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WO2002034113A2 - Procedes et instruments destines au traitement de pseudarthrose - Google Patents

Procedes et instruments destines au traitement de pseudarthrose Download PDF

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Publication number
WO2002034113A2
WO2002034113A2 PCT/US2001/045479 US0145479W WO0234113A2 WO 2002034113 A2 WO2002034113 A2 WO 2002034113A2 US 0145479 W US0145479 W US 0145479W WO 0234113 A2 WO0234113 A2 WO 0234113A2
Authority
WO
WIPO (PCT)
Prior art keywords
bone
mass
elongated member
pseudoarthrotic
drill
Prior art date
Application number
PCT/US2001/045479
Other languages
English (en)
Other versions
WO2002034113A3 (fr
Inventor
William F. Mckay
Original Assignee
Sdgi Holdings, Inc.
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 Sdgi Holdings, Inc. filed Critical Sdgi Holdings, Inc.
Priority to CA002426402A priority Critical patent/CA2426402A1/fr
Priority to JP2002537173A priority patent/JP2004512078A/ja
Priority to EP01988541A priority patent/EP1335771A4/fr
Priority to US10/399,836 priority patent/US8002775B2/en
Priority to AU2002220069A priority patent/AU2002220069B2/en
Priority to AU2006902A priority patent/AU2006902A/xx
Publication of WO2002034113A2 publication Critical patent/WO2002034113A2/fr
Publication of WO2002034113A3 publication Critical patent/WO2002034113A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
    • 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
    • A61F2/4601—Special tools for implanting artificial joints for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • 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
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30224—Three-dimensional shapes cylindrical
    • A61F2002/30235—Three-dimensional shapes cylindrical tubular, e.g. sleeves
    • 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
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • 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
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/64—Animal cells

Definitions

  • the present invention relates generally to methods and instruments for treating pseudoarthrosis.
  • Back pain affects millions of individuals and is a common cause of disability for the middle-aged worfang population.
  • a frequent cause of back pain is rupture or degeneration of intervertebral discs.
  • the only relief from the symptoms of these conditions is a discectomy, or surgical removal of all or a portion of an intervertebral disc.
  • the disc space height must be maintained or restored.
  • One solution to the stabilization of an excised disc space is to fuse the adjacent vertebrae between their respective endplates.
  • a spacer or implant is inserted into the treated or prepared disc space until complete arthrodesis is achieved.
  • the spacer/implant must provide temporary support and allow bone ingrowth. Success of the discectomy and fusion procedure requires development of a contiguous growth of bone or an osseous bridge to create a solid mass between the vertebrae to withstand the compressive loads on the spine for the life of the patient.
  • pseudoarthrosis also known as pseudarthrosis, or failure of a spinal fusion
  • the incidence of pseudoarthrosis has been reported as high as 40% for smokers, as well as for patients having multilevel fusions and unrecognized metabolic disease.
  • Pseudoarthrosis has been shown to be the contributing cause of symptoms in 78% of symptomatic patients requiring reoperation, with each reparative procedure decreasing the probability of success.
  • a conventional, open surgical procedure includes direct exposure of the fusion mass, decortication, bone regrafting and possibly reinstrumentation or addition of new graft and/or new instrumentation.
  • the repair procedure can be very complex, is highly invasive and additional posterior fusion procedures may need to be performed to stabilize the spine after a fusion has failed. Thus, simpler, less invasive methods for treating spinal pseudoarthrosis are needed.
  • an osteoinductive composition to a location of pseudoarthrosis, such as spinal pseudoarthrosis, is effective in promoting bone growth for treating the pseudoarthrosis.
  • a method in one form of the invention, includes delivering to a location of pseudoarthrosis an effective amount of an osteoinductive composition.
  • an osteoinductive composition Preferably the osteoinductive composition is combined with an acceptable carrier, such as a calcium phosphate-containing carrier.
  • the osteoinductive composition is effective in promoting bone growth for treating the spinal pseudoarthrosis.
  • the method includes advancing a first elongated member to a location of spinal pseudoarthrosis in a patient.
  • the first elongated member has a proximal end, a distal end and a lumen extending longitudinally therethrough.
  • the method further includes advancing the osteoinductive composition described herein through the lumen of the first elongated member.
  • the osteoinductive composition is advanced through the lumen of the elongated member to a pseudoarthrotic mass into and extending across the pesudoarthrotic mass.
  • the methods described herein may be accomplished with or without decortication and, in the case of a failed interbody fusion, without removal of the implant. Further the methods can use minimally invasive surgical procedures that can significantly reduce morbidity associated with surgery, reduce the duration of a hospital stay and reduce patient recovery times.
  • surgical instruments are provided.
  • a cannulated drill is provided that includes an elongated member having a proximal end, a distal end, an inner surface, and an outer surface.
  • the inner surface defines a lumen that extends along the length of the elongated member and is sized to receive an elongated obturator
  • the distal end of the elongated member has at least one bone cutting edge.
  • the proximal end of the elongated member has a connector configured for matingly engaging a distal end of a syringe to the proximal end of the elongated member.
  • the elongated member is preferably formed of a biocompatible material.
  • Surgical instrument assemblies including at least the cannulated drill described herein and a syringe.
  • the syringe has a housing that defines a cavity and has a proximal end and a distal end. The distal end of the syringe is matingly engageable to the proximal end of the elongated member.
  • the lumen of the elongated member and the cavity of the housing are in fluid communication when the distal end of the syringe and the proximal end of the elongated member are matingly engaged.
  • FIG. 1 is a side elevation view of one embodiment of a drill provided according to the present invention.
  • FIG. 2 is a first end view of the drill of FIG. 1
  • FIG. 3 is a side elevation of an alternative embodiment of a drill having a plurality of apertures extending along a length of the drill for use in the present invention.
  • FIG. 4 is a side elevation view of an elongated obturator for use in a drill according to the present invention.
  • FIG. 5 is a first end view of the obturator of FIG. 4.
  • FIG. 6A is a side elevation view partially broken away of an obturator/drill assembly according to the present invention.
  • FIG. 6JB is a first end view of the obturator/drill assembly of FIG. 6.
  • FIG. 7 is a side elevation view of an alternative embodiment of a drill for use in the present invention.
  • FIG. 8A is an exploded view of a syringe-drill assembly provided according to the present invention.
  • FIG. 8B is a side elevation view of the syringe-drill assembly of FIG. 8A.
  • FIG. 8C is an exploded view of an alternative embodiment of a syringe-drill assembly provided according to the present invention.
  • FIG. 9 is a side elevation view an elongated delivery member having apertures extending along a length of the member provided according to the present invention.
  • FIG. 10A is a side elevation view of a pair of vertebrae depicting pseudoarthrosis at an intertransverse process fusion site.
  • FIG. 1 OB is a side elevation view of the pseudoarthrosis of the pair of vertebrae of FIG. 10A with a guide wire inserted into a pseudoarthrotic mass.
  • FIG. 1 1 is an enlarged view of the pseudoarthrosis site of FIG. 10A illustrating a cannula positioned adjacent the treatment site.
  • FIG. 12 is a side elevation view of the pseudoarthrotic mass of FIG. 1 1 depicting a cannulated drill having an obturator disposed in its lumen.
  • FIG. 13 is a side elevation view of FIG. 12 depicting a drill in a bored hole in the pseudoarthrotic mass.
  • FIG. 14 is a side elevation view of the pseudoarthrotic mass of FIG. 13 depicting the drill without the obturator.
  • FIG. 15 is a side elevation view of the pseudoarthrotic mass of FIG. 14 depicting a syringe connected to the drill according to the present invention.
  • FIG. 16 is a side elevation view of the pseudoarthrotic site of FIG. 15 partially broken away and depicting delivery of an osteoinductive composition into a bored hole in the pseudoarthrotic mass according to the present invention.
  • FIG. 17 is a side elevation view of the pseudoarthrotic mass of FIG. 11 depicting a plurality of holes bored into the mass according to one embodiment of the present invention.
  • FIG. 18 is a side elevation view in partial section illustrating a fusion cage between a pair of vertebrae wherein a drill is positioned in a pseudoarthrotic mass located within a fusion cage according to another embodiment of the present invention.
  • FIG. 19 is a cross-section view taken along line 19 ⁇ 19 of FIG. 18, illustrating a intervertebral implant, between adjacent vertebrae depicting a plurality of bore holes drilled in the pseudoarthrotic mass inside the implant chamber, as well as in the superior vertebral bodies, adjacent to the implant.
  • Pseudoarthrosis also known as pseudarthrosis, refers to a condition that arises due to an incomplete bone fusion process. With respect to spinal pseudoarthrosis, this includes failure of adjacent vertebrae to fuse or the presence of some other bone discontinuity in the fusion mass.
  • embodiments of methods include delivering to a location of spinal pseudoarthrosis an effective amount of an osteoinductive composition.
  • the composition advantageously includes an osteoinductive factor, such as in a pharmaceutically acceptable carrier.
  • the osteoinductive composition is effective in promoting bone growth to treat the spinal pseudoarthrosis.
  • a surgical instrument in one form, includes a cannulated drill including an elongated member formed of a biocompatible material and having a proximal end, a distal end, an inner surface, and an outer surface.
  • the inner surface defines a lumen that extends along the length of the elongated member and is sized to receive an elongated obturator.
  • the distal end of the elongated member has at least one bone cutting edge.
  • the proximal end of the elongated member has, or otherwise defines, a connector configured to matingly engage a distal end of a syringe.
  • Embodiments of surgical instrument assemblies are also provided that include the drill described herein and a syringe.
  • the surgical assemblies can include a cannulated drill and obturator for sliding engagement within an interior region of the cannulated drill.
  • One or more of the surgical assemblies can be provided for delivery of a flowable or injectible osteoinductive composition into a desired treatment site.
  • kits for treating pseudoarthrosis that include a combination of the surgical instruments and/or instrument assemblies described herein are also provided.
  • a surgical instrument includes an elongated channel-forming and delivery member such as a drill 10 as seen in FIGS. 1 and 2.
  • Drill 10 comprises an elongated member 20 having a proximal end 21, a distal end 22, an exterior surface 23 and an inner surface 24.
  • Distal end 22 has at least one bone cutting edge 26, and preferably about two to about four cutting edges for cutting bone.
  • the drill may include any device capable of forming a passageway or channel in or adjacent to the site of pseudoarthrosis, such as a piercing device, milling device, etc.
  • Inner surface 24 defines a lumen 25 extending along the length of elongated member 20, typically from proximal end 21 to distal end 22.
  • Lumen 25 is illustrated as a cylindrical channel having a first opening 11 adjacent to proximal end 21, and a second opening 12 proximate to distal end 22 permitting access through the interior of drill 10.
  • lumen 25 of elongated member 20 is sized to receive an obturator (not shown).
  • lumen 25 is sized to receive a guide wire, such as, a K-wire.
  • the guide wire can be selected to be any desired diameter and/or length.
  • the guide wire can be inserted into a treatment site to facilitate desired placement of drill 10 during treatment.
  • Proximal end 21 of elongated member 20 is advantageously configured for mating with a syringe.
  • Proximal end 21 of elongated member 20 may therefore include, or otherwise define, a connector 27 that matingly engages the distal end of a syringe to proximal end 21 of elongated member 20.
  • the connector may be formed integral with the elongated member or may be separately connected thereto, such as by use of press-fit threaded connectors, adhesives and any other securing methods or combinations thereof.
  • a wide variety of connectors may be utilized, including luer-lock connectors, Moorse taper connectors and snap-lock connectors.
  • FIG. 3 illustrates an alternative embodiment of a drill 10' for use in the present invention.
  • Drill 10' is formed similar to drill 10 and like reference numbers with a prime are used to denote like elements.
  • Drill 10' includes a plurality of apertures 28 extending through exterior surface 23' to inner surface 24'.
  • apertures 28 are provided in a desired size, number and location along a length of the drill 10'.
  • the apertures are sized and located to effectively deposit an osteoinductive material across a pseudoarthrotic region of the spine with minimal or no repositioning of the drill.
  • a plurality of apertures 28 are located proximate to distal end 22'.
  • Inner surface 44 defines a lumen 45 that extends along the length of elongated member 40, typically from proximal end 41 to distal end 42.
  • Obturator 30 may be advantageously designed and configured to conform to inner surface 24 of elongated member 20 of drills 10 and/or 10' and/or be slidably received within lumen 25 and/or 25'.
  • obturator 30 may be variously shaped, in one form of the invention obturator 30 is cylindrical.
  • obturator 30 is slidably disposed in lumen 20 of drill 10 to provide assembly 35 as best seen in FIG. 6A and FIG. 6B.
  • Obturator 30 can be sized and configured to inhibit material from entering the lumen of the drill during the drilling process.
  • yet other drills may be utilized. Referring to FIG. 7, a drill 10" is shown. Drill 10" is formed similar to drill 10 and like reference numbers with a double prime are used to denote like elements. Drill 10" advantageously may have a built-in depth gauge 29. Depth gauge 29 can be movably secured to a portion of surface 23" that limits the drilling depth of drill 10". Depth gauge 29 may be positionable during surgery.
  • the surgeon can determine a desired depth to bore into a bone or pseudoarthrotic site using x-ray, Computer Tomography (CT), fluoroscopy or other techniques. The surgeon can then measure a distance from distal end 26" toward proximal end 21 " equal to the desired bore depth.
  • CT Computer Tomography
  • Depth gauge 29 can be secured in the desired position using a set screw, or other locking mechanism.
  • the drills and obturators described herein may be formed of biocompatible materials.
  • the drill and obturator may be formed from metallic materials, including stainless steel, titanium, and alloys thereof.
  • Other suitable materials include nitinol, or other shape memory materials.
  • a surgical instrument assembly 50 includes drill 10 and syringe 60. While drill 10 is illustrated it is understood that any of drills 10, 10' and/or 10" can be included in the assembly.
  • Syringe 60 may be any device capable of delivering an osteoinductive composition.
  • syringe 60 includes a barrel, or housing, 61 having a proximal end 62 and a distal end 63. Housing 61 defines a cavity, or chamber, 64 for retaining a composition to be delivered.
  • Plunger 66 having a plunger head 67 is disposed in cavity 64 of syringe 60.
  • Distal end 63 defines a connector portion 68, such as a luer-lock connector provided to relesably engage connector 27 of drill 10. 1 1
  • syringe 60 is matingly engaged to proximal end 21 of drill 10.
  • chamber 64 of syringe 60 is in fluid communication with lumen 25 of drill 10 to form surgical instrument assembly 50.
  • Syringe 60 may be formed of a material that does not react with osteoinductive compositions, such as polymeric materials, including metal, glass, and synthetic polymers, such as polyalkenes, including polyethylene, polypropylene, poly(vinyl chloride), and polystryrene.
  • FIG. 8C an alternative surgical instrument assembly is shown that includes drill 10 and syringe 60'.
  • any of drills 10, 10' and 10" can be combined with syringe 60'.
  • Syringe 60' is formed similar to syringe 60, and thus like reference numbers denote similar components but are denoted with a prime.
  • Plunger 66' includes one or more threads 68 extending along a length of plunger shaft 69. Threads 68 can facilitate incremental adjustment of plunger 66 in chamber 64, and, consequently, facilitate withdrawing or expulsion of material into or out of chamber 64.
  • an elongated delivery member 70 fluidly connectable with an osteoinductive material delivery device includes an elongated member 71 having a proximal end 72, a distal end 73, an outer surface 74 and an inner surface 75.
  • Inner surface 75 defines a lumen 76 extending along the length of elongated member 71, typically from proximal end 72 to distal end 73.
  • distal end 73 can be closed.
  • distal end 73 can include one or more openings extending therethrough providing communication with lumen 76.
  • elongated member 71 may have a plurality of apertures, or other openings or perforations, 78 extending through outer surface 74 anywhere along a length of elongated member 71 , such as adjacent to distal end 73.
  • Proximal end 72 may have a connector 77 for matingly engaging a syringe and may be similar to the connectors 27 described above for the drill 10.
  • the invention provides methods for treating pseudoarthrosis. The methods may be minimally invasive. For example, an

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Neurosurgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne des procédés, des instruments et des nécessaires de traitement de pseudarthrose vertébrale. Dans une réalisation, un procédé consiste à administrer à un emplacement de pseudarthrose vertébrale une quantité efficace d'une composition ostéo-inductrice comprenant une composition ostéo-inductrice sur un support acceptable sur le plan pharmaceutique. Dans d'autres réalisations, des forets à canule (10, 10', 10'') et des assemblages d'instruments chirurgicaux (50, 50') comprennent un foret et une seringue (60) et (60') dans lesquels la seringue possède une extrémité distale qui est engagée en conjonction avec une extrémité proximale du foret. Le foret et d'autres instruments, assemblages d'instruments, et des nécessaires qui en sont formés peuvent avantageusement être utilisés dans un procédé de traitement de pseudarthrose.
PCT/US2001/045479 2000-10-24 2001-10-24 Procedes et instruments destines au traitement de pseudarthrose WO2002034113A2 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
CA002426402A CA2426402A1 (fr) 2000-10-24 2001-10-24 Procedes et instruments destines au traitement de pseudarthrose
JP2002537173A JP2004512078A (ja) 2000-10-24 2001-10-24 偽関節症を治療する方法及び器具
EP01988541A EP1335771A4 (fr) 2000-10-24 2001-10-24 Procedes et instruments destines au traitement de pseudarthrose
US10/399,836 US8002775B2 (en) 2001-10-24 2001-10-24 Methods and instruments for treating pseudoarthrosis
AU2002220069A AU2002220069B2 (en) 2000-10-24 2001-10-24 Methods and instruments for treating pseudoarthrosis
AU2006902A AU2006902A (en) 2000-10-24 2001-10-24 Methods and instruments for treating pseudoarthrosis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US24295000P 2000-10-24 2000-10-24
US60/242,950 2000-10-24

Publications (2)

Publication Number Publication Date
WO2002034113A2 true WO2002034113A2 (fr) 2002-05-02
WO2002034113A3 WO2002034113A3 (fr) 2002-10-24

Family

ID=22916758

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/045479 WO2002034113A2 (fr) 2000-10-24 2001-10-24 Procedes et instruments destines au traitement de pseudarthrose

Country Status (5)

Country Link
EP (1) EP1335771A4 (fr)
JP (1) JP2004512078A (fr)
AU (2) AU2002220069B2 (fr)
CA (1) CA2426402A1 (fr)
WO (1) WO2002034113A2 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1501357A2 (fr) * 2002-05-06 2005-02-02 Genentech, Inc. Utilisation de vegf pour traiter des defauts osseux
FR2860422A1 (fr) * 2003-10-02 2005-04-08 Emmanuel Berque Dispositif d'application de substances adherentes biocompatible a clapet interne
WO2006102417A3 (fr) * 2005-03-22 2008-06-05 Warsaw Orthopedic Inc Mecanismes d'osteoinduction a l'aide d'une proteine de mineralisation lim-1 (lmp-1)
WO2010040076A3 (fr) * 2008-10-02 2010-06-17 Trans1, Inc. Procédé et appareil destinés à l’insertion de greffe osseuse
US7850656B2 (en) 2005-04-29 2010-12-14 Warsaw Orthopedic, Inc. Devices and methods for delivering medical agents
US8002775B2 (en) 2001-10-24 2011-08-23 Warsaw Orthopedic, Inc. Methods and instruments for treating pseudoarthrosis
US8083722B2 (en) 2005-04-29 2011-12-27 Warsaw Orthopedic, Inc Instrumentation for injection of therapeutic fluid into joints
US8690874B2 (en) 2000-12-22 2014-04-08 Zimmer Orthobiologics, Inc. Composition and process for bone growth and repair
CN113631110A (zh) * 2019-03-19 2021-11-09 Mt奥塞有限责任公司 用于椎体成形术的由生物相容性金属材料制成的颗粒

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WO2011111301A1 (fr) * 2010-03-09 2011-09-15 国立大学法人神戸大学 Implant d'apophyse inter-épineux

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8690874B2 (en) 2000-12-22 2014-04-08 Zimmer Orthobiologics, Inc. Composition and process for bone growth and repair
US8002775B2 (en) 2001-10-24 2011-08-23 Warsaw Orthopedic, Inc. Methods and instruments for treating pseudoarthrosis
EP1501357A2 (fr) * 2002-05-06 2005-02-02 Genentech, Inc. Utilisation de vegf pour traiter des defauts osseux
EP1501357A4 (fr) * 2002-05-06 2009-10-21 Genentech Inc Utilisation de vegf pour traiter des defauts osseux
FR2860422A1 (fr) * 2003-10-02 2005-04-08 Emmanuel Berque Dispositif d'application de substances adherentes biocompatible a clapet interne
WO2006102417A3 (fr) * 2005-03-22 2008-06-05 Warsaw Orthopedic Inc Mecanismes d'osteoinduction a l'aide d'une proteine de mineralisation lim-1 (lmp-1)
US7850656B2 (en) 2005-04-29 2010-12-14 Warsaw Orthopedic, Inc. Devices and methods for delivering medical agents
US8012139B2 (en) 2005-04-29 2011-09-06 Warsaw Orthopedic, Inc. Devices and methods for delivering medical agents
US8083722B2 (en) 2005-04-29 2011-12-27 Warsaw Orthopedic, Inc Instrumentation for injection of therapeutic fluid into joints
WO2010040076A3 (fr) * 2008-10-02 2010-06-17 Trans1, Inc. Procédé et appareil destinés à l’insertion de greffe osseuse
CN113631110A (zh) * 2019-03-19 2021-11-09 Mt奥塞有限责任公司 用于椎体成形术的由生物相容性金属材料制成的颗粒

Also Published As

Publication number Publication date
EP1335771A4 (fr) 2006-06-07
EP1335771A2 (fr) 2003-08-20
AU2002220069B2 (en) 2005-12-15
AU2006902A (en) 2002-05-06
CA2426402A1 (fr) 2002-05-02
WO2002034113A3 (fr) 2002-10-24
JP2004512078A (ja) 2004-04-22

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