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Publication numberUS20080300638 A1
Publication typeApplication
Application numberUS 12/188,418
Publication dateDec 4, 2008
Filing dateAug 8, 2008
Priority dateNov 20, 2006
Also published asUS7967821, US8262662, US20080119849, US20080119850, US20090228052, WO2008063416A2, WO2008063416A3
Publication number12188418, 188418, US 2008/0300638 A1, US 2008/300638 A1, US 20080300638 A1, US 20080300638A1, US 2008300638 A1, US 2008300638A1, US-A1-20080300638, US-A1-2008300638, US2008/0300638A1, US2008/300638A1, US20080300638 A1, US20080300638A1, US2008300638 A1, US2008300638A1
InventorsTimothy Beardsley, Douglas Bireley, James J. Roveda, Christopher Sicvol, Anthony R. Carlone
Original AssigneeDepuy Spine, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Break-off screw extensions
US 20080300638 A1
Abstract
The present invention provides minimally invasive devices and methods for delivering a spinal connector to one or more spinal anchor sites in a patient's spinal column. In one embodiment, a spinal implant and access device is provided that includes a U-shaped receiver member, a bone-engaging member, and an extension member. The U-shaped receiver member can have a recess formed therein that is adapted to seat a spinal connector. The bone-engaging member can extend distally from the receiver member and it can be adapted to engage bone to thereby mate the receiver member to bone. The extension member can extend proximally from the receiver member and it can include a frangible portion formed thereon that is adapted to break when a predetermined force is applied thereto thereby allowing at least a portion of the extension member to be separated from the receiver member.
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Claims(35)
1-21. (canceled)
22. A spinal surgical system, comprising:
a connecting member including an elongated body having a length sized to extend between at least two vertebrae; and
an anchor assembly including a distal anchor engageable to bony structure and an extended receiver extending proximally from and pivotally coupled to said anchor, said extended receiver including a distal implantation portion adjacent said anchor sized and shaped to receive said connecting member therein, said extended receiver further including a proximal guide portion including a pair of removable arms extending along a central axis, said arms extending proximally from and formed as a single unit with a respective one of a pair of opposite side members of said implantation portion, said arms defining a channel extending therebetween from said implantation portion through proximal ends of said pair of arms, said channel including a thread profile along only a distal portion of said arms, and said channel being sized and shaped to receive said connecting member through said proximal end opening thereof in a transverse orientation to said central axis.
23. The system of claim 22, wherein each of said arms is joined to said respective side member with a break-off region having a wall thickness reduced comparatively to an adjacent wall thickness of said respective arm and said respective side member.
24. The system of claim 22, wherein each of said side members defines an internal thread profile along said implantation portion and each of said arms defines an internal thread profile adjacent a distal end thereof that forms an extension of the thread profile of said side members.
25. The system of claim 24, wherein each of said arms is joined to said respective side member at a break-off region between said internal thread profile of said side members and said internal thread profile of said arms.
26. The system of claim 22, wherein said anchor includes a head pivotally captured in said implantation portion of said extended receiver, said anchor further including a shaft extending through a distal opening through said implantation portion for engaging the bony structure.
27. The system of claim 26, further comprising a crown positioned about said head of said anchor in said implantation portion.
28. The system of claim 27, further comprising a second anchor assembly including a second distal anchor engageable to a second vertebra and a second extended receiver extending proximally from and pivotal relative to said second anchor, said second extended receiver including a distal implantation portion adjacent said second anchor sized and shaped to receive said connecting member therein, said second extended receiver further including a proximal guide portion including a pair of removable arms extending along a central axis proximally from and formed as a single unit with a respective one of a pair of opposite side members of said implantation portion, said arms defining a channel extending therebetween from said implantation portion through proximal ends of said pair of arms, said channel being sized and shaped to receive said connecting member through said proximal end opening thereof in a transverse orientation to said central axis.
29. The system of claim 28, wherein, for each of said extended receivers, each of said side members defines an internal thread profile along said implantation portion and each of said arms of said respective extended receiver defines an internal thread profile adjacent a distal end thereof that forms an extension of the thread profile of said side members, and further comprising:
first and second engaging members positionable in a respective one of said extended receivers to secure said connecting member in said implantation portion thereof, each of said engaging members including an externally threaded portion threadingly engageable with said internal thread profiles along said arms and said side members of said respective extended receiver.
30. The system of claim 28, wherein said connecting member includes a length sized to extend between at least three vertebrae and further comprising a third anchor assembly including a third distal anchor engageable to a third vertebra and a third extended receiver extending proximally from and pivotal relative to said third anchor, said third extended receiver including a distal implantation portion adjacent said third anchor sized and shaped to receive said connecting member therein, said third extended receiver further including a proximal guide portion including a pair of removable arms extending along a central axis proximally from and formed as a single unit with a respective one of a pair of opposite side members of said implantation portion, said arms defining a channel extending therebetween from said implantation portion through proximal ends of said pair of arms, said channel being sized and shaped to receive said connecting member through said proximal end opening thereof in a transverse orientation to said central axis.
31. The system of claim 22, wherein each of said arms includes a length extending from said respective side member that is at least 30 millimeters.
32. An anchor assembly for securing an elongate connecting member along the spinal column, comprising:
a distal anchor for engaging bony structure and an extended receiver extending proximally from said anchor, said extended receiver including a distal implantation portion adjacent said anchor, said implantation portion being sized and shaped to receive the connecting member therein, said extended receiver further including a guide portion extending proximally from said implantation portion along a central axis, wherein said implantation portion includes opposite side members and said guide portion includes opposite arms defining a channel therebetween and said opposite arms each include a distal end formed as a single unit with a respective one of said side members at a break-off region, said break-off region providing a separation location for separation of said arms from said respective side member upon application of a threshold force to said arms, said separation location providing a recessed surface interrupting an internal thread profile extending along said arms and said side members.
33. The assembly of claim 32, wherein said channel extends through and opens at proximal ends of said arms.
34. The assembly of claim 33, wherein said channel is sized and shaped to receive said connecting member through said proximal end opening thereof in a transverse orientation to said central axis.
35. The assembly of claim 32, wherein each of said break-off regions includes a wall thickness reduced comparatively to an adjacent wall thickness of said respective arm and said respective side member.
36. The assembly of claim 32, wherein said recessed surface extends completely about said arm and said side member.
37. The assembly of claim 32, further comprising an engaging member positionable in said extended receiver, said engaging member including an externally threaded portion threadingly engageable with said internal thread profiles along said arms and said side members.
38. An anchor assembly for securing an elongate connecting member along the spinal column, comprising:
a distal anchor and an extended receiver extending proximally from said anchor, said extended receiver including a distal implantation portion adjacent said anchor, said extended receiver further including a guide portion extending proximally from said implantation portion along a central axis, wherein said implantation portion includes opposite side members and said guide portion includes opposite arms each defining a channel therebetween for receiving the connecting member therethrough, wherein each of said side members defines an internal thread profile along said implantation portion and each of said arms defines an internal thread profile adjacent a distal end thereof along only a portion of a length of said arm, said internal thread profile forming an extension of the thread profile of said side members, wherein each of said arms is joined to said respective side member as a single unit therewith at a reduced thickness region between said internal thread profiles of said arm and said side member, said reduced thickness region defining a separation location for separation of said arm from said respective side member upon application of a threshold force to said arm.
39. The assembly of claim 38, wherein said anchor is pivotally coupled to said extended receiver.
40. A method for securing a connecting element along a spinal column, comprising:
engaging a first anchor assembly to a first vertebra and a second anchor assembly to a second vertebra, the first and second anchor assemblies each including an extended receiver extending proximally from the respective first and second vertebrae through the skin of the patient;
positioning an elongate connecting member through the extended receivers in an orientation generally parallel to the spinal column;
guiding the connecting member along proximal guide portions of the extended receivers and into distal implantation portions of the extended receivers;
securing the connecting member in the implantation portions with engaging members positioned into respective ones of the extended receivers in engagement with the implantation portion thereof; and
removing the guide portions by applying force to each of the guide portions, the force severing the guide portions from the respective implantation portion at a break-off region where the guide portion is formed as a single unit with the implantation portion.
41. The method of claim 40, wherein the guide portions each include a pair of arms and the implantation portions each include a pair of side members, said pair of arms being formed at a distal end thereof as a single unit with a respective one of said side members.
42. The method of claim 41, wherein securing the connecting member includes threadingly advancing the engaging member along an internal thread profile that extends only along a portion of a length of the guide portion and the implantation portion of the respective extended receiver.
43. The method of claim 40, further comprising pivoting the extended receiver of at least one of the anchor assemblies to a desired position relative to an anchor engaged to the respective vertebra.
44. The assembly of claim 38, wherein said reduced thickness portion forms a recessed surface that extends completely about said arm and said side member.
45. The assembly of claim 38, further comprising an engaging member positionable in said extended receiver, said engaging member including an externally threaded portion threadingly engageable with said internal thread profiles along said arms and said side members.
46. An anchor assembly for securing an elongate connecting member along the spinal column, comprising:
a distal anchor engageable to bony structure and an extended receiver extending proximally from and pivotally coupled to said anchor; said extended receiver including a distal implantation portion adjacent said anchor sized and shaped to receive the connecting member therein, said extended receiver further including a proximal guide portion including a pair of removable arms extending along a central axis, said arms extending proximally from and formed as a single unit with a respective one of a pair of opposite side members of said implantation portion, said arms defining a channel extending therebetween from said implantation portion through proximal ends of said pair of arms, said channel including a thread profile along only a distal portion of said arms, and said channel being sized and shaped to receive the connecting member through said proximal end opening thereof in a transverse orientation to said central axis.
47. The assembly of claim 46, wherein each of said arms is joined to said respective side member with a break-off region having a wall thickness reduced comparatively to an adjacent wall thickness of said respective arm and said respective side member.
48. The assembly of claim 46, wherein each of said side members defines an internal thread profile along said implantation portion and each of said arms defines an internal thread profile adjacent a distal end thereof that forms an extension of the thread profile of said side members.
49. The assembly of claim 48, wherein each of said arms is joined to said respective side member at a break-off region between said internal thread profile of said side members and said internal thread profile of said arms.
50. The assembly of claim 46, wherein said anchor includes a head pivotally captured in said implantation portion of said extended receiver, said anchor further including a shaft extending through a distal opening through said implantation portion for engaging the bony structure.
51. The assembly of claim 50, further comprising a crown positioned about said head of said anchor in said implantation portion.
52. The assembly of claim 46, wherein each of said arms includes a length extending from said respective side member that is at least 30 millimeters.
53. The assembly of claim 46, wherein each of said arms is joined to said respective side member with a break-off region having a recessed surface between said respective arm and said respective side member.
54. The assembly of claim 53, wherein said recessed surface extends completely about said arm and said side member.
55. The assembly of claim 46, wherein each of said side members defines an internal thread profile along said implantation portion and further comprising an engaging member positionable in said extended receiver, said engaging member including an externally threaded portion threadingly engageable with said internal thread profiles along said arms and said side members.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 11/561,455 filed on Nov. 20, 2006 and entitled “Break-Off Screw Extensions,” which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to tools for use in spinal surgery, and in particular to minimally invasive methods and devices for introducing a spinal connector to one or more spinal anchor sites within a patient's spine.

BACKGROUND OF THE INVENTION

For a number of known reasons, spinal fixation devices are used in orthopedic surgery to align and/or fix a desired relationship between adjacent vertebral bodies. Such devices typically include a spinal connector, such as a relatively rigid fixation rod, that is coupled to adjacent vertebrae by attaching the connector to various anchoring devices, such as hooks, bolts, wires, or screws. The connector can have a predetermined contour that has been designed according to the properties of the target implantation site, and once installed, the instrument holds the vertebrae in a desired spatial relationship, either until healing or spinal fusion has taken place, or for some longer period of time.

Spinal connectors can be anchored to specific portions of the vertebrae. Since each vertebra varies in shape and size, a variety of anchoring devices have been developed to facilitate engagement of a particular portion of the bone. Pedicle screw assemblies, for example, have a shape and size that is configured to engage pedicle bone. Such screws typically include a threaded shank that is adapted to be threaded into a vertebra, and a head portion having a receiving element, usually in the form of a U-shaped head. A set-screw, plug, or similar type of fastening mechanism is used to lock the spinal connector, e.g., a spinal rod, into the receiving head of the pedicle screw. In use, the shank portion of each screw is threaded into a vertebra, and once properly positioned, a rod is seated through the receiving member of each screw and the rod is locked in place by tightening a cap or other fastener mechanism to securely interconnect each screw and the spinal rod.

Minimally invasive devices and methods for implanting spinal fixation devices are advantageous because such devices and methods utilize few incisions for introducing and implanting anchoring devices and spinal connectors at a target site within a patient's spine. Such procedures offer advantages over invasive techniques because they reduce the amount of damage to surrounding tissue and muscle and the amount of time required to complete the procedure.

Accordingly, there is a need for improved minimally invasive devices and methods for introducing a spinal connector into a patient's spine.

SUMMARY OF THE INVENTION

The present invention provides minimally invasive devices and methods for implanting a spinal anchor in bone, for percutaneously delivering various tools and implants to the spinal anchor through an extension coupled thereto, and for removing the extension coupled to the spinal anchor. In one embodiment, a spinal implant and access device is provided that includes a U-shaped receiver member, a bone-engaging member, and an extension member. The U-shaped receiver member can have a recess formed therein that is adapted to seat a spinal connector, such as a spinal rod. In one exemplary embodiment, the receiver member can have a maximum outer diameter that is substantially the same as a maximum outer diameter of the extension member. The bone-engaging member can extend distally from the receiver member and it can be adapted to engage bone to thereby mate the receiver member to bone. A variety of configurations are available for the bone-engaging member, for example, in one embodiment the bone-engaging member can be a threaded shank such as a bone screw.

As indicated above, the access device can include an extension member. The extension member can extend proximally from the receiver member and it can have a lumen extending therethrough. Although a variety of shapes and sizes are available for the extension member in an exemplary embodiment, the extension member has a length that is adapted to span through a skin surface in a patient to the U-shaped receiver member when the bone engaging member is implanted in a vertebra. The extension member can also include a frangible portion formed thereon that is adapted to break when a predetermined force is applied thereto thereby allowing at least a portion of the extension member to be separated from the receiver member. In one embodiment, the extension member can include a proximal end and a distal end that is coupled to the receiver member. The frangible portion can be formed adjacent to the distal end.

The extension member can also have a variety of configurations. For example, in one embodiment, the extension member can include first and second opposed extension arms that extend proximally from the U-shaped receiver member and that are separated by opposed slots that extend between the arms. The opposed slots can extend from the proximal end to the distal end or the first and second extension arms can be coupled to one another at least one location located proximal to the frangible portion. In another embodiment, the extension member can be a hollow elongate tube. The hollow elongate tube can include opposed slots that extend from a distal end of the tube and that terminate distal to a proximal end of the tube. Various configurations are also available for the frangible portion of the extension member. For example, in one embodiment, the frangible portion can include an annular groove formed around the extension member.

In another embodiment, a removal tool is provided. Although a variety of configurations are available for the removal tool, in an exemplary embodiment the tool can include an elongate member having a proximal portion that is adapted to be positioned adjacent to a skin incision and a distal portion that is adapted to be positioned adjacent to a vertebra and to be received within a lumen formed in an extension member of a spinal anchor. The distal portion can include an engagement mechanism that is adapted to engage an inner surface of the extension member of the spinal anchor and to apply a radially directed force to the extension member disposed therearound to break at least a portion of the extension member apart from the spinal anchor. The engagement mechanism can have a variety of configurations. For example, in one embodiment, the engagement mechanism can be a cam formed on a distal portion of the elongate member. In another embodiment, the engagement mechanism can be a set screw formed on a distal portion of the elongate member. The set screw can have a proximal threaded portion with an outer diameter that is greater than an outer diameter of a distal threaded portion. The removal tool can also include a handle disposed on a proximal portion that is adapted to rotate the elongate member to cause the engagement mechanism to apply a radially directed force to an extension member that is disposed therearound.

Exemplary spinal systems are also provided. In one embodiment, system can include a spinal anchor and a removal tool. The spinal anchor can be adapted to be implanted in bone and it can have a receiver member with a recess formed therein for seating a spinal connector. An extension member can be frangibly coupled to the receiver member and it can be adapted to span through a skin surface in a patient to the receiver member when the receiver member is coupled to a vertebra. A variety of configurations are available for the extension member and the removal tool, including those discussed above.

Methods for implanting a spinal anchor and removing a percutaneous access device from a spinal anchor are also provided. In one embodiment, the method can include percutaneously delivering a spinal anchor to a vertebra, advancing a spinal connector through an extension member that is frangibly attached to the spinal anchor, and separating the extension member from the spinal anchor. Advancing the spinal connector through the extension member can generally include advancing the connector in a first orientation substantially parallel to a longitudinal axis of the extension member and manipulating the connector to extend in a second orientation angled with respect to the first orientation to position the connector in relation to the spinal anchor. In one embodiment, the spinal connector can extend substantially parallel to a patient's spinal column in the second orientation. A variety of techniques can be used to separate the extension member from the spinal anchor. For example, removing the percutaneous access device from the spinal anchor can generally include inserting an elongate member into a lumen formed through the percutaneous access device and actuating the elongate member to cause the elongate member to apply a radially directed force to an inner surface of the access device to break at least a portion of the device away from the spinal anchor. In one exemplary embodiment, actuating the elongate member can include rotating the elongate member such that an engagement mechanism disposed on a distal portion of the member engages and applies the radially directed force to an inner surface of the access device. The elongate member can be rotated by applying a force to a handle disposed on a proximal end of the elongate member.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1A is a perspective view of a spinal implant and access device having an extension frangibly coupled to a spinal anchor according to one embodiment of the present invention;

FIG. 1B is an enlarged perspective view of the frangible portion of the spinal implant and access device shown in FIG. 1A;

FIG. 1C is a cross-sectional view of a portion of the spinal implant and access device of FIG. 1A;

FIG. 1D is a perspective view of another embodiment of an extension member having a closed configuration for use with a spinal anchor and access device;

FIG. 1E is a perspective view of another embodiment of an extension member having an open configuration for use with a spinal anchor and access device;

FIG. 1F is a perspective view of another embodiment of a proximal end of an extension member having threads formed therein and flats formed on an external surface thereof;

FIG. 2A is a perspective view of a removal tool according to one embodiment of the present invention;

FIG. 2B is an enlarged perspective view of a distal end of the removal tool shown in FIG. 2A;

FIG. 2C is a cross-sectional view of the tool shown in FIG. 2B;

FIG. 3A is a perspective view of a removal tool according to another embodiment of the present invention;

FIG. 3B is a cross-sectional view of the removal tool shown in FIG. 3A disposed within the extension member of the device of FIG. 1A;

FIG. 3C is a cross-sectional view of the removal tool and extension member shown in FIG. 3B showing the tool applying a force to an inner surface of the extension member;

FIG. 4A is a perspective view of another embodiment of a removal tool having first and second breaker arms, showing the tool coupled to the device of FIG. 1A;

FIG. 4B is a perspective view of a distal portion of another embodiment of an extension member;

FIG. 5A is an illustration showing the device of FIG. 1A implanted in adjacent vertebra, and showing a spinal rod about to be inserted therethrough;

FIG. 5B is an illustration showing the spinal rod of FIG. 5A being passed through the slots in the extension members of the devices of FIG. 5A;

FIG. 5C illustrates the rod of FIG. 5B positioned within the spinal anchor of the devices of FIG. 5B;

FIG. 6A is an illustration showing a driver tool being used to apply a fastening element to the spinal anchor of FIG. 5C to lock the rod within the anchor;

FIG. 6B is an illustration of one embodiment of a torque driver and a stabilizer to facilitate tightening of the fastening element of FIG. 6A;

FIG. 7A is an illustration showing another embodiment of a technique for removing the extension arms from the spinal anchor of the device of FIG. 1A, showing a removal tool in an initial position;

FIG. 7B is an illustration showing the removal tool of FIG. 7A in a final position;

FIG. 8 is an illustration showing one embodiment of a jig and a targeting device in use with the spinal anchor and access device of FIG. 1A;

FIG. 9 is an illustration showing one embodiment of a distractor device in use with the spinal anchor and access device of FIG. 1A; and

FIG. 10 is an illustration showing one embodiment of a technique for using the spinal anchor and access device of FIG. 1A to correct a spinal deformity.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

The present invention provides minimally invasive methods and devices for introducing a spinal connector into a surgical site in a patient's spinal column. In general, a spinal implant and access device is provided for creating a minimally invasive pathway from a skin incision to a spinal anchor site for delivering various tools and devices to the spinal anchor site. In an exemplary embodiment, the access device can be in the form of an extension member that is mated to or formed on and extends proximally from a spinal anchor. The extension member can be used to implant the spinal anchor, and, once the anchor is implanted, to manipulate the spinal anchor from outside of the patient's body as well as to provide a pathway through a skin surface to the spinal anchor for introducing various tools and spinal system components, such as spinal connectors, fasteners, installation tools, and removal tools. The extension member can also be adapted to be easily detached from or broken off of the spinal anchor once the procedure is complete. Such a configuration eliminates the steps of assembling, disassembling, and cleaning which are currently required for conventional screw extensions.

FIG. 1A illustrates one exemplary embodiment of a spinal implant and access device 10 having an extension member 12 that is mated to a spinal anchor 14. As shown, the anchor 14 includes a U-shaped receiver member 16 and a bone-engaging member 14 b that extends distally from the receiver member 16. The U-shaped receiver member 16 can have a recess 16 a formed therein that is adapted to seat a spinal connector, such as a spinal rod. The bone-engaging member 14 b can extend distally from the receiver member 16 and it can be adapted to engage bone such that it is effective to mate the receiver member 16 to bone. The extension member 12 can include a distal end 12 b that is mated to and extends proximally from the receiver member 16. In use, the extension member 12 can define a pathway from a skin incision in a patient to the spinal anchor, which can be implanted in a vertebra of a spine. In an exemplary embodiment, the extension member 12 can be removably mated to the receiver member 16 to allow at least a portion of the extension member 12 to be separated from the receiver member 16.

The anchor can have a variety of configurations. In the embodiment shown in FIG. 1A, the anchor 14 is in the form of a spinal screw. As shown, the spinal screw 14 includes a distal bone-engaging member 14 b, e.g., a threaded shank, and a proximal U-shaped receiver member 16 that is adapted to seat a spinal connector, such as a rigid or dynamic spinal rod. The U-shaped receiver member 16 can include opposed arms 16 b, 16 c having cut-outs 16 d, 16 e formed therein that define the U-shaped recess 16 a. The bone-engaging member 14 b can be fixedly attached to the receiver member 16 to form a monoaxial screw, or alternatively the bone-engaging member 14 b can be configured as a polyaxial screw that is rotatably disposed through an opening formed in the distal end of the receiver member 16 to allow rotation of the bone-engaging member 14 b with respect to the receiver member 16. A variety of techniques known in the art can be used to allow rotation of the receiver member 16 with respect to the bone-engaging member 14 b. A person skilled in the art will appreciate that a variety of other anchors can be used with the devices and methods of the present invention, including, for example, spinal hooks, bolts, and wires.

The extension member 12 that is coupled to the anchor 14 can also have a variety of configurations. In the illustrated embodiment, the extension member 12 extends proximally from the receiver member 16 and defines a lumen 17 extending therethrough. In particular, a distal end of opposed arms 12 c, 12 d of the extension member 12 can be mated to or integrally formed with and can extend proximally from a proximal end of the opposed arms 16 b, 16 c of the receiver member 16. As will be discussed in more detail below, this will allow opposed slots 13 a, 13 b in the extension member 12 to align with the opposed cut-outs 16 d, 16 e in the receiver member 16. The inner lumen 17 of the extension member 12 can define a longitudinal axis L that extends between proximal and distal ends 12 a, 12 b of the extension member 12. The size of the extension member 12 can vary depending on the intended use, but in an exemplary embodiment it has a length that allows the proximal end 12 a of the extension member 12 to be positioned outside the patient's body, while the distal end 12 b of the extension member 12 is coupled to the spinal anchor 14 which is implanted in a vertebra in a patient's spine. More particularly, the extension member 12 can have a length that allows the extension member 12 to span through the skin surface to the receiver member 16 when the bone engaging member is fully implanted in a vertebra, and the receiver member 16 is positioned adjacent to the vertebrae, e.g., the bottom surface of the receiver member 16 is in contact with or within about 1 mm to 2 mm of the vertebra. Such a configuration is particularly advantageous as it allows the extension member 12 to be used to introduce and facilitate positioning of various tools and devices therethrough, and it also allows the extension member 12 to be used to manipulate the anchor from outside of the patient's body. The length le of the extension member 12 is illustrated in FIG. 1A, and is measured from the proximal-most end of the extension member 12 to the proximal end of the receiver member 16, i.e., to a frangible portion 18 that couples the extension member to the U-shaped receiver member 16 as will be discussed in more detail below. In an exemplary embodiment, the length l is greater than about 25 mm, and more preferably is greater than about 55 mm. Thus, in such embodiments, the length of the extension member 12 and the receiver member 16 (which can be approximately 15 mm from the proximal-most end to the bottom or distal end), can be greater than about 40 mm, and more preferably greater than about 70 mm. Exemplary lengths le of the extension member 12 range from 85 mm to 185 mm (100 mm to 200 mm with the receiver member), and more preferably from 135 mm to 175 mm (150 mm to 190 mm with the receiver member). In certain exemplary embodiments, the extension member can have a length le of about 145 mm (160 mm with the receiver member) where the extension member has an open configuration, as will be discussed in more detail below, and a length le of about 165 mm (180 mm with the receiver member) where the extension member has a closed configuration.

The extension member 12 can also be adapted to provide a minimally invasive pathway for the delivery of various implants and devices. In an exemplary embodiment, shown in FIG. 1C, the extension member 12 has inner and outer diameters di, do that are substantially the same as the inner and outer diameters dri, dro of the receiver member 16. The matching inner diameters will allow spinal connectors, fasteners, and other implants and devices to be inserted therethrough and coupled to the receiver member 16, and the matching outer diameters will allow a relatively small incision to be used to introduce the spinal implant and access device 10 into the body. It will also allow the extension member 12 and the anchor 14 to be introduced through a cannula or other access port, if necessary.

As indicated above, the extension member 12 can also include cut-outs or slots to facilitate the introduction of tools, spinal connectors, and other implants therethrough. A variety of configurations are available for the cut-outs. For example, as shown in FIG. 1A, the extension member 12 can include opposed slots 13 a, 13 b that extend between and separate the first and second opposed extension arms 12 c, 12 d that extend proximally from the U-shaped receiver member 16. The opposed slots 13 a, 13 b can extend from the proximal end 12 a to the distal end 12 b, such that the extension member 12 has an open configuration, or the first and second extension arms 12 c, 12 d can be coupled to one another at one or more locations along the length thereof, such that the extension member 12 has a closed configuration. FIGS. 1A and 1C illustrate the extension having a closed configuration, in which the first and second extension arms 12 c, 12 d are coupled to one another by a web or connector 15 located distal to the midpoint of the extensions 12 c, 12 d and proximal to a frangible portion 18, which will be discussed in more detail below. In use, the slot(s) 13 a, 13 b can be configured to allow various implants and devices to be passed therethrough. Thus, each slot 13 a, 13 b preferably has a width that is sufficient to accommodate the size of an implant or device to be passed therethrough. In another embodiment of an extension having a closed configuration, as shown in FIG. 1D, the first and second extension arms 12 c′, 12 d′ can be coupled to one another at the proximal end 12 a′ of the extension member 12′. Such a configuration resembles a hollow elongate tube having slots 13 a′, 13 b′ formed in the sidewalls thereof and extending proximally from the distal end 12 b′ thereof and terminating distal to the proximal end 12 a′ of the extension member 12′.

Alternatively, the extension member can have an open configuration. This is illustrated in FIG. 1E, which shows an extension member 12″ having first and second extension arms 12 c″, 12 d″ that are separated by slots 13 a″, 13 b″ that extend from the distal end 12 b″ of the extension member 12″ and that extend through the entire proximal portion of the extension member 12″ such that the proximal end 12 a″ of each arm 12 c″, 12 d″ is separated from one another. Accordingly, the quantity, shape, and size of the slot(s) 13 a, 13 b can vary. A person skilled in the art will appreciate that the extension member 12 can include any number of sidewall openings having any shape that is sufficient to allow desired implants and devices to be passed therethrough.

The extension member 12 can also include other features to facilitate use of the device. For example, in another embodiment, shown in FIG. 1F, the extension member 12′″ includes threads 12 t′″ formed in a proximal portion of the extension member 12′″ for mating with corresponding threads formed on a driver tool, reduction device, or other delivery device. The threads 12 t′″ will facilitate advancement of the delivery device through the extension member 12′″. For example, the threads 12 t′″ can mate with corresponding threads on a rod reduction device to allow the rod reduction device to reduce a spinal rod or other spinal connector into the receiver member of the anchor. While FIG. 1F illustrates threads 12 t′″ formed within the proximal end of the extension member 12′″, the threads 12 t′″ can be formed at any location along the length of the extension member 12′″. For example, threads can be formed within the connector 15 (FIG. 1C) and around the circumference of the inner lumen of the extension member 12. As further shown in FIG. 1F, the extension member 12′″ can also or alternatively include one or more flats 12 f′″ formed on an external surface thereof for use with external devices, such as a rod stabilizer. A person skilled in the art will appreciate that the extension member can have various other configurations to facilitate use with other delivery tools and/or fastening elements.

Referring back to FIGS. 1A-1C, as indicated above the extension member 12 can be removably coupled to the receiver member 16. In an exemplary embodiment, the distal end 12 b of the extension member 12 is integrally formed with the receiver member 16, i.e., the extension member 12 and receiver member 16 have a unitary configuration. A frangible portion 18, best shown in FIG. 1A, can be formed on the extension member 12 to allow the extension member 12 to be frangibly separated from the receiver member 16. The frangible portion can be formed at various locations along the extension member 12, but in an exemplary embodiment the frangible portion 18 is located adjacent to the distal end 12 b of the extension member 12. The frangible portion 18 can be adapted to break when a predetermined force is applied thereto thereby allowing at least a portion of the extension member 12 to be separated from the receiver member 16. A variety of techniques can be used to form a frangible portion 18. For example, in one embodiment shown in FIGS. 1A-1B, the frangible portion 18 can be formed by a reduced diameter region or thinned region of material formed between the extension member 12 and the receiver member 16. Other configurations for the frangible portion 18 can include webbing, an annular grooved formed in an outer or inner surface of the extension member 12, or other techniques known in the art. A variety of materials, including both plastics and metals, can be used for the frangible portion 18, and the frangible portion 18 need not be made from the same material used for the anchor 14 or extension member 12. By way of non-limiting example, the anchor 14 can be made from a metallic material, such as stainless steel, and the frangible portion 18 and extension member 12 can be formed from a plastic. Such a configuration allows the extension member 12 and frangible portion 18 to act as insulators during neuromonitoring. In use, the frangible portion 18 can provide a weak spot in the extension member 12 to allow the extension member 12 to be separated from the receiver member 16 when a predetermined force is applied thereto.

Several techniques can be used to apply the predetermined force to the frangible portion 18 of the extension member 12. For example, a removal tool 20 can be inserted through a lumen 17 of the percutaneous access device 12 or extension member 12 and it can be actuated to apply a radially directed force to an inner surface 18 c of the extension member 12 to break the extension member 12 away from the spinal anchor 14. A variety of configurations are available for the removal tool 20. FIG. 2A illustrates one exemplary removal tool 20 that generally includes an elongate member 22 having a proximal end 22 a that is adapted to remain outside the body and a distal end 22 b that is adapted to be inserted through the lumen 17 of the extension member 12 and to be positioned adjacent to the spinal anchor 14. The distal portion 22 b can include an engagement mechanism 24 that is adapted to engage an inner surface 18 c of the extension member 12 and to apply an outward or radially directed force to the extension member 12 disposed therearound to break at least a portion of the extension member 12 apart from the spinal anchor 14. The removal tool 20 can also include a handle 26 disposed on the proximal end 22 a of the elongate member 22. The handle 26 can be used to manipulate the device, as will be discussed in more detail below.

The engagement mechanism 24 can have a variety of configurations, and the size and shape of the engagement mechanism 24 can vary depending on the configuration of the extension member 12. For example, in the embodiment shown in FIGS. 2A-2C, the engagement mechanism 24 is in the form of a set screw or other threaded member formed on a distal portion 22 b of the elongate member 22 and adapted to engage the complementary threads formed in the distal end of the extension portion 12. As shown in FIGS. 2B and 2C, the engagement mechanism 24 has a proximal threaded portion 24 a with an outer diameter that is greater than an outer diameter of a distal threaded portion 24 b. In other words, the thread on the proximal portion is oversized relative to the thread on the distal portion. The proximal threaded portion 24 a can be sized to engage threads formed within the extension portion 12, and the distal threaded portion 24 b can be configured to engage threads formed in the receiver member 16. FIG. 1B illustrates threads 12 t formed on inner surface of the extension member 12 just proximal to the frangible portion 18, and threads 16 t formed on an inner surface of the receiver member 16 just distal to the frangible portion 18. The proximal threaded portion 24 a on the engagement mechanism 24 can also have a size that is configured to apply a radially directed force to the threads 12 t on the extension member 12 to break the frangible portion 18 and thereby separate the extension member 12 from the receiver member 16. This can be achieved using various techniques. For example, a distal-most portion of the extension member 12, i.e., the portion located adjacent to or at the frangible portion 18, can be tapered such that the threaded portion 24 a will apply a radially directed force thereto to cause the frangible portion 18 to break. Alternatively, the threads on the proximal threaded portion 24 a can have an increasing diameter to cause the proximal threaded portion 24 a to apply a radially directed force to the extension member 12. The distal threaded portion 24 b, on the other hand, can have threads that complement the threads 16 t within the receiver member 16 to allow the two portions to mate to one another. In use, the distal threaded portion 24 b can thus function as a locking mechanism for locking a spinal connector, such as a spinal rod, within the receiver member 16.

The engagement mechanism 24, or a portion thereof, can also optionally be frangibly mated to the distal end 22 b of the elongate member 22. This will allow the elongate member 22 to be detached from the engagement mechanism 24, thus allowing the engagement mechanism 24, or a portion thereof, to remain mated to the receiver member 16 of the anchor 14. The frangible portion can be formed at various locations on the removal tool 20. For example, FIG. 2C illustrates a frangible portion 22 f formed within the engagement mechanism 24 at a location that is between the proximal and distal threaded portions 24 a, 24 b. In other embodiments, the proximal and distal threaded portions 24 a, 24 b can be frangibly mated to one another, thus allowing the proximal threaded portion 24 a to be separated from the distal threaded portion 24 b and removed from the body.

In use, the removal tool 20 can be actuated by inserting the elongate member 22 through the extension member 12 to position the engagement mechanism 24 within the distal end 12 b of the extension member 12. The distal threaded portion 24 b can pass through the threads 12 t formed within the distal end 12 b of the extension member 12, as they will have a size that is less than a size of the threads 12 t formed within the extension member 12. The tool 20 can then be rotated with respect to the extension member 12, using, for example, the handle 26. As the tool 20 is rotated, the proximal threaded portion 24 a will engage the threads 12 t formed in the extension portion while the distal threaded portion 24 b engages the threads 16 t formed within the receiver member 16. Continued rotation will cause the proximal threaded portion 24 a to apply a radially directed force to the extension member 12, thereby breaking the frangible portion 18 formed between the extension member 12 and the receiver member 16. The extension member 12 can thus be removed from the patient's body, leaving the spinal anchor 14 implanted in bone.

In another embodiment, the engagement mechanism can be in the form of a cam, wedge, or other inclined surface formed on a distal portion of an elongate shaft of a removal tool. FIGS. 3A-3C illustrate a distal end 22 b′ of an elongate shaft 22′ of a removal tool having an engagement mechanism 24′ in the form of a cam having first and second fins 30 a′, 30 b′ disposed on opposed sides of and extending radially outward from the shaft 22′. Each fin 30 a′, 30 b′ can have a length l that is configured to correspond to a width of the slots 13 a, 13 b formed in the arms 12 c, 12 d of the extension member 12 to allow the fins 30 a′, 30 b′ to be slidably received therein during insertion of the removal tool through the extension member 12. Each fin 30 a′, 30 b′ can also have height h that increases radially to form a ramped surface such that the fins 30 a′, 30 b′ can apply a radially directed force to the arms 12 c, 12 d of the extension member 12. In particular, after the tool is inserted to position the fins 30 a′, 30 b′ within the slots 13 a, 13 b and adjacent to the distal end of the extension member 12, as shown in FIGS. 3A and 3B, the removal tool can be rotated to cause the fins 30 a′, 30 b′ to move in between and into alignment with the arms 12 c, 12 d of the extension member 12, as shown in FIG. 3C. The increasing height h of each fin 30 a′, 30 b′ will apply a radially directed force to an inner surface 18 c of each arm 12 c, 12 d, thereby causing the frangible portion to break thereby separating the extension member 12 from the receiver member 16 of the spinal anchor 14.

In another embodiment, the removal tool shown in FIGS. 3A-3C can include first and second arm members (not shown) that extend along the length of the elongate shaft. The fins can be rotated with respect to the first and second arm members to cause the fins to move in between and into alignment with the arm members. Similar to the removal tool described above, the increasing height of each fin will apply a radially directed force to an inner surface of each arm member, thereby causing the first and second arm members to apply a radially directed force to an inner surface of the extension member. The frangible portion will thus break thereby separating the extension member from the receiver member of the spinal anchor.

In another embodiment, shown in FIG. 4A, the removal tool 20″ can include first and second breaker arms 21 a″, 21 b″ that are configured to engage the proximal end of the first and second arms 12 c, 12 d of the extension member 12. Various techniques can be used to engage the arms 12 c, 12 d, but as shown in FIG. 4A the breaker arms 21 a″, 21 b″ each include a U-shaped member for receiving a proximal end of the arms 12 c, 12 d on the extension member 12. Each breaker arm 21 a″, 21 b″ can also include a handle 23 a″, 23 b″ formed thereon, and once the breaker arms 21 a″, 21 b″ are engaged with the arms 12 c, 12 d on the extension member 12, the handles 23 a″, 23 b″ can be rotated in opposite directions to break the arms 12 c, 12 d of the extension member 12 away from the receiver member 16 of the spinal anchor 14. In another embodiment, in order to facilitate removal of the arms of the extension member, the arms can have complementary features formed therein that allow the arms to pass through one another. For example, FIG. 4B illustrates a distal end of first and second extension arms 11 a, 11 b having cut-outs 11 c formed therein and offset from one another such that one arm, e.g., arm 11 a, can pass through the other arm, e.g., arm 11 b as the arms 11 a, 11 b are rotated by the breaker arms 21 a″, 21 b″.

Exemplary methods for implanting a spinal anchor 14 and delivering various tools and devices are also provided. In one exemplary embodiment, the procedure can begin by forming a minimally invasive percutaneous incision through tissue located adjacent to a desired implant site. The incision can be a relatively small incision having a length that is less than a diameter or width of the device being inserted therethrough, a spinal anchor and access device. Once the incision is made, a spinal anchor and access device, such as device 10, can be delivered to the anchor site. In particular, the anchor 14 can be inserted through the incision with the extension member 12 frangibly attached thereto and extending through the skin incision and outside of the patient's body. The bone-engaging member 14 b of the anchor 14 can be driven into bone using a tool, such as a driver, that is passed through the extension member 12. While not shown, the extension member 12 can optionally include threads formed therein for mating with corresponding threads formed on the driver tool, thus facilitating advancement of the driver through the extension member 12 to drive the bone-engaging member 14 b into bone. When the spinal anchor 14 is fully implanted, the bone-engaging member 14 b will be fully disposed within bone and the receiver member 16 will be located adjacent to the bone such that it is either in contact with the bone or relatively close to the bone, i.e., 1 mm to 2 mm away from the bone. The extension member 12 will extend from the receiver member 16 and through the skin incision, thereby providing a pathway that spans through the skin incision to the anchor 14. Additional spinal anchor and access devices can be implanted in adjacent vertebrae using the same technique, or using other techniques known in the art.

Once the anchor 14 is implanted, the extension member 12 can be used to deliver various spinal connectors, fasteners, and other tools and devices to the implant site. For example, a spinal connector, such as a spinal rod, can be introduced through the extension member and positioned within the spinal anchor 14, and optionally within one or more additional spinal anchors implanted in adjacent vertebrae. FIGS. 5A-5C illustrate one exemplary method for inserting a spinal rod 40. The rod 40 is introduced through the extension member 12 in a first orientation, shown in FIG. 5A, in which the rod 40 is substantially parallel to the longitudinal axis of the extension member 12. The spinal rod 40 can then be manipulated to extend at an angle with respect to the first orientation, such that the rod 40 extends in a direction substantially transverse to the longitudinal axis L of the extension member 12, for example, in a direction that is substantially parallel to the patient's spine, as shown in FIG. 5C. Since the length of the spinal rod 40 will necessarily be greater than the inner diameter of the extension member 12, the slots 13 a, 13 b in the extension member 12 will allow the spinal rod 40 to pivot and pass therethrough while being transitioned from the first orientation to the second orientation, as shown in FIG. 5B. A person skilled in the art will appreciate that the exact position of the spinal rod 40 with respect to the longitudinal axis L of the extension member 12 will of course vary depending on the configuration of the spinal rod 40 or other spinal connector. As further shown in FIGS. 5A-5C, movement of the spinal rod 40 can be achieved using a manipulator or driver device 50. The manipulator device can have a variety of configurations, but it should be effective to allow controlled movement of the rod 40.

Once the spinal rod 40 is properly positioned and fully seated in the receiver member 16, a closure mechanism or fastener can be inserted through the extension member 12 and applied to lock the rod 40 in place. A variety of closure mechanisms and tools for delivering closure mechanisms are known in the art, and they can be used with the present invention. By way of non-limiting example, FIG. 6A illustrates a driver tool 60 for delivering a set screw 62 to the spinal anchor 14 to lock the spinal rod 40 within the receiver member 16 of the spinal anchor 14. As shown, the set screw 62 is coupled to the distal end of the driver tool 60, which is passed through the inner lumen of the extension member 12. The illustrated driver tool 60 includes threads 60 t formed on the shaft thereof for mating with corresponding threads (not shown) formed within the extension member 12. The threaded connection facilitates distal movement or advancement of the driver tool 60 through the extension member 12, thereby allowing the set screw 62 to reduce the rod 50 into the U-shaped recess in the receiver member 16. Final tightening of the set screw 62 can optionally be accomplished using a standard torque driver 64 along with a stabilizer 66 to prevent the receiver member 16 from rotating, as shown in FIG. 6B. The stabilizer 66 can interface with flats formed on the external surface of the extension member 12, as previously discussed with respect to FIG. 1F.

While not shown, removal tool 20 previously described herein can optionally be used to deliver the engagement mechanism 24, which includes a distal threaded portion 24 b that functions as a set screw. Once the engagement mechanism 24 is mated to the receiver member 16, the elongate member 22, and optionally the proximal threaded portion 24 a of the engagement mechanism 24, can be frangibly detached from the distal threaded portion 24 b to allow the removal tool 20 to be removed from the extension member 12 while the distal threaded portion 24 b remains mated to the receiver member 16. This step can be repeated for adjacent spinal anchor(s). A person skilled in the art will appreciate that the spinal connector does not need to be directly attached to each anchor, and that it can be indirectly attached to the anchors using, for example, a band clamp, a slotted offset connector, or other techniques known in the art.

Where the removal tool is not configured to simultaneously deliver a fastening element while breaking the extension member 12 away from the receiver member 16, the extension member 12 can be detached from the anchor 14 by inserting a removal tool through the extension member 12 to apply a force to the frangible portion 18 formed between the extension member 12 and the spinal anchor 14. FIGS. 7A and 7B illustrate one exemplary method for breaking the extension member 12 away from the receiver member 16 of the spinal anchor 14 using the cam-type engagement mechanism 24′ shown in FIGS. 3A-3C. As shown in FIGS. 7A and 7B, the removal tool 20′ is passed through the extension member 12 to position the engagement mechanism (not shown) within the distal end of the extension member 12. The first and second fins on the engagement mechanism can be passed through the slots 13 a, 13 b formed in the extension member 12. The tool 20′ is then rotated to cause the fins to pass between the arms 12 c, 12 d of the extension member 12, thereby applying a radially directed force to the arms 12 c, 12 d to break the frangible portion 18. The extension member 12 can thus be removed from the patient, leaving the spinal anchor 14 implanted in bone. As further shown in FIGS. 7A and 7B, a stabilizing tool 76 can optionally be passed through at least a portion of the extension member 12 for stabilizing the extension member 12 while the removal tool 20′ is rotated.

In other embodiments, one or more spinal anchor and access devices can be implanted in adjacent vertebrae, and the extension member on each device can be used to perform other procedures, such as pedicle targeting, anchor alignment, distraction, deformity correction, etc. For example, the extension member 12 can also be used to manipulate the receiver member 16 coupled thereto. For example, the proximal end 12 a of the extension member 12 can be grasped by a user and angularly oriented to thereby move the receiver member 16 relative to the bone-engaging member 14 b. Where the anchor 14 is a monoaxial bone screw, movement of the extension member 12 will move the vertebra that the anchor 14 is implanted in. FIG. 8 illustrates a jig 70 mated to one or more extension members implanted in adjacent vertebrae. The jig 70 can be used, for example, to guide a pedicle targeting tool 72 and aid in the alignment of adjacent anchors. In yet another embodiment, as shown in FIG. 9, a distractor 80 can be mated to the extension member to facilitate the distraction of adjacent vertebrae. In another embodiment, shown in FIG. 10, multiple spinal anchor and access devices can be implanted in adjacent vertebrae and they can be used to correct a spinal deformity. For example, as shown in FIG. 10, the extension member of each device can aid in the placement of an extra long spinal rod 100, and insertion of the rod 100 through each extension member can move the extension members to thereby move the adjacent vertebrae into a desired orientation relative to one another. Separate instruments can optionally be used to further distract and/or manipulate the adjacent vertebrae. A person skilled in the art will appreciate that a variety of other tools and devices can be mated to and used in conjunction with the extension member disclosed herein.

One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

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Classifications
U.S. Classification606/306, 606/301, 606/308, 606/305
International ClassificationA61B17/04
Cooperative ClassificationA61B17/7091, A61B2017/0256, A61B17/8863, A61B17/7037, A61B2019/307, A61B17/708, A61B17/1757, A61B17/7032, A61B17/7085
European ClassificationA61B17/88F, A61B17/70B2, A61B17/70B5B