Source: http://www.google.de/patents/US20030093155?hl=de
Timestamp: 2017-12-13 13:11:41
Document Index: 534027080

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'art 25', 'art 25', 'arts 308', 'arts 308', 'arts 8']

Patent US20030093155 - Deployment devices and methods for vertebral disc augmentation - Google Patentsuche
Apparatus and methods are directed at stabilizing somatic implants. A site within a body is selected that has a first region having a tight and/or changing curvature bordered by a second region or regions having minimal or constant curvature. An apparatus that has a flexible portion and one or more relatively...http://www.google.de/patents/US20030093155?utm_source=gb-gplus-sharePatent US20030093155 - Deployment devices and methods for vertebral disc augmentation
Veröffentlichungsnummer US20030093155 A1
Anmeldenummer US 10/325,320
Auch veröffentlicht unter US6883520, US7094258, US7124761, US7220281, US7513911, US7553330, US7749275, US8002836, US8105384, US20030009227, US20030014117, US20030014118, US20050033440, US20050033441, US20050038519, US20050060038, US20060161162, US20060282167, US20100057143
Veröffentlichungsnummer 10325320, 325320, US 2003/0093155 A1, US 2003/093155 A1, US 20030093155 A1, US 20030093155A1, US 2003093155 A1, US 2003093155A1, US-A1-20030093155, US-A1-2003093155, US2003/0093155A1, US2003/093155A1, US20030093155 A1, US20030093155A1, US2003093155 A1, US2003093155A1
Erfinder Gregory Lambrecht, Robert Moore, Thomas Banks, Russel Redmond, Claude Vidal
Ursprünglich Bevollmächtigter Lambrecht Gregory H., Moore Robert Kevin, Thomas Banks, Redmond Russel J., Vidal Claude A.
Patentzitate (99), Referenziert von (55), Klassifizierungen (99), Juristische Ereignisse (5)
US 20030093155 A1
1. A method of positioning an apparatus along an inner aspect of a posterior anulus fibrosis of an intervertebral disc, comprising the steps of:
advancing an apparatus deployment cannula through a defect in said anulus fibrosis into an interior of said disc; and
advancing said apparatus into said disc through said deployment cannula, said apparatus being deflected along a path substantially parallel to said posterior anulus fibrosis by said cannula.
9. A method of positioning an implant along an inner surface of an anulus fibrosus lamella within an intervertebral disc, said method comprising the steps of:
advancing an implant deployment cannula through a hole in said anulus fibrosus to a selected depth within the disc along a path that is transverse to the orientation of the lamella; and
advancing said implant into said disc through said deployment cannula, said implant being deflected by said cannula along a path substantially parallel with and adjacent to the lamella at the selected depth.
10. The method of claim 9, wherein the implant comprises a barrier.
11. The method of claim 9, wherein the implant comprises a membrane.
12. The method of claim 9, wherein the implant comprises a biocompatible support member.
13. The method of claim 9, wherein the cannula is advanced into the disc to a depth proximal to the innermost surface of the anulus fibrosus.
14. The method of claim 9, wherein the implant is implanted between two or more lamella.
15. The method of claim 9, wherein the implant is implanted between the innermost lamella and nucleus pulposus.
16. A method of inserting an implant into an intervertebral disc, comprising the steps of:
providing an implant on an insertion device;
inserting the insertion device into the intervertebral disc along a first axis; and
deploying the implant laterally from the insertion device within the intervertebral disc along a second axis which is transverse to the first axis.
17. The method of claim 16, wherein the implant comprises a barrier.
18. The method of claim 16, wherein the implant comprises a membrane.
19. The method of claim 16, wherein the implant comprises a biocompatible support member.
20. The method of claim 16, wherein the insertion device is inserted into to the disc to a depth proximal to the innermost surface of the anulus fibrosus.
21. The method of claim 16, wherein the implant is implanted between two or more lamella.
22. The method in claim 16, wherein the implant is implanted between the innermost lamella and nucleus pulposus.
23. A minimally invasive method for inserting an implant within an intervertebral disc, comprising the steps of:
providing a linear implant deployment cannula;
inserting the cannula into the intervertebral disc along a first axis; and
deploying the implant laterally from the cannula within the intervertebral disc along a second axis which is transverse to the first axis.
24. The method of 23, wherein the cannula has a distal insertion tip with an internal deflecting surface and an opening at said tip for deployment of said implant.
25. The method of claim 23, wherein the tip of the cannula is inserted within the disc to a depth proximal to the innermost lamella of the anulus.
26. The method of claim 23, wherein the implant comprises a barrier.
27. The method of claim 23, wherein the implant comprises a membrane.
28. The method of claim 23 wherein the implant comprises a biocompatible support member.
This application is a continuation of U.S. application Ser. No. 09/696,636 filed on Oct. 25, 2000, which is a continuation-in-part of U.S. application Ser. No. 09/642,450 filed on Aug. 18, 2000, which is a continuation-in-part of U.S. application Ser. No. 09/608,797 filed on Jun. 30, 2000, and claims benefit to U.S. Provisional Application No. 60/149,490 filed Aug. 18, 1999, U.S. Provisional Application No. 60/161,085 filed Oct. 25, 1999 and U.S. Provisional Application No. 60/172,996 filed Dec. 21, 1999 the contents of each of which are incorporated in their entirety into this disclosure by reference.
[0033]FIG. 1A shows a transverse section of a portion of a functional spine unit, in which part of a vertebra and intervertebral disc are depicted.
[0034]FIG. 1B shows a sagittal cross section of a portion of a functional spine unit shown in FIG. 1A, in which two lumbar vertebrae and the intervertebral disc are visible.
[0035]FIG. 1C shows partial disruption of the inner layers of an annulus fibrosis.
[0036]FIG. 2A shows a transverse section of one aspect of the present invention prior to supporting a herniated segment.
[0037]FIG. 2B shows a transverse section of the construct in FIG. 2A supporting the herniated segment.
[0038]FIG. 3A shows a transverse section of another embodiment of the disclosed invention after placement of the device.
[0039]FIG. 3B shows a transverse section of the construct in FIG. 3A after tension is applied to support the herniated segment.
[0040]FIG. 4A shows a transverse view of an alternate embodiment of the invention.
[0041]FIG. 4B shows a sagittal view of the alternate embodiment shown in FIG. 4A.
[0042]FIG. 5A shows a transverse view of another aspect of the present invention.
[0043]FIG. 5B shows the delivery tube of FIG. 5A being used to displace the herniated segment to within its pre-herniated borders.
[0044]FIG. 5C shows a one-piece embodiment of the invention in an anchored and supporting position.
[0045]FIG. 6 shows one embodiment of the invention supporting a weakened posterior annulus fibrosis.
[0046]FIG. 7A shows a transverse section of another aspect of the disclosed invention demonstrating two stages involved in augmentation of the soft tissues of the disc.
[0047]FIG. 7B shows a sagittal view of the invention shown in FIG. 7A.
[0048]FIG. 8 shows a transverse section of one aspect of the disclosed invention involving augmentation of the soft tissues of the disc and support/closure of the annulus fibrosis.
[0049]FIG. 9A shows a transverse section of one aspect of the invention involving augmentation of the soft tissues of the disc with the flexible augmentation material anchored to the anterior lateral annulus fibrosis.
[0050]FIG. 9B shows a transverse section of one aspect of the disclosed invention involving augmentation of the soft tissues of the disc with the flexible augmentation material anchored to the annulus fibrosis by a one-piece anchor.
[0051]FIG. 10A shows a transverse section of one aspect of the disclosed invention involving augmentation of the soft tissues of the disc.
[0052]FIG. 10B shows the construct of FIG. 10A after the augmentation material has been inserted into the disc.
[0053]FIG. 11 illustrates a transverse section of a barrier mounted within an annulus.
[0054]FIG. 12 shows a sagittal view of the barrier of FIG. 11.
[0055]FIG. 13 shows a transverse section of a barrier anchored within a disc.
[0056]FIG. 14 illustrates a sagittal view of the barrier shown in FIG. 13.
[0057]FIG. 15 illustrates the use of a second anchoring device for a barrier mounted within a disc.
[0058]FIG. 16A is an transverse view of the intervertebral disc.
[0059]FIG. 16B is a sagittal section along the midline of the intervertebral disc.
[0060]FIG. 17 is an axial view of the intervertebral disc with the right half of a sealing means of a barrier means being placed against the interior aspect of a defect in annulus fibrosis by a dissection/delivery tool.
[0061]FIG. 18 illustrates a full sealing means placed on the interior aspect of a defect in annulus fibrosis. to FIG. 19 depicts the sealing means of FIG. 18 being secured to tissues surrounding the defect.
[0062]FIG. 20 depicts the sealing means of FIG. 19 after fixation means have been passed into surrounding tissues.
[0063]FIG. 21A depicts an axial view of the sealing means of FIG. 20 having enlarging means inserted into the interior cavity.
[0064]FIG. 21B depicts the construct of FIG. 21 in a sagittal section.
[0065]FIG. 22A shows an alternative fixation scheme for the sealing means and enlarging means.
[0066]FIG. 22B shows the construct of FIG. 22A in a sagittal section with an anchor securing a fixation region of the enlarging means to a superior vertebral body in a location proximate to the defect.
[0067]FIG. 23A depicts an embodiment of the barrier means of the present invention being secured to an annulus using fixation means.
[0068]FIG. 23B depicts an embodiment of the barrier means of FIG. 23A secured to an annulus by two fixation darts wherein the fixation tool has been removed.
[0069]FIGS. 24A and 24B depict a barrier means positioned between layers of the annulus fibrosis on either side of a defect.
[0070]FIG. 25 depicts an axial cross section of a large version of a barrier means.
[0071]FIG. 26 depicts an axial cross section of a barrier means in position across a defect following insertion of two augmentation devices.
[0072]FIG. 27 depicts the barrier means as part of an elongated augmentation device.
[0073]FIG. 28A depicts an axial section of an alternate configuration of the augmentation device of FIG. 27.
[0074]FIG. 28B depicts a sagittal section of an alternate configuration of the augmentation device of FIG. 27.
[0076]FIGS. 30A, 30B, 31A, 31B, 32A, 32B, 33A, and 33B depict axial and sectional views, respectively, of various embodiments of the barrier.
[0077]FIG. 34A shows a non-axisymmetric expansion means or frame.
[0078]FIGS. 34B and 34C illustrate perspective views of a frame mounted within an intervertebral disc.
[0079]FIGS. 35 and 36 illustrate alternate embodiments of the expansion means shown in FIG. 34.
[0081]FIG. 38 shows an alternate expansion means to that shown in FIG. 37A.
[0084]FIGS. 40E, 40F and 40I illustrate a front, back and top view, respectively of the tubular expansion means of FIG. 40A having a sealing means covering an exterior surface of an annulus face.
[0085]FIGS. 40G and 40H show the tubular expansion means of FIG. 40A having a sealing means covering an interior surface of an annulus face.
[0087]FIG. 42A-D depicts cross sections of a preferred embodiment of sealing and enlarging means.
[0088]FIG. 43A and 43B depict an alternative configuration of enlarging means.
[0089]FIG. 44A and 44B depict an alternative shape of the barrier means.
[0090]FIG. 45 is a section of a device used to affix sealing means to tissues surrounding a defect.
[0091]FIG. 46 depicts the use of a thermal device to heat and adhere sealing means to issues surrounding a defect.
[0092]FIG. 47 depicts an expandable thermal element that can be used to adhere sealing means to tissues surrounding a defect.
[0093]FIG. 48 depicts an alternative embodiment to the thermal device of FIG. 46.
[0097]FIGS. 52A and 52B illustrate an implant guide used with the intradiscal implant system.
[0098]FIG. 53A illustrates a barrier having stiffening plate elements.
[0099]FIG. 53B illustrates a sectional view of the barrier of FIG. 53A.
[0100]FIG. 54A shows a stiffening plate.
[0101]FIG. 54B shows a sectional view of the stiffening plate of FIG. 54A.
[0102]FIG. 55A illustrates a barrier having stiffening rod elements.
[0103]FIG. 55B illustrates a sectional view of the barrier of FIG. 55A.
[0104]FIG. 56A illustrates a stiffening rod.
[0105]FIG. 56B illustrates a sectional view of the stiffening rod of FIG. 56A.
[0106]FIG. 57 shows an alternate configuration for the location of the fixation devices of the barrier of FIG. 44A.
[0107]FIGS. 58A and 58B illustrate a dissection device for an intervertebral disc.
[0108]FIGS. 59A and 59B illustrate an alternate dissection device for an intervertebral disc.
[0112]FIGS. 1A and 1B show the general anatomy of a functional spine unit 45. In this description and the following claims, the terms ‘anterior’ and ‘posterior’, ‘superior’ and ‘inferior’ are defined by their standard usage in anatomy, i.e., anterior is a direction toward the front (ventral) side of the body or organ, posterior is a direction toward the back (dorsal) side of the body or organ; superior is upward (toward the head) and inferior is lower (toward the feet).
[0113]FIG. 1A is an axial view along the transverse axis M of a vertebral body with the intervertebral disc 15 superior to the vertebral body. Axis M shows the anterior (A) and posterior (P) orientation of the functional spine unit within the anatomy. The intervertebral disc 15 contains the annulus fibrosis (AF) 10 which surrounds a central nucleus pulposus (NP) 20. A Herniated segment 30 is depicted by a dashed-line. The herniated segment 30 protrudes beyond the pre-herniated posterior border 40 of the disc. Also shown in this figure are the left 70 and right 70′ transverse spinous processes and the posterior spinous process 80.
[0114]FIG. 1B is a sagittal section along sagittal axis N through the midline of two adjacent vertebral bodies 50 (superior) and 50′ (inferior). Intervertebral disc space 55 is formed between the two vertebral bodies and contains intervertebral disc 15, which supports and cushions the vertebral bodies and permits movement of the two vertebral bodies with respect to each other and other adjacent functional spine units.
[0118]FIGS. 2A and 2B depict one embodiment of device 13. FIG. 2A shows the elements of the constraining device in position to correct the herniated segment. Anchor 1 is securely established in a location within the functional spine unit, such as the anterior AF shown in the figure. Support member 2 is positioned in or posterior to herniated segment 30. Leading from and connected to anchor 1 is connection member 3, which serves to connect anchor 1 to support member 2. Depending on the location chosen for support member 2, the connection member may traverse through all or part of the herniated segment.
[0119]FIG. 2B shows the positions of the various elements of the herniation constraining device 13 when the device 13 is supporting the herniated segment. Tightening connection member 2 allows it to transmit tensile forces along its length, which causes herniated segment 30 to move anteriorly, i.e., in the direction of its pre-herniated borders. Once herniated segment 30 is in the desired position, connection member 3 is secured in a permanent fashion between anchor 1 and support member 2. This maintains tension between anchor 1 and support member 2 and restricts motion of the herniated segment to within the pre-herniated borders 40 of the disc. Support member 2 is used to anchor to herniated segment 30, support a weakened AF in which no visual evidence of herniation is apparent, and may also be used to close a defect in the AF in the vicinity of herniated segment 30.
[0124]FIGS. 3A and 3B depict another embodiment of device 13. In FIG. 3A the elements of the herniation constraining device are shown in position prior to securing a herniated segment. Anchor 1 is positioned in the AF and connection member 3 is attached to anchor 1. Support member 4 is positioned posterior to the posterior-most aspect of herniated segment 30. In this way, support member 4 does not need to be secured in herniated segment 30 to cause herniated segment 30 to move within the pre-herniated borders 40 of the disc. Support member 4 has the same flexibility in design and material as anchor 1, and may further take the form of a flexible patch or rigid plate or bar of material that is either affixed to the posterior aspect of herniated segment 30 or is simply in a form that is larger than any hole in the AF directly anterior to support member 4. FIG. 3B shows the positions of the elements of the device when tension is applied between anchor 1 and support member 4 along connection member 3. The herniated segment is displaced anteriorly, within the pre-herniated borders 40 of the disc.
[0125]FIGS. 4A and 4B show five examples of suitable anchoring sites within the FSU for anchor 1. FIG. 4A shows an axial view of anchor 1 in various positions within the anterior and lateral AF. FIG. 4B similarly shows a sagittal view of the various acceptable anchoring sites for anchor 1. Anchor 1 is secured in the superior vertebral body 50, inferior vertebral body 50′ or anterior AF 10, although any site that can withstand the tension between anchor 1 and support member 2 along connection member 3 to support a herniated segment within its pre-herniated borders 40 is acceptable.
[0133]FIGS. 8, 9A, 9B and 10A and 10B depict further embodiments of the disc herniation constraining device 13B in use for augmenting soft tissue, particularly tissue within the intervertebral space. In the embodiments shown in FIGS. 8 and 9A, device 13B is secured within the intervertebral disc space providing additional support for NP 20. Anchor 1 is securely affixed in a portion of the FSU, (anterior AF 10 in these figures). Connection member 3 terminates at support member 2, preventing augmentation material 7 from migrating generally posteriorly with respect to anchor 1. Support member 2 is depicted in these figures as established in various locations, such as the posterior AF 10′ in FIG. 8, but support member 2 may be anchored in any suitable location within the FSU, as described previously. Support member 2 may be used to close a defect in the posterior AF. It may also be used to displace a herniated segment to within the pre-herniated borders of the disc by applying tension between anchoring means 1 and 2 along connection member 3.
[0134]FIG. 9A depicts anchor 1, connection member 3, spacer material 7 and support member 2′ (shown in the “cap”-type configuration) inserted as a single construct and anchored to a site within the disc space, such as the inferior or superior vertebral bodies. This configuration simplifies insertion of the embodiments depicted in FIGS. 7 and 8 by reducing the number of steps to achieve implantation. Connection member 3 is preferably relatively stiff in tension, but flexible against all other loads. Support member 2′ is depicted as a bar element that is larger than passageway 9 in at least one plane.
[0135]FIG. 9B depicts a variation on the embodiment depicted in FIG. 9A. FIG. 9B shows substantially one-piece disc augmentation device 13C, secured in the intervertebral disc space. Device 13C has anchor 1, connection member 3 and augmentation material 7. Augmentation material 7 and anchor 1 could be pre-assembled prior to insertion into the disc space 55 as a single construct. Alternatively, augmentation material 7 could be inserted first into the disc space and then anchored to a portion of the FSU by anchor 1.
[0136]FIGS. 10A and 10B show yet another embodiment of the disclosed invention, 13D. In FIG. 10A, two connection members 3 and 3′ are attached to anchor 1. Two plugs of augmentation material 7 and 7′ are inserted into the disc space along connection members 3 and 3′. Connection members 3 and 3′ are then bound together (e.g., knotted together, fused, or the like). This forms loop 3″ that serves to prevent augmentation materials 7 and 7′ from displacing posteriorly. FIG. 10B shows the position of the augmentation material 7 after it is secured by the loop 3″ and anchor 1. Various combinations of augmentation material, connecting members and anchors can be used in this embodiment, such as using a single plug of augmentation material, or two connection members leading from anchor 1 with each of the connection members being bound to at least one other connection member. It could further be accomplished with more than one anchor with at least one connection member leading from each anchor, and each of the connection members being bound to at least one other connection member.
[0142]FIGS. 11 and 12 illustrate a barrier 12 mounted within an annulus 10 and covering an annular defect 16. The barrier 12 can be secured to the annulus 10 with a fixation mechanism or fixation means 14. The fixation means 14 can include a plurality of suture loops placed through the barrier 12 and the annulus 10. Such fixation can prevent motion or slipping of the barrier 12 away from the annular defect 16.
[0146]FIGS. 16A and 16B depict intervertebral disc 15 comprising nucleus pulposus 20 and annulus fibrosis 10. Nucleus pulposus 20 forms a first anatomic region and extra-discal space 500 (any space exterior to the disc) forms a second anatomic region wherein these regions are separated by annulus fibrosis 10.
[0147]FIG. 16A is an axial (transverse) view of the intervertebral disc. A posterior lateral defect 16 in annulus fibrosis10 has allowed a segment 30 of nucleus pulposus 20 to herniate into an extra discal space 500. Interior aspect 32 and exterior aspect 34 are shown, as are the right 70′ and left 70 transverse processes and posterior process 80.
[0148]FIG. 16B is a sagittal section along the midline intervertebral disc. Superior pedicle 90 and inferior pedicle 90′ extend posteriorly from superior vertebral body 95 and inferior vertebral body 95′ respectively.
[0163]FIGS. 28A and 28B illustrate axial and sagittal sections, respectively, of an alternate configuration of an augmentation device 38. In this embodiment, barrier region 300 extends across the defect 16 and has fixation region 4 facilitating fixation of the device 13 to superior vertebral body 50 with anchor 14′.
[0168]FIGS. 34 through 41 depict various enlarging or expansion devices 53 that can be employed to aid in expanding a sealing element 51 within the intervertebral disc 15. Each embodiment can be covered by, coated with, or cover the sealing element 51. The sealing means 51 can further be woven through the expansion means 53. The sealing element 51 or membrane can be a sealer which can prevent flow of a material from within the annulus fibrosis of the intervertebral disc through a defect in the annulus fibrosis. The material within the annulus can include nucleus pulposus or a prosthetic augmentation device, such as a hydrogel.
[0169]FIGS. 34 through 38 depict alternative patterns to that illustrated in FIG. 33A. FIG. 33A shows the expansion devices 53 within the sealing means 51. The sealing means can alternatively be secured to one or another face (concave or convex) of the expansion means 53. This can have advantages in reducing the overall volume of the barrier means 12, simplifying insertion through a narrow cannula. It can also allow the barrier means 12 to induce ingrowth of tissue on one face and not the other. The sealing means 51 can be formed from a material that resists ingrowth such as expanded polytetraflouroethylene (e-PTFE). The expansion means 53 can be constructed of a metal or polymer that encourages ingrowth. If the e-PTFE sealing means 51 is secured to the concave face of the expansion means 53, tissue can grow into the expansion means 53 from outside of the disc 15, helping to secure the barrier means 12 in place and seal against egress of materials from within the disc 15.
[0172]FIG. 34A shows an embodiment of a non-axisymmetric expander 153 having a superior edge 166 and an inferior edge 168. The expander 153 can form a frame of barrier 12. This embodiment comprises dissecting surfaces or ends 160, radial elements or fingers 162 and a central strut 164. The circular shape of the dissecting ends 160 aids in dissecting through the nucleus pulposus 20 and/or along or between an inner surface of the annulus fibrosis 10. The distance between the left-most and right-most points on the dissecting ends is the expansion means length 170. This length 170 preferably lies along the inner perimeter of the posterior annulus following implantation. The expander length 170 can be as short as 3 mm and as long as the entire interior perimeter of the annulus fibrosis. The superior-inferior height of these dissecting ends 160 is preferably similar to or larger than the posterior disc height.
[0175]FIG. 35 depicts an alternative embodiment to the expander 153 of FIG. 34. Openings or slots 174 can be included along the central strut 164. These slots 174 promote bending of the expander 153 and fingers 162 along a central line 176 connecting the centers of the dissecting ends 160. Such central flexibility has been found to aid against superior or inferior migration of the barrier means or barrier 12 when the barrier 12 has not been secured to surrounding tissues.
[0176]FIGS. 34B and 34C depict different perspective views of a preferred embodiment of the expander/frame 153 within an intervertebral disc 15. Expander 53 is in its expanded condition and lies along and/or within the posterior wall 21 and extends around the lateral walls 23 of the annulus fibrosis 10. The superior 166 and inferior 168 facing fingers 162 of expander 153 extend along the vertebral endplates (not shown) and/or the cartilage overlying the endplates. The frame 153 can take on a 3-D concave shape in this preferred position with the concavity generally directed toward the interior of the intervertebral disc and specifically a region occupied by the nucleus pulposus 20.
[0180]FIG. 36 depicts an embodiment of the expander 153 of FIG. 33A with an enlarged central strut 164 and a plurality of slots 174. This central strut 164 can have a uniform stiffness against superior-inferior 166 and 168 bending as shown in this embodiment. The strut 164 can alternatively have a varying stiffness along its height 178 to either promote or resist bending at a given location along the inner surface of the annulus 10.
The embodiment of the frame 153 as shown in FIGS. 37A-C, can also be employed without the use of a covering membrane. The nucleus pulposus of many patients with low back pain or disc herniation can degenerate to a state in which the material properties of the nucleus cause it to behave much more like a solid than a gel. As humans age, the water content of the nucleus declines from roughly 88% to less than 75%. As this occurs, there is an increase in the cross linking of collagen within the disc resulting in a greater solidity of the nucleus. When the pore size or the largest open area of any given gap in the lattice depicted in FIGS. 37A, 37B, and 37C is between 0.05 mm2 (7.75×10−5 in2) and 0.75 mm2 (1.16×10−3 in2), the nucleus pulposus is unable to extrude through the lattice at pressures generated within the disc (between 250 KPa and 1.8 MPa). The preferred pore-size has been found to be approximately 0.15 mm2 (2.33×10−4 in2). This pore size can be used with any of the disclosed embodiments of the expander or any other expander that falls within the scope of the present invention to prevent movement of nucleus toward the outer periphery of the disc without the need for an additional membrane. The membrane thickness is preferably in a range of 0.025 mm to 2.5 mm.
[0183]FIG. 38 depicts an expander 153 similar to that of FIG. 37A without fingers. The expander 153 includes a central lattice 180 consisting of multiple struts 182.
[0184]FIGS. 39 through 41 depict another embodiment of the expander 153 of the present invention. These tubular expanders can be used in the barrier 12 embodiment depicted in FIG. 31A. The sealer 51 can cover the expander 153 as shown in FIG. 31A. Alternatively, the sealer 51 can cover the interior surface of the expander or an arc segment of the tube along its length on either the interior or exterior surface.
[0185]FIG. 39 depicts an embodiment of a tubular expander 154. The superior 166 and inferior surfaces 168 of the tubular expander 154 can deploy against the superior and inferior vertebral endplates, respectively. The distance 186 between the superior 166 and inferior 168 surfaces of the expander 154 are preferably equal to or greater than the posterior disc height at the inner surface of the annulus 10. This embodiment has an annulus face 188 and nucleus face 190 as shown in FIGS. 39B, 39C and 39D. The annulus face 188 can be covered by the sealer 51 from the superior 166 to inferior 168 surface of the expander 154. This face 188 lies against the inner surface of the annulus 10 in its deployed position and can prevent egress of materials from within the disc 15. The primary purpose of the nucleus face 190 is to prevent migration of the expander 154 within the disc 15. The struts 192 that form the nucleus face 190 can project anteriorly into the nucleus 20 when the barrier 12 is positioned across the posterior wall of the annulus 10. This anterior projection can resist rotation of the tubular expansion means 154 about its long axis. By interacting with the nucleus 20, the struts 192 can further prevent migration around the circumference of the disc 15.
[0188]FIGS. 40E, 40F, and 40I depict the expander 154 of FIGS. 40A-D having a sealing means 51 covering the exterior surface of the annulus face 188. This sealing means 51 can be held against the endplates and the inner surface of the posterior annulus by the expander 154 in its deployed state.
[0189]FIGS. 40G and 40H depict the expander 154 of FIG. 40B with a sealer 51 covering the interior surface of the annulus face 188. This position of the sealer 51 can allow the expander 154 to contact both the vertebral endplates and inner surface of the posterior annulus. This can promote ingrowth of tissue into the expander 154 from outside the disc 15. Combinations of sealer 51 that cover all or part of the expander 154 can also be employed without deviating from the scope of the present invention. The expander 154 can also have a small pore size thereby allowing retention of a material such as a nucleus pulposus, for example, without the need for a sealer as a covering.
[0191]FIGS. 43A and 43B depict an alternative configuration of enlarger 53. Fixation region 4 extends through opening 8 in sealing means 51. Fixation region 4 has a through-hole that can facilitate fixation of enlarger 53 to tissues surrounding defect 16.
[0192]FIGS. 44A and 44B depict an alternative shape of the barrier. In this embodiment, sealing means 51, enlarger 53, or both have a curvature with radius R. This curvature can be used in any embodiment of the present invention and may aid in conforming to the curved inner circumference of annulus fibrosis 10.
[0193]FIG. 45 is a section of a device used to affix sealing means 51 to tissues surrounding a defect. In this figure, sealing means 51 would be positioned across interior aspect 50 of defect 16. The distal end of device 110′ would be inserted through defect 16 and opening 8 into the interior cavity 17. On the right side of this figure, fixation dart 25 has been passed from device 110′, through a wall of sealing means 51 and into tissues surrounding sealing means 51. On the right side of the figure, fixation dart 25 is about to be passed through a wall of sealing means 51 by advancing pusher 111 relative to device 110′ in the direction of the arrow.
[0194]FIG. 46 depicts the use of thermal device 200 to heat sealing means 51 and adhere it to tissues surrounding a defect. In this figure, sealing means 51 would be positioned across the interior aspect 36 of a defect 16. The distal end of thermal device 200 would be inserted through the defect and opening 8 into interior cavity 17. In this embodiment, thermal device 200 employs at its distal end resistive heating element 210 connected to a voltage source by wires 220. Covering 230 is a non-stick surface such as Teflon tubing that ensures the ability to remove device 200 from interior cavity 17. In this embodiment, device 200 would be used to heat first one half, and then the other half of sealing means 51.
[0195]FIG. 47 depicts an expandable thermal element, such as a balloon, that can be used to adhere sealing means 51 to tissues surrounding a defect. As in FIG. 18, the distal end of device 130 can be inserted through the defect and opening 8 into interior cavity 17, with balloon 150′ on the distal end device 130 in a collapsed state. Balloon 150′ is then inflated to expanded state 150, expanding sealing means 51. Expanded balloon 150 can heat sealing means 51 and surrounding tissues by inflating it with a heated fluid or by employing RF electrodes. In this embodiment, device 130 can be used to expand and heat first one half, then the other half of sealing means 51.
[0196]FIG. 48 depicts an alternative embodiment to device 130. This device employs an elongated, flexible balloon 150′ that can be inserted into and completely fill internal cavity 17 of sealing means 51 prior to inflation to an expanded state 150. Using this embodiment, inflation and heating of sealing means 51 can be performed in one step.
[0197]FIGS. 49A through 49G illustrate a method of implanting an intradiscal implant. An intradiscal implant system consists of an intradiscal implant 400, a delivery device or cannula 402, an advancer 404 and at least one control filament 406. The intradiscal implant 400 is loaded into the delivery cannula 402 which has a proximal end 408 and a distal end 410. FIG. 49A illustrates the distal end 410 advanced into the disc 15 through an annulotomy 416. This annulotomy 416 can be through any portion of the annulus 10, but is preferably at a site proximate to a desired, final implant location. The implant 400 is then pushed into the disc 15 through the distal end 410 of the cannula 402 in a direction that is generally away from the desired, final implant location as shown in FIG. 49B. Once the implant 400 is completely outside of the delivery cannula 402 and within the disc 15, the implant 400 can be pulled into the desired implant location by pulling on the control filament 406 as shown in FIG. 49C. The control filament 406 can be secured to the implant 400 at any location on or within the implant 400, but is preferably secured at least at a site 414 or sites on a distal portion 412 of the implant 400, i.e. that portion that first exits the delivery cannula 402 when advanced into the disc 15. These site or sites 414 are generally furthest from the desired, final implant location once the implant has been fully expelled from the interior of the delivery cannula 402.
In another embodiment of the present invention, as illustrated in FIGS. 51A-C, an implant guide 430 maybe employed to aid directing the implant 400 through the annulotomy 416, through the nucleus pulposus 10, and/or along the inner aspect of the annulus 10. This implant guide 430 can aid in the procedure by dissecting through tissue, adding stiffness to the implant construct, reducing trauma to the annulus or other tissues that can be caused by a stiff or abrasive implant, providing 3-D control of the implants orientation during implantation, expanding an expandable implant, or temporarily imparting a shape to the implant that is beneficial during implantation. The implant guide 430 can be affixed to either the advancer 404 or the implant 406 themselves. In a preferred embodiment shown in FIGS. 52A and 52B, the implant guide 430 is secured to the implant 400 by the first 424 and second 426 guide filaments of the first 426 and the second 428 attachment sites, respectively. The guide filaments 424 and 426 may pass through or around the implant guide 430. In this embodiment, the implant guide 430 maybe a thin, flat sheet of biocompatible metal with holes passing through its surface proximate to the site or sites 426 and 428 at which the guide filaments 422 and 424 are secured to the implant 400. These holes allow passage of the securing filament 422 and 424 through the implant guide 430. Such an elongated sheet may run along the implant 400 and extend beyond its distal end 412. The distal end of the implant guide 430 may be shaped to help dissect through the nucleus 10 and deflect off of the annulus 10 as the implant 400 is advanced into the disc 15. When used with multiple guide filaments, such an implant guide 430 can be used to control rotational stability of the implant 400. It may also be used to retract the implant 400 from the disc 15 should this become necessary. The implant guide 430 may also extend beyond the proximal tip 420 of the implant 400 to aid in dissecting across or through the annulus 10 proximate to the desired implantation site.
[0212]FIGS. 53A and 53B illustrate one embodiment of a barrier 12 incorporating the use of a stiffening element 300. The barrier 12 can be a plate and screw barrier 320. In this embodiment, the stiffening element 300 consists of two fixation plates, superior 310 and inferior 312, an example of which is illustrated in FIGS. 54A and 54B with two parts 308 passing through each plate. The parts 308 are located proximal to an opening 8 leading into an interior cavity 17 of the barrier 12. These parts 8 allow passage of a fixation device 306 such as a bone screw. These screws can be used to secure the barrier means 12 to a superior 50 and inferior 50′ vertebra. As the screws are tightened against the vertebral endplate, the fixation plates 310, 312 compress the intervening sealing means against the endplate along the superior and inferior surfaces of the barrier 12. This can aid in creating a sealing engagement with the vertebral endplates and prevent egress of materials from within the disc 15. As illustrated in FIGS. 53A and 53B, only the superior screws have been placed in the superior plate 310, creating a sealing engagement with the superior vertebra.
[0213]FIGS. 55A and 55B illustrate another embodiment of a barrier 12 having stiffening elements 300. The barrier 12 can be an anchor and rod barrier 322. In this embodiment, the stiffening elements 300 consist of two fixation rods 304, an example of which is shown in FIGS. 56A and 56B, imbedded within the barrier 12. The rods 304 can include a superior rod 314 and an inferior rod 316. Sutures 318 can be passed around these rods 314 and 316 and through the barrier means 10. These sutures 318 can in turn, be secured to a bone anchor or other suitable fixation device 306 to draw the barrier 12 into sealing engagement with the superior and inferior vertebral endplates in a manner similar to that described above. The opening 8 and interior cavity 17 of the barrier 12 are not required elements of the barrier 12.
[0214]FIG. 57 illustrates the anchor and rod barrier 322, described above, with fixation devices 306 placed at opposing ends of each fixation rod 316 and 318. The suture 18 on the left side of the superior rod 318 has yet to be tied.
[0216]FIGS. 58A and 58B depict one such method and an associated dissector device 454. In these figures, the assumed desired position of the implant is along the posterior annulus 452. In order to clear a path for the implant, a hairpin dissector 454 can be passed along the intended implantation site of the implant. The hairpin dissector 454 can have a hairpin dissector component 460 having a free end 458. The dissector can also have an advancer 464 to position the dissector component 460 within the disc 15. The dissector 454 can be inserted through cannula 456 into an opening 462 in the annulus 10 along an access path directed anteriorly or anterior-medially. Once a free-end 458 of the dissector component 460 is within the disc 15, the free-end 458 moves slightly causing the hairpin to open, such that the dissector component 460 resists returning into the cannula 456. This opening 462 can be caused by pre-forming the dissector to the opened state. The hairpin dissector component 460 can then be pulled posteriorly, causing the dissector component 460 to open, further driving the free-end 458 along the posterior annulus 458. This motion clears a path for the insertion of any of the implants disclosed in the present invention. The body of dissector component 460 is preferably formed from an elongated sheet of metal. Suitable metals include various spring steels or nickel titanium alloys. It can alternatively be formed from wires or rods.
[0217]FIGS. 59A and 59B depict another method and associated dissector device 466 suitable for clearing a path for implant insertion. The dissector device 466 is shown in cross section and consists of a dissector component 468, an outer cannula 470 and an advancer or inner push rod 472. A curved passage or slot 474 is formed into an intradiscal tip 476 of outer cannula 470. This passage or slot 474 acts to deflect the tip of dissector component 468 in a path that is roughly parallel to the lamellae of the annulus fibrosis 10 as the dissector component 468 is advanced into the disc 15 by the advancer. The dissector component 468 is preferably formed from a superelastic nickel titanium alloy, but can be constructed of any material with suitable rigidity and strain characteristics to allow such deflection without significant plastic deformation. The dissector component 468 can be formed from an elongated sheet, rods, wires or the like. It can be used to dissect between the annulus 10 and nucleus 20, or to dissect between layers of the annulus 10.
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Internationale Klassifikation A61B17/34, A61F2/28, A61F2/46, A61F2/00, A61B17/32, A61B17/88, A61B17/22, A61B19/00, A61B17/70, A61F2/02, A61B5/107, A61F2/30, A61F2/44, A61B17/068, A61B17/064, A61B17/04, A61B17/00
Unternehmensklassifikation A61F2210/0085, A61B17/0057, A61F2002/30131, A61F2002/4635, A61B2017/00659, A61F2002/30589, A61F2310/00017, A61F2210/0061, A61F2002/30062, A61F2002/4661, A61F2002/30228, A61F2/2846, A61B5/1076, A61F2002/4658, A61F2002/4435, A61F2002/30224, A61F2002/448, A61B2017/320044, A61F2002/30677, A61F2/442, A61F2310/00029, A61B17/0487, A61F2230/0091, A61F2002/30583, A61B17/320708, A61F2/4657, A61F2230/0069, A61F2002/30777, A61F2210/0004, A61B2017/00867, A61F2002/2817, A61F2310/00976, A61F2/30907, A61F2002/444, A61B17/068, A61B17/3468, A61B2017/22077, A61F2220/0075, A61F2/441, A61B2017/00637, A61F2002/30462, A61F2/4601, A61F2230/0013, A61B2017/0458, A61B17/7095, A61B17/0469, A61B2090/062, A61F2310/00365, A61F2002/30785, A61B2017/00261, A61B2017/00557, A61B2017/0647, A61F2310/0097, A61B2017/0496, A61B17/064, A61F2002/4662, A61F2310/00023, A61B2017/3445, A61F2002/30291, A61B2017/044, A61F2002/30571, A61B5/4514, A61F2310/00293, A61F2/4611, A61F2002/30075, A61F2/30723, A61B17/320016, A61B17/0401, A61B2017/0488, A61B2017/00654, A61B2090/061
Europäische Klassifikation A61F2/46B7, A61B17/00P, A61F2/44D, A61F2/46M, A61F2/44B, A61B17/32E, A61B5/107J, A61B17/04A, A61B17/068, A61B17/3207C
1. Apr. 2010 FPAY Fee payment