JP2007537834A - Functional spinal unit prosthesis - Google Patents

Abstract

An intervertebral joint replacement component capable of stabilizing an intervertebral joint in a tension state is provided.
An intervertebral joint replacement system having an elongated shaft portion (105) and a polyaxial screw having a groove, the shaft portion of the system being slidably received in the groove of the polyaxial screw. .
[Selection] Figure 2

Description

Disclosure details

[Related data]
This application is filed on Dec. 31, 2002, and is entitled “Prosthetic Facet Joint Ligament” (Attorney Docket No. DEP5014), US patent application Ser. No. 10 / 334,601. To enjoy the benefits. The specification of said application is hereby incorporated in its entirety by reference.

BACKGROUND OF THE INVENTION
One of the most common surgical procedures today is arthrodesis, or spinal fixation, that fixes two or more adjacent vertebral bodies together to reduce pain associated with the intervertebral disc There is art. In the United States alone, such procedures are performed approximately 300,000 times each year. The degree of clinical success varies considerably between skill levels and indications. It is also necessary to consider the associated risks and complications.

  Spinal fusion generally helps to remove certain types of pain, but reduced function due to limiting the patient's range of motion during flexion, extension, rotation, and lateral bending is also observed. I came. Further, it is believed that spinal fusion increases stress on adjacent unfixed motion segments (and thus promotes degeneration of this adjacent unfixed motion segment). In addition, pseudoarthrosis due to incomplete or ineffective fusion may reduce the patient's desired pain relief or not be achieved at all. Also, whether artificial or biological, the fixation device to achieve fixation may move out of the fixation site, thereby causing new serious problems for the patient. sell. Finally, the recovery period after fixation procedures may be long.

  Recently, several attempts have been made to regenerate the natural biomechanics of the spine through the use of artificial discs. Artificial intervertebral discs aim to restore articulation between the vertebral bodies to reproduce the full range of motion normally allowed by the elasticity of the innate intervertebral disc that directly connects to two opposing vertebral bodies . However, artificial discs developed to date do not adequately address the dynamics of spinal motion.

  In addition, posterior elements called facet joints (or facet joints) help to support axial load, torsional load and shear load acting on the spinal column ing. Furthermore, facet joints are movable joints that provide both sliding joint and load transfer functions. The articular surfaces of the facet joints come into contact by stretching, limiting rotation and increasing the compressive load. The articular surface also contacts at one side of the spine during lateral bending and axis rotation, again limiting rotation and transmitting the load.

  However, facet joints can also cause serious spinal abnormalities. In many cases, it can also be a significant cause of debilitating pain. The cartilage surface of the joint can be degraded by mechanical or biological factors, causing pain similar to that of other osteoarthritis or increasing stenosis and causing stenosis There is also. For example, a patient may suffer from facet arthritis, strong facet joint tropism or facet joint deformation, facet joint damage, and the like. There is currently no appropriate treatment for facet joint disorders. Although some reduction is possible by spinal arthrotomy or removal of the facet joint, it significantly reduces the stiffness of the spinal column for all motion surfaces of flexion, extension, lateral bending and rotation (ie, excessive It is also considered to be motility. In addition, problems with the facet joints can complicate treatment for other parts of the spine. For example, maladaptations of artificial discs include facet arthritis, lack of facet joints, strong facet tropism or facet joint deformity. Accordingly, there is a need for a facet joint replacement to address these issues.

  US Pat. No. 36,758 (Fitz I) describes an artificial facet joint in which the lower facet joint process, the matching upper facet process, or both are simply covered with a cap. Is disclosed. The cap covers or preserves the bone structure and articulation structure, since no preparation of bone or articular surfaces for the installation of the cap is required.

  However, simple capping on the facet process results in several potential disadvantages. If the facet joint is osteoarthritic, the cap cannot remove the cause of the pain. Furthermore, at least in the case of replacement of the osteoarthritic femoral head surface, capping of the articular bone has failed clinically due to mechanical loosening. This clinical failure is the result of the destruction of the periosteum and femoral head ligament, both of which serve to supply nutrients to the femoral head, thereby avascular necrosis of the bone support structure in surface replacement Is considered to happen. The corresponding problem may be due to capping of the facet joint process. Another potential disadvantage of facet capping is the wide range of anatomical morphological changes that exist not only between individuals, but also between intra-vertebral levels, and To accommodate anatomical changes due to hypertrophic or degenerative changes, a very wide range of sizes and shapes of caps may be required or may require significant rework.

  US Pat. No. 6,132,464 (Martin) describes articular surface replacements and means for supporting and securing these replacements to the posterior processes. The joint surface itself is described as having the same shape, position and orientation as the natural joint surface. This patent discloses a spinal facet prosthesis supported on a lamina (sometimes referred to as a posterior arch). Extending from the support structure is a lower and / or upper blade that replaces the cartilage of the facet joint. The prosthesis of US Pat. No. 6,132,464 generally preserves the remaining bone structure and therefore does not address pathologies affecting the associated cartilage or facet bone. In addition, the prosthesis of US Pat. No. 6,132,464 requires a fixed fit between the prosthesis and the lamellae. However, this lamella has a very complex and highly variable anatomical surface. As a result, in practice, it is very difficult to design a prosthesis that can be reproducibly positioned with respect to the lamina so that a blade that replaces the cartilage for the facet joint can be correctly placed.

  U.S. Pat. No. 6,132,464 describes an articulating surface and its attachment means, but not a capsule-type replacement.

  U.S. Pat. No. 5,571,191 (Fitz II) includes an upper part and a lower part in a pyramidal or conical shape, fixed on a facet joint and having a low friction mating surface. A facet joint prosthesis is described. This patent describes the joint surface and its attachment means, but does not describe the capsule-type replacement.

  The European spine magazine (Eur. Spine J.) by Gardner et al., Supplement 2 (Supp 2), 2002, pages S157-163, includes one or more serious cases related to degenerative disc disease. A graph (Graf) ligamentoplasty for stabilizing and reducing the mobility of symptomatic motor segments is disclosed. FIG. 1 shows a polyester band wrapped around a pair of pedicle screws extending from adjacent vertebral bodies. This ligament appears to be disclosed in US Pat. No. 5,092,866 (Breard). According to Gardner literature, a suitable Graf band secures the motion segment in lordosis with a facet joint that is very stable in a fully extended position. See page S159. Therefore, graph ligament formation is based on fixing the facet joint. The Gardner document does not disclose a movable ligament across the facet joint.

  Eur. Spine J., Volume 11, 2002, S164-169, by Senegas et al. Has a titanium intervertebral blocker between two spinous processes. A Wallis implant system comprising a titanium intervertebral blocker and a Dacron ligament in which a Dacron ligament encloses the spinous process is disclosed. See page S165. Therefore, the Senegas literature does not disclose a ligament that crosses the facet joint.

  International Patent Application Publication No. WO 00/53126 (Ogun) based on the Patent Cooperation Treaty of the World Intellectual Property Organization has a shape memory metal implant for fixing joints such as facet joints. It is disclosed.

  The Dynesys system is commonly used as a replacement for the natural posterior longitudinal ligament. In this system, the cable is housed in a plastic sheath and attached to the upper and lower pedicles. The Dynecy stem ligament does not cross the facet joint.

  US Published Patent Application No. 2003/0004572 (Goble) discloses a prosthesis that includes an intervertebral disc prosthesis and an intervertebral joint prosthesis. Goble does not disclose the facet ligament. FIG. 12 of Goble discloses a facet joint replacement system in which each of the upper and lower parts is secured to the upper and lower pedicles, respectively. However, the upper parts of the Goble system do not have an adjustment function (ie, the screw-to-joint distance is fixed). Second, the articular surface appears to be set higher than the pedicle screw that secures the lower part. In such cases, long-term bearing can cause the lower part to rotate about the axis of the lower pedicle screw.

[Summary of the Invention]
The inventors have emphasized that the natural facet joint is a true articulating joint in which the facet joint capsule and surrounding ligament play a very important role. The articular surface of the joint transmits compression and the facet joint capsule transmits tension. In flexion, the joint opens and the intervertebral joint capsule and supraspinous ligament (SSL) stretch. Several in vitro biomechanical studies have revealed the contribution of the facet joint capsule and surrounding ligaments to the stiffness of the entire motion segment in flexion. Although replacement of the joint surface may reduce pain, it does not fully restore joint function. Accordingly, the inventors have recognized the desire to stabilize the facet joint in tension.

  In one form of the invention, the patient's natural disc is replaced with an artificial disc, and the patient's natural intervertebral joint is replaced with an upper support component and a lower support component, which are then connected to the upper vertebrae. Stabilized in tension by an artificial ligament that is fastened to either the vertebrae or the lower vertebra, or has a fastener secured to either the upper or lower artificial facet component The

  Thus, in accordance with the present invention, first, the native but affected disc is replaced with an artificial disc that more fully provides the natural mechanical relationship provided by the innate healthy disc. Thus, the intervertebral disc component of the present invention more accurately simulates the physiological contribution of the intervertebral disc, and thus more closely approximates the complete innate disc.

  Also, according to the present invention, secondly, the natural facet joint capsule is replaced with an artificial construct that more fully provides the natural mechanical relationship provided by the natural healthy facet joint. In particular, by providing a ligament that stretches while resisting tension, thereby increasing joint stability, the present invention more accurately simulates the physiological contribution of the facet joint capsule, and thus is completely innate. Approximate the facet joint.

Therefore, a kit for treating according to the present invention, functional spinal unit (functional spinal unit) a (FSU), top of FSU has an upper vertebral body VB _U and an upper facet F _U vertebrae Vu, and comprises a lower vertebra and a lower vertebra VB _L and the lower facet F _L, these vertebral bodies defining a disc space between them, between the upper vertebral articular and between the lower vertebral In a kit in which the articular process defines the facet joint FJ,
a) a moving intervertebral disc configured to be inserted into the intervertebral disc space;
b) a facet joint replacement (“FJR”) configured to replace at least a portion of an innate facet joint including first and second facet processes;
c) a ligament configured to inhibit relative movement between facet joint processes;
A kit is provided.

Detailed Description of the Invention
Referring to FIGS. 10A and 10B, an upper vertebra having an upper vertebral body V _U and an upper facet joint process F _U and a lower vertebra having a lower vertebral body _VL having a lower facet joint process F _L are provided. An anatomical “functional spinal unit” or FSU is provided. The vertebral body is in the anterior A portion of the FSU and the facet joint is in the posterior portion P of the FSU. An intervertebral disc space DISC is arranged between the vertebral bodies. Between the facet joint processes is a “facet joint”. The supraspinatus ligament SSL is behind the spinous process. A posterior longitudinal ligament PLL is posterior to the vertebral body.

1 and 2, a kit for treating a functional spinal unit, wherein the FSU has an upper vertebral body V _U and an upper intervertebral joint process F _U , and a lower vertebral body VB. includes a lower vertebrae and a and a lower facet F _{L L,} these vertebral bodies defining a disc space between them, the upper facet and the lower facet is a facet joint FJ In the defining kit,
a) a moving intervertebral disc 101 configured to be inserted into an intervertebral disc space;
b) a facet joint replacement system 103 that includes an upper part 105 and a lower part 107 so that the system replaces at least a portion of the native facet joint including the first and second facet joint processes. A configured facet joint replacement system;
c) a ligament 109 configured to inhibit relative movement between the facet joints;
A kit is provided.

  The moving intervertebral disc component of the present invention can be any prosthesis that is capable of at least partially restoring the inherent disc motion. In a preferred embodiment, the moving disc is selected from the group consisting of an articulating disc, a cushion disc and a spring-biased disc. US Patent No. 5,071,437 granted to Stefee et al., US Patent No. 6,113,637 granted to Gill et al., US Patent granted to Bryan et al. US Pat. No. 6,001,130, US Pat. No. 4,759,769 granted to Hedman et al., US Pat. No. 5,527,312 granted to Ray, Ray et al. U.S. Pat. No. 5,824,093, U.S. Pat. No. 5,401,269 issued to Buttner-Janz, U.S. Pat. No. 5, Serhan et al. Various moving discs are described in 824,094. These documents are incorporated herein by reference in their entirety.

  Preferred articulating exercise devices are disclosed in US Pat. Nos. 5,556,431 and 5,674,296. These specifications are hereby incorporated by reference.

In some embodiments, the articulating motion disc is a three point design with two endplates and a core. Referring now to FIG. 3, in some embodiments, an articulating three-point motion disc
a) a first artificial vertebral endplate 371,
i) an outer surface 373 configured to engage the first vertebral body;
ii) an inner surface 375 having a first articulating surface 377, and
iii) a main body portion 379 connecting the outer surface and the inner surface;
A first artificial vertebral endplate 371 comprising:
b) a second artificial vertebral endplate 381, comprising:
i) an outer surface 383 configured to engage the second vertebral body, and
ii) an inner surface 385 having a first articulating surface 387;
A second artificial vertebral endplate 381 comprising:
c) a core member 391,
i) a first articular surface 393 configured to articulate with the first articular surface of the first endplate; and
ii) a second articular surface 395 configured to articulate with the first articular surface of the second endplate;
A core member 391 including:
Is included,
The core member creates a first articulation interface between the first articulating surface of the first endplate and the first articulating surface of the core member, and the first articulating surface of the second endplate; It arrange | positions so that a 2nd articulation interface may be produced between the 2nd articular surfaces of a core member.

In some embodiments, the articulating intervertebral disc is a two-point design with two endplates. Referring now to FIG. 4, in some embodiments, the articulating two-point motion disc 401 includes:
a) a first artificial vertebral endplate 431,
i) an outer surface 433 configured to engage the first vertebral body;
ii) an inner surface 435 having a first articulating surface 441, and
iii) a main body portion 443 connecting the outer surface and the inner surface;
A first artificial vertebral endplate 431 comprising:
b) a second artificial vertebral endplate 411,
i) an outer surface 413 configured to engage the second vertebral body, and
ii) an inner surface 415 having a second articulating surface 417;
A second artificial vertebral endplate 411 comprising:
Is included,
The first joint surface and the second joint surface are arranged to generate an articulation interface.

  The FJR component of the present invention can be any prosthesis that can at least partially replace the innate function of the innate facet joint. As described above, the facet joint is a movable joint that provides a slide joint and a load transmission function. The articular surfaces of the facet joints touch when stretched, limiting rotation and increasing the compression load.

  Referring now to FIG. 5, in some embodiments of the invention, the prosthetic upper facet joint component 511 and lower facet joint component 521 are separate parts. In its preferred form, the upper facet joint component 511 forms a fixation portion 513 having an outer surface 515 and an inner joint surface 517 configured to be attached to the first facet joint process, and the lower facet joint component. 521 forms a fixation portion 523 having an outer surface 525 and an inner articular surface 527 configured to be attached to the lower facet joint process. In this form, the internal joint surface is configured to form an articulation interface. For the purposes of the present invention, this embodiment is referred to as an “articulation prosthesis”. Each fixing portion is provided with a through hole 531 for storing a bone screw for fixing the bone.

  In some articulation embodiments, the first internal articulating surface is convex and the second internal articulating surface is concave. This creates a ball and socket joint that is well known in the art.

  In some articulation embodiments, each of the first and second internal articular surfaces is cylindrical.

  In some articulation embodiments, each of the first internal joint surface and the second internal articular surface is plane-shaped.

  In some embodiments, the first articulating surface and the second articulating surface have shape matching. In other embodiments, the first joint surface and the second joint surface do not have shape matching.

Referring now to FIG. 6, in a preferred embodiment, the facet joint replacement component includes:
a) Upper facet joint component 601 comprising:
i) a longitudinally long body 603 having an upper end 605 and a lower end 607, the lower end forming an inner surface 609;
ii) a fastening portion 621 having a distal streak configured to fasten to the bone and a proximal groove 623 configured to receive the upper end of the longitudinally long body; and
iii) a set screw 625 that is received in a groove proximal to the fastener;
An upper facet joint component 601 comprising:
b) Lower facet joint component 631,
i) body portion 633,
ii) an outer portion 635 configured to be attached to the bone and having a through screw hole 637;
iii) an inner portion having an inner surface 639 configured to articulate with the inner surface 609 of the upper facet joint component; and
iv) Fastening portion 641 received in the through screw hole 637,
A lower facet joint component 631, comprising:
Is included.

  Still referring to FIG. 6, in a preferred embodiment, the FJR upper part 601 includes a fastening portion 623 configured to be fastened to the pedicle portion of the upper vertebral body. This pedicle has been chosen as the mounting location because it has clinically proven ability to receive pedicle screws under load, long-term viability, and familiarity with surgery. For being a place that was done. The upper end is designed to extend from the facet joint region to the upper pedicle, and has a diameter designed to fit approximately within the striatum of the fastener and thereby be secured. The lower end has an inner surface 609 configured to support the lower FJR component.

  The set screw 625 shown in FIG. 6 locks only the longitudinally long main body to the fastening portion. However, in another embodiment, the set screw locks the longitudinally long main body and the ligament to the fastening portion. sell.

  Still referring to FIG. 6, the FJR lower part 631 includes a fastening portion 641 configured to be fastened to the pedicle portion of the lower vertebral body. This pedicle has also been selected as an attachment location. The fastening part in this case is a pedicle screw.

  As described above, in the conventional FJR system, it seems that the doctor cannot adjust the distance from the pedicle screw component to the joint surface component. The FJR system of FIG. 6 has particular advantages because this distance can be adjusted during surgery. In some embodiments, the upper part of the FJR of FIG. 6 includes a pedicle screw having a groove configured to receive the upper end of the longitudinally long body. In use, the pedicle screw is first inserted into the bone, and the longitudinally long upper end of the body (in this case a rod) is placed in the groove. The doctor can then slide the longitudinally long body against the groove until the appropriate location on the inner surface 609 is set. The physician can then insert a set screw 625 into the groove at the top of the upper end of the body that is long in the vertical direction to lock the position of the inner surface.

Therefore, according to the present invention, in the facet joint replacement part,
a) a body having an elongated first end and a second end forming an articulating surface;
b) Proximal with a shaft having a distal streak configured to be fastened to the bone and a transverse groove configured to receive an elongated first end of the longitudinally long body A fastening portion having an end;
Including
A part of the elongated first end portion of the longitudinally long main body is slidably accommodated in the groove of the fastening portion.
An intervertebral joint replacement component is provided.

  The FJR system of FIG. 6 also has the special advantage that the placement can be adjusted during surgery. In these embodiments, the pedicle screw is a polyaxial screw having a groove configured to receive the upper end of the body that is substantially longitudinally long. This multi-axial nature of the screw allows the physician to adjust the placement of the groove part of the screw and thereby adjust the placement of the articulating surface.

Therefore, according to the present invention, in the facet joint replacement part,
a) a body having an elongated first end and a second end forming an articulating surface;
b) a polyaxial screw configured to be adjustably fixed to a longitudinally long body;
An intervertebral joint replacement component is provided.

  The FJR system of FIG. 6 also has the particular advantage of reducing or eliminating the moment on the lower pedicle screw by ensuring that the articulation force is substantially transmitted through the lower screw. This is accomplished by ensuring that the articulating surface of the upper part substantially bisects the lower pedicle screw.

Therefore, according to the present invention, in the facet joint replacement part,
a) a first facet joint component,
i) a longitudinally long body having a first end and a second end, the lower end forming a first internal articulating surface; and
ii) means for attaching a longitudinally long body to the bone;
A first facet joint component comprising:
b) a second facet joint component,
i) body part,
ii) an outer portion configured to be attached to the bone and having a through hole;
iii) an inner portion having a second internal articulating surface configured to articulate with the internal articulating surface of the first facet joint component; and
iv) a fastening portion that is received in the through screw hole;
A second facet joint component, including
Including
The first internal joint surface and the second internal joint surface are configured to form an articulation interface that defines an articulation force vector;
An intervertebral joint replacement component is provided in which an articulation force vector is transmitted through the fastener.

  The FJR system of FIG. 6 allows both the upper and lower parts to be attached to or abut to another bone structure (eg, lamina, pedicle, transverse process or spinous process). It also has special advantages. The second attachment point may reduce or eliminate the moment on the pedicle screw.

Referring now to FIG. 7, in other embodiments, the upper and lower facet joint parts do not have an internal articular surface, but rather by an elastic cushion core. Are combined. In its preferred embodiment, the “cushion-type” prosthesis includes:
a) an upper facet joint component 201 forming an upper endplate having an outer surface 203 and an inner surface 205 configured to be attached to an upper facet joint process;
b) a lower facet joint component 211 forming a lower endplate having an outer surface 213 and an inner surface 215 configured to be attached to the lower facet joint process;
c) a resilient core 221 having an upper surface 223 configured to be attached to the inner surface of the upper facet joint component and a lower surface 225 configured to be attached to the inner surface of the lower facet joint component;
It has.

  For purposes of the present invention, this embodiment is referred to as a “cushion prosthesis”. In its preferred embodiment, the device comprises an elastomer configured to be elastically compressed during an axial load and to relax when the load is removed.

  In embodiments of the present invention that include a prosthesis having an upper facet joint part and a lower facet joint part, the fixations may include attachments. Preferred attachments are selected from the group consisting of teeth, keel, spikes, pins, holes and combinations thereof.

In some embodiments, referring again to FIG. 5, the facet joint replacement component is
a) an upper facet joint component 511 having an upper fixation portion 513 having an outer surface 515 configured to be attached to the upper facet joint process;
b) a lower facet joint component 521 having a lower fixation portion 523 having an outer surface 525 configured to be attached to the lower facet joint process;
Is provided.

  In some embodiments, the attachment surface of the FJR is configured to attach to the spinous process. In some embodiments, the mounting surface of the FJR is configured to attach and / or support the thin plate portion. In some embodiments, the FJR attachment surface is configured to attach to the pedicle. In some embodiments, the mounting surface of the FJR is configured to be attached to the transverse protrusion. In some embodiments, the attachment surface of the FJR is configured to attach to the natural facet joint process.

  In some embodiments, the attachment of the FJR attachment surface to the bone is enhanced by the use of an adhesive such as a fibrin adhesive or bone cement.

  In some embodiments, the fastener and / or the bone attachment surface of the FJR component includes a material having bone biological properties. This material aids the bone integration process necessary to securely attach the fasteners and / or attachment surfaces to the bone.

  In some embodiments, the fastening portion and / or the mounting surface comprises an orthoconductive portion. The orthodontic part is typically porous (preferably between about 20 μm and 250 μm) configured to allow the entry of osteoconductive cells and adheres to these cells And an inner surface defined by a porosity configured to. In some embodiments, the fastening portion has an outer surface configured for bone ingrowth. The outer surface may have an osteoinductive coating thereon such as a TCP coating or a hydroxyapatite coating.

  In some embodiments, the fastening portion and / or the attachment surface comprises an orthoinductive portion. The portion having the correction-inducing property is preferably a protein, and more preferably a growth factor. Preferred growth factors include TGF-β, IGF-, BMP-, and CDMP-based growth factors. It is preferred that MP52 is selected as CDMP.

  In some embodiments, the fastening portion and / or the mounting surface comprises an orthogenetic portion. This directed evolution portion preferably has mesenchymal stem cells. More preferably, the MSC is present at a higher concentration than that in the patient's natural bone marrow.

  In some embodiments, the fasteners and / or attachment surfaces may be coated with other desired agents such as antithrombotic or antimicrobial coatings and analgesics such as NSAIDS.

  In some embodiments, the fastener component of the FJR system is a pedicle screw. In some embodiments, the pedicle screw comprises a longitudinally long shank with an integral nut. At the distal portion of the nut, the shank has a first distal streak on the shank and a distal tapered end. At the proximal portion of the integrating nut, the shank has a second proximal streak on the shank and a proximal mounting end with a slot.

  In some embodiments, the pedicle screw is a polyaxial screw.

  In some embodiments, the fastener has a cannulated shank that defines a hole that is adapted to allow bone ingrowth into the hole. In some embodiments, the hole defines an inner surface configured to allow bone ingrowth. The inner surface can have an osteoinductive coating thereon, such as a TCP coating or a hydroxyapatite coating.

  The upper and lower facet joint parts of the present invention may be made from any material suitable for human surgical implantation, including all surgical materials such as titanium, titanium alloys, chromium alloys and stainless steels. Suitable metals and non-metallic materials such as, but not limited to, carbon fiber materials, resins, plastics and ceramics.

  If an elastic core is selected, the core may include polyurethane, foamed polyethylene, silicone, rubber, copolymer or hydrogel.

  In some embodiments, the FJR component is single-sided. Unilateral FJRs at least partially replace the function of a single facet joint. In some embodiments, the FJR component is double-sided. A bilateral FJR at least partially replaces the function of both facets of the FSU.

  In some embodiments, the FJR component replaces a single facet process of the facet joint. The replacement process is configured to articulate with the remaining natural facet joint process. In some embodiments thereof, the upper protrusion is replaced, and in other embodiments, the lower protrusion is replaced.

  In other embodiments, the FJR component replaces both facet joint processes of the facet joint, and these replacement processes articulate with each other.

  In some embodiments, substantially the entire facet process is replaced with an artificial FJR. In other embodiments, substantially only the articular surface of the subject process is replaced, thereby preserving the underlying bone structure. This replacement surface is configured to articulate with the remaining natural facet surface. In some embodiments, the replacement surface comprises a cap.

  In some embodiments, the FJR component is a single level FJR. A single level FJR at least partially replaces the function of a single level FSU. In some embodiments, the FJR component is a multi-level FJR. A multi-level FJR at least partially replaces the facet joint function at at least two levels of the FSU.

  In some embodiments, the FJR is configured to replace the natural vertebra, and thus includes a lateral vertebral component. In some embodiments, the FJR is configured to replace an innate process, and thus includes a spinous process component. In some embodiments, the FJR is configured to replace at least one native transverse process, and thus includes a transverse process component. In some embodiments, the FJR is configured to replace at least one pedicle, and thus includes a pedicle component.

Next, referring to FIGS. 8A to 8D, in the generic ligament 3 of the present invention,
i) middle part 5,
ii) first and second ends 7, 9, and
iii) portions 11 and 13 having first and second shape conformability,
Have
The first shape conformable portion is disposed between the intermediate portion and the first end portion, and the second shape conformable portion is disposed between the intermediate portion and the second end portion. And
iv) first and second fastening portions 15, 17;
Have
The first end 7 has a shape that cooperates with the first fastening portion 15, and the second end 9 has a shape that cooperates with the second fastening portion 17. A universal ligament 3 is provided.

  In some embodiments, the fastening portion is selected from the group consisting of bone screws, hooks, wires, and pins. In some embodiments, the middle portion of the ligament is selected from the group consisting of a cable, a wire, an interconnecting surface, and a flexible polymer coupled to the fastener and extending between the upper and lower fasteners. .

  In one embodiment of the invention, the facet joint is stabilized in both compression and extension by an artificial ligament having fasteners secured in the upper and lower vertebrae or upper and lower artificial facet joint components. In some embodiments, the fastening portion is selected from the group consisting of bone screws, hooks, wires, and pins. In some embodiments, the middle portion of the ligament is selected from the group consisting of a cable, a wire, an interconnection surface, and a flexible polymer coupled to the fastener and extending between the upper fastener and the lower fastener. Is done.

  In a preferred embodiment of the present invention, the ligament has the shape of a sheath that can prevent debris generated by the articulation of the facet joint process from spreading to surrounding tissues, particularly various nervous system structures. Previous facet joint replacement inventions describe surface regeneration techniques that replace the contact surface between the facet joint and the metal or polymer. Due to the unique movement of the facet joints, these regenerated contact surfaces inevitably generate wear debris and tend to irritate the tissue. A thin film or sheath that surrounds the contact surface and captures the generated particles can reduce tissue irritation and inflammation. These membranes or sheaths themselves also have structural integrity and can resist excessive stretching, thereby providing resistance to tensile strength.

  In some embodiments, the sheath is much wider. Preferred sheaths have a size that substantially encompasses the facet joint. In some embodiments, the sheath is liquid permeable. This feature allows the ingress of fluids that help lubricate the joints while preventing wear debris from coming out of the joint surfaces of the facet joints. In some embodiments, the sheath includes a lubricating liquid, thereby mimicking the natural facet joint capsule. In preferred embodiments, the sheath may be pre-assembled prior to implantation, or may be attached by embedding adhesives, sutures, wires, thermally activated coagulation or in situ polymers.

  In a preferred embodiment, the artificial vertebral joint ligament can be attached to the conjugation point on the opposite side of the natural or artificial intervertebral joint so as to inhibit relative movement of the facet joint.

The ligaments of the present invention can be made from any biocompatible material configured to inhibit, but not eliminate, the relative motion between the facet joints. In this regard, the facet ligament of the present invention mimics the natural facet joint capsule. The ligament of the present invention has three characteristics. First, the ligament must be configured to cross the facet joint. Second, the ligament must allow some degree of flexion across the facet joint. Third, the ligament must be resistant to excessive flexion of the facet joint.

  In a preferred embodiment, the ligament comprises a pair of attachment ends and an intermediate portion.

  The middle portion of the ligament can be configured to have favorable mechanical properties found in ligaments such as elasticity, flexibility, tensionability and extensibility. The combination of these properties allows the articular surface to be somewhat displaced but resists excessive displacement.

  The middle part of this facet joint ligament includes polyester (especially aromatic esters such as polyalkylene terephthalate); polyamide; polyalkene; poly (vinyl fluoride); polyurethane; polytetrafluoroethylene ( PTFE); carbon fiber; silk; rubber; hydrogels and glasses, and non-bioresorbable materials including mixtures thereof are preferably included.

  The middle portion of the facet ligament is preferably a woven fabric. This knitted fabric can be made by planar or annular weaving, knitting, braiding, croching or embroidery. The woven or knitted fabric is preferably braided to obtain a high tensile strength. Suitable materials for use as this woven or knitted fabric include polyester, polypropylene, polyethylene, carbon fiber, glass, glass fiber, polyurethane, polyaramid, metal, polymer, copolymer, polylactic acid (PLA), and polyglycolic acid (PGA). Silk, cellusoseic acid and polycaprolactone fibers are preferred.

  During use, the intermediate portion of the facet joint ligament is rubbed into a soft tissue structure, and it is conceivable that not only these structures, but also the intermediate portion itself is damaged. Thus, in some forms, lubricity is imparted to the middle portion of the facet ligament. This lubricant reduces the coefficient of friction between the ligament and the soft tissue, thereby reducing wear. As the lubricant, hyaluronic acid, proteoglycan and hydrogel are preferable.

  In some embodiments, the ligament comprises a material having orthobiologic properties. This material helps the body regeneration process regrow the natural ligament and replace the artificial ligament of the present invention with the natural ligament.

  In some embodiments, the ligament comprises a material having analgesic properties, such as an NSAID.

  In some embodiments, the ligament has an orthoconductive portion. This orthodontic inductive portion typically adheres to these cells (preferably about 20 μm to 250 μm) with a porosity configured to allow the entry of osteoinductive cells. And an inner surface defined by this porosity. In some forms, the portion having correction inductivity has subintestinal submucosa (SIS). In other embodiments, the moiety comprises a synthetic polymer.

  In some embodiments, the ligament has a portion that is orthodontic. This straightening-inducing portion is preferably a protein, and more preferably a growth factor. Preferred growth factors include TGF-β and IGF-type growth factors.

  In some embodiments, the ligament has a directed evolution portion. This directed evolution portion preferably comprises mesenchymal stem cells, more preferably MSC (mesenchymal stem cells) are present at a higher concentration than in the patient's native bone marrow.

  In some embodiments, only the middle portion of the ligament comprises orthodontic biological material. In some embodiments, only the attachment end of the ligament comprises orthodontic biological material. In another form, each of the middle portion and the attached end of the ligament includes orthodontic biological material.

  The ligament is preferably provided in a sterile state. In some embodiments, the ligament is sterilized and then packaged. The inner surface of the package is also preferably sterilized.

  In some embodiments, the middle portion of the ligament can be tensioned. When the ends of the ligament are sufficiently close together and the length of the ligament becomes shorter than the distance between the ends, the tensionable ligament becomes relaxed. This property allows opposing facet joint processes to be closer together in the loaded state without receiving resistance from the ligament. A tensionable ligament also becomes taut when its ends are sufficiently separated from each other so that the length of the ligament is approximately the same as the distance between the ends. This property suppresses relative movement between opposing facet joint processes. In some embodiments, the tonicity of the ligament is between 5 N / mm and 50 N / mm.

  In some embodiments, at least a portion of the middle portion of the ligament is stretchable. The extensible ligament takes a first at-rest length when the end is unloaded and becomes a second, larger length when the ligament is in tension. This property allows the ligament to “give” a predetermined amount under tension. This property is advantageous because the natural facet joint ligament is also extensible. When given a load of about 250 N, the ligament preferably has an extensibility between 10% and 30% of its resting length. In some embodiments, the extensibility of the ligament is between 5 N / mm and 50 N / mm. In other embodiments, the ligament is not stretchable.

  In some embodiments, at least a portion of the middle portion of the ligament is flexible. A flexible ligament bends easily under an axial load with a bending / physiological bending load and easily regains its original shape when the load is removed. This property allows the ligament to “give” a predetermined amount while transmitting stress under an axial load. This property is advantageous because the natural facet joint ligament is also flexible. The flexible portion of the ligament preferably includes a bent portion.

  Preferably, the ligament is configured to allow a controlled movement of the FSU throughout the life of the patient. However, during the period immediately after the part is implanted, the human tissue in the wound area is severely damaged and therefore requires a relatively stable environment for healing. Furthermore, during the initial period after this operation, both the motor disc and FJR components need to be integrated with the bone surface to which they are attached, so a relatively stable environment also seems to be needed. .

  As such, in some embodiments, the ligament is designed to have properties that can change over time. In particular, the ligament is configured so that its stiffness decreases with time. In this condition, the ligament may provide the desired high stiffness during the period immediately following surgery, thereby stabilizing the region and promoting tissue repair and osteointegration. As the wound is healed, the parts are integrated and the stiffness of the ligament is reduced, thereby allowing the desired range of motion of the FSU.

  This ligament preferably has a final (6 months) FSU stiffness in the range of about 1 Nm / (bending degree) to 2 Nm / (bending degree). Similarly, this ligament preferably has a final (6 months) FSU stiffness in the range of about 2 Nm / (stretch) to 3 Nm / (stretch). In some embodiments, the initial stiffness of the ligament is between about 2 to 4 times the final (ie 6 months) stiffness. If the initial stiffness is greater than about 4 times the final stiffness, then coalescence is considered to result. However, the present invention is not limited by this theory.

  These values provide both the desired high stiffness required for the initial stabilization of the damaged area and the long-term flexibility of the FSU.

  In some embodiments, providing a ligament that exhibits significant creep over time allows the stiffness of the ligament to be varied. In a preferred embodiment, the ligament exhibiting creep includes a polymer, preferably selected from the group consisting of polyester, polyolefin and PTFE.

  In a preferred embodiment, providing a resorbable material in the ligament allows the stiffness of the ligament to be varied. In some embodiments, the ligament comprises both a non-resorbable material and a resorbable material. After implantation, each of the non-resorbable and resorbable materials contributes to the high initial stiffness of the ligament. Over time, the resorbable material decomposes, thereby reducing the stiffness of the ligament. In some embodiments, the middle portion of the ligament includes non-resorbable fibers and resorbable fibers. In a particularly preferred embodiment, the middle portion of the ligament includes non-resorbable fibers and resorbable fibers selected from the group consisting of PLA, PGA, PLGA, and mixtures thereof.

  Each attachment end of the ligament is configured to be attached to an opposing fixation surface of the facet joint. Typically, the attachment end includes a fastening portion. In other cases, it can be attached with sutures or biocompatible adhesives. However, in other embodiments, the attachment end may simply be the same end as the intermediate portion in design. In such a case, this end is inserted into a port in the anchoring surface, such as a prosthetic port having a facet joint surface.

As noted above, in some embodiments, the attachment end of the facet ligament has a pair of fasteners. The function of the fastener is to couple to the attachment surface on either side of the facet joint and to securely fasten the middle portion of the facet ligament across the facet joint. The fastening part is the facet joint ligament,
It may be configured to have a structure that fastens to an attachment surface on either a) a facet prosthesis component or b) a bone surface adjacent to the facet prosthesis component.

  The attachment end of the artificial ligament of the present invention can be attached to any two fixation surfaces on opposite sides of the facet joint as long as the ligament crosses the facet joint. These anchoring surfaces may be located on the bone surface of the opposing vertebra or other artificial facet joint component.

  In one embodiment, the first attachment end of the ligament is configured to attach to the first load bearing portion of the facet joint prosthesis. This embodiment is easy to handle for the physician in that attachment can be made by the manufacturer prior to surgery, thereby providing ease of use and repeatability.

  In some embodiments in which the ligament is attached to a pedicle screw, at least one end of the ligament includes a loop having a diameter that is slightly larger than the axial diameter of the pedicle screw. In use, a pilot hole is drilled in the pedicle, a loop is placed over the pilot hole, and a pedicle screw is inserted into the pilot hole, thereby securing the loop therebetween.

  In another embodiment, the first attachment end of the ligament is configured to attach to a portion of an innate vertebra. In some embodiments thereof, the vertebral body is used as the anchoring surface. In its preferred embodiment, the pedicle portion of the vertebral body is used as the anchoring surface. In another embodiment, the facet portion of the vertebra is the anchoring surface. In other embodiments, the side wall of the spinous process is used as the anchoring surface, as shown in FIG. In this particular case, the upper and lower fastening portions 901 of the ligament 903 are each attached to the respective side walls 905 of the upper and lower spinous processes, respectively. In another embodiment, the first end of the ligament is configured to be attached to a transverse process. In another embodiment, the first end of the ligament is configured to be attached to the pedicle. In another embodiment, the ligament is wrapped around the facet joint.

  In embodiments where at least one attachment end of the ligament is attached to bone, the method described in US patent application Ser. No. 09 / 822,126, filed Mar. 30, 2001, may be used. This specification is hereby incorporated in its entirety by reference.

  The fastener may be of any known design in the art, such as a winged, barbed, or screwing mechanism. It is preferable that the fastening portion is a barbed anchor because it is prevented from being pulled out and is easily inserted. If the attachment surface is a bone surface, the fastener may be a bone fastener.

  Next, referring to FIG. 8C, the fastening portion 19 includes a longitudinally long shaft portion 21, an insertion end portion 23 having a protrusion 25 extending laterally from the shaft portion, and an upper side surface 31 for connecting to a ligament. It is preferable that the mounting end portion 27 is provided. The lateral protrusion preferably has a tip 28 that defines an angle α of 45 ° or less with respect to the axis of the shaft. In such embodiments, the distal support surface relative to the vertebral body surface does not substantially prevent the bone fastener from progressing into the bone. The tip preferably defines an angle of 30 ° or less, more preferably between about 20 ° and 30 °. If the angle α is between 20 ° and 30 °, this angle is small enough not to prevent the bone fastener from progressing and large enough to be securely fixed. In some embodiments, the height H of the bone fastener protrusion is no more than 70% of the longitudinally long shaft diameter D. When this condition is selected, the risk that the process becomes stepped and the bone fastener stops further entering the vertebra is minimized. The H / D ratio is preferably 40% or less, more preferably between about 20% and 40%. Within this more preferred frame, the height of the protrusion is sufficiently small that it does not impede the progression of the bone fastener and is large enough to be securely fixed.

The outer diameter (2H + D) of the bone fastener is preferably between about 3 mm and 9 mm, more preferably between about 4 mm and 6 mm. The length L _BF of the bone fastener is preferably between about 3Mm～45mm, more preferably between about 15 mm to 25 mm.

  In some embodiments, the attachment end of the bone fastener is made from a ceramic material. If the bone fastener is ceramic, it can reliably withstand the high impact of the driver.

  In some embodiments, at least the end and the attachment end of the intermediate portion of the bone fastener are made from the same material. If the material is so selected, these parts can be easily fabricated and connected together in advance. This feature also eliminates the need for sutures.

Still referring to FIG. 8C, in another aspect of the invention, the attachment end 27 of the fastening portion is configured to receive a driver element. When this configuration is selected, the bone fastener can be pushed into the bone only by applying an axial force to the upper side surface 31 of the fastening portion by the driver. Therefore, according to the present invention, in the facet joint ligament,
a) a ligament having a first end and a second end;
b) a first fastening portion and a second fastening portion;
With
The first bone fastener is coupled to the first end of the ligament, the second bone fastener is coupled to the second end of the ligament, and the first bone fastener is configured to receive the driver. ing,
An intervertebral joint ligament is provided.

  This configuration preferably defines a recess 29 on the upper side 31 of the attachment end 27 of the fastening portion. The recess 29 is configured to receive a driver (not shown).

  In some embodiments, the bone fastener recess 29 may be configured to allow a rescue screw to be inserted, thereby allowing retrieval of the bone fastener.

  In some embodiments, the fastener includes a material having orthodontic biological properties. This material aids the osteointegrative process necessary for secure attachment of the fastener to the bone.

  In some embodiments, the fastening surface includes a portion having straightening inductivity. The correction-inducing portion typically has a porosity (preferably between about 20 μm and 250 μm) configured to allow the entry of correction-inducing cells and adhere these cells. And an inner surface defined by the configured porosity.

  In some embodiments, the fastening portion includes a portion having correction inductivity. The portion having the correction-inducing property is preferably a protein, and more preferably a growth factor. Preferred growth factors include TGF-β, IGF-, BMP-, and CDMP-based growth factors. It is preferred that MP52 is selected as CDMP.

  In some embodiments, the fastening portion includes a directed evolution portion. The directed evolution portion preferably includes mesenchymal stem cells. More preferably, the MCS is present at a higher concentration than that in the patient's native bone marrow.

The ligament part and the fastening part part are preferably connected in advance. That is, these parts are physically attached before being placed on the spine. Pre-joined parts are beneficial because they ensure a secure attachment to each other and do not waste time for the physician to do so. The parts can be pre-coupled by physical locking, physical connection or adhesion, or making the parts from the same material and connecting them together. When the pre-connected parts are integrally formed (eg, by molding or thermoforming), there is no risk of micromotion. Therefore, according to the present invention, in the facet joint ligament,
a) a ligament having a first end and a second end;
b) comprising a first fastening portion and a second fastening portion;
The first fastening portion is pre-connected to the first end of the ligament and the second fastening portion is pre-connected to the second end of the ligament,
An intervertebral joint ligament is provided.

  In some embodiments, at least a portion of the ligament includes a spring. Due to the nature of the spring, the ligament can initially yield and eventually resist an axial compressive or tension load. In some embodiments, the spring is an expansion spring. In other embodiments, the spring is a compression spring.

  In some embodiments of the invention having both a pair of artificial facet and artificial facet ligaments, the extension of the native spine is limited by the invention. In these embodiments, the extension is limited to 7 ° or less. It is preferable to be limited to 5 ° or less. In order to limit stretch in this manner, the device preferably produces a spinal stiffness of at least 2 Nm / °.

  In some embodiments of the invention having an artificial facet ligament, flexion is resisted by the invention. In these embodiments, the bend is limited to 15 ° or less. It is preferably limited to 12 ° or less. The tensile strength of the artificial facet joint capsule is preferably between 50N and 300N. It is preferably at least 100N, more preferably at least 200N.

  In some embodiments of the invention having both a pair of artificial facet surfaces and an artificial facet ligament, axial rotation is subject to resistance according to the invention. In these embodiments, a pair of devices of the present invention is used so that each facet joint of the functional spinal unit has one device so that the first device rotates axially. Preferably, the ligament of the second device is placed under tension. This movement tends to generate a combined motion with flexion and lateral bending. In some embodiments, the prosthetic surface of the first device is strong enough to withstand a compressive force of at least 100N, more preferably at least 150N, and even more preferably at least 200N.

  In some embodiments of the invention having both a pair of artificial facet surfaces and an artificial facet ligament, at least anterior-posterior shear is subject to the resistance of the invention. In these embodiments, the artificial joint surface is in contact and the artificial joint surface is strong enough to withstand an anterior-posterior contact shear force of at least 500 N, more preferably at least 750 N, and even more preferably at least 1000 N. Have

  In some surgical procedures, such as laminectomy, the patient's supraspinatus ligament (SSL) is often damaged. SSL is important for the stability of FSU because it plays an important role in suppressing patient flexion. Since SSL has the greatest moment with respect to the spinal axis of the ligament associated with the spine, damage to the SSL can result in significant instability in the FSU. Thus, in some embodiments, the ligaments of the present invention are configured to at least partially replace SSL functionality. In such embodiments, the ligaments of the present invention have high flexibility and high ultimate tensile strength. The artificial SSL preferably has a tensile strength of at least 50N, preferably at least 100N, more preferably at least 150N, and most preferably at least 200N.

  In another embodiment, the ligament of the present invention is configured to at least partially replace the function of the interspinous ligament (ISL).

  In another embodiment, the ligament of the present invention is configured to at least partially replace the function of the facet joint capsule (FC).

  In another embodiment, the ligament of the present invention is configured to at least partially replace the function of the yellow ligament (LF). This embodiment may be selected when the back bow is removed.

  In another embodiment, the invention relates to the function of at least two ligaments selected from the group consisting of supraspinous ligament (SSL), interspinous ligament (ISL), facet joint capsule (FC) and yellow ligament. Two ligaments configured to at least partially replace are included.

  In another embodiment, the present invention provides at least three ligament functions selected from the group consisting of supraspinous ligament (SSL), interspinous ligament (ISL), facet joint capsule (FC) and yellow ligament. Three ligaments that are configured to partially replace are included.

  In another embodiment, the present invention is configured to at least partially replace the respective functions of the supraspinous ligament (SSL), the interspinous ligament (ISL), the facet joint capsule (FC), and the yellow ligament. Three ligaments are included.

  The present invention may be used in treatment procedures designed to reduce arthritis, stenosis, spondylolisthesis, post laminectomy and scoliosis and scoliosis.

  The present invention can also be used in connection with the following surgical procedures: decompression laminectomy, facet joint resection, lamellar resection and vertebroplasty.

[Example 1]
This desk-top experimental example shows one method of implanting the parts of the present invention.

  In some embodiments, the name “Method and Apparatus for Disc Insertion” (Attorney No. 3518.100- filed on March 31, 2004, filed by Hawkins et al. The vertebral disc is implanted substantially in accordance with the method described in US Provisional Patent Application No. 60 / 459,280. The specification of this application is incorporated herein by reference in its entirety.

  First, the doctor adopts a standard posterior approach (bilateral or unilateral) to cover the facet joint process. The doctor then cuts (removes) the facet process using a standard resection instrument such as a bone forceps or curette.

  The physician then prepares the surface of each pedicle so that the pedicle screw can be inserted. This requires finding the appropriate trajectory, exploring the pilot hole, and creating the pedicle surface to accommodate the screw.

  The physician then implants the upper pedicle screw into the upper pedicle and places the end of the ligament loop around the screw head.

  Next, the doctor places the longitudinally long part of the upper part in the groove of the screw head, then places the set screw on the longitudinally long part, effectively fixing the longitudinally long part To do.

  The length of the upper part should be such that one surface abuts the natural upper vertebra. If the physician wants to adjust the length of the upper part, the physician need only loosen the upper screw and readjust to the desired length.

  Now that the position of the upper part is fixed, the upper part can be used as a template for fixing the position of the lower part. In particular, the articulating surfaces of these two parts (typically leaving a gap between them) are aligned at the desired location. This alignment should be such that the lower articulation force is transmitted through the axis of the lower pedicle screw. When the alignment is fixed, a mark is made at the position of the screw hole and a pilot hole is drilled.

  The end of the ligament annulus is then placed around the pilot hole and the lower body is positioned so that the pilot hole is aligned with the hole in the lower part.

  Finally, a pedicle screw is inserted through the lower part and through the pilot hole, thereby fixing the position of the lower part.

  Some of the aforementioned facet joint replacement constructs provide the necessary limitations on flexion, extension, and rotation of functional spinal units, but because of the large size of these constructs, they are relatively invasive There may also be a need to be implanted by open surgery. Furthermore, these constructs tend to require complete removal of the facet joint capsule.

  Thus, in some embodiments of the present invention, the implantation is performed by a surgical technique that minimizes the damage that the constructed facet joint replacement will inflict on the facet joint capsule and surrounding soft tissue as much as possible. Designed to do.

  Thus, in some embodiments, these goals are achieved by replacing the natural facet joint with a construct with a bone screw having a head configured to allow facet joint type articulation. Achieved.

  Referring now to FIG. 11A, the physician selects a posterior approach with slight lateral-inferior angulation and makes a small incision to access the targeted facet joint. Build a part. Once accessible, the physician removes the surfaces of the upper and lower facet joint processes and creates a mounting surface 801 on the remainder of the lower facet joint process.

  Referring now to FIG. 11B, the physician inserts the lower facet joint replacement component into the facet joint by passing a screw through the pedicle into the vertebral body. In this embodiment, the lower facet joint replacement part includes a bone screw having a threaded shaft 803 and a proximal head 805 configured to articulate. This approach provides both minimal invasiveness and high fixation force.

  Referring now to FIG. 11C, an upper facet joint replacement 807 is implanted (preferably through the same incision used to implant the lower part) and then on the surface of the upper lamina. Fixed. In this case, fixation is achieved by passing a bone screw 809 through the upper part. In a preferred embodiment, the upper part is provided with a hook (not shown) on its front side. In other embodiments, the upper part has a generally U-shaped shape to improve fixation to the lamina.

  Referring now to FIG. 11D, in another minimally invasive embodiment, the upper and lower parts of the MIS have at least one ligament 811 to form a pre-assembled facet joint. Can be connected to. Improving the performance of this system by mimicking the action of the facet joint ligament by adding a ligament to the system. In some embodiments, this pre-assembled facet joint is inserted together and secured as described above. In other embodiments, the pre-assembled facet joints are inserted apart and assembled in place.

  Referring now to FIG. 11E, in some embodiments, the upper facet joint replacement component is secured to the spine by attachment to a lamina bolt 813 inserted through the second small incision into the lamina. Can be done. As described above, the anterior side of the upper facet joint replacement preferably has a hook for grasping the thin plate portion.

  In other minimally invasive embodiments, pain from the facet joint process is removed by nerve resection and the facet joint replacement component is replaced by a facet joint strengthening part.

  In a preferred embodiment thereof, there is provided a method for treating facet joint pathology wherein primary therapy is first applied to the medial and dorsal branches and the nerves in this area are excised. In some embodiments, the primary therapy is selected from the group consisting of an energy source (such as radio frequency (RF) pulses, ultrasound and microwave), chemotherapy and freezing.

  Once primary therapy is complete, place the patient in a position where the facet joint is not stressed, and place the augmentation in the facet joint (silicone, polymethsiloxiane, polyurethane, Injection material (such as hydrogel and hyaluronic acid) is injected from the syringe into the facet joint. In some embodiments, the injectable material includes morphine, preservative-free morphine, bupivacaine, tetracaine, opioid, tramadol, ziconotide, betamethasone, clonidine, amitriptyline, fluoxetine, antispasmodic (topiramate )), Carbamezapine, gabapentin, methlprednisolone acetate morphine3, aminocaproic acid, anti-TNFα molecule, growth factors (TGF-b3, TGF-b1, GDF-5, etc.) and cholinesterase Infused with at least one therapeutic agent including, but not limited to, inhibitors (such as neostigmine and glantamine), and combinations thereof. Once infused, the joint augmenter has the effect of deflecting the facet joint, reshaping the facet of the facet, providing a cushion, and thereby reducing the pain associated with bone impact .

Thus, in some embodiments, in a method for treating a facet joint,
a) injecting augmentation material into the facet joint;
A method of treatment (claim 32) is provided.

  In some embodiments, if no potentiating material is used, other such as methylprednisolone morphine acetate 3, aminocaproic acid or anti-TNFα molecules and / or growth factors (TGF-b3, TGF-b1, GDF-5, etc.) The therapeutic agent can be injected into the facet joint.

  Referring now to FIG. 12, a portion of the elongated first end of the longitudinally long body is slidably received in the fastener groove (as shown in FIGS. 1 and 2). Another embodiment of the invention is provided. In FIG. 12, an artificial intervertebral joint based on ball and socket articulation is provided. Pedicle screws are placed at the top and bottom of the relevant level, and hardware connected to the screw as a ball joint is placed at the location of the resected facet joint to restore biomechanics between the posterior vertebrae .

Embodiment
Specific embodiments of the present invention are as follows.
(1) In facet joint replacement parts,
a) a body having an elongated first end and a second end forming an articulating surface;
b) configured to house a shaft having thereon a distal threadform configured to be fastened to bone, and an elongated first end of the body that is longitudinally long. A fastening portion having a proximal end having a transverse groove,
Including
A part of the elongated first end of the longitudinally long main body is slidably received in the groove of the fastening portion.
parts.
(2) In the component according to the embodiment (1),
c) a set screw accommodated in the transverse groove of the fastening portion;
Further including parts.
(3) In the component according to the embodiment (1),
The component, wherein the fastening portion further includes an integrating nut.
(4) In the component according to the embodiment (1),
The component, wherein the fastening portion is a multiaxial screw.
(5) In the component according to the embodiment (1),
A component wherein the fastening portion is configured to be fastened to a pedicle portion of a vertebral body.

(6) In the component according to the embodiment (1),
A component wherein the elongated first end is configured to extend from a facet joint process region of a vertebral body to a pedicle region.
(7) In the facet joint replacement system,
a) Upper facet joint component,
i) a longitudinally long body having an upper end and a lower end forming an inner surface;
ii) a first fastener having a distal streak configured to be fastened to bone and a proximal groove configured to receive the upper end of the longitudinally long body And
iii) a set screw received in the proximal groove of the fastening portion;
Including an upper facet joint component,
b) a lower facet joint component,
i) body part,
ii) an outer portion configured to be attached to the bone and having a through threaded hole;
iii) an inner portion having an inner surface configured to articulate with an inner surface of the upper facet joint component; and
iv) a second fastening portion received in the through screw hole;
Including lower facet joint parts, and
Including the system.
(8) In the system according to the embodiment (7),
The system wherein the first fastening portion further comprises an integrating nut.
(9) In the system according to the embodiment (7),
The system, wherein the first fastening portion is a polyaxial screw.
(10) In the system according to the embodiment (7),
The system, wherein the first fastening portion is configured to be fastened to a pedicle portion of a vertebral body.

(11) In the system according to the embodiment (7),
The system wherein the longitudinally long body is configured to extend from the facet joint process region of the vertebral body to the pedicle region.
(12) In the system according to the embodiment (7),
The system, wherein the second fastening portion further comprises an integrating nut.
(13) In the system according to the embodiment (7),
The system, wherein the second fastening portion is a polyaxial screw.
(14) In the system according to the embodiment (7),
The system, wherein the second fastening portion is configured to be fastened to a pedicle portion of a vertebral body.
(15) In the system according to the embodiment (7),
The system wherein the inner surface of the lower facet joint component and the inner surface of the upper facet joint component form a ball and socket.

(16) In the system according to the embodiment (7),
The system wherein the inner surface of the lower facet joint component and the inner surface of the upper facet joint component each have a cylindrical shape.
(17) In the system according to the embodiment (7),
The system wherein the inner surface of the lower facet joint component and the inner surface of the upper facet joint component each have a substantially planar shape.
(18) In the facet joint replacement part kit,
a) a body having an elongated first end and a second end forming an articulating surface;
b) a polyaxial screw configured to be adjustable with respect to the longitudinally long main body;
Including a kit.
(19) In the component according to the embodiment (18),
c) a set screw stored in the lateral groove of the multi-axis screw;
Further including parts.
(20) In the component according to the embodiment (18),
A component wherein the screw is configured to be fastened to a pedicle portion of a vertebral body.

(21) In the component according to the embodiment (18),
A component wherein the elongate first end is configured to extend from an intervertebral process area of a vertebral body to a pedicle area.
(22) In facet joint replacement parts,
a) a first facet joint component,
i) a longitudinally long body having a first end and a second end forming a first internal articulating surface; and
ii) means for attaching the longitudinally long body to the bone;
A first facet joint component comprising:
b) a second facet joint component,
i) body part,
ii) an outer portion configured to be attached to the bone and having a through hole;
iii) an inner portion having a second internal articulating surface configured to articulate with the internal articulating surface of the first facet joint component; and
iv) a fastening portion received in the through screw hole;
A second facet joint component, including
Including
The first internal joint surface and the second internal joint surface are configured to form an articulation interface defining an articulation force vector;
The joint force vector passes through the fastening portion;
parts.
(23) In a kit for treating functional spinal units,
The unit comprises an upper vertebra having an upper vertebral body and an upper facet joint process, and a lower vertebra having a lower vertebral body and a lower facet joint process,
These vertebral bodies define a space for intervertebral discs between each other,
The upper and lower facet joint processes define a facet joint;
The kit is
a) a moving intervertebral disc configured to be inserted into the intervertebral disc space;
b) a facet joint replacement system configured to replace at least a portion of the facet joint;
c) a ligament configured to inhibit relative movement between the facet joint processes;
Having
kit.
(24) In the kit according to embodiment (23),
The kit wherein the moving intervertebral disc comprises an articulating interface.
(25) In the kit according to embodiment (23),
The kit, wherein the motion disc comprises a cushion.

(26) In the kit according to embodiment (23),
The kit, wherein the motion disc comprises a spring.
(27) In the kit according to embodiment (23),
The kit wherein the motion disc is configured for anterior insertion.
(28) In the kit according to embodiment (23),
The kit wherein the motion disc is configured for posterior insertion.
(29) In the kit according to embodiment (23),
The kit, wherein the facet joint replacement comprises an articulating interface.
(30) In the kit according to embodiment (23),
The facet joint replacement system comprises:
i) an upper part configured to attach to the upper vertebra;
ii) a lower part configured to be attached to the lower vertebra;
Comprising
kit.

(31) In the facet joint replacement system,
a) a lower facet joint replacement component with a bone screw having a threaded shank for articulation and a proximal head;
b) an upper facet joint replacement having a lower surface configured to articulate with the proximal head and an upper surface configured to attach to a surface of the upper lamina;
Provide system.

1 is a side view of the present invention implanted in a human spine. FIG. FIG. 3 is a rear view of the present invention implanted in a human spine. It is a figure which shows the 3 point | piece movement disc component of this invention. It is a figure which shows the 2 point | piece movement disc component of this invention. It is a figure which shows the general purpose facet joint replacement component of this invention. FIG. 6 shows a preferred facet joint replacement component of the present invention. It is a figure which shows the cushion type facet joint replacement component of this invention. It is a figure which shows the general purpose ligament component of this invention. It is a figure which shows the general purpose ligament component of this invention. It is a figure which shows the fastening part component of the general purpose ligament component of this invention. It is a figure which shows the general purpose ligament component of this invention. FIG. 2 shows a preferred ligament part of the present invention. FIG. 2 shows a functional spinal unit (FSU) of the human spine. FIG. 2 shows a functional spinal unit (FSU) of the human spine. FIG. 6 is a posterior view of a minimally invasive facet joint replacement system. FIG. 6 is a posterior view of a minimally invasive facet joint replacement system. FIG. 6 is a posterior view of a minimally invasive facet joint replacement system. FIG. 6 is a posterior view of a minimally invasive facet joint replacement system. FIG. 6 is a posterior view of a minimally invasive facet joint replacement system. It is a side view of a ball socket type (ball joint type) facet joint replacement system.

Claims (31)

In facet joint replacement parts,
a) a body having an elongated first end and a second end forming an articulating surface;
b) a shaft having a distal streak configured thereon to be fastened to the bone, and a transverse groove configured to receive a longitudinally elongated first end of the body that is longitudinally long. A fastening end having a proximal end, and
Including
A part of the elongated first end of the longitudinally long main body is slidably received in the groove of the fastening portion.
parts. The component of claim 1,
c) a set screw accommodated in the transverse groove of the fastening portion;
Further including parts. The component of claim 1,
The component, wherein the fastening portion further includes an integrating nut. The component of claim 1,
The component, wherein the fastening portion is a multiaxial screw. The component of claim 1,
A component wherein the fastening portion is configured to be fastened to a pedicle portion of a vertebral body. The component of claim 1,
A component wherein the elongated first end is configured to extend from a facet joint process region of a vertebral body to a pedicle region. In the facet joint replacement system,
a) Upper facet joint component,
i) a longitudinally long body having an upper end and a lower end forming an inner surface;
ii) a first fastener having a distal streak configured to be fastened to bone and a proximal groove configured to receive the upper end of the longitudinally long body And
iii) a set screw received in the proximal groove of the fastening portion;
Including an upper facet joint component,
b) a lower facet joint component,
i) body part,
ii) an outer portion configured to be attached to the bone and having a through threaded hole;
iii) an inner portion having an inner surface configured to articulate with an inner surface of the upper facet joint component; and
iv) a second fastening portion received in the through screw hole;
Including lower facet joint parts, and
Including the system. The system of claim 7, wherein
The system wherein the first fastening portion further comprises an integrating nut. The system of claim 7, wherein
The system, wherein the first fastening portion is a polyaxial screw. The system of claim 7, wherein
The system, wherein the first fastening portion is configured to be fastened to a pedicle portion of a vertebral body. The system of claim 7, wherein
The system wherein the longitudinally long body is configured to extend from the facet joint process region of the vertebral body to the pedicle region. The system of claim 7, wherein
The system, wherein the second fastening portion further comprises an integrating nut. The system of claim 7, wherein
The system, wherein the second fastening portion is a polyaxial screw. The system of claim 7, wherein
The system, wherein the second fastening portion is configured to be fastened to a pedicle portion of a vertebral body. The system of claim 7, wherein
The system wherein the inner surface of the lower facet joint component and the inner surface of the upper facet joint component form a ball and socket. The system of claim 7, wherein
The system wherein the inner surface of the lower facet joint component and the inner surface of the upper facet joint component each have a cylindrical shape. The system of claim 7, wherein
The system wherein the inner surface of the lower facet joint component and the inner surface of the upper facet joint component each have a substantially planar shape. In the facet joint replacement kit,
a) a body having an elongated first end and a second end forming an articulating surface;
b) a polyaxial screw configured to be adjustable with respect to the longitudinally long main body;
Including a kit. The kit according to claim 18,
c) a set screw stored in the lateral groove of the multi-axis screw;
Further comprising a kit. The kit according to claim 18,
A kit, wherein the screw is configured to be fastened to a pedicle portion of a vertebral body. The kit according to claim 18,
The kit, wherein the elongate first end is configured to extend from a facet joint process region of a vertebral body to a pedicle region. In facet joint replacement parts,
a) a first facet joint component,
i) a longitudinally long body having a first end and a second end forming a first internal articulating surface; and
ii) means for attaching the longitudinally long body to the bone;
A first facet joint component comprising:
b) a second facet joint component,
i) body part,
ii) an outer portion configured to be attached to the bone and having a through hole;
iii) an inner portion having a second internal articulating surface configured to articulate with the internal articulating surface of the first facet joint component; and
iv) a fastening portion received in the through screw hole;
A second facet joint component, including
Including
The first internal joint surface and the second internal joint surface are configured to form an articulation interface defining an articulation force vector;
The joint force vector passes through the fastening portion;
parts. In a kit for treating functional spinal units,
The unit comprises an upper vertebra having an upper vertebral body and an upper facet joint process, and a lower vertebra having a lower vertebral body and a lower facet joint process,
These vertebral bodies define a space for intervertebral discs between each other,
The upper and lower facet joint processes define a facet joint;
The kit is
a) a moving intervertebral disc configured to be inserted into the intervertebral disc space;
b) a facet joint replacement system configured to replace at least a portion of the facet joint;
c) a ligament configured to inhibit relative movement between the facet joint processes;
Having
kit. The kit of claim 23,
The kit wherein the moving intervertebral disc comprises an articulating interface. The kit of claim 23,
The kit, wherein the motion disc comprises a cushion. The kit of claim 23,
The kit, wherein the motion disc comprises a spring. The kit of claim 23,
The kit wherein the motion disc is configured for anterior insertion. The kit of claim 23,
The kit wherein the motion disc is configured for posterior insertion. The kit of claim 23,
The kit, wherein the facet joint replacement comprises an articulating interface. The kit of claim 23,
The facet joint replacement system comprises:
i) an upper part configured to attach to the upper vertebra;
ii) a lower part configured to be attached to the lower vertebra;
Comprising
kit. In the facet joint replacement system,
a) a lower facet joint replacement component with a bone screw having a threaded shank for articulation and a proximal head;
b) an upper facet joint replacement having a lower surface configured to articulate with the proximal head and an upper surface configured to attach to a surface of the upper lamina;
A system comprising:

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