US2018110974A1PendingUtilityA1

Dorsal root ganglia surgical leads

Individually held — no corporate assignee on recordPriority: Oct 25, 2016Filed: Oct 25, 2016Published: Apr 26, 2018
Est. expiryOct 25, 2036(~10.2 yrs left)· nominal 20-yr term from priority
Inventors:Timothy R. Deer
A61N 1/36071A61N 1/0558A61N 1/0553A61N 1/06A61N 1/36178
34
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Claims

Abstract

Implementations described and claimed herein provide paddle leads for dorsal root ganglia (DRG) stimulation and methods of implanting the same. In one implementation, the paddle lead has a small profile facilitating deployment into a target space in the neuroforamen dorsal to the DRG and below the vertebral lamina. A paddle body of the paddle lead may include a living hinge and/or a contoured profile to further facilitate implantation in the target space. For suture assisted deployment as well as to resist migration of the paddle lead once deployed, the paddle lead may include a suture loop configuration. The paddle lead further includes an electrode array having electrode contacts arranged in a two dimensional configuration pattern to create an electrical field optimized for stimulation of the DRG.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system for electrical stimulation of a dorsal root ganglion, the system comprising:
 a paddle body extending between a proximal end and a distal end;   a lead body extending from the proximal end forming a paddle lead;   an electrode array disposed on at least one surface of the paddle body, the electrode array having one or more electrode contacts arranged in an electrode array configuration; and   a tapered distal tip formed by the paddle body tapering in width toward the distal end, the tapered distal tip shaped for surgical placement of the paddle body below vertebral lamina dorsal to the dorsal root ganglion following a medial laminectomy and ligament removal, the surgical placement orienting the electrode array for the electrical stimulation of the dorsal root ganglion.   
     
     
         2 . The system of  claim 1 , wherein the surgical placement includes deploying the paddle body into one of lumbar or thoracic neuroformen caudal to pedicles. 
     
     
         3 . The system of  claim 1 , wherein the paddle lead is deployed using a delivery tool having a sheath with a spatula shaped distal tip. 
     
     
         4 . The system of  claim 3 , wherein the spatula shaped distal tip of the sheath is between ten and thirty percent larger in size than the paddle body. 
     
     
         5 . The system of  claim 1 , wherein the tapered distal tip has a rounded shape or a pointed shape. 
     
     
         6 . The system of  claim 1 , wherein the paddle body is configured to cradle the dorsal root ganglion. 
     
     
         7 . The system of  claim 6 , wherein the paddle body has a contoured shape extending along a curve from a first end of the paddle body to a second end of the paddle body to cradle the dorsal root ganglion. 
     
     
         8 . The system of  claim 7 , wherein the contoured shape of the paddle body is maintained with one or more formable elements including at least one of one or more wires, one or more plates, or one or more coils. 
     
     
         9 . The system of  claim 6 , wherein the paddle body includes a living hinge with the paddle body extending from a first side to a first hinge and from a second side to a second hinge, the first and second hinges each forming a joint configured to bend the paddle body along a contour to cradle the dorsal root ganglion. 
     
     
         10 . A system for electrical stimulation of a dorsal root ganglion, the system comprising:
 a paddle body extending between a proximal end and a distal end;   a lead body extending from the proximal end;   an electrode array disposed on at least one surface of the paddle body, the electrode array having one or more electrode contacts arranged in a two-dimensional electrode array configuration forming an asymmetrical paddle lead with the electrical stimulation focused in a single direction within a target area of the dorsal root ganglion; and   a living hinge formed by the paddle body extending from a first side to a first hinge and from a second side to a second hinge, the first and second hinges each forming a joint configured to bend the paddle body along a contour to cradle the dorsal root ganglion.   
     
     
         11 . The system of  claim 10 , wherein the single direction is configured to overcome stimulation loss caused by scar tissue present in the target area. 
     
     
         12 . The system of  claim 10 , wherein the electrode array is configured for at least one of high frequency or burst stimulation patterns. 
     
     
         13 . The system of  claim 10 , wherein the two-dimensional electrode array configuration includes a four-by-two-by-two pattern; a six-by-three-by-three pattern; or a two-by-two pattern. 
     
     
         14 . The system of  claim 10 , wherein the two-dimensional electrode array configuration includes the one or more electrode contacts arranged in a nonlinear pattern with a plurality of columns. 
     
     
         15 . The system of  claim 14 , wherein the plurality of columns includes a first column, a second column, and a third column and the first hinge is disposed between the first column and the second column and the second hinge is disposed between the second column and the third column. 
     
     
         16 . The system of  claim 10 , wherein the one or more electrode contacts each have a size ranging from two to three millimeters. 
     
     
         17 . The system of  claim 10 , wherein the electrode array has a length ranging from thirty to forty-five millimeters and a width ranging from two to four millimeters. 
     
     
         18 . A system for electrical stimulation of a dorsal root ganglion, the system comprising:
 a paddle body extending between a proximal end and a distal end;   a lead body extending from the proximal end forming a paddle lead;   an electrode array disposed on at least one surface of the paddle body, the electrode array having one or more electrode contacts arranged in a two-dimensional electrode array configuration; and   a suture loop configuration having one or more suture loops for suture guided deployment of the paddle lead.   
     
     
         19 . The system of  claim 18 , wherein the one or more suture loops are disposed on the paddle body relative to electrical pathways of the one or more electrode contacts. 
     
     
         20 . The system of  claim 18 , wherein the one or more suture loops are disposed on at least one of a distal tip of the paddle body, the paddle body, a neck, or the lead body.

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