Granted Patent B2

US 12,433,646 · App. 18/432,562 · Granted Oct 7, 2025

Inventor: Zdzislaw Bernard Malinowski (Castaic, CA)

Assignee: Boston Scientific Neuromodulation Corporation

A61B17/7047A61B17/7065A61B2017/00367

Abstract

Claims (43)

1. An interspinous spacer, comprising:

a body having a distal portion, a proximal portion, a proximal surface, and a channel extending longitudinally from the proximal surface toward the distal portion;

an actuator screw comprising a proximal end and a shaped cavity in the proximal end, wherein the shaped cavity is configured for receiving a bit of a driver tool having a complementary shape for rotating the actuator screw using the driver tool, wherein at least a portion of the actuator screw and the channel of the body comprise complementary threading, wherein the actuator screw is at least partially disposed in, and engages, the channel of the body;

a wedge coupled to the actuator screw, wherein, as the actuator screw is rotated using the driver tool, the actuator screw and the wedge move longitudinally relative to the body;

a first arm and a second arm, wherein the first and second arms are rotatably coupled to the distal portion of the body and configured for rotating in response to longitudinal movement of the wedge, wherein the actuator screw, wedge, first arm, and second arm are configured, upon rotation of the actuator screw in a first direction, to rotate the first and second arms from an implantation position, in which the first and second arms extend longitudinally from the distal portion of the body, to a deployed position, in which the first and second arms are rotated from the implantation position; and

two pins, wherein the body comprises two sets of opposing pin holes in the distal portion and the first and second arms each comprise at least one pin hole, wherein each of the pins couples either the first or second arm to the body and extends through one of the sets of opposing pin holes of the body and the pin hole of the corresponding one of the first arm or the second arm.

2. The interspinous spacer of claim 1 , wherein, in the deployed position, the first and second arms extend away from the body in a lateral direction.

3. The interspinous spacer of claim 1 , wherein, in the deployed position, the first and second arms are rotated from the implantation position by at least 75 degrees.

4. The interspinous spacer of claim 1 , wherein the portion of the actuator screw comprising the threading is a threaded shaft and the actuator screw further comprises a disc and a cylinder coupling the disc to the threaded shaft, wherein the cylinder has an outer diameter that is smaller than outer diameters of the disc and the threaded shaft.

5. The interspinous spacer of claim 4 , wherein the wedge defines an engagement slot for receiving the disc of the actuator screw and comprises two overhang portions that extend over the engagement slot are separated by a distance that is greater than the outer diameter of the cylinder and less than the outer diameters of the disc and the threaded shaft.

6. The interspinous spacer of claim 4 , wherein the disc comprises a plurality of teeth arranged around a perimeter of the disc.

7. The interspinous spacer of claim 6 , further comprising at least one locking inset positioned on the wedge for engagement by the disc of the actuator screw, each of the at least one locking inset comprising at least one tooth for interaction with the teeth of the disc to limit rotation of the actuator screw absent the driver tool.

8. The interspinous spacer of claim 4 , further comprising a locking ring comprising a compressible material and configured for engagement with the actuator screw to resist rotation of the actuator screw absent the driver tool, wherein the body comprises a plurality of fingers extending above the proximal surface to retain the locking ring on the proximal surface of the body.

9. The interspinous spacer of claim 1 , wherein the body comprises opposing undercut notches configured for receiving a clamp of a spacer insertion instrument.

10. A kit, comprising:

the interspinous spacer of claim 1 ;

a spacer insertion instrument configured to releasably grip the interspinous spacer for implantation into a patient; and

a driver tool comprising a spacer engaging bit configured to engage the actuator screw of the interspinous spacer and rotate the actuator screw by rotation of the driver tool.

11. An interspinous spacer, comprising:

a body having a distal portion, a proximal portion, a proximal surface, and a channel extending longitudinally from the proximal surface toward the distal portion;

an actuator screw comprising a threaded shaft and a disc coupled to the threaded shaft, wherein the disc comprises a plurality of teeth arranged around a perimeter of the disc and the channel of the body comprises threading complementary to the threaded shaft, wherein the actuator screw is at least partially disposed in, and engages, the channel of the body;

a wedge coupled to the actuator screw, wherein, as the actuator screw is rotated, the actuator screw and the wedge move longitudinally relative to the body;

at least one locking inset positioned on the wedge for engagement by the disc of the actuator screw, each of the at least one locking inset comprising at least one tooth for interaction with the teeth of the disc to limit rotation of the actuator screw; and

a first arm and a second arm, wherein the first and second arms are rotatably coupled to the distal portion of the body and configured for rotating in response to longitudinal movement of the wedge, wherein the actuator screw, wedge, first arm, and second arm are configured, upon rotation of the actuator screw in a first direction, to rotate the first and second arms from an implantation position, in which the first and second arms extend longitudinally from the distal portion of the body, to a deployed position, in which the first and second arms are rotated from the implantation position.

12. The interspinous spacer of claim 11 , wherein, in the deployed position, the first and second arms extend away from the body in a lateral direction.

13. The interspinous spacer of claim 11 , wherein the actuator screw further comprises a cylinder coupling the disc to the threaded shaft, wherein the cylinder has an outer diameter that is smaller than outer diameters of the disc and the threaded shaft, wherein the wedge defines an engagement slot for receiving the disc of the actuator screw and comprises two overhang portions that extend over the engagement slot are separated by a distance that is greater than the outer diameter of the cylinder and less than the outer diameters of the disc and the threaded shaft.

14. The interspinous spacer of claim 13 , wherein the at least one locking insert is positioned within the engagement slot of the wedge.

15. A kit, comprising:

the interspinous spacer of claim 12 ;

a spacer insertion instrument configured to releasably grip the interspinous spacer for implantation into a patient; and

a driver tool comprising a spacer engaging bit configured to engage the actuator screw of the interspinous spacer and rotate the actuator screw by rotation of the driver tool.

16. An interspinous spacer, comprising:

a body having a distal portion, a proximal portion, a proximal surface, and a channel extending longitudinally from the proximal surface toward the distal portion;

an actuator screw comprising a threaded shaft and a disc coupled to the threaded shaft, wherein the channel of the body comprises threading complementary to the threaded shaft and the actuator screw is at least partially disposed in, and engages, the channel of the body;

a wedge coupled to the actuator screw, wherein, as the actuator screw is rotated, the actuator screw and the wedge move longitudinally relative to the body;

a locking ring comprising a compressible material and configured for engagement with the actuator screw to resist rotation of the actuator screw, wherein the body comprises a plurality of fingers extending above the proximal surface to retain the locking ring on the proximal surface of the body; and

a first arm and a second arm, wherein the first and second arms are rotatably coupled to the distal portion of the body and configured for rotating in response to longitudinal movement of the wedge, wherein the actuator screw, wedge, first arm, and second arm are configured, upon rotation of the actuator screw in a first direction, to rotate the first and second arms from an implantation position, in which the first and second arms extend longitudinally from the distal portion of the body, to a deployed position, in which the first and second arms are rotated from the implantation position.

17. The interspinous spacer of claim 16 , wherein the actuator screw further comprises a cylinder coupling the disc to the threaded shaft, wherein the cylinder has an outer diameter that is smaller than outer diameters of the disc and the threaded shaft, wherein the wedge defines an engagement slot for receiving the disc of the actuator screw and comprises two overhang portions that extend over the engagement slot are separated by a distance that is greater than the outer diameter of the cylinder and less than the outer diameters of the disc and the threaded shaft.

18. The interspinous spacer of claim 16 , further comprising two pins, wherein the body comprises two sets of opposing pin holes in the distal portion and the first and second arm comprise at least one pin hole, wherein each of the pins couples either the first or second arm to the body and extends through one of the sets of opposing pin holes of the body and the pin hole of the corresponding one of the first arm or second arm.

19. A kit, comprising:

the interspinous spacer of claim 16 ;

a spacer insertion instrument configured to releasably grip the interspinous spacer for implantation into a patient; and

a driver tool comprising a spacer engaging bit configured to engage the actuator screw of the interspinous spacer and rotate the actuator screw by rotation of the driver tool.

Assignments (1)

Continuity (2)

References Cited (400)