|Publication number||US20090248161 A1|
|Application number||US 12/408,100|
|Publication date||Oct 1, 2009|
|Filing date||Mar 20, 2009|
|Priority date||Mar 20, 2008|
|Also published as||US8728163, US20120209389|
|Publication number||12408100, 408100, US 2009/0248161 A1, US 2009/248161 A1, US 20090248161 A1, US 20090248161A1, US 2009248161 A1, US 2009248161A1, US-A1-20090248161, US-A1-2009248161, US2009/0248161A1, US2009/248161A1, US20090248161 A1, US20090248161A1, US2009248161 A1, US2009248161A1|
|Inventors||Charles Theofilos, George England|
|Original Assignee||K2M, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (3), Classifications (19), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims priority to, and the benefit of, U.S. Provisional Patent Application Ser. No. 61/070,126, filed Mar. 20, 2008, the entire contents of which are hereby incorporated by reference.
1. Technical Field
This application relates to a device for use in orthopedic spine surgery. In particular, the present invention relates to an artificial disc replacement device that replaces a damaged or diseased intervertebral disc.
2. Background of Related Art
The human spine is composed of thirty-three vertebrae at birth and twenty-four as a mature adult. Between each pair of vertebrae is an intervertebral disc, which maintains the space between adjacent vertebrae and acts as a cushion under compressive, bending, and rotational loads and motions. A healthy intervertebral disc has a great deal of water in the nucleus pulposus, which is the center portion of the disc. The water content gives the nucleus a spongy quality and allows it to absorb spinal stress. Excessive pressure or injuries to the nucleus can cause injury to the annulus, which is the outer ring that holds the disc together. Generally, the annulus is the first portion of the disc that experiences injury. These injuries are typically in the form of small tears. These tears heal by scar tissue. The scar tissue is not as strong as normal annulus tissue. Over time, as more scar tissue forms, the annulus becomes weaker. Eventually this can lead to damage of the nucleus pulposus. The nucleus begins to lose its water content due to the damage; it begins to dry up. Because of water loss, the discs lose some of their ability to act as a cushion. This can lead to even more stress on the annulus and still more tears as the cycle repeats. As the nucleus loses its water content, it collapses, allowing the vertebrae above and below the disc space to move closer to one another. This results in a narrowing of the disc space between the two vertebrae. As this shift occurs, the facet joints located at the back of the spine are forced to shift. This shift changes the way the facet joints work together and can cause problems in the facet joints as well.
When a disc or vertebrae is damaged due to disease or injury, standard practice is to remove all or part of the intervertebral disc, insert a natural or artificial disc spacer, and construct an artificial structure to hold the affected vertebrae in place to achieve a spinal fusion. In doing so, while the diseased or injured anatomy is addressed and the accompanying pain is significantly reduced, the natural biomechanics of the spine are affected in a unique and unpredictable way. More often than not, the patient will develop complicating spinal issues in the future.
To that end, there is an overall need to treat the disease or injury while maintaining or preserving the natural spine biomechanics. Normal spine anatomy, specifically intervertebral disc anatomy, allows one vertebra to rotate with respect to its adjacent vertebra about all three axes. Similarly, the intervertebral disc also allows adjacent vertebra to translate along all three axes with respect to one another.
For the above stated reasons, a need exits for an implantable device which may be used as an artificial disc replacement thereby maintaining disc height and motion. More specifically, the motion maintained must address at least the principle motions of rotation about all three axes. The device must also have a means to inhibit or minimize expulsion of the device from its installed location. The implantable device has an additional need of having a prolonged life span in the body that can withstand early implantation, as is often indicated for younger patients. In addition, the implantable device will have a limited amount of particulate debris so as to reduce complications over the useful life of the device.
The present disclosure relates to an artificial disk replacement device or disk. The disk includes opposing plate members with a pivoting assembly disposed therebetween. The pivoting assembly may include a support member and a cup. Additionally, the pivoting assembly may include an engagement member. The pivoting assembly is configured for slidable insertion into openings in the first and second plate members. Each plate member may include one or more teeth for securely engaging endplates of adjacent vertebral bodies.
The pivoting assembly is adapted for allowing relative movement of the first and second plate members with respect to each other in a first direction, while inhibiting relative movement of the first and second plate members in a second direction. The first direction is transverse or orthogonal with respect to the first direction.
One embodiment of the disk is adapted for use in lumbar procedures. In this embodiment, the support member includes a hemispherical dome with opposing arms that lie in the first direction. The cup has opposing openings adapted for pivotally engaging the arms of the support member. As such, the cup moves symmetrically about the axis extending through the arms and the openings.
In an alternate embodiment, the disk is adapted for use in cervical procedures. In this embodiment, the dome of the support member is eccentric or asymmetric with respect to the axis extending through the opposing arms. Thus, when the cup pivots about the axis extending through the arms, the asymmetric configuration of the dome interacts with the cup causing the plate members of the disk to pivot and lift (i.e. increase the distance between the plate members).
An installation tool and a method of installing the disk are also disclosed. The installation tool has a handle, a knob, and a shaft. At the distal end of the installation tool, a pair of opposing jaws or blade portions exists. The blade portions releasably engage the first and second plate members. An attachment portion is located at a distal end of the shaft for releasably engaging the pivoting assembly of the disk. With the first and second plate members attached to the blade portions and the pivoting assembly coupled to the attachment portion, the physician inserts the distal end of the installation tool between the adjacent vertebral bodies. Rotating the handle in one direction causes the shaft to translate distally through the installation tool. As the pivoting assembly moves distally, it engages inner surfaces of the blade portions urging them apart. Once the pivoting assembly is fully translated in the distal direction, the support member and the engagement member slide into openings in the respective first and second plate members, thereby securing the pivoting assembly between the first and second plate members and completing the assembly of the disk. Since the distraction of the adjacent vertebral bodies is performed prior to installing the pivoting assembly, this reduces the installation force necessary to install the disk. Thus, the potential trauma to the patient is reduced and any possibility of deforming the disk is also reduced.
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
Particular embodiments of the present disclosure will be described herein with reference to the accompanying drawings. In the drawings and in the description that follows, the term “proximal,” will refer to the end of a device or system that is closest to the operator, while the term “distal” will refer to the end of the device or system that is farthest from the operator. In addition, the term “cephalad” is used in this application to indicate a direction toward a patient's head, whereas the term “caudad” indicates a direction toward the patient's feet. Further still, for the purposes of this application, the term “medial” indicates a direction toward the middle of the body of the patient, whilst the term “lateral” indicates a direction toward a side of the body of the patient (i.e., away from the middle of the body of the patient). The term “posterior” indicates a direction toward the patient's back, and the term “anterior” indicates a direction toward the patient's front.
Referring now to the drawings, in which like reference numerals identify identical or substantially similar parts throughout the several views,
Each of the first and second plate members 10, 60 have a superior surface adapted for engaging an endplate of a vertebral body. One or more teeth 12 are disposed on the superior surface 14, 64 of the first and second plate members 10, 60. Each tooth 12 has a generally pyramidal configuration for securely engaging the endplate of the respective vertebral body. It is contemplated that each tooth 12 may have other configurations that are configured and dimensioned for securely engaging the vertebral endplate. The superior surfaces 14, 64 are curvate surfaces, although other configurations are contemplated. In addition, each plate member 10, 60 includes an opening 15, 65 along one side thereof.
With reference to
Referring now to
The coupling member 40 (
The engaging member 50 (
The disk 100 may be considered as the first and second plate members 10, 60 having a pivoting assembly 70 (
The presently disclosed disk 100 is suitable for use in cervical applications as well as in lumbar applications. When used in cervical applications, the dome 22 of the support member 20 (
An installation tool 200 is shown in
The disk 100 is installed between adjacent vertebral bodies using the installation tool 200. With the first and second plate members 10, 60 attached to respective blade portions 228, 226 and the pivoting assembly 70 releasably coupled to the attachment portion 218, the physician inserts the distal end of the installation tool 200 between the adjacent vertebral bodies until the stop portions 225, 227 engage the exterior of the adjacent vertebral bodies indicating that the maximum insertion depth has been achieved. Subsequently, handle 210 is rotated in a first direction and advances shaft 214 distally, thereby advancing the pivoting assembly 70 distally. During the distal movement of the pivoting assembly 70, the engaging member 50 and the support member 20 slidably engage inner surfaces of the blade portions 226, 228 urging them apart and distracting the adjacent vertebral bodies. Continued distal translation of the pivoting assembly 70 positions the pivoting assembly 70 between the first and second plate members 10, 60 such that the support member 20 and the engaging member 50 are attached to the first and second plate members 10, 60. Once the pivoting assembly 70 is attached to the first and second plate members 10, 60, the knob 212 is rotated so that the pivoting assembly 70 separates from the attachment portion 218 of the shaft 214. Subsequently, the installation tool 200 is removed. Since the first and second plate members 10, 60 are installed prior to any distraction of the adjacent vertebral bodies, inserting the pivoting assembly 70 between the first and second plate members 10, 60 requires a minimal amount of insertion force. As such, this reduces trauma to the patient and reduces deformation of the disk 100.
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Thus the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7905919||Feb 26, 2010||Mar 15, 2011||Biomedflex Llc||Prosthetic joint|
|US7914580||Jun 29, 2010||Mar 29, 2011||Biomedflex Llc||Prosthetic ball-and-socket joint|
|US9107754||Nov 9, 2012||Aug 18, 2015||Biomedflex, Llc||Prosthetic joint assembly and prosthetic joint member|
|U.S. Classification||623/17.15, 623/17.11|
|Cooperative Classification||A61F2002/3065, A61F2002/30367, A61F2002/3082, A61F2002/30934, A61F2/4425, A61F2220/0025, A61F2/4611, A61F2002/4628, A61F2220/0033, A61F2002/443, A61F2002/30604, A61F2002/4627, A61F2002/30841, A61F2002/30387|
|European Classification||A61F2/44D2, A61F2/46B7|
|Jun 8, 2009||AS||Assignment|
Owner name: SNJ PATENTS, LLC, FLORIDA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:THEOFILOS, CHARLES S.;ENGLAND, GEORGE;REEL/FRAME:022790/0764;SIGNING DATES FROM 20090604 TO 20090605
|Sep 1, 2009||AS||Assignment|
Owner name: AEGEAN DISC HOLDING, LLC, FLORIDA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SNJ PATENTS, LLC;REEL/FRAME:023178/0649
Effective date: 20090813
|Jul 8, 2011||AS||Assignment|
Free format text: ADDENDUM TO INTELLECTUAL PROPERTY SECURITY AGREEMENT;ASSIGNOR:K2M, INC.;REEL/FRAME:026565/0482
Effective date: 20110629
Owner name: SILICON VALLEY BANK, CALIFORNIA
|May 22, 2013||AS||Assignment|
Owner name: K2M, INC., VIRGINIA
Effective date: 20121029
Free format text: TERMINATION;ASSIGNOR:SILICON VALLEY BANK;REEL/FRAME:030918/0426
|Jul 2, 2013||AS||Assignment|
Effective date: 20130625
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:AEGEAN DISC HOLDINGS LLC;REEL/FRAME:030726/0015
Owner name: K2M, INC., VIRGINIA