IP Library › Granted Patent US 10,933,234
Granted Patent B2
US 10,933,234 · App. 16/409,616 · Granted Mar 2, 2021

System, devices, and methods combining spinal stabilization and neuromodulation

Inventors: Gregory F. Molnar (Blaine, MN); Harry Puryear (Shoreview, MN); Nazmi Peyman (Glen Allen, VA); Justin D. Zenanko (Minneapolis, MN)
Assignee: SynerFuse, Inc.
A61N1/0558A61B17/7034A61N1/0553
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Quick Facts
Patent No.
US 10,933,234
App. No.
16/409,616
Granted
Mar 2, 2021
Kind
B2
Abstract

A pain management system includes a spinal stabilization device and a neuromodulation device. The spinal stabilization device includes a rod, a plurality of pedicle screws each having a screw-head defining a screw-head cavity configured to receive a portion of the rod, and a corresponding plurality of inserts configured to engage with the inner wall of the cavity to secure the rod in place in the cavity. The neuromodulation device includes a therapy module comprising electronics packaged within a housing. The housing has a form factor having at least one feature configured to mate with a corresponding feature of the screw-head of one of the plurality of pedicle screws. The respective features mate in a manner that enables the therapy module to mechanically couple to and subsequently decouple from the screw-head of the pedicle screw.

Claims (29)

1. An implantable neuromodulation device for implant with a spinal stabilization device that includes a pair of pedicle screws, a rod, and a pair of inserts, each insert configured to secure a portion of the rod in a screw-head cavity of a screw-head of one of the pedicle screws, the neuromodulation device comprising:

a therapy module comprising a housing having a form factor comprising at least one feature configured to mate with a corresponding feature of the screw-head of one of the pedicle screws, wherein the respective features mate in a manner that enables the therapy module to mechanically couple to and subsequently decouple from the screw-head of the pedicle screw; and

a lead comprising a distal-end region having a plurality of electrodes and a proximal-end region having a lead interface structure configured to mechanically and electrically couple to and subsequently decouple from the therapy module.

2. The neuromodulation device of claim 1 , wherein:

the at least one feature of the housing comprises a center projection having an outer wall;

the corresponding feature of the screw-head comprises the screw-head cavity;

the center projection mates with the screw-head cavity through one of: a threaded engagement between the outer wall of the center projection and one or more inner walls of the cavity, and a friction fit between the outer wall of the projection and one or more inner walls of the cavity.

3. The neuromodulation device of claim 2 , wherein:

the at least one feature of the housing comprises a pair of opposed side projections defining a housing cavity;

the corresponding feature of the screw-head comprises the screw-head itself;

the screw-head mates with the housing cavity through one of: a threaded engagement between the outer wall of the screw-head and one or more inner walls of the opposed side projections, and a friction fit between the outer wall of the screw-head and one or more inner walls of the opposed side projections.

4. The neuromodulation device of claim 3 , wherein the therapy module comprises a therapy-module interface structure configured to couple with the lead interface structure.

5. The neuromodulation device of claim 4 , wherein the therapy-module interface structure comprises a dongle having at least one in-line connector configured to mate with a corresponding connector of the lead interface structure.

6. The neuromodulation device of claim 4 , wherein the housing comprises an upper region, and the therapy-module interface structure comprises a plurality of electrical contacts exposed at the upper region and configured to mate with a corresponding plurality of electrical contacts of the lead interface structure.

7. The neuromodulation device of claim 1 , wherein the housing comprises a groove formed in a pliable surface of the housing, the groove configured to receive a portion of the lead body and secure the portion in place through a friction fit.

8. A pain management system comprising:

a spinal stabilization device comprising a rod, a plurality of pedicle screws each having a screw-head defining a screw-head cavity configured to receive a portion of the rod, and a corresponding plurality of inserts configured to engage with the inner wall of the cavity to secure the rod in place in the cavity; and

a neuromodulation device comprising a therapy module comprising electronics packaged within a housing having a form factor comprising at least one feature configured to mate with a corresponding feature of the screw-head of one of the plurality of pedicle screws, wherein the respective features mate in a manner that enables the therapy module to mechanically couple to and subsequently decouple from the screw-head of the pedicle screw.

9. The pain management system of claim 8 , further comprising an implantable medical lead comprising a ribbon structure having a plurality of electrodes and a lead interface structure configured to mechanically and electrically couple to and subsequently decouple from the therapy module.

10. The pain management system of claim 8 , further comprising an implantable medical lead comprising:

a ribbon structure having a first side and a second side opposite the first side;

a plurality of first electrodes associated with the first side and arranged in a first pattern; and

a plurality of second electrodes associated with the second side and arranged in a second pattern;

wherein the ribbon structure is configured to transition from a planar state to a non-planar state upon the application of a force and to remain in the non-planar state upon removal of the force.

11. A method of implanting a pain management system that includes spinal stabilization hardware and a neuromodulation device having a therapy module configured to mechanically couple to and decouple from a component of the spinal stabilization hardware, the method comprising:

creating direct access to nerve structures while implanting the spinal stabilization hardware during a spinal fusion procedure;

placing a lead on or adjacent to target nerve structures under direct visual access;

mechanically coupling the therapy module to a component of the spinal stabilization hardware; and

mechanically and electrically coupling the lead to the therapy module.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 30, 2019
From: MOLNAR, GREGORY F.; PURYEAR, HARRY; PEYMAN, NAZMI; ZENANKO, JUSTIN D.
To: SYNERFUSE, INC.
Reel/Frame 049324/0934 →
Continuity (2)
Provisional Application 62670034 · May 11, 2018
Related Publication 20190344070A1 · Nov 14, 2019
Cited By (4)
US 12,357,792 US 12,440,656 US 12,661,487 US 12,685,644