WO2006047356A1 - Annulotomie: dispositifs et methodes d'acces et de fermeture - Google Patents

Annulotomie: dispositifs et methodes d'acces et de fermeture Download PDF

Info

Publication number
WO2006047356A1
WO2006047356A1 PCT/US2005/038074 US2005038074W WO2006047356A1 WO 2006047356 A1 WO2006047356 A1 WO 2006047356A1 US 2005038074 W US2005038074 W US 2005038074W WO 2006047356 A1 WO2006047356 A1 WO 2006047356A1
Authority
WO
WIPO (PCT)
Prior art keywords
annulotomy
subject
nucleus
intervertebral disc
artificial
Prior art date
Application number
PCT/US2005/038074
Other languages
English (en)
Inventor
Michael S. Williams
Jeffrey A. Smith
Original Assignee
Synecor, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synecor, Llc filed Critical Synecor, Llc
Publication of WO2006047356A1 publication Critical patent/WO2006047356A1/fr

Links

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
    • A61F2/44—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • 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
    • A61F2/30721—Accessories
    • A61F2/30744—End caps, e.g. for closing an endoprosthetic cavity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/869—Pins or screws or threaded wires; nuts therefor characterised by an open form, e.g. wire helix
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00261—Discectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A61B2017/00871—Material properties shape memory effect polymeric
    • 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
    • A61F2002/30092—Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30289—Three-dimensional shapes helically-coiled
    • 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
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30461—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched
    • 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
    • A61F2002/30583—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with hardenable fluid, e.g. curable in-situ
    • 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
    • A61F2002/30584—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid filled with gas
    • 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
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2002/4435—Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
    • 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
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
    • 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
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2210/0085—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof hardenable in situ, e.g. epoxy resins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Definitions

  • the invention herein relates generally to medical devices and methods of treatment, and more particularly to devices and methods used in the treatment of a degenerated intervertebral disc.
  • Intervertebral disc degeneration is a leading cause of pain and disability, occurring in a substantial majority of people at some point during adulthood.
  • the intervertebral disc comprising primarily the nucleus pulposus and surrounding annulus fibrosus, constitutes a vital component of the functional spinal unit.
  • the intervertebral disc maintains space between adjacent vertebral bodies, absorbs impact between and cushions the vertebral bodies.
  • the disc allows for fluid movement between the vertebral bodies, both subtle (for example, with each breath inhaled and exhaled) and dramatic (including rotational movement and bending movement in all planes.)
  • Deterioration of the biological and mechanical integrity of an intervertebral disc as a result of disease and/or aging may limit mobility and produce pain, either directly or indirectly as a result of disruption of the functioning of the spine.
  • Estimated health care costs of treating disc degeneration in the United States exceed $60 billion annually.
  • Age-related disc changes are progressive, and, once significant, increase the risk of related disorders of the spine.
  • the degenerative process alters intradiscal pressures, causing a relative shift of axial load-bearing to the peripheral regions of the endplates and facets of the vertebral bodies.
  • Such a shift promotes abnormal loading of adjacent intervertebral discs and vertebral bodies, altering spinal balance, shifting the axis of rotation of the vertebral bodies, and increasing risk of injury to these units of the spine.
  • the transfer of biomechanical loads appears to be associated with the development of other disorders, including both facet and ligament hypertrophy, osteophyte formation, lyphosis, spondylolisthesis, nerve damage, and pain.
  • Trauma induced damage may include ruptures, tears, prolapse, herniations, and other injuries that cause pain and reduce strength and function
  • Non-operative therapeutic options for individuals with neck and back pain include rest, analgesics, physical therapy, heat, and manipulatioa These treatments fail in a significant number of patients.
  • Current surgical options for spinal disease include discectomy, discectomy combined with fusion, and fusion alone. Numerous discectomies are performed annually in the United States. The procedure is effective in promptly relieving significant radicular pain, but, in general, the return of pain increases proportionally with the length of time following surgery. In fact, the majority of patients experience significant back pain by ten years following lumbar discectomy. iln attempt to overcome some of the possible reasons for failure of discectomy, fusion has the potential to maintain normal disc space height, to eliminate spine segment instability, and eliminate pain by preventing motion across a destabilized or degenerated spinal segment.
  • spinal fusion may have harmful consequences as well. Fusion involves joining portions of adjacent vertebrae to one another. Because motion is eliminated at the treated level, the biomechanics of adjacent levels are disrupted. Resulting pathological processes such as spinal stenosis, disc degeneration, osteophyte formation, and others may occur at levels adjacent to a fusion, and cause pain in many patients. In addition, depending upon the device or devices and techniques used, surgery may be invasive and require a lengthy recovery period.
  • an artificial nucleus that can be implanted within the annulus fibrosus, in order to restore normal disc functioning.
  • Such a nucleus must comprise the characteristic lower durometer than the annulus fibrosus, and the annulus fibrosus must comprise the requisite stiffness as compared with the nucleus.
  • an artificial disc that can withstand typical cyclic stresses and perform throughout the life a patient.
  • An artificial disc that can be implanted using minimally invasive techniques is also needed.
  • the introduction of filler material to replace a damaged disc nucleus has been proposed. In order to achieve an artificial nucleus using filler material requires that minimally invasive techniques for the introduction of and the securement of such material is needed.
  • a device that is compatible with current imaging modalities, such as Magnetic Resonance Imaging (MRI) is needed.
  • annulotomy closure device comprising a percutaneous delivery configuration and a deployed configuration.
  • the annulotomy closure device comprises a first end and a second end, wherein said first end and said second end comprise thickened regions when Ae device is in its deployed configuration and may comprise means for securing the device to the disc of a subject.
  • the means for securing the device may comprise more sutures, clips, tethers, barbs, connectors, staples, or adhesives.
  • An artificial intervertebral disc nucleus for use foil owing an annulotomy may compris a main body portion and a neck portion.
  • the neck portion may be configured to extend through an annulotomy of a subject and may comprise means for securing the device to an intervertebral disc of a subject including, for example, one or more thickened regions.
  • the thickened regions may be configured to secure the disc nucleus against the interior surface of a disc annulus of a subject, the exterior surface of a disc annulus of a subject, or both the interior and exterior surface of a disc annulus of a subject.
  • An intervertebral disc nucleus access device configured to be received within an annulotomy an intervertebral disc of a subject, and capable of receiving one or more delivery devices therethrough is disclosed.
  • the device may comprise one or more erodible materials.
  • the access device may be configured to perform an annulotomy on a subject.
  • An access device may comprise means for securing said device within an annulotomy of a subject, such as, for example, a substantially helical thread.
  • a method for implanting an artificial disc nucleus in a subject comprising the steps of placing an opening in a native intervertebral disc annulus fibrosus of a subject in order to access a native intervertebral disc nucleus; removing all of or a portion of a native disc nucleus; implanting an artificial disc nucleus; and closing the opening in the native intervertebral disc annulus fibrosus.
  • the step of placing an opening in a native intervertebral disc annulus fibrosus of a subject may be performed using an annulotomy access or closure device.
  • An alternative step of implanting an artificial nucleus access device after removing all or a portion of a native nucleus of a subject and thereafter closing the artificial nucleus access device may be taken.
  • the method may have the added step of deploying the artificial disc nucleus following the step of implanting the artificial disc nucleus.
  • the step of closing the opening in the native annulus fibrosus comprises percutaneously implanting an annulotomy closure device comprising a delivery configuration and a deployed co ⁇ figurauo ⁇
  • the step of deploying said artificial disc nucleus may comprise filling the nucleus with a suitable material, and/or exposing the nucleus and/or the closure device to one or more stimuli.
  • the step of implanting an annulotomy closure device may comprise advancing a generally helical closure device into an annulotomy of a subject.
  • the annulotomy closure device may comprise a dehydrated material when the device is in its delivery configuration and a rehydrated material when the device is in its deployed configuration. It may comprise means for securing said device within an annulotomy of a subject, such as, for example, a helical thread.
  • FIG. 1 illustrates a cross-sectional plan view of an intervertebral disc comprising an artificial nucleus and annulotomy closure device according to the invention.
  • FIG. 2 illustrates an enlarged detail of area A of FIG. 1.
  • FIG.3 illustrates a cross-sectional plan view of an intervertebral disc comprising an artificial nucleus and annulotomy access and/or closure device according to the invention
  • FIG. 4 illustrates an enlarged detail of area A of FIG. 3.
  • FIG. 5 illustrates a cross-sectional plan view of an intervertebral disc comprising an artificial nucleus and annulotomy closure device according to the invention.
  • FIG. 6 illustrates an enlarged detail of area A of FIG. 5.
  • FIG. 7 illustrates an end view of a portion of the embodiment of FIG. 6.
  • FIG. 8 illustrates a cross-sectional plan view of an intervertebral disc and a step of a method according to the invention.
  • FIG. 9 illustrates a cross-sectional plan view of an intervertebral disc and a step of a method according to the invention.
  • FIG. 10 illustrates a cross-sectional plan view of an intervertebral disc and a step of a method according to the inventioa
  • FIG. 11 illustrates a perspective view of a portion of a spinal column and an embodiment according to the inventioa
  • FIG. 12 illustrates a perspective view of a portion of a spinal column and an embodiment according to the inventioa
  • FIG. 13 illustrates a perspective view of an embodiment according to the inventioa
  • FIG. 14 illustrates a perspective view of an embodiment according to the invention and a portion of an intervertebral disc.
  • FIG. 15 illustrates a perspective view of an embodiment according to the invention and a portion of an intervertebral disc following a step of a method according to the invention.
  • FIG. 16 illustrates a perspective view of an embodiment according to the invention and a portion of an intervertebral disc following a step of a method according to the invention.
  • FIG. 17 illustrates a perspective view of an embodiment according to the invention and a portion of an intervertebral disc following a step of a method according to the invention.
  • An endoprosthesis known as an artificial disc and/or an artificial disc nucleus are designed to replace a degenerated intervertebral disc. Such an artificial disc or disc nucleus may be expandable and/or self-expanding.
  • An "expandable" endoprosthesis comprises a reduced profile configuration and an expanded profile configuration.
  • An expandable endoprosthesis according to the invention may undergo a transition from a reduced configuration to an expanded profile configuration via any suitable means, or may be self-expanding.
  • Some embodiments according to the invention may comprise a substantially hollow interior that may be filled with a suitable medium, examples of which are set forth below.
  • Embodiments according to the invention may accordingly be introduced into the body in a collapsed configuration, and, following introduction, may be filled to form a deployed configuratioa
  • Embodiments according to the invention may accordingly be implanted percutaneously or surgically. If implanted surgically, embodiments according to the invention may be implanted from either an anterior or a posterior approach, following the removal of some or all of a native disc.
  • Preservation of mobility refers to the desired maintenance of normal motion between separate spinal segments.
  • Spinal unit refers to a set of the vital functional parts of the spine including a vertebral body, endplates, facets, and intervertebral disc.
  • operably refers to any generally elongate member fabricated from any suitable material, whether polymeric, metal or metal alloy, natural or synthetic.
  • fiber refers to any generally elongate member fabricated from any suitable material, whether poJymeric, metal or metal alioy, natural or synthetic. Unless specified, suitable means of attachment may include by thermal melt, chemical bond, adhesive, sintering, welding, or any means known in the art.
  • a device is "implanted” if it is placed within the body to remain for any length of time following the conclusion of the procedure to place the device within the body.
  • diffusion coefficient refers to the rate by which a substance elutes, or is released either passively or actively from a substrate.
  • suitable means of attachment may include by thermal melt, chemical bond, adhesive, sintering, welding, or any means known in the art.
  • Shape memory refers to the ability of a material to undergo structural phase transformation such that the material may define a first configuration under particular physical and/or chemical conditions, and to revert to an alternate configuration upon a change in those conditions.
  • Shape memory materials may be metal alloys including but not limited to nickel titanium, or may be polymeric.
  • a polymer is a shape memory polymer if the original shape of the polymer is recovered by heating it above a shape recovering temperature (defined as the transition temperature of a soft segment) even if the original molded shape of the polymer is destroyed mechanically at a lower temperature than the shape recovering temperature, or if the memorized shape is recoverable by application of another stimulus.
  • Such other stimulus may include but is not limited to pH, salinity, hydration, radiation, including but not limited to radiation in the ultraviolet range, and others.
  • Some embodiments according to the invention may comprise one or more polymers having a structure that assumes a first configuration, a second configuration, and ahydrophilic polymer of sufficient rigidity coated upon at least a portion of the structure when the device is in the second configuratioa Upon placement of the device in an aqueous environment and consequent hydration of the hydrophilic polymer, the polymer structure reverts to the first configuration.
  • Some embodiments according to the invention may nonetheless readily convert from a constrained configuration to a deployed configuration upon removal of constraints, as a result of a material's elasticity, super-elasticity, a particular method of "rolling down” and constraining the device for delivery, or a combination of the foregoing.
  • Such embodiments may comprise one or more elastomeric or rubber materials.
  • segment refers to a block or sequence of polymer forming part of the shape memory polymer.
  • the terms hard segment and soft segment are relative terms, relating to the transition temperature of the segments. Generally speaking, hard segments have a higher glass transition temperature than soft segments, but there are exceptions.
  • 'Transition temperature refers to the temperature above which a shape memory polymer reverts to its original memorized configuration.
  • strain fixity rate is a quantification of the fixability of a shape memory polymer's temporary form, and is determined using both strain and thermal programs.
  • the strain fixity rate is determined by gathering data from heating a sample above its melting point, expanding the sample to 200% of its temporary size, cooling it in the expanded state, and drawing back the extension to 0%, and employing the mathematical formula:
  • strain recovery rate R r describes the extent to which the permanent shape is recovered:
  • a “switching segment” comprises a transition temperature and is responsible for the shape memory polymer's ability to fix a temporary shape.
  • thermoplastic elastomer is a shape memory polymer comprising crosslinks that are predominantly physical crosslinks.
  • thermoset is a shape memory polymer comprising a large number of crosslinks that are covalent bonds.
  • Shape memory polymers are highly versatile, and many of the advantageous properties listed above are readily controlled and modified through a variety of techniques. Several macroscopic properties suck as transition temperature and mechanical properties can be varied in a wide range by only small changes in their chemical structure and composition. More specific examples are set forth in Provisional U.S. Patent Application Serial No. 60/523,578 and are incorporated in their entirety as if fully set forth herein.
  • Shape memory polymers are characterized by two features, triggering segments having a thermal transition Th 308 within the temperature range of interest, and crosslinks determining the permanent shape.
  • shape memory polymers can be thermoplastic elastomers or thermosets. By manipulating the types of crosslinks, the transition temperature, and other characteristics, shape memory polymers can be tailored for specific clinical applications. More specifically, according the invention herein, one can the control shape memory behavior and mechanical properties of a shape memory polymer through selection of segments chosen for their transition temperature, and mechanical properties can be influenced by the content of respective segments.
  • the extent of crosslinking can be controlled depending on the type of material desired through selection of materials where greater crosslinking makes for a tougher material than a polymer network.
  • the molecular weight of a macromonomeric crosslinker is one parameter on the molecular level to adjust crystallinity and mechanical properties of the polymer networks.
  • An additional monomer may be introduced to represent a second parameter.
  • the annealing process (comprising heating of the materials according to chosen parameters including but not limited to time and temperature) increases polymer chain crystallization, thereby increasing the strength of the material. Consequently, according to the invention, the desired material properties can be achieved by using the appropriate ratio of materials and by annealing the materials.
  • the properties of polymers can be enhanced and differentiated by controlling the degree to which the material crystallizes through strain-induced crystallization.
  • Means for imparting strain-induced crystallization are enhanced during deployment of an endoprosthesis according to the invention.
  • focal regions of plastic deformation undergo strain-induced crystallization, further enhancing the desired mechanical properties of the device, such as further increasing radial strength.
  • the strength is optimized when the endoprosthesis is induced to bend preferentially at desired points.
  • Natural polymer segments or polymers include but are not limited to proteins such as casein, gelatin, gluten, zein, modified zein, serum albumin, and collagen, and polysaccharides such as alginate, chitin, celluloses, dextrans, pullulane, and polyhyaluronic acid; poly(3-hydroxyalkanoate)s, especially poly(. beta -hydroxybutyrate), poly(3-hydroxyoctanoate) and poly(3-hydroxyfatty acids).
  • proteins such as casein, gelatin, gluten, zein, modified zein, serum albumin, and collagen
  • polysaccharides such as alginate, chitin, celluloses, dextrans, pullulane, and polyhyaluronic acid
  • poly(3-hydroxyalkanoate)s especially poly(. beta -hydroxybutyrate), poly(3-hydroxyoctanoate) and poly(3-hydroxyfatty acids).
  • Suitable synthetic polymer blocks include polyphosphazenes, polyvinyl alcohols), polyamides, polyester amides, poly(amino acid)s, synthetic poly(amino acids), polycarbonates, polyacrylates, polyalkylenes, polyacrylamides, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyvinyl ethers, polyvinyl esters, polyvinyl halides, polyvinylpyrrolidone, polyesters, polyethylene terephthalate, polysiloxanes, polyurethanes, fluoropolymers (including but not limited to polytetrafluoroethylene), and copolymers thereof.
  • suitable polyacrylates include poly(methyl methacrylate), poly(ethyl methacrylate), poly(butyl methacrylate), poly(isobutyl methacrylate), poly(hexyl methacrylate), poly(isodecyl methacrylate), poly(lauryl methacrylate), poly(phenyl methacrylale), poly(niethyl acrylate), poly(isopropyl acrylate), poly(isobutyl acrylate) and poly(octadecyl acrylate).
  • Synthetically modified natural polymers include cellulose derivatives such as alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers, cellulose esters, nitrocelluloses, and chitosan.
  • suitable cellulose derivatives include methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxybutyl methyl cellulose, cellulose acetate, cellulose propionate, cellulose acetate butyrate, cellulose acetate phthalate, arboxymethyl cellulose, cellulose triacetate and cellulose sulfate sodium salt. These are collectively referred to herein as "celluloses”.
  • the degree of crystallinity of the polymer or polymeric block(s) is between 3 and 80%, more often between 3 and 65%.
  • the tensile modulus of the polymers below the transition temperature is typically between 50 MPa and 2 GPa (gigapascals), whereas the tensile modulus of the polymers above the transition temperature is typically between 1 and 500 MPa. Most often, the ratio of elastic modulus above and below the transition temperature is 20 or more.
  • the melting point and glass transition temperature of the hard segment are generally at least 10 degrees C, and preferably 20 degrees C, higher than the transition temperature of the soft segment.
  • the transition temperature of the hard segment is preferably between -60 and 270 degrees C, and more often between 30 and 150 degrees C.
  • the ratio by weight of the hard segment to soft segments is between about 5:95 and 95:5, and most often between 20:80 and 80:20.
  • the shape memory polymers contain at least one physical crosslink (physical interaction of the hard segment) or contain covalent crosslinks instead of a hard segment
  • the shape memory polymers can also be interpenetrating networks or semi-interpenetrating networks.
  • a typical shape memory polymer is a block copolymer.
  • hydrophilic polymers include but are not limited to poly(ethylene oxide), polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol), polyacrylamide poly(hydroxy alkyl methacrylates), poly(hydroxy ethyl methacrylate), hydrophilic polyurethanes, HYPAN, oriented HYPAN, poly(hydro ⁇ y ethyl acrylate), hydroxy ethyl cellulose, hydroxy propyl cellulose, methoxylated pectin gels, agar, starches, modified starches, alginates, hydroxy ethyl carbohydrates and mixtures and copolymers thereof.
  • Hydrogels can be formed from polyethylene glycol, polyethylene oxide, polyvinyl alcohol, polyvinyl pyrrolidone, polyacrylates, poly (ethylene terephthalate), poly(vinyl acetate), and copolymers and blends thereof.
  • polymeric segments for example, acrylic acid, are elastomeric only when the polymer is hydrated and hydrogels are formed.
  • Other polymeric segments for example, methacrylic acid, are crystalline and capable of melting even when the polymers are not hydrated. Either type of polymeric block can be used, depending on the desired application and conditions of use.
  • highly elastic materials including but not limited to vulcanized rubber, polyurethanes, thermoplastic elastomers, and others may be used according to the invention.
  • Curable materials include any material that cures or can be cured, that is, capable of being able to transform from a fluent or soft material to a harder material, by cross- linking, polymerization, or other suitable process.
  • Materials may be cured over time, thermally, chemically, or by exposure to radiation. For those materials that are cured by exposure to radiation, many types of radiation may be used, depending upon the material. Wavelengths in the spectral range of about 100-1300 nm may be used. The material should absorb light within a wavelength range that is not readily absorbed by tissue, blood elements, physiological fluids, or water. Ultraviolet radiation having a wavelength ranging from about 100-400 nm may be used, as well as visible, infrared and thermal radiation.
  • curable materials are some examples of curable materials: urethanes, polyurethane oligomer mixtures, acrylate monomers, aliphatic urethane acrylate oligomers, acrylamides, UV curable epoxies, photopolymerizable polyanhydrides and other UV curable monomers.
  • the curable material can be a material capable of being chemically cured, such as silicone based compounds which undergo room temperature vulcanization
  • some embodiments of the invention comprise materials that are bioerodible.
  • “Erodible” refers to the ability of a material to maintain its structural integrity for a desired period of time, and thereafter gradually undergo any of numerous processes whereby the material substantially loses tensile strength and mass. Examples of such processes comprise hydrolysis, enzymatic and non-enzymatic degradation, oxidation, enzymatically-assisted oxidation, and others, thus including bioresorption, dissolution, and mechanical degradation upon interaction with a physiological environment into components that the patient's tissue can absorb, metabolize, respire, and/or excrete. Polymer chains are cleaved by hydrolysis and are eliminated from the body through the Krebs cycle, primarily as carbon dioxide and in urine. "Erodible” and “degradable” are intended to be used interchangeably herein.
  • Representative natural erodible polymer segments or polymers include polysaccharides such as alginate, dextran, cellulose, collagen, and chemical derivatives thereof (substitutions, additions of chemical groups, for example, alkyl, alkylene, hydroxylations, oxidations, and other modifications routinely made by those skilled in the art), and proteins such as albumin, zein and copolymers and blends thereof, alone or in combination with synthetic polymers.
  • Suitable synthetic polymer blocks include polyphosphazenes, poly( vinyl alcohols), polyamides, polyester amides, poly(amino acid)s, synthetic poly(amino acids), polyanhydrides, polycarbonates, polyacrylates, polyalkylenes, polyacrylamides, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyortho esters, polyvinyl ethers, polyvinyl esters, polyvinyl halides, polyvinylpyrrolidone, polyesters, polylactides, polyglycolides, polysiloxanes, polyurethanes and copolymers thereof.
  • suitable polyacrylates include poly(methyl methacrylate), poly(ethyl methacrylate), poly(bvityl methacrylate), poly(isobutyl methacrylate), poly(hexyl methacrylate), poly(isodecyl methacrylate), poly(lauryl methacrylate), poly(phenyl methacryfate), pofy(methyf acryfate), pofytfs ⁇ pr ⁇ py/ acrylate), poly(isobutyl a ⁇ late) and ⁇ oly(octadecyl acrylate).
  • Synthetically modified natural polymers include cellulose derivatives such as alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers, cellulose esters, nitrocelluloses, and chitosan.
  • suitable cellulose derivatives include methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxybutyl methyl cellulose, cellulose acetate, cellulose propionate, cellulose acetate butyrate, cellulose acetate phthalate, arboxymethyl cellulose, cellulose triacetate and cellulose sulfate sodium salt. These are collectively referred to herein as "celluloses”.
  • Examples of synthetic degradable polymer segments or polymers include polyhydroxy acids, polylactides, polyglycolides and copolymers thereof, poly(ethylene terephthalate), poly(hydroxybutyric acid), poly(hydroxyvaleric acid), poly[lactide-co- (epsilon-caprolactone)], poly[glycolide-co-(epsilon-caprolactone)], polycarbonates, poly- (epsilon caprolactone) poly(pseudo amino acids), poly(amino acids), poly(hydroxyalkanoate)s, polyanhydrides, polyortho esters, and blends and copolymers thereof.
  • some embodiments according to the invention comprise one or more therapeutic substances that will elute from the surface.
  • Suitable therapeutics include but are not limited to bone growth accelerators, bone growth inducing factors, osteoinductive agents, immunosuppressive agents, steroids, anti ⁇ inflammatory agents, pain management agents (e.g, analgesics), tissue proliferative agents to enhance regrowth and/or strengthening of native disc materials, and others.
  • such surface treatment and/or incorporation of therapeutic substances may be performed utilizing one or more of numerous processes that utilize carbon dioxide fluid, e.g., carbon dioxide in a liquid or supercritical state.
  • a supercritical fluid is a substance above its critical temperature and critical pressure (or "critical point").
  • an endoprosthesis comprising polymeric materials has the additional advantage of compatibility with magnetic resonance imaging, potentially a long-term clinical benefit.
  • some embodiments according to the invention may comprise components that have a substantially hollow interior that may be filled after being delivered to a treatment site with a suitable material in order to place the device in a deployed configuration.
  • such embodiments may comprise a fluid retention bag having a membrane layer comprising polyvinyl chloride (PVC), polyurethane, and or laminates of polyethylene terephthalate (PET) or nylon fibers or films within layers of PVC, polyurethane, polycarbonate polyurethane or other suitable material.
  • PVC polyvinyl chloride
  • PET polyethylene terephthalate
  • Such a fluid retention bag or membrane layer alternatively may comprise Kevlar, polyimide, a suitable metal, or other sx ⁇ table material within layers of PVC, polyurethane or other suitable material.
  • Such laminates may be of solid core, braided, woven, wound, or other fiber mesh structure, and provide stability, strength, and a controlled degree of compliance.
  • Such a laminate membrane layer may be manufactured using radiofrequency or ultrasonic welding, adhesives including ultraviolet curable adhesives, or thermal energy.
  • a generally cylindrical access device may also be filled to form a closure device.
  • a fluid retention bag and/or or closure device as set forth above may be filled with any suitable material including but not limited to saline, contrast media, hydrogels, a polymeric foam, or any combination thereof.
  • a polymeric foam may comprise a polyurethane intermediate comprising polymeric diisocyanate, polyols, and a hydrocarbon, or a carbon dioxide gas mixture. Such a foam may be loaded with any of numerous solid or liquid materials known in the art that confer radiopacity.
  • Such a device may comprise a single unit, or may be two or more individual parts. If the device comprises two or more component parts, the parts may fit together in a puzzle-like fashion.
  • the device may further comprise alignment tabs for stable alignment between the vertebral bodies.
  • Such a fluid retention membrane and/or bag may comprise interbody connections and/or baffles and/or partitions or generally vertically oriented membranes in order to maintain structural integrity after filling, to increase the devices ability to withstand compressive, shear, and other loading forces, and/or to direct filling material flow and positioning, and/or to partition portions of the disc in order to separate injection of different types or amounts of filling materials.
  • a device may comprise a characteristic durometer selected for suitability to the level of the vertebra within the spine for which the intervertebral disc is being treated.
  • an artificial intervertebral disc nucleus within the cervicai spine may comprise a tower durometer than a replacement nucleus in the lumbar region.
  • Any steerable catheter and drill, cutting device and/or obturator may be suitable for use in order to prepare a spinal unit or disc according to the invention.
  • a deflated fluid retention bag or membrane may be delivered to the intervertebral space surgically or through a catheter and/or cannula
  • the membrane and/or bag is positioned within the intervertebral space.
  • the membrane inflation port or ports may be preattached or may be then attached to the injection source. Filling material is then injected.
  • FIG. 1 illustrates a plan view of an intervertebral disc which has undergone treatment according to the invention.
  • Intervertebral disc 10 comprises annulus 12 and artificial nucleus 14.
  • intervertebral disc 10 comprises annulotomy 16, which extends from the exterior of intervertebral disc 10, through annulus 12, and into the interior of intervertebral disc 10.
  • annulotomy 16 is filled with annulotomy closure device 18.
  • annulotomy closure device 18 Following a partial discectomy or nucleoectomy to remove all or a substantial portion of the native nucleus (not pictured), artificial nucleus 14 has been introduced via annulotomy 16. Artificial nucleus 14 has been partially or completely deployed, and may cure and/or be cured.
  • Annulotomy closure device 18 may comprise a dehydrated and compacted structure which is inserted into annulotomy 16 following placement and, in come cases, filling and/or deployment, of artificial nucleus 14. Following insertion of annulotomy closure device 18, the device may rehydrate to expand and fill annulotomy 16.
  • annulotomy closure device 18 swells further to form thickened regions 20 and 22, which prevent movement and/or extrusion or expulsion of annulotomy closure device 18.
  • Annulotomy closure device may thereafter cure or be cured to form a firmer material.
  • FIG. 4 illustrates an expanded view of detail area A of FIG. 3.
  • Artificial disc 30 comprises annulus 32, artificial nucleus 34, and annulotomy 33 (which is filled by artificial nucleus septum 36.)
  • Septum 36 extends from (and may be integral with) artificial nucleus 34, and tfirough annulotomy 33 to the exterior of annulus 32.
  • Annulotomy closure device 38 fills annulotomy 36, and is secured by thickened regions 35 and 37.
  • an annulotomy closure device may comprise a substantially hollow or otherwise readily penetrable interior in order to provide access to the interior of a nucleus and/or an artificial disc.
  • annulotomy closure device comprising a substantially hollow interior may later be filled with a material or a second device in order to perform the closure function following completion of one or more procedures.
  • an embodiment according to the invention may comprise features as illustrated in FIGS. 5-7.
  • FIG. 5 illustrates a plan view of an intervertebral disc which has undergone treatment according to the invention.
  • FIG. 6 illustrates an expanded view of detail area A of FIG. 5.
  • intervertebral disc 40 comprises annulus 42, annulotomy 46, and artificial nucleus 44.
  • Artificial nucleus 44 comprises septum 48 which extends from the interior of intervertebral disc 40, through annulotomy 46, and to the exterior of intervertebral disc 40.
  • sutures 50 seen in a side view in FIGS. 5 and 6 and an end view in FIG. 7, have been placed to attach distal portion 52 of septum to the exterior surface 54 of annulus 42.
  • clips, barbs, tethers, or any suitable attachment means may be used in place of sutures 50.
  • Such materials may comprise, for example, one or more shape memory materials.
  • annulotomy closure device may alternatively comprise a substantially hollow or otherwise readily penetrable interior in order to provide access to the interior of a nucleus and/or an artificial disc. Further, an annulotomy closure device comprising a substantially hollow interior may later be filled with a material or a second device in order to perform the closure function following completion of one or more procedures.
  • FIG. 8 illustrates the cross-sectional plan view of disc 100 following a partial or complete removal of the native disc nucleus (not pictured).
  • the nucfeoectomy has been performed bifateraHy, through a ⁇ nufot ⁇ r ⁇ fes 102 and 104 vi ⁇ any suitable means.
  • Expandable artificial nucleus membranelO6 is delivered to the interior space of disc 100 within delivery sheath 108, which is fed first through one and then the other of annulotomies 102 and 104. As illustrated in FIG. 9, delivery sheath 108 is then removed. Septum 110 and septum H 2 extend through annulotomies 102 and 104 respectively.
  • the membrane is filled through fill tube 114 as a step in deployment of artificial nucleus 115, as shown in FIG. 10.
  • the fill material eventually and/or within a series of steps may cure or be cured, and/or allowed to hydrate.
  • Fill tube 114 is removed, excess membrane may be trimmed, and closure of annulotomies 102 and 104 permitted, to form artificial nucleus 115, illustrated in FlG 10.
  • annulotomy 135 is configured to receive annulotomy closure device 130, which comprises helical thread 132.
  • Helical thread 132 serves to secure annulotomy closure device 130 within annulotomy 135.
  • FlG. 12 illustrates annlulotomy closure device 130 once in place within annulotomy 135.
  • device 130 may comprise means for accessing the interior of an intervertebral disc.
  • the interior of device 132 or comparable devices described above may comprise a conveniently penetrable material, or, as an additional example, may be substantially hollow. If it is required to repeatedly access the interior of a disc, device 132 may provide a semi-permanent or permanent "channel" for access, and, among other advantages, may enable a clinician to avoid potential damage to tissue which may result from repeated penetration.
  • Device 132 may comprise an erodible material or materials which may gradually erode and be replaced by tissue.
  • the device may be configured for use in performing an annulotomy on a subject also. The interior may later be filled with, for example, an erodible polymer, a curable material, collagen, or a second device comprising suitable materials in order to form a closure device.
  • FIG. 13 ⁇ ffustrates an alternative embodiment in perspective view.
  • Annulotomy closure device 150 comprises a helical structure. Variations of the thickness, pitch, material, orientation, and other characteristics are possible within the scope of the invention
  • Annulotomy closure device 150 is shown in perspective and in relation to disc 152 and annulotomy 155 in FIG. 14. The appearance of the device and the annulotomy following progressive stages of insertion and deployment of annulotomy closure device 150 are shown in FIGS. 15-17. As the tapered helix is rotated, the device advances and pulls the annular walls together until the annulolmy is closed. The collagen rich annulus will thereafter heal to form a unitary structure, thereby permanently closing the annulotomy.
  • Annulotomy closure device 150 may comprise a dehydrated material that may rehydrate, expand and/or cure following insertion into annulotomy 155, thereby securing positioning of annulotomy closure device 150 and completely filling annulotomy 155.
  • Annulotomy closure device 150 may in addition or alternatively comprise a shape memory or highly convertible polymeric material suitable for very low profile delivery and ready conversion to a helical and higher volume material according to the invention. While all of the foregoing embodiments can most advantageously be delivered in a minimally invasive, percutaneous manner, the foregoing embodiments may also be implanted surgically. Further, while particular forms of the invention have been illustrated and described above, the foregoing descriptions are intended as examples, and to one skilled in the art it will be apparent that various modifications can be made without departing from the spirit and scope of the invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Neurology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)

Abstract

Cette invention concerne des dispositifs et des méthodes d'accès et/ou de fermeture d'une annulotomie. Lesdits dispositifs peuvent être distincts, solidaires ou faire partie intégrante d'un noyau discal artificiel et peuvent comporter l'un quelconque de nombreux moyens de fixation possible à l'intérieur de l'annulotomie. Ces dispositifs peuvent permettre d'accéder à un noyau discal en vue d'une ou de plusieurs interventions et de refermer l'annulotomie une fois la ou les interventions terminées. L'invention concerne également des méthodes de mise en oeuvre de dispositifs d'accès et/ou de fermeture après annulotomie.
PCT/US2005/038074 2004-10-26 2005-10-24 Annulotomie: dispositifs et methodes d'acces et de fermeture WO2006047356A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US62238804P 2004-10-26 2004-10-26
US60/622,388 2004-10-26

Publications (1)

Publication Number Publication Date
WO2006047356A1 true WO2006047356A1 (fr) 2006-05-04

Family

ID=36228118

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/038074 WO2006047356A1 (fr) 2004-10-26 2005-10-24 Annulotomie: dispositifs et methodes d'acces et de fermeture

Country Status (1)

Country Link
WO (1) WO2006047356A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008042612A1 (fr) 2006-10-03 2008-04-10 Depuy Spine, Inc. Dispositifs et procédés d'injection de nucleus pulposus

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6425919B1 (en) * 1999-08-18 2002-07-30 Intrinsic Orthopedics, Inc. Devices and methods of vertebral disc augmentation

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6425919B1 (en) * 1999-08-18 2002-07-30 Intrinsic Orthopedics, Inc. Devices and methods of vertebral disc augmentation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008042612A1 (fr) 2006-10-03 2008-04-10 Depuy Spine, Inc. Dispositifs et procédés d'injection de nucleus pulposus

Similar Documents

Publication Publication Date Title
US20090105823A1 (en) Artificial intervertebral disc nucleus
US20050119752A1 (en) Artificial intervertebral disc
US20060064170A1 (en) Closed system artificial intervertebral disc
US20080177392A1 (en) Closed system artificial intervertebral disc
US8690919B2 (en) Surgical spacer with shape control
US7628800B2 (en) Formed in place corpectomy device
US8052728B2 (en) Method for stabilizing a facet joint
US7744630B2 (en) Facet repair and stabilization
AU2004263122B2 (en) Implants formed of shape memory polymeric material for spinal fixation
US20060271197A1 (en) Spinal disc annulus augmentation
US20120296379A1 (en) Expandable interspinous process spacer with lateral support and method for implantation
US20090297603A1 (en) Interspinous dynamic stabilization system with anisotropic hydrogels
JP4891991B2 (ja) レールベースのモジュラー式円板髄核プロテーゼ
US20090131939A1 (en) Inflatable mold for maintaining posterior spinal elements in a desired alignment
JP2006515780A (ja) 人工髄核およびその注入方法
WO2006047356A1 (fr) Annulotomie: dispositifs et methodes d'acces et de fermeture

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BW BY BZ CA CH CN CO CR CU CZ DK DM DZ EC EE EG ES FI GB GD GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV LY MD MG MK MN MW MX MZ NA NG NO NZ OM PG PH PL PT RO RU SC SD SG SK SL SM SY TJ TM TN TR TT TZ UG US UZ VC VN YU ZA ZM

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GM KE LS MW MZ NA SD SZ TZ UG ZM ZW AM AZ BY KG MD RU TJ TM AT BE BG CH CY DE DK EE ES FI FR GB GR HU IE IS IT LU LV MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 05816171

Country of ref document: EP

Kind code of ref document: A1