Methods and apparatus for provision of therapy to adjacent motion segments

• US 7,776,042 B2
• Filed: 08/13/2005
• Issued: 08/17/2010
• Est. Priority Date: 12/03/2002
• Status: Expired due to Fees

• Current Assignee: Mis Ip Holdings LLC
• Original Assignee: TranS1 Incorporated (Baxano Surgical, Inc.)
• Inventors: Schwarz, Tawney A., Assell, Robert L., Cragg, Andrew H., Wessman, Bradley J., Ainsworth, Stephen D., Dickhudt, Eugene A.
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US11/202,655
• Publication Number:
  US 20060058800A1
• Time in Patent Office: 1,830 Days
• Field of Search: 606/86.A, 606/249, 606/279, 606/90, 606/99, 606/247, 606/257, 606/96, 433/172, 433/173, 433/174, 433/175, 623/17.11, 623/16.11
• US Class Current: 606/86.00A
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8645 Headless screws, e.g. ligament interference screws
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/0256 for the spine

Abstract

Disclosed are methods and apparatus for the provision of spinal therapy to two or more adjacent motion segments accessed through a trans-sacral approach. The spinal therapies include fusion and dynamic stabilization with and without a distraction of the most cephalad motion segment of the two or more adjacent motion segments provided therapy. The disclosure includes methods and apparatus to impart a distraction on a second more caudal motion segment after providing therapy to the more cephalad motion segment. Related concepts for the extraction of previously inserted devices and the delivery and removal of plugs for plugging the interior cavities of implantable devices are disclosed.

Claims

1. A spinal device assembly, the spinal device assembly comprising a distal component and a proximal component, the distal component comprising:

an elongate body with anchoring means for engagement with at least a first vertebral body;

a distal end; and

a proximal end adapted to engage a distal end of the proximal component along a centerline of a longitudinal axis of the distal component; and

the proximal component comprising;

the distal end adapted to engage the proximal end of the distal component along the centerline of the longitudinal axis of the proximal component;

a proximal end with anchoring means for engagement with a second, more inferior vertebral body, said proximal end adapted to engage a removable driver that rotates and axially advances the proximal component so that the distal end of the proximal component engages the proximal end of the distal component to impart axial force to the distal component without imparting rotation to the distal component thereby causing distraction of the first vertebral body relative to the second vertebral body.

2. The spinal device assembly of claim 1 wherein said distal component and said proximal component are adapted for deployment through a channel created through a trans-sacral axial surgical approach.

3. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a driver engagement section;

wherein

the distal device and the proximal device are each adapted for delivery through a single access channel created during surgery with an opening at a proximal end of the access channel that receives the distal device and the proximal device.

4. The assembly of claim 3 wherein the extension is adapted to be a close fit to a corresponding portion of the engagement zone to maintain axial alignment of the proximal device and the distal device while retaining an ability for the proximal device to rotate relative to the distal device without imparting rotation to the distal device.

5. The assembly of claim 3 wherein the proximal device further comprises a shoulder that surrounds the extension on the distal end of the proximal device such that upon sufficient axial advancement of the proximal device towards the distal device, the shoulder portion of the proximal device abuts against at least a portion of a surface area of the distal device.

6. The assembly of claim 3 wherein upon sufficient axial advancement of the proximal device towards the distal device, the extension of the proximal device abuts against at least a portion of a surface area of the engagement zone in the distal device.

7. The assembly of claim 3 wherein the threaded section of the proximal device comprises cancellous type bone threads with generally flat faces oriented towards a caudal side of the vertebral body.

8. The assembly of claim 3 wherein the distal device further comprises a first set of male threads for engagement with a distal vertebral body and a second set of male threads with a same handedness for engagement with a less distal vertebral body.

9. The assembly of claim 8 wherein the first set of male threads and the second set of male threads on the distal device have a same pitch.

10. The assembly of claim 8 wherein the first set of male threads on the distal device has a finer pitch than the second set of male threads on the distal device such that rotation of the distal device after engagement of the first set of threads with a distal vertebral body and the engagement of the second set of threads with a less distal vertebral body causes an axial distraction of the distal vertebral body relative to the less distal vertebral body.

11. The assembly of claim 10 wherein the first set of male threads on the distal device has a major diameter and the second set of male threads on the distal device has a minor diameter that is larger than the major diameter of the first set of threads so that the first set of male threads can pass through a previously formed bore in the less distal vertebral body without the need for rotation of the distal device and the creation of a thread path in the less distal vertebral body.

12. The assembly of claim 10 wherein the rotation of the proximal device while the extension of the proximal device abuts against the at least a portion of the surface of the engagement zone of the distal device does not alter the axial distraction of the distal vertebral body relative to the less distal vertebral body.

13. The assembly of claim 10 wherein the first set of male threads on the distal device has a major diameter and the second set of male threads on the distal device has a minor diameter that is smaller than the major diameter of the first set of threads and the second set of male threads on the distal device has a major diameter that is larger than the major diameter of the first set of threads.

14. The assembly of claim 8 further characterized by sizing the lengths of the distal device and the proximal device, and the lengths of the set of threads for engagement with the distal vertebral body, the set of threads for engagement with the less distal vertebral body, and the set of threads on the proximal device for engaging the vertebral body are selected so that the assembly can be positioned to engage the L4 vertebral body, the L5 vertebral body, and the sacrum.

15. The assembly of claim 3 wherein the proximal device and the distal device are joined by a plug with a threaded engagement to maintain a set of post-operative relative axial positions of the distal and proximal devices.

16. The assembly of claim 15 wherein the assembly is further characterized by the plug having a cavity on its proximal end with:

an engagement zone for receiving a corresponding driver head so that a driver can impart a rotation to the plug to cause the plug to engage the threads to act to maintain the post-operative relative axial positions of the distal and proximal devices; and

a threaded bore to receive a male threaded distal end of a retention rod, so that the male threaded distal end of the retention rod of a plug driver can be threadedly engaged with the proximal end of the plug before the plug and the distal end of the plug driver are inserted through the single access channel for delivery of the plug to the cavity of the proximal device.

17. The assembly of claim 15 wherein the plug engages with a set of corresponding threads in the cavity on the proximal end of the distal device to pull together the distal device and the proximal device.

18. The assembly of claim 15 wherein the plug engages with a set of corresponding threads in a cavity along a centerline of a plug previously inserted in the distal device to pull together the distal device and the proximal device.

19. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a driver engagement section;

wherein the distal device further comprises a first set of male threads for engagement with a distal vertebral body and a second set of male threads with the same handedness for engagement with a less distal vertebral body; and

the distal device is adapted to provide therapy to a motion segment comprising the distal vertebral body, the less distal vertebral body, and an intervertebral disc space between the distal vertebral body and the less distal vertebral body by insertion of material into the intervertebral disc space through fenestrations in the distal device.

20. The assembly of claim 19 wherein the spinal therapy provides for dynamic stabilization of the motion segment and the material inserted into the intervertebral disc space expands a flexible portion of the distal device.

21. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a driver engagement section;

wherein the distal device is provided with a proximal end with a set of threads for engagement with one vertebral body and a distal tip of the distal end for placement in an intervertebral disc space between the one vertebral body and a more distal vertebral body and the distal device is adapted to insert material into the intervertebral disc space between the one vertebral body and the more distal vertebral body.

22. The assembly of claim 21 wherein the distal device further comprises a flexible component in the portion of the distal device intended for placement in the intervertebral disc space between the one vertebral body and the more distal vertebral body.

23. The assembly of claim 22 wherein the distal device is adapted to insert material into the intervertebral disc space between the one vertebral body and the more distal vertebral body by receiving material through a central axial cavity to expand the flexible component outward from the distal device and into the intervertebral disc space.

24. The assembly of claim 22 wherein the distal device is adapted for use in fusing together the one vertebral body, the intervertebral disc space, and the more distal vertebral body and to insert material into the intervertebral disc space that promotes fusion.

25. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body;

a proximal end with a cavity having an engagement zone, the cavity along a centerline of a longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the distal device can be delivered into an intervertebral disc space; and

an internal set of threads in the cavity to receive a plug;

a plug placed in the distal device in threaded engagement with the internal set of threads in the distal device such that material delivered into the intervertebral disc space is limited in its ability to ingress back through the fenestration and into the cavity of the distal device;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a driver engagement section.

26. The assembly of claim 25 wherein the assembly is further characterized by:

the proximal device having a cavity along a centerline of a longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the proximal device can be delivered into an intervertebral disc space;

the proximal device having an internal set of threads in the cavity to receive a plug;

a plug placed in the proximal device in threaded engagement with the internal set of threads in the proximal device such that material delivered into the intervertebral disc space is limited in its ability to ingress back through the fenestration and into the cavity of the proximal device.

27. The assembly of claim 25 wherein the assembly is further characterized by the plug having a cavity on its proximal end with:

an engagement zone for receiving a corresponding driver head so that a plug driver can impart a rotation to the plug to cause the plug to engage the internal set of threads in the distal device; and

a threaded bore to receive a male threaded distal end of a retention rod, so that the male threaded distal end of the retention rod can be threadedly engaged with the proximal end of the plug before the plug and the distal end of the plug driver are inserted through the trans-sacral approach channel for delivery of the plug to the cavity of the distal device.

28. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a driver engagement section;

wherein;

the cavity in the proximal end of the distal device having a socket for receipt of a corresponding polygonal driver for transfer of rotational forces from the polygonal driver to the distal device to rotate the distal device with respect to the at least one vertebral body;

the cavity in the proximal end of the distal device having a threaded section for receipt of a corresponding set of threads on a distal end of a disengagement tool, the threaded section having an opposite handedness to the at least one set of threads on the distal device for engagement with the at least one vertebral body so that a disengagement tool can be rotated to engage the disengagement tool with the distal device and after completion of the threaded engagement impart a rotation to the distal device to disengage the distal device from the at least one vertebral body such that once disengaged from the at least one vertebral body but still engaged with the disengagement tool, the disengaged distal device can be removed with the distal end of the disengagement tool from an access channel.

29. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a driver engagement section;

wherein;

the driver engagement section in a cavity in the proximal end of the proximal device comprising a socket for receipt of a corresponding polygonal driver for the transfer of rotational forces from the driver to the proximal device to rotate the proximal device with respect to the vertebral body;

the cavity in the proximal end of the proximal device having a threaded section for receipt of a corresponding set of threads on a distal end of a disengagement tool, the threads having an opposite handedness to the threaded section of the proximal device for engagement with the vertebral body so that the disengagement tool can be rotated to engage the disengagement tool with the proximal device and after completion of the threaded engagement impart a rotation to the proximal device to disengage the proximal device from the vertebral body but still engaged with the disengagement tool, the disengaged proximal device can be removed with the distal end of the disengagement tool from an access channel.

30. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a driver engagement section; and

a thrust bearing located between the proximal end of the distal device and the distal end of the proximal device so that rotation of the proximal device causing the proximal device to advance towards the previously inserted distal device imparts an axial force through the thrust bearing to the distal device.

31. The assembly of claim 30 wherein the thrust bearing is a washer-shaped structure formed of a biocompatible polymer with a coefficient of sliding friction between the thrust bearing and the proximal device being less than a coefficient of sliding friction between the proximal device and the distal device.

32. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a cavity having a driver engagement section;

wherein;

the distal device;

is adapted for use in fusing together a motion segment comprising a vertebral body, an adjacent and more distal vertebral body and an intervertebral disc space between the vertebral body and the adjacent and more distal vertebral body, the distal device having the cavity along a centerline of a longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the distal device can be delivered into the intervertebral disc space; and

the proximal device;

is adapted for use in fusing together a motion segment comprising a vertebral body, an adjacent and more distal vertebral body and an intervertebral disc space between the vertebral body and the adjacent and more distal vertebral body, the proximal device having the cavity along a centerline of a longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the proximal device can be delivered into the intervertebral disc space;

such that the assembly can be used in providing fusion therapy to two adjacent motion segments accessed through a single access channel.

33. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a cavity having a driver engagement section;

wherein;

the distal device;

further comprises a flexible component in a portion of the distal device intended for placement in an intervertebral disc space between a vertebral body and an adjacent and more distal vertebral body and the distal device is adapted to insert material into the intervertebral disc space between the vertebral body and the more distal vertebral body by receiving material through the cavity to expand the flexible component outward from the distal device and into the intervertebral disc space; and

the proximal device;

is adapted for use in fusing together a motion segment comprising a vertebral body, an adjacent and more distal vertebral body and an intervertebral disc space between the vertebral body and the adjacent and more distal vertebral body, the proximal device having the cavity along a centerline of a longitudinal axis in fluid communication with a set of at least one fenestration so that material provided to the proximal end of the proximal device can be delivered into the intervertebral disc space;

such that the assembly can be used in providing therapy to allow dynamic stabilization of a distal motion segment and to provide for fusion of an adjacent and more proximal motion segment, both motion segments accessed through a single access channel.

34. An assembly comprising a distal device and a proximal device;

the distal device comprising;

a distal end;

at least one set of threads for engagement with at least one vertebral body; and

a proximal end with a cavity having an engagement zone;

the proximal device comprising;

a distal end with an extension adapted to fit at least a portion of the extension within the engagement zone in the cavity of the distal device;

a threaded section for engagement with a vertebral body; and

a proximal end with a cavity with a driver engagement section;

wherein;

the distal device further comprises a flexible component in a portion of the distal device intended for placement in an intervertebral disc space between a vertebral body and an adjacent and more distal vertebral body and the distal device is adapted to insert material into the intervertebral disc space between the vertebral body and the more distal vertebral body by receiving material through the cavity to expand the flexible component outward from the distal device and into the intervertebral disc space; and

the proximal device further comprises a flexible component in a portion of the proximal device intended for placement in an intervertebral disc space between a vertebral body an adjacent and more distal vertebral body and the proximal device is adapted to insert material into the intervertebral disc space between a vertebral body and a more distal vertebral body by receiving material through the cavity to expand the flexible component outward from the proximal device and into the intervertebral disc space;

such that the assembly can be used in providing therapy to allow dynamic stabilization of both a distal motion segment and an adjacent and more proximal motion segment, both motion segments accessed through a single access channel.

35. An assembly comprising a distal device and a proximal device, the components of the assembly adapted for delivery by a trans-sacral approach such that the distal device is placed more distal to a sacrum than the proximal device;

the distal device comprising;

a distal end

at least one set of threads for engagement with at least one vertebral body and

a proximal end with an extension along a centerline of a longitudinal axis of the distal device;

the proximal device comprising;

a distal end with a cavity with an engagement zone adapted to receive at least a portion of the extension of the distal device within the engagement zone in the cavity;

a threaded section for engagement with a vertebral body;

a proximal end with a cavity along a centerline of a longitudinal axis of the proximal device containing a driver engagement section such that rotational force imparted by a corresponding driver head causes the threaded section of the proximal device to engage with a proximal vertebral body and advance the proximal device towards a previously inserted distal device such that the extension of the distal device enters into the cavity of the proximal device and the proximal device abuts against at least a portion of a surface of the distal device so that further rotation of the proximal device exerts an axial force upon the distal device while rotating relative to the distal device to move the distal device and the at least one engaged vertebral body away from the vertebral body engaged with the proximal device.

36. A spinal device assembly for providing therapy to at least two adjacent spinal motion segments, the spinal assembly comprising a distal component and a proximal component, the distal component comprising:

an elongate body with anchoring means for engagement with at least a first vertebral body;

a distal end; and

a proximal end adapted to engage a distal end of the proximal component along a centerline of a longitudinal axis of the distal component; and

the proximal component comprising;

the distal end adapted to reversibly engage the proximal end of the distal component along the centerline of the longitudinal axis of the distal component;

a proximal end with an anchoring means for engagement with a second, more inferior vertebral body, said proximal end adapted to engage a removable driver that rotates and axially advances the proximal component so that the distal end of the proximal component engages the proximal end of the distal component to impart axial force to the distal component without imparting rotation to the distal component thereby causing distraction of an intervertebral disc space between the first vertebral body and the second, more inferior vertebral body.