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WO2010115138A2 - Dispositifs et compositions injectables ou implantables pour la fusion intervertébrale - Google Patents

Dispositifs et compositions injectables ou implantables pour la fusion intervertébrale Download PDF

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Publication number
WO2010115138A2
WO2010115138A2 PCT/US2010/029831 US2010029831W WO2010115138A2 WO 2010115138 A2 WO2010115138 A2 WO 2010115138A2 US 2010029831 W US2010029831 W US 2010029831W WO 2010115138 A2 WO2010115138 A2 WO 2010115138A2
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WO
WIPO (PCT)
Prior art keywords
mpmma
canula
barrier
cement
injectable
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.)
Ceased
Application number
PCT/US2010/029831
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English (en)
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WO2010115138A3 (fr
Inventor
Brian Perri
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Light Cure LLC
Original Assignee
Light Cure LLC
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Filing date
Publication date
Application filed by Light Cure LLC filed Critical Light Cure LLC
Publication of WO2010115138A2 publication Critical patent/WO2010115138A2/fr
Publication of WO2010115138A3 publication Critical patent/WO2010115138A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8811—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer tip, i.e. the part inserted into or onto the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
    • A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
    • A61B17/8855—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc inflatable, e.g. kyphoplasty balloons
    • 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
    • A61F2/4455—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
    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4684—Trial or dummy prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
    • 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
    • A61F2/28—Bones
    • A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • 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
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • 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
    • 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
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00185—Ceramics or ceramic-like structures based on metal oxides
    • A61F2310/00239—Ceramics or ceramic-like structures based on metal oxides containing zirconia or zirconium oxide ZrO2
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

  • the present invention is in the field of improved materials, devices and methods for intervertebral fusions and intravertebral stabilization.
  • VCF vertebral compression fractures
  • PMMA cement is surgically administered to a patient during a surgical technique, such as vertebroplasty or kyphoplasty.
  • Vertebroplasty involves the percutaneous injection of PMMA into a fractured vertebral body via a trocar and canula system.
  • the targeted vertebrae are identified under fluoroscopy.
  • a needle is introduced into the vertebrae body under fluoroscopic control, to allow radiographic visualization.
  • a bilateral transpedicular approach is typical but the procedure can also be done unilaterally. Since the PMMA needs to be forced into the cancellous bone, the techniques may require high pressures and fairly low viscosity cement. Since the cortical bone of the targeted vertebra may have a recent fracture, there is the risk of PMMA leakage.
  • Kyphoplasty (Kyphon®) is a modification of percutaneous vertebroplasty.
  • Kyphoplasty involves, as a preliminary step, the percutaneous placement of an inflatable balloon tamp in the vertebral body. Inflation of the balloon creates a cavity in the bone prior to injection of the PMMA cement.
  • the kyphoplasty technique generally allows for application of the PMMA cement at lower pressures than are needed for application using the vertebroplasty technique. Leakage of PMMA during vertebroplasty or kyphoplasty can result in serious complications, including compression of adjacent structures that necessitate emergency decompressive surgery. See Groen, R. et al, "Anatomical and Pathological Considerations in Percutaneous Vertebroplasty and Kyphoplasty: A Reappraisal of the Vertebral Venous System", Spine, 29(13): 1465-1471 (2004).
  • the PMMA leakage could lead to serious adjacent tissue injury, such as a compressive or thermal neural injury. It has been found that leakage of PMMA is related to various clinical factors such as the vertebral compression pattern, and the extent of the cortical fracture, bone mineral density, the interval from injury to operation, the amount of PMMA injected and the location of the injector tip. Leakage or extravasion of PMMA includes paravertebral leakage, venous infiltration, epidural leakage and intradiscal leakage.
  • PMMA cement is formed by combining powdered PMMA with liquid methyl methacrylate (MMA) at the time of surgery in the operating room.
  • MMA liquid methyl methacrylate
  • the surgical "scrub" technician mixes the materials while the patient is asleep on the operating table.
  • Temperature and humidity affect the time for the PMMA to cure and form the solid PMMA cement.
  • Typical cure times range from 2 to 10 minutes following mixing the powdered PMMA with liquid MMA. This variability places a time constraint upon the surgeon during the surgery. The surgeon must time the use and implantation of the cement appropriately in order for it to be injected into the body and placed in the appropriate location and in an appropriate volume. If it cures too fast, not enough PMMA is able to be injected or the PMMA is not delivered to the desired location, and the operation is compromised.
  • cement embolization results when PMMA cement enters the vascular system and travels to the lungs or even the brain and becomes lodged into blood vessels of either of these organs.
  • Intervertebral or spinal fusion is a surgical procedure used to correct problems with the vertebrae of the spine. The spine is stabilized by fusing together two or more vertebrae, typically using intervertebral cages, bone grafts and metal rods and screws.
  • Spinal implant such as interbody bone grafts or synthetic cages
  • spinal fusion devices are known in the art and are routinely used by spine surgeons to keep adjacent vertebrae in a desired spaced-apart relation while interbody bone ingrowth and fusion takes place.
  • Such spinal fusion devices are also used to provide weight bearing support between adjacent vertebral bodies and thereby correct clinical problems.
  • Such spinal fusion devices are indicated for medical treatment of conditions, such as degenerative disc disease, discogenic low back pain and spondylolisthesis. These conditions have been treated by using constructs, typically made from metals such as titanium or cobalt chrome alloys such as used in orthopedic implants, and allograft (from a third party donor) or autograft (from the patient) bone to promote bone ingrowth and fusion between two or more vertebrae.
  • Allograft bone implants are made from titanium alloy and allograft (donor) bone.
  • the former implant devices exhibit poor radiolucency characteristics, presenting difficulties in post-operative monitoring and evaluation of the fusion process due to the artifact produced by metals.
  • these implant devices are load bearing, they are not osteoconductive.
  • Use of allograft bone in implants has risks, such as transmission of infectious diseases or bioresorption and collapse prior to the patient developing a solid intervertebral fusion.
  • allograft bone implants exhibit good osteoconductive properties, they have variable materials properties and are in limited supply.
  • porous tantalum-based metal constructs e.g. Trabecular Metal® implants, which are fabricated of elemental tantalum metal using a vapor deposition technique to create a metallic strut configuration that is similar to trabecular bone
  • these implants are prefabricated in particular shapes that can be surgically placed through an open or mini-open surgical exposure technique.
  • a device for injecting materials for intervertebral fusions contains an outer canula (20), an inner canula (30) that is in telescoping relation with respect to the outer canula (20) and removable therefrom, and one or more barrier forming materials, preferably two balloons.
  • mPMMA poly(methyl methacrylate)
  • the mPMMA cement has sufficient compressive strength to withstand physiologic loads of the body during weight bearing activity and exhibits a Young's modulus of elasticity which is slightly less than cortical bone. Additionally, the mPMMA is able to bind to calcium phosphate and/or BMP. In yet another embodiment, the mPMMA is a preformed, pre-cured implant.
  • Figures 1 A-ID illustrate a system for administering an injectable material into the intervertebral space in a spinal fusion.
  • Figures IA and IB illustrate a canula/trocar assembly, assembled and disassembled, respectively.
  • Figures 1C and ID illustrate a preferred embodiment for a device for administering an injectable material into the intervertebral space in a spinal fusion.
  • Figure 1C shows the syringe, inner canula, which is inserted into the outer canula when the device is assembled, and the barrier forming materials (i.e. 2 deflated balloons).
  • Figure ID shows the outer canula with the inner canula inserted inside the outer canula.
  • Figures 2A-2D illustrate a preferred embodiment for a device for administering an injectable material into the intervertebral space in a spinal fusion.
  • Figure 2A shows the device with the balloon in a deflated position.
  • Figure 2B shows the device with the balloons in the inflated position to form the barrier.
  • Figure 2C is a side view of the device with the balloons in the inflated position.
  • Figure 2D shows the device with the injectable material in the center of and surrounded by the barrier.
  • Figures 3A-C are illustrations of the shaped of an implant designed for lateral intervertebral fusions.
  • Figure 3A is a side view;
  • Figure 3B is a top plan view; and
  • Figure 3 C is a front view.
  • Figures 4 A and B are illustrations of the shape of an implant designed for transforaminal interbody fusions (TLIF).
  • Figure 4A is a side view and
  • Figure 4B is a top plan view.
  • Figures 5 A and B are illustrations of the shape of an implant designed for posterior lateral interbody fusions (PLIF).
  • Figure 5A is a side view and Figure 5B is a top plan view.
  • Figures 6 A and B are illustrations of the shape of an implant designed for anterior intervertebral fusions.
  • Figure 6A is a side view and Figure 6B is a top plan view.
  • Figure 7 is a cross-sectional illustration of a patient's spine showing the relationship of the barrier relative to the patient's spine.
  • Figure 8 is an illustration of the percutaneous insertion a canula/trocar into a patient via using an extra-pedicular approach.
  • modified poly(methyl methacrylate” or “mPMMA” means a material containing poly(methyl methacrylate) (PMMA) and other comonomers, additives, and/or fillers, and/or PMMA that is chemically modified such as with different functional groups, where the material has at least the following properties: (1) curable upon demand and activated by ultraviolet light and (2) an isothermic curing reaction to prevent thermal tissue injury, and where, when the material is cured, it produces a cement with a sufficient porosity to allow for bone growth onto and through the cement.
  • compositions for Intervertebral Fusions Compositions for intervertebral or spinal fusions are described herein.
  • compositions primarily contain a modified poly (methyl methacrylate) (mPMMA).
  • the compositions may contain additional materials, such bioactive agents, additives, or fillers.
  • the mPMMA is an injectable material.
  • the mPMMA is an implantable material with prefabricated shapes.
  • the mPMMA is used in a spinal fusion technique.
  • the mPMMA can be designed to be suitable for other medical applications, such as to stabilize a vertebral compression fracture (VCF). The porosity and other modifications of PMMA are useful in both scenarios.
  • VCF vertebral compression fracture
  • An injectable form of the mPMMA can be delivered via injection to the intervertebral space or within the vertebral body (i.e. intravertebral delivery).
  • the injectable material is particularly preferred for use in percutaneous or mini-open intervertebral fusions.
  • Suitable methods for delivery of the injectable mPMMA to the intervertebral space include using a posterior percutaneous approach (such as the technique used to access the disc for discography) or a percutaneous or mini-open lateral transpsoas approach. These surgical approaches are particularly useful for intervertebral fusions.
  • the mPMMA can be injected into the vertebral body for intravertebral applications, such as the treatment of vertebral compression fractures.
  • a suitable method for injection into a vertebral body includes using a percutaneous transpedicular surgical approach, such as by using a canulated trocar technique.
  • the injectable form of the mPMMA preferably has the following properties: a putty consistency; and a curing time which is preselected, preferably longer than ten (10) minutes.
  • the curing time is regulated by the surgeon by exposing the mPMMA to UV light.
  • the injectable mPMMA also contains a material selected for its relatively high osteoconductive and osteoinductive properties, such as a hydroxyapatite or a calcium phosphate material.
  • osteoconductive and osteoinductive materials can be administered separately from the injectable mPMMA, such as before or after the mPMMA is injected into the desired location.
  • the mPMMA is cured, preferably by exposure to UV light, and thereby solidifies forming a mPMMA cement with a sufficient porosity to allow for bone growth onto and through the implant, forming a fusion of adjacent vertebral endplates.
  • the mPMMA cement has sufficient compressive strength to withstand physiologic loads of the body during weight bearing or activity.
  • the compressive strength typically ranges from about 50 MPa, i.e. a typical compressive strength for trabecular or cancellous bone, to about 150 MPa, i.e. a typical compressive strength for cortical bone; preferably the compressive strength ranges from about 50 MPa to about 150 MPa.
  • the mPMMA cement generally has a Young's modulus of elasticity ranges from 0.8 GPa, i.e. the Young's modulus of elasticity for trabecular bone, to 15 GPa, i.e. the Young's modulus of elasticity for allograft cortical bone, or a Young's modulus of elasticity which is greater than the Young's modulus of elasticity for cancellous bone but similar to or slightly less than the Young's modulus of elasticity for cortical bone.
  • the Young's modulus of elasticity for the mPMMA is about 3 GPa.
  • the mPMMA may be modified, as needed, to provide a material with the desired compressive strength and Young's modulus of elasticity.
  • the Young's modulus of elasticity is selected to correspond with the modulus of elasticity for a patient's bone.
  • the modulus of elasticity of a patient's bone is a function of the bone's density.
  • the Young's modulus of elasticity for the mPMMA is lower than the Young's modulus of elasticity of mPMMA used for a typical healthy individual. This reduces the risk of the cement itself inducing a compression fracture as a result of a "modulus mismatch" of the mPMMA and the patient's bone.
  • the mPMMA may be in the form of an implantable material, such as a putty.
  • the implantable mPMMA may be implanted using a minimally open surgical approach.
  • the mPMMA material is a prefabricated structural graft.
  • the graft is also cured prior to implantation.
  • Prefabricated structural grafts can be formed in a various sizes and shapes for implantation in the intervertebral space, typically using an open surgical approach. Suitable methods include an anterior, posterior or lateral intervertebral approach.
  • the grafts may be of a suitable size and shape for anterior lumbar interbody fusion (ALIF) surgery.
  • the grafts may be designed to be used as anterior cervical interbody grafts, such as for anterior cervical discectomy and fusion surgery.
  • Banana or crescent-shaped grafts may be implanted in a patient for transforarninal lumbar interbody fusion (TLIF).
  • Straight grafts may be implanted in a patient for posterior lumbar interbody fusion (PLIF) surgery.
  • Grafts with a generally rectangular shape may be used in minimally invasive, open transpsoas implantation in the intervertebral space.
  • rectangular grafts, built with lordotic angulation and to conform to the lumbar and thoracic vertebral endplates may be used for implantation for intervertebral fusions.
  • Exemplary shapes for the implantable materials are illustrated in Figures 3-6.
  • Preferred shapes include a generally rectangular implant with a tapered or lordotic cross section to suit the required curvature of the intervertebral space ⁇ see Figures 3A-3C), in the case of a spinal fusion device.
  • this implant would be used in a lateral intervertebral fusion.
  • Another preferred shape is a crescent shape (also referred to as "banana-shaped”) implants, optionally with a tapered or lordotic cross section for improved fit into the inter-vertebral space ⁇ see Figures 4A and 4B).
  • This implant can be used in transforaminal interbody fusions (TLIF).
  • Another preferred shape is a generally oblong, rectangular implant, optionally with a tapered or lordotic cross section for improved fit into the inter-vertebral space ⁇ see Figures 5A and 5B).
  • This implant can be used for posterior lateral interbody fusions (PLIF).
  • Another preferred shape is a generally circular implant ⁇ see Figures 6 A and 6B). This implant can be used for anterior intervertebral fusions.
  • the prefabricated implants typically are lordotic to restore the vertebral alignment as needed, for example used commonly in the lumbar or cervical spine.
  • Other areas of the spine, such as the thoracolumbar section, are more likely to require a neutral alignment, thus parallel or neutral prefabricated grafts are better suited than the above-described shapes when implanted in the thoracolumbar section.
  • the implantable material has a coefficient of friction which is suitable for preventing the material from moving out of the site of implantation as the spine experiences physiologic loads.
  • the implantable material may have a coefficient of friction that ranges from 0.58 to 0.86, which is generally a suitable coefficient of friction to prevent dislocation of the graft from the site of implantation as the spine experiences physiologic loads.
  • the implantable material contains one or more means for attaching to tissue ⁇ e.g. vertebral end plate), such as points, hooks or spikes.
  • tissue e.g. vertebral end plate
  • the one or more means for attaching to tissue are generally suitable for preventing the implant material from moving out of the site of implantation (i.e. dislocation) as the spine experiences physiologic loads.
  • the prefabricated structural graft is coated with or contains within and/or throughout the graft a material that has relatively high osteoconductive and osteoinductive properties, such as a hydroxyapatite or a calcium phosphate material.
  • the mPMMA implant is cured prior to implantation.
  • the mPMMA implant has a sufficient porosity to allow for bone growth through the implant.
  • the mPMMA implant has the same compressive strength and Young's modulus of elasticity as described above with respect to the injectable mPMMA material.
  • the injectable or implantable material contains one or more bioactive agents, preferably the injectable or implantable material contains the one or more bioactive agents in an effective amount to enhance bone fusion and/or bone ingrowth at the site of treatment.
  • Suitable bioactive agents include natural or synthetic osteoconductive, osteoinductive, osteogenic agents, and other fusion enhancing agents or beneficial therapeutic agents, such as bone morphogenic proteins (BMPs), growth factors, bone marrow aspirate, stem cells, progenitor cells, and antibiotics.
  • BMPs bone morphogenic proteins
  • bioactive agents include agents that preferentially bind to bone morphogenic proteins (BMPs),calcium phosphate outer surface area covering, FORTEO® (Eli Lilly and Company) (teriparatide (rDNA origin) injection, which contains recombinant human parathyroid hormone (1-34), agents that bind to rhPTH(l-34), or stem cells.
  • BMPs bone morphogenic proteins
  • FORTEO® Eli Lilly and Company
  • rDNA origin teriparatide (rDNA origin) injection, which contains recombinant human parathyroid hormone (1-34), agents that bind to rhPTH(l-34), or stem cells.
  • the bioactive agent is encapsulated in micro- or nano-particles within the mPMMA material.
  • the bioactive agent may be delivered locally to the site at which the pMMA is delivered via injection or implantation.
  • the bioactive agents are delivered to the tissue surrounding the mPMMA when the micro- or nanoparticles rupture and/or degrade.
  • the micro- or nano-particles are biodegradable and release the bioactive agent as they degrade.
  • the spheres may be fractured after the polymer is cured, such as following exposure to UV light, and thereby release the bioactive agent.
  • the injectable or implantable material contains one or more osteobiologic materials, such as bone morphogenetic proteins (BMP), such as, recombinant BMP-2 (rhBMP-2) (e.g. INFUSE® Bone Graft by Medtronic®, Memphis, TN) 5 LIM mineralization protein- 1 (LMP-I), demineralized bone matrix (DBM), growth differentiation factors (GDF), transforming growth factors (TGF), hydroxyapatite, tri-calcium phosphate (TCP), bioactive glass, calcium phosphate, calcium sulfates, collagen, or alginate.
  • BMP bone morphogenetic proteins
  • rhBMP-2 recombinant BMP-2
  • INFUSE® Bone Graft by Medtronic® Memphis, TN
  • LMP-I LIM mineralization protein- 1
  • DBM demineralized bone matrix
  • GDF growth differentiation factors
  • TGF transforming growth factors
  • TGF hydroxyapatite
  • TCP tri-calcium phosphate
  • Suitable materials include biodegradable porous mixtures of hydroxyapatite and tricalciumphosphate, such as TRICOS® from Biomatlante (France) or CAMCERAM® from Cam Implants, Leiden (Netherlands).
  • TRICOS® from Biomatlante (France)
  • CAMCERAM® Cam Implants, Leiden (Netherlands).
  • the implantable or injectable material contains one or more additives, fillers or excipients.
  • the implantable or injectable material contains one or more radio-opaque agents in order to track the material, and in the case of the injectable material, detect any possible leakage.
  • Radio-opaque agents are commercially available and can be readily synthesized, as is well-known to the man skilled in the art. Monitoring of the radio-opaque agent may be accomplished with the methods generally used in the art, for example by X-ray imaging.
  • Suitable radio-opaque agents include standard X-ray contrast agents such as barium sulfate (BaS ⁇ 4), zirconium oxide (ZrO 2 ), gold, or titan.
  • the radio-opaque agent is barium sulphate (BaSO 4 ).
  • iodinated radio-opaque agents may also be used.
  • non-ionic, iodinated contrast agents include iodixanol, iohexol, iopamidol, iopentol, iopromide, iorneprol, ios ⁇ mide, iotasul, iotrolan, ioversol, ioxilan, and metrizamide.
  • Examplary ionic, iodinated contrast agents include diatrizoate, iobenzamate, iocarmate, iocetamate, iodamide, iodipamide, iodoxamate, ioglicate, ioglycamate, iopanoate, iophendylate, iopronate, ioserate, iothalamate, iotroxate, ioxaglate, ioxithalamate, and metrizoate.
  • the implantable or injectable material contains an effective amount of a radiopaque agent to provide a uniform radiopaque background under X-ray radiation.
  • the injectable or implantable material contains one or more fillers, such as silica, zirconium oxide and barium sulfate.
  • fillers such as silica, zirconium oxide and barium sulfate.
  • the addition of fillers result in an increase of the mechanical properties (e.g., compressive strength and Young's modulus E) of the resulting cement compared to the mechanical properties of the same cement in the absence of the fillers.
  • the injectable material contains one or more thixotropic agents.
  • the thixotropic agent can contain organic (e. g. hydroxypropylcellulose) or inorganic materials, such as hydrophilic or hydrophobic silica, smectite and hormite clay.
  • a system for administering injectable materials in the intervertebral space, such as in an intervertebral fusion, is described herein.
  • the system (10) contains (i) a canula- trocar assembly (26), which contains an outer canula (20) and an inner trocar (25), which is used to place the outer canula in the desired site; (ii) an inner canula (30), (iii) a catheter (40), (iv) one or more barrier forming materials that form a barrier (50) when inflated, and (v) a syringe (60).
  • the system contains a canula-trocar assembly (26), which contains an outer canula (20) and an inner trocar (25).
  • the canula- trocar assembly (26) is inserted percutaneously into the patient, typically via a posterior-lateral approach, to gain access to the disc space using an extra- pedicular approach (see Fig. IA and B).
  • the inner trocar (25) is removed, leaving the outer canula (20) in place, which provides canula access to the intervertebral disc space.
  • the outer canula (20) is formed from any suitable biocompatible material.
  • the outer canula is formed from a radio-opaque material, such as a metal, to facilitate imaging.
  • the outer canula (20) has a proximal end (22) and a distal end (24).
  • the outer canula has an inner diameter of at least 4 to 5 mm and does not exceed 10 mm and typically has an outer diameter of 6mm, where the outer diameter ranges from 5mm to 12 mm. Suitable canulas are available from a variety of manufacturers, including Medtronic®.
  • the inner trocar (25) is formed from any suitable biocompatible material.
  • the diameter of the inner trocar is less than the inner diameter of the outer canula so that the trocar is slidable within the outer canula and slidably removable therefrom.
  • Suitable trocars are available from a variety of manufacturers, including Medtronic®. b. mPMMA injection Device
  • the mPMMA injection device (15) is assembled.
  • This device (15) is illustrated in Figures 1C and D and 2A-2D and contains the outer canula (20), an inner canula (30), a catheter (40), one or more barrier forming materials that form a barrier (50) when inflated, and a first syringe (60).
  • Inner Canula 20
  • an inner canula (30)
  • a catheter 40
  • barrier forming materials that form a barrier (50) when inflated
  • a first syringe 60.
  • the inner canula (30) is formed of any suitable inert, biocompatible material.
  • the inner canula is formed from a clear plastic.
  • the inner canula contains two delivery portions (36 and 38) in the shape of tubes.
  • the outer diameter of the inner canula is less than the inner diameter of the outer canula. The inner canula is inserted into the outer canula so that it is in telescoping relation to thereto and can be slidably removed therefrom.
  • a first delivery portion (36) is designed to deliver a fluid to inflate the one or more barrier forming materials.
  • the first delivery portion has an inner diameter of about 2 mm, and may range from lmm to 5 mm.
  • the second delivery portion (38) is designed to deliver the injectable mPMMA to the desired site in the patient.
  • the second delivery portion has the same inner diameter as the first delivery portion, such as an inner diameter of about 2 mm, and may range from lmm to 5 mm.
  • the first delivery portion has a proximal end (42) and a distal end (44).
  • the second delivery portion (38) has a proximal end (32) and a distal end (34).
  • the location of the proximal end (42) of the first delivery portion and the proximal end (32) of the second delivery portion (38) are preselected so that opening (39) in the proximal end of the second delivery portion (38) is in the hollow portion (46) of the barrier (50) that forms when the barrier forming materials are inflated.
  • the barrier forming material(s) typically one or more balloons, are attached to the distal end (42) of the first delivery portion (36) of the inner canula (30).
  • the proximal end (44) of the first delivery portion (36) is attached to a catheter (40), which is attached to a first syringe (60).
  • a second syringe (not shown in figures) is filled with a suitable volume of the mPMMA to form the bone cement.
  • the syringe is connected via a suitable connector to the proximal end (34) of the second delivery portion (38) of the inner canula.
  • the syringe is pre-filled with the mPMMA.
  • the mPMMA is mixed and then placed into the syringe.
  • the catheter (40) is designed to deliver a fluid, preferably saline, to the first delivery portion (36) of the inner canula.
  • the first syringe (60) stores and delivers a fluid, preferably saline, to the catheter (40) to inflate the barrier forming materials and thereby form a barrier having the desired size.
  • a fluid preferably saline
  • the volume of fluid that is delivered is suitable for inflating the barrier forming materials to the necessary height to restore the intervertebral disc height and sagittal balance.
  • the syringe able to contain at least 5 cc of fluid.
  • the syringe is a 5 cc syringe.
  • the catheter attaches to a syringe via a valve, or other suitable attachment device at its distal end (45).
  • the attachment device is a 3-way stopcock (48), which is used to regulate the amount of fluid that is delivered to fill the barrier forming materials.
  • the barrier (50) may be formed by inflating one or more balloons.
  • the barrier has a suitable shape and size to restore the disc height and alignment and retain the cement at the desired location, m the preferred embodiment, the barrier is in the shape of an asymmetric ring, where one portion is higher than the opposite portion on the ring ⁇ see e.g. Fig. 2C and 2D).
  • the higher portion of the barrier corresponds with the anterior portion of the patient's spine, while the lower portion of the barrier corresponds with the posterior portion of the spine.
  • the posterior portion (60) of the barrier protects the neural elements within the spinal canal, and the anterior portion (62) inflates to a height that is greater than the height of the posterior portion, thereby introducing lordosis where needed in the lumbar spine.
  • the height of the barrier varies based on the level of inflation. In some embodiments, the highest portion of the barrier typically has a height ranging from 6 to 14 mm, with preferred heights of 6, 8, 10, 12 and 14 mm. The lowest portion of the barrier typically has a height ranging from 3 to 8 mm,
  • the barrier is typically about 6 to 10 mm thick ⁇ i.e., the difference between the inner and the outer diameters of the resulting barrier), however, the thickness varies based on the level of inflation.
  • the outer diameter for the barrier will generally correspond with the width of the vertebrae at its widest dimension. Standard dimensions for the barrier are: an outer diameter ranging from 15 to 25 mm (measured anterior to posterior) and from 20 to 30 mm (measured side to side). b. Materials
  • the barrier is formed from any biocompatible, inflatable material.
  • Suitable materials are strong enough to resist the high pressures required for inflation of the balloon in the intervertebral space and include, but are not limited to, non-elastic materials, such as polyethylene terephthalate (PET), nylon, and Kevlar®. (E. I. du Pont de Nemours and Co.) or other medical balloon materials (see e.g. U.S. Patent No. 7,261,720 to Stevens et al).
  • the balloon can also be made of semi-elastic materials, such as silicone, rubber, thermoplastic rubbers and elastomers or elastic materials such as latex or polyurethane, if appropriate restraints are incorporated.
  • the restraints can be continuous or made of discrete elements of a flexible, inelastic high tensile strength material including, but not limited to, the materials described in U.S. Patent No. 4,706,670, which is incorporated herein by reference.
  • the barrier is formed from a bioresorbable material, such as poly hydroxyl acids or blends or copolymers thereof.
  • Preferred poly hydroxyl acids include poly lactic acid, poly glycolic acid, and copolymers (e.g. polyOactide-co-glycolide)) and blends thereof.
  • the barrier is preferably bioresorbable, and preferably degrades in less than six months, more preferably less than one month, following insertion into the patient's body.
  • the one or more barrier forming materials are deflated prior to insertion into the patient.
  • the barrier forming materials can be inflated by any suitable means, such as filling with an inert gas or mixture of gases, such as air, or by injecting a liquid into the balloon, such as water or saline.
  • the barrier forming materials are balloons, which are inflated by injecting saline into the balloons, more preferably the saline contains a radio- opaque material, such as barium sulfate (BaSO 4 ).
  • the barrier is formed by inflating two balloons.
  • One balloon forms the left side (52) (referred to herein as “left balloon") of the barrier and the other balloon forms the right side (54) of the barrier (referred to herein as “right balloon") which meet to form a ring when they are inflated.
  • Each balloon has a distal end (51 and 53) which attaches to one side of the proximal end (42) of the first portion (36) of the inner canula (30).
  • the proximal ends (55 and 56) of the inflated right and left balloons meet to form the barrier (50).
  • the barrier (50) is a discontinuous ring that surrounds a hollow center portion (46).
  • Each of the left balloon and the right balloon are preferably asymmetrical, such that each of each inflated balloon has a greater height at its proximal end (55 and 56) than at its distal end (51 and 53) ⁇ see e.g. Fig. 2C).
  • the above-described device for administration of mPMMA is included in a kit.
  • the kit contains (a) powdered mPMMA precursor material, (b) the canula trocar assembly, (c) the inner canula (30), catheter (40), and or more barrier forming materials to form a barrier (50) when inflated, to form the rnPMMA injection device and (d) instructions for use thereof.
  • the kit also contains a first syringe (60) to inflate the barrier forming material(s) and, optionally, a second syringe for delivering the rnPMMA. More preferably the kit also contains a plunger to administer the mPMMA to the desired site.
  • the kit contains (a) the canula trocar assembly, (b) the inner canula (30), catheter (40), and the one or more barrier forming materials to form a barrier (50) when inflated, to form the mPMMA injection device, (c) instructions for use thereof, and (d) a pre-filled syringe which contains a suitable volume of the injectable mPMMA to form the desired bone cement.
  • the kit also contains a first syringe (60) to inflate the barrier forming material(s). More preferably the kit also contains a plunger.
  • the kit may ensure that the above-describe device is a single-use device and protect patients from the potential adverse consequences occasioned by multiple use, which include disease transmission, or material stress and instability, or decreased or unpredictable performance.
  • the kit may include at least one wrap, which is peripherally sealed by heat or the like, to enclose the above-listed components of the kit and prevent contact with the outside environment.
  • One end of the inner wrap preferably includes a conventional peal-away seal, to provide quick access to the above- listed components of the kit upon instance of use, which preferably occurs in a sterile environment, such as within an operating room.
  • At least one portion of the wrap e.g. a top sheet, is made of transparent plastic film, such as polyethylene or MYLAR® material, to allow visual identification of the contents of the kit.
  • at least one portion of the wrap e.g. a bottom sheet, is made from a material that is permeable to EtO sterilization gas, e.g., TYVEC® plastic material (available from DuPont).
  • the sterile kit preferably contains a label or insert, which includes the statement "For Single Patient Use Only” (or comparable language) to affirmatively caution against reuse of the contents of the kit
  • the label also preferably instructs the physician or user to dispose of the entire contents of the kit upon use in accordance with applicable biological waste procedures.
  • the intervertebral space is cleaned using standard methods.
  • the system contains a canula/trocar assembly (26).
  • the canula/trocar assembly is advanced into the intervertebral space via an oblique posterior approach (also referred to as the "discogram approach").
  • the canula/trocar assembly (26) is inserted percutaneously into the patient, typically via a posterior-lateral approach, to gain access to the disc space using an extra-pedicular approach ⁇ see Fig. 8).
  • a mini-open technique may be used.
  • the canula/trocar assembly is advanced into the intervertebral space via a lateral transpsoas approach.
  • the inner trocar (25) is removed, leaving the outer canula (20) in place, which provides canula access to the intervertebral disc space.
  • the intervertebral disc material is evacuated using standard procedures and the effacing vertebral endplates are prepared for fusion by scraping the cartilaginous disc attachments to the bone. Any suitable technique for performing the discectomy may be used.
  • instruments that fit through the outer canula and that can curette and aspirate within the disc space can be inserted into the canula to curette and aspirate within the disc space.
  • suitable instruments for removing the intervertebral disc material include, but are not limited to, HydroCision®'s instruments ⁇ e.g. HydroCision®'s HydroSurgery system, such as SpineJet®), which use a high pressure, pulsatile means for evacuating the disc, and nitinol brushes, etc.
  • the barrier forming materials preferably deflated or collapsed balloons (52 and 54) are advanced through the outer canula (20) into the intervertebral space by pushing the inner canula (30) into and through the outer canula (20) ⁇ see Fig. 2A).
  • the inner canula (30) is pushed through the outer canula until the proximal end (42) of the first delivery portion (36) and the proximal end (32) of the second delivery portion (38) are beyond the proximal end (12) of the outer canula (20).
  • the barrier forming materials preferably deflated or collapsed balloons (52 and 54)
  • the barrier forming materials are inflated, such as by depressing the syringe device.
  • the syringe contains a normal saline solution, preferably containing a radio-opaque material, which is injected into the one or more, and preferably two, balloons to the desired fill level.
  • the barrier forming materials, preferably balloons (52 and 54) are inflated to a sufficient height to restore the intervertebral height and alignment in both the coronal and sagittal planes.
  • the barrier forming materials can be inflated to restore lumbar lordosis.
  • the barrier forming materials form a barrier (50) that is suitable for retaining the mPMMA cement in the desired site, thereby preventing cement extravasation.
  • the shape of the resulting barrier is a hollow rectangle and side view of the barrier generally corresponds with the shape of the side view of the implant illustrated in Figure 3 A.
  • the desired fill level and location of the barrier (50) is determined by intraoperative fluoroscopic imaging. Typically the location of the barrier is confirmed, and adjusted, if necessary by the surgeon, prior to delivery of the injectable mPMMA.
  • the fill level of the barrier forming materials can also be increased, or decreased, if necessary, prior to delivery of the injectable mPMMA.
  • the balloons are filled with a sufficient amount of fluid to restore the intervertebral disc height and sagittal balance ⁇ see Fig. 2C).
  • the balloons are filled with a sufficient amount of fluid to restore the anatomic reduction of the disc height and sagittal and coronal balance.
  • the injectable mPMMA can be delivered percutaneously into the intervertebral space guided by fluoroscopy (intraoperative x-ray).
  • the opening (39) at the proximal end (32) of the second delivery portion (38) of the inner canula (30) is located in the hollow portion (46) of the barrier (50), and the injectable mPMMA is forced out of the second syringe and through the inner canula (30) by depressing the second syringe.
  • the injectable mPMMA is forced out of the inner canula (30) by pushing a plunger (not shown in figures) through the second delivery portion (38) the inner canula (30).
  • the plunger is in telescoping relation to the second delivery portion (38) of the inner canula and removable therefrom.
  • the mPMMA is pushed out of the second delivery portion (38) of the inner canula and into the area within the intervertebral space that corresponds with the hollow portion (46) of the barrier.
  • the injected mPMMA is surrounded by the barrier (50), which prevents cement extravasation.
  • the placement of the mPMMA is verified radiographically using intraoperative fluoroscopy.
  • the amount of contrast agent in the mPMMA is different than the amount of contrast agent in the saline to facilitate distinguishing the mPMMA from the barrier (50) and thereby determining the location of the mPMMA.
  • the mPMMA has a greater concentration of contrast agent than the concentration of contrast agent in the saline. This difference in concentrations of contrast agents allows the surgeon to distinguish the barrier from the mPMMA using fluoroscopic imaging.
  • the mPMMA is cured.
  • the curing occurs by merely waiting a sufficient period of time, preferably greater than 10 minutes following mixing the powder MMA with the liquid to form the injectable mPMMA.
  • the mPMMA is exposed to UV light for a sufficient period of time to cure the mPMMA, typically a few seconds or less, preferably for about one second.
  • the plunger is removed from the second delivery portion (38) of the inner canula (30) after the mPMMA is delivered to the desired site.
  • a UV light source (not shown in figures) is passed down the second delivery portion (38) of the inner canula until it reaches the proximal end (32) of the second delivery portion (38) and is located proximal to the mPMMA material in the hollow portion (46) of the barrier.
  • the plunger may contain a UV light source at its proximal end, which is located inside the proximal end (32) of the second delivery portion (38), or a UV light source may be located at the distal end (34) of the second delivery portion (38) of the inner canula.
  • the barrier (50) is deflated by aspirating the fluid via the syringe.
  • the inner canula (30) along with the one or more deflated barrier forming materials are withdrawn and removed from the distal end (24) of the outer canula (20). Finally, the outer catheter (20) is removed from the patient. 1. Delivery of Implantable mPMMA
  • Implantable mPMMA materials such as prefabricated interbody grafts may be implanted into the intervertebral space in need of treatment via open surgical procedures using the traditional anterior, posterior or lateral surgical approaches.
  • Typical surgical approaches include posterior approaches such as the transforaminal lumbar interbody fusion (TLIF) and posterior lateral interbody fusion (PLIF).
  • TLIF transforaminal lumbar interbody fusion
  • PLIF posterior lateral interbody fusion
  • an anterior approach may be used, such as the anterior lumbar interbody fusion (ALIF).
  • ALIF anterior lumbar interbody fusion
  • the lateral transpsoas approach may be used to place a lateral intervertebral graft.
  • the implantable mPMMA material can be implanted using a standard open or mini-open approach.
  • the placement of the prefabricated implantable mPMMA is verified by direct visualization by the surgeon.
  • the prefabricated implants contain cured mPMMA.
  • the implant may be formed into a variety of shapes. These implants are porous, with a trabecular network of channels that allows fluids to flow through easily (e.g.,, blood or BMP).
  • the mPMMA may then be able to bind to BMP or calcium hydroxyapetite or calcium phosphate prior to implantation.
  • the implant can be bathed in a solution of BMP at the time of surgery prior to implantation.
  • Trial size implants are used by the surgeon to determine the final size and shape to implant intraoperatively.
  • the device described herein may be used in a lateral, mini- open approach to treat not only the lumbar spine, but also the thoracic spine
  • the surgical approach for this use is a lateral mmi-thoracotomy. which is used to access the thoracic spine.
  • a retractor system which fixes to the operating table is used to protect the lung parenchyma and major vessels (inferior vena cava and thoracic aorta). Examples of this existing technology are NuVasive XLIF, Medtronic DLIF or Synthes Oracle instrumentation sets. After the discectomy is performed using traditional techniques, templating of the final implant is performed using any of various existing technologies noted above.
  • the final mPMMA implant is tamped across the intervertebral disc space using anterior-posterior and lateral fluoroscopic imaging to guide the placement.
  • These implants are similar in shape to the implants illustrated in Figures 6A and 6B for the anterior lumbar intervertebral fusion (ALIF), however the end of the shape of the implant is parallel rather than lordotic. Further typical sizes for these implants are: from 6 to 14 mm in height, from 30 to 50 mm in length.
  • the mPMMA prefabricated implants would exhibit the same properties as those described for the lumbar and cervical spine.
  • the implantable mPMMA can be implanted in a patient's neck by using the standard Smith Robinson approach for the access to the cervical spine.
  • the implant also contains a radio-opaque material to allow for fluoroscopic imaging.
  • the standard techniques for performing a discectomy and osteophyte and disc decompression of the spinal cord and neural foraminal can be performed prior to implanting the prefabricated mPMMA graft.
  • Implant sizes range from 5 to 8 mm in height, 10 to 13 mm in depth, to 8 to 12 mm in width in lordotic configuration to restore or maintain the normal lordotic sagittal alignment of the cervical spine.
  • Implants are shaped to match the typical endplate shapes of the adjacent vertebrae to the treatment disc level. The appropriate sized and shaped implant is then tamped into position under direct visualization and can be imaged fluoroscopically to verify positioning. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed invention belongs.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un dispositif pour l'injection de matériaux pour des fusions intervertébrales, des kits contenant le dispositif, des matériaux poly(méthacrylate de méthyle) modifiés (mPMMA), injectables et implantables, et des procédés d'utilisation de ceux-ci, en particulier dans les fusions intervertébrales ou la fortification structurale intervertébrale. Le dispositif contient une canule externe (20), une canule interne (30), qui est en relation télescopique avec la canule externe (20) et qui peut être ôtée de celle-ci, et un ou plusieurs matériaux formant barrière, de préférence deux ballonnets. Lorsque le matériau mPMMA est durci, il produit un ciment ayant une porosité suffisante pour permettre la croissance osseuse dans le ciment, de manière à connecter un plateau vertébral avec le plateau adjacent. Le ciment mPMMA a une résistance à la compression suffisante pour résister aux charges physiologiques du corps pendant une activité conduisant à porter du poids, et présente un module d'élasticité de Young, qui est légèrement inférieur à celui de l'os cortical. En outre, le mPMMA est capable de lier le phosphate de calcium et/ou le BMP.
PCT/US2010/029831 2009-04-03 2010-04-02 Dispositifs et compositions injectables ou implantables pour la fusion intervertébrale Ceased WO2010115138A2 (fr)

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WO2013083935A1 (fr) 2011-12-09 2013-06-13 Polymerexpert Sa Ciments polymeres pour la fixation de protheses, la reparation osseuse et la vertebroplastie obtenus a partir de formulations monophasiques liquides.
CN107212919A (zh) * 2017-06-22 2017-09-29 苏州博习医疗科技有限公司 椎间成形融合装置及使用方法
US10238507B2 (en) 2015-01-12 2019-03-26 Surgentec, Llc Bone graft delivery system and method for using same
US10687828B2 (en) 2018-04-13 2020-06-23 Surgentec, Llc Bone graft delivery system and method for using same
CN112168325A (zh) * 2020-09-27 2021-01-05 温州医科大学附属第二医院、温州医科大学附属育英儿童医院 一种用于椎体成形术的球囊及医疗装置
US11116647B2 (en) 2018-04-13 2021-09-14 Surgentec, Llc Bone graft delivery system and method for using same
WO2022062779A1 (fr) * 2020-09-23 2022-03-31 宁波华科润生物科技有限公司 Système de fusion intervertébrale transpédiculaire

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013083935A1 (fr) 2011-12-09 2013-06-13 Polymerexpert Sa Ciments polymeres pour la fixation de protheses, la reparation osseuse et la vertebroplastie obtenus a partir de formulations monophasiques liquides.
FR2983734A1 (fr) * 2011-12-09 2013-06-14 Polymerexpert Sa Ciments polymeres pour la fixation de protheses, la reparation osseuse et la vertebroplastie obtenus a partir de formulations monophasiques liquides
US9393346B2 (en) 2011-12-09 2016-07-19 Polymerexpert Sa Polymer cements used for fixing prostheses, for bone repair and for vertebroplasty, and obtained from liquid single-phase formulations
US10238507B2 (en) 2015-01-12 2019-03-26 Surgentec, Llc Bone graft delivery system and method for using same
US11116646B2 (en) 2015-01-12 2021-09-14 Surgentec, Llc Bone graft delivery system and method for using same
CN107212919A (zh) * 2017-06-22 2017-09-29 苏州博习医疗科技有限公司 椎间成形融合装置及使用方法
US10687828B2 (en) 2018-04-13 2020-06-23 Surgentec, Llc Bone graft delivery system and method for using same
US11116647B2 (en) 2018-04-13 2021-09-14 Surgentec, Llc Bone graft delivery system and method for using same
US12245953B2 (en) 2018-04-13 2025-03-11 Surgentec, Llc Bone graft delivery system and method for using same
WO2022062779A1 (fr) * 2020-09-23 2022-03-31 宁波华科润生物科技有限公司 Système de fusion intervertébrale transpédiculaire
CN112168325A (zh) * 2020-09-27 2021-01-05 温州医科大学附属第二医院、温州医科大学附属育英儿童医院 一种用于椎体成形术的球囊及医疗装置

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