Source: https://patents.google.com/patent/WO2006133315A2
Timestamp: 2018-02-25 21:56:43
Document Index: 262426576

Matched Legal Cases: ['art 28', 'arts 28', 'art 28', 'arts 28', 'art 28', 'arts 28']

WO2006133315A2 - Pseudo arthrosis device - Google Patents
WO2006133315A2
WO2006133315A2 PCT/US2006/022178 US2006022178W WO2006133315A2 WO 2006133315 A2 WO2006133315 A2 WO 2006133315A2 US 2006022178 W US2006022178 W US 2006022178W WO 2006133315 A2 WO2006133315 A2 WO 2006133315A2
PCT/US2006/022178
WO2006133315A3 (en )
A pseudo arthrosis device (20) may be placed in a disc space to provide support for adjacent vertebrae. The device may have an enclosure (22) formed, from a flexible, permeable material. A core may be packed in the enclosure. The core may be compressible and/or flexible. In certain embodiments, the core may include a plurality of elongated members (24). In other embodiments, the core may include ridges or grooves. The enclosure may be placed in an intervertebral space between the adjacent vertebrae such that the core is disposed between the adjacent vertebrae. The pseudo arthrosis device may include a tab (28) designed to couple the enclosure to an adjacent vertebrae.
Surgical alternatives to spinal fusion may include spinal disc replacement. U.S. Patent Nos. 3,567,728 to Stubstad et al.; 5,071,437 to Steffee; 5,320,644 to Baumgaitner; 5,522,899 to Michelson; 5,961,554 to Janson et al.; 5,976,186 to Bao et al.; 6,162,252 to Kuras et al.; 6,206,924 to Timm; 6,214,049 to Gayer et al; and 6,093,205 to McLeod et al., each of which is incorporated by reference as if folly set forth herein, describe devices for surgical treatment of deteriorated and/or damaged spinal discs.
Figure 5 is aback view of a pseudo arthrosis device.
Figure 10 depicts a pseudo arthrosis device positioned for insertion into a disc space.
Figure 12 depicts a pseudo arthrosis device positioned in a disc space. Figure 13 depicts a portion of a spine showing compression of an implanted pseudo arthrosis device when a patient bends backwards.
Figure 20 is a perspective view of a pseudo arthrosis device with an enclosure containing a core.
Figure 21 is a side view of a pseudo arthrosis device.
Figure 22 is a perspective view of a pseudo arthrosis device that includes a tab and a core.
Figure 23 is a perspective view of a pseudo arthrosis device with openings fitted with grommets. Figures 24A-24H are perspective views of cores for use in pseudo arthrosis devices.
Figures 25-26 show pseudo arthrosis devices positioned in a patient's spine.
Figures 27-28 show a plurality of pseudo arthrosis devices in a multi-level implant application.
Figure 29 is a perspective view of an artificial anterior longitudinal ligament.
Figure 30 is a side view of an artificial anterior longitudinal ligament.
Figure 31 is an artificial anterior longitudinal ligament positioned in a patient's body.
Figure 32 shows a plurality of artificial anterior longitudinal ligaments in a multi-level implant application.
Figure 33 is a perspective view of an alternative embodiment of an artificial anterior longitudinal ligament.
Figure 34 shows the artificial anterior longitudinal ligament of Figure 33 positioned in a patient's body.
Figure 35 shows a plurality of the artificial anterior longitudinal ligaments of Figure 33 in a multi-level implant application.
Figure 36 shows an alternative application of the artificial anterior longitudinal ligament of Figure 33. Figure 37 shows an alternative application of the artificial anterior longitudinal ligament of Figure 33 in a multi-level implant.
Figure 1 depicts pseudo arthrosis device 20 with enclosure 22. Enclosure 22 may be formed from a non-allergenic, biocompatible material. The material may be flexible and/or permeable. The material may include, but is not limited to, synthetic fabrics such as
Dacron®, Proline Mesh®, and Goretex®. Enclosure 22 may have a cross-sectional shape corresponding to a cross-sectional shape of an intervertebral space between two adjacent vertebrae in a human spine. Enclosure 22 may be in the form of a tube, a sleeve, an envelope, or other suitable configuration.
Longitudinal placement of elongated members 24 in enclosure 22 may allow pseudo arthrosis device 20 to function as a compressible, flexible body. Since the compressibility and flexibility arise from a plurality of elongated members 24, pseudo arthrosis device 20 may provide greater local adaptation to stress between vertebrae than a single deforrnable piece of material. Flexibility of elongated members 24 and enclosure 22 may allow movement in non- longitudinal directions (e.g., bending and rotation) relative to axes of elongated members 24.
As shown in Figure 1, pseudo arthrosis device 20 may include at least one tab 28. Tab
28 may be of any suitable size, shape, or configuration to couple pseudo arthrosis device 20 to a vertebra. In some embodiments, tab 28 may be an integral part of pseudo arthrosis device 20. In other embodiments, tab 28 may be coupled to enclosure 22. In some embodiments, tab 28 may extend substantially perpendicularly upward from enclosure 22. In other embodiments, tab 28 may extend substantially perpendicularly downward from enclosure 22. In certain embodiments, tab 28 may extend substantially perpendicularly upward and downward from enclosure 22. Alternatively, a first tab 28 may extend substantially perpendicularly upward from enclosure 22 and a second tab 28 may extend substantially perpendicularly downward from enclosure 22. In certain embodiments, enclosure 22 and tab 28 may be made of substantially the same material. Tab 28 may include at least one opening 30. Opening 30 may be reinforced with a grommet. A grommet used to reinforce opening 30 may be made of titanium or any other durable biocompatible material. In an embodiment, pseudo arthrosis device 20 may be secured to a vertebra by a connector or fastener inserted through opening 30. In certain embodiments, a connector may be a threaded screw. Alternatively, tab 28 may be connected to a vertebra by methods including the use of, but not limited to the use of, sutures, staples, barbs, and/or adhesive.
Figure 4 depicts a side view of pseudo arthrosis device 20 with enclosure 22 and tab
28. Figure 5 depicts a back view of pseudo arthrosis device 20 with enclosure 22, tab 28, and openings 30.
Figure 6 depicts a cross-sectional view of pseudo arthrosis device 20 taken substantially along plane 6-6 of Figure 4. Figure 7 depicts a cross-sectional view of pseudo arthrosis device 20 taken substantially along plane 7-7 of Figure 5. Figures 6 and 7 depict a plurality of elongated members 24 placed longitudinally in enclosure 22 with coupled tab 28. In the embodiment shown in Figure 7, enclosure 22 has top 32 and bottom 34 to promote retention of elongated members 24 in the enclosure. In some embodiments, top 32 and/or bottom 34 may be made of bioabsorbable material (e.g., Surgicel).
In other embodiments, such as the embodiment shown in Figure 20, rather than elongated members 24, a core 60 may be used in device 20. Core 60 is made of viscoelastic material, such as flexible polymers, hydrogels, collagen, and the like. Generally, core 60 may be made of biocompatible materials. Core 60 provides adaptability, compressibility, pliability and/or flexibility as an artificial disc when inserted in the intervertebral space in a spine. Core 60 may have a plurality of elongated members, columns, walls, bore holes, grooves, and/or dimples, as described below in detail.
Figure 21 shows a side view of an illustrative embodiment of a pseudo arthrosis device 20. In this embodiment, enclosure 22 forms a jacket around core 60 (core 60 packed within enclosure 22). Similar to the configuration shown in Figure 7, enclosure 22 has top 32 and bottom 34 to promote retention of core 60 in the enclosure.
Tab 28 and enclosure 22 may generally have the configurations and be made of the same materials described above. In the illustrative embodiment shown in Figure 20, tab 28 has a first portion or tab that extends upward from enclosure 22, and a second portion or tab that extends downward from enclosure 22. Furthermore, tab 28 includes a plurality of openings 30 on each of the portions that extend upward and downward from enclosure 22.
A variety of numbers, shapes, and configurations of openings 30 may be used, as desired. For example, the embodiment shown in Figure 22 includes a substantially round opening 30 in each of the upward and downward portions of tab 28. As another example, the embodiment shown in Figure 23 uses grommets 65 in each of the openings in the tab. As yet another example, openings 30 may have an elongated shape, similar to the shape of a button hole (see Figures 27 and 28 and their corresponding descriptions).
In some embodiments, as shown for example in Figure 22, core 60 is coupled to tab 28 without the use of an enclosure. In other embodiments, tab 28 and enclosure 22 may have a one-piece configuration or, alternatively, may be separate pieces coupled together (for example, sewn together, glued together, stapled together, and the like). Figures 24A-24H show illustrative embodiments of core 60 for use in pseudo arthrosis devices. In the embodiment of Figure 24A, core 60 has a plurality of ridges or grooves 70 on its top and bottom surfaces. Ridges 70 have a lateral direction (side-to-side, when implanted in the patient's body). The embodiment of Figure 24B also includes a plurality of ridges or grooves 70 on its top and bottom surfaces. Ridges 70 in the core in Figure 24B, however, have a front-to-back (anterior-to-posterior, when implanted in the patient's body) direction. In yet another configuration (not shown), the ridges on the top and bottom surfaces of core 60 may have differing directions, a mixture of directions, and/or other directions (e.g., diagonal) as desired.
Core 60 in Figure 24C has a plate 75 that couples to an upper portion 80 and lower portion 82 of core 60. The top surface of core 60 (i.e., the top surface of upper portion 80) has a plurality of grooves 85 formed as co-centric circles. The bottom surface of core 60 may have a similar or different arrangement of grooves. Grooves 85 help to promote ingrowth of tissue into core 60.
Core 60 in Figure 24D has a plurality of grooves 85 on its top surface. The plurality of grooves 85 may be co-centric circles. The bottom surface of core 60 may have a similar or different arrangement of grooves. Similar to the core in Figure 24C, grooves 85 help to promote ingrowth of tissue into core 60.
Note that grooves 85 in Figures 24C and 24D may have other features or configurations, such as one or more spirals, as desired. Furthermore, top and bottom surfaces of core 60 may have different features or configurations of grooves 85, as desired (for example, circles on one surface of core 60, and a spiral on another surface).
The cores in Figures 24E and 24F include a plurality of elongated members 24 arranged within an outer portion or shell 90. Outer portion 90 generally surrounds elongated members 24. Elongated members 24 may be integral to core 60, or may be constructed by using a pliable retaining plate (not shown explicitly), similar to the embodiment of Figure 8. Core 60 in Figure 24E has the additional feature of a plurality of dimples or indentations 95 on the top surface of outer portion 90. Indentations 95 promote ingrowth of tissue and help to stabilize the patient's spine. The bottom surface of outer portion 90 may have a similar or different arrangement of indentations, as desired. Note that indentations 95 may have a variety of shapes (round or annular, triangular, rectangular, etc.), configurations (e.g., depth), and arrangements, as desired.
Core 60 in Figure 24G has a plurality of dimples or indentations 95 arranged on its top surface. Indentations 95 help to promote ingrowth of tissue. The bottom surface of outer portion 90 may have a similar or different arrangement of indentations, as desired.
Indentations 95 may have a variety of shapes (round or annular, triangular, rectangular, etc.), configurations (e.g., depth), and arrangements, as desired.
The core in Figure 24H includes a plate 75 and a plurality of elongated members 24. Elongated members 24 may be integral to core 60, or may be constructed by using a pliable retaining plate (not shown explicitly), similar to the embodiment of Figure 8. Elongated members 24 may have a variety of shapes, configurations, and arrangements, as described above.
Note that a core (or cores in multi-level applications, as described below) configuration may be used that allows certain forces in the spine, while limiting or tending to limit other forces. For example, the cores shown in Figures 24A, 24B, and 24H tend to allow translational movements of the affected vertebrae. The cores shown in Figures 24C-24G, however, tend to limit translational movements and provide a more rigid support to the spine. Furthermore, generally, the number, shape, size, type, and arrangement of the various physical attributes of the cores (e.g., the number of ridges, pores, dimples, elongated members, etc.) may be varied to suit a particular application, as desired.
Figure 10 depicts pseudo arthrosis device 20 with enclosure 22 and tab 28 positioned for insertion into disc space 46 between adjacent vertebrae 44. As shown in Figure 11 , elongated members 24 in enclosure 22 are disposed longitudinally between adjacent vertebrae 44 in disc space 46. In an embodiment, tab 28 may be coupled to adjacent vertebrae 44 with connectors 48. Tab 28 may be sized to secure enclosure 22 to adjacent vertebrae 44 with minimal limitation of vertebral movement. Figure 12 depicts pseudo arthrosis device 20 implanted into spinal column 40. In an embodiment, tab 28 and connectors 48 may secure enclosure 22 of pseudo arthrosis device 20 in disc space 46 between adjacent vertebrae 44.
Figure 17 depicts pseudo arthrosis device 20 after implantation in a disc space between adjacent vertebrae 44. Figure 18 depicts a cross-sectional view of pseudo arthrosis device 20 taken substantially along line 18-18 in Figure 17. As shown in Figure 18, fibers 50 of a patient may penetrate enclosure 22. Fibers 50 that penetrate enclosure 22 may promote fibrous tissue growth in spaces between elongated members 24. Normal movement of the patient and flexibility of pseudo arthrosis device 20 may inhibit conversion of fibrous tissue growth in enclosure 22 into bone. Figure 19 depicts growth of fibers 50 through perforations 26 in elongated member 24. In an embodiment, fibers 50 may grow longitudinally through hollow elongated member 24. Over time, pseudo arthrosis device 20 may be incorporated into scar tissue formed from fibrous ingrowth of a patient. In certain embodiments, pseudo arthrosis device 20 may advantageously function as a scaffold or matrix to promote natural body repair by fibrous ingrowth.
Figures 25-28 show illustrative embodiments of pseudo arthrosis device 20, including core 60, implanted within a spine. Figures 25-26 show implants for a single level, whereas Figures 27-28 illustrate implants for multiple levels.Note that the figures show two-level or three-level applications as illustrative examples, and that the disclosed implants may be used generally in multi-level applications involving different numbers of levels.
Referring to Figure 25, pseudo arthrosis device 20 couples to vertebrae 11OA and HOB. In the embodiment shown, pseudo arthrosis device 20 has openings 30 fitted with grommets 65. A pair of screws 105 fasten the upper and lower parts of tab 28 to vertebrae HOA and 11OB, respectively. In the embodiment shown in Figure 26, screws 105 (or other suitable fastener) fasten the upper and lower parts of tab 28 to vertebrae HOA and HOB, respectively, without the use of grommets.
Figure 27 shows two pseudo arthrosis devices, 2OA and 2OB, in a multi-level implant, involving vertebrae 11 OA-11OC. Note that one of the openings for pseudo arthrosis device 2OA may overlap with one of the openings for pseudo arthrosis device 20. In such a situation, one of the pseudo arthrosis devices may use an opening without a grommet 65, such as opening 3OA of pseudo arthrosis device 2OA. Opening 3OA provides a lower profile for the two overlapping openings of pseudo arthrosis devices 2OA and 20B. Opening 3OA may have a variety of desired shapes, sizes, and arrangements, such as an elongated shape, similar to a button hole. Opening 3OA may also have woven edges to provide additional strength and resist tearing. Figure 28 shows a multi-level implant with three pseudo arthrosis devices 20A-20C coupled to vertebrae 11 OA-11OD. Note that each of pseudo arthrosis devices 2OA and 2OB has an opening (30A and 3OB, respectively) without a grommet. Opening 30A of pseudo arthrosis device 2OA overlaps with the upper opening of pseudo arthrosis device 20, whereas opening 30B of pseudo arthrosis device 20B overlaps with the upper opening of pseudo arthrosis device 20C. Openings 3OA and 30B lack grommets in order to provide a lower profile for the implant.
Another aspect of the invention relates to artificial replacements for anterior longitudinal ligaments (ALLs). An artificial anterior longitudinal ligament may replace and/or reinforce the function of the patient's natural anterior longitudinal ligament. With the introduction of an interbody implant from an anterior approach for fusion devices or motion- preservation devices, the anterior longitudinal ligament is disrupted. The artificial anterior longitudinal ligament restores the tension band in extension in such a situation. Furthermore, when used with an interbody device (e.g., cores 60 described above), the artificial anterior longitudinal ligament prevent expulsion of an interbody device from the spine. The artificial anterior longitudinal ligament may be used for both fusion and non-fusion applications.
The artificial anterior longitudinal ligament is a tension and scaffold band or tab, such as tab 28 of the pseudo arthrosis devices described above, and may be made of similar materials. The band is secured to at least one vertebral body above and below the affected level. It can be used with or without fixation to an interbody device, such as an artificial disc. As an example, tab 28 in the embodiment in Figure 22 may either be used as a standalone artificial anterior longitudinal ligament, or as an artificial anterior longitudinal ligament coupled to core 60, which serves as an interbody device. The implant could be attached with permanent or resorbable screws, anchors, sutures, bioglue, staples, or with other fastening methods, as desired.
Figure 29 shows an embodiment of an artificial anterior longitudinal ligament. The artificial anterior longitudinal ligament includes tab 28, having elasticity, with openings 30 for coupling to the vertebrae, as described above. Openings 30 may have a variety of shapes, configurations, and arrangements, as described above.
Tab 28 may include inter-woven elastic material that provides elasticity to it. The tab can therefore limit extension and provide stability to the patient's spine. Figure 30 shows a side view of an illustrative embodiment of tab 28. Tab 28 may include an inter-woven band 120. Band 120 may be made of any suitable material that provides elasticity to tab 28. Alternatively, tab 28 may be made using elastic materials, or may enclose an elastic band.
Figure 31 shows an artificial anterior longitudinal ligament coupled to a patient's vertebrae. Tab 28 has two openings 30, each aligned with a respective one of vertebrae 11OA and HOB. Screws 105 (or other desired suitable fastener) couples tab 28 to vertebrae HOA, 110B.
Note that, as desired, one may use a plurality of tabs 28 (with the respective openings 30 aligned between neighboring tabs 28) in multi-level applications, as shown, for example, in Figure 32. Using a suitable fastener (such as screws 105 shown as an example), tab 28A couples to vertebrae HOA and 11OB, and tab 28B couples to vertebrae 11OB and 11OC. Tab 28A has two openings 30A and 3OB. Upper opening 3OA couples to vertebrae 11OA, and lower opening 30B couples to vertebrae 11OB. Tab 28B also has two openings, an upper opening (not shown explicitly), and a lower opening 3OC. The upper opening of tab 28B aligns with the lower opening 3OB of tab 28 A and shares a common fastener. Figure 33 shows another embodiment of an artificial anterior longitudinal ligament. In this embodiment, tab 28 has an "inverted Y" configuration, with an upper part 28A and a pair of lower parts 28B. Upper part 28A and each of lower parts 28B has an opening 30. Note that the embodiment shown in Figure 33 may be used as part of a pseudo arthrosis device by coupling an enclosure (including a core) to tab 28, or fabricating the tab integrally to the enclosure, as desired. In this application, the enclosure may include one of the cores 60 described above.
Figure 34 shows the artificial anterior longitudinal ligament of Figure 33 implanted in the patient's body. Upper part 28A of tab 28 couples to one vertebra 11OA via fastener 105A. Lower parts 28B of tab 28 are arranged in a crossed configuration, such that their respective openings 30 align with one another, and couple to vertebra 11OB using fastener 105C.
Figure 35 shows a multi-level application of the artificial anterior longitudinal ligament of Figure 33. In this configuration, tab 28A couples to vertebrae HOA and 11OB using fasteners 105A and 105B, respectively. The lower parts of tab 28A align with the upper part of tab 28 and may use a common fastener. Thus, tab 28B couples to vertebrae HOB and HOC using fasteners 105B and 105C, respectively.
Figures 36 and 37 show further applications of the artificial anterior longitudinal ligament of Figure 33 in single-level and multi-level situations, respectively. Unlike Figures 34 and 35, the lower parts of tabs 28 (single-level application in Figure 36) and tabs 28A and 28B (multi-level application in Figure 37) are not crossed. Thus, the lower parts of the tabs do not share a common fastener.
1. An implant device, comprising: an enclosure comprising a core packed within the enclosure, wherein the core comprises a plurality of elongated members; and at least one tab coupled to the enclosure for attaching the implant device to a vertebra.
6. The device of claim 1 , wherein the enclosure comprises a top and a bottom.
10. An implant device, comprising: an enclosure comprising a core packed within the enclosure, wherein the core comprises at least one groove on a surface of the core; and at least one tab coupled to the enclosure for attaching the implant device to a vertebra.
PCT/US2006/022178 2001-12-28 2006-06-07 Pseudo arthrosis device WO2006133315A3 (en)
US11147526 US20060129242A1 (en) 2001-12-28 2005-06-08 Pseudo arthrosis device
US11/147,526 2005-06-08
WO2006133315A2 true true WO2006133315A2 (en) 2006-12-14
WO2006133315A3 true WO2006133315A3 (en) 2007-04-05
PCT/US2006/022178 WO2006133315A3 (en) 2001-12-28 2006-06-07 Pseudo arthrosis device
WO (1) WO2006133315A3 (en)
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