US20070162132A1 - Flexible elongated chain implant and method of supporting body tissue with same - Google Patents

Flexible elongated chain implant and method of supporting body tissue with same Download PDF

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Publication number
US20070162132A1
US20070162132A1 US11/633,131 US63313106A US2007162132A1 US 20070162132 A1 US20070162132 A1 US 20070162132A1 US 63313106 A US63313106 A US 63313106A US 2007162132 A1 US2007162132 A1 US 2007162132A1
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Prior art keywords
bone
bodies
elongated member
links
chain
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Dominique Messerli
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DePuy Spine LLC
DePuy Synthes Products Inc
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Individual
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Priority to US11/633,131 priority Critical patent/US20070162132A1/en
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Assigned to SYNTHES (U.S.A.) reassignment SYNTHES (U.S.A.) ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MESSERLI, DOMINIQUE
Publication of US20070162132A1 publication Critical patent/US20070162132A1/en
Assigned to SYNTHES USA, LLC reassignment SYNTHES USA, LLC CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: SYNTHES (U.S.A.)
Priority to US13/558,662 priority patent/US9289240B2/en
Assigned to DePuy Synthes Products, LLC reassignment DePuy Synthes Products, LLC CHANGE OF NAME Assignors: HAND INNOVATIONS LLC
Assigned to HAND INNOVATIONS LLC reassignment HAND INNOVATIONS LLC ASSIGNMENT OF ASSIGNOR'S INTEREST Assignors: DEPUY SPINE, LLC
Assigned to DEPUY SPINE, LLC reassignment DEPUY SPINE, LLC ASSIGNMENT OF ASSIGNOR'S INTEREST Assignors: SYNTHES USA, LLC
Assigned to DePuy Synthes Products, Inc. reassignment DePuy Synthes Products, Inc. CHANGE OF NAME Assignors: DePuy Synthes Products, LLC
Priority to US15/040,217 priority patent/US10881520B2/en
Priority to US15/259,817 priority patent/US20160374818A1/en
Priority to US15/333,275 priority patent/US9956085B2/en
Assigned to HAND INNOVATIONS LLC reassignment HAND INNOVATIONS LLC CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT APPL. NO. 13/486,591 PREVIOUSLY RECORDED AT REEL: 030359 FRAME: 0001. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: DEPUY SPINE, LLC
Assigned to DEPUY SPINE, LLC reassignment DEPUY SPINE, LLC CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT APPLICATION NO. US 13/486,591 PREVIOUSLY RECORDED ON REEL 030358 FRAME 0945. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: SYNTHES USA, LLC
Priority to US15/801,335 priority patent/US11406508B2/en
Priority to US17/115,777 priority patent/US11701233B2/en
Abandoned legal-status Critical Current

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    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • 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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    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7094—Solid vertebral fillers; devices for inserting such fillers
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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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    • A61F2/00—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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    • A61F2/00—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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/4465—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 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
    • A—HUMAN NECESSITIES
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • 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
    • A61F2/447—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 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
    • A—HUMAN NECESSITIES
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    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
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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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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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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    • A61F2002/4415—Joints for the spine, e.g. vertebrae, spinal discs elements of the prosthesis being arranged in a chain like manner
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    • 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
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the invention relates to implants, and more particularly to flexible chain implants for augmenting or supporting bones or other structures, such as, for example vertebral discs.
  • Vertebral compression fractures represent a generally common spinal injury and may result in prolonged disability. These fractures involve collapsing of one or more vertebral bodies 12 in the spine 10 . Compression fractures of the spine usually occur in the lower vertebrae of the thoracic spine or the upper vertebra of the lumbar spine. They generally involve fracture of the anterior portion 18 of the affected vertebra 12 (as opposed to the posterior side 16 ). Spinal compression fractures can result in deformation of the normal alignment or curvature, e.g., lordosis, of vertebral bodies in the affected area of the spine.
  • Spinal compression fractures and/or related spinal deformities can result, for example, from metastatic diseases of the spine, from trauma or can be associated with osteoporosis. Until recently, doctors were limited in how they could treat such compression fractures and related deformities. Pain medications, bed rest, bracing or invasive spinal surgery were the only options available.
  • vertebral compression fractures More recently, minimally invasive surgical procedures for treating vertebral compression fractures have been developed. These procedures generally involve the use of a cannula or other access tool inserted into the posterior of the effected vertebral body, usually through the pedicles. The most basic of these procedures is vertebroplasty, which literally means fixing the vertebral body, and may be done without first repositioning the bone.
  • a cannula or special bone needle is passed slowly through the soft tissues of the back.
  • Image guided x-ray, along with a small amount of x-ray dye, allows the position of the needle to be seen at all times.
  • a small amount of polymethylmethacrylate (PMMA) or other orthopedic cement is pushed through the needle into the vertebral body.
  • PMMA is a medical grade substance that has been used for many years in a variety of orthopedic procedures.
  • the cement is mixed with an antibiotic to reduce the risk of infection, and a powder containing barium or tantalum, which allows it to be seen on the X-ray.
  • Vertebroplasty can be effective in the reduction or elimination of fracture pain, prevention of further collapse, and a return to mobility in patients.
  • this procedure may not reposition the fractured bone and therefore may not address the problem of spinal deformity due to the fracture. It generally is not performed except in situations where the kyphosis between adjacent vertebral bodies in the effected area is less than 10 percent.
  • this procedure requires high-pressure cement injection using low-viscosity cement, and may lead to cement leaks in 30-80% of procedures, according to recent studies. In most cases, the cement leakage does no harm. In rare cases, however, polymethymethacrylate or other cement leaks into the spinal canal or the perivertebral venous system and causes pulmonary embolism, resulting in death of the patient.
  • More advanced treatments for vertebral compression fractures generally involve two phases: (1) reposition, or restoration of the original height of the vertebral body and consequent lordotic correction of the spinal curvature; and (2) augmentation, or addition of material to support or strengthen the fractured or collapsed bone.
  • balloon kyphoplasty (Kyphon, Inc.), is disclosed in U.S. Pat. Nos. 6,423,083, 6,248,110, and 6,235,043 to Riley et al., each of which is incorporated by reference herein in its entirety.
  • a catheter having an expandable balloon tip is inserted through a cannula, sheath or other introducer into a central portion of a fractured vertebral body comprising relatively soft cancellous bone surrounded by fractured cortical bone.
  • Kyphoplasty then achieves the reconstruction of the lordosis, or normal curvature, by inflating the balloon, which expands within the vertebral body restoring it to its original height.
  • the balloon is removed, leaving a void within the vertebral body, and PMMA or other filler material is then injected through the cannula into the void as described above with respect to vertebroplasty.
  • the cannula is removed and the cement cures to augment, fill or fix the bone.
  • Disadvantages of this procedure include the high cost, the repositioning of the endplates of the vertebral body may be lost after the removal of the balloon catheter, and the possible perforation of the vertebral endplates during the procedure.
  • a neurologic deficit may occur through leakage of bone cement into the spinal canal.
  • Such a cement leak may occur through the low resistance veins of the vertebral body or through a crack in the bone which was not appreciated previously.
  • Other complications include additional adjacent level vertebral fractures, infection and cement embolization.
  • Cement embolization occurs by a similar mechanism to a cement leak. The cement may be forced into the low resistance venous system and travel to the lungs or brain resulting in a pulmonary embolism or stroke.
  • Still another procedure used in the treatment of vertebral compression fractures is an inflatable polymer augmentation mass known as a SKy Bone Expander.
  • This device can be expanded up to a pre-designed size and (Cubic or Trapezoid) configuration in a controlled manner.
  • the SKy Bone Expander is removed and PMMA cement or other filler is injected into the void. This procedure therefore entails many of the same drawbacks and deficiencies described above with respect to kyphoplasty.
  • bone grafts are used to repair or otherwise treat the damaged area.
  • bone grafting procedures In the United States alone, approximately half a million bone grafting procedures are performed annually, directed to a diverse array of medical interventions for complications such as fractures involving bone loss, injuries or other conditions necessitating immobilization by fusion (such as for the spine or joints), and other bone defects that may be present due to trauma, infection, or disease.
  • Bone grafting involves the surgical transplantation of pieces of bone within the body, and generally is effectuated through the use of graft material acquired from a human source. This is primarily due to the limited applicability of xenografts, transplants from another species.
  • Orthopedic autografts or autogenous grafts involve source bone acquired from the same individual that will receive the transplantation.
  • this type of transplant moves bony material from one location in a body to another location in the same body, and has the advantage of producing minimal immunological complications.
  • the acquisition of bone material from the body of a patient typically requires a separate operation from the implantation procedure.
  • the removal of material oftentimes involving the use of healthy material from the pelvic area or ribs, has the tendency to result in additional patient discomfort during rehabilitation, particularly at the location of the material removal.
  • Grafts formed from synthetic material have also been developed, but the difficulty in mimicking the properties of bone limits the efficacy of these implants.
  • allografts are bone grafts from other human sources (normally cadavers).
  • the bone grafts are placed in a host bone and serve as the substructure for supporting new bone tissue growth from the host bone.
  • the grafts are sculpted to assume a shape that is appropriate for insertion at the fracture or defect area, and often require fixation to that area for example by screws, pins, cement, cages, membranes, etc. Due to the availability of allograft source material, and the widespread acceptance of this material in the medical community, the use of allograft tissues is likely to expand in the field of musculoskeletal surgery.
  • the various bones of the body such as the femur (thigh), tibia and fibula (leg), humerus (upper arm), radius and ulna (lower arm) have geometries that vary considerably.
  • the lengths of these bones vary; for example, in an adult the lengths may vary from 47 centimeters (femur) to 26 centimeters (radius).
  • the shape of the cross section of each type of bone varies considerably, as does the shape of any given bone over its length. While a femur has a generally rounded outer shape, a tibia has a generally triangular outer shape.
  • the wall thickness varies in different areas of the cross-section of each bone.
  • the use of any given bone to produce an implant component may be a function of the bone's dimensions and geometry. Machining of bones, however, may permit the production of implant components with standardized or custom dimensions.
  • bone As a collagen-rich and mineralized tissue, bone is composed of about forty percent organic material (mainly collagen), with the remainder being inorganic material (mainly a near-hydroxyapatite composition resembling 3Ca 3 (PO 4 ) 2 Ca(OH) 2 ). Structurally, the collagen assumes a fibril formation, with hydroxyapatite crystals disposed along the length of the fibril, and the individual fibrils are disposed parallel to each other forming fibers. Depending on the type of bone, the fibrils are either interwoven, or arranged in lamellae that are disposed perpendicular to each other.
  • organic material mainly collagen
  • inorganic material mainly a near-hydroxyapatite composition resembling 3Ca 3 (PO 4 ) 2 Ca(OH) 2 .
  • the collagen assumes a fibril formation, with hydroxyapatite crystals disposed along the length of the fibril, and the individual fibrils are disposed parallel to each other forming fibers.
  • the fibrils
  • Bone tissues have a complex design, and there are substantial variations in the properties of bone tissues depending upon the type of bone (i.e., leg, arm, vertebra) as well as the overall structure.
  • leg and arm bones when tested in the longitudinal direction, leg and arm bones have a modulus of elasticity of about 17 to 19 GPa, while vertebra tissue has a modulus of elasticity of less than 1 GPa.
  • the tensile strength of leg and arm bones varies between about 120 MPa and about 150 MPa, while vertebra have a tensile strength of less than 4 MPa.
  • the compressive strength of bone varies, with the femur and humerus each having a maximum compressive strength of about 167 MPa and 132 MPa respectively.
  • the vertebra have a far lower compressive strength usually of no more than about 10 MPa.
  • a long bone such as the femur has both compact bone and spongy bone.
  • Cortical bone the compact and dense bone that surrounds the marrow cavity, is generally solid and thus carries the majority of the load in major bones.
  • Cancellous bone, the spongy inner bone is generally porous and ductile, and when compared to cortical bone is only about one-third to one-quarter as dense, one-tenth to one-twentieth as stiff, but five times as ductile.
  • cancellous bone has a tensile strength of about 10-20 MPa and a density of about 0.7 g/cm 3
  • cortical bone has a tensile strength of about 100-200 MPa and a density of about 2 g/cm 3
  • the strain to failure of cancellous bone is about 5-7%
  • cortical bone can only withstand 1-3% strain before failure. It should also be noted that these mechanical characteristics may degrade as a result of numerous factors such as any chemical treatment applied to the bone material, and the manner of storage after removal but prior to implantation (i.e. drying of the bone).
  • cancellous bone incorporate more readily with the surrounding host bone, due to the superior osteoconductive nature of cancellous bone as compared to cortical bone.
  • cancellous bone from different regions of the body is known to have a range of porosities.
  • cancellous bone in the iliac crest has a different porosity than cancellous bone in a femoral head.
  • the design of an implant using cancellous bone may be tailored to specifically incorporate material of a desired porosity.
  • a flexible chain comprises a series or other plurality of preferably solid, substantially non-flexible body portions (also referred to as bodies or beads) and a series of flexible link portions (also referred to as links or struts).
  • the preferably solid, substantially non-flexible body portions preferably are capable of withstanding loads that are applied in any direction
  • the flexible link portions of the implant preferably are disposed between the substantially non-flexible body portions and preferably are flexible in any direction, although they may be flexible in only selected or desired directions.
  • the bodies may be substantially solid, semi-solid or hollow and preferable of sufficient strength to support the loads typical for the body location in which they are implanted.
  • the link portions may be solid, semi-solid, or hollow and preferably of sufficient flexibility to allow the adjacent bodies to touch one another upon bending of the elongate member or chain.
  • the material of both portions, the flexible link and non-flexible body portions, preferably is the same and form one single, flexible monolithic chain (FMC).
  • an apparatus for augmentation of body tissue for example bone, comprises a flexible elongated member, or chain, having a longitudinal length substantially larger than its height or its width.
  • the flexible elongated member comprises a plurality of substantially non-flexible bodies and a plurality of substantially flexible links interconnecting the bodies.
  • the bodies and links are connected end-to-end to form the elongated member, wherein the elongated member is formed of a biocompatible material.
  • the bodies may be different sizes and shapes than the links or they may be the same shape, same size, or both.
  • each body and link may be a different size and shape than other bodies or links.
  • the beads can be shaped so that they can fit together to minimize interstial spaces.
  • the beads may be shaped as cubes or other polyhedrals that can be stacked together in such a way that there is little space between beads, or a predetermined percentage range of interstial space.
  • the elongated member may be formed as an integral monolithic chain, which may be formed of bone, such as, for example, allograft bone.
  • the flexible links may be formed of bone that has been demineralized to a greater extent than the bodies.
  • a coating may be applied to at least a portion of the elongated member, e.g. a coating comprising a therapeutic agent, a bone cement, an antibiotic, a bone growth stimulating substance, bone morphogenic protein (BMP) or any combination thereof.
  • Therapeutic agents, or drug agents (e.g., antibodies), or biologics (e.g., one or more BMPs) can be coated, or attached via peptides, adsorbed, sorbed or in some other way perfused onto or into the elongated member; either the bodies, the links or both.
  • the coating may comprise a bone cement that may be activated upon insertion into the bone.
  • at least a portion of the bodies comprise an outer surface configured to promote bone in-growth.
  • a flexible chain implant may be impacted or inserted into a cavity, void or hollow space, e.g., through a small narrow opening.
  • cavities may be, for example, voids in long bones, intervertebral disc spaces or vertebral bodies. Such voids may have occurred due to infections, disease, trauma fractures, degenerative disc disease process, tumors or osteotomies.
  • a void may be created by using a tool to compact or remove cancellous or cortical bone or other tissue prior to implantation. The chain may thereafter be implanted to fill the created void.
  • the device will fill and/or support the tissue structure, preferably bone structure to a restored size and/or height.
  • no void or cavity may be present, and even if a void or cavity is present the chain implant or elongated member may be inserted and/or implanted in a manner to compact the material and bone cells within the bone and to further fill the bone in a manner that it can better support a load and preferably fill the bone in a manner to restore its original and/or treated size and height.
  • one or more flexible monolithic chains may be implanted into diseased, damaged or otherwise abnormal bones to treat, for example, long bone infections, comminuted complex fractures, tumor resections and osteotomies.
  • An FMC device may also be used to treat disease or abnormal pathology conditions in spinal applications, including, for example, degenerative disc disease, collapsed intervertebral discs, vertebral body tumor or fractures, and vertebral body resections.
  • the elongated member or chain device can be used as a preventive measure to augment a bone, spinal disc or an implant, e.g., and intervertebral body implant to promote fusion.
  • the elongated member may be used within a vertebra or between two vertebra.
  • the elongated member or chain also may be used for example in an intervertebral body fusion procedure, for example, as an implant inserted into the disc space between two vertebra, as an implant inserted into and retained by the disc annulus, or in combination with an additional implant inserted in the disc space between two vertebra.
  • kits comprises various combinations of assemblies and components according to the present invention.
  • a kit may include, for example, a package or container comprising an elongated member, for example an FMC device, and a cannula or other introducer or device for implanting the elongated member.
  • a kit may comprise instruments to create a cavity (e.g., balloon catheter), an FMC device and a cement or other filler material and/or a syringe or other apparatus for injecting a FMC device and/or such filler material into a vertebral body.
  • FIG. 1 is a side view of a portion of a spine with a vertebral compression fracture.
  • FIG. 2A is a side view of a flexible monolithic chain according to an embodiment of the present invention.
  • FIG. 2B is a close-up cross-sectional side view of the flexible monolithic chain of FIG. 2A taken through line B-B.
  • FIGS. 3 A-D is an illustration depicting a method of fabricating a flexible monolithic chain.
  • FIGS. 4 A-C are perspective views of other embodiments of a flexible monolithic chain having flexible portions and non-flexible portions with substantially uniform dimensions.
  • FIG. 5 is a perspective, cross-sectional view of another embodiment of a flexible monolithic chain.
  • FIGS. 6A and B are side cross-sectional views of a flexible monolithic chain being implanted within a fractured vertebral body.
  • FIG. 7 is a cross-sectional top view of a flexible monolithic chain implanted within a vertebral body.
  • FIG. 8A is a cross-sectional side view of a vertebra having a flexible monolithic chain implanted within a vertebral body.
  • FIG. 8B is a cross-sectional side view of a vertebra having an implanted flexible monolithic chain as in FIG. 8A , showing an end of the chain extending from the vertebra.
  • FIG. 8C is a cross-sectional side view of a vertebra having an implanted flexible monolithic chain as in FIG. 8A , and further including a pedicle screw implant.
  • FIGS. 9 A-D are top views depicting a minimally invasive method for implanting a flexible monolithic chain within a vertebral body.
  • FIG. 10A is a cross-sectional top view of another method of implanting a flexible monolithic chain within a vertebral body.
  • FIG. 10B is a top view of a flexible monolithic chain that may be used in the method of FIG. 10A .
  • FIG. 10C is a side view of another embodiment of a flexible monolithic chain that may be used in the method of FIG. 10A .
  • FIG. 11A is a side view of a screw device for driving a chain implant through an introducer.
  • FIG. 11B is an end view of a screw device for driving a chain implant through an introducer.
  • FIG. 12 is a side view of a plunger device for driving a chain implant through an introducer.
  • FIG. 13 is a side view of a sprocket device for driving a chain implant through an introducer.
  • FIGS. 14A and B are cross-sectional side views of a flexible monolithic chain implanted into the head of a femur.
  • FIG. 15 is a cross-sectional view of a chain implant inserted through a cannula into the head of a femur.
  • a chain 200 (sometimes referred to as an elongated member) comprises one or more bodies 210 (sometimes referred to as beads).
  • Chain 200 is preferably a monolithic chain, e.g., formed from a single, common material or type of material forming an integral structure.
  • Bodies 210 are preferably substantially non-flexible, and may be solid, semi-solid, porous, non-porous, hollow, or any combination thereof.
  • Chain 200 may also comprise one or more linking portions 220 , also sometimes referred to as struts or links 220 .
  • Struts 220 may be disposed between each pair of adjacent bodies 210 .
  • Struts 220 are preferably substantially flexible or semiflexible, e.g. to allow for bending of the chain 200 between bodies 210 .
  • Bodies 210 of chain 200 are preferably formed of bone, e.g., cortical bone, cancellous bone or both, but preferably cortical bone.
  • chain 200 may be comprised of any biocompatible material having desired characteristics, for example a biocompatible polymer, metal, ceramic, composite or any combination thereof.
  • Bodies 210 may be absorbable or resorbable by the body.
  • the bodies 210 preferably have osteoinductive properties or are made at least partly from osteoinductive materials.
  • the outer circumferential shape of the body may be the same as adjacent links. Alternatively or in addition, the outer circumferential shape of the body may be the same size as adjacent links.
  • Bodies 210 may be of uniform or non-uniform size, shape and/or materials, and may be linked in series, for example by one or more flexible or semi-flexible linking portions 220 , which can form struts of any desired length between bodies 210 .
  • Linking portions are preferably, although not necessarily, formed of the same material as bodies 210 .
  • a chain 200 may have any desired number of linked bodies 210 , and may have a first end 202 and a second end 204 .
  • chain 200 may be formed in a loop, ring, or other configuration having no ends, or may be configured to have multiple extensions and/or multiple ends, for example like branches of a tree.
  • the one or more linking portions 220 may be comprised of any biocompatible material having desired characteristics of flexibility, strength, and the like.
  • linking portions 220 may be formed, at least in part, of substantially the same material as bodies 210 .
  • chain 200 including bodies 210 and/or linking portions 220 , may be resorbable.
  • the bodies 210 may be of uniform or non-uniform size, and may be spaced by linking portions 220 at uniform or non-uniform increments.
  • FIG. 2B is a close up cross-sectional view of chain 200 , taken at line B-B in FIG. 2A .
  • chain 200 is a monolithic chain, with bodies 210 and flexible portions 220 formed from a uniform material, e.g., bone.
  • bodies 210 are shown as substantially spherical, and linking portions 220 are shown as substantially cylindrical, numerous other shapes are contemplated.
  • chains 200 including body 210 and/or linking portion 220 , may be of any desired shape, such as for example, cylindrical, elliptical, spherical, rectangular, etc.
  • Body 210 and/or linking portion 220 may also be of any particular cross sectional shape such as round hexagonal, square, etc.
  • Bodies 210 and linking portions 220 may have the same or different shapes.
  • the configurations of bodies 210 may vary within a chain 200 , for example as described herein with respect to FIGS. 5 and 10 .
  • the configuration of links 220 may vary within a chain.
  • the bodies can be shaped so that they fit together to minimize interstitial spacing or provide a predetermined range of interstitial spacing.
  • the diameter 230 of bodies 210 may be between about 1 mm and about 15 mm, preferably between about 2 mm and about 8 mm, or more preferably between about 4 mm and about 6 mm.
  • the non-flexible bodies 210 are larger in shape and size than the flexible struts 220 .
  • height 232 of struts 220 may be between about 0.5 mm and about 8 mm, preferably between about 0.8 mm and about 4 mm, and may depend in part upon the size of bodies 210 .
  • Struts 220 may have any desired length 238 , e.g., between about 0.5 mm and about 5.0 mm, preferably between about 1.5 mm and 3.5 mm, or greater than 5 mm.
  • distance 234 between bodies 210 may be any desired distance, e.g., depending upon the size of bodies 210 and/or length 238 struts 220 . In some embodiments, for example, distance 234 may be between about 4 mm and about 15 mm, or between about 6 mm and about 10 mm.
  • the junctions between bodies 210 and struts 220 may have a radius 236 of any desired dimension, e.g., less than 1.0 mm, between about 1.0 mm and about 2.0 mm, or greater than about 2.0 mm.
  • each of the bodies 210 and struts 220 of a chain may be of the same configuration and/or dimensions as other bodies 210 and struts within the chain 200 .
  • bodies 210 and/or struts 220 within a chain may have different configurations or dimensions.
  • the non-flexible bodies 210 and flexible portions 220 may be of the same shape and size to form a relatively uniform structure, for example as shown in FIG. 4 .
  • a chain 200 may be made as long as practical for a particular application.
  • an exemplary chain 200 for implantation into a bone may be about 100 mm in length.
  • chain 200 may be of other lengths, for example less than about 1 mm, between about 1 mm and about 100 mm, or greater than 100 mm.
  • two or more chains 200 and/or other implants may be used in combination with each other.
  • Chain 200 may be connected end to end to form larger chains.
  • the present invention is preferably directed to the creation of implants from allograft material
  • the present invention may also be applied to implants that utilize other materials, including but not limited to the following: xenograft, autograft, metals, alloys, ceramics, polymers, composites, and encapsulated fluids or gels.
  • the implants described herein may be formed of materials with varying levels of porosity, such as by combined bone sections from different bones or different types of tissues and/or materials having varying levels of porosity.
  • the implants described herein may be formed of bone materials with varying mineral content.
  • cancellous or cortical bone may be provided in natural, partially demineralized, or demineralized states.
  • Demineralization is typically achieved with a variety of chemical processing techniques, including the use of an acid such as hydrochloric acid, chelating agents, electrolysis or other treatments.
  • the demineralization treatment removes the minerals contained in the natural bone, leaving collagen fibers with bone growth factors including bone morphogenic protein (BMP). Variation in the mechanical properties of bone sections is obtainable through various amounts of demineralization.
  • BMP bone morphogenic protein
  • a demineralizing agent on bone transforms the properties of the bone from a stiff structure to a relatively pliable structure.
  • the flexibility or pliability of demineralized bone may be enhanced when the bone is hydrated.
  • Any desired portions of bone components, e.g., link portions 220 or any other desired portion may be demineralized or partially demineralized in order to achieve a desired amount of malleability, elasticity, pliability or flexibility, generally referred to herein as “flexibility”.
  • the amount of flexibility can be varied by varying in part the amount of demineralization.
  • bone components initially may be provided with moisture content as follows: (a) bone in the natural state fresh out of the donor without freezing, (b) bone in the frozen state, typically at ⁇ 40° C., with moisture content intact, (c) bone with moisture removed such as freeze-dried bone, and (d) bone in the hydrated state, such as when submersed in water.
  • moisture content as follows: (a) bone in the natural state fresh out of the donor without freezing, (b) bone in the frozen state, typically at ⁇ 40° C., with moisture content intact, (c) bone with moisture removed such as freeze-dried bone, and (d) bone in the hydrated state, such as when submersed in water.
  • the implants may be formed entirely from cortical bone, entirely from cancellous bone, or from a combination of cortical and cancellous bone. While the implants may be created entirely from all bone material, it is also anticipated that one or more components or materials may be formed of non-bone material, including synthetics or other materials. Thus, while the implants disclosed herein are typically described as being formed primarily from bone, the implants alternatively may be formed in whole or in part from other materials such as stainless steel, titanium or other metal, an alloy, hydroxyapatite, resorbable material, polymer, or ceramic, and may additionally incorporate bone chips, bone particulate, bone fibers, bone growth materials, and bone cement.
  • the structure optionally may include perforations or through bores extending from one outer surface to another outer surface, or recesses formed in outer surfaces that do not extend through inner surfaces (surface porosity), or recesses formed internally.
  • Surface texture such as depressions and/or dimples may be formed on the outer surface.
  • the depressions and/or dimples may be circular, diamond, rectangular, irregular or have other shapes.
  • the flexible monolithic chain devices described herein may be used to treat disease and pathological conditions in general orthopedic applications such as long bone infections, comminuted complex fractures, tumor resections and osteotomies. Additionally the device can be used to treat disease and pathological conditions in spinal applications, such as, for example, degenerative disc disease, collapsed intervertebral discs, vertebral body tumor or fractures, vertebral body resections or generally unstable vertebral bodies. In other embodiments, a flexible monolithic chain device may be used in maxillofacial applications or in non-fusion nucleus replacement procedures.
  • FIG. 3 shows an example of a method 300 for fabricating a monolithic chain device 200 out of bone material 310 .
  • allograft femoral bone 310 is used as a base material, preferably, cortical allograft bone.
  • Other bones may be used for forming implants, for example, radius, humerous, tibia, femur, fibula, ulna, ribs, pelvic, vertebrae or other bones.
  • an initial step comprises machining a rough monolithic chain 200 ′, having a desired general shape, out of the raw material 310 , preferably bone.
  • a desired general shape for example, conventional milling and/or other fabrication techniques may be used.
  • Device 200 may have any desired shape, for example including generally elliptical or spherical bodies 210 separated by cylindrical linking portions 220 as shown.
  • chain 200 may be formed of a substantially uniform shape as shown, for example, in FIG. 4 .
  • the rough monolithic device 200 ′ may then be removed from the raw material 310 , as shown for example in step B.
  • an upper side 312 of the rough device 200 ′ has been fabricated to have a desired general shape as described above.
  • An opposite side 314 may include excess material that was not removed in step A.
  • opposite side 314 is machined to remove excess material, for example using conventional milling methods.
  • Side 312 may also be further machined or shaped as desired, in order to form a monolithic chain device 200 having the desired shapes and configurations of bodies 210 and linking portions 220 .
  • the shaped chain 200 may be demineralized, e.g., in container 320 containing a demineralizing solution 322 (e.g., hydrochloric acid) or using another method.
  • Demineralization may be allowed to occur for a specified amount of time, for example to allow the smaller, lower volume portions 220 of the device 200 to become more flexible or elastic, while the larger bodies 210 of the device remain structurally intact and substantially rigid.
  • the amount of time and/or the concentration or composition of the demineralizing solution may be varied to provide the desired amount of flexibility or elasticity.
  • this secondary process of demineralization can be applied to specific portions of the device 200 , e.g., by masking or shielding the portions that do not or should not be treated.
  • the flexible portions 220 can be partially or entirely demineralized, and the non-flexible portions 210 may retain their original mineralized state prior to the masking.
  • an allograft device may be submerged entirely into demineralization acid without masking any portions of the device.
  • the flexible portions 220 may demineralize entirely, or at least substantially more than the larger portions 210 , which may undergo only surface demineralization. Therefore, the smaller portions 220 may become flexible and elastic while the larger portions 210 may remain relatively stiff and substantially non-flexible.
  • FIG. 2B shows regions 240 that are substantially demineralized and regions 242 that have substantially their natural or original composition and mineralization content.
  • Table 1 provides examples of demineralization times of four monolithic chains having different strut configurations.
  • Each of the chains were formed of cortical allograft bone and had body portions 210 that were approximately 5 mm in diameter.
  • Configurations and dimensions of the struts 220 differed between the samples.
  • the struts were fully demineralized between about 31 ⁇ 2 and 4 hours, while the beads were demineralized to an extent, but were not fully demineralized across their entire thickness.
  • Strut dimensions correspond to distance 238 in FIG. 2B
  • strut radius corresponds to radius 236 in FIG. 2B .
  • Full flexibility is considered to be the condition when the chain can be bent until two adjacent beads contact each other without the chain cracking or breaking.
  • Table 2 below provides an example of approximate incremental changes in flexibility of strut portions 220 of a sample, e.g., Sample 1 of Table 1, as a function of duration of exposure to the hydrochloric acid bath. TABLE 2 Incremental changes in flexibility of struts with exposure to acid bath. Exposure Time Flexibility (min) (% of maximum) 0-5 0 5-10 0 10-15 10 15-20 15 20-30 25 30-45 35 45-90 50 90-140 70 140-200 85 200-240 100
  • Various other configurations and methods for manufacturing monolithic or other chain implants may be used. The choice of methods may depend, at least in part, on the material or materials to be used in the particular chain device 200 . If the device is made of a biocompatible polymeric material, the device can be manufactured by using conventional manufacturing methods such as but not limited to milling and turning. Alternatively, if the chain device 200 is made out of a biocompatible polymeric material, the entire device can also be injection molded.
  • the chain 200 is made of a metallic material, it can be manufactured by using conventional manufacturing methods such as but not limited to milling and turning.
  • the flexible components may undergo secondary processes such as annealing.
  • the secondary process can be limited to the flexible portions of the device only, for example by masking or shielding the non-flexible portions.
  • a chain implant 200 can be formed of any type of biocompatible material that will allow for sufficient flexibility in areas of reduced material sections (e.g., relatively narrow and flexible portions 220 ), while having larger sections (e.g., bodies 210 ) that are substantially rigid and allow for load bearing characteristics.
  • the reduced material portions 220 may be flexible, pliable, or have elastic properties in all directions preferably without fracturing or breaking.
  • the reduced material portions 210 may allow for fracture during device 200 insertion, or at another stage in a method, to allow for proper void filling.
  • Materials may be metallic and include but are not limited to titanium and steels. Polymeric and alternatively allograft tissue materials can be used.
  • bone device 200 may comprise one or more other materials, e.g., a metal (titanium, a steel, or other metal), an alloy, or a polymer.
  • the material of the device 200 may have osteoconductive, osteoinductive, and/or osteogenic properties.
  • the implant device 200 may be made out of non-monolithic materials.
  • a chain 200 may have any desired geometric configuration.
  • rigid portions 210 and flexible portions 220 may have the same or different shapes, such as cubes, cylinders, any polyhedral shapes, balls, banana or kidney shaped, or any combination thereof.
  • Portions 210 and/or 220 may have any desired cross-sectional shape, such as for example rectangular, circular, elliptical, pentagonal, hexagonal, etc.
  • the flexible 220 and non-flexible 210 portions may be of the same shape to form relatively uniform shaped structures as shown in FIGS. 4 A-C.
  • one or more bodies 210 may have cavities 510 or central holes 512 .
  • Such holes 512 or cavities 510 may be empty or may be filled, for example with a cement, bone filler, adhesive, graft material, therapeutic agent, or any other desired materials.
  • the filling material may incorporate radiopaque agents so that the chain, or bodies can be visualized during and after a procedure.
  • an implant device 200 may be coated with different substances that will support and promote bone healing, reduce infections and/or deliver therapeutic agents to the treated site.
  • the device 200 or portions thereof may be coated with antibiotics, BMP, bone growth enhancing agents, porous or non-porous bone ingrowth agents, therapeutic agents, etc.
  • the implant may be coated with a material that may incorporate a radiopaque agent so that the implant may be visualized during or after implantation.
  • therapeutic agents, drug agents, BMPs, tissue growth enhancing agents, osteoinductive agents may be absorbed, sorbed or other wise perfused onto or into some portion of the chain implant.
  • the solid, non-flexible portions 210 may have cavities, axial or side holes or a combination thereof that can be filled with different substances or agents.
  • a minimally invasive method 600 of augmenting a damaged vertebral body 12 may comprise implanting one or more chains 200 into an inner portion 612 of a vertebral body 12 between endplates 614 and 616 .
  • one or more chains 200 may be implanted as a preventive measure to augment a vertebra before compression or a compression fracture.
  • a hole may be formed in the outer coritcal shell of vertebral body 12 by a trocar, drill or other instrument. Chain 200 may then be implanted, for example, through a cannula 602 or other introducer inserted into vertebral body 12 .
  • Suitable procedures and materials for inserting a cannula through which chain 200 may be introduced are known in the art, and may be similar to those described above for kyphoplasty and other procedures.
  • cannula 602 may be introduced through the posterior portion 16 of vertebral body 12 , e.g., through pedicle 14 (e.g., transpedicular approach).
  • a chain 200 may be inserted and may compact the cancellous and osteoporotic bone inside the vertebral body.
  • a passageway may be formed into the interior of the vertebral body, for example using a drill or other instrument.
  • the chain 200 may then be inserted through the passageway, and may compact or compress the bone material inside the vertebral body.
  • instruments such as, for example, currettes or balloon catheter may be used to compress and compact the bone inside the vertebral body to create a cavity.
  • the instruments may then be removed.
  • the balloon portion of the catheter may remain within the vertebral body or may form a container for the implant.
  • the cavity in the vertebral body also may be formed by removing bone material as opposed to compacting the bone.
  • a reamer or other apparatus could be used to remove bone material from the inside of the vertebral body.
  • a cavity is first formed in the bone structure or the chain(s) are inserted without first creating a cavity
  • they may fill central portion 612 and provide structural support to stabilize a vertebral body.
  • the implant, and particularly the linked bodies 210 can push against the interior or inner sides of endplates 614 and 616 , thereby tending to restore vertebral body 12 from a collapsed height h 1 to its original or desired treated height h 2 and provide structural support to stabilize vertebral body 12 .
  • an instrument can be inserted through the passageway to restore the height of the vertebra and plates.
  • a balloon catheter can be inserted to restore vertebra end plates, or an elongated instrument that contacts the inside of the end plates and pushes on them may be utilized.
  • the flexibility of one or more portions 220 between bodies 210 may allow bending of chain within space 612 , e.g., in a uniform pattern or in a non-uniform or tortuous configuration, to aid in ensuring a thorough integration of the implant 200 within the bone 12 .
  • the configuration of bodies 210 attached by flexible portions also may permit bending to substantially fill the cavity and/or vertebral bone so no large pockets or voids are created or remain which may result in weak spots or a weakened bone structure.
  • the flexible links may also allow the chain to collapse and possibly become entangled so that it becomes larger than its insertion hole so that it cannon be easily ejected.
  • chain 200 may be inserted into a bone such as a vertebral body 12 , e.g., through the lumen 604 of a cannula 602 or other sheath, and such sheath may be removed after implantation within the bone 12 .
  • chain 200 or a portion thereof, may remain in vertebral body 12 , for example, to continue augmenting the vertebra and maintain proper lordosis.
  • PMMA or another bone cement or filler for example bone chips
  • bodies 210 may be inserted sequentially or simultaneously into vertebral body 12 , e.g., through shaft and/or a cannula 602 , along with bodies 210 to further enhance fixation or repair of the damaged region.
  • a plug of bone cement may be inserted into the hole that was initially formed to insert chains 200 (e.g., plug 812 of FIG. 8A ).
  • the plug may cover the insertion hole to prevent the implant (chains) from being removed or ejected.
  • some or all of bodies 210 of chain 200 may be removed after repositioning the bone, and PMMA or another bone cement or filler may be injected into a void created by chain 200 .
  • a bone growth promoting filler may be inserted into vertebral body 12 and a plug of bone cement utilized to hold the linked bodies and filler material in the vertebrae.
  • flexible chain 200 may be coated with an adhesive, such that chain 200 may be inserted into vertebral body 12 in a flexible state and may become tangled and/or convoluted during or after insertion. After insertion, bodies 210 may become attached together by the adhesive so that the flexible chain becomes a mass that may be locked into the vertebral body, or otherwise secured such that chain 200 may not be easily removed through the insertion opening.
  • linked bodies 210 may be coated with an adhesive and chain may be inserted, with or without becoming tangled or convoluted, into a vertebral body.
  • a portion of chain 200 may be exposed to an energy source (e.g., an ultraviolet light, ultrasonic radiation, radio waves, heat, electric filed, magnetic field), for example to activate the adhesive, such that the exposed portion of chain 200 becomes joined to form a mass, or becomes rigid, or both, thereby further augmenting the vertebral body 12 and/or preventing removal or ejection of chain 200 through the insertion opening.
  • an energy source e.g., an ultraviolet light, ultrasonic radiation, radio waves, heat, electric filed, magnetic field
  • FIG. 7 is a top cross-sectional view illustration of a vertebral body 12 having one or more chains 200 implanted within portion 612 of vertebral body 12 .
  • the one or more chains 200 may comprise a plurality of bodies 210 , which may be joined in series by one or more linking portions as described above.
  • One or more cannulae 602 each for example having a lumen 604 of sufficient size for passing linked bodies 210 , can be used to implant chain 200 into vertebral body.
  • the one or more cannulae 602 may be inserted into vertebral body 12 , preferably through pedicles 14 .
  • the one or more cannulae 602 may be left within vertebral body 12 , and remain extending from pedicles 14 , for example held in place by sutures (not shown).
  • chains 200 may be implanted completely within vertebral body 12 as shown in FIG. 8A , and the cannulae or other introducer may be removed. The chains may remain entirely within the interior of the bone.
  • a passageway 810 through which chains 200 were inserted may be filled with a plug 812 , e.g., a bone cement plug.
  • a plug 812 e.g., a bone cement plug.
  • a bone screw 800 may be inserted into vertebral body 12 in conjunction with chain implant 200 to further augment vertebral body 12 .
  • the extended end 204 or additional implant 800 may be used, for example, as an anchoring element for imparting an eternal force on vertebra to reposition the vertebra 12 .
  • Screw 800 may be inserted into the opening used to insert the chains, and may further serve as a plug to prevent removal or ejection of the chains.
  • Screw 800 may be hollow or solid, and may be comprised of stainless steel, a metal alloy, a ceramic, polymer, composite or any other desired material.
  • screw 800 may be hollow, e.g., including a lumen such as lumen 604 of cannula 602 , and used as an introducer to create a passage for passing chain 200 into vertebral body 12 .
  • a bone cement or other material may be injected into vertebral body 12 to further secure implants 200 and/or 800 and augment vertebral body 12 .
  • the bone cement or other material may be inserted through the cannulation of the screw.
  • FIGS. 9 A-D show another example of a flexible monolithic chain device being implanted into vertebral body.
  • a chain device 200 may be placed into an introducer or delivery device 910 that aids in insertion and/or impaction of the chain 200 to a desired cavity, void, space or interior of a bone.
  • delivery device 910 has an elongated cannula-like shaft 912 having a lumen through which chain 200 may pass.
  • Device may have a funnel 914 or other structure to facilitate loading of the chain 200 and/or for holding a portion of the chain 200 prior to implantation.
  • An insertion end 916 of the insertion device 910 may have a tip 918 , which may be blunt, pointed, tapered or otherwise configured as desired to facilitate insertion of end 916 into a bone or other structure.
  • FIG. 9B shows end 916 of insertion device 910 being inserted through pedicle 14 of vertebra 12 , such that tip 918 enters interior portion 612 of the vertebral body.
  • An access hole may be formed in the outer cortical shell of the vertebral body by a trocar, drill or other instrument to provide a passage through which introducer 910 device may be inserted.
  • chain 200 After insertion of end 916 of delivery device 910 into the desired region, e.g., into a vertebral body 12 , preferably through a pedicle, chain 200 may be inserted.
  • FIG. 9C shows first end 202 of a chain 200 being inserted through the introducer 910 into space 612 of vertebral body 12 .
  • Chain 200 may be forced into vertebral body 12 , for example by manually applying an axial force from opposite end 204 of chain 200 to drive chain 200 through introducer 910 .
  • a displacement member, sprocket, screw mechanism, or other device is used to apply an axial force for implanting chain 200 , for example as described below with respect to FIGS. 11-13 .
  • one long flexible monolithic device 200 may be inserted and impacted into the surgical site.
  • multiple shorter or different chain devices 200 and/or other implants can be impacted or otherwise inserted into the desired cavity, void or space.
  • the multiple shorter chain devices may be attached to each other sequentially end to end as they are inserted. In this manner as one chain is almost inserted, and with an end extending out of the patient, the leading end of the next chain is attached to the chain that is partially inserted.
  • FIG. 9D shows the one or more chains 200 completely inserted into the central portion 612 of vertebral body 12 .
  • a chain or other implant 200 may compact the cancellous and/or osteoporotic bone inside a collapsed vertebral body during insertion into the vertebral body.
  • a tool such as, for example, currettes or balloon catheter may be used to compress and compact the bone inside the vertebral body to create a cavity.
  • the cavity in the vertebral body also may be formed by removing bone material as opposed to compacting the bone.
  • a reamer or other apparatus could be used to remove bone material from the inside of the vertebral body.
  • PMMA or another bone cement or filler may be inserted into vertebral body 12 , e.g., through the introducer 910 or another cannula, sheath, syringe or other introducer, simultaneously with implant 200 to further enhance fixation or repair of a damaged region.
  • the PMMA, bone cement or filler may be inserted into the interior of the bone after the chains (or portions thereof) have been inserted into the interior of the bone.
  • a bone growth promoting filler may be inserted into the vertebral body, and a plug of bone cement may be utilized to hold the implant 200 and filler material in the vertebrae 12 . In this manner, the plug of cement is not inserted into the interior of the bone, but covers the opening created in the bone to insert the implant.
  • FIGS. 10 A-C A minimally invasive system for fusion or non-fusion implants and insertion instruments is shown in FIGS. 10 A-C.
  • a flexible monolithic chain device 1000 device may be inserted into a vertebral body 12 , e.g., through a cannula 1030 or other introducer inserted through a pedicle 14 as shown in FIG. 10A .
  • a guide or other tool 1032 having a curved or otherwise configured tip 1034 may also be inserted through the cannula 1030 and serve to distract the end plates of the vertebral body 12 and/or guide the bodies 1010 of chain 1000 in a desired direction.
  • flexible portions 1020 of chain 1000 may bend or flex to allow chain 1000 to curve or otherwise convolute in a desired fashion to fill the central portion 612 .
  • the flexible portions allow the implant to fold and collapse upon itself to substantially fill the interior of the bone preferably with minimal porosity or open spaces.
  • chain 1000 may have flexible portions, or struts, 1020 and non-flexible portions 1010 of different shapes.
  • flexible joints 1010 may be narrower than the non-flexible portions 1020 , which may be kidney shaped, rectangular, or any other shape.
  • Some of the non-flexible bodies may be a different size or shape than others, for example they may increase in size from a first non-flexible body 1010 - 1 having a width Y 1 to a last non-flexible body 1010 - 5 having a width Y 2 that is larger than width Y 1 .
  • FIG. 10 in the exemplary embodiment of FIG.
  • width Y 1 may be between about 5 mm and about 2 mm or less, and width Y 2 may be between about 6 mm and about 8 mm or less.
  • body 1010 - 1 may have a length X 1 that is substantially shorter than the length X 2 of body 1010 - 5 .
  • length X 1 may be between about 2 mm and about 6 mm
  • length X 2 may be between about 6 mm and about 14 mm.
  • Overall length of chain 1000 may vary depending upon the desired application, for example from about 10 mm to about 150 mm, more preferably from about 40 mm to about 100 mm. Of course various other sizes and relative differences in size or configuration of width, circumference, shape, curvature, or other dimensions of bodies 1010 and/or flexible portions 1020 may be employed without departing from the scope of the present invention.
  • one or more of the bodies 1010 may have one or more openings or cavities 1012 or 1014 .
  • Such openings or cavities 1012 , 1014 may be empty or may be filled, for example with a cement, bone filler, adhesive, graft material, therapeutic agent, or any other desired materials.
  • an implant device 1000 may be coated with different substances that will support and promote bone healing, reduce infections and/or deliver therapeutic agents to the treated site.
  • the non-flexible or flexible portions may also have porous surfaces 1016 , for example to facilitate in growth of bone or other tissues.
  • FIG. 10C shows another embodiment of a chain 1050 having substantially rectangular or cylindrical bodies 1010 - 1 , 1010 - 2 , 1010 - 3 , 1010 - 4 and 1010 - 5 , which may be separated by flexible link portions 1020 , and may have the same or different dimensions as each other.
  • all of the bodies 1010 - 1 , 1010 - 2 , 1010 - 3 , 1010 - 4 and 1010 - 5 have the same height h but different lengths.
  • the struts 1020 in FIG. 10C have a different smaller height than the bodies 1010 .
  • FIG. 11 is a side view illustration of an insertion device 1100 for implanting a chain 200 into a bone or other desired structure.
  • insertion device 110 may include an insertion tube or cannula 1120 having a wall 1122 and a lumen 1223 .
  • a rotatable screw mechanism 1110 Disposed within and extending through at least a portion of lumen 1223 is a rotatable screw mechanism 1110 having spiral threads 1114 surrounding an axial shaft 1112 .
  • Threads 1114 preferably extend from shaft and are dimensioned and spaced to engage chain 200 , e.g., between bodies 210 .
  • Such an insertion device may allow for enhanced insertion force of an implant, for example in order to move vertebral endplates to restore the height of the end plates of a vertebra, to compress cancellous bone in a region of the implant, or to otherwise force the implant into a desired area.
  • FIGS. 12 and 13 show other mechanisms for forcing a chain 200 through an introducer and into a desired region.
  • FIG. 12 shows a plunger, pusher or other displacement member 1200 inserted within cannula 1102 .
  • Displacement member 1200 may be used to displace or push bodies 210 of chain through cannula 1102 and into vertebral body 12 .
  • Displacement member 1200 may be driven, for example, by pressure, e.g., from a syringe, rod, or other apparatus that forces displacement member 1200 into cannula 1102 and towards vertebral body 12 .
  • pressure e.g., from a syringe, rod, or other apparatus that forces displacement member 1200 into cannula 1102 and towards vertebral body 12 .
  • FIG. 12 shows a plunger, pusher or other displacement member 1200 inserted within cannula 1102 .
  • Displacement member 1200 may be used to displace or push bodies 210 of chain through cannula
  • a sprocket 1300 or apparatus that may be wheel-like and have teeth, gears or other extensions 1302 may be configured to engage bodies 210 of chain 200 .
  • Sprocket 1300 rotates about a central axis 1304 , for example in a direction shown by arrow 1306 , teeth 1302 may engage bodies 210 and force chain 200 through cannula 1102 and into portion 612 of vertebral body 12 .
  • sprocket 1300 may be rotated in an opposite direction to remove some or all of chain 200 , for example after restoring a height of vertebral body 12 .
  • the flexible monolithic chain devices and/or methods described herein may be used in conjunction with or instead of other methods or devices for augmenting vertebral bodies or other bones, such as, for example are described in U.S. Provisional Patent Application No. 60/722,064, filed Sep. 28, 2005 entitled “Apparatus and Methods for Vertebral Augmentation using Linked Bodies”, which is incorporated by reference herein in its entirety.
  • an implantable monolithic chain 200 may be used to augment vertebrae where a compression or a compression fracture has not yet occurred and thus can be preventative in nature.
  • the chain can be used in-between two vertebra.
  • the chain implant can be inserted in the annulus of a spinal disc, or the disc can be removed and the chain implant inserted in-between adjacent vertebra to promote fusion of adjacent vertebrae.
  • the chain implant in some embodiments may be insertable in an additional implant, such as a cage implanted in-between adjacent vertebrae.
  • the chain implant may also be used to reposition and/or augment other damaged bone regions such as a fractured or weakened proximal femur 1400 as shown in FIG. 14 .
  • one or more chains 200 may be inserted into a head 1410 of femur 1400 , e.g., through a cannula 1102 or other introducer as show in FIG. 15 . Once inserted, chain 200 may compact material within head 1410 and provide solid support to augment the head 1410 . A bone cement or other filler may also be used to aid augmentation.
  • another implant 1420 may be inserted in addition to or instead of one or more chains 200 .
  • the implants and methods described herein may be used in conjunction with other apparatus and methods to restore lordosis and augment the vertebral body.
  • one or more chains 200 may be used in conjunction with known procedures, e.g., a balloon kyphoplasty, that may be used to begin repositioning of a vertebral body and/or create a space within the body for chain 200 .
  • one or more chains 200 may be used in conjunction with other tools or external fixation apparatus for helping to manipulate or fix the vertebrae or other bones in a desired position.
  • kits comprises various combinations of assemblies and components.
  • a kit may include, for example, a cannula or other introducer and one or more flexible monolithic chains 200 .
  • the one or more chains 200 may be provided in different sizes, e.g., different lengths and/or diameters.
  • a kit may include an introducer, one or more chains, and a syringe or other apparatus for injecting a cement or other filler into a vertebral body or other space.
  • a kit may comprise one or more balloon catheters, curettes, and other instruments and may additionally include anchoring elements, tensioning members, fixation members, or any combination thereof, for example as described in U.S. Provisional Patent Application No.
  • various minimally invasive implants and methods for alleviating discomfort associated with the spinal column may employ anchors and other implants described herein.
  • a monolithic chain implant within an expandable container may be implanted between spinous processes of adjacent vertebrae to distract the processes and alleviate pain and other problems caused for example by spinal stenosis, facet arthropathy, and the like.
  • augmentation systems described herein may be used instead of or in addition to expandable interspinous process apparatus and methods described in U.S. Patent Publication number 2004/018128 and U.S. Pat. No. 6,419,676 to Zucherman et al.
  • a cannula may be inserted laterally between adjacent spinous processes to insert a container that may be filled with the flexible chains and expand the container and thus keep the adjacent spinous processes at the desired distance.
  • a balloon container, with a deflatable balloon portion can be inserted laterally through adjacent spinous processes and filled with the flexible chains to expand the balloon to a desired size to hold adjacent spinous processes at a desired distances. The balloon can thereafter be sealed and detached from the catheter.
  • Other materials may be inserted within the balloon volume to supplement flexible bodies.

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US11/633,131 US20070162132A1 (en) 2005-12-23 2006-12-01 Flexible elongated chain implant and method of supporting body tissue with same
US13/558,662 US9289240B2 (en) 2005-12-23 2012-07-26 Flexible elongated chain implant and method of supporting body tissue with same
US15/040,217 US10881520B2 (en) 2005-12-23 2016-02-10 Flexible elongated chain implant and method of supporting body tissue with same
US15/259,817 US20160374818A1 (en) 2005-12-23 2016-09-08 Flexible elongated chain implant and method of supporting body tissue with same
US15/333,275 US9956085B2 (en) 2005-12-23 2016-10-25 Flexible elongated chain implant and method of supporting body tissue with same
US15/801,335 US11406508B2 (en) 2005-12-23 2017-11-02 Flexible elongated chain implant and method of supporting body tissue with same
US17/115,777 US11701233B2 (en) 2005-12-23 2020-12-08 Flexible elongated chain implant and method of supporting body tissue with same

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US75378205P 2005-12-23 2005-12-23
US81045306P 2006-06-02 2006-06-02
US11/633,131 US20070162132A1 (en) 2005-12-23 2006-12-01 Flexible elongated chain implant and method of supporting body tissue with same

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US13/558,662 Active 2027-05-14 US9289240B2 (en) 2005-12-23 2012-07-26 Flexible elongated chain implant and method of supporting body tissue with same
US15/040,217 Active 2029-05-02 US10881520B2 (en) 2005-12-23 2016-02-10 Flexible elongated chain implant and method of supporting body tissue with same
US15/259,817 Abandoned US20160374818A1 (en) 2005-12-23 2016-09-08 Flexible elongated chain implant and method of supporting body tissue with same
US15/333,275 Active US9956085B2 (en) 2005-12-23 2016-10-25 Flexible elongated chain implant and method of supporting body tissue with same
US15/801,335 Active US11406508B2 (en) 2005-12-23 2017-11-02 Flexible elongated chain implant and method of supporting body tissue with same
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US15/040,217 Active 2029-05-02 US10881520B2 (en) 2005-12-23 2016-02-10 Flexible elongated chain implant and method of supporting body tissue with same
US15/259,817 Abandoned US20160374818A1 (en) 2005-12-23 2016-09-08 Flexible elongated chain implant and method of supporting body tissue with same
US15/333,275 Active US9956085B2 (en) 2005-12-23 2016-10-25 Flexible elongated chain implant and method of supporting body tissue with same
US15/801,335 Active US11406508B2 (en) 2005-12-23 2017-11-02 Flexible elongated chain implant and method of supporting body tissue with same
US17/115,777 Active 2027-07-27 US11701233B2 (en) 2005-12-23 2020-12-08 Flexible elongated chain implant and method of supporting body tissue with same

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US20160374818A1 (en) 2016-12-29
US9956085B2 (en) 2018-05-01
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US20210113346A1 (en) 2021-04-22
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US20170035573A1 (en) 2017-02-09
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US11406508B2 (en) 2022-08-09
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US11701233B2 (en) 2023-07-18
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US20160199107A1 (en) 2016-07-14
US9289240B2 (en) 2016-03-22
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US20120290096A1 (en) 2012-11-15
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KR20080085058A (ko) 2008-09-22
US10881520B2 (en) 2021-01-05
JP4990293B2 (ja) 2012-08-01
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