Surgical instruments and techniques for percutaneous placement of spinal stabilization elements

• US 7,520,879 B2
• Filed: 02/07/2006
• Issued: 04/21/2009
• Est. Priority Date: 02/07/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Justis, Jeff R., Pond, John D. Jr.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): HAMMOND, ELLEN CHRISTINA
• Application Number:
  US11/348,999
• Publication Number:
  US 20070213714A1
• Time in Patent Office: 1,169 Days
• Field of Search: 606/61, 606/99, 606/86.A, 606250-262, 606264-275, 606/278, 606/86.R
• US Class Current: 606/86.00A
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7022 Tethers, i.e. longitudinal elements capable of transmitting tension only, e.g. straps, sutures or cables A61B17/702 takes precedence
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7083 Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
• CPC Class Codes: A61B 17/7086 Rod reducers, i.e. devices providing a mechanical advantage to allow a user to force a rod into or onto an anchor head other than by means of a rod-to-bone anchor locking element; rod removers
• CPC Class Codes: A61B 17/7089 wherein insertion is along an arcuate path
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis

Abstract

Systems and methods for positioning a connecting element adjacent the spinal column in minimally invasive procedures include instruments that guide the connecting element from a location remote from one or more anchors to a location proximate to the one or more anchors. The instruments include extensions mountable to anchors, and inserter instruments mountable to the connecting element for positioning the connecting element adjacent the anchors in a minimally invasive procedure. The inserter instruments need not be mounted to the anchors or to the anchor extensions, and are operable independently thereof to position the connecting element into the patient along a minimally invasive insertion path from a location remote from the anchor extensions.

Claims

1. A system for minimally invasive surgical procedures in a patient, comprising:

a number of anchor extensions each including an elongated body extending between a distal end and a proximal end, said body having a length wherein when said distal end is mounted to at least one anchor engaged to bony structure of the patient said proximal end is located outside the patient;

an inserter instrument including a proximal handle portion and an inserter arm extending distally from said proximal handle portion, wherein said inserter arm includes a curved profile from said handle portion to a distal end of said inserter arm and said handle portion includes an elongated grasping portion about which a user'"'"'s hand is positioned for manipulating said inserter arm in the patient, said grasping portion extending in a first direction from and transversely to said inserter arm; and

a connecting element for implantation in the body of the patient, said connecting element releasably engaged to and extending distally from said inserter arm in a second direction opposite said first direction so that said grasping portion and said connecting element extend generally parallel to one another when said connecting element is engaged to said inserter arm and said releasable engagement between said connecting element and said inserter is structured to permit said connecting element to be pushed through tissue of the patient by manipulating said grasping portion while maintaining said generally parallel relationship with said proximal handle portion, wherein said inserter arm includes a bore with a locking mechanism therein, said locking mechanism including a shaft portion extending between an engaging end adjacent a distal end of said inserter arm and an opposite end coupled to an actuating member adjacent a proximal end of said inserter arm, wherein said shaft portion extends along said curved profile of said inserter arm from said engaging end to said opposite end, said actuating member being pivotally mounted to said inserter instrument for movement between an unlocked position wherein said engaging end projects from said distal end of said inserter arm to receive said connecting element to a locked position wherein said actuating member moves said engaging end into said bore of said inserter arm, said inserter arm engaging said engaging end as said engaging end is moved therein to engage said connecting element to said engaging end.

2. The system of claim 1, wherein said number of anchor extensions includes three or more anchor extensions, each of said anchor extensions including an anchor releasably engaged to said distal end thereof.

3. The system of claim 1, wherein said curved profile of said inserter arm extends between said connecting element and said proximal handle portion.

4. The system of claim 1, wherein said connecting element includes a leading end and an opposite trailing end, said trailing end being engageable to said inserter arm and with said connecting element extending away from said inserter arm to said leading end.

5. The system of claim 4, wherein said leading end is tapered.

6. The system of claim 5, wherein said trailing end is tapered and includes a notches for engagement with said inserter instrument.

7. The system of claim 4, wherein said connecting element is linear between said leading insertion end and said trailing end.

8. The system of claim 1, wherein said inserter arm and said handle portion are joined at a junction portion forming a general L-shape.

9. The system of claim 1, wherein said connecting element includes a lumen extending between and opening at leading and trailing ends of said connecting element, said lumen being adapted to receive a guide wire.

10. The system of claim 1, wherein said engaging member includes a pair of arms and a hinge portion therebetween, said inserter arm pivoting said arms toward one another to engage said connecting element therebetween when said actuating member is moved to said locked position.

11. The system of claim 1, wherein said connecting element is elongated and extends between a leading insertion end and a trailing end and said engaging end is engaged to said trailing end.

12. The system of claim 1, wherein said actuating member is coupled to said inserter instrument with a coupling mechanism, said coupling mechanism including at least one link member having a first end pivotally coupled to said actuating member and a second end pivotally coupled to said inserter arm.

13. The system of claim 12, wherein said actuating member is pivotally coupled at one end thereof at a junction of said handle portion and said inserter arm, and in said locked position said actuating member extends along said handle portion and in said unlocked position said actuating member is pivoted away from said handle portion about said pivotal connection.

14. A system for minimally invasive surgical procedures in a patient, comprising:

at least one anchor extension including an elongated body extending between a distal end and a proximal end, said body having a length wherein when said distal end is mounted to an anchor engaged to bony structure of the patient said proximal end is located outside the patient;

an inserter instrument including a proximal handle portion and an inserter arm having a proximal end joined to said proximal handle portion, said inserter arm having a curved profile extending from said proximal end to a distal end spaced from said handle portion, wherein said handle portion includes an elongated grasping portion about which a user'"'"'s hand is positioned for manipulating said inserter arm in the patient, said grasping portion extending in a first direction from and transversely to said inserter arm; and

a connecting element for implantation in the body of the patient, said connecting element rigidly engageable to said inserter arm, wherein said connecting element includes a generally linear profile extending distally from said distal end of said inserter arm when engaged thereto, wherein said connecting element extends distally from said inserter arm in a second direction opposite said first direction so that said grasping portion and said connecting element extend generally parallel to one another when said connecting element is engaged to said inserter arm and permit said connecting element to be pushed through tissue of the patient by manipulating said grasping portion while maintaining said generally parallel relationship with said proximal handle portion, wherein said inserter arm includes a bore with a locking mechanism therein, said locking mechanism including a shaft portion extending between an engaging end adjacent a distal end of said inserter arm and an opposite end coupled to an actuating member adjacent a proximal end of said inserter arm, wherein said shaft portion extends along said curved profile of said inserter arm from said engaging end to said opposite end, said actuating member being pivotally mounted to said inserter instrument for movement between an unlocked position wherein said engaging end projects from said distal end of said inserter arm to receive said connecting element to a locked position wherein said actuating member moves said engaging end into said bore of said inserter arm, said inserter arm engaging said engaging end as said engaging end is moved therein to engage said connecting element to said engaging end.

15. The system of claim 14, wherein said handle portion and said connecting portion form an L shape.

16. The system of claim 14, wherein said anchor extension defines a space adjacent to said anchor when mounted thereto, said connecting element being sized for positioning through said space with said inserter instrument in a transverse orientation to said anchor extension.

17. The system of claim 16, wherein said anchor extension includes a first member for engagement with said anchor and a second member moveable relative to said first member into said space to contact said connecting element and move said anchor and said connecting element toward one another with said first member engaged to said anchor.

18. The system claim 14, wherein said number of anchor extensions includes three or more anchor extensions, each of said anchor extensions including an anchor releasably engaged to said distal end thereof.

19. The system of claim 14, wherein said curved profile of said inserter arm extends between said connecting element and said proximal handle portion.

20. The system of claim 14, wherein said connecting element includes a leading end and an opposite trailing end, said trailing end being engageable to said inserter arm and with said connecting element extending away from said inserter arm to said leading end.

21. The system of claim 14, wherein said inserter arm and said handle portion are joined at a junction portion forming a general L-shape.

22. The system of claim 14, wherein said connecting element includes a lumen extending between and opening at leading and trailing ends of said connecting element, said lumen being adapted to receive a guide wire.

23. The system of claim 14, wherein said engaging member includes a pair of arms and a binge portion therebetween said inserter arm pivoting said arms toward one another to engage said connecting element therebetween when said actuating member is moved to said locked position.

24. The system of claim 14, wherein said actuating member is coupled to said inserter instrument with a coupling mechanism, said coupling mechanism including at least one link member having a first end pivotally coupled to said actuating member and a second end pivotally coupled to said inserter arm.

25. The system of claim 24, wherein said actuating member is pivotally coupled at one end thereof at a junction of said handle portion and said inserter arm, and in said locked position said actuating member extends along said handle portion and in said unlocked position said actuating member is pivoted away from said handle portion about said pivotal connection.

26. A surgical system, comprising:

an anchor including a distal bone engaging portion and a proximal connecting element engaging portion;

an extension releasably engageable to said connecting element engaging portion, said extension extending along a longitudinal axis and comprising;

an inner sleeve along the longitudinal axis including a pair of distal fingers at a distal end of said inner sleeve engageable to said connecting element engaging portion, said inner sleeve extending to a proximal end opposite said distal end and including an outer surface extending around said inner sleeve, said outer surface including a threaded section adjacent said proximal end;

an outer sleeve extending along the longitudinal axis between a proximal end of said outer sleeve and a distal end of said outer sleeve and about said inner sleeve, said outer sleeve moveable distally relative to said inner sleeve from a first configuration wherein said fingers are movable to receive and release said connecting element engaging portion therebetween and a second configuration wherein said outer sleeve engages said fingers in clamping engagement with said connecting element engaging portion; and

a reducing actuator rotatably mounted to said outer sleeve at said proximal end of said outer sleeve in threaded engagement with said threaded section of said inner sleeve extending through said reducing actuator, wherein rotation of said reducing actuator displaces said inner sleeve proximally relative to said outer sleeve and through said reducing actuator from said second configuration to a third configuration where said distal end of said outer sleeve is positioned more adjacent to said fingers of said inner sleeve, and wherein said reducing actuator disengages from said threaded section in said second configuration with said inner and outer sleeves locked in axial position relative to one another.

27. The system of claim 26, wherein in said second configuration said outer sleeve includes a locking mechanism having a locking position wherein said locking mechanism includes a first projection that engages a recess in said outer surface of said inner sleeve to resist said inner sleeve moving distally relative to said outer sleeve, said locking mechanism further including a second projection that interferes with a protrusion extending from said inner sleeve to resist said inner sleeve moving proximally relative to said outer sleeve.

28. The system of claim 27, wherein said locking mechanism is movable to a release configuration wherein said inner sleeve is movable distally and proximally relative to said outer sleeve.

29. The system of claim 28, wherein said recess and said protrusion of said inner sleeve are located in a non-threaded flat wall surface extending along said threaded section of said inner sleeve.

30. The system of claim 28, wherein said locking mechanism includes an elongated locking button pivotally coupled to said outer sleeve, said first and second projections being located adjacent a proximal end of said button, said button being movable by depressing a distal end of said button and rotating said button about a connection therewith to said outer sleeve located between said distal and proximal ends of said button.

31. The system claim 26, wherein said inner sleeve defines a passage extending therethrough and opening at said proximal end thereof for receiving an engaging member for engaging said anchor.

32. The system of claim 26, wherein said proximal end of said outer sleeve includes an end collar extending therearound, and said reducing actuator includes a bearing hub extending between said reducing actuator and said end collar to rotatably and axially retain said reducing actuating on said outer sleeve.

33. The system of claim 32, wherein said reducing actuator extends proximally from said proximal end of said end collar and said proximal end of said outer sleeve to provide access to said reducing actuator for applying a rotational force about said reducing actuator.

34. A system or minimally invasive surgical procedures in a patient, comprising:

at least one anchor extension including an elongated body extending between a distal end and a proximal end, said body having a length wherein when said distal end is mounted to an anchor engaged to bony structure of the patient said proximal end is located outside the patient;

an inserter instrument including a proximal handle portion and an inserter arm having a proximal end joined to said proximal handle portion, said inserter arm having a curved profile extending from said proximal end to a distal end spaced from said handle portion, wherein said handle portion includes an elongated grasping portion about which a user'"'"'s hand is positioned for manipulating said inserter arm in the patient, said grasping portion extending in a first direction from and transversely to said inserter arm; and

a connecting element for implantation in the body of the patient, said connecting element rigidly engageable to said inserter arm, wherein said connecting element includes a generally linear profile extending distally from said distal end of said inserter arm when engaged thereto, wherein said connecting element extends distally from said inserter arm in a second direction opposite said first direction so that said grasping portion and said connecting element extend generally parallel to one another when said connecting element is engaged to said inserter arm and permit said connecting element to be pushed through tissue of the patient by manipulating said grasping portion while maintaining said generally parallel relationship with said proximal handle portion, wherein said at least one anchor extension includes;

an inner sleeve along a longitudinal axis including a pair of distal fingers at a distal end of said inner sleeve engageable to the anchor, said inner sleeve extending to a proximal end opposite said distal end and including an outer surface extending around said inner sleeve, said outer surface including a threaded section adjacent said proximal end;

an outer sleeve extending along the longitudinal axis between a proximal end of said outer sleeve and a distal end of said outer sleeve and about said inner sleeve, said outer sleeve moveable distally relative to said inner sleeve from a first configuration wherein said fingers are movable to receive and release the anchor therebetween and a second configuration wherein said outer sleeve engages said fingers in clamping engagement with the anchor; and

a reducing actuator rotatably mounted to said outer sleeve at said proximal end of said outer sleeve in threaded engagement with said threaded section of said inner sleeve extending through said reducing actuator, wherein rotation of said reducing actuator displaces said inner sleeve proximally relative to said outer sleeve and through said reducing actuator from said second configuration to a third configuration where said distal end of said outer sleeve is positioned more adjacent to said fingers of said inner sleeve, and wherein said reducing actuator disengages from said threaded section in said second configuration with said inner and outer sleeves locked in axial position relative to one another.

35. The system of claim 34, wherein said proximal end of said outer sleeve includes an end collar extending therearound, and said reducing actuator includes a bearing hub extending between said reducing actuator and said end collar to rotatably and axially retain said reducing actuating on said outer sleeve.

36. The system of claim 35, wherein said reducing actuator extends proximally from said proximal end of said end collar and said proximal end of said outer sleeve to provide access to said reducing actuator for applying a rotational force about said reducing actuator.

37. A system for minimally invasive surgical procedures in a patient, comprising:

a number of anchor extensions each including an elongated body extending between a distal end and a proximal end, said body having a length wherein when said distal end is mounted to at least one anchor engaged to bony structure of the patient said proximal end is located outside the patient;

an inserter instrument including a proximal handle portion and an inserter arm extending distally from said proximal handle portion, wherein said inserter arm includes a curved profile from said handle portion to a distal end of said inserter arm and said handle portion includes an elongated grasping portion about which a user'"'"'s hand is positioned for manipulating said inserter arm in the patient, said grasping portion extending in a first direction from and transversely to said inserter arm; and

a connecting element for implantation in the body of the patient, said connecting element releasablv engaged to and extending distally from said inserter arm in a second direction opposite said first direction so that said grasping portion and said connecting element extend generally parallel to one another when said connecting element is engaged to said inserter arm and said releasable engagement between said connecting element and said inserter is structured to permit said connecting element to be pushed through tissue of the patient by manipulating said grasping portion while maintaining said generally parallel relationship with said proximal handle portion, wherein at least one of said number of anchors extensions includes;

an inner sleeve along a longitudinal axis including a pair of distal fingers at a distal end of said inner sleeve engageable to the anchor, said inner sleeve extending to a proximal end opposite said distal end and including an outer surface extending around said inner sleeve, said outer surface including a threaded section adjacent said proximal end;

an outer sleeve extending along the longitudinal axis between a proximal end of said outer sleeve and a distal end of said outer sleeve and about said inner sleeve, said outer sleeve moveable distally relative to said inner sleeve from a first configuration wherein said fingers are movable to receive and release the anchor therebetween and a second configuration wherein said outer sleeve engages said fingers in clamping engagement with the anchor; and

a reducing actuator rotatably mounted to said outer sleeve at said proximal end of said outer sleeve in threaded engagement with said threaded section of said inner sleeve extending through said reducing actuator, wherein rotation of said reducing actuator displaces said inner sleeve proximally relative to said outer sleeve and through said reducing actuator from said second configuration to a third configuration where said distal end of said outer sleeve is positioned more adjacent to said fingers of said inner sleeve, and wherein said reducing actuator disengages from said threaded section in said second configuration with said inner and outer sleeves locked in axial position relative to one another.

38. The system of claim 37, wherein said proximal end of said outer sleeve includes an end collar extending therearound, and said reducing actuator includes a bearing hub extending between said reducing actuator and said end collar to rotatably and axially retain said reducing actuating on said outer sleeve.

39. The system of claim 38, wherein said reducing actuator extends proximally from said proximal end of said end collar and said proximal end of said outer sleeve to provide access to said reducing actuator for applying a rotational force about said reducing actuator.