Introducer for inserting a connecting rod into a spine

• US 8,167,887 B2
• Filed: 06/18/2010
• Issued: 05/01/2012
• Est. Priority Date: 06/18/2010
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: McLean, Scott
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): NEGRELLIRODRIGUEZ, CHRISTINA
• Application Number:
  US12/818,983
• Publication Number:
  US 20110313475A1
• Time in Patent Office: 683 Days
• Field of Search: 606/86.A, 606/96, 606/98, 606/99, 606/100, 606/103, 606/104, 606/246, 606/250, 606/279
• US Class Current: 606/86.A
• CPC Class Codes: A61B 17/7002 Longitudinal elements, e.g. rods
• CPC Class Codes: A61B 17/7004 with a cross-section which varies along its length A61B17/7019 takes precedence
• CPC Class Codes: A61B 17/7011 Longitudinal element being non-straight, e.g. curved, angled or branched adjustable length longitudinal elements A61B17/7014; A61B17/7019 takes precedence, e.g. coil springs
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7034 characterised by a lateral opening
• CPC Class Codes: A61B 17/7035 Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
• CPC Class Codes: A61B 17/7037 wherein pivoting is blocked when the rod is clamped
• CPC Class Codes: A61B 17/7076 for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
• CPC Class Codes: A61B 17/7077 for moving bone anchors attached to vertebrae, thereby displacing the vertebrae
• CPC Class Codes: A61B 17/7079 Tools requiring anchors to be already mounted on an implanted longitudinal or transverse element, e.g. where said element guides the anchor motion
• CPC Class Codes: A61B 17/7082 for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws driving other bone screws A61B17/8875
• 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 17/7085 for insertion of a longitudinal element down one or more hollow screw or hook extensions, i.e. at least a part of the element within an extension has a component of movement parallel to the extension's axis
• 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 17/8875 Screwdrivers, spanners or wrenches

Abstract

An introducer is provided for inserting a connecting rod into tissue of a spine that comprises an outer sleeve with an actuatable rod attachment portion at a distal end thereof to releasably pivotally attach to a connecting rod, and an elongate inner shaft movable translationally within the outer sleeve. The proximal end of the shaft is coupled to an actuation mechanism for selectively translating the inner shaft. The distal end of the shaft includes a rod engagement surface that is movable y the actuation mechanism to a first position to engage a cooperative engagement surface on the rod to hold the rod in a selected locked orientation, to a second position to space the rod engagement surface from the cooperative engagement surface of the rod to allow pivoting of the rod, and to a third position to release the rod from the outer sleeve.

Claims

1. An introducer for inserting a connecting rod into tissue of a spine, comprising:

an elongate hollow outer sleeve having a proximal end and a distal end;

a handle attached to said outer sleeve at the proximal end;

an actuatable rod attachment portion at the distal end of said outer sleeve to releasably pivotally attach to one end of said connecting rod; and

an elongate inner shaft movable translationally within said outer sleeve and having a proximal end and a distal end, said shaft at the proximal end coupled to an actuation mechanism in said handle for selectively translating said inner shaft, said shaft at the distal end including a rod engagement portion including a rod engagement surface, said rod engagement surface being movable distally upon actuation of said actuation mechanism to a first position to place said rod engagement surface in engagement with a cooperative engagement surface on said rod to hold said rod in a selected locked orientation, proximally upon actuation of said actuation mechanism to a second position to space said rod engagement surface a distance from the cooperative engagement surface of said rod to allow pivoting of said rod relative to the axis of said inner shaft, and more proximally from said second position upon actuation of said actuation mechanism to a third position to actuate said actuatable rod attachment portion to release said rod from said outer sleeve.

2. The introducer of claim 1, where said actuatable rod attachment portion of said outer sleeve includes a pair of spaced opposing flexible legs defining therebetween an expandable opening for receipt of said one end of said connecting rod.

3. The introducer of claim 2, wherein said legs respectively include thereon a pair of posts adjacent the distal end of said legs projecting toward each other, said posts being disposed generally perpendicular to the longitudinal axis of said outer sleeve.

4. The introducer of claim 3, wherein said legs each include a cam spaced proximally from said pins and wherein said inner shaft includes a cam surface movable with said translatable inner shaft to said third position to cause said cam surface to cooperatively engage said cam and thereby separate said opposing legs and expand said expandable opening.

5. The introducer of claim 4, wherein said actuation mechanism in said handle includes a hand lever, pivotally joined to said handle and pivotally movable from an open position to a closed position, said lever being pivotally coupled at one end to the proximal end of said inner shaft, such that in said lever open position said inner shaft is in said third position for release of said rod, and upon movement of said lever to said closed position said inner shaft is translated to said first position for holding said rod in said locked orientation.

6. The introducer of claim 5, wherein said lever is spring-biased to urge said lever to a normally open position in said handle.

7. The introducer of claim 6, wherein said lever includes adjacent the opposite end first and second locking surfaces.

8. The introducer of claim 1, wherein said actuation mechanism includes a first releasable locking element engagable with said first locking surface on said lever to releasably maintain said lever in said closed position and said inner shaft in said first position, and upon disengagement of said first locking element from said first locking surface said lever is pivotally moved under said spring bias to an intermediate position between said open position and said closed position translating said shaft proximally from said first position to said second position.

9. The introducer of claim 8, wherein said first release locking element as a spring-loaded button supported by said handle.

10. The introducer of claim 8, wherein said actuation mechanism includes a second releasable locking element engagable with said second locking surface on said lever to releasably maintain said lever in said intermediate position and said inner shaft in said second position, and upon disengagement of said second locking element from said second locking surface said lever is pivotally moved under said spring bias to said open position translating said inner shaft from said second position to said third position.

11. An apparatus for percutaneously inserting a connecting rod into tissue of a spine, comprising:

the introducer of claim 1; and

an elongate connecting rod releasably pivotally attached to said introducer and having a distal end contoured for insertion into tissue and a proximal end having a connecting portion including a cooperative engagement surface for cooperative engagement with the rod engagement surface at the distal end of said inner shaft of said rod introducer.

12. The apparatus of claim 11, wherein said cooperative engagement surface of said rod connecting portion and said rod engagement surface of said inner shaft are each substantially flat surfaces, said flat rod engagement surface of said inner shaft lying generally perpendicular to the longitudinal axis of said inner shaft and the flat cooperative engagement surface of said rod connecting portion being oriented at a selected angle with respect to the axis of said rod, such that in said first position said flat rod engagement surface and said flat cooperative surface are in engagement thereby locking said rod in a selected angle relative to the axis of said inner shaft.

13. The apparatus of claim 11, wherein:

said rod engagement portion of said inner shaft defines a socket including said rod engagement surface therein; and

said connecting portion of said rod defines a projection including said cooperative engagement surface thereon said socket configured to receive said projection.

14. The apparatus of claim 13, wherein said projection and said socket have configurations that are substantially mirror images of each other.

15. The apparatus of claim 14, wherein in said first position said cooperative engagement surface on said projection and said rod engagement surface in said socket are in engagement.

16. The apparatus of claim 14, wherein in said second position said cooperative engagement surface on said projection and said rod engagement surface in said socket are spaced from each other.

17. The apparatus of claim 16, wherein said socket operates as a detent allowing pivoting movement of said rod relative to the axis of said inner shaft to a plurality of discrete positions.

18. The apparatus of claim 17, wherein said projection and said socket are each configured in a polygon shape.

19. The apparatus of claim 18, wherein between pivoting movements of said rod from one discrete position to another corners of said polygonal shape of said projection frictionally interfere with polygonal surfaces of said socket in a manner overcome by manual force creating tactile feedback to a user and audible snapping into subsequent positions.

20. An apparatus for percutaneously inserting a connecting rod into tissue of a spine, comprising:

an elongate connecting rod having a distal end contoured for insertion into tissue and a proximal end having a connecting portion including at least one flat connecting surface; and

a rod introducer releasably pivotally attached to said rod, including;

an elongate hollow outer sleeve having a proximal end and a distal end;

a handle attached to said outer sleeve at the proximal end;

a rod attachment portion at the distal end of said outer sleeve releasably pivotally attached to said connecting portion of said rod; and

an elongate inner shaft movable translationally within said outer sleeve and having a proximal end and a distal end, said shaft at the proximal end coupled to an actuation mechanism in said handle for selectively translating said inner shaft, said shaft at the distal end including a rod engagement portion including at least one flat engagement surface lying in a plane transverse to and crossing the longitudinal axis of said shaft, said flat engagement surface being movable distally upon actuation of said actuation mechanism to a first position to place said engagement surface in engagement with said flat connecting surface on said rod to hold said rod in a selected discrete locked orientation and proximally upon actuation of said actuation mechanism to a second position to space said engagement surface a distance from said flat connecting surface of said rod to allow pivoting of said rod relative to the axis of said inner shaft while being pivotally attached to the rod attachment portion of the outer sleeve.

21. The apparatus of claim 20, wherein said flat engagement surface lies in a plane substantially perpendicular to the longitudinal axis of said inner shaft.

22. The apparatus of claim 21, wherein said rod engagement portion of said inner shaft includes at least one other flat engagement surface disposed at an angle with respect to said flat engagement surface.

23. The apparatus of claim 22, wherein there are plural flat engagement surfaces defining a socket in the shape of a polygon.

24. The apparatus of claim 23, wherein said polygon shape is in the form of a partial hexagon.

25. The apparatus of claim 23, wherein said connecting portion of said rod includes plural flat connecting surfaces arranged at angles with respect to each other and in a shape configured to extend into the socket defined at the distal end of said inner shaft such that flat connecting surfaces of said rod connecting portions are in engagement with flat engagement surfaces of the socket defined at the distal end of said inner shaft.

26. The apparatus of claim 20, wherein said connecting portion of said rod defines a projection including said at least one flat connecting surface and wherein said rod engagement portions of said inner shaft defines a socket including said at least one flat engagement surface, said socket configured to be in a shape generally the mirror image of said rod projection and to receive said projection with at least said flat connecting surface of said rod being in engagement with said one flat engagement surface of the socket at the distal end of said inner shaft in said first position.

27. An introducer for percutaneously inserting a connecting rod into tissue of a spine, comprising:

an elongate hollow outer sleeve having a proximal end and a distal end;

a handle attached to said outer sleeve at the proximal end;

a rod attachment portion at the distal end of said outer sleeve to releasably pivotally attach to one end of said connecting rod; and

an elongate inner shaft movable translationally within said outer sleeve and having a proximal end and a distal end, said shaft at the proximal end coupled to an actuation mechanism in said handle for selectively translating said inner shaft, said shaft at the distal end including a rod engagement portion including at least one flat engagement surface lying in a plane transverse to and crossing the longitudinal axis of said shaft, said flat engagement surface being movable distally upon actuation of said actuation mechanism to a first position to place said engagement surface in engagement with a cooperative engagement surface on said rod to hold said rod in a selected discrete locked orientation and proximally upon actuation of said actuation mechanism to a second position to space said engagement surface a distance from the cooperative engagement surface of said rod to allow pivoting of said rod relative to the axis of said inner shaft thereby unlock said rod from said locked orientation.

28. The introducer of claim 27, wherein said inner shaft in said second position is spaced from the cooperative engagement surface of said rod to allow pivoting of the rod relative to the axis of said inner shaft.