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WO1995022946A1 - Dispositif d'ecartement intervertebral - Google Patents

Dispositif d'ecartement intervertebral Download PDF

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Publication number
WO1995022946A1
WO1995022946A1 PCT/US1995/002201 US9502201W WO9522946A1 WO 1995022946 A1 WO1995022946 A1 WO 1995022946A1 US 9502201 W US9502201 W US 9502201W WO 9522946 A1 WO9522946 A1 WO 9522946A1
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WIPO (PCT)
Prior art keywords
spacer means
anterior
lateral surfaces
posterior
tapering
Prior art date
Application number
PCT/US1995/002201
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English (en)
Inventor
Mark R. Foster
Original Assignee
Foster Mark R
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Foster Mark R filed Critical Foster Mark R
Priority to AU19680/95A priority Critical patent/AU1968095A/en
Publication of WO1995022946A1 publication Critical patent/WO1995022946A1/fr

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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Definitions

  • the present invention pertains to an intervertebral spacer for promoting anterior intervertebral fusion in a patient.
  • the presacral vertebrae of the human spine are normally held in a precise relation to each other by intervertebral disks, longitudinal ligaments, and the musculature of the body. These vertebrae can move relative to adjacent vertebrae in various manners, permitting the head to be turned relative to the body and providing a wide range of flexibility to the spine.
  • the movement between individual pairs of vertebrae is limited, however, to prevent local pressure . on, or excessive bending of, the spinal cord. Such pressure or bending could result in disorders associated with blockage of the nerve impulses traveling along the spinal cord, in turn producing pain, paresthesia, or loss of motor control, which must be resolved by removing the causative condition.
  • Nerve conduction disorders may also be associated with the intervertebral disks or the bones themselves .
  • One such condition is a herniation of the intervertebral disk, in which a small amount of tissue protrudes from the sides of the disk into the foramen to compress the spinal cord or nerve roots.
  • a second common condition involves the development of small bone spurs, termed osteophytes, along the posterior surface of the vertebral body, again impinging on the spinal cord or nerve roots .
  • surgery may be required to correct the problem if more conservative treatment fails.
  • intervertebral discectomy is one such surgical procedure for those problems associated with the formation of osteophytes or herniations of the intervertebral disk.
  • a second procedure termed a spinal fusion, may then be required to fix the vertebral bodies together to prevent movement and maintain the space originally occupied by the intervertebral disk.
  • an implant - may be inserted into the intervertebral space.
  • This intervertebral implant is often autologous bone, i.e., a bone graft removed from another portion of the patient ' s body, termed an "autograft.”
  • autograft a bone graft removed from another portion of the patient ' s body
  • the use of bone taken from the patient ' s body has the important advantage of avoiding rejection of the implant, but has some shortcomings. There is always a risk in opening a second surgical site for obtaining the implant, which can lead to infection, pain, or donor site morbidity for the patient, and the site of the implant is weakened by the removal of bony material .
  • the bone implant may not be perfectly shaped and placed, leading to slippage or absorption of the implant, or failure of the implant to fuse with the vertebrae.
  • Other options for a graft source for the implant are bone removed from cadavers, termed an "allograft, " or from another species, termed a "xenograft.”
  • an autograft bone removed from cadavers
  • xenograft bone removed from another species
  • allograft bone loses up to half its strength during the first six months and may remain weakened for another six months following surgery, which exceeds any realistic period of immobilization or clinical protection of the neck for this potential mechanical weakening interval of 12 months.
  • Fibular allograft usually has no central structural content, and as well as subsidence, may have delayed healing. Both allograft and autograft may have late resorption with successful union, leaving the long-term reconstruction of sagittal alignment unreliable.
  • an implant comprising a generally rectangular block of hydroxylapatite
  • the block having a pattern of serrations to prevent slippage following implantation, and a ridge on at least one transverse face of the implant to assist in positioning and maintaining the implant between adjacent vertebrae.
  • the use of the ridge requires using a drill to create a groove in either or both of the superior and inferior vertebrae, in order to shape the vertebrae to complement the shape of the ridge(s). This requirement of fashioning grooves in the vertebrae obviously increases the risk of complications during and after the implant procedure, including weakening of the adjacent vertebrae, risking fracture or subsidence with time and healing, which results also in loss of maintenance of the corrected sagittal alignment.
  • vertebrae and plates are a complex shape, with the intervertebral joints often likened to "saddle joints", which do -not suit a rectangular graft end with a groove for the ridge.
  • Failure to consider the complex anatomy of the intervertebral space and reluctance to destroy the strong cortical vertebral endplate to shape it to suit an artificial implant leads to less than optional contact areas to unite, stress concentrations, and dislodgement.
  • the present invention fulfills this need, and further provides related advantages.
  • the present invention provides a surgical implant, and its method of use, wherein the implant is implanted between two vertebrae during a procedure following which the two vertebrae are fused together.
  • the surgical disk implant is readily manufactured of biologically compatible materials in the required shape and with preselected dimensions, so that a properly dimensioned implant is available for the particular vertebrae being fused together.
  • the disk implant of the invention may be readily implanted by established surgical procedures, with minimal changes of surgical difficulty.
  • the geometry of the implant ensures good load bearing and support through the fused vertebrae, and minimizes the likelihood of the implant dislocating relative to the vertebrae either during surgery or during the post-operative fusing process.
  • an intervertebral spacer for promoting anterior intervertebral fusion in a patient comprises a solid body having a rapidly tapering presenting portion comprising the posterior end of the spacer, the spacer further including a pair of spaced-apart, opposed lateral surfaces-, each lateral surface having an anterior end and a posterior end, the lateral surfaces being joined at their posterior ends by the rapidly tapering presenting portion.
  • the lateral surfaces taper apart from one another from their posterior ends to their anterior ends, and are joined at their anterior ends by a face comprising a trailing edge portion.
  • the unique shape of the implant of the invention allows it to be used virtually universally in patients without requirement for serrations or shaping grooves in the vertebrae. Unlike previous art, this unique shape restores and maintains normal sagittal alignment of the spine.
  • Figure 1A is a lateral elevational view of a preferred spacer of the present invention.
  • Figure IB is a top plan view of the spacer illustrated in Figure 1A.
  • Figure 1C is a left side elevational view of the spacer of Figure 1A.
  • Figure 2 is a preoperative lateral x-ray of a patient, with C5-6 kyphosis of 3°.
  • Figure 3 is a postoperative lateral x-ray of the same patient of Figure 2, following surgical implant, with a hydroxyapatite spacer of the present invention distracting the interspace and producing 7° of cervical lordosis at C5-
  • Figure 4A is a lateral elevational view of a preferred spacer of the present invention.
  • Figure 4B is a top plan view of the spacer illustrated in Figure 4A.
  • Figure 4C is a left side elevational view of the spacer of Figure 4A.
  • the implant includes a rapidly tapering presenting portion, generally 12, which tapers rapidly from two opposed lateral surfaces 14 and 16.
  • the presenting portion 12 comprises a semi- circular region having a radius Rl when viewed from an elevational orientation, and comprises a second semi ⁇ circular region having a radius R2 when viewed from a plan orientation as illustrated in Figure IB.
  • the radius Rl is .138 inches (3.46 mm) and the radius R2 is .236 inches (5.78 mm).
  • radius dimension and other tapering shapes including by way of example but not limitation, ellipsoidal and conical tapering sections for the presenting portion 12 would be possible, as will now be appreciated by those of ordinary skill in the art. All such shapes are specifically embraced within the meaning of "rapidly tapering" as used herein.
  • the rapidly tapering presenting portion 12 tapers to a convex tip, which enables the spacer 10 to function in wedge-like fashion, facilitating insertion and implantation of the spacer in a patient.
  • the opposed lateral surfaces • 14 and 16 each include a posterior end 14A and 16A, and an anterior end 14B and 16B, respectively.
  • the lateral surfaces 14 and 16 are joined at their posterior ends 14A and 16A by the rapidly tapering presenting portion 12.
  • the lateral surfaces 14 and 16 taper apart from one another from their posterior ends 14A, 16A to their anterior ends 14B, 16B, by an angle 0, as illustrated in Figure 1A.
  • this taper may vary, a taper of 5-8 degrees has proven preferable, with a most preferred embodiment having a taper of 6 degrees 46'.
  • the taper angle approximates the degree of cervical lordosis produced between adjacent vertebrae when the implant 10 is implanted.
  • anterior and posterior ends 14B, 16B of the opposed lateral surfaces 14, 16 are preferably joined by a face portion 18 comprising a trailing edge of the implant. It is this face 18 that the surgeon impacts in order to insert the implant into a patient as will subsequently be described.
  • the implant of the present invention when viewed perpendicularly to the face 18 comprising the trailing edge portion, it is evident that at least one, and preferably both, of the opposed lateral surfaces 14, 16 include a convex portion. Most preferably, this convex portion extends the entire length L2 of the opposed lateral surfaces. In a highly preferred embodiment of the invention, the convex portions of the opposed lateral surfaces 14, 16 join at the face 18 to create an ellipsoidal shape, as illustrated in Figure 1C.
  • both opposed lateral surfaces 14, 16 include a convex portion, it would be possible to employ only one convex portion on one opposed lateral surface.
  • the opposed lateral surfaces 14 and 16 preferably meet at parallel surfaces 20, 22.
  • the spacer implant is universal in size for cervical application for adult human patients, being about 11-13 millimeters in length (LI) , the presenting portion 12 being about 3-5 millimeters in length (L3) and about 4-6 millimeters in width (W3) when viewed perpendicularly from an elevational view ( Figure 1A) , the presenting portion 12 further being about 6-8 millimeters in width (W2) when viewed perpendicularly from a plan view ( Figure IB) .
  • the presenting portion preferably meets the opposed lateral surfaces approximately 4-5 millimeters (L3) from the posterior end of the implant.
  • the trailing edge portion 18 is preferably about 6-8 millimeters at its widest point (Wl) when viewed perpendicularly in an elevational view (Figure 1C) of the spacer.
  • the trailing edge portion 18 is also preferably about 11-13 millimeters in width (W2) when the spacer is viewed perpendicularly from an elevational view (Figure 1C) .
  • FIG. 4A-C A most highly preferred embodiment of the invention is illustrated in Figures 4A-C.
  • the width W2 has been stretched out by a distance W4 relative to the spacer illustrated in Figure 1C.
  • This region W4 is preferably flat, and increases the contact between the implant and the spinal end plates.
  • the embodiment illustrated in Figure 4C continues to include the elliptical ends, joined in the middle by the flat region W4 as illustrated, however, as previously discussed, other curvilinear segments could also be used.
  • the width W4 comprises a flat portion on the presenting portion 12 of the implant.
  • This flat portion W4 is joined to the parallel surfaces 20 and 22 by radiused sections 30 each having a radius R2.
  • the radiused sections 30 may comprise segments of other curvilinear shapes.
  • the lateral elevational view of the spacer remains unchanged from that of Figures lA-lC.
  • Wl 7 millimeters
  • W2 15 millimeters
  • W3 4 millimeters
  • W4 3 millimeters
  • Ll 12 millimeters
  • L2 8 millimeters
  • L3 4 millimeters.
  • Other dimensions are, of course, possible.
  • the implant 10 is desirably made from a material that, after surgical implantation, bonds to the natural bone of the adjacent vertebrae to form a rigid structure.
  • the implant is preferably made from a ceramic, most preferably a hydroxyapatite such as calcium hydroxylapati e, having a chemical formula Ca 10 (P0 4 ) g (OH) 2 , available from Smith & Nephew Richards, Inc., 1450 Brooks Road, Memphis, Tennessee 38116 U.S.A.
  • the implant 10 may also be made from a composite material, such as the carbon-fiber reinforced material disclosed in U.S. Patent No. 4,904,261, also incorporated in its entirety by reference herein.
  • the implant 10 may also be ⁇ made from a biocompatible orthopedic polymer
  • BOP such as a copolymer of methylmethacrylate and N- vinylpyrrolidone and calcium gluconate, reinforced with polyamide fibers.
  • BOP Interbody Biopolymer
  • the implant may be made from an uncoated biocompatible metal, such a titanium or a titanium alloy such as Ti-6A1-4V, or a nonreactive metal such as gold, or such a metal coated with a layer of the ceramic.
  • a coated implant is prepared by providing a piece of metal, preferably a non-reactive biocompatible metal, such as titanium, titanium alloy, stainless steel, gold, vanadium/aluminum alloys, or other metals and alloys known in the art, in the shape of the implant but slightly undersized in all dimensions.
  • a coating of ceramic or polymer, of the types described previously, is applied over the piece of metal to enlarge the implant to the proper final dimensions.
  • the implant 10 may be solid or hollow, and may be made microporous, so that it functions as a delivery vehicle for antibiotics or bone stimulating factors such as bone morphogenic protein or osteogenin, which are introduced into the implant before implantation surgery.
  • bone stimulating factors such as bone morphogenic protein or osteogenin
  • the density and/or surface morphology of the ceramic can be varied in the sintering process so that it retains the materials to be delivered.
  • the delivery of chemicals by this approach is known in the art, see, for example, H.A. Benghuzzi et al., "The Effects of Density of the Ceramic Delivery Devices on Sustained Release of Androgens in Castrated Rodents," 17th Annual Meeting of the
  • the spacer of the present invention is shaped using any acceptable method, and in the case of solid hydroxylapatite as the material, the brittleness of this material suggests the use of high speed diamond tools as a preferred approach to contour and shape the implant.
  • the implant 10 Because of the unique shape of the implant 10, including the rapidly tapering presenting portion 12, and the outwardly tapering opposed lateral convex surfaces 14, 16 the implant 10 seats itself quite readily between adjacent vertebrae, as seen in Figure 3, eliminating the need for serrations, ridges requiring grooving of vertebrae, and excessive impaction force for implantation.
  • an implant having the unique shape described herein is implanted in the lumbar region of the spine, restoring normal sagittal alignment of the spine.
  • the patient was positioned on the operating table.
  • a halter was placed on the anterior part of the neck and taped to the chin, so that it would not slide down during surgical prep or up during application of traction, and was attached to a traction spreader bar for intraoperative axial distraction.
  • a triangular roll was placed under the scapulae to elevate shoulders and trunk, and muslin tied to the operating table over ABD pads on the shoulders to maintain the position of the patient during traction for intraoperative x-ray when the lower cervical disc spaces were involved.
  • Towels and a donut were placed under the head, which were removed to provide mild extension of the neck to facilitate graft insertion (Figure 2) .
  • Somatosensory evoked potentials were used and applied prior to patient positioning when a myelopathy was suspected or present, as opposed to a pure radiculopathy without spinal stenosis.
  • a doubly bent 18 gauge needle (to prevent excess needle penetration) was inserted into the disc space and an x-ray taken to confirm level of the needle.
  • an anterior spur or some other identifying mark such as the carotid tubercle, is used to identify the level and direct needle insertion.
  • the anterior longitudinal ligament was excised with a 15 blade, and the disc was then removed with a pituitary rongeur under microscope visualization. A freer was used to develop a plane between the bony endplate of the vertebral body and the cartilaginous endplate, to facilitate dissection down to the posterior lip of the vertebral body.
  • the posterior longitudinal ligament was visualized and retained, except when disc material was suspected to have herniated through the ligament, or if prominent uncovertebral spurs were present causing foraminal encroachment and were elected to be curetted or removed. After thorough removal of disc material, a Hall burr was used to prepare the endplates without significant disruption, but allowing bleeding for incorporation of the bone graft or hydroxyapatite.
  • the spacer was cut from a block of the hydroxyapatite material with a Midas Rex diamond wheel (WH-1) and then shaped as set forth in Figures 1A, IB, and 1C to approximate the concave vertebral endplates of the saddle joint of the cervical spine. Careful contouring of the material was performed to reduce stress concentration and eliminate subsequent subsidence of the implant with the leading edge reduced to about 4 mm for easy insertion into the disc space.
  • the block was then contoured to a maximum of 7 mm in height, with the leading edge tapered to about 6 mm following a small radius of curvature from the presenting leading edge, attempting to match the posterior lip of the endplate of the superior vertebral body and thus nestle into this space (Figure 3) .
  • the implant After shaping with the Midas Rex, the implant was impacted with care to follow the direction of the disc space, particularly the lower cervical levels which are directed somewhat cephalad, while the neck was in mild extension by removing the cervical donut and having the anesthesiologist apply halter traction to open the intervertebral disc space.
  • X-ray confirmation of position was performed to not only evaluate depth of penetration but also evaluate sagittal alignment and distraction of the intervertebral disc space, as seen in Figure 3, which shows a post operative lateral x-ray of a hydroxylapatite spacer of the present invention distracting the interspace and producing 7° of cervical lordosis at C4- 5.
  • the wound was subsequently lavaged and closed with dissolvable sutures in the platysma, subcutaneous tissues, and then a subcuticular skin closure with Steri-strips was used.
  • the anterior lip of the cephalad vertebral body was retained when possible, as the customary osteophyte at this point was felt to potentially resist dislodgement of the graft and did not obstruct graft insertion.
  • Gauze bandages were placed over the subcuticular closure usually without tape, and the patient was placed in a Philadelphia collar to then be reversed, extubated, and taken to the recovery room.
  • the Philadelphia collar was used for a period of six weeks with follow-up x-rays shortly after surgery and at six weeks. Following adequate reduction of prevertebral fascia swelling and resolution of the patient's symptoms, the patient was weaned from the collar over the next several days to two weeks with subsequent resumption of range-of-motion exercises, and when appropriate, isometric exercises or formal physical therapy, if needed. Generally, full activities were resumed at two months. Trabeculae could generally be seen crossing from the adjacent -vertebral bodies into the graft with autologous bone, so the time course was more clinically determined but supplemented by current practice with other uses of hydroxyapatite, such as coated prostheses.
  • hydroxyapatite spacer of the present invention provides a reliable sagittal alignment, which has been increasingly recognized significant in the lumbar spine, and with maintenance of intervertebral disc height, which indirectly decompressing the neural foremen.
  • the ability to predictably reconstruct sagittal alignment and maintain foraminal decompression is particularly important with multilevel fusions, or revisions done sequentially over several years in patients with chronic pain. Such cases may have diminished vascularity, scar from previous procedures, and residual sagittal plane deformity. While the stress at adjacent levels is presumably from immobilization due to the fusion, disruption of the contiguous sagittal alignment may contribute to increased stress with subsequent degeneration in adjacent levels and potentially pain. The expectation for osteophytes over the ensuing several years is that they will resorb, but a radiculopathy deserves prompt relief for which the use of the microscope allows resection.
  • the dense, solid hydroxyapatite material is selected for maximal strength. Porous material may be adequate for the cervical spine, but like bone graft, is not anticipated to be as reliable for maintaining sagittal alignment and foraminal decompression.
  • the brittleness of hydroxyapatite has suggested the use of high speed diamond tools to contour and shape the material, and special care on insertion.
  • the described technique allows rapid incorporation and return to full function on the time schedule of autologous bone, but without the donor site morbidity. This bone substitute avoids the risks of bank bone, such as delayed incorporation, and subsidence with late loss of sagittal correction or disc height distraction through immunologic reaction, delaying healing, or potentially, fatigue fracture.

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Abstract

Dispositif d'écartement ou implant intervertébral (10) comprenant une partie avant (12) fortement effilée et deux surfaces latérales opposées (14) et (16). La partie avant (12) peut comporter une région semi-circulaire qui présente un rayon R1 lorsqu'on la regarde de face, et comprend une deuxième région semi-circulaire qui présente un rayon R2 lorsqu'on la regarde de dessus. Les deux surfaces latérales opposées (14 et 16) comprennent chacune respectivement une extrémité postérieure (14A et 16A) et une extrémité antérieure (14B et 16B), ces surfaces latérales opposées (14 et 16) s'éloignant l'une de l'autre en formant un cône au niveau d'un angle thêta variant de préférence entre 5 et 8 degrés.
PCT/US1995/002201 1994-02-25 1995-02-23 Dispositif d'ecartement intervertebral WO1995022946A1 (fr)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998017208A3 (fr) * 1996-10-22 1998-12-17 Surgical Dynamics Inc Appareil destine a fusionner des structures osseuses adjacentes
US6083225A (en) * 1996-03-14 2000-07-04 Surgical Dynamics, Inc. Method and instrumentation for implant insertion
US6740091B2 (en) 1997-03-06 2004-05-25 Sulzer Spine-Tech Inc. Lordotic spinal implant
US6899734B2 (en) 2001-03-23 2005-05-31 Howmedica Osteonics Corp. Modular implant for fusing adjacent bone structure
US7018416B2 (en) 2000-07-06 2006-03-28 Zimmer Spine, Inc. Bone implants and methods

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4863476A (en) * 1986-08-29 1989-09-05 Shepperd John A N Spinal implant
US5123926A (en) * 1991-02-22 1992-06-23 Madhavan Pisharodi Artificial spinal prosthesis

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4863476A (en) * 1986-08-29 1989-09-05 Shepperd John A N Spinal implant
US5123926A (en) * 1991-02-22 1992-06-23 Madhavan Pisharodi Artificial spinal prosthesis

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6083225A (en) * 1996-03-14 2000-07-04 Surgical Dynamics, Inc. Method and instrumentation for implant insertion
WO1998017208A3 (fr) * 1996-10-22 1998-12-17 Surgical Dynamics Inc Appareil destine a fusionner des structures osseuses adjacentes
EP1364617A3 (fr) * 1996-10-22 2003-12-03 Howmedica Osteonics Corp. Perceuse et écarteur chirurgicaux
US6740091B2 (en) 1997-03-06 2004-05-25 Sulzer Spine-Tech Inc. Lordotic spinal implant
US7267689B2 (en) 1997-03-06 2007-09-11 Zimmer Spine, Inc. Lordotic spinal implant
US7018416B2 (en) 2000-07-06 2006-03-28 Zimmer Spine, Inc. Bone implants and methods
US6899734B2 (en) 2001-03-23 2005-05-31 Howmedica Osteonics Corp. Modular implant for fusing adjacent bone structure
US7303584B2 (en) 2001-03-23 2007-12-04 Howmedica Osteonics Corp. Modular implant for fusing adjacent bone structure

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