inserting a stylet into a lumen defined along at least one of the at least one lead bodies.

20. A method for percutaneously implanting an electrical stimulation paddle lead into a patient, the method comprising:

providing the insertion kit of claim 1;

inserting an epidural needle into the patient and guiding the epidural needle to the target stimulation location;

inserting a lead blank into the epidural needle;

removing the epidural needle, leaving the lead blank in the patient;

disposing the sheath and the dilator of the insertion kit over the lead blank;

removing the dilator and lead blank, leaving the sheath in the patient;

inserting the paddle lead into the sheath and guiding the paddle lead to the target stimulation location, the paddle lead comprising a paddle body having a first major surface, an opposing second major surface, a longitudinal length, at least one lead body, each of the at least one lead bodies having a proximal end and a distal end, the distal end of the at least one lead body being coupled to the paddle body, a plurality of electrodes disposed on the first major surface of the paddle body, a plurality of terminals disposed at the proximal ends of each of the at least one lead bodies, and a plurality of conductive wires coupling the plurality of electrodes electrically to the plurality of terminals; and

removing the sheath from the paddle lead, leaving the paddle lead implanted in the patient.