WO2016077208A1

WO2016077208A1 - Percutaneous rod inserter and method of use

Info

Publication number: WO2016077208A1
Application number: PCT/US2015/059693
Authority: WO
Inventors: John Franklin Cummins; William Francis Xavier FAHEY, III; Melissa D. COALE
Original assignee: Spinal Usa, Inc.
Priority date: 2014-11-10
Filing date: 2015-11-09
Publication date: 2016-05-19

Abstract

Devices and methods are provided for assisting with spinal stabilization. One or more spinal stabilization systems can be positioned in a patient's vertebrae. The spinal stabilization systems can include a threaded shaft configured to be anchored in the bone, a housing, and a rod. The spinal stabilization systems can include extended tab screws. A rod insertion device can be used to insert the rod percutaneously to the housings. The rod insertion device can include an inner shaft disposed within an outer shaft and an actuating mechanism to cause relative axial movement between the inner and outer shafts. The outer shaft can include a distal portion having a transverse opening configured to receive the rod. Distal movement of the inner shaft relative to the outer shaft causes a distal end of the inner shaft to engage the rod to secure the rod to the rod insertion device.

Description

PERCUTANEOUS ROD INSERTER AND METHOD OF USE

RELATED APPLICATIONS

[0001] This application claims priority benefit of U.S. Provisional Application No. 62/077,843, filed November 10, 2014, the entirety of which is hereby incorporated by reference herein. Additional features and aspects of some advantageous systems and methods that may be utilized in combination with embodiments found in this application are described in U.S. and PCT Patent Applications incorporated by reference herein, including, for example, U.S. Patent Application No. 14/374,882, filed July 25, 2014, published as US 2015/0066042 Al ; U.S. Provisional Application Nos. 61/933,272, filed January 29, 2014, and 62/046,635, filed September 5, 2014; and PCT Application PCT/US2015/013188, filed January 28, 2015, published as WO 2015/116624, all which are expressly incorporated by reference herein in their entireties so as to form part of this specification.

BACKGROUND

Field

[0002] The present application generally relates to devices and methods for treating the spine. In particular, the present application relates to minimally invasive devices and methods for delivering fixation devices and implants into a spine.

Description of the Related Art

[0003] Spinal bone and disc degeneration can occur due to trauma, disease, or aging. Such degeneration can cause abnormal positioning and motion of the vertebrae, which can subject nerves that pass between vertebral bodies to pressure, thereby causing pain and possible nerve damage to a patient. In order to alleviate the pain caused by bone degeneration, it is often helpful to maintain the natural spacing between vertebrae to reduce the pressure applied to nerves that pass between vertebral bodies.

[0004] To maintain the natural spacing between vertebrae, spinal stabilization devices are often provided to promote spinal stability. These spinal stabilization devices can include fixation devices, such as spinal screws, which are implanted into vertebral bone. The fixation devices work in conjunction with other implanted members, such as rod members, to form stabilization systems. [0005] Conventional stabilization systems and techniques often require open surgeries and other invasive procedures in order to deliver the implants into the body. These invasive procedures often cause a great deal of pain and trauma to the patient, and require a substantial recovery time. There is therefore a need for minimally invasive devices and methods that can assist in providing spinal stabilization.

SUMMARY

[0006] In some embodiments, an apparatus for inserting a rod into a patient includes an elongate outer shaft, an elongate inner shaft, and an actuator member. The outer shaft includes a distal portion having a transverse opening that is configured to receive a rod. At least a majority of the inner shaft is disposed within the outer shaft. A distal end of the inner shaft is configured to extend into the transverse opening. The actuator member is configured to cause relative axial movement between the inner shaft and outer shaft. Distal movement of the inner shaft relative to the outer shaft or proximal movement of the outer shaft causes the distal end of the inner shaft to move into engagement with the rod when the rod is positioned within the transverse opening.

[0007] In some embodiments, the outer shaft further includes an internally threaded portion, the inner shaft includes an externally threaded portion configured to engage the internally threaded portion of the outer shaft, and the actuator member includes a knob coupled to a proximal end of the inner shaft. Rotation of the knob causes rotation of the inner shaft relative to the outer shaft, and engagement of the external threads of the inner shaft with the internal threads of the outer shaft translates rotation of the inner shaft into axial movement of the inner shaft relative to the outer shaft. In some such embodiments, the externally threaded portion of the inner shaft and the internally threaded portion of the outer shaft include double lead threads.

[0008] In some embodiments, the outer shaft further includes an arm extending at least partially radially outwardly from the outer shaft proximate the proximal end and a handle at a proximal end of the arm. The distal portion of the outer shaft can include a pin extending across a distal edge of the transverse opening. The pin is configured to engage a corresponding channel in the rod. In some embodiments, the transverse opening is generally partially hex-shaped. A perimeter of the transverse opening can be oriented at an obtuse angle relative to a longitudinal axis of the rod insertion device such that the rod is oriented at an angle relative to the longitudinal axis when disposed in the transverse opening. The apparatus for inserting a rod into a patient can further include the rod, which can include an elongate, generally cylindrical body extending from a first end to a second end. An end portion proximate to the first end is generally partially hex-shaped.

[0009] In some embodiments, a spinal rod includes an elongate, generally cylindrical body extending from a first end to a second end. An end portion proximate to the first end is generally hex-shaped, and a recess is formed in the end portion. In some embodiments, a channel is formed in a side of the end portion diametrically opposed to the recess. The channel extends transverse to a longitudinal axis of the spinal rod. In some embodiments, the rod is curved. In other embodiments, the rod is substantially straight.

[0010] In some embodiments, a method of delivering a rod to a spinal location includes providing a rod and a rod insertion device. The rod has a recess proximate a first end. The rod insertion device has an elongate outer shaft, and elongate inner shaft, and an actuator member. The outer shaft has a transverse opening at a distal end. The inner shaft is disposed within the outer shaft and has a distal end extending into the transverse opening. The actuator member is configured to cause relative axial movement between the inner shaft and outer shaft. The method further includes positioning the first end of the rod in the transverse opening, actuating the actuator member to cause distal movement of the inner shaft or proximal movement of the outer shaft to cause the distal end of the inner shaft to engage the recess of the rod, and delivering the rod to the spinal location with the rod insertion device.

[0011] In some embodiments, a portion of the outer shaft includes internal threads, a portion of the inner shaft includes external threads configured to engage the internal threads of the outer shaft, the actuator member includes an adjustment knob disposed at a proximal end of the inner shaft, and actuating the actuator member includes rotating the knob. In some embodiments, the method further includes actuating the actuator member to cause proximal movement of the inner shaft to disengage the distal end of the inner shaft from the recess of the rod once the rod is delivered to the spinal location. [0012] All of these embodiments are intended to be within the scope of the disclosure herein. These and other embodiments will become readily apparent to those skilled in the art from the following detailed description having reference to the attached figures, the disclosure not being limited to any particular disclosed embodiment(s).

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other features, aspects, and advantages of the present disclosure are described with reference to the drawings of certain embodiments, which are intended to schematically illustrate certain embodiments and not to limit the disclosure.

[0014] Figure 1 illustrates an example embodiment of a spinal stabilization system;

[0015] Figure 2 illustrates an example embodiment of an access device;

[0016] Figures 3A-3C illustrate an example embodiment of an extended tab screw;

[0017] Figure 4 illustrates an example embodiment of a rod insertion device;

[0018] Figure 4B illustrates and exploded view of the rod insertion device of Figure 4;

[0019] Figure 5 illustrates a distal end of the rod insertion device of Figure 4;

[0020] Figures 6A-6C illustrate a spinal rod disposed in the distal end of the rod insertion device;

[0021] Figure 7 illustrates the spinal rod coupled to the rod insertion device of Figures 4-6C;

[0022] Figure 8 illustrates a proximal portion of the rod insertion device of Figures 4-7;

[0023] Figure 8B illustrates a longitudinal section view of the outer shaft of the rod insertion device;

[0024] Figure 8C illustrates a side view of the inner shaft of the rod insertion device;

[0025] Figure 9 illustrates a screw driver engaged with the proximal portion of the rod insertion device of Figures 4-8; [0026] Figure 10 illustrates two extended tab screws positioned in a patient's body through two minimally invasive incisions;

[0027] Figures 1 1-14 illustrate a method of using the rod insertion device of Figures 4-9 of deliver a spinal rod to the extended tab screws;

[0028] Figure 15A illustrates an example embodiment of a rod reduction sleeve;

[0029] Figures 15B and 15C illustrate rod reduction sleeves disposed over extended tab screws disposed in the body;

[0030] Figure 16A illustrates an example embodiment of a set screw inserter;

[0031] Figure 16B illustrates a distal end of the set screw inserter and a set screw;

[0032] Figure 17 illustrates a method of rod reduction and set screw insertion with the rod insertion device in place;

[0033] Figure 18 A illustrates a top view of an example embodiment of a curved spinal rod;

[0034] Figure 18B illustrates a side view of the curved spinal rode;

[0035] Figure 19A illustrates a top view of an example embodiment of a straight spinal rod;

[0036] Figure 19B illustrates a side view of the straight spinal rode; and

[0037] Figure 20 illustrates an end view of a spinal rod.

DETAILED DESCRIPTION

[0038] Although certain embodiments and examples are described below, those of skill in the art will appreciate that the disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the disclosure herein disclosed should not be limited by any particular embodiments described below.

[0039] The present application relates to minimally invasive devices and methods for assisting in the delivery of fixation devices and other implants to a target location in a patient. While the minimally invasive devices described herein can be used to assist various procedures, in some embodiments, they are used to assist in delivering fixation devices and other implants to help stabilize the spine. For example, a spinal stabilization system (e.g., including a bone fastening assembly such as a pedicle screw and an elongated connecting member or a rod) can be used to provide stability to two or more adjacent vertebrae. A bone fastener assembly is placed in each of the vertebrae to be stabilized, and the elongated connecting member or rod is coupled to the assemblies.

[0040] As shown in Figure 1, an example embodiment of a spinal stabilization system 100 can include a threaded shaft 1 10 configured to be secured to a vertebra, a housing 112, a set screw 116, and a rod 118. The threaded shaft 110 can be cannulated and configured to receive a guidewire or k-wire. The housing 112 can have a U-shaped seat 1 14 for receiving the rod 118. The housing 112 can further include internal threads 126 at its upper end configured to receive the externally threaded set screw 116. In some embodiments, the threaded shaft 110 can polyaxially rotate relative to the housing 112 prior to being fixed. Once the threaded shaft 1 10 has been inserted into the patient's vertebra, the rod 118 is inserted in the U-shaped seat 114 of the housing 112. The set screw 116 is inserted into the housing 1 12 to secure the rod 1 18 and fix the treaded shaft 110 relative to the housing 112. Additional details regarding example spinal screws and related apparatuses, systems and methods are described in U.S. Patent No. 8,241,341, issued August 14, 2014, entitled "Pedicle Screws and Methods of Using the Same," the entirety of which is hereby incorporated by reference.

[0041] In some embodiments, a minimally invasive access device can be coupled to the system 100, for example, to the housing 112, for delivery of the threaded shaft 1 10 and housing 112 into the target bone and to serve as a portal or opening that extends from the bone to outside of the patient. Instruments and/or implants can be then delivered through the access device via minimally invasive procedures. An example embodiment of a minimally invasive access device 200 is shown in Figure 2.

[0042] In some embodiments, a spinal stabilization system can include an extended tab screw 702, for example, as shown in Figures 3A-3C. Figures 3A and 3B illustrate side views of the screw and Figure 3C shows a cross-sectional view. The screw can include a shank or shaft 762 that is preferably cannulated and includes external threading. The screw can also include a housing 770, which can include a base portion 766 and extended portion 764. The base portion 766 and extended portion 764 together may form a monolithic housing. Preferably, the extended portion and the base portion include at least two walls, prongs, or tabs 778 that define an opening or transverse channel 772 between them. The channel 772 can serve as a portal or opening for the delivery of instruments and/or implants from outside of the patient to the bone. The extended portion in various embodiments can be formed of different materials. In some embodiments, it can be generally rigid and can be formed, for example, of a hard metal or plastic. In some embodiments, it can be flexible. In some embodiments, the channel 772 can be used to receive a fusion rod and/or help guide a fusion rod to the base of the channel in the base portion 766. In some embodiments, the structure of the base portion 766 and the shaft 762 are identical to the housing 112 and shaft 1 10 illustrated and described with respect to Figure 1. The base portion 766 and shaft 762 can rotate polyaxially relative to each other prior to being fixed, but during insertion a screw driver utilized may immobilize the base portion 766 relative to the shaft 762 to create a temporary monoaxial screw.

[0043] In various embodiments, the extended portion 764 can include a variety of features that can assist with surgical procedures using the screw 702. For example, in some embodiments, the extended portion can include one or more frangible or weakened sections 750. In some embodiments, these sections can be score marks, areas of thinner material, or have other structural features such that the extended portion can break more easily at the weakened sections than at other sections of the extended portion 764. This can help with removing sections of the screw as needed during a surgical procedure. In some embodiments, the lower most or distal most weakened section 750 can mark the boundary between the base portion 766 and the extended portion 764, such that the entirety of the extended portion 764 can be removed from the base portion if desired. In some embodiments, the screw housing 770 can include a portion with internal threading 776. In some embodiments, the internal threading 776 can be entirely within the base portion 766. In some embodiments, the internal threading can extend from the base portion into the extended portion 764. The internal threading can be used to receive a component, such as the set screw 1 16 (e.g., Figure 1) that can help maintain a fusion rod into position. Additional details regarding extended tab screws are described in U.S. Provisional Application No. 62/046,635, filed September 5, 2014, and PCT Publication No. WO 2015/1 16624, the entireties of both of which are hereby incorporated by reference. [0044] Various instruments can be used in connection with access devices, such as the access device 200 described herein, extended tab screws, such as the extended tab screw 702 described herein, and/or other access devices and/or screws to prepare a surgical site and/or deliver spinal fixation devices to the spine or another target location percutaneously. However, various implants and/or instruments such as those described herein can also be used in mini-open and open procedures.

[0045] For example, a pedicle access needle, guidewire, mallet, one or more dilation tubes, awl, and/or tap can be used to access a target pedicle, prepare a working channel, and prepare the pedicle for the insertion of fixation devices such as those described herein. A screw delivery device and/or screw driver can be used to insert a screw, such as shaft 1 10 or shaft 762 into the target pedicle. Additional details regarding various instruments that can be used in such procedures can be found in U.S. Patent Application No. 14/374,882, filed July 25, 2014, published as US 2015/0066042 Al, the entirety of which is hereby incorporated by reference.

[0046] Once one or more screws coupled to access devices or extended tab screws are secured to one or more adjacent vertebrae, a rod insertion device can be used to insert a spinal rod, for example, so that the rod sits in the U-shaped seat of the housing 1 12 or base portion 766. The rod can sit in the seat of two or more adjacent screws to connect the screws and provide fixation of the adjacent vertebrae.

[0047] An example embodiment of a rod insertion device 400 according to some embodiments of the present disclosure is shown in Figures 4-9. The rod insertion device 400 includes a body portion 402 extending from a proximal end 404 to a distal end 406. The body portion 402 includes an outer shaft 420 and an inner shaft 450 disposed at least partially within the outer shaft 410. In some embodiments, the rod insertion device 400 further includes an arm 408 extending from the outer shaft 420. In the illustrated embodiment, the arm 408 includes a first segment 410 and a second segment 412. The first segment 410 extends outwardly and proximally at an angle from the outer shaft 420 near the proximal end 404 of the body portion 402. The second segment 412 extends proximally from the first segment 410 and may be parallel or substantially parallel with a longitudinal axis of the body portion 402. As shown, a handle 414 is disposed at a proximal end of the second segment 412. However, in other embodiments, the arm 408 and/or handle 414 can have other shapes, sizes, and/or configurations, and in yet other embodiments, the rod insertion device 400 need not include an arm 408 and/or handle 414.

[0048] The distal end 406 of the body portion 402 is configured to be coupled to a spinal rod. Figures 18A-18B illustrate an example embodiment of a curved spinal rod 500a configured to be used with the rod insertion device 400. Figures 19A-19B illustrate an example embodiment of a straight rod 500b configured to be used with the rod insertion device 400. As shown in Figure 5, a distal portion 422 of the outer shaft 420 has an enlarged width compared to a diameter of a remainder of the outer shaft 420. As shown in Figure 8B, the distal portion 422 can have a thickness less than a thickness of the remainder of the outer shaft 420. The distal portion 422 includes a transverse opening 424 configured to receive the rod. In the illustrated embodiment, the transverse opening 424 has a partial hex shape. A perimeter 426 of the transverse opening 424 has a proximal wall that is perpendicular to a longitudinal axis of the body portion 402, two side walls extending distally from the proximal wall parallel to the longitudinal axis of the body portion 402, two lower walls, each extending distally from a distal end of one of the side walls and inclined or at an angle toward and relative to the longitudinal axis of the body portion 402, and a distal wall extending between the distal ends of the lower walls and perpendicular to the longitudinal axis of the body portion 402. One side of the distal portion 422 (the bottom in Figure 8B) can be straight, and a portion of the opposite side (the top in Figure 8B) can be angled surrounding the transverse opening 424.

[0049] As shown in Figures 6A-6C, an end 502 of a rod 500 configured to be used with the rod insertion device 400 has an at least corresponding hex shape, which may be a partial hex-shape or may be entirely hexagonal, for example, as shown in the end view of the rod 500 in Figure 20. As shown in Figure 5, the hex-shaped perimeter 426 of the transverse opening 424 may be oriented at an obtuse angle relative to a longitudinal axis of the body portion 402 of the rod insertion device 400. Therefore, when the rod 500 is secured in the transverse opening 424, the rod 500 is oriented at an angle relative to the body portion 402 as shown in Figure 7. In some embodiments, the rod 500 is oriented at an angle of about 15° relative to an axis perpendicular to the longitudinal axis of the body portion 402, although other angles are also possible. In other embodiments, the transverse opening 424 and end 502 of the rod 500 can have corresponding shapes other than a hex shape or partial hex shape. Other shapes that provide for mating or geometrical fitting between the transverse opening 424 and rod 500 can be used.

[0050] The rod insertion device 400 can include features to secure the rod 500 to the rod insertion device 400, for example, so that the rod 500 does not fall out of the transverse opening 424 due to the angled orientation of the transverse opening perimeter 426 and/or to inhibit or reduce the likelihood of movement of the rod 500 relative to the rod insertion device 400 as the rod 500 is being delivered into the patient's body and manipulated into position. For example, as shown in Figures 5-6C, a distal end 452 of the inner shaft 450 extends into the transverse opening 424. The distal end 452 is configured to be received in a corresponding recess 504 (shown in Figures 18A and 19A) formed in one side of the end 502 of the rod 500 as shown in Figure 6C. In some embodiments, the distal end 452 can have a reduced diameter compared to a remainder of the inner shaft 450, as shown in Figures 5-6C.

[0051] In some embodiments, the distal portion 422 of the outer shaft 420 includes one or more features to secure the rod 500 to the rod insertion device 400. For example, as shown in Figures 5 and 6C, the distal portion 422 includes a pin 428 disposed at least partially in the transverse opening 424 along a distal edge of the transverse opening perimeter 426. The pin 428 is oriented perpendicularly to the longitudinal axis of the body portion 402 and to an axis extending through the transverse opening 424 along which the transverse opening 424 is configured to receive the rod 500. In other words, the pin 428 is perpendicular to a longitudinal axis of the rod 500 when the rod 500 is disposed in the transverse opening 424. The pin 428 is configured to be received in a corresponding channel 506 formed in the end 502 of the rod 500 across a side of the rod 500 opposite the side including the recess 504 configured to receive the distal end 452 of the inner shaft 450, as shown in Figures 18B and 19B. Therefore, when the rod 500 is disposed in the transverse opening 424, the distal end 452 of the inner shaft 450 secures the rod 500 on a proximal side and the pin 428 secures the rod 500 on a distal side. The pin 428 helps inhibit or prevent the rod 500 from sliding along the angled perimeter 426 of the transverse opening 424. In the illustrated embodiment, the pin 428 and corresponding channel 506 are at least partially cylindrical; however, in other embodiments, the pin 428 and channel 506 can have other corresponding shapes. In the illustrated embodiment, the pin 428 is partially embedded or formed in the distal edge of the transverse opening perimeter 426 to secure the pin 428 to the distal portion 422. As shown in Figure 6B, the pin 428 also extends to outer edges of sidewalls of the distal portion 422, which can help secure the pin 428 to the distal portion 422. The pin 428 can be welded in place in the distal portion 422.

[0052] The rod insertion device 400 includes an actuation mechanism configured to cause relative axial movement between the inner shaft 450 and the outer shaft 420. When the rod 500 is inserted in the transverse opening 424 and the inner shaft 450 moves distally relative to the outer shaft 420, or the outer shaft 420 moves proximally relative to the inner shaft 450, the distal end 452 of the inner shaft 450 moves into engagement with the rod 500 to secure the rod 500 to the rod insertion device 400. In the illustrated embodiment, the rod insertion device 400 includes an adjustment knob 456 configured to be actuated to move the inner shaft 450 relative to the outer shaft 420. The adjustment knob 456 is disposed at the proximal end of the inner shaft 450. A portion of the outer shaft 420 includes internal threads, and a portion of the inner shaft 450 includes corresponding external threads configured to engage the internal threads of the outer shaft 420. In some embodiments, a proximal portion 421 (shown in the section view of Figure 8B) of the outer shaft 420 includes the internal threads, and a proximal portion 451 (shown in Figure 8C) of the inner shaft 450 includes the external threads. As shown, the proximal portion 451 of the inner shaft 450 can have a slightly larger diameter than a remainder of the inner shaft 450. In use, rotation of the adjustment knob 456 causes rotation of the inner shaft 450 relative to the outer shaft 420. The threaded engagement of the inner shaft 450 and outer shaft 420 translates rotation of the knob 456 and inner shaft 450 into axial movement of the inner shaft 450 relative to the outer shaft 420. In some embodiments, the internal threads of the outer shaft 420 and external threads of the inner shaft 450 are double lead threads. The double lead threads can produce greater axial movement of the inner shaft 450 per rotation, which can advantageously allow the rod 500 to be engaged and/or disengaged to the rod insertion device 400 relatively more quickly. In some embodiments, a proximal end of the adjustment knob 456 can include a recess, for example, a hex-shaped recess, although other shapes are also possible. As shown in Figure 9, the recess is configured to receive a screw driver 600, which can be used to tighten or loosen the adjustment knob 456.

[0053] Figures 10-14 illustrate an example embodiment of a method of using the rod insertion device 400. Figure 10 illustrates two extended tab screws 702 positioned in adjacent vertebrae. As shown, each extended tab screw 702 is inserted into the body through a separate or discrete minimally invasive incision 650, although a mini-open or open procedure may also be utilized. To couple the rod 500 to the rod insertion device 400 for insertion, the surgeon or other user loosens the adjustment knob 456 (if necessary) to move the inner shaft 450 proximally relative to the outer shaft 420 and move the distal end 456 of the inner shaft 450 proximally within the transverse opening 424. The user can then insert the end 502 of the rod 500 into the transverse opening 424. In doing so, the user can engage the channel 506 of the rod 500 with the pin 428. The user then secures the rod 500 to the rod insertion device 400 by tightening the adjustment knob 456 so that the inner shaft 450 distally advances relative to the outer shaft 420 until the distal end 452 of the inner shaft 450 engages the corresponding recess 504 in the rod 500. The user can further tighten the adjustment knob 456 using screw driver 600.

[0054] As shown in Figure 11 , the user then positions the rod insertion device 400 such that the body portion 402 is parallel or generally parallel to the patient and disposed in the opening or transverse channel 772 of the extended tab screws 702. The user positions the end of the rod 500 opposite the end 502 coupled to the rod insertion device 400 in one of the percutaneous incisions 650 and in or aligned with the transverse channel 772. In the illustrated embodiment, the extended tab screw 702 on the right is positioned superiorly or cephalad relative to the other, and the extended tab screw 702 on the left is positioned inferiorly or caudal to the other. The rod insertion device 400 is oriented such that the rod 500 is positioned on the superior or cephalad side of the superior extended tab screw 702, and the proximal end 404 and handle 414 of the rod insertion device 400 are positioned inferior or caudal to the inferior extended tab screw 702. The user advances the rod 500 in situ by arcing the handle 414 of the rod insertion device 400 in a cephalad direction such that the rod 500 slides in the U-shaped seat of the housing 1 12 or base portion 766, for example as shown in Figure 12. When the rod 500 has been fully advanced into the housings 112 or base portions 766, the body portion 402 of the rod insertion device 400 is disposed superior to and adjacent the superior extended tab screw 702, as shown in Figure 13. However, in other embodiments, the orientation of the rod insertion device 400 can be reversed such that the rod 500 is initially positioned on the inferior side of the inferior extended tab screw 702, and the rod insertion device 400 is disposed inferior to and adjacent the inferior extend tab screw 702 once the rod 500 has been positioned. The distal portion 422 of the outer shaft 420 is wider than the U-shaped seat 114 of the base portion 766 (e.g., a dimension of the distal portion 422 perpendicular to the axis through the transverse opening 424 along which the rod 500 extends is greater than the a distance between edges of the upwardly extending arms forming the U- shaped seat) so that the distal portion 422 cannot pass through or into the base portion 766. This advantageously provides a stop to further advancement of the rod 500 and rod insertion device 400 and provides the user with tactile feedback that the rod 500 has been fully inserted. The user can confirm proper rod placement via imaging techniques, for example, intraoperative fluoroscopy.

[0055] During insertion and manipulation of the rod 500 using the rod insertion device 400, the distal end 452 of the inner shaft 450 and the pin 428 help prevent or inhibit disengagement of the rod 500 from the rod insertion device 400 and/or cephalad/caudal movement of the rod 500 relative to the rod insertion device 400. Additionally, the hex shape of the end 502 of the rod 500 and the corresponding hex shape of the transverse opening 424 allow the rod 500 and rod insertion device 400 to be keyed such that rotation of the rod 500 during insertion and manipulation causes corresponding rotation of the rod insertion device 400. Rotation of the rod insertion device 400 therefore indicates rotational movement of the rod 500 to the user so the user can correct for rotation if undesired. For example, in some embodiments, the rod 500 is curved, and the user may want to ensure the curvature is oriented in a particular direction.

[0056] The angle of the transverse opening 424 advantageously allows the rod insertion device 400 to be positioned out of the transverse channel 772 of the extended tab screws 702 once the rod 500 is fully inserted, as shown in Figures 13 and 14. This allows the user to insert other implants and/or instruments within the transverse channel 772 or about the tabs 778 or access device while maintaining the position of the rod 500 with the rod insertion device 400 if desired.

[0057] For example, the user can dispose rod reduction sleeve(s) over the tabs 778 to fully seat the rod 500 in the base portion 766 and/or insert a set screw through the channel 772 using a set screw inserter to secure the rod 500. Figure 15A illustrates an example embodiment of a rod reduction sleeve 620. As shown, a distal end of the rod reduction sleeve 620 can include U-shaped openings 622 extending proximally on opposite sides. The U-shaped openings 622 are configured to receive the rod 500 when the rod reduction sleeve 620 is disposed over the extended tab screw 702 and rod 500 and to press down on the rod 500 as the rod reduction sleeve 620 is advanced into the patient. In the illustrated embodiment, the rod reduction sleeve 620 also includes opposed side openings 624 extending along a length of the rod reduction sleeve 620. The side openings can advantageously reduce the weight of the rod reduction sleeve 620. Figure 15B illustrates a rod reduction sleeve 620 disposed over one of the extended tab screws 702 after the rod 500 has been delivered, and Figure 15C illustrates two rod reduction sleeves 620, each disposed over one of the extended tab screws 702 after the rod 500 has been delivered. Figure 16A illustrates an example embodiment of a set screw inserter 630, and Figure 16B illustrates a distal end of the set screw inserter 630 before being coupled to the set screw 116 for insertion. Figure 17 illustrates two rod reduction sleeves 620, each disposed over one of the extended tab screws 702, with the set screw inserter 630 disposed in one of the extended tab screws 702 to deliver the set screw 1 16 to secure the rod 500 with the rod insertion device 400 still in place and maintaining the position of the rod 500 while the rod 500 is urged into place with the rod reduction sleeves 620 and the set screw 116 is delivered. To remove the rod insertion device 400, the user loosens the adjustment knob 456 to disengage the distal end 452 of the inner shaft 450 from the rod 500. The user can then remove the distal portion 422 from the rod 500 and remove the rod insertion device 400 from the patient's body.

[0058] It will be apparent to those skilled in the art that various modifications and variations can be made in the present embodiments without departing from the scope or spirit of the advantages of the present application. Thus, it is intended that the present application cover the modifications and variations of these embodiments and their equivalents.

Claims

WHAT IS CLAIMED IS:

1. An apparatus for inserting a rod into a patient, comprising:

an elongate outer shaft comprising a distal portion having a transverse opening, the transverse opening configured to receive a rod;

an elongate inner shaft, at least a majority of the inner shaft disposed within the outer shaft, a distal end of the inner shaft configured to extend into the transverse opening; and

an actuator member configured to cause relative axial movement between the inner shaft and the outer shaft, wherein distal movement of the inner shaft relative to the outer shaft or proximal movement of the outer shaft causes the distal end of the inner shaft to move into engagement with the rod when the rod is positioned within the transverse opening.

2. The apparatus of Claim 1, wherein the outer shaft further comprises an internally threaded portion, the inner shaft comprises an externally threaded portion configured to engage the internally threaded portion of the outer shaft, and the actuator member comprises a knob coupled to a proximal end of the inner shaft, wherein rotation of the knob causes rotation of the inner shaft relative to the outer shaft and engagement of the external threads of the inner shaft with the internal threads of the outer shaft translates rotation of the inner shaft into axial movement of the inner shaft relative to the outer shaft.

3. The apparatus of Claim 2, wherein the externally threaded portion of the inner shaft and the internally threaded portion of the outer shaft comprise double lead threads.

4. The apparatus of Claim 1, wherein the outer shaft further comprises an arm extending at least partially radially outwardly from the outer shaft proximate the proximal end and a handle at a proximal end of the arm.

5. The apparatus of Claim 1, wherein the distal portion of the outer shaft further comprises a pin extending across a distal edge of the transverse opening, the pin configured to engage a corresponding channel in the rod.

6. The apparatus of Claim 1, wherein the transverse opening is generally partially hex-shaped.

7. The apparatus of Claim 1, wherein a perimeter of the transverse opening is oriented at an obtuse angle relative to a longitudinal axis of the rod insertion device such that the rod is oriented at an angle relative to the longitudinal axis when disposed in the transverse opening.

8. The apparatus of Claim 1, further comprising the rod, wherein the rod comprises an elongate, generally cylindrical body extending from a first end to a second end, wherein an end portion proximate to the first end is generally partially hex-shaped.

9. A spinal rod comprising:

an elongate, generally cylindrical body extending from a first end to a second end, wherein an end portion proximate to the first end is generally partially hex- shaped; and

a recess formed in the end portion.

10. The spinal rod of Claim 9, further comprising a channel formed in a side of the end portion diametrically opposed to the recess and extending transverse to a longitudinal axis of the spinal rod.

11. The spinal rod of Claim 9, wherein the rod is curved.

12. The spinal rod of Claim 9, wherein the rod is substantially straight.

13. A method of delivering a rod to a spinal location, comprising:

providing a rod having a recess proximate a first end;

providing a rod insertion device comprising:

an elongate outer shaft having a transverse opening at a distal end; an elongate inner shaft disposed within the outer shaft and having a distal end extending into the transverse opening; and

an actuator member configured to cause relative axial movement between the inner shaft and the outer shaft;

positioning the first end of the rod in the transverse opening;

actuating the actuator member to cause distal movement of the inner shaft or proximal movement of the outer shaft to cause the distal end of the inner shaft to engage the recess of the rod; and

delivering the rod to the spinal location with the rod insertion device.

14. The method of Claim 13, wherein a portion of the outer shaft comprises internal threads, a portion of the inner shaft comprises external threads configured to engage the internal threads of the outer shaft, the actuator member comprises an adjustment knob disposed at a proximal end of the inner shaft, and actuating the actuator member comprises rotating the knob.

15. The method of Claim 13, further comprising actuating the actuator member to cause proximal movement of the inner shaft to disengage the distal end of the inner shaft from the recess of the rod once the rod is delivered to the spinal location.