BRPI0720922A2 - Implants of spinous processes and associated methods. - Google Patents

Description

“IMPLANTS OF THOROUGH PROCESSES AND METHODS ASSOCIATED WITH THEM”

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefits of United States Provisional Application No. 60 / 912,273 filed April 7, 2007, and the Provisional Application No. 60 / 884,581 filed January 11, 2007.

FIELD OF INVENTION

The present invention relates to spinous process implants and methods associated therewith.

BACKGROUND OF THE INVENTION

The vertebrae of the human backbone are arranged in one column with one vertebra on top of the other. An invertebrate disc lies between the adjacent vertebra to transmit force between the adjacent vertebra and provides a mattress between them. The disc allows the spine to flex and rotate. With age, the spinal discs begin to rupture, or degenerate resulting in fluid loss in the discs and consequently resulting in them becoming less flexible. Otherwise, the discs become thinner allowing the vertebrae to move closer and closer together. Degeneration may also result in tears or cracks in the outer layer or disc rings.

The disk can bulge outwardly. In stiffer cases, the disc's internal material, or core, may actually extrude off the disc. Additionally, degenerative changes in the disc and spine may succeed due to trauma due to motor vehicle accidents, falls, weightlifting and other activities. Additionally, in a process known as spinal stenosis, the spinal canal narrows due to excessive bone growth, tissue thickening in the canal (such as ligament) or both. In all of these conditions, the space through which the spinal line and the roots of the spinal nerve pass can become narrow, leading to pressure in the nervous tissue that can cause pain, numbness, weakening or even paralysis in various parts of the body. Lastly, the facet joints between the adjacent vertebra can degenerate and cause local and / or radiant pain. All of the above conditions are collectively referred to herein as spinal diseases. Conventionally, surgical interventions in the treatment of spinal disease arise in an attempt to restore the normal space between adjacent vertebrae. This may be sufficient to relieve pressure on the affected nerve tissue. However, it is often also necessary to surgically remove material from the disc, bone or other tissues that impinges on nerve tissue and / or removes the facet joints. More often, restoration of vertebral spacing is complemented by the insertion of a rigid spacer made of bone, metal, or plastic into the disc space between the adjacent vertebra and the next vertebra so that they both grow together or merge. if in one piece of bone. Vertebrae are typically stabilized during the fusion process using bone plates and / or pedicle screws attached to the adjacent vertebrae.

Although techniques for placement of vertebrate spacers, plates, and pedicle screw-type fixation systems have become less invasive in recent processes, they still require placement of an in-depth feature within the surgical site adjacent to the backbone. Recovery from each surgery may require many days of hospitalization and lengthy, slow rehabilitation to normal activity levels. Recently, researchers have promoted the use of motion-preserving implants and techniques in which adjacent vertebrae are allowed to move relative to each other. In each implant that has found only limited success is the artificial disc implant. These typically include either a flexible material or a two-piece pivot joint inserted into the disc space. Another type of implant is the spinal process spacer that is inserted between the spinous processes that extend posteriorly from the adjacent vertebra to act as an interruption of the extension and to maintain minimal spacing between the spinal processes. when the backbone is in extension. The spinal process spacer allows adjacent spinal processes to move apart as the spine flexes.

SUMMARY

The present invention provides a spinous implant process and methods

associated with them. In one aspect of the present invention, an implant for placement between the spinal process of the adjacent vertebra includes a spacer and an extension.

The spacer has sides generally parallel to its longitudinal axis and having operable lower and upper surfaces to confine the spinal processes and to maintain the spinal processes in a spaced apart relationship. The designs extend from the transverse spacer to the transverse axis to lie generally along the spinous process of the adjacent vertebra and engage the spinous process to limit the maximum spacing between the spinous processes.

In another aspect of the present invention, the extension includes an adjustable

speed

In another aspect of the present invention, the extension includes a removable clipper.

In another aspect of the present invention, an implant for placement between the adjacent vertebral spinal processes includes a spacer having at least one transverse opening communication of at least one of an upper and lower outer surface to internally facilitate growing tissue. .

In another aspect of the present invention, the spacer includes an inner hollow space and a plurality of transverse openings communicating the lower and upper surfaces to the inner hollow space to facilitate tissue growth.

In another aspect of the present invention, the spacer includes a porous structure and the transverse opening comprises a plurality of pores.

In another aspect of the present invention, it relates to an implant to be placed between the spinous processes of adjoining spine vertebrae includes a spacer and separate extensions engaging with the spacer as it ends. The spacer is provided in a variety of lengths and bottom to top surface spacings.

In another aspect of the present invention, an implant for placement between the spinous processes of adjacent vertebrae of a spine includes a spacer and a circling member. The circling element is subsequently adjusted from the intermediate line in use so that the spacer defines a fulcrum and the circling element is extendable about a portion of a vertebra and operative to propel a moment into the vertebra around the spacer.

In another aspect of the present invention, the instrumentation includes two instruments each having a tapering operation portion from a transverse sectional dimension closer to handling to a smaller transverse sectional dimension closer to a free end. . The free end of one of the instruments defines a hollow portion sized to engage the free end of the first instrument and sized to engage the hollow portion of the implant.

In another aspect of the present invention, a method includes inserting a spacer between adjacent spinal processes of vertebrae to provide both an extension stop and a flexion stop.

In another aspect of the present invention, a method includes inserting a spacer between the spinal processes of adjacent vertebrae and connecting a circling member to the adjacent vertebrae to propel a moment into the vertebra around the spacer.

In another aspect of the present invention, a method includes inserting a tapered instrument between the adjacent spines process; engaging one end of a spinous process spacer with the tapered instrument tip and pairing the back engaging the adjacent spinous process to insert the spacer between the spinous processes.

BRIEF DESCRIPTION OF DRAWINGS

Several examples of the present invention will be discussed with reference to the accompanying figures. These figures represent only illustrative examples of the present invention and are not intended to be construed as limiting the present scope. Figure 1 is a cross-sectional view of an implant according to the present invention in situ;

Figure 2 is a side elevational view of the implant of Figure 1 in situ;

Figure 3 is an exploded perspective view of the implant of Figure 1;

Figure 4 is a front elevational view of the implant of Figure 1;

Figure 5 is a rear elevational view of the implant of Figure 1 Figure 6 is a top plan view of the implant of Figure 1;

Figure 7 is a front elevational view of the implant of Figure 1 showing mounting in an alternate position;

Figure 8 is a side elevational view of the implant of Figure 1;

Figure 9 is a perspective view of a pair of implants like that of Figure

1 in situ;

Figure 10 is a cross-sectional view of an implant like that of Figure

1 illustrating alternating material and circling elements;

Figures 11-13 are side elevational views of an implant such as that of the

Figure 1 shown in use with circlage elements;

Figures 14-24 are perspective views of alternative embodiments of the present invention;

Figure 25 is a perspective view of instrumentation for implanting the implant of Figure 1;

Figure 26 is a perspective view of the instrumentation of Figure 25 being used to implant the implant of Figure 1.

DESCRIPTION OF THE ACHIEVEMENTS OF

ILLUSTRATIVE EXAMPLES

Spinal process implants according to the present invention include a spacer and an externally extending extension of the spacer. The spinous implant process can be configured for insertion between the adjacent spinous processes of the cervical, thoracic and I or lumbar spine. The spacer can be provided in a variety of sizes to accommodate anatomical variations between patients and varying degrees of bone. space correction. The spacer may include openings to facilitate growing tissue to support the spacer for vertebral bodies such as growing tissues of spinal processes. The spacer may be configured for growing tissue from the upper and lower spinous processes to promote fusion of adjacent spinous processes. The openings may be relatively wide and or communicate to an internal spacer space. An interior hollow space may be configured to receive bone growth promoting substances such as by accommodating the substances in the interior space. The apertures may be relatively smaller and / or comprise interconnecting pores or pores over at least a portion of the spacer surface. The openings may be filled with bone growth promoting substances.

The spacer may have any suitable cross-sectional shape. For example it may be cylindrical, D-shaped, C-shaped, H-shaped, include curved radii, and / or any other suitable shape. The shape may include chamfers, fillets, planes, soft cuts, and / or other shapes to accommodate anatomical features such as for example Iamines and / or facets.

The extension may extend transversely from the relative spacer to a longitudinal spacer axis to maintain between adjacent spinous processes. A singular extension may extend in one or more directions or even in multiple directions may be provided extending in multiple directions. One or more extensions may be longitudinally adjustable relative to each other and / or the spacer to allow the extension to be positioned relative to the spinal processes. A movable extension may be provided as long as it is axially movable to the spacer and to another extension. Alternatively, a plurality of movable extensions may be provided. For example, an extension may clamp against the sides of the spinous process to immobilize relative to one another and promote fusion between the adjacent vertebrate. Extensions may include lockable fasteners with the lockable processes. Fasteners may include sutures, threads, pins, bandages, staples, nails, screws, teeth, adhesives, and / or other suitable fasteners. Fasteners may be integrated into extensions or they may be modular. Modular fasteners may be adjustable, replaceable, and / or removable to enable the type and quality of fastening of the rigid non-fastening to be secured. The spacer, extensions and / or fasteners may advantageously be made of different materials. For example, the spacer and extensions may be made of a relatively softer material while the fastener may be made of a relatively harder material. For example, the spacer and / or extension may be made of a polymer and / or other relatively softer material and the fastener may be made of a metal and / or other harder material.

Circlage can be used to stabilize the spinous process implant and / or provide other benefits. For example, wires, bandages, cables, cords, and / or other elongated limbs may shrink the pedicles, laminate, spinous processes, transverse processes, and / or other spinous structures. The circlage may be relatively non-extensible so as to provide an accurate check for thorny flexion of the circlage may be relatively extensible so as to provide increased flexural strength. The circlage may be relatively flexible and draped such that as a nonwoven fabric or it may be relatively rigid such as a metal band. Circulation can have format memory properties that make an adjustment format after deployment. The circlage may be independent of or may engage the spinous process implant. For example, the circlage may pass through a hollow interior of the spinous process implant and / or engage the extension. The circlage may be adjusted from the spacer and provide a tensioning force that uses the spacer as a fulcrum to discharge from the disc and / or open the disc space.

The implant may be supplemented with bone growth promoting substances to facilitate fusion of adjacent vertebrae between the spinous processes, lamina, transverse processes, facets, and / or other spinal structures. Bone growth promoting substances may be spaced from the implant, placed adjacent the implant, sandwiched between the implant and overlying bones placed within the implant, coated over the implant, and / or otherwise placed. relative to the implant. If coated over the implant it may be to cover the entire implant or only selected portions of the implant such that the extensions, fasteners, spinal process contact portions of the spacer, and / or other portions.

As used herein, bone growth promoting substances may include

include bone paste, bone slices, bone strips, structural bone grafts, growth factor-derived plaques, bone marrow aspirate, cell structures, bone growth proteins, bone growth peptides, bone fixation proteins, growth peptides. bone, hydroxylapatite, calcium phosphate, and / or other bone growth promoting substances.

The implant and any associated circlage or other components may be made from any biocompatible material including other metals, absorbable ceramics, nonabsorbable ceramics, and nonabsorbable polymers. Specific examples include stainless steel, titanium and its alloys including nickel-titanium alloy, tantalum, hydrolapatite, calcium phosphate, bone, zirconium, alumina, carbon.biovitreo, polyesters, polylactic acid, polyglycolic acid, polyolefins, polyamides , polyimides, polyacrylates, polyketones, fluoropolymers, and / or other biocompatible materials and combinations thereof.

The spinous process implant may be used to treat spinal diseases in a variety of surgical techniques including posterior approaches to sacrificial ligament sacrifice, posterior approaches to spinal ligament preservation, lateral approaches, and / or other suitable approaches. The spinal process implant can be used to treat spinal diseases by fusing adjacent vertebrates or by preserving movement between the adjacent vertebra. It may include only an extension stop such as a spacer, only a bending stop such as bendable members, or both a bend and an extension stop. The spinous process implant can be used to reduce veneer joint loads, increase the spinous process spacing, reduce disc loads, increase the anterior disc spacing and / or otherwise treat spine problems. Earlier effects may be complemented by tensioning backbone elements after the spacer to apply a mechanical advantage to the spinal construct. Techniques for implanting the spinal process may include leaving the tissues in an unmodified surgical site or modifying tissues such as ornamentation, scraping, roughness, and / or otherwise modifying tissues at the implant site.

Figures 1 and 2 illustrate posterior and anterior views of a pair of vertebrae adjacent to the lumbar spine 10. An upper vertebra 12 is separated from a lower vertebra 14 by a disc 16. Each vertebra includes a pair of transverse processes 18 19, a laterally projecting spinous process 20, 21, and a pair of Imines 22, 23 connecting the transverse processes 18, 19 to the spinous process 20, 21. In addition to the connection through disc 16, the vertebra 12, 14 articulate into a pair of facet joints 24.

Figures 1-9 illustrate an exemplary spinous process implant 100. The implant 100 includes a spacer 102 positioned between the spinous processes 20, 21. The height 104 of the spacer 102 limits how close the spinous processes 20, 21 can be. move together. Thus, the spacer 102 maintains a minimum distance between the spinous processes 20, 21. In the case of a posteriorly spinal malformation involving the adjacent vertebrae slowing, insertion of the spacer 102 between the spinous processes 20, 21 will move the vertebrae distal and relieve pressure on nerve tissue and 20-facet joints 24.

As shown in Figure 3, spacer 102 includes a first end 106, a second end 108, and a longitudinal axis 110 extending from the first end to the second end. The spacer 102 has a sidewall 112, generally parallel to the longitudinal axis 110, including upper 25 and lower outer surfaces 114, 115. Transverse openings 118 (see Figure 6) communicate from the lower and upper outer surfaces 114, 116 internally to facilitate tissue growth. Exemplary spacer 102 includes an inner void 120 connected by an inner surface 122 such that the openings118 communicate from the outer surface to the inner void 120. Bone-growth promoting substances 124 are comfortably contained within. of inner void 120 in Figures 1 and 2 to promote fusion of vertebra 12, 14 by bone growth between spinous processes 20.

The spinous process implant 100 additionally includes a first extension 126 projecting externally from the spacer 102 transverse to the longitudinal axis 110 to fall generally along the upper spinous process. The confinement of first extension 126 with spinous process 20 helps maintain spacer 102 between spinous processes 20. In the exemplary spinous process implant 100, first extension 126 is attached to spacer 102 and the implant includes a second mountable extension 128. next to the spacer for axial movement relative to the first extension 126. The second extension 128 may be moved towards the first extension 126 so as to approximate the width of the spinous process 20 and better stabilize the implant 100. It is fixed. in place by tightening screw 130 against spacer 102. Extensions 126, 128 include fasteners 132, 134, 136 that project from extensions 126, 128 to engage the thorns process 20 to secure the spacer 102 to the spinous process 20 Figure 1 illustrates an additional bone growth promoting substance in the form of bone strips 125 sandwiched between extensions 126, 128 to along the sides of the spinous processes 20 so as to promote bone growth along the sides of the spinous processes to further increase vertebrate fusion 12, 14. Extensions 126, 128 preferably extend inferiorly (as shown) as well. upper to optionally attach to the lower spinous processes to immobilize the spinous processes relative to each other while fusion takes effect.

Fasteners 132, 134 and 136 may take any suitable form. They may be integrally formed with extensions 126, 128 such as by machining or molding them with extensions or they may be formed separately and permanently affixed to extensions 126, 128. Fasteners 132 have a stud shape which threadably engages extension 126. The threaded coupling allows fastener 132 to be replaced with a different fastener 132. For example, fastener 132 may be replaced by one having a different shape, a different size, a different material or a different surface finish. The threaded engagement also allows the fastener 132 to be adjusted to extend by varying the amounts from extension 126 to vary as it engages the bone. In this way, the fastener 132 can be adjusted to accommodate differently from bone shapes or to penetrate a bone by varying amounts. For example, multiple threaded fasteners 132 may be adjusted to extend by different amounts to conform to the curved or angled bone. Lastly, the threaded coupling allows the user to remove the fixture 132 when fixation is not desired as when it is desired to use implant 100 in a non-fusion procedure as an extension stop with no flexural limit.

Fasteners 134 and 136 are provided as multiple blackhead pods to be quickly adjusted, changed, or omitted. Fasteners 134 includes a non-circular lockable 138 with a non-circular opening 140 at extension 126. Non-circular engagement prevents the fastener 134 from rotating. The board 138 may form an adjusting pressure, quick adjust, or other suitable engagement with opening 140. The board 138 may be additionally secured by an additional screw 142. Fasteners 136 include a threaded shaft 144 threadedly engaged. a base member 146 for releasing the length of fastener 136 to be adjusted. The shaft 144 engages the extension 126 in a pivotal and rotational manner such that the fixer 136 can be rotationally and angularly adjusted to engage the bone surface. In the illustrative embodiment, shaft 144 terminates in a ball bearing 144 which engages aperture 140 in a socket-bearing device for three degrees of play. However, any mechanism that allows any number of degree of slack can be used. The fastener 136 may be released to move in use such that as the extension 126 is pressed towards a bone the fastener 136 adjusts to the angle of the bone surface. Fastener 136 may also be fastened such as by a screw 142 to adjust joint tension and / or lock fastener 136 in a predetermined orientation.

Figure 4 illustrates the axial relationship of fasteners at opposite extensions 126,

In illustrative implant 100, the fasteners 132 at the top of implant 100 are shown aligned along a common axis. The fasteners 134 at the bottom of the implant 100 are shown to fit so that they can interleave if necessary as they are pressed into the bone. Any combination of fixative type, number, and alignment may be provided in implant 100.

As seen in Figures 5 and 6, the ends 106, 108 of the spacer 102 include front chamfers 152. These chamfers 152 allow ends 106, 108 to later erase vertebrate exposed structures 12, 14 as well as junctions. Also, as seen in Figures 5 and 6, the spacer 102 is adjusted 20 anteriorly with respect to extensions 126, 128 such as that of the longitudinal axis 110 of spacer 102 is anterior to the intermediate line 154 of extensions 126, 128. The anterior adjustment of the spacer 102 releases it to fit deeply between the spinous processes 20, 21 while the extensions 126, 128 fit along the processes 20, 21.

As best seen in Figures 3 and 8, the second extension 128 defines an aperture 155 generally conforming to the transverse sectional shape of the spacer 102. In the illustrative embodiment of Figures 1-9, aperture 155 opens earlier to form a shape. "Ç". Planks 156 extend inwardly from the lower and upper portions of the opening to slidably engage slots 158 on the upper and lower surfaces of the spacer 102. The second extension 128 may be moved longitudinally towards and also distal from the first extension. 126. Tightening the screw 130 against the back side 160 of the spacer 102 forces the boards 156 posteriorly against the sides of the slots 158 and blocks the second extension 128 from being longitudinally positioned. Rear side 60 of spacer 102 may be roughened as shown to better capture screw 130. Screw 130 may also drill into the surface of spacer 102 under aperture to properly capture spacer 102. Aperture 155 may conform proximally to spacer 102 to compelling second extension 128 to relatively parallel movement along first extension 126. Alternatively, aperture 155 may be larger than spacer 102 by a predetermined amount to allow a predetermined amount of angular adjustment of second extension 128 to first extension 126 as shown in Figure 7 to release extension 128 in fitting the underlying bone surface.

As best seen in Figure 8, the second extension 128 includes a first response.

heel 161 having a first centered shoulder 162 and a second shoulder 164 having a second centered shoulder 166. In the illustrative embodiment, the first centered shoulder 162 and the second centered shoulder 166 are parallel and spaced apart so that the second extension 128 generally has a plane shape in the "Z" shape. This format allows the extension of one implant 100 to intersect, if necessary, with another implant 100 in a multilevel intervention, as shown in Figure 9 to allow for proximal implant spacing, and / or extension shoulders. longer durations for more extensive bone engagements. In the illustrative embodiment of Figures 1-9, the center lines 162 and 166 are equidistantly adjusted from the midline 154 of the second extensions 128. The center lines 162 and 166 may vary from parallel and they may be asymmetrically adjusted. to form different shapes and thus accommodate different anatomical shapes. For example, the shape may be made by different portions of the spine 10. In the illustrative embodiment of Figures 1-9, the first extension 126 has the same shape as the second extension 128. However, the shape may be varied between the first and second portions. second extensions 126 and 128.

Figure 10 illustrates an implant 200 having a spacer 202 and a first and second extension 204, 206. The spacer 202 includes pores 208 for growth tissues. The pores 208 may be individual openings spaced from each other, interconnecting openings, or combinations of individual openings and interconnecting openings. The spacer 202 may be a monolithic block having uniform porosity therethrough. Alternatively, spacer 202 may include a porous outer layer 210 and an inner layer 212 of different composition, for example, the inner layer 212 may be solid, porous, hollow, or some other configuration. A porous inner layer may have pores of different sizes and / or distribution than outer layers 210. Similarly, any porous portion may have uniform porosity or porosity that varies in pore size or density. A variety of pore configurations are suitable. Preferably the pore size is in the range of 1 μηη to 2 mm. More preferably, the pore size is in the range from 1pm to 500 µm. Even more preferably, the pore size is in the range of 75μιη at 300pm. Pores can be produced by a variety of processes such as particle sintering; Leaching soluble component from the material;

Plaiting; weaving, or otherwise combining fibers and / or by any other known process. The pore size may be made to preferably promote stiffened tissue growth, soft tissue growth, or a combination of stiff and soft growth. Extensions 204, 206 may be solid or they may have large or small openings to encourage bone growth 5 in and / or around extensions 204, 206. Spacer 202 and / or extensions 204, 206 may also be coated as previously described.

The extensions 204, 206 may be fixed and / or adjustable. In illustrative implant 200 of Figure 10, the first extension 204 is attached to one end of the spacer 202 and the second extension 206 is translatable along the spacer 202 to allow the 10 extensions to be placed adjacent to the spinous processes. Extensions 204, 206 are shown with optional studs 214 which may engage the spinous processes 20, 21 to secure the spinous processes 20, 21 in relationship to one another.

Figure 10 also illustrates the use of circling in conjunction with implant 200. For example, one or more bands 216 are placed around blade 22, 23 to provide a bending stop. The web 216 may help to carry the load exerted on the black nails 214 during spinal flexion. Alternatively or in addition to band 216, one or more bands 218, 220 may be placed around transverse processes 18, 19.

Figures 11-13 illustrate further examples of the use of circlage in conjunction with a spinous process implant 300 according to the present invention. The implant includes a spacer 302 for placement between adjacent spinous processes 20, 21 and an extension 304.

In the example of Figure 11, a web 310 of flexible material is wrapped around the spinous processes 20, 21. By placing the web 310 behind the areas 312, 314 where the spinous processes contact the spacer 302 an adjustment 318 is created. . Clamping of the Strap 31 A moment 320, 322 occurs at each vertebral 2, 14 that releases some of the pressure on the disc 16 between the adjacent vertebra 12, 14. With increasing clamping 310, the anterior spacing324 of vertebra 12, 14 can indeed be increased. Thus, by using the spinous process implant 300 in combination with stage 310, the 30 vertebra 12, 14 can be leveled apart with implant 300 being used as the fulcrum. In addition to the advantages already mentioned, this combination produces an anterior disk space effect with a posterior spinous process procedure that is less invasive than typical disk spacing procedures.

In the examples of Figures 12 and 13, implant 300 includes a mechanism for affixing circlage band 310 to implant 300. In the example of Figure 12, the mechanism includes openings 330, 332 at the lower and upper ends of extension 304. By affixing the band 310 extension 304, strip 310 and extension 304 help stabilize each other against anterior-posterior displacement. This affixing also helps to position the band 310 at a predetermined setting 318 from the spacer 302. In the example of Figure 13, the band 310 is enveloped through an inner void of the spacer 302 by itself. In this example, the abanda is unadjusted and produces minimal or no moment over the vertebra.

Figures 14-24 illustrate alternative mechanisms for affixing a movable extension to the implant of Figure 1. With reference to Figure 14, an implant 400 includes a spacer 402, a first extension 404 and a second, movable extension 406. The movable tension 406 includes a ring-shaped body 408 with an inner surface generally forming the outer surface of the spacer 402 so that the ring is slidably receptive on the spacer 402. A screw 412 is tightened against the spacer 402 to secure the movable extension 406 in a desired position on the spacer 402. Tightening the screw 412 tilts the movable extension 406 relative to the spacer 402. The front portion 414 of the ring presses against the front portion 416 of the spacer 15 402 to count this forward inclination and allow bolt 412 to lock extension 406. Spacer 402 p It may include a plurality of indentations 418 to create a positive engagement with screw 412 at predetermined axial locations. Ring 408 may be sized to allow a predetermined amount of inclinations of extension 406 relative to spacer 402.

Referring to Figure 15, an implant 500 includes a spacer 502, a first

504, and a second movable extension 506. Spacer 502 includes a plurality of curved radii 508, 510 extending parallel to the longitudinal axis 512 distal to first extension 504. In the example of Figure 15, spacer 502 includes a pair of opposing “C” shaped rays 508, 510, with their concave surfaces directly internally. Spacer 502 includes openings 514 through radii 508, 510, and defines extended openings 516, 518 and thereafter between the radii. The movable extension 506 includes a body in the form of a broken ring 520. The ring 520 is opened anteriorly and the opening margins further define straight hooks 522, 524. The inner surface 526 of the ring generally conforms to the outer surface of the rings. 508, 510 so that the ring is slidably receptive on spacer 502. The anterior opening configuration of ring 520 provides clarity by facilitating sliding of the ring in vivo. A screw 528 is tightened against the spacer 502 to secure the movable extension 506 to a desired longitudinal position on the spacer. The hooks 522, 524 bend around a portion of the front edge of the spokes 508, 510 to resist further translation of the ring to the spacer 502 when screw 528 is tightened.

Referring to Figure 16, an implant 600 is illustrated as being similar to implant 500 of Figure 15 having a spacer 602, a first extension 604, and movable extension 606. However, ring 608 is anteriorly truncated to provide even more. earlier clarity than ring 520 of Figure 15. Ring 608 includes a key 610 projecting anteriorly from the rear side of ring 608 and expanding top and bottom to engage inner surface 612 of spokes 614, 616 to resist further translation of the ring with respect to spacer 602. Key 610 also partially blocks the interior void 618 of spacer 602 to help retain material optionally embedded within 618.

Referring to Figure 17, an implant 700 includes a spacer 702, a first extension 70, and a second movable extension 706. The spacer 702 includes a sidewall 708 defining an outer surface 710 and an inner surface 712. In the Example Example 17, the spacer 702 is generally in the form of a hollow level cylinder with a "D" cross section. However, spacer 702 may be of any desired shape. Spacer 702 includes a plurality of openings 714 communicating from outer surface 710 to inner surface 712. Moveable extension 706 includes a projection 716 generally configured as spacer 701, but is sized to slide within spacer 702 in a relationship. telescopic. The projection (or spacer) may optionally include one or more clamping mechanisms for locking the extensions 704, 706 to a desired longitudinal spacing. The clamping mechanisms may include a bolt 718, a ridge 720 forming a break with a slot 722 or other feature, a detachable detent 724 with openings 714, and / or other suitable clamping mechanisms. Either or combinations of these mechanisms may be used and they may be reversed from the guidelines shown.

Referring to Figures 18-20, an implant 800 includes a spacer 802, a first extension 804, and a second movable extension 806. The spacer 802 includes a plurality of curved radii similar to Figures 15 and 16 except that in this example there are three radii 808, 810, 812. The radii project parallel to the longitudinal axis 814 distant from the first extension 804. In the example of Figure 18, the anterior radius 812 later includes opening slots 816. The posterior radii 808, 810 and anterior radius 812 define an elongated slot between them opening top and bottom. Posterior radii 808, 810 further define an elongated slot 820 between them opening laterally. Figure 20 illustrates a cruciform opening 822 defined by projecting slot 816 and slots 818 and 820 projected through first extension 804. Moveable extension 806 includes a body 824 sized to slidably engage slot 818. An optional shoulder 826 may previously project to the slot 816 for compelling slopes of the movable extension 806 relative to the first extension 804. The shoulder 826 may be sized for proximal fit within the slot 816 to prevent tilting of the movable extension 806 or may be sized smaller than the slot 816 to allow a certain amount of inclination. A set of screws 828 is provided for locking the movable extension 806 to the spacer 802.

Referring to Figure 21, an implant 900 is shown to be configured generally as that of Figure 16. However, an end wall 9025 adjacent to the first extension 904 includes a through probe 906 and movable extension 908. includes a wrench 910 with a through probe 912. Probes 906, 912 are provided with a fastener for securing extensions 904, 908 to a maximum spacing to prevent them from drifting apart. Fasteners may include threaded screws, cap screws, composite arc portion, cables, connector wires, bars, rods and / or other suitable fastener. In the Example of Figure 21, the fastener includes an elongated crimping receiving member 914, such as a handle, and crimping members 916, 918, such as ferrules or balls.

Referring to Figure 22, an implant 1000 includes a spacer 1002, a first extension 1004, and a second extension 1006. The spacer 1002 includes an outer surface 1008 defining one or more longitudinal grooves 1010 extending along the outer surface 1008 and through. of the first extension1004. First extension 1004 includes one or more corresponding slots 1012 having an externally radially extending portion 1014 through first extension 1004 and communicating with slots 1010. Slots 1012 have a radially internal extending portion 1016 defining a shoulder 1018 at one end of the grooves 1010. The second extension 1006 includes one or more corresponding projections 1020 which project longitudinally towards the first extension 1004 and terminating in a radially inner directed board 1022. The second extension 1006 additionally includes a diameter 1024 having an engageable conical opening with a free end 1026 of spacer 1002. Second extension 1006 is affixed to spacer 1002 by pressing boards 1022 against tapered end 1026 of spacer 1002 to open projections externally until boards 1022 engage slots 1010. The boards 1022 are slidable along the the slots 1010 until they exit through the slots 1012 and the boards 1022 snap internally over the shoulders 1018 and into the portions 1016. Confinements of the boards 1022 against the shoulders 1018 prevent the first and second extensions 1004, 1006 in shape. find themselves on the move. The tapered end engagement 1026 of spacer 1002 with diameter 1024 provides radial stability to the assembled assembly.

Referring to Figure 23, an implant 1100 includes a spacer 1102, a first extension 1104, and a second extension 1106. The spacer 1102 includes a transverse groove 1108 with a central drive 1110 having an enlarged head. Second extension 1016 includes a portion 1114 sized to fit into slot 1118 and an opening 1116 bordered by one or more angled boards 1118. Second extension 1112 is mounted to the spacer by pressing portion 1114 into slot 1108. with center control 1110 directed to opening 1116. Just as control 1110 is pressed through opening 1116, the boards 1118 flex outwardly to allow it to pass. Once the command 1110 is outperformed by the boards, the boards 1118 return to their original positions and snap behind the enlarged head of the 1112. In this configuration, the command 1110 retains the second extension 1106 longitudinally and the slot 1108 prevents the second one. extension 1106 of rotating about the longitudinal axis of implant 1100.

Referring to Figure 24, an implant 1200 includes a spacer 1202, a first extension 1204 and a second extension 1206. The spacer 1202 includes a solid cylindrical Yacht wall 1208 defining an interior void 1210. Extensions 1204, 1206 are similarly configured and each includes a projection 1212, 1214 sized for internal adjustment of spacer 1202. Extensions 1204, 1206 may attach to spacer by snapping, quick adjusting, bolting, and / or otherwise engage projections 1212, 1214.

With spacer 1202, alternatively or additionally, extensions 1204,

1206 may be attached to spacer 1202 with either of the illustrated fastening mechanisms such as with a screw as shown in Figure 3, or an elongated fastener as shown in Figure 21. In the example of Figure 24, extensions 1204, 1206 are longitudinally slit to form flexible petals 1216 that presses into spacer 1202. Extensions 1204, 1206 include openings 1218 to allow tissue growth, allow attachment of circlage members, and / or additional fixators attached to spinous processes .

The spacer 1202 of Figure 24 could have openings as shown in some of the other examples. Likewise, the other examples could have a solid surface as shown in Figure 24. Similarly the extensions of either example may be solid, having openings or otherwise advantageously configured.

Implants according to the present invention may be implanted using a variety of requirements and techniques. Surgical appeals may include superspinous ligament sacrificing the posterior appeals, superspinous ligaments preserving the posterior appeals, lateral appeals, and / or other appropriate appeals. Techniques may include leaving tissues at an unmodified surgery site or modifying tissues such as stuffing, grazing, roughness, and / or otherwise modifying them. For example, in Figure 1, a lateral approach is used and the spinous process is cut on its upper surface to widen the interspinous space to receive the implant 100. After the interspinous space is prepared, the spacer 102 is inserted into the space. interspinous. If the first extension 126 is present it may be pressed internally to fall close or to confine one or more processes. If a second extension is used, it is engaged with the spacer 102 and also optionally pressed internally. In Figure 1, opposing extensions 126, 128 having internally directed bone fasteners have been used and internally pressed so that the fasteners 132 engage the spinous processes 20, 21. The engagement of the linkers 132 with the upper spinous process is not. shown in Figure 1 because the extensions are adjusted upper and lower as shown in Figures 3, 8 and 9.

Referring to Figures 25 and 26, an instrument cluster 1300 is provided to facilitate lateral insertion of an implant into the interspinous space. The instrument set includes a plurality of inserters 1302, 1303 in which each inserter 1302, 1302 has a first or hand portion 1304 and a second or working portion 1306. Working portion 1306 is insertable into the interspinous space. Preferably, the hand portion 1304 extends transversely of the working portion 1306 in order to facilitate and manipulate the inserter 1302, 1303 while the working portion 1306 is in the spaced space. Hand portion 1304 and working portion 1306 may define a curve, angle, fit, and / or any other suitable transverse orientation. In the example of Figure 25, inserters 1302, 1303 are generally "L" shaped. The working portion 1306 tapers from a relatively wider transverse sectional dimension into a first spaced apart portion 1307 from its free end 1308 to a smaller transverse sectional dimension at its free end 1308. In the illustrative embodiment, the portion of work is tapered and tapers from a larger diameter to a smaller diameter. End 1308 defines a hollow end having an aperture 1310. Instrument assembly 1300 is provided with a plurality of similarly configured inserters having differently sized working portions 1306 such that end 1308 of an inserter 1302 will adjust the inner side. opening 1310 at the tip of another inserter 1303. Optionally, the working portion 1306 may be separated into opposing halves attached to opposing manuals 1314, 1316. As opposed manuals 1314, 1316 are moved relative to one another, the opposite halves of the working portion 1306 move relative to each other. In the illustrative embodiment, pushing manuals 1314, 1316 towards each other causes the working portion 1306 to expand as the opposite halves of the working portion 1306 are externally distal from one another.

When in use, a first inserter 1302 is inserted into the interspinous space. First inserter 1302 is relatively small to facilitate insertion. As the end 1308 is further inserted, the tapered working portion 1306 expands the interspinous space. Optionally, the interspinous space may be further expanded by expanding the working portion while entering the interspinous space somewhat as squeezing manuals 1314, 1316. A second, larger inserter 1302 is engaged with the first inserter 1303 by placing its hollow tip over the tip of the first insert 1303 and then passing the overlapping instruments back through the interspinous space to remove the first insert 1303 and insert the second insert 1302. As the end of the second insert 1303 is additionally inserted, the portion tapered work space expands the interspinous space. Optionally, the interspinous space may be further expanded by expanding the working portion while interspinous space is entered. Progressively wider inserters can be inserted in this mode until the interspinous space has expanded to the desired size. Once the desired size has been reached the appropriate implant size can be determined by noting the size of the last inserter. The inserter may optionally include indicia 1320 at the tapered working end corresponding to different spacer sizes to further facilitate implant sizing. The implant is inserted through the spacer 1402 with the end of the inserter as shown in Figure 26. The implant may be engaged within the hollow tip of the inserter or the tip may engage a hollow tip in the implant as shown. Spacer 1402 is present within the interspinous space as the inserter is removed.

Although examples of the implantation of spinous processes and associated instruments and techniques have been described and illustrated in detail, it should be understood that it is intended by way of illustration and example only and should not be taken by limitation. Accordingly, variations and modifications to the spinous process implant, instruments and techniques will be apparent to those of ordinary skill in the art, and the following claims are intended to cover all such modifications and equivalents.

Claims (43)

1. An implant for placement between the spinous processes of adjacent vertebrae and a spine, the implant is characterized by the fact that it comprises: a spacer with a first end, a second end, and a longitudinal axis extending the first end to a second end, the spacer having a sidewall generally parallel to the longitudinal axis and having operable lower and upper surfaces to confine the spinous processes and keep the spinous processes in a spaced apart relationship, the lower and upper surfaces being spaced apart. spaced by a distance corresponding to a minimum spacing between the spinous processes, and a first extension projection from the transverse spacer to the longitudinal axis to generally lie along the adjacent spinous spinous processes, the first extension being engageable. with the spinous processes to l imitate the maximum spacing between the spinous processes. Implant according to claim 1, characterized in that the first extension includes at least one engaging fastener with one vertebra, the fixture being selected from the group consisting of hooks, screws, nuts, teeth, stud, attachments , staples, and circlage elements. Implant according to Claim 1, characterized in that the first extension comprises a relatively softer first material and the fixative comprises a relatively harder second material. Implant according to claim 2, characterized in that by further comprising a second extension as opposed to the first extension, the second extension being axially translatable forward and distal from the first extension, the second extension including in at least one engaging fastener with one vertebra, the at least one first extension fastener and at least one second extension fastener projecting away from the respective extension in the prickly process to peck the spinous processes. Implant according to Claim 4, characterized in that the first extension fasteners are adjusted relative to the second extension fasteners such that the fasteners transit as the second extension is moved towards the first extension. Implant according to claim 4, characterized in that at least one fixative is angularly adjustable with respect to the extension. Implant according to claim 4, characterized in that a fastener is adjustable to vary the extending distance of the extension. Implant according to claim 4, characterized in that it is at least removable from the extension. Implant according to claim 8, characterized in that at least one fastener comprises a plurality of fasteners connected together in a common base, the common base being removably engageable with the extension. Implant according to claim 1, characterized in that the first extension has a first upper extending portion and a second lower extending portion, the upper and lower portions being adjusted before and after. relative to each other in order to generally define a fit in the Z format, the extensions of multiple implants in adjacent integer spaces being capable of being removable. Implant according to claim 1, characterized in that the spacer includes an anterior side between the upper and lower surfaces by pre-facing the lower and upper surfaces by confining the spinous processes, the spacer having spacer facing chamfers in its first and second ends. Implant according to claim 1, characterized in that the upper and lower surfaces of the spacer have an intermediate line and the first extension is adjusted posteriorly to the intermediate line so that the spacer is positioned in a more anterior relationship. the extension is positioned in a later relationship. Implant according to Claim 1, characterized in that the spacer comprises halves of the first and second spacers spaced apart longitudinally, the first and second halves being telescopically engageable. Implant according to claim 1, characterized in that it comprises a second extension as opposed to the first extension, the second extension being axially translatable in direction and distant from the first extension, the second extension defining a ring. engaging with the spacer in an axially slidable relationship. Implant according to claim 1, characterized in that it additionally comprises a second extension as opposed to the first extension, the second extension being axially transplaceable towards and away from the first extension, the second extension defining a partial ring. ending in hooks hookable with the spacer in an axially sliding relationship. Implant according to claim 1, characterized in that it further comprises a second extension as opposed to the first extension, the second extension being axially translatable towards and away from the first extension, the spacer having an outer surface and an inner surface and defining longitudinal slit communication from the outer surface to the inner surface, the second extension including a protrusion having an enlarged end, the protrusion being slidably engageable with the slit and being retained by the enlarged end confining the inner surface of the spacer. Implant according to claim 1, characterized in that it further comprises a second extension as opposed to the first extension, the second extension being axially translatable towards and away from the first extension, the second extension and the first extension being associated with a cable and crimped device. Implant according to Claim 1, characterized in that it further comprises a second extension opposing the first extension, the second extension being axially translatable towards and away from the first extension, one from the first and second extension. including one projection and the other of the first and second extensions defining an engageable aperture with the projection in a rapidly adjusting relationship. 19. Process for treating spinal column disease, characterized in that it comprises: providing a spacer having a first end, a second end, and a longitudinal axis extending from the first end to the second end. , the spacer having a side wall generally parallel to the longitudinal axis and having upper and outer outer surfaces adapted to confine the spinous processes and keep the spinous processes in a spaced apart relationship, the lower and upper surfaces being spaced apart a corresponding distance apart. at a minimum spacing between the spinous processes, a first extension extending externally superiorly and inwardly from the transverse spacer to the longitudinal axis to fall generally along the spinous processes, a second external extending superiorly and inferiorly, a second extending exter- upper and lower from the transverse spacer to the longitudinal axis to generally fall along the spinous processes as opposed to the first extension, the second extension being axially translatable and distant from the first extension; and inserting the spacer between the spinous processes of adjacent vertebrates to provide both an extension stop and bending stop. Process according to claim 19, characterized in that it comprises: securely attaching the extension to the spinous processes; and allow the adjacent vertebra to merge with each other 21. Implant for placement between the spinal processes of the adjacent vertebra of a backbone, characterized in that the implant comprises: a spacer having a first end, a second end, and a longitudinal axis extending from the first end to the second end. , the spacer having a sidewall generally parallel to the longitudinal axis and having upper and lower outer surfaces adapted to confine the spinal processes, the sidewall including at least one transverse opening communicating at least one of the upper outer surfaces. and lower inwardly to facilitate growing tissue, and at least one extension extending externally from the transverse spacer to the longitudinal axis to generally fall in at least one spinous process to maintain the spacer between the spaced processes. adjacent inhosos. An implant according to claim 19, characterized in that the spacer defines an inner void, at least one transverse opening comprising a plurality of transverse openings communicating from the upper and lower outer surfaces to the void. interior to facilitate tissue growth through the sidewall into the inner void to fuse the adjacent vertebrate. Implant according to claim 22, characterized in that it comprises a tissue promoting substance placed within the inner void to promote tissue growth within the spacer. Implant according to claim 19, characterized in that the sidewall comprises a porous structure and the transverse openings comprise a plurality of pores in the range of 1 pm to 500pm. Implant according to claim 19, characterized in that the spacer comprises a plurality of spaced apart inclined radii generally spaced parallel to the longitudinal axis. 26. The method of treating a spine disorder, characterized in that it comprises: a spacer having a first end, a second end, and a longitudinal axis extending from the first end to the second end, the spacer having a side wall generally parallel to the longitudinal axis and having upper and lower outer surfaces adapted to confine the spinous processes, the side wall including at least transverse opening communicating from at least one of the upper and lower outer surfaces internally to facilitate growing tissue. and at least one extension extending externally from the transverse spacer to the longitudinal axis to generally fall along at least one spinous process to maintain the spacer between adjacent spinous processes; inserting the spacer between the spinous processes of adjacent vertebrates; allow the adjacent vertebrate to fuse together. 27. Implant for placement between the spinous processes of adjacent vertebrae of a spine the implant is characterized by the fact that it comprises: a spacer having a first end, a second end, and a longitudinal axis extending from the first end to the At the second end, the spacer having a sidewall generally parallel to the longitudinal axis and having external surfaces adapted to confine the spinous processes and keep the spinous processes in a spaced apart relationship, the upper and lower surfaces being spaced apart at a distance. corresponding to a desired minimum spacing between the spinous processes, the sidewall defining an opening at each end; a first extension separated from the spacer and engageable with the spacer at the first end to extend transverse to the longitudinal axis; and a second extension separated from the spacer and engageable with the spacer at a first transverse end with respect to the longitudinal axis, the spacer being provided in a variety of upper and lower surface lengths and spacings, the spacer and extensions being capable of to be mounted intraoperatively. Implant according to claim 26, characterized in that the extensions engage the spacer in a quick-fit relationship. 29. Implant for placement between the spinal processes adjacent to a spine, the implant is characterized by the fact that it comprises: a spacer with a first end, a second end, and a longitudinal axis extending from the first end to at the second end, the spacer having a sidewall generally parallel to the longitudinal axis and having operable upper and lower surfaces to confine the spinous processes and keep the spinous processes in a spaced apart relationship, the upper and lower surfaces being spaced apart at a distance corresponding to a predetermined minimum spacing between the spinous processes; and a circling element, wherein the lower and upper surfaces of the spacer have an intermediate line and the circling element is adjusted after the intermediate line is in use, the spacer defining a fulcrum and the circling element extending around a portion of a vertebra is operative to propel a moment into the vertebra around the spacer. Implant according to claim 29, characterized in that the circling member engages the spacer. Implant according to claim 29, characterized in that it further comprises an extension extending transversely from the spacer and the circling member connects to the extension. Implant according to claim 29, characterized in that the circling member rigidly engages the implant with a vertebra. Implant according to claim 29, characterized in that the circling member elastically engages the implant with a vertebra. Implant according to claim 29, characterized in that the circling element extends through the spacer. 35. Method of treating spine disease Characterized by the fact that it comprises: inserting a spacer between the spinous processes of adjacent vertebrae; and attaching a circlage element to the adjacent vertebrae to propel a moment into the adjacent vertebra around the spacer. A method according to claim 35, characterized in that it further comprises: connecting the circling member to the spacer. A method according to claim 35, characterized in that it further comprises: tensioning the circling member to increase the space of the anterior disc between the adjacent vertebra. 38. Instrumentation for placing an implant between the spinal processes of adjacent vertebrae of a spine, the implant having an insertion end defining a hollow tip, the instrumentation characterized by the fact that it comprises: a first instrument having an operating portion and a hand portion connected to the hand and extending to a free end, the operating portion tapering to a wider transverse sectional dimension and closer to a smaller transverse sectional dimension and closer to the free end. ; and a second instrument having a manual and operative portion connected to the manual and extending to a free end, the operating portion tapering from a larger transverse sectional dimension and closer to the manual to a wider sectional transverse dimension. near the free end, the free end defining a hollow tip sized to engage the free end of the first instrument and sized to engage the hollow tip of the implant. An instrument according to claim 38, characterized in that the operative portion is divided into a plurality of operable portions for opening externally from one to another to expand the operative portion. The instrument of claim 38, wherein the operating portion comprises indications indicating the size of the funnel at various locations along the funnel. 41. Method of treating spinal disease Characterized by the fact that it comprises: inserting a tapered instrument between adjacent spinous processes; engaging one end of a spinous process spacer with the tip of the tapered instrument and the double back passage engaging the adjacent spinous processes to insert the spacer between the spinous processes, one of the spacers and the instruments comprising one hollow end for receiving the other end. 42. The method of claim 41 further comprising: inserting a first tapered instrument between the adjacent spinous processes; engaging the tip of a second tapered instrument with a tip of the first tapered instrument and passing the double back hitched between the adjacent spinous processes, one of the first and second instruments comprising a hollow tip for receiving the tip of the other of the first and second instruments; and engaging one end of the spacer with the tip of the second tapered instrument and passing the double-back hitch between the adjacent spinous processes to insert the spacer between the spinous processes. A method according to claim 19, characterized in that one of the spacers and second instrument comprises a hollow tip capable of receiving the tip of the other.