METHODS AND APPARATUS FOR IMPLANTING AN INTERBODY DEVICE

Abstract

A delivery device for inserting an interbody implant into an intervertebral space in a patient has an elongate tube with a channel and is sized to fit in an intervertebral space. The elongate tube has a proximal portion, a distal portion, a longitudinal axis, and a window with a longitudinal axis. The window is disposed adjacent the distal portion of the elongate tube and the longitudinal axis of the window is offset from the longitudinal axis of the elongate tube. The channel is sized to receive the interbody implant, and also the channel is configured such that the interbody implant is advanced therealong from the proximal region toward the distal region. The interbody implant is deployed into the intervertebral space from the window.

Claims

1.-41. (canceled)

42. A method of inserting an interbody implant into an intervertebral disc space via a delivery device assembly, the method comprising: assembling the delivery device assembly, the delivery device assembly comprising a first device, a second device, and an interconnecting member for connecting the first device and the second device, the first device comprising a first elongate member having a proximal portion, a distal portion, a first longitudinal axis extending therebetween, and a first channel extending through the first elongate member, the second device comprising a second elongate member having a first portion and a second portion, the first portion of the second elongate member configured to couple with the interconnecting member; inserting the distal portion of the first elongate member into the intervertebral disc space, the distal portion comprising a first side window in communication with the first channel, a distal segment of the distal portion comprising a first element, the first element disposed at one end of the channel; advancing a first interbody implant through the first channel of the first elongate member toward the first element by applying a force along the direction of the first longitudinal axis on at least a first portion of the first interbody implant; and engaging at least a second portion of the first interbody implant with the first element, the engaging of at least the second portion of the first interbody implant with the first element causing a least a portion of the force applied at least partly along the direction of the first longitudinal axis to be directed into a lateral force for advancing the first interbody implant through the first side window of the distal portion of the first elongate member and into the intervertebral disc space; wherein the first element maintains a fixed position relative to the distal portion of the first elongate member during each of (i) the inserting the distal portion of the first elongate member into the intervertebral disc space, (ii) the advancing of the first interbody implant through the first channel, and (iii) the engaging at least the second portion of the first interbody implant with the first element.

43. The method of claim 42, wherein the forming the delivery device assembly at least in part comprises: coupling a first coupling element of the first portion of the second elongate member to a second coupling element of the interconnecting member; and adjusting a distance between the first elongate member and the second elongate member by adjusting one or more of the first coupling element or the second coupling element.

44. The method of claim 43, wherein the forming the delivery device assembly further comprises immobilizing the second elongate member relative to the first elongate member via the coupling of the first coupling element and the second coupling element.

45. The method of claim 42, wherein the advancing of the first interbody implant through the first channel of the first elongate member comprises utilizing an elongate pusher apparatus to advance the first interbody implant through the first channel.

46. The method of claim 42, further comprising, subsequent to the advancing the first interbody implant through the first side window, removing the distal portion of the first elongate member from the intervertebral disc space; wherein the first element maintains the fixed position relative to the distal portion of the first elongate member during the removing of the distal portion of the first elongate member from the intervertebral disc space.

47. The method of claim 42, wherein the second portion of the second elongate member at least in part comprises a bone fastener; and the method further comprises affixing the bone fastener onto a vertebral bone prior to the advancing of the first interbody implant through the first channel of the first elongate member.

48. The method of claim 42, wherein the second portion of the second elongate member (i) at least in part comprises a second channel extending along a second longitudinal axis having a second side window in communication therewith, and (ii) is configured for delivery of a second interbody implant into the intervertebral disc space through the second side window, a distal segment of the second channel comprising a second element; and the method further comprises advancing the second interbody implant through the second channel of the second elongate member toward the second element by applying a force at least partly along the direction of the second longitudinal axis on at least a first portion of the second interbody implant.

49. The method of claim 48, wherein the advancing of the second interbody implant through the second channel of the second elongate member comprises utilizing an elongate pusher apparatus to advance the second interbody implant through the second channel.

50. The method of claim 48, further comprising engaging at least a second portion of the second interbody implant with the second element, the engaging of at least the second portion of the second interbody implant with the second element causing a least a portion of the force applied at least partly along the direction of the second longitudinal axis to be converted into a lateral force for advancing the second interbody implant through the second side window of the second elongate member and into the intervertebral disc space.

51. The method of claim 42, wherein: at least the distal portion of the first elongate member further comprises first and second opposing surfaces configured to enable the distal portion of the first elongate member to be moveable between a collapsed configuration and an expanded configuration; and the method further comprises moving the at least distal portion from the collapsed configuration to the expanded configuration.

52. The method of claim 51, wherein: the inserting the distal portion of the first elongate member into the intervertebral disc space comprises inserting the distal portion of the first elongate member into the intervertebral disc space while the distal portion is in the collapsed configuration; and the engaging the at least second portion of the first interbody implant with the first element comprises engaging the at least second portion of the first interbody implant with the first element while the distal portion is in the expanded configuration.

53. A method for inserting one or more interbody implants into an intervertebral disc space via a delivery device system, the method comprising: placing the delivery device system into an assembled configuration, the placing comprising: coupling a first device to a first segment of an interconnecting member, the first device comprising (i) a first coupling element for coupling with first segment of the interconnecting member, (ii) and a first elongate member comprising a first proximal portion, a first distal portion, a first longitudinal axis extending therebetween, and a first channel extending through the first elongate member, the first distal portion comprising a first side window; coupling a second device to a second segment of the interconnecting member, the second device comprising (i) a second coupling element for coupling with the second segment of the interconnecting member, (ii) and a second elongate member comprising a second proximal portion and a second distal portion, the second distal portion comprising a second side window; inserting the first distal portion of the first elongate member into the intervertebral disc space; advancing a first interbody implant through the first channel of the first elongate member by applying a force along the direction of the first longitudinal axis on at least a first portion of the first interbody implant, a distal end of the first channel comprising a first element that limits movement of the first interbody implant therepast; and engaging at least a second portion of the first interbody implant with the first element, the engaging causing creation of a lateral force that advances the first interbody implant through the first side window and into the intervertebral disc space; wherein the placing the delivery device system into the assembled configuration further comprises orienting and fixing each of a first position of the first window and a second position of the second window such that a plane of the first window is non-coextensive with a plane of the second window.

54. The method of claim 53, wherein the advancing of the first interbody implant through the first channel of the first elongate member at least in part comprises utilizing a pusher apparatus to advance the first interbody implant through the first channel.

55. The method of claim 53, wherein the second elongate member further comprising a second longitudinal axis extending between the second proximal portion and the second distal portion, and a second channel extending through the second proximal portion and the second distal portion; and wherein the method further comprises: inserting the second distal portion of the second elongate member into the intervertebral disc space; advancing a second interbody implant through the second channel of the second elongate member by applying a force along the direction of the second longitudinal axis on at least a first portion of the second interbody implant, a distal end of the second channel comprising a second element that limits movement of the second interbody implant therepast; and engaging at least a second portion of the second interbody implant with the second element, the engaging causing a least a portion of the force applied along the direction of the second longitudinal axis of the second elongate member to be directed into a lateral force that advances the second interbody implant through the second side window and into the intervertebral disc space.

56. The method of claim 55, wherein the advancing of the second interbody implant through the second channel of the second elongate member at least in part comprises utilizing a pusher apparatus to advance the second interbody implant through the second channel.

57. The method of claim 53, wherein: the advancing of the first interbody implant through the first channel of the first elongate member at least in part comprises utilizing a first pusher apparatus to apply the force along the direction of the first longitudinal axis on the at least first portion of the first interbody implant; and the advancing of the second interbody implant through the second channel of the second elongate member at least in part comprises utilizing a second pusher apparatus to apply the force along the direction of the second longitudinal axis on the at least first portion of the second interbody implant.

58. The method of claim 53, the placing the delivery device system into the assembled configuration further comprises utilizing the interconnecting member to: (i) adjust a position of the first elongate member relative to the second elongate member, and (ii) fix the position of the first elongate member relative to the second elongate member.

59. The method of claim 58, wherein the adjusting the position of the first elongate member relative to the second elongate member comprises adjusting each of an axial aspect and a lateral aspect of the position the first elongate member relative to the second elongate member.

60. A method for inserting an implant into a skeletal system of a subject via a delivery system, the delivery system comprising at least (i) an elongate member having a proximal portion, a distal portion, and an internal channel extending between the proximal portion and the distal portion, the internal channel extending along a longitudinal axis of the elongate member, and (ii) an elongate pusher configured to be at least partially received within the internal channel, the method comprising: inserting the distal portion of the elongate member into a target location of the skeletal system, the distal portion comprising a side window in communication with the internal channel, a distal segment disposed at a distal end of the internal channel comprising a first element which is integrally formed with the distal portion; advancing the implant through the internal channel of the elongate member toward the first element by applying a force on at least a first portion of the implant along the direction of the longitudinal axis utilizing the elongate pusher; engaging at least a second portion of the implant with the first element, the engaging converting a least a portion of the force applied along the direction of the longitudinal axis of the elongate member into a lateral force; advancing the implant through the side window and into the intervertebral disc space via the lateral force, the side window comprising a lateral axis that is offset from, and parallel to the longitudinal axis of the internal channel; removing the distal portion from the target location of the skeletal system after the advancing of the implant through the side window; wherein the first element maintains a fixed position relative to the distal segment throughout (i) the engaging of the at least second portion of the implant with the first element, (ii) the advancing of the implant through the side window, and (iii) the removing of the distal portion from the target location.

61. The method of claim 60, wherein the advancing of the implant through the side window and into the intervertebral disc space comprises advancing the implant in a direction that is perpendicular to the lateral axis of the window.

62. The method of claim 60, wherein the advancing of the implant through the side window and into the intervertebral disc space comprises utilizing the elongate pusher and the first element to expel a totality of the implant from the internal channel through the side window in a lateral direction relative to the longitudinal axis of the elongate member.

63. The method of claim 60, further comprising maintaining a height of the implant during the removing of the distal portion from the target location of the skeletal system.

64. The method of claim 60, wherein: at least the distal portion of the elongate member further comprises first and second opposing surfaces configured to enable the distal portion of the elongate member to be moveable between a collapsed configuration and an expanded configuration; and the method further comprises moving the distal portion from the collapsed configuration to the expanded configuration.

65. The method of claim 64, wherein: the inserting the distal portion of the elongate member into the intervertebral disc space comprises inserting the distal portion of the elongate member into the intervertebral disc space while the distal portion is in the collapsed configuration; and the advancing the implant through the side window and into the intervertebral disc space comprises advancing the implant through the side window and into the intervertebral disc space while the distal portion is in the expanded configuration.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0025] FIG. 1 is a perspective view illustrating a spinal implant insertion tube;

[0026] FIG. 2 is a perspective view of a spinal implant to be inserted;

[0027] FIGS. 2A-2C are a top view of a plurality of spinal implants;

[0028] FIG. 3 is a perspective view illustrating one insertion tube placed in the intervertebral space;

[0029] FIG. 4 is an elevation view of an insertion tube;

[0030] FIG. 4A is a top plan view of the insertion tube in FIG. 4;

[0031] FIG. 5 is a cross-sectional elevation view of the distal end of the insertion tube illustrated in FIG. 4;

[0032] FIG. 5A is a cross-sectional top view of the distal end of the insertion tube illustrated in FIG. 4A;

[0033] FIG. 6 is a cross-sectional view of the insertion tube in FIG. 4;

[0034] FIG. 7 is a perspective view of the insertion tube of the present invention placed in and the intervertebral space and anchored to the pedicle of the adjacent vertebral body;

[0035] FIG. 8 is a top plan view of bilateral insertion tubes of the present invention placed in the intra-vertebral space and coupled to each other by a connecting member;

[0036] FIG. 9 is an end elevation view of the insertion tubes and connecting member in FIG. 8;

[0037] FIG. 10 is an elevation view of the insertion shaft;

[0038] FIG. 10A is a top plan view of the insertion shaft;

[0039] FIG. 11 is a cross-sectional elevation view of the distal end of the insertion shaft in FIG. 10;

[0040] FIG. 11A is a cross-sectional top view of the distal end of the insertion shaft in FIG. 10A;

[0041] FIG. 12 is an elevation view of the insertion shaft in FIG. 10 coupled to an implant.

[0042] FIG. 12A is a top plan view of the insertion shaft in FIG. 10 coupled to an implant;

[0043] FIG. 13 is an elevation view of the insertion tube, with the shaft and implant inserted within the insertion tube;

[0044] FIG. 14 is a top plan view of the insertion tube of FIG. 7 showing an implant deployed lateral to the insertion tube;

[0045] FIG. 15 is an elevation view of the shaft fully inserted into the insertion tube after deployment of the implant (implant not shown for clarity);

[0046] FIG. 16 is an elevation view of an alternate embodiment of an insertion tube;

[0047] FIG. 17 is a cross-sectional view of the distal end of the insertion tube in FIG. 16; and

[0048] FIG. 18 is a cross-sectional view of the insertion tube in FIG. 16 showing it expanded as the implant is inserted into the distal end of the insertion tube.

[0049] FIG. 19 is a side view of another exemplary embodiment of an insertion tube.

DETAILED DESCRIPTION OF THE INVENTION

[0050] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

[0051] FIG. 1 shows the insertion tube 20 with slot 26 for insertion of an intervertebral implant and insertion shaft. The slot 26 (also referred to as a channel) extends along the insertion tube 20 toward the distal end 21. The distal end of the insertion tube 21 includes a rounded atraumatic distal tip 24 for ease of insertion into the disk space, a stepped region forms a protuberance 23 which serves as a mechanical stop to prevent insertion of the tube 20 past the desired placement in the disc space and window 22, which allows for deployment of the intervertebral implant. Additional relief 25 in window 22 and/or distal end of the insertion tube 20 provides clearance for the distal end of the insertion shaft during deployment of the intervertebral implant. In alternative embodiments, the distal end 21 may have an opening that provides the clearance. The window has a longitudinal axis that preferably is laterally offset from the longitudinal axis of the insertion tube 20. Thus, the longitudinal axis of the window in preferred embodiments is parallel to the longitudinal axis of the insertion tube 20, but not coaxial therewith. In alternative embodiments, the window may be angled transversely to the longitudinal axis of the insertion tube 20. The insertion tube 20 also includes a handle 7 that allows a surgeon to easily hold and manipulate the device. An optional threaded portion 5 in the handle allows a pusher shaft (not illustrated here) to be threadably actuated so that it moves along the slot 26. Optional through holes 9 extending from the outer surface of the insertion tube and communicating with the slot 26 may be disposed in the sidewalls of the insertion 20. The through holes 9 help lighten the device which may be fabricated from metals such as stainless steel or polymers such as ABS, PVC, or other polymers used for surgical instruments. Additionally, the through holes 9 allow the device to be more easily cleaned and sterilized if the device is reusable and resterilizable. The device may be single use. The slotted region 26 is offset from the longitudinal axis of the handle 7 thereby forming a shoulder 3 which acts as a stop to prevent over insertion of the pusher shaft as discussed below. Additionally, the offset allows a surgeon to look down the slot to view the surgical field. FIGS. 4 and 4A illustrate alternative views of the insertion tube. Hole 27 (best seen in FIG. 4A) allows a fastener such as a screw to coupled to the insertion tube. This allows other instruments such as a second insertion tube to be coupled to the first insertion tube. FIG. 6 illustrates yet another alternative view of the insertion tube 20.

[0052] FIG. 2 is an illustration of an exemplary interbody implant 30 that may be used as an intervertebral implant, often during spinal fusion. The implant 30 includes a textured surface 37 on the superior and inferior surfaces of the implant that help grip and keep the implant in position between vertebral endplates. An aperture 35 on one end of the implant allows a radiopaque marker such as a metal pin to be inserted therein to facilitate visualization under x-ray or other fluoroscopic imaging techniques. A slotted region 33 allows the implant to be coupled with a second implant. In certain circumstances, it may be advantageous to couple two implants together such as in FIG. 2A where implant 30 is coupled with a second implant 30a. The two implants may be identical to one another or different. Additional information related to the implants and their use is disclosed in U.S. patent application Ser. No. 13/797,586; the entire contents of which is incorporated herein by reference. A pin 31 is used to couple the two implants together and the pin 31 allows the implants to move relative to one another as seen in FIGS. 2B and 2C where the implants move from a serial configuration to a parallel configuration. This provides a lower profile for delivery and a larger support area once implanted.

[0053] FIG. 3 shows the distal end 21 of insertion tube 20 fully inserted into the intervertebral disc space, 51 between the superior adjacent vertebra 52 and the inferior adjacent vertebra 53. Further insertion of insertion tube 20 is prohibited because the stepped region 23 abuts against the bone, thereby providing a mechanical stop.

[0054] FIG. 5 is a cross-sectional view of the distal end 21 of insertion tube 20, showing the closed end 28 of the insertion tube, which prevents expulsion of the intervertebral implant along the axis of the tube, thereby enabling deployment through window 22. Additionally, receptacle 35 provides a recessed region for receiving the distal end of the pusher shaft. The closed end prevents the pusher shaft from extending past the distal end of the insertion tube thereby preventing any sharp points from protruding from the insertion tube 20. The recessed region also accommodates the distal portion of the pusher shaft which may have a coupling mechanism for coupling with the implant. By accommodating the coupling mechanism, the pusher shaft does not have to be moved further distally to account for the length of the coupling mechanism, and the window similarly may be positioned more proximally along the insertion tube. In alternative embodiments, instead of a receptacle, a small aperture may be disposed in the distal end of the insertion tube to accommodate a coupling mechanism or the distal portion of the pusher shaft. FIG. 5A illustrates an alternative view of FIG. 5.

[0055] FIG. 7 shows supplemental fixation of tube 20 by attaching pedicle anchor 29 to tube 20 and securing anchor 29 directly to the pedicle of the inferior adjacent vertebra 53. The pedicle anchor 29 may comprise a tube that is coupled to a coupling member 29a which is fixedly or releasably attached to insertion tube 20. The tube 29 may be slidably adjustable along coupling member 29a to adjust the lateral distance between the tube 29 and the insertion tube 20. The tube 29 has a channel extending through it and is sized to receive an elongate screw which is threadably engaged with the pedicle or any portion of the vertebrae, thereby rigidly supporting and helping to stabilize the insertion tube.

[0056] FIG. 8 illustrates a bilateral use of two tubes 20, rigidly coupled for stability by connecting member 27. A connector element 27 may be fixedly or releasably attached to the two insertion tubes 20 to rigidly connect them together as previously described in FIG. 7 above. The connector element 27 may be slotted in order to allow adjustment of the two tubes 20 relative to one another; either axially, laterally, or both, as indicated by the arrows in FIG. 8. FIG. 9 illustrates an alternative view of FIG. 8.

[0057] FIG. 10 shows the insertion shaft 60 (also referred to herein as a pusher shaft), which is used to insert and deploy the intervertebral implant 30. The insertion shaft is optional, as the implant may be advanced along the insertion tube by other means. The implant attachment connector 61 is flexibly formed on the distal end 64 of the shaft 60, such that when assembled to the intervertebral implant 30, the connector 61 collapses slot 63 sufficiently to connect or disconnect from implant 30 by applying force along the long axis of the shaft 60. In this embodiment, the attachment connector or coupling mechanism 61 is a T-shaped connector element having a base with two arms extending therefrom and forming the T. The arms may be received in a cooperating receptacle on the implant so that the implant is releasably coupled therewith. The proximal end of the shaft (not numbered) is adapted for applying force to the shaft by a variety of methods, including hand pressure, mallet or screw thread. Additionally, the proximal end of the pusher shaft has a portion 65 which extends radially outward. This portion will abut against stop 3 (seen in FIG. 1) to prevent the pusher shaft from being advanced too far. FIG. 10A further illustrates the angled surface 62 at the distal end 64 of the shaft 60. Angled surface 62 applies a lateral force to implant 30 when the implant reaches the distal end of tube 20 and force is applied to shaft 60. The lateral force pushes the implant out the window of the insertion tube.

[0058] FIG. 11 and FIG. 11A are enlarged views of the distal end 64 of shaft 60.

[0059] FIG. 12 and FIG. 12A show implant 30 assembled on shaft 60. FIG. 12 shows the T-shaped connector element 61 releasably coupled to a receptacle in the implant 30. As the pusher shaft advances the implant along the channel in the insertion tube, it will exert a lateral force on the implant and eject the implant from the window. This force also decouples the T-shaped connector element 61 from the implant and releases the implant so that it may be delivered to the treatment site.

[0060] FIG. 13 illustrates implant 30, assembled on shaft 60, inserted into tube 20 as implant 30 approaches the distal end 21 of tube 30, just prior to deployment of implant 30 from tube 20. As the pusher shaft 60 is further advanced distally, the implant will be pushed out the window in the insertion tube. FIG. 14 shows the lateral position of a fully deployed implant 30, with tube 20 still in place in the intervertebral space.

[0061] FIG. 15 illustrates the position of the distal end 64 of shaft 60 in the distal end 21 of tube 20 when implant 30 (not shown) is fully deployed. The implant attachment connector 61 can be seen in the relief area 25 (see FIG. 5) of window 22 (see FIG. 5). This relief allows full insertion of distal end 64 of shaft 60, thereby providing full lateral deployment of implant 30.

[0062] FIG. 16 shows an alternate embodiment 120 of the insertion tube. This embodiment generally takes the same form as the previous embodiment with the main difference being the expandable insertion tube that accommodates implants with greater height. The distal end 121 of tube 120 includes a rounded distal tip 124, window 122, relief area 125 and insertion stop 123. The expandable insertion tube is formed from two half tubes or otherwise opposable surfaces which expand away from one another.

[0063] FIG. 17 is an enlarged view of distal end 121, which has an upper surface and a lower surface which are opposed surfaces that are split and can spread apart. The splitting 129 of distal end 121 is highlighted in FIG. 17. The split distal end 121 provides flexibility, such that an implant 30 of height greater than the height of the split distal end 121 may be implanted into a disc space of height less than that of the implant, by insertion of distal end 121 in a closed position and expansion of distal end 121 during implantation. FIG. 18 illustrates expansion of distal end 121 of tube 120 by insertion of implant 30. In alternative embodiments, the upper and lower surfaces of the insertion tube may form a plurality of fingers which pivotably or resiliently spread apart.

[0064] FIG. 19 illustrates another exemplary embodiment of an insertion tube that is generally similar to previous embodiments. The insertion tube includes a handle 302, an insertion slot 304 for receiving the implant and a rounded atraumatic distal tip 306. The distal portion of the insertion tube has an upper surface 308 and a lower surface 310 that can separate away from one another as the implant is advanced through a channel in the insertion tube. The upper and lower opposable surfaces may be pivotably coupled together as seen in FIG. 19, or the opposable surfaces may be resilient and deflect away from one another.

[0065] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.