MULTIPLE EXPANSION STAGE INTERBODY DEVICES
20250057664 ยท 2025-02-20
Inventors
Cpc classification
A61F2/4455
HUMAN NECESSITIES
A61F2002/3042
HUMAN NECESSITIES
International classification
Abstract
An example expandable interbody device can include a structural body having an upper endplate and a lower endplate. The device can include at least one wedge block and at least one linkage block arranged between the upper and lower endplates. The linkage block can include a plurality of linkages and a shear pin disposed at a respective proximal end of each of the linkages. The device can include a drive screw extending through the wedge and linkage blocks. The drive screw can be configured to rotate and drive the wedge block to expand the upper and lower endplates of the structural body from the closed position to an intermediate position. Additionally, the drive screw can be further configured to rotate and drive the linkage block to expand the upper and lower endplates of the structural body from the intermediate position to an open position.
Claims
1-38. (canceled)
39. An expandable interbody device comprising: a structural body that has an upper endplate and a lower endplate; said upper and lower endplates are movable between an open and a closed position; a first wedge block that is at least partially positioned between said upper and lower endplates of said structural body; a first linkage arrangement that is at least partially positioned between said upper and lower endplates of said structural body; and a first drive screw that extends at least partially through said first wedge block and said first linkage arrangement; said first drive screw is configured to cause said upper and lower endplates of said structural body to move from said closed position to an intermediate position; said first drive screw is engaged with said first wedge block and is configured to cause said first wedge to move and cause said upper and lower endplates of said structural body to move from said closed position toward said intermediate position; said first screw is also configured to engage and to cause movement of said first linkage arrangement so as to cause further movement of said upper and lower endplates of said structural body; said first screw is configured to cause initial movement of said first linkage arrangement after said first screw has caused movement of said first wedge.
40. The expandable interbody device as defined in claim 39, further including: a second wedge block that is at least partially positioned between said upper and lower endplates of said structural body; a second linkage that is at least partially positioned between said upper and lower endplates of said structural body, and wherein said first drive screw extends at least partially through said second wedge block and said second linkage arrangement; said first drive screw is engaged with said second wedge block and is configured to cause said second wedge to move and cause said upper and lower endplates of said structural body to move from said closed position toward said intermediate position; said first screw is also configured to engage and to cause movement of said second linkage arrangement so as to cause further movement of said upper and lower endplates of said structural body; said first screw is configured to cause initial movement of said second linkage after said first screw has caused movement of said second wedge.
41. The expandable interbody device as defined in claim 40, wherein said first screw is configured to cause simultaneous movement of said first and second wedge blocks toward one another.
42. The expandable interbody device as defined in claim 40, wherein said first screw is configured to cause simultaneous movement of said first and second linkage arrangements toward one another.
43. The expandable interbody device as defined in claim 41, wherein said first screw is configured to cause simultaneous movement of said first and second linkage arrangements toward one another.
44. The expandable interbody device as defined in claim 39, wherein said upper and lower endplates include first endplate oblique surfaces; said first wedge block includes first wedge oblique surfaces; said first endplate oblique surfaces on said upper and lower endplates are configured to engage said first wedge oblique surfaces to facilitate in moving said upper and lower endplates of the structural body from said closed position toward said intermediate position.
45. The expandable interbody device as defined in claim 41, wherein said upper and lower endplates include first endplate oblique surfaces; said first wedge block includes first wedge oblique surfaces; said first endplate oblique surfaces on said upper and lower endplates are configured to engage said first wedge oblique surfaces to facilitate in moving said upper and lower endplates of the structural body from said closed position toward said intermediate position.
46. The expandable interbody device as defined in claim 43, wherein said upper and lower endplates include first endplate oblique surfaces; said first wedge block includes first wedge oblique surfaces; said first endplate oblique surfaces on said upper and lower endplates are configured to engage said first wedge oblique surfaces to facilitate in moving said upper and lower endplates of the structural body from said closed position toward said intermediate position.
47. The expandable interbody device as defined in claim 39, wherein said first linkage arrangement includes a first pin and a first linkage; said first linkage is connected to said first pin and one of said upper and lower endplates; said first pin is positioned in a first wedge slot of said first wedge block; said first pin is movable in said first wedge slot during movement of said upper and lower endplates of the structural body from said closed position toward said intermediate position.
48. The expandable interbody device as defined in claim 46, wherein said first linkage arrangement includes a first pin and a first linkage; said first linkage is connected to said first pin and one of said upper and lower endplates; said first pin is positioned in a first wedge slot of said first wedge block; said first pin is movable in said first wedge slot during movement of said upper and lower endplates of the structural body from said closed position toward said intermediate position.
49. The expandable interbody as defined in claim 39, wherein said first drive screw includes a first threaded portion and a second threaded portion; said second threaded portion is spaced apart from said first threaded portion; said first threaded portion is configured to threadedly engage said first wedge block and said second threaded portion is configured to threadedly engage said first linkage arrangement.
50. The expandable interbody as defined in claim 48, wherein said first drive screw includes a first threaded portion and a second threaded portion; said second threaded portion is spaced apart from said first threaded portion; said first threaded portion is configured to threadedly engage said first wedge block and said second threaded portion is configured to threadedly engage said first linkage arrangement.
51. The expandable interbody as defined in claim 50, wherein said first drive screw includes a third threaded portion and a fourth threaded portion; said third threaded portion is spaced apart from said fourth threaded portion; said third threaded portion is configured to threadedly engage said second wedge block and said fourth threaded portion is configured to threadedly engage said second linkage arrangement.
52. The expandable interbody as defined in claim 39, wherein at least a portion of said expandable interbody device is formed of one or more materials selected from the group consisting of molybdenum-rhenium (MoRe) alloy, titanium (Ti) alloy, titanium-molybdenum (TiMo) alloy, and cobalt-chromium (CoCr) alloy.
53. The expandable interbody as defined in claim 51, wherein at least a portion of said expandable interbody device is formed of one or more materials selected from the group consisting of molybdenum-rhenium (MoRe) alloy, titanium (Ti) alloy, titanium-molybdenum (TiMo) alloy, and cobalt-chromium (CoCr) alloy.
54. A method of expanding an interbody from a closed position to an intermediate position comprising: providing an expandable interbody device; said expandable interbody device including: a structural body that has an upper endplate and a lower endplate; said upper and lower endplates are movable between an open and a closed position; a first wedge block that is at least partially positioned between said upper and lower endplates of said structural body; a first linkage arrangement that is at least partially positioned between said upper and lower endplates of said structural body; and a first drive screw that extends at least partially through said first wedge block and said first linkage arrangement; said first drive screw is configured to cause said upper and lower endplates of said structural body to move from said closed position to an intermediate position; said first drive screw is engaged with said first wedge block and is configured to cause said first wedge to move and cause said upper and lower endplates of said structural body to move from said closed position toward said intermediate position; said first screw is also configured to engage and to cause movement of said first linkage arrangement so as to cause further movement of said upper and lower endplates of said structural body; said first screw is configured to cause initial movement of said first linkage arrangement after said first screw has caused movement of said first wedge; initially rotating said first drive screw to cause said first wedge block to move and to initially cause said upper and lower endplates of said structural body to move from said closed position toward said intermediate position; said first drive screw not causing movement of said first linkage arrangement during said initial movement of said first wedge block; and continuing rotation of said first drive screw to cause said first drive screw to move said first linkage arrangement after said initial movement of said first wedge block; said movement of said first linkage arrangement causing said upper and lower endplates of said structural body to move toward said intermediate position.
55. The method as defined in claim 54, wherein during said step of continuing rotation of said first drive screw, said upper and lower endplates of said structural body disengage from contact with said first wedge block.
56. The method as defined in claim 54, wherein said expandable interbody device further includes: a second wedge block that is at least partially positioned between said upper and lower endplates of said structural body; a second linkage that is at least partially positioned between said upper and lower endplates of said structural body, and wherein said first drive screw extends at least partially through said second wedge block and said second linkage arrangement; said first drive screw is engaged with said second wedge block and is configured to cause said second wedge to move and cause said upper and lower endplates of said structural body to move from said closed position toward said intermediate position; said first screw is also configured to engage and to cause movement of said second linkage arrangement so as to cause further movement of said upper and lower endplates of said structural body; said first screw is configured to cause initial movement of said second linkage after said first screw has caused movement of said second wedge.
57. The method as defined in claim 56, wherein said step of initial rotation of said first screw causes simultaneous movement of said first and second wedge blocks toward one another.
58. The method as defined in claim 56, wherein said step of continued rotation of said first screw causes simultaneous movement of said first and second linkage arrangements toward one another.
59. The method as defined in claim 54, wherein said upper and lower endplates include first endplate oblique surfaces and said first wedge block includes first wedge oblique surfaces; said first endplate oblique surfaces on said upper and lower endplates are configured to engage said first wedge oblique surfaces to facilitate in moving said upper and lower endplates of the structural body from said closed position toward said intermediate position.
60. The method as defined in claim 54, wherein said first linkage arrangement includes a first pin and a first linkage; said first linkage is connected to said first pin and one of said upper and lower endplates; said first pin is positioned in a first wedge slot of said first wedge block; said first pin is movable in said first wedge slot during movement of said upper and lower endplates of the structural body from said closed position toward said intermediate position.
61. The method as defined in claim 54, wherein said first drive screw includes a first threaded portion and a second threaded portion; said second threaded portion is spaced apart from the said first threaded portion; said first threaded portion is configured to threadedly engage said first wedge block and said second threaded portion is configured to threadedly engage said first linkage arrangement.
62. The method as defined in claim 54, wherein at least a portion of said expandable interbody device is formed of one or more materials selected from the group consisting of molybdenum-rhenium (MoRe) alloy, titanium (Ti) alloy, titanium-molybdenum (TiMo) alloy, and cobalt-chromium (CoCr) alloy.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The components in the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding parts throughout the several views.
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DETAILED DESCRIPTION
[0028] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure. As used in the specification, and in the appended claims, the singular forms a, an, the include plural referents unless the context clearly dictates otherwise. The term comprising and variations thereof as used herein is used synonymously with the term including and variations thereof and are open, non-limiting terms. The terms optional or optionally used herein mean that the subsequently described feature, event or circumstance may or may not occur, and that the description includes instances where said feature, event or circumstance occurs and instances where it does not. Ranges may be expressed herein as from about one particular value, and/or to about another particular value. When such a range is expressed, an aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent about. it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
[0029] Multiple expansion stage interbody devices are described herein. An interbody device is a spine implant to position within an intervertebral space to facilitate bone fusion. More specifically, the interbody devices described herein are expandable to be used, for example, in a Transforaminal Lumbar Interbody Fusion (TLIF) approach. The interbody device can be inserted in the intervertebral space at an initial height profile, and through actuation of a control screw (e.g., turned clockwise), can cause the upper and lower bodies of the assembly to extend superiorly and inferiorly, respectively. The control screw can be turned in the counter-clockwise direction to cause the interbody to collapse to its initial height to reposition or remove the interbody device. The interbody device described herein has a two-stage expansion mechanism; where at lower heights, the expansion is controlled by the ramps on proximal and distal blocks, and at a certain height, the upper and lower bodies disengage from the ramps and the expansion is controlled by the linkages assembled within the interbody device. The use of linkages allows expansion to be controlled by the length of the linkages, which pivot around a point. Because of this, the linkages can fit within the insertion profile of the interbody device, but are also able to pivot, extending beyond the initial profile if the length of the profile is larger than the height of the profile.
[0030] The interbody devices described herein facilitate a less invasive surgical procedure because the devices allow the implant to be inserted at a lower insertion profile and expanded to fit within the patient's intervertebral space. Additionally, the use of multiple expansion stages (e.g., ramps and linkages) allows for a greater range of expansion than conventional ramped devices, allowing the upper and lower bodies to extend beyond its initial height profile. The ramped portion also provides greater mechanical stability to mitigate the linkages' inherent weakness at more acute angles.
[0031] Referring now to
[0032] The endplates 1001 are configured to make direct contact with the patient's bone. e.g., with vertebral bodies in the section of the spine undergoing fixation/fusion. The endplates 1001 are designed to nest tightly with protrusions beyond center line to allow angled bosses to extend farther and thus allow more expansion of the structural body. Each of the endplates 1001 has faces oblique to the surfaces configured to contact the patient's bone (e.g., first oblique surfaces 1005 in
[0033] The device can also include at least one linkage block 1003 arranged between the upper and lower endplates 1001 of the structural body. As shown in
[0034] Additionally, as described herein, the device can further include a drive screw 1004 extending through the wedge blocks 1002 and the linkage blocks 1003. The drive screw 1004 can include threads, and the wedge blocks 1002 and/or linkage blocks 1003 can include threads corresponding to the threads of the drive screw 1004. In this way, the threads of the drive screw 1004 can engage corresponding threads of the wedge blocks 1002 and/or linkage blocks 1003. In some implementations, only the wedge blocks 1002 include threads. In other implementations, both the wedge blocks 1002 and the linkage blocks 1003 include threads. Optionally, the pitches of the respective threads for controlling the wedge blocks 1002 and the linkage blocks 1003 are the same. Optionally, the pitches of the respective threads for controlling the wedge blocks 1002 and the linkage blocks 1003 are different. The drive screw 1004 can include a driver hole 1007 at one end of the drive screw 1004. The driver hole 1007 can be configured to accept the bit of a driver instrument or tool. Optionally, this disclosure contemplates that the drive screw 1004 can be operated from either end by providing a driver hole 1007 at both ends.
[0035] Referring again to
[0036] Referring again to
[0037] Referring again to
[0038] As described herein, the device has a dual stage mechanism (e.g., wedge blocks 1002 and linkage blocks 1003) controlled by rotation of the drive screw 1004. In a first stage, the device expands between the closed and intermediate positions. Expansion in the first stage is controlled exclusively using the wedge blocks 1002. To accomplish this, the threads of the drive screw 1004 are timed such that the wedge blocks 1002 are engaged by the drive screw 1004 during the first stage. The threads can be timed such that the wedge blocks 1002 move together and in opposite directions. The drive screw 1004 is therefore configured to rotate and drive the wedge blocks 1002, which moves the upper and lower endplates 1001 of the structural body from a closed position to an intermediate position.
[0039] In a second stage, the device expands between the intermediate and open positions. Expansion in the second stage is controlled exclusively using the linkage blocks 1003, for example, by deployment of the linkages 1003a-1003d. Horizontal translation of the proximal end of the linkages 1003a-1003d can be limited so that the endplates 1001 cannot re-engage with the wedge blocks 1002 during the second stage. This can be accomplished in different ways. For example, in some implementations, the linkage blocks 1003 are provided with threads corresponding to threads of the drive screw 1004 such that displacement of the linkage blocks 1003 is controlled directly by a pitch of the threads of the drive screw 1004. This is described in detail with regard to
[0040] Referring again to
[0041] Referring now to
[0042] On the other hand, during a second stage of expansion, the linkage blocks 1003 exclusively control expansion of the device. The drive screw 1004 is actuated to drive the linkage blocks 1003, which move together and in opposite directions. For example, when the device is expanded, the linkage blocks 1003 move towards one another (e.g., one linkage block moves to the left and the other linkage block moves to the right). It should be understood that when the device is collapsed, the linkage blocks 1003 move away from one another (e.g., one linkage block moves to the left and the other linkage block moves to the right). To accomplish this, both the wedge blocks 1002 and the linkage blocks 1003 are provided with threads corresponding to those of the drive screw 1004. For example, the drive screw 1004 includes the first threaded portion 1004a and the second threaded portion 1004b, which is spaced apart from the first threaded portion 1004a. The portion of the drive screw 1004 between the first threaded portion 1004a and the second threaded portion 1004b (i.e., the unthreaded portion) does not have any threads. The first threaded portion 1004a engages with the wedge block 1002 during the first stage (see
[0043] Referring now to
[0044] On the other hand, during a second stage of expansion, the linkage blocks 1003 exclusively control expansion of the device. The drive screw 1004 is actuated to deploy the linkages 1003a-1003d, which are attached to the endplates 1001 by endplate pins 1012 and to the linkage blocks 1003 by shear pins 1010 as described above. To accomplish this, a shear pin 1010 can extend through the proximal end of each of the linkages 1003a-1003d and through a portion of the wedge block 1002. One shear pin 1010 can extend through the proximal end of each of the linkages of each linkage block 1003. For example, the device in
[0045] Although examples are provided for expanding the device, it should be understood that the drive screw can be rotated in the opposite direction to contract or collapse the device. For example, the linkage blocks can be used to collapse the device from the open position to the intermediate position, and the wedge blocks can be used to collapse the devices from the intermediate position to the closed position. Additionally, it should be understood that the device can be expanded to a desired height and stay at this desired height during and after implantation. The desired height is independent of the intermediate and/or fully open positions. For example, some patients may require the device to be expanded to a height less than the intermediate position, while some patients may require the device to be expanded to a height greater than the intermediate position. In other words, the device does not need to be expanded to the fully open position (or even the intermediate position) in every case. The dual stage expansion mechanism facilitates the ability of the device to expand to a larger range of heights.
[0046] This disclosure contemplates that the devices (e.g., components of the devices such as the structural body, wedge blocks, linkage blocks, linkages, drive screw, etc.) described herein can be made using alternative medical grade materials. This disclosure contemplates that some or all of the components can be made of the same material in some implementations, while in other implementations some or all of the components can be made of different materials. In some implementations, the device can be made of a molybdenum-rhenium (MoRe) alloy. Optionally, the MoRe alloy is Mo47.5Re. Alternatively, the alloy is optionally 99.99% pure with at least 40 weight percent (wt. %) rhenium. Optionally, the alloy is optionally 99.99% pure with between 40 wt. % and 99.9 wt. % rhenium (e.g., 40.0 wt. %, 40.01 wt. %, 40.02 wt. % . . . 99.88 wt. %, 99.89 wt. %, 99.9 wt. %) and any value or range therebetween. In other implementations, the device can be made of titanium (Ti). In other implementations, the device can be made of a titanium-molybdenum (TiMo) alloy including, but not limited to, Ti-15 Mo. In other implementations, the device can be made of a titanium (Ti) alloy. In other implementations, the device can be made of a cobalt-chromium (CoCr) alloy. Other example alloys that can be used are described, for example, in U.S. 2019/0008995, published Jan. 10, 2019, titled Molybdenum Alloys for Medical Devices, the disclosure of which is expressly incorporated herein by reference in its entirety.
[0047] Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.