Source: https://patents.justia.com/patent/10624680
Timestamp: 2020-08-11 04:33:28
Document Index: 591322881

Matched Legal Cases: ['§ 119', 'Application No. 61', 'art\n5372598', 'art\n20150257770', 'Application No. 16180368', 'Application No. 2', 'Application No. 2016', 'Application No. 2016', 'Application No. 2014241989', 'Application No. 2014241989', 'Application No. 2014241994', 'Application No. 2014327083', 'Application No. 2014327083', 'Application No. 16743832', 'Application No. 2015', 'Application No. 2016', 'Application No. 2016', 'Application No. 2014241989', 'Application No. 2', 'Application No. 2', 'Application No. 16180368', 'Application No. 2014277721', 'Application No. 2014277721', 'Application No. 2', 'Application No. 11818586', 'Application No. 2013', 'Application No. 2015', 'Application No. 2015', 'Application No. 12749251', 'Application No. 12749251', 'Application No. 14774714', 'Application No. 14776445', 'Application No. 14850082', 'Application No. 19158915', 'Application No. 12749251', 'Application No. 14774714', 'Application No. 2016212009']

US Patent for Device and method for reinforcement of a facet Patent (Patent # 10,624,680 issued April 21, 2020) - Justia Patents Search
Justia Patents Facet ImplantUS Patent for Device and method for reinforcement of a facet Patent (Patent # 10,624,680)
Nov 6, 2017 - Spinal Elements, Inc.
In some embodiments, a device for reinforcement of a facet joint is provided. The device comprises a lumen configured to receive a fastener member. In some embodiments, a second segment comprises a second lumen configured to receive a fastener member or fastener. In some embodiments, kits are provided with a fastener member and a facet reinforcement device. Methods are also provided for treating a spine. In some embodiments, the fastener member is placed through both articular processes of a facet joint and a facet reinforcement device.
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This application is a divisional application of U.S. patent application Ser. No. 14/274,575 filed May 9, 2014, which claims priority benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61/883,960, filed Sep. 27, 2013, the entirety of each is hereby incorporated by reference herein.
Injuries and/or surgical procedure on and/or effecting other bones can also result in the desire to fixate and/or stabilize a bone until the bone, or bone portions, can fuse, for example, to stabilize a sternum after heart surgery, to stabilize a rib after a break, etc. Current procedures to fixate and/or stabilize adjacent vertebrae and/or other bones can be slow and/or complex
In some embodiments, a device for reinforcing a facet joint implant is provided. The device comprises a first securing segment comprising a proximal surface and a distal surface. The first securing segment comprises a first lumen disposed between the proximal surface and the distal surface. The first lumen is adapted for receiving a fastener member. The device comprises a second securing segment comprising a proximal surface and a distal surface. The second securing segment comprises a second lumen. The device comprises a central portion between the first securing segment and the second securing segment.
In some embodiments a longitudinal axis of the first securing segment is disposed at an angle relative to a longitudinal axis of the second securing segment. In some embodiments, a plane of the distal surface of the first securing segment is not parallel to a plane of the distal surface of the second securing segment. In some embodiments, the distal surface of the facet reinforcement device is configured for engaging a bony surface of a facet. In some embodiments, the distal surface of the facet reinforcement device comprises sharp engagement members.
In some embodiments, a kit for treating a spine is provided. The kit comprises a fastener member. The kit comprises a facet reinforcement device. The facet reinforcement device comprises a proximal surface and a distal surface. The facet reinforcement device comprises a lumen disposed between the proximal surface and the distal surface. The lumen is adapted for receiving the fastener member.
In some embodiments, the facet reinforcement device further comprises a second portion adapted to attach to a spinous process of a vertebra. In embodiments, the second portion of the facet reinforcement device comprises at least one lumen. Some embodiments of the kit, further comprise a fastener for securing the facet reinforcement device to the vertebra. In some embodiments, the fastener secures the facet reinforcement device to the spinous process of the superior vertebra. In some embodiments, the fastener is a screw or bolt.
In some embodiments, a method for treating a spine is provided. The method may include placing a facet reinforcement device comprising a lumen adjacent to a first vertebra. The method may include passing a fastener member through the lumen. The method includes passing the fastener member through a first articular process of a facet joint. The method may include passing the fastener member through a second articular process of the facet joint. The method may include securing one end of the fastener member to the other end of the fastener member, thereby retaining the facet reinforcement device.
In some embodiments, a method for treating a spine is provided. The method may include the step of preparing a facet joint for fixation. The method may include passing a fastener member through a first articular process of a facet joint. The method may include passing a fastener member through a second articular process of the facet joint. The method may include placing a facet reinforcement device with a lumen for receiving the flexible fastening band against a surface of the first articular process. The method may include passing a fastener member through the lumen. The method may include securing the fastener member. The method may include securing the facet reinforcement device to a spinous process with a fastener. The methods may further comprise inserting a facet implant with an interface configured to receive the fastener member into the facet joint. The methods may further comprise passing the fastener member through the interface of the facet implant.
In some embodiments, a method for treating a spine is provided. Methods may further comprise preparing a second facet joint at a same level of the spine for fixation. The method may include placing a second facet reinforcement device against a first articular process of the second facet joint. The method may include passing a second fastener member through a first articular process of the second facet joint. The method may include passing a second fastener member through a second articular process of the second facet joint. The method may include securing the second fastener member. The method may include securing the second facet reinforcement device to a spinous process with a fastener. The methods may further comprise inserting a second facet implant with an interface configured to receive the fastener member into the facet joint. The methods may further comprise passing the second fastener member through the interface of the second facet implant.
In some embodiments, a device for placement on a facet joint is provided, the purpose of the device being to provide reinforcement to the bone when a fastener member is used to secure the joint. The device may include sharp engagement members on a bone contact side to prevent migration. The device may include a through-opening to accept a primary facet fixation device. In some embodiments, the device for placement on a facet joint has a second through-opening for accepting at least one additional fastener. In some embodiments, a screw may be provided for placement through the second through-opening.
FIGS. 34A to 35B are one embodiment comprising friction fit fastener rings. FIGS. 34A and 34B depict the fastener rings in their reduced state and FIGS. 35A and 35B depict the fastener rings in their expanded state.
FIGS. 36A to 36C illustrate embodiments comprising a implant with a close-ended threaded fastener interface and a threaded fastener member.
FIGS. 36B and 36C depict a threaded fastener member with a pivotable washer.
FIG. 45 shows the implant of FIG. 44 implanted into a facet joint.
FIG. 48B is a side view of the implant of FIG. 48A.
FIG. 82 is a front perspective view of a facet reinforcement device according to an embodiment.
FIGS. 83-84 are posterior perspective views of a portion of the vertebral column depicting a method of stabilizing a vertebra using the facet reinforcement device of FIG. 82 and a fastener member according to an embodiment.
FIG. 85 is a front perspective view of a facet reinforcement device according to an embodiment.
FIGS. 86-87 are posterior perspective views of a portion of the vertebral column depicting a method of stabilizing a vertebra using the facet reinforcement device of FIG. 85 and a fastener member according to an embodiment.
FIG. 88 is a front perspective view of a facet reinforcement device according to an embodiment.
FIGS. 89-91 are perspective views of a portion of the vertebral column depicting a method of stabilizing a vertebra using a first facet reinforcement device of FIG. 88, a second facet reinforcement device, and one or more fastener members according to an embodiment.
Implant 160 includes fastener interface 166. Fastener interface 166 can be configured to retain implant 160 in substantially the same position. Specifically, fastener interface 166 can be configured to accept a fastener member (not shown) to substantially prevent movement of implant 160. Fastener interface 166 can include an aperture and/or other opening. Fastener interface 166 can extend through implant 160, e.g. can extend from first side 162 and through to second side 164. In some embodiments, fastener interface 166 can extend through only a portion of implant 160, e.g. can extend from first side 162 and through less than half of a width (not shown) of implant 160. Fastener interface 166 can be disposed on and/or through first side 162, second side 164, and/or both first side 162 and second side 164. Fastener interface 166 can be disposed through a center (not shown) of implant 160. In other embodiments, fastener interface 166 can be disposed anywhere on and/or through implant 160, e.g., offset from center. Fastener interface 166 can be substantially circular (cylindrical). In other embodiments, fastener interface 166 can be other shapes and/or can be shaped based on a shape of the fastener member, for example, rectangular (cuboid). In some embodiments, fastener interface 166 can be a irregular shape, based at least in part in the location of fastener interface 166, see, e.g., FIG. 48, and/or partial shapes, see, e.g., FIG. 23B. Fastener interface 166 can include a substantially smooth inner surface (not shown) to allow the fastener member to easily pass through and/or into fastener interface 166, and/or can include a threaded inner surface to allow the fastener member to thread into fastener interface 166. While depicted in FIG. 7 as including one fastener interface, implant 160 can include more than one fastener interface 160.
Implant 160 includes substance interface 168. Substance interface can be configured to retain, carry and/or otherwise deliver a substance to aid in fusion, such as, for example, medicines, adhesives, bone graft, and/or combinations of substances. Substance interface 168 can include an aperture and/or other opening. Substance interface 168 can extend through implant 160, e.g. can extend from first side 162 and through to second side 164. In some embodiments, fastener interface can extend through only a portion of implant 160, e.g. can extend from first side 162 and through less than half of a width (not shown) of implant 160. Substance interface 168 can be disposed on and/or through first side 162, second side 164, and/or both first side 162 and second side 164. Substance interface 168 can be disposed through a center (not shown) of implant 160. In other embodiments, substance interface 168 can be disposed anywhere on and/or through implant 160, e.g., offset from center. Substance interface 168 can be substantially circular (cylindrical). In other embodiments, substance interface 168 can be other shapes and/or can be shaped based on a shape of the fastener member, for example, rectangular (cuboid). In some embodiments, substance interface 168 can be an irregular shape, based at least in part in the location of substance interface 168. While depicted in FIG. 7 as including one substance interface, implant 160 can include more than one substance interface 160. The location, size, shape, and/or number of substance interface(s) 168 can be determined based on the location, size, shape, and/or number of fastener interface(s) 166.
In one embodiment, the wire or cable fastener member is secured to the articular processes with sufficient laxity or length between the secured ends or between the implant and one secured end so that the two articular processes are not fixed in position relative to each other and remain capable of performing movements such as flexion, extension, lateral flexion and/or rotation. In one embodiment, the fastener member comprises a cable of braided polymer, including but not limited to a braided polymer such as PEEK or PEKK, or a braided metal, such as braided cobalt chromium or titanium. The cable can be selected with different degrees of flexibility to provide different degrees of movement at that facet joint. The cable has a first segment capable of engaging the implant at its fastener interface to limit the movement.
FIGS. 49-51 show posterior perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using an implant 260 according to an embodiment. As shown in FIG. 49, implant 260 and a fastener member 280 can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. Any fastener member can include any biocompatible material, e.g., stainless steel, titanium, PEEK, nylon, etc. Also as shown in FIG. 49, an implant 360 and a fastener member 380 are used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2. In some embodiments, vertebra V1 and/or vertebra V2 are fused using only one of implant 260 or implant 360. In some such embodiments, one of implant 260 and fastener member 280 or implant 360 and fastener member 380 can be used to stabilize vertebra V1 and/or vertebra V2 via one of via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2, or, via the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2. In other such embodiments, one of fastener member 280 or fastener member 380 can be used to stabilize vertebra V1 and/or vertebra V2 via both of the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2 (for example, in combination with implant 260), and, the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2 (for example, in combination with implant 360).
The proximal end portion 282 of fastener member 280 is inserted into the lumen of inferior articular process IAP1A of vertebra V1, at 6014. The fastener member can be secured, at 6016. Securing the fastener member 280 can be based on the type of fastener member used. By way of example, securing a fastener member similar to a flexible fastener band as depicted in FIGS. 49-51, can include inserting the proximal end portion 282 into a fastening mechanism of a distal end portion 284 of the fastener member 280, and advancing the proximal end portion 282 through the fastening mechanism to secure the fastening mechanism. In other embodiments, fastener member can be secured by tying a first portion the fastener member to a second portion of the fastener member, by screwing the fastener member into a threaded fastener interface, threading a fastener onto a threaded end of a fastener member disposed through a fastener interface, combinations of above, etc. In some embodiments, implant 260 can be disposed prior to inserting the proximal end portion of the fastener member 280 into the lumen of superior articular process SAP2A of vertebra V2. The cannula can be removed and/or reinserted at various points during the method 6000, including, for example, after the proximal end portion 282 of fastener member 280 is inserted into the lumen formed within the superior articular process SAP2A of vertebra V2, after vertebra V1 and/or Vertebra V2 has been stabilized, or at other points during method 6000.
After the fastener member is secured, superior articular process SAP2A of vertebra V2 can fuse to inferior articular process IAP of vertebra V1. Fusing can include one or more of bone material from superior articular process SAP2A of vertebra V2, bone material from inferior articular process IAP1A of vertebra V1, and the substance that fuses articular process SAP2A of vertebra V2 to inferior articular process IAP of vertebra V1 through substance interface 268. In some embodiments, after superior articular process SAP2A of vertebra V2 is fused to inferior articular process IAP1A of vertebra V1, the fastener member 280 is not removed. In some other embodiments, after superior articular process SAP2A of vertebra V2 is fused to inferior articular process IAP1A of vertebra V1, all or a portion of the fastener member 280 can be removed. In other embodiments, fastener member 280 can be removed after fusion of superior articular process SAP2A of vertebra V2 to inferior articular process IAP1A of vertebra V1 has started, but has not finished.
FIG. 55 is a side view and FIG. 56 is a top view of a fastener member 840. Fastener member 840 can be a flexible fastening band (“band”) 580 according to another embodiment. Band 840 can be similar to band 280 and band 480 described above and can include similar components. By way of example, band 840 includes a proximal end portion 842, a first portion 844 including a gear rack 847, a second portion 846, and a distal end portion 848 including a fastening mechanism 850 and a ratchet 862. In contrast to gear rack 487, a cross sectional area of each gear 864 of gear rack 847 is rectangular in shape instead of wedge shaped. Furthermore, in contrast to first portion 282, first portion 844 is cylindrical in shape instead of cuboidal in shape. In this manner, the lumen 866 of the fastening mechanism 850 is cylindrical in shape. A band according to this embodiment may be particularly useful in deployments where a single band in used to stabilize adjacent vertebrae. In this manner, the second portion can be disposed within the lumen of the first articular process of the first vertebra and a portion of the first portion can be disposed within the lumen of the second articular process of the first vertebra. In these embodiments the portion of the band within the first articular process of the first vertebra and the portion of the band within in the second articular process of the first vertebra can both have substantially the same shape as the lumen in the first articular process of the first vertebra and the lumen in the second articular process of the first vertebra. In this manner, and as described above regarding band 480, the amount of open space within the lumens can be minimized, the amount of surface area of the first portion and/or second portion of the band in contact with the lumens can increase, and subsequently the movement of the first vertebra and/or the second vertebra can be reduced or minimized. Furthermore, when movement of the first vertebra and/or the second vertebra does occur, forces acting against the band can be more equally distributed throughout the first portion and/or the second portion, due at least to the increased surface area of the band in contact with the lumens.
FIG. 57 is a side view a fastener member 940. Fastener member 940 can be a flexible fastening band (“band”) 940 according to an embodiment. Band 940 can be similar to band 280, band 480, and band 840 described above and can include similar components. By way of example, band 840 includes a proximal end portion 942, a first portion 944 including a gear rack 947, a second portion 946, and a distal end portion 948 including a fastening mechanism 950. Similar to gear rack 847, a cross sectional area of each gear 964 of gear rack 947 is rectangular in shape. In contrast to gear rack 847, each of gears 964 extend the entire circumference of first portion 944 instead of only a portion of the circumference of first portion 944. Furthermore, in contrast to first portion 282, but similar to first portion 844, first portion 944 is cylindrical in shape instead of cuboidal in shape. In this manner, the lumen 966 of the fastening mechanism 950 is cylindrical in shape. A band according to this embodiment may be particularly useful in deployments where the movement and repositioning of the band after implantation may be difficult. In this manner, because each of the gears can be the entire circumference of the first portion and/or the second portion, the first portion and/or the second portion can enter the fastening mechanism in any radial orientation and still engage the ratchet.
FIGS. 66-69 depict an implant 1060 according to an embodiment. Specifically, FIG. 66 is a front perspective view of implant 1060, FIG. 67 is a rear perspective view of implant 1060, FIG. 68 is a side view of implant 1060, and FIG. 69 is a cross-sectional side view of implant 1060. Implant 1060 can be similar to, and have similar elements and uses as implant 160 and implant 260 described above. By way of example, a fastener interface 1066 of implant 1060 can be similar to fastener interface 166 of implant 160, and similar to fastener interface 266 of implant 260 Implant 1060 includes a concave first face 1062, a convex second face 1064, a centrally-disposed substantially-circular fastener interface 1066, and six substantially-circular shaped substance interfaces 1068.
Facet Reinforcement Device
Although the flexible fastening band may be used alone or with an embodiment of facet implant as described above, in some applications it may be desirable to reinforce the fixation of the band as it exits the bone of the articular process. This may prevent cut out by relieving pressure on the surface of the articular process and hold in the bone from the fastener band and/or fastening mechanism. The facet reinforcement may also anchor the flexible facet band to the vertebra using a fastener. This may prevent migration of the band and restrict motion at the facet joint to improve fusion.
FIG. 82 depicts one arrangement of facet reinforcement device 1400. The facet reinforcement device 1400 of the illustrated arrangement can include a proximal surface 1402, a distal surface 1406, an ablumenal surface 1404 extending from the proximal surface 1402 to the distal surface 1406. In certain arrangements, the proximal surface 1402 and/or distal surface 1406 can be curved and/or malleable to conform to the shape of the facet. The facet reinforcement device 1400 can include a luminal surface 1410 surrounding a central lumen 1420. The luminal surface 1410 can extend from the proximal surface 1402 to the distal surface 1406. The central lumen 1420 can be centrally disposed within the device 1400. As described below, the luminal surface 1410 can include a fastener interface (not illustrated) in certain embodiments.
As will be explained below, the facet reinforcement devices described herein can be used in combination with the implants depicted in FIGS. 8A-81A and/or other implants described herein. The facet reinforcement device 1400 can also be used in combination with the fastener members depicted in FIGS. 20-65, and/or other fastener members described herein. Accordingly, the fastener member 1480 depicted in FIG. 84 can refer to any fastener member described herein; and the fastener member 1580 depicted in FIG. 87 can refer to any fastener member described herein; and the fastener members 1680, 1680A depicted in FIG. 89 can refer to any fastener member described herein.
As shown in FIG. 82, at least a portion of one surface of the facet reinforcement device 1400 can include a roughened surface. A roughened surface may be advantageous when in contact with a bone or tissue surface because it may prevent slippage or migration of the facet reinforcement device 1400 against the bone. A roughened surface may aid in maintaining the facet reinforcement device 1400 and the fastener member 1480 (see FIG. 83) engaged with tissue or bone.
The roughened surface can include at least one projection 1416. As shown in FIG. 82, the facet reinforcement device 1400 can comprise a plurality of projections 1416. The projections 1416 can extend from the distal surface 1406 and can include a sharp edge or tip. The projections 1416 can also extend between the ablumenal surface 1404 and the luminal surface 1410 or in certain embodiments only extend along a portion of said area. In some embodiments, the projections 1416 comprise at least one spike, barb, wedge, or hook projecting from at least a portion of one surface of the facet reinforcement device 1400. In some embodiments, the projections 1416 can be ribbed, barbed, or threaded to resist separation after insertion into bone or tissue. The projections 1416 may have different shapes from one another or they may have a uniform shape. A portion of the surface of the projections 1416 can be porous. A porous surface can be created in any a variety of ways known in the art, such as by applying sintered beads or spraying plasma onto the surface of the projection 1416. A porous surface can allow bone to grow into or attach to the surface of the projection 1416, thus securing the projection 1416 and the facet reinforcement device 1400 to the bone. In certain embodiments, other surfaces of the facet reinforcement device 1400 can be porous. In one embodiment, an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate, or other adhesive known in the art, is used to bond at least one surface of the facet reinforcement device 1400 to a bone or tissue surface. In some embodiments, an adhesive or sealant is used to bond the distal surface 1406 of the facet reinforcement device 1400 to the surface of the facet.
The facet reinforcement device 1400 may include one row of projections 1416 or may include multiple rows of projections 1416. The facet reinforcement device 1400 may include projections 1416 arranged in a random order or orientation.
The ablumenal surface 1404 of the facet reinforcement device 1400 can include a substantially circular cross-section (cylindrical), as shown in FIG. 82. The ablumenal surface 1404 can have other cross-sectional shapes including, but not limited to, circular (cylindrical), hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. In certain embodiments, the ablumenal surface 1404 may conform to the shape of an insertion tool.
In the illustrated embodiment of FIG. 82, the central lumen 1420 and the luminal surface 1410 can be circular (cylindrical). The central lumen 1420 and the luminal surface 1410 can have other cross-sectional shapes including, but not limited to, hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The central lumen 1420 and the luminal surface 1410 may conform to the shape of an insertion tool. In certain embodiments, the central lumen 1420 and the luminal surface 1410 can be shaped based on a shape of the fastener member (not shown) (e.g., the central lumen and luminal surface can have a similar cross-sectional shape as the fastener member extending through the central lumen). In certain embodiments, the central lumen 1420 and the luminal surface 1410 can include a substantially smooth inner surface to allow the fastener member 1480 to easily pass through. In other embodiments, the central lumen 1420 and the luminal surface 1410 can include a threaded inner surface to allow the fastener member 1480 to thread into central lumen 1420.
The central lumen 1420 and the luminal surface 1410 may be configured to match the shape of a lumen formed in the articular process, during a method of use. The central lumen 1420 and the luminal surface 1410 may be smaller than a lumen formed in the articular process, during a method of use. In this configuration, the facet reinforcement device 1400 may reduce stress at the outer aspect of the lumen in the bone. The central lumen 1420 and the luminal surface 1410 may be larger than a lumen formed in the articular process, during a method of use. In this configuration, the facet reinforcement device 1400 may be in contact with a larger surface area of the facet, thereby distributing the forces of the fastener member.
The proximal surface 1402 may have a feature to mechanically interfit with an insertion tool, including grooves and/or protrusions configured to mate with a corresponding groove and/or protrusion of the insertion tool. The proximal surface 1402 may have a feature (e.g., a groove or recess) to mechanically interfit with a portion of the fastener member 1480 (shown in FIG. 84). The feature to mechanically interfit with a portion of the fastener member may increase stability of the system and resistance to migration of components of the system.
The diameter of the facet reinforcement device 1400 may be in the range of 2 mm-20 mm or in the range of 4 mm-15 mm. The diameter of the central lumen 1420 may be in the range of 0.5 mm-10 mm or range of 1-7 mm.
FIGS. 83-84 show posterior perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using the embodiment of the facet reinforcement device 1400 shown in FIG. 82. The method can include using an implant deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra.
In one method of use, a drill or other device can be used to form a lumen in superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1. A portion of the surface of the facet of SAP2A and a portion of the surface of the facet of IAP1A can be prepared for fusion. For example, a portion of the surface of the facet can be ground, scored, roughened, sanded, etc., such that the surface of the facet can better adhere to any substances to aid in fusion and/or otherwise fuse more readily to an implant positioned within the facet joint.
FIG. 83 illustrates the facet reinforcement device 1400 placed on the outer, posterior facing surface of the left inferior articular process IAP1A of the superior vertebra V1. In other embodiments and/or in addition, the facet reinforcement device can be placed on the surface of the facet of SAP2A. A lumen is formed in the articular process. The facet reinforcement device 1400 can be placed after a lumen is formed in the articular process. In another arrangement, the facet reinforcement device 1400 can be placed prior to forming a lumen in the articular process. In this method, the facet reinforcement device 1400 may serve as a guide for drilling the lumen. The facet reinforcement device 1400 can be placed after or prior preparation for fusion. An insertion tool may remain on the facet reinforcement device 1400 during the steps of forming the lumen and/or during the step of preparing for fusion.
As shown in FIG. 84, a facet reinforcement device 1400 and a fastener member 1480 can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. In some embodiments, at least one implant (not shown in FIG. 84) is used with the fastener member 1480 to fuse a vertebra V1 and vertebra V2. FIG. 84 depicts fusing the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. However, the inferior articular process IAP1B of vertebra V1 can be fused to the superior articular process SAP2B of vertebra V2.
In one method of use, the fastener member 1480 can be positioned within a cannula and can be advanced through the cannula. The proximal end portion of fastener member 1480 can then be inserted into the central lumen 1420 of the facet reinforcement device 1400. The proximal end portion of the fastener member 1480 can be adjacent and/or abut the luminal surface 1410. The proximal end portion of fastener member 1480 can then be inserted into the lumen of inferior articular process IAP1A of vertebra V1. The proximal end portion of fastener member 1480 can be advanced until a proximal end portion of fastener member is positioned near the lumen of superior articular process SAP2A of vertebra V2. In some embodiments, the proximal end of the cannula can have a bend to direct the proximal end portion of fastener member 1480 into the lumen of superior articular process SAP2A of vertebra V2. The proximal end portion of fastener member 1480 can be inserted into the lumen of superior articular process SAP2A of vertebra V2. An implant can be inserted between the superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1. In some embodiments, the implant can be disposed prior to inserting the proximal end portion of the fastener member 1480 into the lumen of superior articular process SAP2A of vertebra V2. The cannula can be removed and/or reinserted at various points during the method, including, for example, after the proximal end portion of fastener member 1480 is inserted into the lumen formed within the superior articular process SAP2A of vertebra V2, after vertebra V1 and/or vertebra V2 have been stabilized, or at any other point during the method.
The fastener member 1480 can be secured. Securing the fastener member 1480 can be based on the type of fastener member used. By way of example, securing a fastener member 1480 having the characteristics of the fastener member depicted in FIGS. 49-51, can include the following steps: inserting the proximal end portion of the fastener member 1480 into a fastening mechanism 1484; the fastener mechanism located at a distal end portion of the fastener member 1480; securing an end of the fastener member 1480 to the opposite end of the fastener member 1480; securing the proximal end portion of the fastener member 1480 to the distal end portion of the fastener member 1480; and/or advancing the proximal end portion of the fastener member 1480 through the fastening mechanism 1484. In other embodiments, fastener member 1480 can be secured by tying a first portion the fastener member to a second portion of the fastener member, by forming a knot in a first end and second end; by screwing the fastener member into a threaded central lumen, by threading a fastener onto a threaded end of a fastener member disposed through a threaded central lumen, by including enlarged portion at the end of the fastener member, and/or combinations of above. The fastener member 1480 can be secured in order to retain the facet reinforcement device 1400. The facet reinforcement device 1400 is retained within a loop or other defined segment of the fastener member 1480. The reinforcement device 1400 can remain freely movable along a portion of the defined segment after the fastener member 1480 is secured. In some embodiments, the reinforcement device 1400 is immobile or otherwise secured along a portion of the defined segment after the fastener member 1480 is secured.
FIG. 84 illustrates the assembled system, including the facet reinforcement device 1400 and the fastener member 1480. The assembled system is implanted on the left facet joint 1490 between the superior vertebra V1 and the inferior vertebra V2. The left facet joint 1490 may be compressed by the assembled system, thereby bringing the two facet surfaces in close apposition. This compression is in contrast with the unsecured right facet joint 1492.
A second facet reinforcement device 1400, a second fastener member 1480 with or without a second implant may be implanted in the right facet joint 1492, according to the method described above with respect to the left facet joint 1490. The implantation of a second facet reinforcement device 1400 and a second fastener may improve stabilization. A second facet reinforcement device 1400 and a second fastener member 1480 with or without a second implant may be implanted on other levels of the spine. A plurality of reinforcement devices 1400 and a plurality of fastener members 1480 with or without a plurality of implants may be implanted on other levels of the spine, and at various locations on the spine. In some embodiments, the same and/or similar method of fixation, the same fastener members 1480, the same implants and/or the same facet reinforcement devices 1400 may be used at different locations. In other embodiments, a different method of fixation, different fastener members 1480, different implants and/or different facet reinforcement devices 1400 may be used at different locations.
FIG. 85 shows another embodiment of a facet reinforcement device 1500. In the illustrated arrangement, the facet reinforcement device 1500 has an inferior end 1502 and a superior end 1504. The facet reinforcement device 1500 has a first securing portion 1530 toward the inferior end 1502 and a second securing portion 1540 toward the superior end 1504. The first securing portion 1530 and second securing portion 1540 can be connected to each other by a central portion 1510.
The first securing portion 1530 can be configured for placement on an outer facet surface of a facet. The first securing portion 1530 can include a lumen 1506 surrounded by a luminal surface 1511. The lumen 1506 and the luminal surface 1511 can be substantially circular (cylindrical) as shown in the illustrated embodiment. The lumen 1506 can have other cross-sectional shapes including, but not limited to, circular (cylindrical), hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The lumen 1506 and the luminal surface 1511 can be shaped based on a shape of a fastener member 1580 (e.g., having a shape complimentary or similar to the outer shape of the portion of the fastener member 1580 extending there-through). The lumen 1506 and the luminal surface 1511 may conform to the shape of an insertion tool. The lumen 1506 and the luminal surface 1511 can include a substantially smooth inner surface to allow the fastener member 1580 to easily pass through. In other embodiments, the lumen 1506 and the luminal surface 1511 can include a threaded surface to allow the fastener member to thread into the lumen 1506.
The first securing portion 1530 can include one (as illustrated), two, three or a plurality of lumens 1506. The one or more lumens 1506 can have the same shape or different shape. The first securing portion 1530 may include one row of lumen 1506, for example, the lumens 1506 can be aligned along an axis. In other arrangements, the first securing portion 1530 may include multiple rows of lumens 1506. The first securing portion 1530 may include lumens 1506 arranged in a random order or orientation. As will be described below, the one or more lumens 1506 can be configured to accept one or more fastener members 1580 and/or one or more fasteners 1590.
The second securing portion 1540 can be configured for placement on a vertebral structure. The vertebral structure can be remote or distanced from the outer facet surface of a facet. For example, in one arrangement, the second securing portion 1540 can be configured for placement on an outer surface or base of the spinous process 1570; a translaminar position, and/or for placement on an outer surface of the lamina (e.g., base of spinous process).
The second securing portion 1540 can include a lumen 1508 surrounded by a luminal surface 1521. The lumen 1508 and the luminal surface 1521 can be circular (cylindrical). The lumen 1508 can have other cross-sectional shapes including, but not limited to, hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The lumen 1508 can be shaped based on a shape of the fastener member 1580 and/or the fastener 1590. The lumen 1508 and the luminal surface 1521 may be circular, hexagonal, rectangular (cuboid), square, elliptical, and/or have a combination of curved, flat surfaces and/or partial shapes. The lumen 1508 and the luminal surface 1521 may conform to the shape of an insertion tool. The lumen 1508 and the luminal surface 1521 can include a substantially smooth surface to allow the fastener member 1580 and/or the fastener 1590 to easily pass through, or the lumen 1508 can include a threaded surface to allow the fastener member 1580 and/or the fastener 1590 to thread into the lumen 1508.
The second securing portion 1540 can include one, two (as illustrated), three or a plurality of lumens 1508. Additional lumens 1508 may increase fixation security and reduce torsional forces.
The one or more lumens 1508 can have the same shape or different shape. The two lumens 1508 depicted in FIG. 85 have substantially the same shape. The second securing portion 1540 may include one row of lumens 1508, for example, the lumens 1508 can be aligned along an axis. The row of lumens 1508 may be aligned along a longitudinal axis of the second securing portion 1540. The second securing portion 1540 may include multiple rows of lumens 1508. The second securing portion 1540 may include lumens 1508 arranged in a random order or orientation. The one or more lumens 1508 can be configured to accept one or more fastener members 1580 and/or one or more fasteners 1590. The one or more lumens 1508 can be oriented in order to facilitate placement of the fastener members 1580 and/or the fasteners 1590. The fastener 1590 may be placed in a translaminar position. The fastener 1590 may be placed in the spinous process, or the base of the spinous process. The fastener 1590 may be placed across the spinous process of a vertebra.
At least one surface of the facet reinforcement device 1500 may have a feature to mechanically interfit with an insertion tool (not shown), including grooves and/or protrusions configured to mate with a corresponding groove and/or protrusion of the insertion tool. At least one surface of the facet reinforcement device 1500 can have a feature (e.g., a recess or groove) to mechanically interfit with the fastener member 1580 and/or fastener 1590. The feature to mechanically interfit with the fastener member 1580 and/or fastener 1590 member may increase stability of the system and resistance to migration of components of the system.
The diameter of the first securing portion 1530 may be in the range of 2 mm-20 mm or the diameter may be in the range of 4 mm-15 mm. The diameter of the lumen 1506 may be in the range of 0.5 mm-10 mm or in the range of 1-7 mm. The diameter of the lumen 1508 may be in the range of 0.5 mm-10 mm or 1-7 mm.
In some embodiments, at least a portion of one surface of the facet reinforcement device 1500 has a roughened surface and/or a porous surface, as described above with respect to FIG. 82. The roughened surface can comprise at least one projection 1516. In one embodiment, the projection 1516 can comprise at least one spike, barb, wedge, or hook projecting from one surface of the facet reinforcement device 1500. The first securing portion 1530, the second securing portion 1540, the central portion 1510, and/or any combination of these portions may include a roughened surface and/or a porous surface. In some embodiment, an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate, or other adhesive known in the art, is used to bond one surface of the facet reinforcement device 1500 to a bone or tissue surface. In some embodiments, at least a portion of one surface of the facet reinforcement device 1500 may be curved or malleable. The portion of one surface of the facet reinforcement device 1500 may be shaped to conform to a shape of an anatomic structure, such as a facet or spinous process.
As shown the first securing portion 1530 and the second securing portion 1540 may lie on different planes as shown in FIG. 85. The first securing portion 1530 can lie on a plane P1, as shown in FIG. 85. The first securing portion 1530 can include the lumen 1506. The lumen 1506 has a central, longitudinal axis, Axis 1, extending through the lumen 1506. The plane P1 can lie perpendicular to the Axis 1 of the lumen 1506 of the first securing portion 1530. The plane P1 can lie adjacent to a distal surface 1531 of the first securing portion 1530. The plane P1 can lie adjacent to a surface of the first securing portion 1530 configured to engage a bone or tissue.
The second securing portion 1540 can lie on a plane P2. The second securing portion 1540 can include at least one lumen 1508. The lumen 1508 has a central, longitudinal axis, Axis 2, extending through the lumen 1508. The plane P2 can lie parallel to the Axis 2 of the lumen 1508 of the second securing portion 1540. The plane P2 can lie adjacent to a distal surface 1541 of the second securing portion 1540. The plane P2 can lie adjacent to a surface of the second securing portion 1540 configured to engage a bone or tissue.
The plane P1 may be angled relative to the plane P2 to form an angle A (see FIG. 85) between the plane P1 and the plane P2. The angle A may be between 30-150 degrees. The angle A may be 60-105 degrees in one arrangement. The Axis 1 and the Axis 2 may not be parallel in such arrangements. In one embodiment, the Axis 1 and the Axis 2 may be perpendicular. In other embodiments, the Axis 1 may be angled relative to the Axis 2.
In certain arrangements, the first securing portion 1530 may be offset in multiple dimensions from the second securing portion 1540. The first securing portion 1530 may be offset along a longitudinal axis of the facet replacement device 1500 from the second securing portion 1540. The longitudinal axis of the first securing portion 1530 may be offset, angled, or otherwise not aligned with the longitudinal axis of the second securing portion 1540.
For example, as illustrated in FIG. 86, the second securing portion 1540 may lie medial and/or posterior to the first securing portion 1530. The second securing portion 1540 may lie superior to the first securing portion 1530. Proximal or posterior, as referred to here, refers to the part of the vertebra or the facet reinforcement device that is configured to be implanted in a vertebra toward the tip of the spinous process. Distal and anterior refer to the part of the vertebra or the facet reinforcement device that is configured to be implanted in a vertebra toward the vertebral body. Medial refers to toward the midline (center of spinous process), lateral refers to a direction away from the midline (toward the tip of the transverse processes). Superior refers to a direction toward the head, or to a part of the facet reinforcement device that configured to face toward the head on placement, and inferior to a structure or part of the facet reinforcement device which faces or is positioned toward the feet. The central portion 1510 may be bent and/or twisted to provide the offset and/or angulation of the first securing portion 1530 relative to the second securing portion 1540.
FIGS. 86-87 show perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using the facet reinforcement device 1500. The method may include using an implant deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra.
In one method of use, a drill or other device can be used to form a lumen in superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1. A portion of the surface of the facet of SAP2A and a portion of the surface of the facet of IAP1A can be prepared for fusion. Specifically, a portion of the surface of the facet can be ground, scored, roughened, sanded, etc., such that the surface of the facet can better adhere to any substances to aid in fusion and/or otherwise fuse more readily to the implant if used.
FIG. 86 illustrates the facet reinforcement device 1500 placed on an outer surface of the superior vertebra V1. The first securing portion 1530 is placed on outer, posterior facing surface of the left inferior articular process IAP1A of the superior vertebra V1. The second securing portion 1540 is placed on outer surface of the spinous process, near the base of the spinous process of V1.
In one method of use, a lumen is formed in the articular process. The facet reinforcement device 1500 can be placed after a lumen is formed in the articular process. The facet reinforcement device 1500 can be placed prior to forming a lumen in the articular process. In this method, the facet reinforcement device 1500 may serve as a guide for drilling the lumen. The facet reinforcement device 1500 can be placed after preparation for fusion. The facet reinforcement device 1500 can be placed before preparation for fusion. An insertion tool may remain on the facet reinforcement device 1500 during the steps of forming the lumen and/or during the step of preparing for fusion.
As shown in FIG. 87, a facet reinforcement device 1500 and a fastener member 1580 can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP of vertebra V1 and the superior articular process SAP2A of vertebra V2. In some embodiments, at least one implant is used with the fastener member 1580 to fuse a vertebra V1 and vertebra V2. FIG. 87 depicts fusing the inferior articular process IAP1A of vertebra V1 and the superior articular process SAP2A of vertebra V2. However, the inferior articular process IAP1B of vertebra V1 can be fused to the superior articular process SAP2B of vertebra V2.
The fastener member 1580 can be secured. Securing the fastener member 1580 can be based on the type of fastener member used. By way of example, securing a fastener member 1580 having the characteristics of the fastener member depicted in FIGS. 49-51, can include the following steps: inserting the proximal end portion of the fastener member 1580 into a fastening mechanism 1584; the fastener mechanism located at a distal end portion of the fastener member 1580; securing an end of the fastener member 1580 to the opposite end of the fastener member 1580; securing the proximal end portion of the fastener member 1580 to the distal end portion of the fastener member 1580; and/or advancing the proximal end portion of the fastener member 1580 through the fastening mechanism 1584. In other embodiments, fastener member 1580 can be secured by tying a first portion the fastener member to a second portion of the fastener member, by forming a knot in a first end and second end; by screwing the fastener member into a threaded central lumen, by threading a fastener onto a threaded end of a fastener member disposed through a threaded central lumen, by includ at the end of the fastener member, and/or combinations of above. The fastener member 1580 can be secured in order to retain the facet reinforcement device 1500. The facet reinforcement device 1500 is retained within a loop or other defined segment of the fastener member 1580. The reinforcement device 1500 can remain freely movable along a portion of the defined segment after the fastener member 1580 is secured. In some embodiments, the reinforcement device 1500 is immobile or otherwise secured along a portion of the defined segment after the fastener member 1580 is secured. The fastener member 1580 can be secured in order to retain the first securing portion 1530.
A lumen is formed in the spinous process. The facet reinforcement device 1500 can be placed after a lumen is formed in the spinous process. The facet reinforcement device 1500 can be placed prior to forming a lumen in the spinous process. In this method, the facet reinforcement device 1500 may serve as a guide for drilling the lumen. The second securing portion 1540 can be secured to V1 using fastener member 1580 and/or other fastener 1590. The fastener 1590 may be a screw, a bolt, a dual headed screw, a pedicle screw, a transpedicular screw, a post, a plug, a tether, artificial ligament, a rod or any other device of securing a plate to bone, which would be known to one skilled in the art. The fasteners 1590 may pass translaminally or through the base of the spinous process 1570. In some embodiments, the fastener 1590 is threaded and the lumen 1508 is threaded. The corresponding threading between lumen 1508 and fastener 1590 may facilitate the securing and/or locking of the fastener 1590 to the facet reinforcement device 1500. FIG. 86 depicts two lumens 1508 in the second securing portion 1540. The fasteners 1590 associated with the lumens 1508 may be the same or different, or a combination of similar and different fasteners for three or more lumens 1508.
FIG. 87 illustrates the assembled system, including the facet reinforcement device 1500 and the fastener member 1580. The assembled system is implanted on the left facet joint between a superior vertebra V1 and an inferior vertebra V2. The left facet joint may be compressed by the assembled system, thereby bringing the two facet surfaces in close apposition. This compression is in contrasts with the unsecured right facet joint.
FIG. 88 shows an embodiment of a facet reinforcement device 1600. The facet reinforcement device 1600 has similar features to the facet reinforcement device 1500, described herein. The facet reinforcement device 1600 includes a first securing portion 1630 toward an inferior end 1602 and a second securing portion 1640 toward a superior end 1604. A central portion 1610 connects the first securing portion 1630 and the second securing portion 1640. The first securing portion 1630 can include at least one lumen 1606 surrounded by a luminal surface 1611. The first securing portion 1630 can be configured for placement on an outer facet surface of a facet. In some embodiments, at least a portion of one surface of the facet reinforcement device 1600 has a roughened surface and/or a porous surface, which may include at least one projection 1616.
The second securing portion 1640 can be configured for placement on a vertebral structure. The vertebral structure can be remote from the outer facet surface of a facet. The second securing portion 1640 can be configured for placement on an outer surface of the spinous process 1670.
The second securing portion 1640 can include at least one lumen 1608 surrounded by a luminal surface 1621. The second securing portion 1640 can include two lumens 1608. The two lumens 1608 may be in a different configuration than lumens 1508, shown in FIG. 85. For example, the two lumens 1608 are oriented vertically along the spinous process in the second securing portion 1640. The two lumens 1508 are oriented horizontally along the base of the spinous process in the second securing portion 1540. The orientation of the two lumens 1608 of the facet reinforcement device 1600 is generally perpendicular to the lumens 1508 of the facet reinforcement device 1500. The orientation shown in FIG. 89 may be advantageous in countering forces on the facet reinforcement device 1600. The orientation shown in FIG. 89 may permit increased visualization of posterior vertebral structures such as the V1 lamina. The orientation of the lumens 1608 permits placement of fasteners 1690A across the spinous process 1670.
The first securing portion 1630 and the second securing portion 1640 may lie on different planes. The first securing portion 1630 lies on a plane P3, as shown in FIG. 88. The lumen 1606 has a central, longitudinal axis, Axis 1, extending through the lumen 1606. The plane P3 lies perpendicular to the Axis 1 of the lumen 1606 of the first securing portion 1630. The plane P3 can lie adjacent to a distal surface 1631 of the first securing portion 1630.
The second securing portion 1640 lies on a plane P4. The second securing portion 1640 can include at least one lumen 1608. The lumen 1608 has a central, longitudinal axis, Axis 2, extending through the lumen 1608. The plane P4 lies parallel to the Axis 2 of the lumen 1608 of the second securing portion 1640. The plane P4 can lie adjacent to a distal surface 1641 of the second securing portion 1640. The plane P3 may be angled relative to the plane P4. An angle A may be formed between the plane P3 and the plane P4. The angle A may be between 30-150 degrees. The angle A may be 60-105 degrees. The first securing portion 1630 may be offset in multiple dimensions from the second securing portion 1640.
FIGS. 89-91 show perspective views of a portion of the vertebral column during a method for fusing adjacent vertebrae using a facet reinforcement device 1600 and a facet reinforcement device 1600A. The implantation of the facet reinforcement devices 1600, 1600A can be substantially similar to the implantation of the facet reinforcement device 1500.
FIG. 90 illustrates the facet reinforcement devices 1600 and 1600A placed on an outer surface of the superior vertebra V1. A first securing portion 1630 is placed on outer, posterior facing surface of the left inferior articular process IAP1A of the superior vertebra V1. A second securing portion 1640 is placed on outer surface of the spinous process 1670. A first securing portion 1630A is placed on outer, posterior facing surface of the right inferior articular process IAP1B of the superior vertebra V1. A second securing portion 1640A is placed on outer surface of the spinous process 1670.
The second securing portion 1640 can include two lumens 1608. The two lumens 1608 are oriented vertically along the spinous process in the second securing portion 1640. The second securing portion 1640A can include two lumens 1608A. The two lumens 1608A are oriented vertically along the spinous process in the second securing portion 1640A. The orientation of the lumens 1608, 1608A permits placement of fasteners 1690A across the spinous process 1670.
A lumen can be formed in superior articular process SAP2A of vertebra V2 and inferior articular process IAP1A of vertebra V1. A lumen can be formed in superior articular process SAP2B of vertebra V2 and inferior articular process IAP1B of vertebra V1. A fastener member 1680 and a fastener member 1680A can be inserted in a manner as described above. The proximal end portion of a fastener member 1680 can be inserted into the lumen 1606 of the first securing portion 1630, the lumen of inferior articular process IAP1A of vertebra V1, and the lumen of superior articular process SAP2A of vertebra V2. The proximal end portion of a fastener member 1680A can be inserted into a lumen in the first securing portion 1630A, the lumen of inferior articular process IAP1B of vertebra V1, and the lumen of superior articular process SAP2B of vertebra V2. An implant can be inserted between the superior articular process and the inferior articular process.
The fastener members 1680, 1680A can have the characteristics of the fastener member 1580 and can be secured in a similar manner to securing fastener member 1580. The proximal end portion of the fastener member 1680, 1680A can be inserted into a fastening mechanism 1684, 1684A. The fastener mechanism 1684, 1684A can be located at a distal end portion of the fastener member 1680, 1680A. As shown in FIG. 90, the facet reinforcement device 1600 and the fastener member 1680 can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP1A of vertebra V1 and the superior articular process SAP2A of vertebra V2. The facet reinforcement device 1600A and a fastener member 1680A can be used to fuse a vertebra V1 and vertebra V2 via the inferior articular process IAP1B of vertebra V1 and the superior articular process SAP2B of vertebra V2. The facet reinforcement device 1600 can be substantially similar to the facet reinforcement device 1600A. The facet reinforcement device 1600 can be a mirror image of the facet reinforcement device 1600A.
A lumen is formed in the spinous process 1670. The second securing portions 1640, 1640A can be secured to V1 using the fastener members 1680, the fastener 1690, and/or the fastener 1690A. The fastener members 1680 and the fastener 1690 can be inserted in a manner as describe above with respect to fastener members 1580 and the fastener 1590. The fastener 1690 may be a screw, a bolt, a dual headed screw, a pedicle screw, a transpedicular screw, a post, a plug, a tether, artificial ligament, a rod or any other means of securing a plate to bone, which would be known to one skilled in the art. In some embodiments, the fastener 1690 is threaded and the lumen 1608 is threaded. The corresponding threading between the lumen 1608 and the fastener 1690 may facilitate the securing and/or locking of the fastener 1690 to the facet reinforcement device 1600. FIG. 89 depicts two lumens 1608 in the second securing portion 1640. The fasteners 1690 associated with the lumens 1608 may be the same or different, or a combination of similar and different fasteners for three or more lumens 1608.
The fastener 1690A may pass translaminally or through the spinous process 1670. The fastener 1690A is located between the lumen 1608 and the lumen 1608A. The fastener 1690A is located between the second securing portion 1640 and the second securing portion 1640A. Referring to FIGS. 90 and 91, the fastener 1690A is illustrated with head 1694, shaft 1696, and nut 1692. The shaft 1696 may be threaded or smooth. The fastener 1690A can take the form of a screw, a bolt, a dual headed screw, a pedicle screw, a transpedicular screw, a post, a plug, a tether, artificial ligament, a rod or any other form known in the art. Additional security may be provided by securing the two facet reinforcement devices 1600, 1600A together through the spinous process.
FIGS. 89-91 illustrate the assembled system, including the facet reinforcement device 1600 and 1600A. FIG. 91 illustrates the system, viewed from superior to V1. The fasteners 1690A may be seen passing through lumen 1608 in facet reinforcement device 1600, through spinous process 1670 and through lumen 1608A in facet reinforcement device 1600A in FIG. 90.
The assembled system is implanted on the left facet joint and the right facet joint between a superior vertebra V1 and an inferior vertebra V2. The facet joints may be compressed by the assembled system, thereby bringing the two facet surfaces in close apposition. The implantation of the second facet reinforcement device 1600A and the second fastener member 1680A may improve stabilization.
The facet reinforcement device 1400, 1500, 1600, 1600A and fasteners 1580, 1590, 1680, 1690, 1690A may be made of any of a variety of materials known in the art, including but not limited to a polymer such as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene, fluoropolymer, hydrogel, or elastomer; a ceramic such as zirconia, alumina, or silicon nitride; a metal such as titanium, titanium alloy, cobalt chromium or stainless steel; or any combination of the above materials. The facet reinforcement device 1400, 1500, 1600, 1600A may be made of multiple materials in combination. For example, the ablumenal surface 1404 can comprise a polymer, such as PEEK or polyethylene, and the luminal surface 1410 can comprise a metal or ceramic. For example, the proximal surface 1402 can comprise a polymer and the distal surface 1406 and/or the projections 1416 can comprise a metal or ceramic. The material of the facet reinforcement device 1400 can be the same as the material of the fastener member and/or the implant. The material of the facet reinforcement device 1400 can be different from the material of the fastener member and/or the implant.
Kits may be provided to facilitate spine fixation procedures. Kits may include one or more facet reinforcement devices, such as any of those described herein. Different sizes and configurations of facet reinforcement devices may be provided in a single kit. Different kits may be available that have different sizes and configurations of facet reinforcement devices. Kits may include one or more fastener members, such as any of those described herein. The kits may include one or more fasteners, such as any of those described herein. These fasteners may be screws, bolts and nuts, tethers, plugs, posts or other configurations of fastener that would be known to one of skill in the art. Kits may include one or more facet implants, such as any of those described herein.
Kits may include drills or drill bits for creating lumens in the articular processes of a facet joint. The kits may include drills or drill bits for creating lumens in the spinous process. Kits may include drills or drill bits for creating a fastener lumen in bone. The kits may include tools for preparing the facet joint surface. Kits may include one or more tools for implantation.
Methods of use may include any of the following steps. Method steps may include: using an implant deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra; forming a lumen in a superior articular process of a vertebra; forming a lumen in a inferior articular process of a vertebra; forming a lumen in a second superior articular process of a vertebra; forming a lumen in a second inferior articular process of a vertebra; and/or preparing the surface of the facet for fusion.
Method steps may include: placing a facet reinforcement device on an outer surface of the superior vertebra; placing the first securing portion on the inferior articular process; and/or placing second securing portion on outer surface of the spinous process.
Method steps may include: fusing the vertebra with a fastener member; positioning the fastener member in a first securing portion; inserting the fastener member into a lumen of a first securing portion; inserting the fastener member into the lumen of an inferior articular process of a vertebra; advancing the fastener member; and/or inserting the fastener member into the lumen of a superior articular process of a vertebra.
Method steps may include: securing the fastener member; inserting an end of the fastener member into a fastening mechanism; advancing the fastener member through the fastening mechanism; retaining the facet reinforcement device; and/or retaining the first securing portion.
Method steps may include: forming a lumen in the spinous process; positioning a fastener member in a second securing portion; positioning a fastener in a second securing portion; positioning a fastener in a second securing portion that passes tranlaminally; and/or positioning a fastener between the second securing portion of a first facet reinforcement device and the second securing portion of a second facet reinforcement device.
Method steps may include: preparing a facet joint; positioning a facet reinforcement device, placing a fastener member through a facet reinforcement device; placing a fastener member through a first articular process of a facet joint; placing a fastener member through a second articular process of the facet joint; and/or securing the fastener member over the facet reinforcement device. The positioning of the facet reinforcement device may be performed prior to preparing the facet joint or after preparing the facet joint. The step of preparing the facet joint may involve drilling a lumen through both articular processes of the facet joint. The step of preparing the facet joint may involve roughening up, drilling, burring, or otherwise preparing the articular surfaces of the facet joint.
The method may include passing the fastener member through an aperture in an implant. The method may include any of the following steps from the following order: placing a fastener member through the facet reinforcement device; then placing the fastener member through a first articular process of a facet joint; then placing the fastener member through an implant; then placing the fastener member through a second articular process of the facet joint.
The method may include securing the fastener member. The method may include passing an end of the fastener member through a fastening mechanism; inserting the proximal end portion of the fastener member 1480 into a fastening mechanism 1484; the fastener mechanism located at a distal end portion of the fastener member 1480; securing an end of the fastener member 1480 to the opposite end of the fastener member 1480; securing the proximal end portion of the fastener member 1480 to the distal end portion of the fastener member 1480; and/or advancing the proximal end portion of the fastener member 1480 through the fastening mechanism 1484. The method may include tying a first portion the fastener member to a second portion of the fastener member; forming a knot in a first end and second end; screwing the fastener member into a threaded central lumen; threading a fastener onto a threaded end of a fastener member disposed through a threaded central lumen; and/or including enlarged portions at the end of the fastener member. The method may include using the fastener member to secure the facet reinforcement device; and/or using the fastener member to secure the facet first securing portion.
The method may include securing the fastener. The method may include passing an end of the fastener through the second securing portion; passing an end of the fastener through the second securing portion of a first facet reinforcement device; and/or passing an end of the fastener through the second securing portion of a second facet reinforcement device. The step of positioning the facet reinforcement device may be followed by the step of using a fastener. The method may include using a fastener to secure the facet reinforcement device to a vertebral structure. This vertebral structure may be a spinous process, the base of a spinous process, or other posterior structure. The step of using a fastener may include placing one or more fasteners.
The method may include repeating steps to place a second facet reinforcement device at the contralateral facet joint. The method may include repeating steps to place a second facet reinforcement device at another facet joint. The method may include repeating steps to place a second facet reinforcement device at another vertebral level. The method may include using a fastener to secure the facet reinforcement device to a vertebral structure. The method may include by placing one or more fasteners through a lumen in the first facet reinforcement device and through a lumen in the second facet reinforcement device. The fastener may be placed through a vertebral structure. The fastener may be placed through a spinous process. The fastener may be secured with a nut or other securing element. The fastener may be threaded into a lumen in the first facet reinforcement device and/or a lumen in the second facet reinforcement device.
In the above embodiments, it should be understood that fastener member similar to any of those described above, for example, at 72, 280, 380, 480, 580, 680, 780, and 880, may be used with any of the embodiments of the facet reinforcement device described herein. Furthermore, the facet reinforcement devices may be used with various of the facet implants described herein, such as those with a wire or cable retaining device. Though the facet reinforcement devices are primarily described in relation to reinforcing the inferior articular process, it is to be understood that embodiments may also be used to reinforce the superior articular process. For example, for use on a surface of a superior facet, embodiments of a facet reinforcement device similar to 1500 may be shaped and sized such that the second securing portion 1540 meets the vertebra. The facet reinforcement device 1500 could permit placement of one or more fasteners 1590 through, for example, the pedicle or into the vertebral body.
Similarly, through the illustrations of the facet reinforcement device show the facet reinforcement device applied to lumbar vertebrae, it will be understood that multiple sizes and shapes may be provided adapted for placement on facet surfaces in the cervical or thoracic region.
The terms “generally” “approximately”, “about”, and “substantially” as used herein represent an amount or characteristic close to the stated amount or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “generally” “about”, and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount or characteristic.
The term “up to about” as used herein has its ordinary meaning as known to those skilled in the art and may include 0 wt. %, minimum or trace wt. %, the given wt. %, and all wt. % in between.
1. A device for reinforcing a facet joint, comprising:
a proximal surface, a distal surface, and a first side surface and a second side surface, the first side surface and the second side surface extending between the proximal surface and the distal surface,
a first securing segment comprising a first lumen extending from the proximal surface to the distal surface, the first lumen adapted for receiving a first fastener member;
a second securing segment comprising a second lumen extending from the first side surface to the second side surface, the second lumen adapted for receiving a second fastener member; and
a central portion between the first securing segment and the second securing segment.
2. The device of claim 1, wherein a longitudinal axis of the first securing segment is disposed at an angle relative to a longitudinal axis of the second securing segment.
3. The device of claim 1, wherein a plane of the first securing segment is not parallel to a plane of the second securing segment.
4. The device of claim 1, wherein the second securing segment comprises at least two lumens.
5. The device of claim 1, further comprising the first fastener member.
6. The device of claim 1, wherein at least one surface of the device comprises a groove to mechanically interfit with the first fastener member.
7. The device of claim 1, wherein at least one surface of the device comprises a feature to mechanically interfit with an insertion tool.
8. The device of claim 1, wherein the first securing segment is configured for placement on an outer facet surface of a facet and the second securing segment is configured for placement on a vertebral structure, remote from the outer facet surface of the facet.
9. The device of claim 1, wherein at least a portion of one surface of the device is malleable.
10. The device of claim 1, wherein at least a portion of one surface of the device is roughened.
11. The device of claim 1, wherein the device is made of multiple materials in combination.
12. The device of claim 1, wherein the central portion comprises a bend.
13. A facet reinforcement device, comprising:
an inferior end and a superior end;
a first securing portion toward the inferior end and a second securing portion toward the superior end, the first securing portion and the second securing portion connected to each other by a central portion, wherein the first securing portion and the second securing portion lie on different planes; and
the first securing portion comprising a first lumen and the second securing portion comprising a second lumen, wherein a first fastener inserted into the first lumen extends transverse to a proximal surface of the inferior end, wherein a second fastener inserted into the second lumen extends transverse to a side surface of the superior end.
14. The device of claim 13, wherein the angle between the different planes is between 30 and 150 degrees.
15. The device of claim 13, wherein the angle between the different planes is between 60 and 105 degrees.
16. The device of claim 13, wherein the first lumen comprises a first longitudinal axis and the second lumen comprises a second longitudinal axis, wherein the first longitudinal axis and the second longitudinal axis are perpendicular.
17. The device of claim 13, wherein the first lumen comprises a first longitudinal axis and the second lumen comprises a second longitudinal axis, wherein the first longitudinal axis is angled relative to the second longitudinal axis.
18. A facet reinforcement device, comprising:
a proximal surface and a distal surface;
a first securing portion comprising a first lumen extending between the proximal surface and the distal surface, the first lumen configured to receive a fastener member;
a second securing portion comprising a second lumen; and
a central portion between the first securing portion and the second securing portion, wherein the central portion is twisted to provide an offset or an angulation of the first securing portion relative to the second securing portion, wherein a transverse dimension of the proximal surface is greater at the first securing portion than the second securing portion.
19. The device of claim 18, wherein the first securing portion is offset in multiple dimensions from the second securing portion.
20. The device of claim 18, wherein a longitudinal axis of the first lumen and a longitudinal axis of the second lumen are angled.
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Patent number: 10624680
Patent Publication Number: 20180085148
Assignee: Spinal Elements, Inc. (Carlsbad, CA)
Inventors: Jason Blain (Encinitas, CA), Christopher Newton (San Diego, CA), Gregory Martin (Encinitas, CA)
Application Number: 15/804,112
Current U.S. Class: Facet Implant (606/247)
International Classification: A61B 17/70 (20060101); A61B 17/82 (20060101);