WO2017212441A1

WO2017212441A1 - Apparatuses for vertebrae stabilization and fixation and related methods

Info

Publication number: WO2017212441A1
Application number: PCT/IB2017/053402
Authority: WO
Inventors: Andy J. REDMOND; Charles R. Gordon; Erik Wagner
Original assignee: West End Bay Partners, Llc
Priority date: 2016-06-09
Filing date: 2017-06-08
Publication date: 2017-12-14

Abstract

This disclosure includes devices for vertebrae fixation and stabilization and methods for using the same. Some devices for use in intervertebral fixation, comprise: an cage housing having a first channel; a carriage assembly removably disposable in the first channel, the carriage assembly comprising: a carriage housing having a second channel, an engagement member movable between a retracted position and an extended position, and an actuation member movable in the second channel and configured to effectuate movement of the engagement member between the retracted position and the extended position.

Description

DESCRIPTION

APPARATUSES FOR VERTEBRAE STABILIZATION AND FIXATION

AND RELATED METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62/348,076, filed on June 9, 2016, hereby incorporated by reference in its entirety.

BACKGROUND

1. Field of the Invention

[0002] The present invention relates generally to the fields of bone fixation devices and techniques. More particularly, it concerns devices for vertebrae fixation and stabilization and methods for using the same.

2. Description of Related Art

[0003] The human intervertebral disc can degenerate or become injured, leading to pain and instability. In severe cases the intervertebral disc must be removed and bone graft placed between vertebrae in order to cause bone to grow between the vertebrae and eliminate the pain and instability. Surgical intervertebral disc removal may further destabilize the spinal segment and bone graft alone may not support the spine prior to the fusion of the bone. Therefore, an interbody fusion device must be placed between the vertebrae to contain the bone graft, while maintaining spine alignment and disc height. Unfortunately, interbody fusion devices do little to stabilize the spine in other directions, specifically axial rotation and extension, so they are often supplemented with devices such as screws and plates. Bony fusion may then occur between the vertebrae over time.

[0004] One common problem with interbody fusion devices is post-operative migration of the interbody fusion device, which may become a source of non-union and recurrent pain. Furthermore, plates and screws increase the necessary surgical access as compared to using the cage alone. They can also break, subside, or back out leading to significant complications.

[0005] Therefore there is a need for a low profile device that provides a rigid secondary fixation means to prevent migration of the device while limiting surgical exposure and other associated risks.

SUMMARY OF THE INVENTION

[0006] This disclosure includes embodiments of anchor devices and methods of using anchor devices that comprise a movable engagement member configured to engage a vertebra.

[0007] Some embodiments of the present anchor devices for use in intervertebral fixation comprise: a cage housing having a first channel; a carriage assembly removably disposable in the first channel, the carriage assembly comprising: a carriage housing having a second channel, an engagement member movable between a retracted position and an extended position, and an actuation member movable in the second channel and configured to effectuate movement of the engagement member between the retracted position and the extended position.

[0008] Some embodiments of the present anchor devices include a carriage assembly for use in intervertebral fixation, comprise: a housing having a channel, an engagement member at least partially disposed in the channel and movable between a retracted position and an extended position, and an actuation member movable in the channel and configured to effectuate movement of the engagement member between the retracted position and the extended position.

[0009] Some embodiments of the present methods (e.g., of using an anchor device for intervertebral fixation), comprise: positioning a cage housing between a first vertebra and a second vertebra; inserting a carriage assembly into an aperture of the cage housing while the cage housing is positioned between the first vertebra and the second vertebra, the carriage assembly comprising: a carriage housing, an engagement member movable between a retracted position and an extended position, and an actuation member; moving the carriage housing relative to the cage housing; and engaging the actuation member with the engagement member, thereby moving the engagement member from the retracted position toward the extended position.

[0010] The term "coupled" is defined as connected, although not necessarily directly, and not necessarily mechanically. Two items are "couplable" if they can be coupled to each other. Unless the context explicitly requires otherwise, items that are couplable are also decouplable, and vice-versa. One non-limiting way in which a first structure is couplable to a second structure is for the first structure to be configured to be coupled (or configured to be couplable) to the second structure. The terms "a" and "an" are defined as one or more unless this disclosure explicitly requires otherwise. The term "substantially" is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any disclosed embodiment, the term "substantially" may be substituted with "within [a percentage] of what is specified, where the percentage includes .1, 1, 5, and 10 percent.

[0011] Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.

[0012] The terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has" and "having"), and "include" (and any form of include, such as "includes" and "including") are open-ended linking verbs. As a result, an apparatus that "comprises," "has," or "includes" one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that "comprises," "has," or "includes" one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.

[0013] Any embodiment of any of the apparatuses, systems, and methods can consist of or consist essentially of - rather than comprise/include/have - any of the described steps, elements, and/or features. Thus, in any of the claims, the term "consisting of or "consisting essentially of can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open- ended linking verb.

[0014] The feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.

[0015] Some details associated with the embodiments described above and others are described below. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of specific embodiments presented herein.

[0017] FIGs. 1-3 are perspective, first side, and second side views, respectively, of one embodiment of the present anchor devices, shown with a plurality of engagement members in a first position.

[0018] FIG. 4 is a third side view of the anchor device of FIGs. 1-3 positioned in between a first vertebra and a second vertebra.

[0019] FIG. 5 is a cross-section view of the anchor device of FIGs. 1-3, taken along line 5-5 of FIG. 2.

[0020] FIGs. 6-9 are the first side, the third side, a fourth side, and a cross-section view, respectively, of the anchor device of FIGs. 1-3, shown with the plurality of engagement members in a second position.

[0021] FIGs. 10-12 are a perspective, a first side, and a cross-section view, respectively, of one embodiment of a carriage assembly of the anchor device of FIGs. 1-3, shown with the plurality of engagement members in the first position.

[0022] FIGs. 13-15 are a cross-section, the first side, and a second side view, respectively, of the carriage assembly of FIGs. 10-12, shown with the plurality of engagement members in the second position.

[0023] FIG. 16 is a perspective view of one embodiment of a housing of the anchor device of FIGs. 1-3.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0024] Referring now to the drawings, and more particularly to FIGs. 1-10, shown therein and designated by the reference numeral 10 is one embodiment of the present anchor devices. In the depicted embodiment, device 10 may be configured to be positioned between two vertebrae bodies in order to promote bone fusion and stabilization. For example, device 10 may be used in a wide variety of procedures including anterior lumbar interbody fusion (ALIF), anterior cervical discectomy and fusion (ACDF), posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), and/or oblique and lateral lumbar interbody fusion (DLIF, OLIF, or XLIF).

[0025] In the depicted embodiment, device 10 comprises a cage housing 14 configured to be positioned between an upper vertebra 18 and a lower vertebra 22. In this embodiment, cage housing 14 may be characterized by and described relative to a midline 26 extending along a length thereof. In the depicted embodiment, cage housing 14 may include a first end 30 and a second end 34. In the embodiment shown, device 10 may include an actuation aperture 38 at first end 30 and a channel 42 extending through at least a portion of the cage housing. As shown, at least a portion of an upper surface 46 of cage housing 14 may include a grooved upper surface 50 and at least a lower surface 54 of the cage housing may include a grooved lower surface 58. In some embodiments (e.g., 10), at least a portion of an upper surface (e.g., 46) and/or a lower surface (e.g., 54) of a cage housing (e.g., 14) may include a textured surface. In the depicted embodiment, upper surface 46 may be configured to engage a cortical wall 62 of upper vertebra 18 and lower surface 54 may be configured to engage a cortical wall 66 of lower vertebra 22. As shown, cage housing 14 may include one or more chamber(s) 70 configured to support bone graft matter. In the embodiment shown, cage housing 14 may be configured to include one or more cage aperture(s) 74 (e.g., two cage apertures, as shown). More specifically, in this embodiment, upper surface 46 of cage housing 14 includes a cage aperture 74 and lower surface 54 of the cage housing includes a cage aperture 74.

[0026] In the embodiment shown, device 10 may include a carriage assembly 78 (e.g., removably) disposable in cage housing 14. As shown, carriage assembly 78 may include a carriage housing 82, an actuation member 86, and one or more engagement member(s) 90 (e.g., two engagement members, as shown) coupled to the carriage housing.

[0027] In the depicted embodiment, carriage housing 82 may include one or more carriage apertures 94 (e.g., two carriage apertures, as shown) corresponding to cage apertures 74 of cage housing 14. In this embodiment, carriage housing 82 and cage housing 14 may be configured to cooperate to prevent rotation of the carriage housing relative to the cage housing when the carriage housing is disposed in channel 42 of the cage housing. More specifically, carriage housing 82 and cage housing 14 may cooperate to prevent circumferential misalignment between cage aperture(s) 74 and carriage aperture(s) 94. For example, in the embodiment shown, an outer surface 98 of carriage housing 82 may include one or more protrusion(s) 102 (e.g., two protrusions, as shown) extending radially outward relative to midline 26 and configured to be keyed into corresponding alignment slot(s) 106 (e.g., two alignment slots, as shown) defined by an inner surface 110 of cage housing 14. In the depicted embodiment, carriage housing 82 and cage housing 14 may (e.g., also) be configured to cooperate to prevent axial misalignment between cage aperture(s) 74 and carriage aperture(s) 94 when the carriage housing is disposed in channel 42 of the cage housing. For example, in this embodiment, an end 114 of carriage housing 82 may be configured to engage a stop 118 defined by cage housing 14 (e.g., at a predetermined distance from first end 30 and/or second end 34 of the cage housing such that, when the end of the carriage housing engages the stop, one or more engagement member(s) 90 may be at least partially axially aligned with respective carriage aperture(s) 94 and cage aperture(s) 74). In this embodiment, stop 118 may be configured to inhibit further axial movement of carriage housing 82 relative to cage housing 14 (e.g., inhibit axial movement towards second end 34 of the cage housing).

[0028] In the depicted embodiment, one or more engagement member(s) 90 may be movable between a retracted position and an extended position. In the retracted position, one or more engagement member(s) 90 may be configured to extend a first distance 122 from midline 26. In the extended position, one or more engagement member(s) 90 may be configured to extend a second distance 116 from midline 26, where second distance 116 is greater than first distance 112. More particularly, in this embodiment, at least a portion of one or more engagement member(s) 90 may be configured to extend through respective carriage aperture(s) 94 and respective cage aperture(s) 74 when the one or more engagement member(s) are in the extended position.

[0029] In the depicted embodiment, one or more engagement member(s) 90 may include any appropriate shape such that, when the engagement member is the extended position, the engagement member is configured to securely engage a vertebra and prevent (e.g., translational and/or rotational) movement of cage housing 14 relative to the vertebra. For example, in the embodiment shown, a respective first end 120 of one or more engagement member(s) 90 may be coupled to a respective hinge 124 disposed in a channel 128 of carriage housing 82 and at least one of the one or more engagement member(s) may rotatable between the retracted position and the extended position via the respective hinge. In the depicted embodiment, hinge 124 may be laterally movable in a slot 130 formed in carriage housing 82. In this embodiment, one or more engagement member(s) 90 may include a second end 132 comprising a substantially sharp endpoint such that the second end engages (e.g., stabs into) cortical wall 62, 66 of a respective upper and lower vertebrae 18, 22 to secure (e.g., prevent translational and/or rotational movement of) device 10 relative to the respective vertebra. More specifically, in the depicted embodiment, (e.g., second end 132 of) one or more engagement member(s) 90 may be configured to pierce cortical wall 62 of upper vertebra 18, thereby securely fixing (e.g., translationally and/or rotationally) device 10 relative to the upper vertebra when the one or more engagement member(s) are in the extended position. Similarly, in the depicted embodiment, (e.g., second end 132 of) one or more engagement member(s) 90 may be configured to pierce cortical wall 66 of lower vertebra 22, thereby securely fixing (e.g., translationally and/or rotationally) device 10 relative to the lower vertebra when the one or more engagement member(s) are in the extended position.

[0030] In this embodiment, one or more engagement member(s) 90 may be coupled with hinge 124 such that the engagement member moves uniaxially, biaxially, or multiaxially relative to the respective hinge, thereby allowing the engagement member to engage respective upper and lower vertebra 18, 22 and adjust to irregularities and variable angles of a corresponding cortical wall 62, 66 of the vertebrae.

[0031] In some embodiments (e.g., 10), second end (e.g., 132) of one or more engagement member(s) (e.g., 90) may include any suitable shape such that the second end engages (e.g., stabs into) cortical wall (e.g., 62, 66) of a vertebra (e.g., 18, 22) to prevent movement of a device (e.g., 10) relative to the vertebrae.

[0032] In this embodiment, when one or more engagement member(s) 90 are in the retracted position, the one or more engagement member(s) may be configured to be substantially flush with outer surface 98 of carriage housing 14. In some embodiments (e.g., 10), one or more engagement member(s) (e.g., 90) may be configured to be biased toward the retracted position (e.g., by a biasing member such as, for example, a spring and/or the like).

[0033] In this embodiment, actuation member 86 may comprise a screw. In the depicted embodiment, carriage housing 82 may include a threaded inner surface 136 configured to mate with a threaded surface 140 of actuation member 86. In this embodiment, actuation member 86 includes a cap portion 144 having grooves configured to mate with an expansion member (e.g., insertable into and out of the cap portion of the actuation member). As shown, cap portion 144 of actuation member 86 may include a shoulder 146 configured to engage a corresponding shoulder 148 defined by cage housing 14. In this embodiment, shoulder 148 may be configured to inhibit axial movement of actuation member 86 relative to cage housing 14 (e.g., inhibit axial movement towards second end 34 of the cage housing) when the shoulder of the actuation member engages the shoulder of the cage housing.

[0034] As shown, one or more engagement member(s) 90 may include an inwardly-facing arcuate surface 152. In the depicted embodiment, actuation member 86 may be configured to effectuate movement of one or more engagement member(s) 90 between the retracted position and/or the extended position. More specifically, in this embodiment, actuation member 86 may be axially movable relative to one or more engagement member(s) 90 (e.g., by threading the actuation member along threaded inner surface 136 of carriage housing 82) such that the actuation member engages (e.g., arcuate surface 152 of) the one or more engagement member(s). In turn, actuation member 86 urges one or more engagement member(s) 90 toward the extended position. In some embodiments (e.g., 10), one or more engagement member(s) (e.g., 90) may include any other appropriately shaped inner-facing surface (e.g., 152) configured to engage an actuation member (e.g., 86) such as, for example, a tapered inner-facing surface.

[0035] In the depicted embodiment, in operation, an intervertebral disc between upper vertebra 18 and lower vertebra 22 may be removed and the volume between the upper and lower vertebrae may be at least partially cleared and/or cleaned. In this embodiment, cage housing 14 having one or more chamber(s) 70 at least partially filled with bone graft may be inserted into the volume between upper and lower vertebrae 18, 22. Thereafter, an insertion device, such as, for example, an elongated cannula, may be securely coupled to cage housing 14 (e.g., proximate to actuation aperture 38). In this embodiment, the insertion device may include an inner profile configured to accommodate carriage assembly 78. In this configuration, when carriage assembly 78 is guided through the insertion device, actuation member 86 may be at least partially disposed (e.g., threaded) in channel 128 of carriage housing 82 and one or more engagement member(s) 90 are in the retracted position in order to facilitate movement of the carriage assembly through the insertion device. In the depicted embodiment, carriage assembly 78 may be urged through the insertion device (e.g., by the expansion member) and into cage housing 14 (e.g., via actuation aperture 38). In the embodiment shown, axial movement of carriage housing 82 through channel 42 cage housing 14 may continue until the carriage housing engages stop 118. Thereafter, actuation member 86 may be moved (e.g., rotated by the expansion member) such that the actuation member moves axially relative to carriage housing 82 toward second end 34 of cage housing 14 (e.g., while the carriage housing remains axially fixed due to engagement between end 114 and stop 118). Next, in this embodiment, shoulder 146 of actuation member 86 may engage shoulder 148 of cage housing 14, thereby inhibiting further axial movement of the actuation member toward second end 34 of the cage housing. After shoulder 146 of actuation member 86 engages shoulder 148 of cage housing 14, the actuation member may continue to be rotated (e.g., by the expansion member), thereby causing carriage housing 82 to axially move relative to the cage housing toward first end 30 of the cage housing. For example, in this embodiment, the engagement between threaded surface 140 of actuation member 86 and threaded inner surface 136 of carriage housing 82 may cause the carriage housing to move toward first end 30 of the cage housing when the actuation member is engaged with shoulder 148 of the cage housing. In the depicted embodiment, axial movement of carriage housing 82 relative to actuation member 86 may cause the actuation member to engage arcuate surface 152 of one or more engagement member(s) 90. More specifically, in this embodiment, arcuate surface 152 of one or more engagement member(s) 90 may move along actuation member, thereby moving (e.g., rotating) the one or more engagement member(s) from the retracted position toward the extended position via respective hinge 124. In the depicted embodiment, as one or more engagement member(s) 90 move axially relative to actuation member 86 toward first end 30, hinge 124 may move laterally in slot 130 such that the one or more engagement member(s) penetrate respective vertebrae 18, 22 in a trajectory of an arch 164. In this way and others, actuation member 86 may be configured to guide one or more engagement member(s) 90 through respective cage aperture(s) 74 by simultaneously moving carriage housing 82 toward first end 30 of cage housing 14 and by moving one or more engagement member(s) 90 toward the extended position while the carriage housing moves toward the first end of the cage housing.

[0036] In this way and others, device 10 maintains the spacing of the vertebrae 18, 22 while bone fusion occurs. After bone fusion occurs, a solid bone mass forms and the vertebrae 18, 22 are joined together. [0037] In the embodiment shown, to move one or more engagement member(s) 90 toward the retracted position, actuation member 86 may be moved (e.g., rotated by the expansion member) such that the carriage housing 82 moves axially relative to the actuation member toward second end 34 of cage housing 14. As a result, actuation member 86 may disengage one or more engagement member(s) 90, thereby allowing the one or more engagement member(s) to move toward the retracted position. In this way and others, engagement between device 10 and upper and lower vertebrae 18, 22 may be reversible and revisable.

[0038] In the embodiment shown, one or more components of device 10 may include cadaver bone and/or any suitable biocompatible material, such as plastic, stainless steel, a viscoelastic polymer (e.g., rubber), titanium, and/or the like.

[0039] In this embodiment, device 10 may be configured to reestablish and maintain a height between upper and lower vertebrae 18, 22 and/or inhibit rotational movement of the upper and lower vertebrae and/or separation of the device from the upper and lower vertebrae. In the embodiment shown, when one or more engagement member(s) 90 are in the extended position and extend through cortical wall 62, 66 of vertebrae 18, 22, the one or more engagement member(s) prevent back-out movement of device 10 along the path 156 of the original insertion of the device. In the depicted embodiment, when one or more engagement member(s) 90 are in the extended position, the one or more engagement member(s) may be configured to extend substantially perpendicularly relative to a rotational arch 160 of the spine. As shown, an instantaneous center of rotation (ICR) 162 for rotational arch 160 may be located posteriorly and/or adjacent to lower vertebra 22. For example, in the cervical spine, an ICR (e.g., 162) may be anterior to an anatomical coordinate system of a lower vertebra (e.g., 22) as a person moves from full flexion into extension. For further example, in the lumbar spine, an ICR (e.g., 162) may be posterior relative to an anatomical coordinate system of a lower vertebra (e.g., 22) as a person moves from full flexion into extension.

[0040] Some embodiments of the present devices (e.g., 10) may be configured in different arrangements and/or sizes to accommodate a wide variety of patients. For example, some embodiments (e.g., 10) may include a cage housing (e.g., 14) having a plurality actuation apertures (e.g., 38) for use with a respective plurality of carriage assemblies (e.g., 78), each of which include one or more engagement members (e.g., 90). For further example, some embodiments (e.g., 10) may include any appropriate number of engagement members (e.g., 90) extending from an upper surface (e.g., 46) and a lower surface (e.g., 54), such as, for example two, three, four, five, or six or more engagement members extending from respective upper and lower surface. For yet further example, in some embodiments, a plurality of devices (e.g., 10) may be positioned between an upper vertebra (e.g., 18) and a lower vertebra (e.g., 22) to provide additional stability and/or fixation. In some embodiments, a kit may include one or more device(s) (e.g., 10) having different sizes configured to accommodate stabilization and/or fixation between any two vertebrae in the spine.

[0041] The above-described embodiments include the benefits of provide strong constructs that can sustain the weight of the patient's body, resist rotational and translational forces between the vertebrae, promote vertebrae fusion over time, and/or take advantage of the cortical layer to resist pull-out. Furthermore, the above-described embodiments include the benefit of a reduced overall outer diameter of the device such that multiple devices may be placed closer together and such that the incision needed to insert the device is minimized.

Claims

WHAT IS CLAIMED IS:

An anchor device for use in intervertebral fixation, comprising:

a cage housing having a first channel;

a carriage assembly removably disposable in the first channel, the carriage assembly comprising:

a carriage housing having a second channel,

an engagement member movable between a retracted position and an extended position, and

an actuation member movable in the second channel and configured to

effectuate movement of the engagement member between the retracted position and the extended position.

A carriage assembly for use in intervertebral fixation, comprising:

a housing having a channel,

an engagement member at least partially disposed in the channel and movable

between a retracted position and an extended position, and

an actuation member movable in the channel and configured to effectuate movement of the engagement member between the retracted position and the extended position.

A method of using an anchor device for intervertebral fixation, comprising:

positioning a cage housing between a first vertebra and a second vertebra;

inserting a carriage assembly into an aperture of the cage housing while the cage housing is positioned between the first vertebra and the second vertebra, the carriage assembly comprising:

a carriage housing,

an actuation member;

moving the carriage housing relative to the cage housing; and

engaging the actuation member with the engagement member, thereby moving the engagement member from the retracted position toward the extended position.