Patent Grant
11957600
An interbody device is a prosthesis used during spinal surgery. An interbody device is inserted into the space between spinal disks to provide stability. For example, an interbody device can be introduced between vertebrae of a patient's spine (i.e., in the disk space between adjacent vertebrae) for fixation with bone to immobilize the joint as part of a surgical treatment. Interbody devices are fastened with anchors and often have a plurality of single openings for insertion of each anchor. The single openings provide a predetermined location in the spinal column for each anchor to be inserted during an operation. However, due to differences in patients' spines and existing medical hardware, the specific anchor locations of current interbody devices may be unsuitable in some cases.
Thus, a need exists for an implantable interbody device that provides for versatility of anchor insertion locations.
Various implementations include an implant. The implant includes a body defining a central opening, the body has a first surface and a second surface spaced apart and opposite from the first surface. The second surface at least partially defines the central opening. The first surface defines a plurality of openings including a first opening and a second opening. Each of the openings extends along an axis from the first surface to the second surface. The first opening and the second opening at least partially overlap at the first surface, and the axis of the first opening is transverse to the axis of the second opening.
In some implementations, the plurality of openings further includes a third opening, a fourth opening, a fifth opening and a sixth opening. The third opening and the fourth opening at least partially overlap at the first surface, and the axis of the third opening is transverse to the axis of the fourth opening. The fifth opening and the sixth opening at least partially overlap at the first surface, and the axis of the fifth opening is transverse to the axis of the sixth opening.
In some implementations, the first surface of the body further includes an alignment axis. An intersection point of the axis of the first opening with the first surface and an intersection point of the axis of the second opening with the first surface are equally spaced on opposite sides of the alignment axis from each other. An intersection point of the axis of the third opening with the first surface and an intersection point of the axis of the fourth opening with the first surface are equally spaced on opposite sides of the alignment axis from each other. An intersection point of the axis of the fifth opening with the first surface and an intersection point of the axis of the sixth opening with the first surface are equally spaced on opposite sides of the alignment axis from each other.
In some implementations, the first opening and the second opening are configured such that a first anchor is disposable within the first opening and a second anchor is disposable within the second opening simultaneously.
In some implementations, the axis of the first opening and the axis of the second opening define an anchor plane that is perpendicular to the alignment axis. The axis of the first opening is disposed at a first angle from 30 degrees to 60 degrees relative to the second surface of the body. The axis of the second opening is disposed at a second angle from 30 degrees to 60 degrees relative to the second surface of the body.
In some implementations, the first angle is 45 degrees and second angle is 45 degrees.
In some implementations, a projection of the axis of the third opening onto the anchor plane is disposed at a third primary angle from 15 degrees to 60 degrees relative to the second surface of the body. A projection of the axis of the fourth opening onto the anchor plane is disposed at a fourth primary angle from 15 degrees to 60 degrees relative to the second surface of the body. A projection of the axis of the fifth opening onto the anchor plane is disposed at a fifth primary angle from 15 degrees to 60 degrees relative to the second surface of the body. A projection of the axis of the sixth opening onto the anchor plane is disposed at a sixth primary angle from 15 degrees to 60 degrees relative to the second surface of the body.
In some implementations, the third primary angle is 30 degrees, fourth primary angle is 30 degrees, fifth primary angle is 30 degrees, and sixth primary angle is 30 degrees.
In some implementations, the axis of the third opening intersects the anchor plane at a third secondary angle of 30 degrees or less, and wherein the axis of the fourth opening intersects the anchor plane at a fourth secondary angle of 30 degrees or less. The axis of the fifth opening intersects the anchor plane at a fifth secondary angle of 30 degrees or less. The axis of the sixth opening intersects the anchor plane at a sixth secondary angle of 30 degrees or less.
In some implementations, the third secondary angle is 15 degrees, the fourth secondary angle is 15 degrees, the fifth secondary angle is 15 degrees, and the sixth secondary angle is 15 degrees.
In some implementations, the axes of the third opening and the fourth opening intersect the anchor plane at a first point that is closer to the second surface than to the first surface. The axes of the fifth opening and the sixth opening intersect the anchor plane at a second point that is closer to the second surface than to the first surface.
In some implementations, the plurality of openings further includes a seventh opening, an eighth opening. The seventh opening and the eighth opening at least partially overlap at the first surface, and the axis of the seventh opening is transverse to the axis of the eighth opening.
In some implementations, the seventh opening and the eighth opening are configured such that a first anchor is disposable within the seventh opening and a second anchor is disposable within the eighth opening simultaneously.
In some implementations, the axis of the seventh opening and the axis of the eighth opening extend parallel to the anchor plane, wherein the axis of the seventh opening is disposed at a 45 degree angle relative to the second surface of the body. The axis of the eighth opening is disposed at a 45 degree angle relative to the second surface of the body and at a 90 degree angle relative to the axis of the seventh opening.
In some implementations, the implant includes an anti-backout device coupled to the first surface of the body, wherein the anti-backout device is positionable to cover a portion of at least the first opening and the second opening.
In some implementations, the implant includes an interbody device.
In some implementations, the body includes a molybdenum-rhenium (MoRe) alloy.
In some implementations, the MoRe alloy is Mo47.5Re.
In some implementations, the body includes at least 40 weight percent rhenium (Re).
In some implementations, the body includes a titanium-molybdenum (TiMo) alloy.
In some implementations, the body comprises a cobalt-chromium (CoCr) alloy.
In some implementations, the body comprises a titanium (Ti) alloy.
In some implementations, the body comprises polyether ether ketone (“PEEK”).
In some implementations, the body defines a plurality of micro-apertures having an average size between about 2 to about 10 micrometers (μm) and a plurality of macro-apertures having an average size between about 300 to about 800 micrometers (μm).
Example features and implementations are disclosed in the accompanying drawings. However, the present disclosure is not limited to the precise arrangements and instrumentalities shown.
The devices, systems, and methods disclosed herein provide for an implantable interbody device that can be implanted between adjacent vertebrae in the lumbar region of the spine to promote fusion of the vertebrae. The implant includes a plurality of anchor openings at different angles to allow a surgent to determine the optimal anchor location in each case. By partially overlapping the anchor openings of the implant, the implant is able to include more anchor openings to provide more anchoring options.
Various implementations include an implant. The implant includes a body defining a central opening. The body has a first surface and a second surface spaced apart and opposite from the first surface. The second surface at least partially defines the central opening. The first surface defines a plurality of openings including a first opening and a second opening. Each of the openings extends along an axis from the first surface to the second surface. The first opening and the second opening at least partially overlap at the first surface, and the axis of the first opening is transverse to the axis of the second opening.
The first surface 124 and the second surface 126 each have a width as measured between the superior surface 120 and the inferior surface 122. The first surface 124 has a width that is greater than the width of the second surface 126 such that the superior surface 120 and the inferior surface 122 form a lordosis angle relative to each other that corresponds with a lordosis angle of the adjacent vertebrae between which the device will be implanted. The lordosis angle of the implant 100 shown in
The superior surface 120 and inferior surface 122 of the body 110 shown in
The superior surface 120 and inferior surface 122 of the body 110 also include a plurality of macro-apertures 132. Example macro-apertures 132 are shown in detail in
In some implementations, the micro- and/or macro-apertures 130, 132 can be provided such that the implant 100 has a stiffness equal to or greater than cancellous bone. Alternatively or additionally, the interbody device 100 can optionally have a composite porosity of 75-85% with 300-800 μm pores and 2-10% porosity with 10-50 μm pores. For comparison, cancellous bone has 75-85% porosity with 300-600 μm pores and cortical bone has 5-10% porosity with 10-50 μm pores. By including micro- and macro-apertures 132, 112B, highly porous contacting superior surfaces 120 and inferior surfaces 122 are provided. Such porous superior surfaces 120 and inferior surfaces 122 facilitate spinal fusion. Porosity is achieved by providing a plurality of apertures (i.e., both micro- and macro-apertures 130, 132) that connect the superior surface 120 and inferior surface 122. As described below, the micro- and macro-apertures 130, 132 can be manufactured using a chemical etching process.
The body 110 includes Mo47.5Re molybdenum-rhenium (MoRe) alloy. But in some implementations, the body 110 includes any molybdenum-rhenium (MoRe) alloy. In other implementations, the body 110 includes any material that includes 40 weight percent rhenium (Re). In other implementations, the body includes polyether ether ketone (“PEEK”), but in other implementations, the body can include any other polymer suitable. In other implementations, the body includes material that includes titanium-molybdenum (TiMo) alloy, cobalt-chromium (CoCr) alloy, titanium (Ti) alloy, or any other material suitable for implantation in a human body. The body 110, 210 shown in
Each of the openings partially overlap with another of the openings at the first surface 124. For example, in
The first surface 124 of the body 110 includes an alignment axis 180 that extends longitudinally along the first surface 124 and runs centrally between sets of overlapping openings on the first surface 124. Specifically, an intersection point of the axis 142 of the first opening 140 with the first surface 124 and an intersection point of the axis 146 of the second opening 144 with the first surface 124 are equally spaced on opposite sides of the alignment axis 180 from each other. Similarly, an intersection point of the axis 152 of the third opening 150 with the first surface 124 and an intersection point of the axis 156 of the fourth opening 154 with the first surface are equally spaced on opposite sides of the alignment axis 180 from each other. Furthermore, an intersection point of the axis 162 of the fifth opening 160 with the first surface 124 and an intersection point of the axis 166 of the sixth opening 164 with the first surface 124 are equally spaced on opposite sides of the alignment axis 180 from each other.
Although the implementations shown in
Although the implementations shown in
Although the implementations shown in
The axis of each opening 142, 144, 146, 148, 150, 152 is angled relative to the second surface 126 to provide a surgeon with a plurality of angles through which the anchor 199 can be disposed. The axis 142 of the first opening 140 extends from the first surface 124 to the second surface 126 in a superior direction, and the axis 146 of the second opening 144 extends between the first surface 124 and the second surface 126 in an inferior direction. The axes 142, 146 of the first opening 140 and the second opening 144 define an anchor plane 182 that is perpendicular to the alignment axis 180.
The axis 142 of the first opening 140 is disposed at a first primary angle of 45 degrees relative to the second surface 126 of the body 110. The axis 146 of the second opening 144 is disposed at a second primary angle of 45 degrees relative to the second surface 126 of the body 110 and transverse to the axis 142 of the first opening 140.
A projection of the axis 148 of the third opening 150 onto the anchor plane 182 is disposed at a third primary angle of 30 degrees relative to the second surface 126 of the body 110 toward the superior surface 120. A projection of the axis 156 of the fourth opening 154 onto the anchor plane 182 is disposed at a fourth primary angle of 30 degrees relative to the second surface 126 of the body 110 and transverse to the projection of the axis 152 of the third opening 150 onto the anchor plane 182.
A projection of the axis 162 of the fifth opening 160 onto the anchor plane 182 is disposed at a fifth primary angle of 30 degrees relative to the second surface 126 of the body 110 toward the superior surface 120. A projection of the axis 166 of the sixth opening 164 onto the anchor plane 182 is disposed at a sixth primary angle of 30 degrees relative to the second surface 126 of the body 110 and transverse to the projection of the axis 162 of the fifth opening 160 onto the anchor plane 182.
The third opening 150, fourth opening 154, fifth opening 160, and sixth openings 164 are also angled inwardly toward the anchor plane 182. The axis 152 of the third opening 150 intersects the anchor plane 182 at a third secondary angle of 15 degrees, and the axis 156 of the fourth opening 154 intersects the anchor plane 182 at a fourth secondary angle of 15 degrees. The axes of the third opening 150 and the fourth opening 154 intersect the anchor plane 182 at a first point that is closer to the second surface 126 than to the first surface 124 such that the axes of the third opening 150 and the fourth opening 154 are angled inwardly. The axis 162 of the fifth opening 160 intersects the anchor plane 182 at a fifth secondary angle of 15 degrees or less, and the axis of the sixth opening 164 intersects the anchor plane 182 at a sixth secondary angle of 15 degrees. The axes 162, 166 of the fifth opening 160 and the sixth opening 164 intersect the anchor plane 182 at a second point that is closer to the second surface 126 than to the first surface 124 such that the axes of the fifth opening 160 and the sixth opening 164 are angled inwardly.
Although the axes of each of the openings are oriented at specific primary angles in
Although the axes of the third opening 150 and the fourth opening 154 of the implant 100 shown in
Although the body 110 of the implant 100 shown in
The axis 272 of the seventh opening 270 is transverse to the axis 276 of the eighth opening 274, and the axes of the seventh opening 270 and eighth opening 274 extend parallel to the anchor plane 282. The axis 272 of the seventh opening 270 is disposed at a 45 degree angle relative to the second surface 226 of the body 210, and the axis 276 of the eighth opening 274 is disposed at a 45 degree angle relative to the second surface 126 of the body 210. But in other implementations, the seventh opening 270 and the eighth opening 274 can be disposed an any angle between 15 and 60 degrees relative to the second surface 126 of the body 210. And, the eighth opening 274 can be disposed at any angle relative to the axis 272 of the seventh opening 270.
Although anchors 199, 299 shown in
In the implementation shown in
During an implanting procedure, the surgeon selects an implant 100 with a specific lordosis angle to compliment the curvature of the patient's spine where the implant will be inserted. The implant 100 is inserted between two adjacent lumbar vertebrae (L1-S1) from anterior to posterior of the patient such that the second surface 126 faces toward the posterior of the patient and the superior surface 120 faces the head of the patient.
Once the implant 100 is disposed between the adjacent vertebrae, screws 199 are inserted through the openings of the implant 100 and secured into selected sections of the spine. A surgeon observing the spine of the patient identifies any existing hardware or conditions in the patient's spine and determines which openings of the implant 100 to use for coupling the implant 100 to the vertebrae. The multiple openings extending at various angles provides the surgeon with multiple options for anchor points in the spine. At least a first anchor 199 is inserted through one of the first, third, or fifth opening 160s to couple the implant 100 to the superior vertebrae, and at least a second anchor 199 is inserted through one of the second, fourth, or sixth openings 144, 154, 164 to couple the implant 100 to the inferior vertebrae. Third and fourth anchors 199 can be inserted into the remaining openings to further secure the implant 100 to the superior and inferior vertebrae. The screws 199 are advanced into the spine until the screw heads no longer protrude from the first surface 124.
The anti-backout device(s) are secured into place to prevent the screws 199 from backing out. The anti-backout devices shown in
A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the claims. Accordingly, other implementations are within the scope of the following claims.
Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present claims. In the drawings, the same reference numbers are employed for designating the same elements throughout the several figures. A number of examples are provided, nevertheless, it will be understood that various modifications can be made without departing from the spirit and scope of the disclosure herein. 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. Although the terms “comprising” and “including” have been used herein to describe various implementations, the terms “consisting essentially of” and “consisting of” can be used in place of “comprising” and “including” to provide for more specific implementations and are also disclosed.
Disclosed are materials, systems, devices, methods, compositions, and components that can be used for, can be used in conjunction with, can be used in preparation for, or are products of the disclosed methods, systems, and devices. These and other components are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these components are disclosed that while specific reference of each various individual and collective combinations and permutations of these components may not be explicitly disclosed, each is specifically contemplated and described herein. For example, if a device is disclosed and discussed each and every combination and permutation of the device, and the modifications that are possible are specifically contemplated unless specifically indicated to the contrary. Likewise, any subset or combination of these is also specifically contemplated and disclosed. This concept applies to all aspects of this disclosure including, but not limited to, steps in methods using the disclosed systems or devices. Thus, if there are a variety of additional steps that can be performed, it is understood that each of these additional steps can be performed with any specific method steps or combination of method steps of the disclosed methods, and that each such combination or subset of combinations is specifically contemplated and should be considered disclosed.
This application claims the benefit of U.S. Provisional Patent Application No. 62/978,060, filed Feb. 18, 2020, the contents of which are incorporated herein by reference in their entirety.
| Number | Name | Date | Kind |
|---|---|---|---|
| 7488444 | Furst et al. | Feb 2009 | B2 |
| 8740983 | Arnold | Jun 2014 | B1 |
| 9381093 | Morris | Jul 2016 | B1 |
| 9655742 | Marnay | May 2017 | B2 |
| 9662226 | Wickham | May 2017 | B2 |
| 9687358 | Bertele et al. | Jun 2017 | B2 |
| 9848995 | Ullrich, Jr. | Dec 2017 | B2 |
| 9848996 | Faulhaber | Dec 2017 | B2 |
| 9855150 | Altarac | Jan 2018 | B2 |
| 10687956 | Ullrich, Jr. | Jun 2020 | B2 |
| 11116644 | Marrocco | Sep 2021 | B2 |
| 20020153348 | Say et al. | Oct 2002 | A1 |
| 20030040798 | Michelson | Feb 2003 | A1 |
| 20060074490 | Sweeney | Apr 2006 | A1 |
| 20110035009 | Sweeney | Feb 2011 | A1 |
| 20110082551 | Kraus | Apr 2011 | A1 |
| 20110224796 | Weiland et al. | Sep 2011 | A1 |
| 20110301714 | Theofilos | Dec 2011 | A1 |
| 20120172991 | Bertele et al. | Jul 2012 | A1 |
| 20120277870 | Wolters | Nov 2012 | A1 |
| 20120303127 | Ullrich, Jr. et al. | Nov 2012 | A1 |
| 20120316653 | Ullrich, Jr. et al. | Dec 2012 | A1 |
| 20130116793 | Kloss | May 2013 | A1 |
| 20130226300 | Chataigner | Aug 2013 | A1 |
| 20140012380 | Laurence | Jan 2014 | A1 |
| 20140100662 | Patterson et al. | Apr 2014 | A1 |
| 20140277491 | Fang et al. | Sep 2014 | A1 |
| 20140336771 | Zambiasi | Nov 2014 | A1 |
| 20150018958 | Ullrich, Jr. et al. | Jan 2015 | A1 |
| 20150328005 | Padovani | Nov 2015 | A1 |
| 20150359639 | Ullrich, Jr. | Dec 2015 | A1 |
| 20160235448 | Seex | Aug 2016 | A1 |
| 20160270920 | Dawson et al. | Sep 2016 | A1 |
| 20160331543 | Butler et al. | Nov 2016 | A1 |
| 20170156880 | Halverson et al. | Jun 2017 | A1 |
| 20170189204 | Riemhofer | Jul 2017 | A1 |
| 20180071113 | Melkent et al. | Mar 2018 | A1 |
| 20180318099 | Altarac | Nov 2018 | A1 |
| 20180318100 | Altarac | Nov 2018 | A1 |
| 20190254840 | Gray et al. | Aug 2019 | A1 |
| 20200054461 | Marrocco | Feb 2020 | A1 |
| 20200246162 | Schultz | Aug 2020 | A1 |
| 20210077268 | Struck | Mar 2021 | A1 |
| 20210154022 | Walsh | May 2021 | A1 |
| 20210251769 | Hapstack | Aug 2021 | A1 |
| 20220233329 | Marrocco | Jul 2022 | A1 |
| Entry |
|---|
| International Search Report and Written Opinion, issued in the related international application No. PCT/US2017/052019 dated Nov. 17, 2017 (9 pages). |
| Pavon, J. et al., “Titanium scaffolds with multi-scale porosity obtained by controlled chemical and electrochemical treatments of porous solids from PM space holder technique,” 10th World Biomaterials Congress Event Abstract, 2016 http://www.frontiersin.org/10.3389/conf.FBIOE.2016.01.02952/2893/10th_World_Biomaterials_Congress/all_events/event_abstract (accessed Sep. 7, 2017) (3 pages). |
| “FDA Clearance for Signus Mobisc (R) II ST interbody fusion device,” SpinalSurgeryNews, 2015, http://www.spinalsurgerynews.com/2015/03/fda-clearance-for-signus_mobis-ii-st-interbody-fusion-device/9549 (accessed Sep. 7, 2017) (1 page). |
| Number | Date | Country | |
|---|---|---|---|
| 20210251769 A1 | Aug 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62978060 | Feb 2020 | US |
