The present application relates generally to medical devices. More specifically, the present application related to devices, kits, and methods for treatment of a spine.
The human spine is a flexible weight bearing column formed from a plurality of bones called vertebrae. Typically, a human spine includes thirty-three vertebrae, grouped into five regions (cervical, thoracic, lumbar, sacral, and coccygeal). Moving down the spine along the cranial-caudal direction, there are typically seven cervical vertebrae, twelve thoracic vertebrae, five lumbar vertebrae, five sacral vertebrae, and four coccygeal vertebrae.
The human vertebrae and associated connective elements are susceptible to a variety of diseases and conditions which may cause pain and disability. These diseases and conditions include spondylosis, spondylolisthesis, vertebral instability, spinal stenosis, degenerated intervertebral discs, and herniated intervertebral discs. The vertebrae and associated connective elements are also susceptible to injuries, including fractures and torn ligaments and further may endure surgical manipulations, including a laminectomy to relieve pressure on the spinal cord or nearby nerves.
The pain and disability related to the diseases and conditions often result from the displacement of all or part of a vertebra from the remainder of the vertebral column. Spinal fusion is a surgical procedure that aims to restore displaced vertebrae to their normal position and to fix those previously displaced vertebrae within the vertebral column. During a spinal fusion procedure, vertebrae are fused together so that relative motion no longer occurs between the fused vertebrae. Typically, a spinal fusion procedure includes removing a damaged intervertebral disc and restoring the spacing between the fused vertebrae, thereby eliminating the instability and removing the pressure on the neurological elements that are causing pain as a result of the disease or condition. The spinal fusion procedure can further include implanting an intervertebral implant between vertebrae, for example adjacent vertebrae, to recreate the natural intervertebral spacing between adjacent vertebrae, previously provided by the damaged and now removed intervertebral disc.
Intervertebral implants and techniques associated with implanting them typically involve an open surgical procedure. An open surgical procedure is any surgical technique where the size of an incision in a patient's body is sufficient to permit the surgical procedure to take place under the direct vision of the surgeon. In other words, the structures and tissues involved can be seen and touched, and they are directly exposed to the air. Open surgical procedures may results in higher cost, lengthy in-patient hospital stays and increased post-operative pain.
An alternative to an open surgical procedure is a minimally invasive surgical procedure, for example a surgical procedure that involves endoscopic techniques. A minimally invasive surgical procedure typically includes accessing the site of pathology through one or more small incisions, with the goal of protecting the integrity of intervening tissues. A minimally invasive surgical procedure may result in reduced post-operative pain, reduced post-operative recovery time, and damage to healthy tissue compared to an open surgical procedure.
Minimally invasive surgical techniques are particularly desirable for spinal and neurosurgical applications because of the need for access to locations deep within the body and the danger of damage to vital intervening tissues. For example, such minimally invasive techniques can be utilized for spinal discectomy, or removal of an intervertebral disc, and spinal fusion, in which two or more vertebrae are fused together to stop the motion between them.
However, in a minimally invasive spinal fusion procedure using an intervertebral implant, the size of the opening in the patient's body must be large enough to accommodate the largest dimension of the intervertebral implant. Additionally, the maximum dimension of the intervertebral implant may limit the approaches available to a surgeon for use during a minimally invasive spinal fusion procedure. These and other short comings of the prior art are addressed by the present disclosure.
In accordance with an aspect of the disclosure, the present application discloses an implant including a frame including an end member and an intermediate member pivotally coupled to the end member about a first pivot axis. The implant includes a first vertebral contact member pivotally coupled to the frame about a second pivot axis that is substantially perpendicular to the first pivot axis, the first vertebral contact member defining a face configured to engage a first vertebra. The implant includes a second vertebral contact member coupled to the frame, the second vertebral contact member defining a face configured to engage a second vertebra. The frame is configured such that pivoting the intermediate member with respect to the end member about the first pivot axis changes a width between the first vertebral contact member and the second vertebral contact member with respect to a direction that is substantially parallel to the second pivot axis. The frame is also configured such that pivoting the first vertebral contact member with respect to the frame about the second pivot axis changes a height between the first vertebral contact member and the second vertebral contact member with respect to a direction that is substantially parallel to the first pivot axis.
In accordance with an aspect of the disclosure, the present application discloses an implant including a frame including an end member and an intermediate member pivotally coupled to the end member about a first pivot axis. The implant includes a first vertebral contact member pivotally coupled to the frame about a second pivot axis that is substantially perpendicular to the first pivot axis, the first vertebral contact member defining a face configured to engage a first vertebra. The implant includes a second vertebral contact member coupled to the frame, the second vertebral contact member defining a face configured to engage a second vertebra. The frame is configured such that pivoting the intermediate member with respect to the end member about the first pivot axis changes a width of the first vertebral contact member, the width measured along a straight line that is substantially parallel to the second pivot axis. The frame is also configured such that pivoting the first vertebral contact member with respect to the frame about the second pivot axis changes a height measured from the face of the first vertebral contact member to the face of the second vertebral contact member along a straight line that is substantially parallel to the first pivot axis.
In accordance with an aspect of the disclosure, an implant includes a first vertebral contact member defining a face configured to engage a first vertebra, and a second vertebral contact member defining a face configured to engage a second vertebra. The implant includes a frame including an end member, an intermediate member, a first linkage pivotally coupling the end member to the intermediate member such that the end member and the intermediate member are pivotable relative one another about a first pair of pivot axes that are parallel to each other, and a second linkage pivotally coupling the intermediate member to the first vertebral contact member such that the intermediate member and the first vertebral contact member are pivotable relative to one another about a second pair of pivot axes that are parallel to each other and perpendicular to the first pair of pivot axes. The first pair of pivot axes are separated by a first distance as measured along a straight line that is substantially parallel to the second pair of pivot axes, the second pair of pivot axes are separated by a second distance as measured along a straight line that is substantially parallel to the first pair of pivot axes, and the first distance is greater than the second distance.
The foregoing summary, as well as the following detailed description of illustrative embodiments of the application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the present disclosure, there is shown in the drawings illustrative embodiments. It should be understood, however, that the application is not limited to the specific embodiments and methods disclosed, and reference is made to the claims for that purpose. In the drawings:
Certain terminology is used in the following description for convenience only and is not limiting. The words “right”, “left”, “lower” and “upper” designate directions in the drawings to which reference is made. The words “proximally” and “distally” refer to directions toward and away from, respectively, the surgeon using the medical device. The words, “anterior”, “posterior”, “superior”, “inferior” and related words and/or phrases designate preferred positions and orientations in the human body to which reference is made and are not meant to be limiting. The terminology includes the above-listed words, derivatives thereof and words of similar import.
Aspects of the disclosure will now be described in detail with reference to the drawings, wherein like reference numbers refer to like elements throughout, unless specified otherwise. Certain terminology is used in the following description for convenience only and is not limiting. The term “plurality”, as used herein, means more than one. The terms “a portion” and “at least a portion” of a structure include the entirety of the structure. Certain features of the disclosure which are described herein in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the disclosure that are described in the context of a single embodiment may also be provided separately or in any subcombination.
Reference herein to a first structure being pivotally coupled to or pivoting with respect to a second structure includes each of: 1) the first structure being pivotally coupled to or pivoting with respect to the second structure (such that the first structure moves while the second structure remains stationary); 2) the second structure being pivotally coupled to or pivoting with respect to the first structure (such that the second structure moves while the first structure remains stationary); and 3) both the first structure and the second structure being pivotally coupled to or pivoting with respect to each other (such that both the first structure and the second structure move either simultaneously or sequentially). The term “pivotally coupled” as used herein with respect to first and second structures includes both the first and second structures being directly coupled (such that the respective pivot axis passes through both the first structure and the second structure), and indirectly coupled (such that the respective pivot axis passes through only one of the first and second structures, in addition to passing through an intermediate structure).
A first three dimensional coordinate system is provided in reference to a human body, for example into which an intervertebral implant is to be implanted. The first three dimensional coordinate system includes a cranial-caudal direction CC, a medial-lateral direction ML that is perpendicular to the cranial-caudal direction CC, and an anterior-posterior direction AP that is perpendicular to both the cranial-caudal direction CC and the medial-lateral direction ML. Each of the cranial-caudal direction CC, the medial lateral direction ML, and the anterior-posterior AP is bidirectional. The cranial-caudal direction CC includes a cranial direction CC1 and a caudal direction CC2 that is opposite the cranial direction CC1. The medial-lateral direction ML includes a medial direction and a lateral direction that is opposite the medial direction. The anterior-posterior direction AP includes an anterior direction and a posterior direction that is opposite the anterior direction.
A second three dimensional coordinate system is also provided in reference to a medical device configured to be implanted, for example into a human body. The second three dimensional coordinate system includes a longitudinal direction L, a lateral direction A that is perpendicular to the longitudinal direction L, and a transverse direction T that is perpendicular to both the longitudinal direction L and the lateral direction A.
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The region 4 includes a region known as Kambin's triangle 18. Kambin's triangle 18 is a right triangle positioned over a dorsolateral portion of the intervertebral disc space 10. As shown in the illustrated embodiment, the hypotenuse 20 of Kambin's triangle 18 is defined by the exiting nerve root 12. A first leg 22, also referred to as a base or width, of Kambin's triangle 18 is defined by the superior border 24 of the inferior vertebra 8, and a second leg 26, also referred to as the height, of Kambin's triangle 18 is defined by the traversing nerve root 14.
Kambin's triangle 18 is a known site used during minimally invasive discectomy procedures using a posterolateral approach. Using the posterolateral approach may protect body tissues adjacent to the region from harm during the discectomy procedure. Kambin's triangle 18 defines an approach with a cross-sectional access window at the intervertebral disc space 10 of roughly about 5 mm by about 10 mm. The size limitations imposed by Kambin's triangle 18 restrict the use of instruments and implants with a cross-sectional footprint greater than about 5 mm by about 10 mm in a posterolateral approach. Further, an implant with a cross-sectional footprint equal to or less than about 5 mm by about 10 mm may not provide the stability needed for a solid fusion between the superior vertebra 6 and the inferior vertebra 8. It will be appreciated
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According to one aspect of the disclosure, the implant body 34 further includes a frame 46, and the first vertebral contact member 42 is pivotally coupled to the frame 46 as described in detail below. The frame 46 includes an end member, for example a first end member 48, and an intermediate member, for example a first intermediate member 50, pivotally coupled to the first end member 48. As shown in the illustrated embodiment, the first end member 48 is pivotally coupled to the first intermediate member 50 about a first pivot axis P1. The intervertebral implant 30 may be oriented such that the first pivot axis P1 is substantially parallel to the transverse direction T.
The intervertebral implant 30 is configured such that the first vertebral contact member 42 is pivotally coupled to the frame 46 about a second pivot axis P2 that is substantially perpendicular to the first pivot axis P1. Substantially perpendicular as used herein refers to elements that are exactly perpendicular or nearly perpendicular within manufacturing tolerances. The intervertebral implant 30 may be oriented such that the second pivot axis P2 is substantially parallel to the lateral direction A. The first vertebral contact member 42 defines a face 52 that is configured to directly contact a vertebra, for example the superior vertebra shown in
According to one aspect of the disclosure, the frame 46 may be configured such that pivoting the first intermediate member 50 with respect to the first end member 48 about the first pivot axis changes a width W2 between the first vertebral contact member 42 and the second vertebral contact member 44 with respect to a direction that is substantially parallel to the second pivot axis P2. As shown in the illustrated embodiment, the frame 46 may be configured such that pivoting the first intermediate member 50 with respect to the first end member 48 about the first pivot axis changes a width W2 between a portion of the first vertebral contact member 42 and a portion of the second vertebral contact member 44 with respect to the lateral direction A.
According to one aspect of the disclosure, the frame 46 may be configured such that pivoting the first vertebral contact member 42 with respect to the frame 46 about the second pivot axis P2 changes a height H2 between the first vertebral contact member 42 and the second vertebral contact member 44 with respect to a direction that is substantially parallel to the first pivot axis P1. As shown in the illustrated embodiment, the frame 46 may be configured such that pivoting the first vertebral contact member 42 with respect to the frame 46 about the second pivot axis P2 changes a height H2 between a portion of the first vertebral contact member 42 and a portion of the second vertebral contact member 44 with respect to the transverse direction T.
The second vertebral contact member 44 may be pivotally coupled to the frame 46 about a third pivot axis P3 that is substantially parallel to the second pivot axis P2. The frame 46 may be configured such that pivoting the second vertebral contact member 44 with respect to the frame 46 about the third pivot axis P3 changes the height H2 between the first vertebral contact member 42 and the second vertebral contact member 44 with respect to the direction that is substantially parallel to the first pivot axis P1. As shown in the illustrated embodiment, the frame 46 may be configured such that pivoting the second vertebral contact member 44 with respect to the frame 46 about the third pivot axis P3 changes the height H2 between the portion of the first vertebral contact member 42 and the portion of the second vertebral contact member 44 with respect to the transverse direction T.
The frame 46 may include a second end member 54 and a second intermediate member 56 pivotally coupled to the second end member 54 about a fourth pivot axis P4 that is substantially parallel to the first pivot axis P1. The frame 46 may be configured such that pivoting the second intermediate member 56 with respect to the second end member 54 about the fourth pivot axis P4 changes the width W2 between the first vertebral contact member 42 and the second vertebral contact member 44 with respect to the direction that is substantially parallel to the second pivot axis P2. As shown in the illustrated embodiment, the frame 46 may be configured such that pivoting the second intermediate member 56 with respect to the second end member 54 about the fourth pivot axis P4 changes the width W2 between a portion of the first vertebral contact member 42 and a portion of the second vertebral contact member 44 with respect to the lateral direction A.
As shown in the illustrated embodiment, the first vertebral contact member 42 may include a first vertebral contact component 58 and a second vertebral contact component 60 separated from the first vertebral contact component 58 with respect to the direction that is substantially parallel to the second pivot axis P2. The first vertebral contact component 58 may be pivotally coupled to the frame 46 about the second pivot axis P2 and the second vertebral contact component 60 may be pivotally coupled to the frame 46 about a fifth pivot axis P5 that is substantially parallel to the second pivot axis P2. In accordance with one aspect of the disclosure, the second pivot axis P2 and the fifth pivot axis P5 are collinear. Alternatively, the second pivot axis P2 and the fifth pivot axis P5 are offset with respect to a direction perpendicular to the second pivot axis P2, for example the longitudinal direction L.
The frame 46 may be configured such that pivoting the first vertebral contact component 58 with respect to the frame 46 about the second pivot axis P2 changes a height H3 measured between the first vertebral contact component 58 and the second vertebral contact member 44 with respect to the direction that is substantially parallel to the first pivot axis P1. The frame 46 may further be configured such that pivoting the second vertebral contact component 60 with respect to the frame 46 about the fifth pivot axis P5 changes a height H4 between the second vertebral contact component 60 and the second vertebral contact member 44 with respect to the direction that is substantially parallel to the first pivot axis P1. The height H3 may be equal to the height H4, as shown in the illustrated embodiment. Alternatively, the height H3 may be different than, for example either greater than or less than, the height H4.
The second vertebral contact member 44 may include a first vertebral contact component 62 and a second vertebral contact component 64 separated from the first vertebral contact component 62 with respect to the direction that is substantially parallel to the second pivot axis P2. The first vertebral contact component 62 may be pivotally coupled to the frame 46 about the third pivot axis P3 and the second vertebral contact component 64 may be pivotally coupled to the frame 46 about a sixth pivot axis P6 that is substantially parallel to the second pivot axis P2. In accordance with one aspect of the disclosure, the third pivot axis P3 and the sixth pivot axis P6 are collinear. Alternatively, the third pivot axis P3 and the sixth pivot axis P6 are offset with respect to a direction perpendicular to the second pivot axis P2, for example the longitudinal direction L.
The frame 46 may be configured such that pivoting the first vertebral contact component 62 with respect to the frame 46 about the third pivot axis P3 changes the height H3 measured between the first vertebral contact component 58 and the first vertebral contact component 62 with respect to the direction that is substantially parallel to the first pivot axis P1. The frame 46 may further be configured such that pivoting the second vertebral contact component 64 with respect to the frame 46 about the sixth pivot axis P6 changes the height H4 measured between the second vertebral contact component 60 and the second vertebral contact component 64 with respect to the direction that is substantially parallel to the first pivot axis P1. The height H3 may be equal to the height H4, as shown in the illustrated embodiment. Alternatively, the height H3 may be different than, for example either greater than or less than, the height H4.
The implant body 34, for example the frame 46, according to one aspect of the disclosure, includes a plurality of linkages. The plurality of linkages may include a first linkage 66 pivotally coupled to the first end member 48 about the first pivot axis P, and further pivotally coupled to the first intermediate member 50 about a seventh pivot axis P7 that is substantially parallel to the first pivot axis P1. The plurality of linkages may include a second linkage 68 pivotally coupled to the first intermediate member 50 about the second pivot axis P2, and further pivotally coupled to the first vertebral contact member 42 about an eighth pivot axis P8 that is substantially parallel to the second pivot axis P2.
The plurality of linkages may include a third linkage 70 pivotally coupled to the first intermediate member 50 about the third pivot axis P3, and further pivotally coupled to the second vertebral contact member 44 about a ninth pivot axis P9 that is substantially parallel to the third pivot axis P3. The plurality of linkages may include a fourth linkage 72 pivotally coupled to the second end member 54 about the fourth pivot axis P4, and further pivotally coupled to the second intermediate member about a tenth pivot axis P10 that is substantially parallel to the fourth pivot axis P4.
The plurality of linkages may include a fifth linkage 74 pivotally coupled to the second intermediate member 56 about the fifth pivot axis P5, and further pivotally coupled to the first vertebral contact member 42 about a eleventh pivot axis P11 that is substantially parallel to the fifth pivot axis P5. The plurality of linkages may include a sixth linkage 76 pivotally coupled to the second intermediate member 56 about the sixth pivot axis P6, and further pivotally coupled to the second vertebral contact member 44 about a twelfth pivot axis P12 that is substantially parallel to the sixth pivot axis P6.
The intervertebral implant 30 may include a plurality of horizontal linkages that pivot about one or more axes that are substantially parallel to the first pivot axis P1, and a plurality of vertical linkages that pivot about one or more axes that are substantially parallel to the second pivot axis P2. As shown in the illustrated embodiment, the plurality of horizontal linkages includes the first linkage 66 and the fourth linkage 72, and the plurality of vertical linkages includes the second linkage 68, the third linkage, 70, the fifth linkage 74, and the sixth linkage 76.
As shown in the illustrated embodiment, the first intermediate member 50 may include a first intermediate component 78 and a second intermediate component 80 separated from the first intermediate component 78 along the direction that is substantially parallel to the second pivot axis P2. Additionally, the second intermediate member 56 may include a first intermediate component 82 and a second intermediate component 84 separated from the first intermediate component 82 along the direction that is substantially parallel to the second pivot axis P2.
The first linkage 66 may include a first link 86 and a second link 88. As shown in the illustrated embodiment, the first link 86 may be both pivotally coupled to the first end member 48 about the first pivot axis P1, and pivotally coupled to the first intermediate component 78 of the first intermediate member 50 about the seventh pivot axis P7. The second link 88 may be both pivotally coupled to the first end member 48 about a thirteenth pivot axis P13 that is substantially parallel to the first pivot axis P1, and pivotally coupled to the second intermediate component 80 about a fourteenth pivot axis P14 that is substantially parallel to the first pivot axis P1.
The first linkage 66 may further include a first pin 90 pivotally coupling the first link 86 to the first end member 48 about the first pivot axis P1, a second pin 92 pivotally coupling the first link 86 to the first intermediate component 78 about the seventh pivot axis P7, a third pin 94 pivotally coupling the second link 88 to the first end member 48 about the thirteenth pivot axis P13, and a fourth pin 96 pivotally coupling the second link 88 to the second intermediate component 80 about the fourteenth pivot axis P14.
The second linkage 68 may include a first link 98 and a second link 100. As shown in the illustrated embodiment, the first link 98 may be both pivotally coupled to the first intermediate component 78 about the second pivot axis P2, and pivotally coupled to the first vertebral contact component 58 about the eighth pivot axis P8. The second link 100 may be both pivotally coupled to the second intermediate component 80 about a fifteenth pivot axis P15 that is substantially parallel to the second pivot axis P2, and pivotally coupled to the second vertebral contact component 60 about a sixteenth pivot axis P16 that is substantially parallel to the second pivot axis P2.
The second linkage 68 may further include a first pin 102 pivotally coupling the first link 98 to the first intermediate component 78 about the second pivot axis P2, a second pin 104 pivotally coupling the first link 98 to the first vertebral contact component 58 about the eighth pivot axis P8, a third pin 106 pivotally coupling the second link 100 to the second intermediate component 80 about the fifteenth pivot axis P15, and a fourth pin 108 pivotally coupling the second link 100 to the second vertebral contact component 60 about the sixteenth pivot axis P16.
The third linkage 70 may include a first link 110 and a second link 112. As shown in the illustrated embodiment, the first link 110 may be both pivotally coupled to the first intermediate component 82 about the third pivot axis P3, and pivotally coupled to the first vertebral contact component 62 about the ninth pivot axis P9. The second link 112 may be both pivotally coupled to the second intermediate component 84 about a seventeenth pivot axis P17 that is substantially parallel to the second pivot axis P2, and pivotally coupled to the second vertebral contact component 64 about an eighteenth pivot axis P18 that is substantially parallel to the second pivot axis P2.
The third linkage 70 may further include a first pin 114 pivotally coupling the first link 110 to the first intermediate component 82 about the third pivot axis P3, a second pin 116 pivotally coupling the first link 110 to the first vertebral contact component 62 about the ninth pivot axis P9, a third pin 118 pivotally coupling the second link 112 to the second intermediate component 84 about the seventeenth pivot axis P17, and a fourth pin 120 pivotally coupling the second link 112 to the second vertebral contact component 64 about the eighteenth pivot axis P18.
The fourth linkage 72 may include a first link 122 and a second link 124. As shown in the illustrated embodiment, the first link 122 may be both pivotally coupled to the second end member 54 about the fourth pivot axis P4, and pivotally coupled to the first intermediate component 82 about the tenth pivot axis P10. The second link 124 may be both pivotally coupled to the second end member 54 about a nineteenth pivot axis P19 that is substantially parallel to the first pivot axis P1, and pivotally coupled to the second intermediate component 84 about a twentieth pivot axis P20 that is substantially parallel to the first pivot axis P1.
The fourth linkage 72 may further include a first pin 126 pivotally coupling the first link 122 to the second end member 54 about the fourth pivot axis P4, a second pin 128 pivotally coupling the first link 122 to the first intermediate component 82 about the tenth pivot axis P10, a third pin 130 pivotally coupling the second link 124 to the second end member 54 about the nineteenth pivot axis P19, and a fourth pin 132 pivotally coupling the second link 124 to the second intermediate component 84 about the twentieth pivot axis P20.
The fifth linkage 74 may include a first link 134 and a second link 136. As shown in the illustrated embodiment, the first link 134 may be both pivotally coupled to the first intermediate component 82 about the fifth pivot axis P5, and pivotally coupled to the first vertebral contact component 58 about the eleventh pivot axis P11. The second link 136 may be both pivotally coupled to the second intermediate component 84 about a twenty-first pivot axis P21 that is substantially parallel to the second pivot axis P2, and pivotally coupled to the second vertebral contact component 60 about a twenty-second pivot axis P22 that is substantially parallel to the second pivot axis P2.
The fifth linkage 74 may further include a first pin 138 pivotally coupling the first link 134 to the first intermediate component 82 about the fifth pivot axis P5, a second pin 140 pivotally coupling the first link 134 to the first vertebral contact component 58 about the eleventh pivot axis P11, a third pin 142 pivotally coupling the second link 136 to the second intermediate component 84 about the twenty-first pivot axis P21, and a fourth pin 144 pivotally coupling the second link 136 to the second vertebral contact component 60 about the twenty-second pivot axis P22.
The sixth linkage 76 may include a first link 146 and a second link 148. As shown in the illustrated embodiment, the first link 146 may be both pivotally coupled to the first intermediate component 82 about the sixth pivot axis P6, and pivotally coupled to the first vertebral contact component 62 about the twelfth pivot axis P12. The second link 148 may be both pivotally coupled to the second intermediate component 84 about a twenty-third pivot axis P23 that is substantially parallel to the second pivot axis P2, and pivotally coupled to the second vertebral contact component 64 about a twenty-fourth pivot axis P24 that is substantially parallel to the second pivot axis P2.
The sixth linkage 76 may further include a first pin 150 pivotally coupling the first link 146 to the first intermediate component 82 about the sixth pivot axis P6, a second pin 152 pivotally coupling the first link 146 to the first vertebral contact component 62 about the twelfth pivot axis P12, a third pin 154 pivotally coupling the second link 148 to the second intermediate component 84 about the twenty-third pivot axis P23, and a fourth pin 156 pivotally coupling the second link 148 to the second vertebral contact component 64 about the twenty-fourth pivot axis P24.
According to one aspect of the disclosure, at least one of the pivot axes P1-P24 passes through a center of one of the pins. As shown in the illustrated embodiment, each of the pivot axes P1-P24 passes through a center of one of the pins.
The intervertebral implant 30 may further include an actuator 200 configured to be actuated to transition the intervertebral implant 30 from a first configuration, for example as shown in
The actuator 200 may further be configured to transition the intervertebral implant 30 from the first configuration to a third configuration, for example as shown in
The actuator 200 may be configured to exert a compressive force on the first end member 48 and the second end member 54 such that the compressive force transitions the intervertebral implant 30 from the first configuration to the second configuration, for example through the intermediate third configuration. As shown in the illustrated embodiment, the actuator 200 includes an actuation screw 202 that is elongate along a central axis 204, and the actuation screw 202 includes an outer surface 206 that includes external threads 208 on at least a portion of the outer surface 206. According to one aspect of the disclosure, the actuation screw 202 defines a fixed length as measured along the central axis 204.
The actuation screw 202 may be secured to the frame 46 such that the actuation screw 202 is rotatable about the central axis 204 relative to both the first end member 48 and the second end member 54. The actuation screw 202 may further be secured to the frame 46 such that the central axis 204 is parallel to the longitudinal direction L, the actuation screw 202 is translationally fixed relative to one of the first end member 48 and the second end member 54, and translatable relative to the other of the first end member 48 and the second end member 54.
According to one aspect of the disclosure, the actuation screw 202 is configured to be rotated about the central axis 204 such that the external threads 208 engage the one of the first end member 48 and the second end member 54. For example, the first end member 48 may include internal threads (not shown) that threadedly mate with the external threads 208 of the actuation screw 202. The second end member 54 may be connected, for example journaled, to the actuation screw 202 such that the actuation screw 202 can rotate freely with respect to the second end member 54 about the central axis 204, and the actuation screw 202 is fixed, or cannot translate, with respect to the second end member 54 along a direction parallel to the actuation screw 202.
The actuator 200 may include a locking mechanism 210 configured to, in a locked configuration, prevent actuation of the actuator 200. The locking mechanism 210 may further be configured such that in an unlocked configuration the locking mechanism 210 does not prevent actuation of the actuator 200. As shown in the illustrated embodiment, the locking mechanism 210 may include a nut with internal threads (not shown) that are configured to mate with the external threads 208 of the actuation screw 202. In an unlocked configuration the locking mechanism 210 is spaced from the first end member 48 of the implant body 34 such that the actuator 200 is actuatable to move the first end member 48 either towards or away from the second end member 54 along the longitudinal direction L. In an unlocked configuration the locking mechanism 210 abuts the first end member 48 such that the actuator 200 is not actuatable to move the first member 48 away from the second end member 54 along the longitudinal direction L.
Referring to
The first end member 48 and the first intermediate member 50 may define a plurality of stop surfaces configured to abut to prevent further pivoting relative to one another. As shown in the illustrated embodiment, the first end member 48 and the first intermediate component 78 collectively define a first pair of stop surfaces 160 and the first end member 48 and the second intermediate component 80 collectively define a second pair of stop surfaces 162.
In accordance with one aspect of the disclosure, the first vertebral contact component 58 and the second vertebral contact component 60 are coupled with the first intermediate component 78 and the second intermediate component 80, respectively, such that as the distance increases between the first intermediate component 78 and the second intermediate component 80, a distance between the first vertebral contact component 58 and the second vertebral contact component 60, measured along a straight line parallel to the lateral direction A, also increases.
The first vertebral contact component 62 and the second vertebral contact component 64 may be coupled with the first intermediate component 78 and the second intermediate component 80, respectively, such that as the distance increases between the first intermediate component 78 and the second intermediate component 80, a distance between the first vertebral contact component 62 and the second vertebral contact component 64, measured along a straight line parallel to the lateral direction A, also increases.
The first vertebral contact component 58 and the second vertebral contact component 60 may be coupled with the first intermediate component 78 and the second intermediate component 80, respectively, and the first vertebral contact component 62 and the second vertebral contact component 64 may be coupled with the first intermediate component 78 and the second intermediate component 80, respectively, such that as the distance increases between the first intermediate component 78 and the second intermediate component 80, a distance between the first vertebral contact component 58 and the second vertebral contact component 64, with respect to the lateral direction A and measured along a straight line parallel to the lateral direction A, also increases.
The compressive force F may further pivot the second intermediate member 56 relative to the second end member 54. In accordance with one embodiment, the compressive force F pivots the first intermediate component 82 relative to the second end member 54 about both the fourth pivot axis P4 and about the tenth pivot axis P10. The compressive force F further pivots the second intermediate component 84 relative to the second end member 54 about both the nineteenth pivot axis P19 and the twentieth pivot axis P20, thereby increasing a distance between the first intermediate component 82 and the second intermediate component 84, the distance measured along a straight line parallel to the lateral direction A.
The second end member 54 and the second intermediate member 56 may define a plurality of stop surfaces configured to abut to prevent further pivoting relative to one another. As shown in the illustrated embodiment, the second end member 54 and the first intermediate component 82 collectively define a third pair of stop surfaces 164 and the second end member 54 and the second intermediate component 84 collectively define a fourth pair of stop surfaces 166.
In accordance with one aspect of the disclosure, the first vertebral contact component 58 and the second vertebral contact component 60 are coupled with the first intermediate component 82 and the second intermediate component 84, respectively, such that as the distance increases between the first intermediate component 82 and the second intermediate component 84, a distance between the first vertebral contact component 58 and the second vertebral contact component 60, measured along a straight line parallel to the lateral direction A, also increases.
The first vertebral contact component 62 and the second vertebral contact component 64 may be coupled with the first intermediate component 82 and the second intermediate component 84, respectively, such that as the distance increases between the first intermediate component 82 and the second intermediate component 84, a distance between the first vertebral contact component 62 and the second vertebral contact component 64, measured along a straight line parallel to the lateral direction A, also increases.
The first vertebral contact component 58 and the second vertebral contact component 60 may be coupled with the first intermediate component 82 and the second intermediate component 84, respectively, and the first vertebral contact component 62 and the second vertebral contact component 64 may be coupled with the first intermediate component 82 and the second intermediate component 84, respectively, such that as the distance increases between the first intermediate component 82 and the second intermediate component 84, a distance between the first vertebral contact component 58 and the second vertebral contact component 64, with respect to the lateral direction A and measured along a straight line parallel to the lateral direction A, also increases.
Referring to
In accordance with another embodiment, the compressive force F pivots the first vertebral contact member 42 relative to both the first intermediate member 50 and the second intermediate member 56 prior to the first pair of stop surfaces 160 abutting each other, the second pair of stop surfaces 162 abutting each other, the third pair of stop surfaces 164 abut each other, the fourth pair of stop surfaces 166 abutting each other, or any combination thereof. For example, the intervertebral implant 30 may be configured, for example by changing the friction characteristics of the respective pivot axis, such that pivoting through a first portion of an arc requires less force than pivoting through a second portion of the arc. Thus, the intervertebral implant 30 may be configured such that the compressive force F pivots the first vertebral contact member 42 relative to both the first intermediate member 50 and the second intermediate member 56 prior to the first pair of stop surfaces 160 abutting each other, after the first intermediate member 50 has pivoted relative to the first end member 48 about the first pivot axis P1 through the first portion of an arc, and prior to the first intermediate member 50 pivoting relative to the first end member 48 about the first pivot axis P1 through the second portion of the arc.
Referring to
The second linkage 68 and the first intermediate member 50 may define a plurality of stop surfaces configured to abut to prevent further pivoting relative to one another. As shown in the illustrated embodiment, the first link 98 and the first intermediate component 78 collectively define a fifth pair of stop surfaces 168 and the second link 100 and the second intermediate component 80 collectively define a sixth pair of stop surfaces 170. The fifth linkage 74 and the second intermediate member 56 may define a plurality of stop surfaces configured to abut to prevent further pivoting relative to one another. As shown in the illustrated embodiment, the first link 134 and the first intermediate component 82 may define a seventh pair of stop surfaces 172, and the second link 136 and the second intermediate component 84 may define an eighth pair of stop surfaces 174.
The intervertebral implant 30 may be further configured such that the compressive force F pivots the second vertebral contact member 44 relative to both the first intermediate member 50 and the second intermediate member 56. According to one embodiment of the disclosure, the compressive force F pivots the second vertebral contact member 44 relative to both the first intermediate member 50 and the second intermediate member 56 after the first pair of stop surfaces 160 abut each other, the second pair of stop surfaces 162 abut each other, the third pair of stop surfaces 164 abut each other, the fourth pair of stop surfaces 166 abut each other, or any combination thereof.
The intervertebral implant 30 may be configured such that the compressive force F pivots the second vertebral contact member 44 relative to both the first intermediate member 50 and the second intermediate member 56 and pivots the first vertebral contact member 42 relative to both the first intermediate member 50 and the second intermediate member 56 simultaneously. Alternatively, the intervertebral implant 30 may be configured such that the compressive force F pivots the second vertebral contact member 44 relative to both the first intermediate member 50 and the second intermediate member 56 either before or after the compressive force pivots the first vertebral contact member 42 relative to both the first intermediate member 50 and the second intermediate member 56.
In accordance with one embodiment, the compressive force F pivots the first vertebral contact component 62 relative to the first intermediate component 78 about both the third pivot axis P3 and about the ninth pivot axis P9, and the compressive force F also pivots the first vertebral contact component 62 relative to the first intermediate component 82 about both the sixth pivot axis P6 and the twelfth pivot axis P12. The compressive force F further pivots the second vertebral contact component 64 relative to the second intermediate component 80 about both the seventeenth pivot axis P17 and the eighteenth pivot axis P18, and also pivots the second vertebral contact component 64 with respect to the second intermediate component 84 about both the twenty-third pivot axis P23 and the twenty-fourth pivot axis P24, thereby increasing a distance between the first vertebral contact member 42 and the second vertebral contact member 44, the distance measured along a straight line parallel to the transverse direction T.
Referring to
Referring again to
Referring to
For example, the intervertebral implant 30 may be configured such that when the first pair of stop surfaces 160 abut each other, the second pair of stop surfaces 162 abut each other, the third pair of stop surfaces 164 abut each other, the fourth pair of stop surfaces 166 abut each other, the fifth pair of stop surfaces 168 abut each other, the sixth pair of stop surfaces 170 abut each other, the seventh pair of stop surfaces 172 abut each other, the eighth pair of stop surfaces 174 abut each other, the ninth pair of stop surfaces 176 abut each other, the tenth pair of stop surfaces 178 abut each other, the eleventh pair of stop surfaces 180 abut each other and the twelfth pair of stop surfaces 182 abut each other, the intervertebral implant 30 is in the second configuration, as shown in
Referring to
Referring to
According to one embodiment, the intervertebral implant 30 is configured to be implanted such that resistance provided by the superior vertebra 6 and the inferior vertebra 8 on the intervertebral implant 30 cause the compressive force F to pivot the plurality of horizontal linkages prior to pivoting the plurality of vertical linkages. For example, the implant 30 may be configured such that in an environment devoid of external resistances applied to the intervertebral implant 30, the compressive force F pivots the plurality of horizontal linkages and the plurality of vertical linkages simultaneously.
According to anther embodiment, the intervertebral implant 30 defines a first distance D1 measured between the two pivot axes that pass through one of the links of the plurality of vertical linkages along a straight line that is substantially parallel to the transverse direction T, and the intervertebral implant 30 defines a second distance D2 measured between the two pivot axes that pass through one of the links of the plurality of horizontal linkages along a straight line that is substantially parallel to the lateral direction A. The intervertebral implant 30 may be configured such that when D2 is greater than D1, the compressive force F pivots the plurality of horizontal linkages prior to pivoting the plurality of vertical linkages. The intervertebral implant 30 may be configured such that when D1 is greater than D2, the compressive force F pivots the plurality of vertical linkages prior to pivoting the plurality of horizontal linkages.
For example, if the second distance D2 measured between the thirteenth pivot axis P13 and the fourteenth pivot axis P14 along the lateral direction A is greater than the first distance D1 measured between the second pivot axis P2 and the eighth pivot axis P8 along the transverse direction T, the compressive force F may pivot the second link 88 prior to pivoting the first
Referring to
As shown in the illustrated embodiment, the first and second links, of each of the respective linkages may be equal in length as measured along a straight line that passes perpendicularly through each of the respective pivot axes that pass through the respective link. For example the first link 98 may have a length measured along a straight line that passes perpendicularly through the second pivot axis P2 and the eighth pivot axis P8 that is equal to a length of the link 100 measured along a straight line that passes perpendicularly through the fifteenth pivot axis P15 and the sixteenth pivot axis P16.
Referring to
As shown in the illustrated embodiment, the first and second links, of at least some of the respective linkages may have different lengths as measured along a straight line that passes perpendicularly through each of the respective pivot axes that pass through the respective link. For example the first link 98 may have a length measured along a straight line that passes perpendicularly through the second pivot axis P2 and the eighth pivot axis P8 that is different than a length of the link 100 measured along a straight line that passes perpendicularly through the fifteenth pivot axis P15 and the sixteenth pivot axis P16. Additionally, the first link 134 may have a length measured along a straight line that passes perpendicularly through the fifth pivot axis P5 and the eleventh pivot axis P11 that is different than a length of the link 136 measured along a straight line that passes perpendicularly through the twenty-first pivot axis P21 and the twenty-second pivot axis P22.
The intervertebral implant 30 may be configured such that the first link 110 may have a length measured along a straight line that passes perpendicularly through the third pivot axis P3 and the ninth pivot axis P9 that is different than a length of the link 112 measured along a straight line that passes perpendicularly through the seventeenth pivot axis P17 and the eighteenth pivot axis P18. Additionally, the first link 146 may have a length measured along a straight line that passes perpendicularly through the sixth pivot axis P6 and the twelfth pivot axis P12 that is different than a length of the link 148 measured along a straight line that passes perpendicularly through the twenty-third pivot axis P23 and the twenty-fourth pivot axis P24.
The intervertebral implant 30 with a non-uniform height H1 may be used during a spinal fusion procedure being performed on a patient with a curved spine, for example to restore proper lordosis. The non-uniform height H1 of the intervertebral implant 30 may be used to correct the curvature deformity while also fusing the adjacent vertebrae.
Referring to
As shown in the illustrated embodiment, the first linkage 66 may include a first deformable portion 290 pivotally coupling the first link 86 to the first end member 48 about the first pivot axis P1, a second deformable portion 292 pivotally coupling the first link 86 to the first intermediate component 78 about the seventh pivot axis P7, a third deformable portion 294 pivotally coupling the second link 88 to the first end member 48 about the thirteenth pivot axis P13, and a fourth deformable portion 296 pivotally coupling the second link 88 to the second intermediate component 80 about the fourteenth pivot axis P14.
The second linkage 68 may further include a first deformable portion 302 pivotally coupling the first link 98 to the first intermediate component 78 about the second pivot axis P2, a second deformable portion 304 pivotally coupling the first link 98 to the first vertebral contact component 58 about the eighth pivot axis P8, a third deformable portion 306 pivotally coupling the second link 100 to the second intermediate component 80 about the fifteenth pivot axis P15, and a fourth deformable portion 308 pivotally coupling the second link 100 to the second vertebral contact component 60 about the sixteenth pivot axis P16.
The third linkage 70 may further include a first deformable portion 314 pivotally coupling the first link 110 to the first intermediate component 78 about the third pivot axis P3, a second deformable portion 316 pivotally coupling the first link 110 to the first vertebral contact component 62 about the ninth pivot axis P9, a third deformable portion 318 pivotally coupling the second link 112 to the second intermediate component 84 about the seventeenth pivot axis P17, and a fourth deformable portion 320 pivotally coupling the second link 112 to the second vertebral contact component 64 about the eighteenth pivot axis P18.
The fourth linkage 72 may further include a first deformable portion 326 pivotally coupling the first link 122 to the second end member 54 about the fourth pivot axis P4, a second deformable portion 328 pivotally coupling the first link 122 to the first intermediate component 82 about the tenth pivot axis P10, a third deformable portion 330 pivotally coupling the second link 124 to the second end member 54 about the nineteenth pivot axis P19, and a fourth deformable portion 332 pivotally coupling the second link 124 to the second intermediate component 84 about the twentieth pivot axis P20.
The fifth linkage 74 may further include a first deformable portion 338 pivotally coupling the first link 134 to the first intermediate component 82 about the fifth pivot axis P5, a second deformable portion 340 pivotally coupling the first link 134 to the first vertebral contact component 58 about the eleventh pivot axis P11, a third deformable portion 342 pivotally coupling the second link 136 to the second intermediate component 84 about the twenty-first pivot axis P21, and a fourth deformable portion 344 pivotally coupling the second link 136 to the second vertebral contact component 60 about the twenty-second pivot axis P22.
The sixth linkage 76 may further include a first deformable portion 350 pivotally coupling the first link 146 to the first intermediate component 82 about the sixth pivot axis P6, a second deformable portion 352 pivotally coupling the first link 146 to the first vertebral contact component 62 about the twelfth pivot axis P12, a third deformable portion 354 pivotally coupling the second link 148 to the second intermediate component 84 about the twenty-third pivot axis P23, and a fourth deformable portion 356 pivotally coupling the second link 148 to the second vertebral contact component 64 about the twenty-fourth pivot axis P24.
According to one aspect of the disclosure, each of the linkages of the intervertebral implant 30 includes respective first and second deformable portions, such that the implant body 34 may include a single, monolithic structure that includes each of the first end member 48, the second end member 54, the first intermediate member 50, the second intermediate member 56, the first vertebral contact surface 42, the second vertebral contact surface 44, and each of the linkages. Alternatively, the intervertebral implant 30 may be configured such that some of the linkages include respective pins and some of the linkages include respective deformable portions.
Referring to
As shown in the illustrated embodiment, the first support component 186 abuts the first vertebral contact component 58 such that the first support component 186 resists movement of the first vertebral contact component 58 towards the first vertebral contact component 62 along the transverse direction T. The second support component 188 similarly may abut the second vertebral contact component 60 such that the second support component 188 resists movement of the second vertebral contact component 60 towards the second vertebral contact component 64 along the transverse direction T.
The intervertebral implant 30 may be configured such that both a first leg 190 of the first support component 186 is parallel to the first link 98, and a second leg 192 of the first support component 186 is parallel to the first link 134, regardless of the current configuration the intervertebral implant 30. The intervertebral implant 30 may be configured such that both a first leg 194 of the second support component 188 is parallel to the second link 100, and a second leg 196 of the second support component 188 is parallel to the second link 136, regardless of the current configuration of the intervertebral implant 30.
The intervertebral implant 30 may include a second support member 284 configured to provide support for the second vertebral contact member 44 when the intervertebral implant 30 is in the second configuration. The second support member 284 may include a first support component 286 configured to support, for example directly abut, the first vertebral contact component 62, and further include a second support component 288 configured to support, for example directly abut, the second vertebral contact component 64.
As shown in the illustrated embodiment, the first support component 286 abuts the first vertebral contact component 62 such that the first support component 286 resists movement of the first vertebral contact component 62 towards the first vertebral contact component 58 along the transverse direction T. The second support component 288 similarly may abut the second vertebral contact component 64 such that the second support component 288 resists movement of the second vertebral contact component 64 towards the second vertebral contact component 60 along the transverse direction T.
The intervertebral implant 30 may be configured such that both a first leg 290 of the first support component 286 is parallel to the first link 110, and a second leg 292 of the first support component 286 is parallel to the first link 146, regardless of the current configuration the intervertebral implant 30. The intervertebral implant 30 may be configured such that both a first leg 294 of the second support component 288 is parallel to the second link 112, and a second leg 296 of the second support component 288 is parallel to the second link 148, regardless of the current configuration of the intervertebral implant 30.
Referring to
Referring to
Referring to
Referring to
As shown in the illustrated embodiment, the locking mechanism 220 includes the teeth 218 on the outer surface 216 of the actuation member 212. The locking mechanism 220 may further include a pawl 222 carried by the first end member 48. The teeth 218 and the pawl 222 may be configured as a one-way ratchet, such that the teeth 218 and the pawl 222 engage such that the actuation member 212 is translatable along a first direction 224 and not translatable along a second direction 226 opposite the first direction 224. For example, the pawl 222 may be configured to cam over the teeth 218 as the actuation member 212 translates relative to the first end member 48 in the first direction 224, and the pawl 222 may further be configured not to cam over the teeth 222 as a force is applied to the actuation member 212 in the second direction 226 thereby blocking movement of the actuation member 212 relative to the first end member 48 in the second direction 226. According to one aspect of the disclosure, the pawl 222 is a separate member attached to the first end member 48 as shown, for example, in
Referring to
Referring to
According to one aspect of the disclosure, a portion of the actuation screw 402, for example one of the first portion 410 and the second portion 412, is configured to be rotated about the central axis 404, relative to the other of the first portion 410 and the second portion 412 such that the external threads 408 engage internal threads (not shown) of the second portion 412 so as to change the length L2 of the actuation screw 402. As the length L2 of the actuation screw 402 changes, for example shortens, the actuation screw 402 exerts a compressive force on the first end member 48 and the second end member 54 thereby transitioning the intervertebral implant from one configuration, for example the first configuration, to another configuration, for example the third configuration.
Referring to
Referring to
Referring to
Referring to
Referring to
It will be appreciated that the foregoing description provides examples of the disclosed system and technique. However, it is contemplated that other implementations of the disclosure may differ in detail from the foregoing examples. All references to the disclosure or examples thereof are intended to reference the particular example being discussed at that point and are not intended to imply any limitation as to the scope of the disclosure more generally. All language of distinction and disparagement with respect to certain features is intended to indicate a lack of preference for those features, but not to exclude such from the scope of the disclosure entirely unless otherwise indicated.
Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.
Although the disclosure has been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present disclosure is not intended to be limited to the particular embodiments described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, composition of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure.
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