US3867728A - Prosthesis for spinal repair - Google Patents

Prosthesis for spinal repair Download PDF

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Publication number
US3867728A
US3867728A US348140A US34814073A US3867728A US 3867728 A US3867728 A US 3867728A US 348140 A US348140 A US 348140A US 34814073 A US34814073 A US 34814073A US 3867728 A US3867728 A US 3867728A
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US
United States
Prior art keywords
disc
prosthesis
shaped
spinal
reinforced
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
US348140A
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English (en)
Inventor
James A Stubstad
James R Urbaniak
Paul Kahn
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Bayer Corp
Original Assignee
Cutter Laboratories Inc
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Publication date
Application filed by Cutter Laboratories Inc filed Critical Cutter Laboratories Inc
Priority to US348140A priority Critical patent/US3867728A/en
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Publication of US3867728A publication Critical patent/US3867728A/en
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Expired - Lifetime legal-status Critical Current

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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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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    • A61F2/441—Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0015—Kidney-shaped, e.g. bean-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/21—Silicone

Definitions

  • ABSTRACT A shaped article comprising at least a core element having generally flat top and bottom surfaces, the core element being made of elastic polymer and preferably reinforced.
  • Presently preferred forms of the article are those in which the core element has a covering element secured to one or, in some cases, to both flat surfaces and providing an outer surface of an openpore tissue-ingrowth-receptive material.
  • Another preferred form of the prosthesis comprises a curved, flat, bar-like element shaped into a spiral configuration, so that the overall appearance approximates a flat disc.
  • Still another version includes a plurality of flexible, curved, bar-like elements with configurations which allow them to lie side by side so as to occupy the interior space of a natural disc from which the nucleus pulposus has been removed.
  • This invention relates to spinal disc prostheses.
  • Recurrent pain has stemmed from recurrent sources, among them post-operative'failure of fusion or resorption and settling of the graft site and additional bending stress imposed upon discs adjacent to the fusion; each of these factors has tended to apply undesirable pressure on the nerve passages which interlace the vertebrae both longitudinally and transversely. Recurrence is believed often to -be associated with the settling of bone around the grafted wedges or plugs for several reasons:
  • the iliac crest is a poor source of load-carrying bone, because it consists mainly of porous cancellous bone,,as contrasted with hard cortical bone. Additionally,the entire cross-section of the vertebra against which the wedges bear is also cancellous bone, with the exception of-a narrow peripheral ring of cortical bone around the outside of each vertebra.
  • the grafted bone segments often fail to cover as much load-bearing area as the naturaldisc which they replace, and this failure to cover promotes resorption due to high unit contact pressures.
  • Cortical bone exists only in the exterior shells on the outside of bones and becomes well developed only when the bone is under stress, as in a leg bone. Iliac crest bone receives practically no stress and so is not well developed.
  • An iliac bone plug may have the advantage of providing an excellent fit, but this is outweighed by the disadvantages of inadequate area, little cortical contact, and poor mechanical strength, and the area close to the spinal cord is not repaired.
  • a refinement of existing graft procedure provides a simpler technique of using a single cylindrical bone plug cut with a hollow coring device; the surgeon is benefited by simplification of the bone fitting.
  • This invention concerns a shaped spinal disc prosthesis and, more particularly, a synthetic prosthesis of this type which is resilient, rugged, strong, durable, capable of resisting compressive forces, compatible with body fluids and tissues, and equipped to attach itself where desired to adjacent tissues through natural tissue ingrowth.
  • the synthetic prosthetic disc of this invention has a flattened kidney shape to conform to the shape of the total natural disc it is intended to replace in a human or animal spine, or has a shape which conforms more or less to the space in a spinal disc from which the nucleus pulposus has been removed.
  • the prosthetic disc may be a reinforced resilient block of elastomer, such as silicone rubber or polyurethane, interposed between the natural surfaces of the cavity from which the replaced disc has been excised.
  • This simple prosthetic disc is retained in place by reconstructed natural tissue surfaces, such as the cortical plate of the vertebral bodies, and the anterior and posterior longitudinal ligaments.
  • the elastomer may be unreinforced or may, for betterresistance of compressive forces, be reinforced, e.g., by an annular ring of laminated fibrous material such as Dacron filaments embedded in the silicone elastomer.
  • the prosthetic disc of this invention may more nearly duplicate the construction and function of the natural disc which it is intended to replace. It may then comprise a resilient central core element and have at least one open-pore, tissue-ingrowth-receptive surface positioned to abut the exposed bony surface of an adjacent spinal vertebra.
  • the core element may have side and end walls to contain' the core.
  • the core of this more complex configuration may be a solid resilient pure biocompatible elastomer, either unreinforced or reinforced, to which a reinforced peripheral side wall and two flattened or oblate reinforced end walls are vulcanized and bonded.
  • the core may comprise biocompatible viscoelastic liquid contained between reinforced side and end walls that provide a sealed chamber or pressure vessel capable of containing the core fluid and resisting-undesirable deformation under compressive loading, while enablingnatural motion and shock mitigation.
  • the peripheral or side wall may have a plurality of layers of a medical elastomer, such as silicone rubber, reinforced withembedded fibrous material, either polymeric such as Dacron filaments or metal. The whole is all vulcanized and bonded together and to the central core.
  • a medical elastomer such as silicone rubber
  • reinforced withembedded fibrous material either polymeric such as Dacron filaments or metal. The whole is all vulcanized and bonded together and to the central core.
  • the prosthesis may comprise a more or less elongated, flexible, bar-like element formed into a spiral or coiled configuration which at the time of installation may be unwound and threaded through a small opening into the hollow space of a natural disc from which the nucleus pulposus has been removed. Once installed, elastic action causes the prosthesis to assume its original spiral shape and is retained by the annulus fibrosis of the natural disc as well as by tissue ingrowth, and subsequent scarring.
  • Another form of the prosthesis comprises two or more cresent shaped bar-like elements which may also be threaded through a similar small opening one after another into the hollow space of a disc following removal of the nucleus pulposus until the space is occupied and the elements lie closely packed one against another.
  • prosthetic disc Relief from this situation can be.obtained by a special form of prosthetic disc according to this'invention.
  • the core element of this special form does not have a vertically reinforced side wall; instead the side surface of the core element is preferably indented so as to create relatively flexible resilient edges which then follow the motion of adjacent vertebrae through a wider-than-normal angular movement without creating large tensile stresses in the tissues.
  • Such as prosthetic disc may be described as a disc for gymnasts or for very active persons. The net effect-is a spreading of the stress over a wider peripheral area so as to reduce the stress per unit area to a more acceptable level.
  • This form of the prosthesis provides a center core which is relatively rigid or stable so far as vertical displacement or vertical loading is concerned, but it is capable of deflection an gularly in lateral and anterior-posterior planes.
  • the indented configuration of the side surface additionally avoids bulging at this portion of the prosthesis and thus avoids making painful contact with adjacent nerves.
  • the problem of exaggerated stress at the edge of the prosthesis which can lead to tearing of the tissue in growth bond atthese edges can also be alleviated by the use of a disc prosthesis in which only one of the flat surfaces, i.e., either the upper or lower surface, is completely covered with a tissue-ingrowth-receptive surface.
  • the opposite surface may be entirely smooth and incapable of supporting tissue ingrowth or it may be smooth at its edges and have a small centrally located area of ingrowth receptive material.
  • an outer element comprises a resilient component, with one or two layers from 0.010 inch to 0.100 inch thick of silicone elastomer or the like.
  • One layer may have an exterior surface of open-woven fiber.
  • the resilient component is coveredby a stitchable component, i.e., one adapted to retain stitching, such as at least one layer of Dacron mesh or a mesh of other suitable material or a velour, thus forming a stack or sandwich of the described layers.
  • tissue-ingrowth-receptive fabric such as Dacron mesh or velour, also compatible with body fluids, isapplied as a covering over the stack or sandwich, covering the outer surface of the outermost layer of stitchable ingrowth material and the side walls of the stack, so that the tissue-ingrowth-receptive fabric will be in contact with adjacent vertebral surface when emplaced.
  • tissue-ingrowth-receptive fabric may be irregularly thickened, e.g. by pleating or by mechanical brushing and fluffing the fibers, to create a deeper pile,
  • pleat rows advantageously may be sewn or stitched to the underlying mesh layer and also sewn together at a folded-over portion over the lowermost rubber layer of the end wall, using a suitable thread or filament, such as Dacron filament.
  • compatible materials arethose which are not unduly attacked by body chemistry, including attack by body fluids.
  • Second is a physiological aspect, for compatible materials do not adversely affect the body chemistry by reaction with or degrading of body tissues and fluids.
  • Third is a mechanical aspect, compatibility on a mechanical level with the bone, soft tissue, and so on.
  • Compatible elastomer is compliant, soft, yielding, flexing and stretching like the natural tissue it replaces, absorbing shock without crushing adjacent tissue and distributing loads over wide areas.
  • Compatible fibrous material is strong, flexible, bondable to the elastomer, and relatively immune to wear and breakdown from the intended use.
  • the fibrous material used for tissue ingrowth has a pore size micron or 0.006 inch or larger) to enable invasion by fibroblasts and tiny blood vessels and deposit thereby of calcium, phosphorous, and other bond-building materials carried in the blood stream. It is also desirable for the fibrous material to trigger the foreign body response in mild degree as does Dacron in order to stimulate faster healing and fibrous encapsulation by body tissue.
  • the two outer or covering elements are assembled with the core into a sandwich" with the-core as the central element and with the fully covered face of the outer element re mote from the core and facing outwardly.
  • the fully covered face is thus adapted to abut a surface of a vertebra when the device is emplaced in a spinal column to replace a diseased or damaged disc.
  • the elastomeric elements. have not been vulcanized, and the assembly is then vulcanized to join the three elements firmly together, along with the fabric coating.
  • the assembly is thoroughly stitched together entirely around the periphery, the stitching being spaced inwardly fromthe outer surface edges and being done with a suitable polymeric filament-or thread, such as Dacron, being sewn through in an X pattern such that resilient stretching and compression can take place longitudinally along the spine, as in a bellows or accordion.
  • a suitable polymeric filament-or thread such as Dacron
  • the core element may have reinforced elastomer secured to its peripheral side wall to contain that portion of the core.
  • the side wall surface may be flat, but preferably it should curve concavely from its upper surface to its lower surface to create a grooved side wall so that the edges of the wall extend beyond the innermost portion of the wall sur face.
  • the two outer or covering elements may be secured to this core element in a manner similar to that described above. Stitching, such as in an X pattern, may be spaced around the periphery but set back from the outer surface edges sufficiently so as to be inside the innermost portion of the curved side wall.
  • the core element preferably should contain reinforcement, for example, fabric mesh.
  • the single covering element in addition to being made to adhere to the core element by vulcanization, may be more securely attached by stitching running through both the covering element and the core element.
  • the surface not bearing a covering element should have a coating of elastomer of aboutat least 1 mm. thickness.
  • Dacron mesh or other open-pore fabric such as Dacron velour and Teflon mesh or.
  • velour, titanium wool, porous carbon or porous ceramic is receptive to or invites tissue ingrowth, such as fibrous or bony ingrowth', and thus after emplacement in a spine abutting a pair of vertebrae is typically within 4 to 8 weeks, permanently affixed to the adjacent vertebrae by such ingrowth.
  • the outermost layer of the core element may be made from a reinforced metal screen capable of integration with the elastomer used and having stitches passing through its pores. Specially stiffened end plates may be desirable, at least in some instances.
  • One advantage of this invention is its provision of a preformed, shaped disc prosthesis or replacement which is sufficiently resilient to absorb most shocks to which a spine may normally be subjected, which has high compressive strength and high tensile strength, and which enables relatively normal flexing and twisting of the spinal structure.
  • the prosthesis of this invention restores the proper spacing between vertebrae and thus helps to hold the spine in place, reducing or eliminating pressure on or constriction of the nerve channels.
  • the maintenance of the intervertebral disc space by the prosthesis prevents degenerative changes about the facets and other posterior spinal elements.
  • the article is easily made sterile and is easily kept sterile for use. Another important advantage is that use of-the prosthesis of this invention in lieu of fusion reduces the mechanical stress on adjacent discs during flexion.
  • the strengths of the components are quite satisfactory for the use to which the article is to be put.
  • the tensile strength of silicone rubber is about I000 p.s.i., and that of Dacron fiber about 20,000 p.s.i.; whereas cortical bone has a tensile strength ranging from about 10,000 to about 20,000 p.s.i., with about the same relative compressive strengths.
  • the maximum compressive load to which a spinal disc is normally subjected has been found to be 350 p.s.i., although much higher loadings can be encountered under extraordinary circumstances. For example, it has been reported that loadings of 1000 p.s.i. can occur in catapultejection of pilots of jet aircraft.
  • the components each have strengths exceeding thosenormally'or extraordinarily required in the spine. It appears that the prosthesis of this invention has a safety factor of4 to 5 as related to normal compressive loading, e.g., 350 p.s.i.
  • FIG. 1 is a view in perspective of a spinal disc prosthesis embodying the principles of the present invention.
  • FIG. 2 is an exploded vertical cross-sectional view of the article taken on the line 22 of FIG. 1.
  • FIG. 3 is a top plan view, partially cut away to show side wall detail in section, and taken on the line 33 of FIG. 2.
  • FIG. 4 is a view in side elevation showing the article of this invention in place between two vertebrae.
  • FIG. 6 is a view in side elevation and in section of a modified form of central core having a viscous liquid interior.
  • FIG. 7 is a diagrammatic view showing how heavy compressive loading may be exerted against the posterior wall of a spinal disc.
  • FIG. 8 is a view in perspective of a modified form of central core with box sutures providing reinforcement to protect against the pressures illustrated in FIG. 7.
  • FIG. 9 is a view in perspective of another modified form of central core having a posterior reinforcement.
  • FIG. 10 is a diagrammatic view illustrating how the prosthesis of this invention reduces the mechanical stress on adjacent discs.
  • FIG. 11 is a top plan view, partly broken away and shown in section of a modified form of prosthetic disc embodying the principles of this invention.
  • FIG. 12 is a view in elevation taken along the line 12-12 in FIG. 11, and partly broken away and shown in section.
  • FIG. 13 is a view similar to FIG. 12 ofa further modified form ofprosthetic disc of this invention.
  • FIG. 14 is a top plan view of another modified form of prosthetic disc of the invention.
  • FIG. 15 is a view in elevation taken along the line 15-15 in FIG. 14, partly broken away and shown in section.
  • FIG. 16. is avview in elevation of another modified form of prosthetic disc embodying the principles of this invention.
  • FIG. 17 is atop planv view of the prosthesis of FIG. l6.
  • FIG. 18 is a view in vertical cross section of a stack of layers thatmay be used to make the core element of FIG. 16.
  • FIG. 19 is a view in side elevation showing what happens to the prosthetic disc of FIG. 16 when a bending moment is applied to its top and bottom surfaces.
  • FIG. is an enlarged. view in perspective of another modified form of prosthetic disc embodying the principles of the invention.
  • FIG. 21 is a top plan view of the prosthetic disc of FIG. 20.
  • FIG. 22 is a view 22-22 in FIG. 21.
  • FIG. 23 is an enlarged view in perspective of yet another modified form of prosthetic disc embodying the principles of the invention.
  • FIG. 24 is a top plan view thereof, partially broken away and shown in section.
  • FIG. is a view similar to FIG. 12 of still another modified form of prosthetic disc embodying the principles of the invention.
  • FIG. 26 in section taken along the line FIG. 26 is anothertview similar to FIG. 12 of yet another modified form of prosthetic disc embodying the principles of the invention.
  • each layer 14 is preferably reinforced with a mesh of Dacron filaments, and suitably this wall 13 can be made by winding a suitable reinforced strip of such rubber several times around a shaped center portion 16 of the core 15, applying heat to vulcanize and weld the whole together.
  • Other compatible material may be used.
  • the central portion 16 may be of clear rubber of the same type or of a like type, reinforced or not, preferably cast into the proper shape, so that the wound strip automatically assumes the desired kidney or disc shape. Lest this shape be distorted under load, localized reinforcing techniques are available to limit deflection into sensitive areas, as will be described below in connection with FIGS. 7 to 9.
  • the top element 11 preferably comprises a bottom layer 17 of silicone elastomer, which may be of the same type as in the core 15, and this layer 17 is preferably unvulcanized at the time of assembly.
  • a central layer 18 Disposed above the bottom layer 17. is a central layer 18, which may also be siliconeelastomer but in many instances is preferably aperforate reinforcing plate of metal or rigid plastic.
  • Above the layer 19 are one or more layers 20 of a suitable fabric, such as Dacron mesh, having an open porous weave to invite tissue ingrowth.
  • This covering 21 is brought down over a side wall or edge 25 of the element 11 and folded back partially over a surface 26 of the lower still unvulcanized layer 17, which, upon assembly, abuts an upper surface 27 of the core element 15.
  • the folded-over edge 28 of the coating 21 is secured in place by running a filament, preferably also of Dacron, through it, drawing it up tightly as in a pursestring closure, and securing the ends of such filament.
  • the lower element 12 may be and preferably is exactly like the upper element 11, except that its layers 17, 18', 19', 20 and 21' are in reverse order, so that the elements 11 and 12 form covering layers for the core 15, with the Dacron mesh coatings 21 and 21' facing outwardly in each instance, the inner face 26' of the as yet unvulcanized layer 17, abutting a lower face 30 of the core 15 and the face 26 of the as yet unvulcanized layer 17 ofthe upper element 11 abutting the upper face 27 of the core 15, as indicated above.
  • the article 10 is thoroughly stitched together through the fabric 21 at the sides and top by a filament 29 to join all parts firmly together, preferably using an X-pattern through stitch. Then the assembly is subjected to vulcanizing heat which acts to weld the surfaces 26 and 27 and 26 and 30, respectively, together, while the other unvulcanized layers are also vulcanized together and are also welded to adjacent surfaces.
  • the open-pore fabric coatings 21, 21' face outwardly, and when the article 10 is placed between two vertebrae 31, 31' as shown in FIGS. 4 and 5, the coatings 21, 21' abut the lower and upper faces 32 and 32', respectively, of the vertebrae 31 and 31.
  • the article 10 is of sufficient resilience and depth of pile to adapt itself to any small irregularities in the vertebral surfaces; also, the surgeon is at liberty to resect more bone, as required to clear an adequate cavity for the disc, and the prosthesis may be made intentionally oversized to facilitate such surgery.
  • the prosthesis 10 acts to hold each vertebra in position and in proper alignment with respect to the spinal cord 33. After about four to eight weeks of immobility, firm fibrous tissue developed at the vertebral surface will have grown into surfaces 21, 21 interlocking the article 10 and the abutting vertebrae.
  • the preparation for the retroperitoneal surgery may be the same as in abdominal surgery.
  • a retroperitonealanterior or anterior-lateral approach is used to expose the disc spaces.
  • the great vessels and ureters are identified and protected.
  • the anterior longitudinal ligament is incised transversely and opened like a door to expose the injured or degenerated disc.
  • the disc, end plates, and adjacent bones are removed with a curette, chisel, rongeurs, or power drill.
  • the bone is trimmed so that,
  • Temporary fixation devices such as wire or plastic sutures may be set through the bone and prosthesis.
  • the anterior longitudinal ligament and a portion of the annular ligament are then closed with sutures.
  • the overlying fascia, soft tissue, and skin are closed.
  • the patient is kept at bed rest for three weeks and then ambulated in a lumbo-sacral cor set.
  • the fabric coverings 21 and 21' provide tissue ingrowth surfaces.
  • the depth of the pile provided by the fabric layers 20, 21 and 20', 21' enable deeper ingrowth and also 'make the prosthetic disc 10 comformable to the cavity left by the excised disc.
  • the outermost silicone elastomer layers 19 and 19 preferably have as their outer surface the open-pore velour. These layers 19 and 19' serve a double purpose, for the velour adds to the depth of the pile that assists tissue ingrowth, and the silicone elastomer, having been vulcanized before assembly, inhibits the migration of raw silicone into the pile during the subsequent vulcanization of those silicone layers that have not been previously vulcanized.
  • the reinforcing ply 18 or 18 adds to the stiffness of the article 10 and may carry, when required, stiffer reinforcement such as a suitable screen wire, impregnated with the raw silicone elastomer that is to be vulcanized after assembly.
  • stiffer reinforcement such as a suitable screen wire
  • the raw silicone elastomer layers 17 and 17 serve, when vulcanized after assembly, to bond the various components together into a unitary assembly. 6.
  • the central portion 16 of the core provides an elastomeric bulk for spacing the vertebrae to the original anatomical spacing.
  • the annular reinforced core side walls 13 resist the tendency of the disc 10 to become flattened under compressive loading.
  • the walls 13 are impregnated with silicone so that they resist tissue ingrowth, which would bind the prosthetic vertebral disc 10 and prevent the desired natural action.
  • the through-and-through X-pattern stitching 29 ties all the layers together and provides a strong, elastic, mechanical connection, to reinforce the chemical bond produced by vulcanization.
  • the core unit 15 itself after vulcanization, is a complete prosthetic unit in itself, needing no units 11 or 12 for completion and omitting all of the tissueingrowth-promoting material.
  • the unit 15 is then simply inserted between two intact natural end plates that, in this instance, are left attached to each of the two vertebrae between which the unit 15 is inserted.
  • FIG. 6 shows a core unit 15A having the same layers 13 as in the core 15, but these layers 13 enclose a saclike container 40 of solid elastomer or other suitable material encasing a visco-elastic fluid polymer 41 such as another form of silicone. So long as the core 15A has a polymer that has resilience and is not too hard nor too liquid, the requirements are met, whether the core unit 15A comprises the complete prosthetic unit or is part of the more complex unit 10.
  • the prosthetic disc of this invention may have suitably reinforced posterior wall, as shown by way of example in FIGS. 8 and 9. Both of these show structures where the posterior wall 44 of the prosthetic disc is kept from deforming into a rounded shape, by ballooning according to the laws of thin-wall pressure vessels.
  • a core unit 158 is provided with a series of box sutures 45 of suitable material, such as Dacron. These sutures 45 hold the core 158 in its kidney-like shape and are assisted by the great resistance to posterior deflection already provided by the woven mesh and cloth incorporated in the end plates 11 and 12, where they are present, a bi-directional weave resisting deflection in the plane of the end plates.
  • suitable material such as Dacron.
  • the core 15C has its posterior wall 44 stiffened by a shape reinforcing member 46 of metal or strong rigid plastic.
  • FIG. 10 An important advantage of the invention over the prior art is illustrated in FIG. 10.
  • One side of this view shows a series of vertebrae 50, 51, 52, 53, in which the vertebrae 51 and 52 have been fused together, as by a prior art treatment, in which the disc was removed.
  • the adjacent discs 54 and 55 have to flex considerably.
  • the other side of FIG. 10 shows a series of vertebrae 60, 61, 62, 63, with the prosthetic disc 10 between the vertebrae 61 and 62.
  • the adjacent discs 64 and 65 have to flex considerably less to reproduce the equal amount of spinal flexion, the intervertebral distance X in the invention obviously being less than the corresponding distance X in the prior art.
  • FIGS. 1 1-15 Further modifications of the core element 15, shown in FIGS. 1 1-15, are especially pertinent when core unit is used as a complete prosthetic element in itself.
  • the core element 15D of FIGS. 11 and 12 is shaped as a spinal disc, as are all forms of this invention.
  • silicone or other suitable elastomer is reinforced by a plurality of layers 71 of fabric. It may be a substantially flat laminated sandwich of silicone 70 and Dacron 71 with silicone covering all the exposed surfaces. There may be from two to twenty plies of Dacron.
  • the core element 15E of FIG. 13 has silicone elastomer 72 reinforced by random chopped fibers 73, which may be of Dacron.
  • the core element 15F of FIGS. 14 and 15 is made by spirally wrapping a strip 75 of Dacron covered with silicone elastomer 76, and again as in all instances the exposed surfaces are silicone, the fabric being fully covered.
  • FIGS. 16 to 19 Another modified form of the prosthetic spinal disc is illustrated in FIGS. 16 to 19. It utilizes two outer covering elements 81 and 82 that are essentially the same as elements 11 and 12 of FIG. 2. However, its core member 83 may be a single piece of biocompatible elastomer molded into a suitable shape and preferably indented at its side surfaces, as by the concave surface 84. The core member 83 preferably has at least a portion of its interior reinforced with fabric, for exam- 1 1 ple, woven Dacron mesh, or with fibers, e.g., Dacron fiber.
  • One method of forming the disc prosthesis 80 is to stack several layers of silicone elastomer, each essentially kidney-shaped but of varying overall length and width dimensions, as shown in FIG. 18.
  • the outer layers 90 and 91 and also in most cases the nextto-outer layers 92-and 93, are of elastomer containing reinforcing mesh 94 to strengthen those portions of the finished core element 80 to which the top element 81 and lower element 82 are secured.
  • the inner layers 95, 96, and. 97 which are smaller in area then the layers 90 and 9 1, are of unreinforced elastomer, such as the same silicone elastomer, to enable better yielding.
  • the outer elements 81 and 82 are placed on the top and bottom of the stack of silicone layers, and the assembly is placed in a suitable press mold and cured or vulcanized, typically at about 320 F. for an hour or more, at which time the outer elements 81, 82 and the layers 90 through 97 of the core have fused to form a unitary member 83 with a smoothly-curved indented or concaved side surface 84.
  • the various elements of the disc prosthesis may be further secured by stitching, preferably by X-stitches 86 near the peripheral edges of the outer elements 81 and 82 extending through the core 83.
  • an uneven load or bending moment M applied to the cover members 81 and 82 leaves the central portion 87 unaffected but compresses the prosthesis 80 atone side 88 while stretching it somewhat at the other side 89.
  • the "core .83 may be made with its top and bottom surfaces parallel, or they may be molded to diverge so that in the finished prosthesis 80, the upper surface of 81 is inclined in one direction or another to the lower surface of 82, i.e., from front to back or back to front, not side to side.
  • a modification of prosthetic member 10 can be used to accomplish essentially what prosthetic member 80 is designed to do; namely, to avoid tearing oftissue bonds at the edges of the prosthesis as a result of extreme flexing stresses.
  • This modification may comprise'substantially the same elements as those in prosthetic member 10except that only one covering element 11 or 12 is I secured to the core element 15.
  • FIG. 25 shows a prosthetic disc 98 which consists of the core member 15D of FIG. 12 in combination with the bottom element 12 of FIG. 2. It has no member corresponding to the top element 11.
  • the laminations 70 of elastomer alternate with the laminations 71 of fabric to provide the reinforced-core 15D with good strength and ability to withstand compression.
  • the element 12 has the covering or coating 21 of tissue-ingrowthreceptive material 21", but the upper surface 99 of the disc 98 is an elastomeric surface that prevents tissue ingrowth there. Tissue ingrowth thus occurs only on one side of the prosthesis, so that during severe flexing of the spine following emplacement of this modified prosthetic disc 98, there is no possibility of tearing at the junction between the ingrowth tissue and the openpore fabric covering 21 The prosthetic disc 98 nevertheless remains intact and cannot be displaced since it is secured by tissue growth to the vertebra on that one side.
  • FIG. 26 shows modified form of prosthetic disc 35, combining a core 15D like that of FIG. 12, a'top element 11 like that of FIG. 2, and a lower element 36, which structurally is like the bottom element 12 but is much smaller in area and is confined to the central portion of the lower surface 37 of the core 15D.
  • the lower surface 37 is elastomer and is not receptive to tissue ingrowth.
  • the tissue-ingrowth attachment to the element 36 with its fabric covering 38 of Dacron or the like is not torn away during movement of the patient because it serves only as a central anchorage. The effect is similar to that in the prosthesis 98.
  • the spinal disc prosthesis of this invention are of a shape which requires that they be installed retroperitoneally, some surgeons prefer to use the posterior approach for repair of spinal discs.
  • the area in the operative field available for inserting a prosthesis is necessarily confined to a space very little more than a square centimeter.
  • most of the disc problems stem from the rupture of a portion of the posterior wall of the annulus fibrosis whereby the nucleus pulposus is allowed to extrude through the rupture site and press against nervetrunks thus causing pain.
  • Certain embodiments of the prosthesis of the present invention allow the surgeon to repair a. damaged disc with a prosthesis which will maintain intervertebral spacing, resist compressive forces, and at the same time permit the surgeon to install it despite the limitation in space available to him in a posterior surgical approach to the spine.
  • a prosthetic member comprises a flexible spirally-wound bar-like element 101 which can be made to extend into a long generally straight shaped object by unwinding, but it will recoil back into its originally spiral configuration on its own by virtue of its elastic memory created at the time the prosthesis is made.
  • the overall appearance of the coiled structure generally is that of a more or less flat oval-shaped disc.
  • the number of windings or coils which make up the complete prosthesis may be as few as one or it may have several coils, preferably about two or three. In the embodiment as illustrated in the drawings, it has two coils and a portion of a third coil.
  • the width of the coils When viewed horizontally, the width of the coils generally vary, so that the coils when in contact with each other will form an oval-shaped member.
  • the width of the coil at position 102 is smaller than the width at position 103, the net result being that an object is created which has a minor and a major axis.
  • the outside terminal end 104 of the prosthesis is generally tapered so that the coiled structure may assume a more or less smooth non-interrupted periphery at this portion of the prosthesis.
  • the bar-like element 101 of the coils comprises a core 105 of elastomeric polymer such as Silastic which is impregnated with reinforcement means 106 such as Dacron mesh.
  • An outer coating 107 generally of the same material as the core, covers the core 105 completely.
  • the top surface 108 has an open-pore tissueingrowth-receptive layer 109, which may be the same the rupture site of the annulus fibrosis after the prosthesis has been installed.
  • Substantially the entire length of the coiled core 105 may additionally have embedded in it a form-retaining member (not shown) such as a metal spring to assist the bar-like element in returning to the spiral configuration after it is released from an extended position.
  • the bottom surface of the bar-like element 101 may also be covered with an open-pore mate rial; although this is not critical in the proper functioning of the prosthesis. lnaddition, the side wall 111 of the outer terminal portion of the prosthesis may have an open-pore tissue-receptive surface to promote the growth of tissue and seal the rupture site in the posterior portion of the annulus fibrosis.
  • the prosthesis 100 may be made in a variety of sizes and shapes depending on which particular disc in the spine is to be repaired. Generally, they are roughly about one-fourth of an inch thick from top to bottom and the width at the widest point is not much more than three-eighths of an inch. Thus it is readily apparent that the unique spiral configuration of the prosthesis 100 allows it to be unwound into a smaller cross-sectional shape so that it can be introduced through a small aperture of a hollowed-out spinal disc, and then it will automatically rewind into a solid space-filling replacement of the resilient nucleus pulposus formerly contained in the disc. 1
  • the prosthetic disc 120 comprises two narrow, flexible, more or less cresentshaped segments or members 121 and 122.formed to fit together in a nesting arrangement so that together they may occupy the space created by removal of the nucleus'pulposus from a spinal disc. Although only two members 121 and 122 are shown, the composite disc 120 may be formed by more than two segments of narrower width provided the combined widths of the nesting segments results in a composite structure which fills the space in a hallowed-out disc.
  • the width of the widest portion of any segment should not be much greater than about three-eighths of an inch, and the thickness from top to bottom is roughly about 'onefourth of an inch.
  • Segments 121 and 122 need not be identical in shape or length, but the concave wall surface 123 of segment 121 and the convex wall surface 124 of segment 122 should have approximately the same degree of curvature.
  • the walls 123 and 124 may be straight up and down, or they may have other configurations such as the wall 123 having a vertical concavity and the wall 124 having a vertical convexity so the two walls may fit snugly together.
  • a core 125 of elastomeric polymer is preferably reinforced as with fabric mesh 126, and the entire peripheral wall 127 surrounding the core 125 is a smooth coating of elastomeric polymer.
  • the latter may also be reinforced internally as with fabric mesh.
  • the core in either segment may additionally have rigidifying means, heretobefore described, embedded within it.
  • Means for stabilizing the prosthesis may be incorporated as by one or more cords 129 extending from the segment 121. After the two segments 121 and 122 have been inserted into the space of a hollowed-out disc, the cords 29 on the segment 121 may be tied around the segment 122 so as to helpv maintain the two segments as a composite entity.
  • the procedure for the posterior approach to repair of the disc is followed'After the interlaminar space is exposed, laminectomy is performed to gain better access to the disc space and to provide an opening of approximately a square centimeter through which the nucleus pulposus will be removed and the prosthesis inserted.
  • the spinal dura and nerve root are identified, the root is dissected free, and together these are retracted laterally to expose the herniation.
  • the disc space is carefully debrided, preserving the cartilaginous end plates and the annulus thus creating a space sufficient to accommodate either form of the prosthesis.
  • the spiral prosthetic disc 100 is extended and inserted through the opening and allowed to coil upon itself therby filling the void in the intervertebral disc.
  • the anterior segment 121 is inserted into the anterior disc space, followed by the posterior segment 122, care being taken that the two segments abut each other snugly and fill the space provided without stressing adjacent tissues.
  • the two segments may be further stabilized by tying them together by cords 129 or by suturing to one of the adjacent vertebrae or other available tissue.
  • the wound is closed in layers insuring that proper hemostasis is obtained.
  • either prosthesis 100 or 120 prevents instability of the spine, maintains proper spacing between vertebrae, and minimizes mechanical bending loads on adjacent discs which was not possible heretofore with fusion procedures of the past.
  • a resilient shaped prosthesis for replacement of a damaged or degenerated spinal disc comprising:
  • a spinal-disc-shaped element having two generally flat faces, and" whereinsaid element is a laminated sandwich of horizontal shaped sheets of elastomer and horizontal shaped sheets of fabric-reinforced elastomer, all
  • said element comprises a spirally-wound strip of fabric coated with and bonded by elastomer, all outer surfaces consisting of said elastomer.
  • a resilient shaped prosthesis for replacement of a damaged or degenerated spinal disc comprising:
  • a spinal-disc-shaped element having two generally wherein said element is a laminated sandwich of horizontal shaped sheets of elastomer and horizontal shaped sheets of fabric, and
  • said spinal-disc-shaped element has, affixed to one said face of said element, an outward-facing covering of tissue-ingrowth-receptive, open-pore material.
  • a resilient, biocompatible, shaped prosthesis for replacement of a degenerated or damaged spinal disc including in combination:
  • a spinal-disc-shaped core element having a central portion of viscoelastic fluid polymer encased in a protecting and confining sac with two generally flat faces
  • each of said closure elements having a flat elastomeric portion resting against one said face, and an outward-facing covering of tissue-ingrowthreceptive, open-pore fabric,
  • a resilient, bicompatible, shaped prosthesis for replacement of a degenerated or damaged spinal disc including in combination:
  • a spinal-disc-shaped core element having a central portion of unreinforced elastic polymer with two generally flat faces and a surrounding wall of reinforced polymer affixed to said central portion
  • each of said outer elements having a flat elastomeric portion resting against one said face, and an outward-facing covering of tissue-ingrowth-receptive, open-pore fabric,
  • prosthesis of claim 9 wherein said additional 5 means comprises box sutures linking said posterior portion to opposite portions of said wall.
  • said additional means comprises a rigid strip lying against the interior surface of said posterior portion.
  • a resilient, bicompatible, shaped prosthesis for replacement of a degenerated or damaged spinal disc including in combination:
  • a spinal-disc-shaped core element having a central portion of elastic polymer with two generally flat faces
  • each of said outer elements having a flat elastomeric portion resting against one said face and comprising a plurality of silicone rubber layers in stacked arrangement, and an outward-facing covering of tissue-ingrowth-receptive, open-pore fabric,
  • a resilient, shaped prosthesis for replacement of a degenerated or damaged spinal disc comprising:
  • a spinal-disc-shaped element having two generally flat faces and having a central portion consisting of elastic polymer compatible with body fluids and tissues, and
  • a resilient, shaped prosthesis for replacement of a degenerated or damaged spinal disc comprising:
  • a spinal-disc-shaped element having two generally flat faces and having a central portion consisting of elastic polymer compatible with body fluids and tissues, and
  • said polymer is a visco-elastic fluid encased in a protecting and confining sac.
  • a resilient, shaped prosthesis for replacement of 60 a degenerated or damaged spinal disc comprising:
  • a spinal-disc-shaped element having two generally flat faces and having a central portion consisting of elastic polymer compatible with body fluids and tissues, and
  • said reinforced surrounding wall being made of silicone elastomer reinforced with a mesh of fabric filaments, and having a posterior portion and additional means for rigidifying said posterior portion.
  • prosthesis of claim 20 wherein said additional means comprises box sutures linking said posterior portion to opposite portions of said wall.
  • a resilient, shaped prosthesis for replacement of a degenerated or damaged spinal disc comprising:
  • a spinal-disc-shaped element having two generally flat faces and having a central portion consisting of elastic polymer compatible with body fluids and tissues, and
  • said surrounding wall is a plurality of layers of silicone rubber, each layer being reinforced with Dacron mesh.
  • a resilient, shaped prosthesis for replacement of a damaged or a degenerated spinal disc including in combination:
  • a spinal-disc-shaped core element having two generally flat faces, a central portion of silicone elastomer, initially unvulcanized
  • each of said covering elements having a stack of flat elastomeric layers, with an inner initially unvulcanized layer resting against one side face and an initially vulcanized outer layer, and an outward-facing covering of tissue-ingrowth-receptive, open-pore fabric, secured to said outer layer, all of said elements being firmly affixed together by vulcanization together after assembly of said initially unvulcanized elastomeric layers and portions.
  • a resilient, biocompatible, shaped prosthesis for replacement of a degenerated or damaged spinal disc including in combination:
  • a spinal-disc-shaped core element having a central portion of fabric-reinforced elastic polymer with two generally flat faces of said polymer
  • a spinal-disc shaped outer element coterminous in area with said core element affixed to one said face only of said core element and having an outwardfacing covering of tissue-ingrowth-receptive, openpore fabric,
  • a resilient, shaped prosthesis for replacement of a damaged or a degenerated spinal disc including in combination:
  • a spinal-disc-shaped core element having first and second generally flat faces and comprising fabricreinforced elastomer, said faces having outer surfaces of said elastomer, 3
  • each of said covering elements having an outwardfacing covering of tissue-ingrowth-receptive, openpore fabric, secured to said outer layer,
  • a resilient, shaped prosthesis for repair of a degenerated or damaged spinal disc comprising:
  • spiral sppinal-disc-shaped member having two generally flat faces and comprising a specially-covered bar-like elastomeric element compatible with body fluids and tissues, capable of being unwound into a long generally straight form and inherently tending to recoil itself, upon release, into its spiral spinal-disc shape.
  • prosthesis of claim 34 having an outer covering of tissue-ingrowth-receptive material on at least one said face.
  • the prosthesis of claim 34 having a corestiffening yielding member embedded in at least its outermost terminal portion to aid in preventing bulging.
  • a resilient, shaped prosthesis for repair of a damaged or a degenerated spinal disc including in combination:
  • a generally spinal-disc-shaped assembly having two generally flat faces and comprising a plurality of curved segments arranged to nest in a horizontal manner when in place so as to provide said flat faces, each said segment being sufficiently narrow for installation through a narrow opening.
  • prosthesis of claim 38 having an outwardfacing covering of tissue-ingrowth-receptive, openpore fabric, secured to one said face on each said segment.
  • a resilient, shaped prosthesis for replacement of a damaged or degenerated spinal disc comprising:
  • said element comprises a spirally-wound strip of fabric coated with and bonded by elastomer and said element has, affixed to one said fiat face, an outward-facing covering of tissue-ingrowth-receptive open-pore fabric.

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  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Public Health (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Neurology (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)
US348140A 1971-12-30 1973-04-05 Prosthesis for spinal repair Expired - Lifetime US3867728A (en)

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CA992255A (en) 1976-07-06
DE2203242C3 (de) 1975-10-09
GB1306660A (en) 1973-02-14
SE391122B (sv) 1977-02-07
FR2124815A5 (xx) 1972-09-22
DE2203242B2 (xx) 1975-03-06
DE2203242A1 (de) 1972-08-10

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